re: docket no. fda- distinct from other devices; proposed list of … · 2018-10-16 · docket no....

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Bringing innovation to patient care worldwide

October 16, 2018

Division of Dockets Management (HFA-305)

Food and Drug Administration

5630 Fishers Lane, Room 1061

Rockville, MD 20852

Re: Docket No. FDA- FDA-2018-N-3066: Medical Devices; Classification of Accessories

Distinct From Other Devices; Proposed List of Accessories Suitable for Class I; Request

for Comments

To Whom It May Concern:

The Advanced Medical Technology Association (“AdvaMed”) appreciates the opportunity to

provide comment on the Food and Drug Administration’s (“FDA” or “Agency”) Request for

Comments, Medical Devices; Classification of Accessories Distinct From Other Devices;

Proposed List of Accessories Suitable for Class I (“Notice”).1 AdvaMed represents

manufacturers of medical devices, diagnostic products, and health information systems that

are transforming health care through earlier disease detection, less invasive procedures, and

more effective treatment. Our members range from the smallest to the largest medical

technology innovators and companies.

We appreciate FDA’s efforts to reclassify medical device accessories based on the risk of the

accessory when used as intended. While we agree with the down-classification of the

devices and associated product codes (“procodes”) identified in the Notice,2 as described

more fully below we believe there are additional devices currently on the market that the

Agency should down-classify.

Through a 2016 final guidance, the FDA defined a medical device “accessory” as “[a]

finished device that is intended to support, supplement, and/or augment the performance of

one or more parent devices.”3 Thus, medical device accessories can be a simple medical

device, such as a tray that holds instruments next to a LASIK machine, or highly

sophisticated, such as an ultrasound probe. In 2016, Congress enacted Section 3060(c) of the

21st Century Cures Act,4 which requires FDA to classify a device accessory “independent”

of the parent device. While this provision was welcomed by industry and FDA, the Agency

1 Medical Devices; Classification of Accessories Distinct From Other Devices; Proposed List of Accessories

Suitable for Class I; Request for Comments (Aug. 17, 2018), 83 Fed. Reg. 41023.

2 The Notice identifies the following procodes to be reclassified to class I: FCG, JCW, FHW, FAD, FGE, KOB,

EZY, FYD, and LQE.

3 Medical Device Accessories – Describing Accessories and Classification Pathways; Guidance for Industry and

FDA Staff (Dec. 20, 2017) (“Accessory Guidance”).

4 Pub. Law 114-255.

http://www.advamed.org/

Docket No. FDA-2018-N-3066

October 16, 2018

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did not have a procedural mechanism to perform a premarket review of a device accessory

independent of the parent device. As a result, FDA reviewed the device accessory in

conjunction with the 510(k) or PMA submission of the parent device. This process placed

many device accessories into a higher risk classification than is necessary or appropriate for

their safe and effective use, regardless of the accessory’s underlying procode. For example, a

plastic tray that is an accessory to a class III LASIK machine would also be subject to class

III manufacturing and postmarket surveillance requirements. However, the same tray sold on

its own would be subject to class I requirements.

To remedy this issue, the FDA Reauthorization Act of 2017 (“FDARA”)5 provides a

mechanism for FDA to re-classify this cohort of device accessories through a Federal

Register Notice. Specifically, section 513(6)(D) of the Federal Food, Drug and Cosmetic Act

(“Act”), as amended by FDARA, provides that if an accessory currently has, or in the past

had, a stand-alone procode and FDA subsequently classified the accessory with a higher risk-

classification due to a parent device’s 510(k) or PMA submission, the accessory’s

classification should revert to its original stand-alone classification. Congress’ rationale is

simple: The initial risk-based classification should be restored because the accessory,

pursuant to the 21st Century Cures Act and FDARA, must be classified independent of the

parent device.

Consistent with the intent of FDARA, we believe accessories currently on the market that

fall within the procodes identified in the attached document should be administratively

down-classified to class I through this Notice. While these procodes may fall within class

I, many device accessories that fall within these procodes are currently on the market and

were “up-classified” solely due to the risk level of their parent device. Action by FDA is

required for these accessories to become subject to class I controls. It is not the procode that

requires re-classification; rather, device accessories that fall within these procodes and that

are currently on the market were unnecessarily “up-classified” through FDA’s previous

review practices. Through the Notice, FDA can appropriately re-classify these accessories as

class I, consistent with their procode and related regulation.

Policy Clarification for Classification of Certain Accessories Used in Orthopedic

Surgery

We appreciate FDA’s attempt to rectify the issue many orthopedic instruments face due to

their status as an accessory through this new “Policy Clarification.” However, we do not

believe this Policy Clarification is necessary or consistent with law.

FDARA makes no distinction between a “device-specific” accessory or a “general use”

accessory. Instead, FDARA clearly states that an accessory shall be classified “based on the

risks of the accessory when used as intended and the level of regulatory controls necessary to

provide a reasonable assurance of safety and effectiveness of the accessory, notwithstanding

the classification of any other device with which such accessory is intended to be used.” The

automatic assignment of device-specific instruments for class III implants into class III, as an

5 Pub. Law 115-52.


October 16, 2018

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example, is inconsistent with the risk-based approach mandated by the 21st Century Cures

Act and FDARA. We therefore disagree with the use of this Policy Clarification to

implement the accessory provisions of FDARA.

Within the orthopedics industry, many instruments fall under one of two groups of product

classifications: manual surgical instrument for general use, 21 C.F.R. § 878.4800, or

orthopedic manual surgical instrument, 21 C.F.R. § 888.4540. Both regulations provide that

the instruments defined within them are class I exempt medical devices, exempt from both

pre-market notification or approval and design control. Typically, these instruments include

screw drivers, awls, retractors, and other tools used to facilitate surgical procedures and

device implantation. In the Notice, FDA argues that “certain device-specific instruments are

accessories and require precise technical specifications or design characteristics to function

as intended to support, supplement or augment the parent device and if they are not designed

appropriately could cause implant malpositioning or migration.” As a result, the Notice

states these accessories are ineligible for reclassification in class I. However, it is unclear

why the majority of the devices listed in 21 C.F.R. § 878.4800 and 21 C.F.R. § 888.4540,

which are class I and subject to general controls, do not also require precise technical

specifications or design characteristics in their manufacture in order to function as intended.

Moreover, instruments included in instrument sets provided with implants are not accessories

to the device per se but are often provided solely for the convenience of the surgeon to

facilitate processing through central services and to improve patient safety by ensuring the

surgeon has immediate access to all instruments that facilitate timely completion of the

surgery. In some cases, the instruments will be more specially associated with a device, such

as sizing templates, trials, and specialized inserters. These instruments can also have

separate classifications outside of 21 C.F.R. § 878.4800 and 21 C.F.R. § 888.4540. In these

instances, the regulation provides for the accessory’s unique classification (e.g., 21 C.F.R. §

872.4120 regulates bone drills).

Although an instrument may be designed for use with a specific device or system (and

therefore considered “device-specific”), it may still be a low risk, Class I accessory based on

its design, intended use and the level of controls necessary to mitigate potential risks. For

example, some instruments may be designed for use with a specific implant system but may

be optionally used by the surgeon as part of the surgical procedure, therefore introducing a

different risk profile than an instrument that is intended to be used as an integral part of the

procedure. Other instruments may likewise carry lower risks, such as an introducer that is

used to hold and position a device before implantation. While design controls may be

necessary to provide a reasonable assurance of the safety and effectiveness of some

orthopedic instruments, this determination should be risk-based and not based solely on

whether the instrument is considered a “general use” or “device-specific” instrument.

We believe FDA should continue its longstanding practice and treat all manual surgical

instruments provided with Class II or Class III orthopedic implant systems as Class I

(510(k)/PMA exempt) devices, in accordance with their current classification designation

(i.e., manual surgical instrument for general use, 21 C.F.R. § 878.4800, or orthopedic manual

surgical instrument, 21 C.F.R. § 888.4540). If not, and consistent with Section 513(6)(D)(iii)


October 16, 2018

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of the Act, FDA should provide a detailed description and justification for each device type

that explains the Agency’s rationale. The general rationale provided in the Notice is not

applicable to many of the devices listed in the attached document.

Alternatively, FDA should publish new classifications (with associated procode

description(s)) for those instruments the Agency believes carry a higher risk and, therefore,

should be classified as Class II or III. This process would establish a more consistent and

transparent approach to the classification of manual surgical orthopedic instruments and

would allow higher risk instruments to be clearly defined and differentiated from those

whose risk and classification is consistent with a Class I designation. This would also ensure

greater clarity of UDI compliance requirements for instruments that are assigned a higher

classification based on their risk.

Lastly, we appreciate the Agency’s desire to review the classification of device-specific

instruments under 513(f)(6)(D)(ii) of the Act. Given the vast number of instrument types, it

would be helpful for FDA to provide guidance that is specific to the classification of

orthopedic instrument accessories. This guidance should include considerations for

reclassification of instruments that have been previously classified through a premarket

submission based on their association with a particular implant system and should outline the

specific information that FDA would expect to see in the requests for instrument

reclassification, preferably in a standardized submission format.

Additions to Table I

Below we offer several edits to Table I of the Notice, titled “Proposed Accessories for

Classification into Class I and Distinct from Other Devices:”

Penile implant surgical accessories

(JCW, FAE and FHW)

Manual devices designed to be used for surgical procedures

associated with the implantation of a penile inflatable implant or

penile rigidity implant. This generic type of device includes the

cylinder sizer, cylinder insertion tool and needle, device

placement tool, connector assembly tool, incision closing tool,

corporeal dilator, tubing passer, measurement tool or tape,

temporary tubing plug, blunt needles, and hemostat shod tubing.

Implanted mechanical/hydraulic

urinary continence

device surgical

accessories (EZY)

Manual devices designed to be used for surgical procedures

associated with the implantation of an implanted

mechanical/hydraulic urinary continence device. This generic

type of device includes the measurement tool or tape, connector

assembly tool, temporary tubing plug, incision closing tool,

tubing passer, blunt needles, and hemostat shod tubing.

* * *

AdvaMed would like to thank the FDA for its consideration of these comments. Please do

not hesitate to contact me at 202-434-7224 or [email protected] if you have any

questions.


October 16, 2018

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Respectfully submitted,

/s/

Zachary A. Rothstein, Esq.

Vice President

Technology and Regulatory Affairs

Attachment

AdvaMed Comments

Docket No. FDA- FDA-2018-N-3066: Medical Devices; Classification of Accessories Distinct From Other Devices; Proposed List of

Accessories Suitable for Class I; Request for Comments

Accessories That Should Be Reclassified to Class I

Device Procode Regulation Brief Description of

Accessory Rationale for the Reclassification of the Device to Class I

DWE 870.4390 Cardiopulmonary bypass

pump tubing

These common accessory devices are used with a blood pump (roller

and centrifugal) to facilitate the movement of blood during bypass.

From a risk perspective, these are tools to aid with connecting other

devices to complete the extracorporeal blood circuit and may be

supplied with multiple other devices.

FEG 876.5980 Wire guide

Guiding catheter (introducer)

These common accessory devices are often bundled together as a kit to

facilitate the initial placement of a colon decompression tube. Unlike

the colon decompression tube, these simple accessories have limited

patient contact.

FMK 878.4800 Lancets This device is specifically identified within the regulation definition.

FZO 878.4800 Chisel This device is specifically identified within the regulation definition.

FZX 878.4800

Cut Guide

Stabilization Pin

Pin Guide

Jig

Drill Guide

Instrument guide is specifically identified within the regulation

definition and product code. From a risk perspective, these are tools to

aid with the implant and may be supplied with a device, but can be

used with multiple devices.


October 16, 2018

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NeoReamer Depth Stop Half

Wedge

FZY 878.4800 Hammer

This device is specifically identified within the regulation definition.

From a risk perspective, these are tools to aid with the implant and may

be supplied with a device, but can be used with multiple devices.

GAB 878.4800 Needles

Specifically identified by product code name and regulation. From a

risk perspective, these are tools to aid with the implant and may be

supplied with a device, but can be used with multiple devices.

GAD 878.4800 Retractors

Specifically identified by product code name and within regulation.



GDJ 878.4800 Clamp




GEI 878.4400 Adapters

These common accessory devices simply provide an interface between

active accessory components but are not considered an active accessory

themselves in the relevant FDA Guidance documents. Unlike active

accessories which could impact the parent device performance (e.g.

cord length on 60601-1-2 testing), adapters do not have an impact on

the parent device performance and are not complex by nature.

GEI 878.4400 Gas regulator

Gas cylinder

Gas regulators and cylinders under procode GEI are similar to, and

have similar or less risks as, gas regulators and cylinders under procode

CAN (21 CFR 868.2700), which are Class I and 510(k) Exempt.

GFA 878.4820 Saw and blades Specifically identified within the regulation definition and product

code name. From a risk perspective, these are tools to aid with the

implant and may be supplied with a device, but can be used with


October 16, 2018

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multiple devices.

GFC 878.4820 Surgical pin driver This device is specifically identified within the regulation definition.

GFG 878.4820 Screw driver bit




GFJ 878.4800 Mallet This device is specifically identified within the regulation definition.

HBL 882.4460 Neurosurgical head holder

(skull clamp)

This HBL product code is readily compared to (or described) within

the existing Class I HAO (882.4535) Neurosurgical device code, i.e.,

non-powered neurosurgical device.

HRX 888.1100 Arthroscope

Sheath is inserted into the body just like a cannula. A scope can enter

the body through the sheath (in a similar way as other instruments enter

body through a cannula).

Sheaths are similar in function to cannulas. Under 21 CFR 888.1100

(HRX Class II Arthroscope), Cannulas are listed as Class I Exempt

devices. Sheaths should be part of that list as well.

HTD 878.4800

Cleaning Rod

Forceps

Grasper



HTE 878.4800 Elevator

Specifically identified by product code name and within regulation.



HTF 878.4800 Scraper




HTJ 888.4300 Depth Gauge This device is specifically identified within the regulation definition for


October 16, 2018

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this use. From a risk perspective, these are tools to aid with the


multiple devices.

HTO 888.4540 Reamer

This device is specifically identified by product code within the

regulation definition. It can be used across various orthopedic

procedures. From a risk perspective, these are tools to aid with the


multiple devices.

HTY 888.3040

Insertion/Placement

Accessories to implantable

orthopedic pins:

Arc attachment – affixes to

the guide block/guide frame.

Used in combination with

bone gauge pin (provided

with implant kit) to determine

available bone stock.

Guide block – contains a

screw (for tightening) that

allows the arc to move freely

along the guide frame for the

purpose of adjusting desired

cross pin angle

Guide frame – capable of

being adjusted for desired

angle of femoral cross pin

implantation

Femoral rod – affixes to the

guide frame. Aids in the

placement of the cross pins.

These are manual, reusable, orthopedic surgical devices that have been

historically (mentioned in past 510(k) submissions) accepted by FDA

as Class I devices under Procode LXH (21 CFR 888.4540).

These reusable instruments were up-classified to class II as they are

designed to be used with orthopedic pins implants (Class II) and

therefore become part of a system (Class II).


October 16, 2018

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HTQ 888.4540 Broach

This device is specifically identified within the regulation definition. It

can be used across various orthopedic procedures. From a risk

perspective, these are tools to aid with the implant and may be supplied

with a device, but can be used with multiple devices.

HTR 878.4800 Rasp

Specifically identified by product code name and within the regulation.



HTW 888.4540 Bit, Drill

This device is specifically identified within the product code and




multiple devices.

HTZ 878.4800 Planer

Cutter

This device is implied within the within the regulation definition. It

can be used across various orthopedic procedures.

HWA 888.4540 Impactor / Impactor Tip





HWB 888.4540 Extractor


can be used across various orthopedic procedures. Implied as it is

similar to impactor and bone tap that are specifically identified within

the regulation. From a risk perspective, these are tools to aid with the


multiple devices.

HWE 878.4820

Reamer

Drill

Drill Bit

Specifically identified within the regulation definition and product

code name. From a risk perspective, these are tools to aid with the


multiple devices.


October 16, 2018

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Slides, Shafts, burrs

HWJ 888.4540 Awl / accessories





multiple devices.

HWK 888.454

Trephine

These are generic types of instruments that fall within the regulation

definitions, in most cases specifically called out by the regulation.



HWM 878.4800 Osteotome




HWN 888.4540 Compressor





multiple devices.

HWQ 888.4540 Suture Passer





HWT 888.4800 Sizing spools, trials

These are devices that are clearly defined by regulation as Class I

devices. They are intended to help select and / or position the chosen

implant. From a risk perspective, these devices are the first step in

selecting and positioning an implant. After using these instruments,

the surgeon continues to "fit" the device by removing and shaping bone

and positioning the implant. While these instruments make the implant


October 16, 2018

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simpler, they are not required for the implant.

HWX 888.4540

Screw Tap

Punches

Taps





HXB 888.4540 Probe





multiple devices.

HXC 888.4540 Wrench





multiple devices.

HXD 878.4800 Clamp

Specifically identified by product code name. This device is

specifically identified within the regulation definition. From a risk



HXG 888.4540 Tamp





multiple devices.

HXL 878.4800 Mallet

Specifically identified by product code name. From a risk perspective,

these are tools to aid with the implant and may be supplied with a

device, but can be used with multiple devices.


October 16, 2018

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HXO 888.4540 Pusher





multiple devices.

HXP 888.4540 Bending tool





HXW 888.4540 Bender





multiple devices.

HXX 888.4540 Drivers and Screw Driver Bit





IXQ 892.1980 Table, radiographic,

stationary top

Radiologic tables are Class II, 510(k) exempt and are relatively simple

electromechanical technologies that are well established and

understood. They have the same or comparable risk profile as other

components of diagnostic x-ray systems, such as x-ray tube housing

assemblies (21CFR 892.1760) or wall-mounted radiographic cassette

holder (21 CFR 892.1880), which are classified to Class I.

IXR 892.1980 Table, radiographic, tilting







October 16, 2018

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IZS 892.1610 Aperture, radiographic

These devices are Class II, 510(k) exempt and are relatively simple


understood. Diagnostic x-ray beam limiting devices have the same or a

comparable risk profile as other components of diagnostic x-ray

systems, such as x-ray tube housing assemblies (21CFR 892.1760) or

diagnostic x-ray high voltage generators (21 CFR 892.1700), which are

classified in Class I.

IZT 892.1610 Cone, radiographic








IZW 892.1610 Collimator, automatic,

radiographic








IZX 892.1610 Collimator, manual,

radiographic









October 16, 2018

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IZZ 892.1980 Table, radiographic, non-

tilting, powered







JQW 862.2750 Capping and de-capping

accessory

Pipetting and diluting systems are classified as Class I in the

regulation.

KDG 878.4820 Chisel This device is specifically identified within the regulation definition.

KGC 876.5980

Needle

Wire Guide

Dilator

Introducer

These common accessory devices are often bundled together as a kit to

facilitate the initial placement of a feeding tube via gastrostomy.

Unlike the feeding tube, these simple accessories have limited patient

contact.

KIK 878.48 Bone hook




KQW 888.1520 Goniometer This device is specifically identified within the regulation definition.

KPW 892.1610 Device, beam limiting, x-ray,

diagnostic









October 16, 2018

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KXJ 892.1980 Table, radiologic







LRY 878.4800 Punch

Specifically identified by product code name. This device is

specifically identified within the regulation definition. From a risk



LXH 888.4540

Pin holder

Instrument Handles

Restrictor

Revision Tool

These are generic types of instruments that fall within the regulation

definitions, in most cases specifically called out by the regulation.



LZZ 892.2050 Picture archiving and

communications system

Class I General Controls are sufficient to control these devices.

Hospitals and other healthcare facilities will not purchase this

equipment if it is not compliant with existing voluntary standards (e.g.,

Digital Imaging and Communications in Medicine (DICOM)), so that

the product can interact with existing equipment.

MAI 888.3030

Insertion/Placement

Accessories to implantable

orthopedic pins:

Arc attachment – affixes to

the guide block/guide frame.

Used in combination with

bone gauge pin (provided

with implant kit) to determine

These are manual, reusable orthopedic surgical devices, that have been

historically (mentioned in past 510(k) submissions) accepted by FDA

as Class I devices, under Procode LXH (21 CFR 888.4540).

These reusable instruments were up-classified to class II based on them

being designed to be used with orthopedic pins implants (Class II), and

therefore becoming part of a system (Class II).


October 16, 2018

Page 12 of 14



available bone stock.

Guide block – contains a

screw (for tightening) that

allows the arc to move freely

along the guide frame for the

purpose of adjusting desired

cross pin angle.

Guide frame – capable of

being adjusted for desired

angle of femoral cross pin

implantation.

Femoral rod – affixes to the

guide frame. Aids in the

placement of the cross pins.

MQF 884.6110

Obturator

Stylet

Flush Catheter

The accessory devices listed can be used to help facilitate assisted

reproduction procedures but are not directly interacting with

embryos/gametes/zygotes/pre-embryos. For example, a flush catheter

may be used to rinse the cervical passage prior to the actual procedure.

Similarly, the obturator/stylet facilitate placement of a guide catheter

but do not interact with the catheter that delivers the embryo or

gametes.

NDC 868.1890 Apps such as bolus calculator This device is specifically identified within the regulation definition.

ODC 876.1500 Accessory Irrigation Adapter

The Accessory Irrigation Adapter can be used to facilitate the

introduction of irrigation fluid through the working channel of an

endoscope.

The use of an irrigation adapter is fundamentally the same as the use of

an introduction/drainage catheter regulated under the exempt procode

GBX (878.4200). We propose that accessories like the irrigation

adapter be regulated similarly to the devices that fall under GBX.


October 16, 2018

Page 13 of 14



ACCESSORIES FOR WHICH A PROCODE IS NOT ASSIGNED

N/A N/A Manual Measuring and Sizing

Tools

These accessories are manual measurement devices that augment the

performance of the PMA device by improving the procedure speed in

choosing the appropriate size penile implant or artificial urinary

sphincter diameter size, e.g., plastic tape measure to measure the

urethra’s circumference or the metal rod/ruler utilized to measure the

penis’ length. While these accessories are within the PMA device kits,

their actual use should be considered class I as described in 21 CFR

878.4800. Under that regulation, manual surgical instruments for

general use includes “measuring tape.” Additionally, the corresponding

FDA Product Code “FTY” is “Tape, Measuring, Rulers and Calipers.”

N/A 876.5280

Plastic tape measure to

measure the urethra’s

circumference

This accessory is a manual measurement device that augments the





penis’ length. While the accessory is within the PMA device kit, its

actual use should be considered class I as described in 21 CFR




N/A 876.3350 Penile Inflatable Implant












October 16, 2018

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N/A 876.3630 Penile Rigidity Implant











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