sanarus medical ps-71-0001 rev. e medical product specification title: product specification, visica...

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Sanarus MedicalProduct Specification

Title: Product Specification, Visica II

PS-71-0001 Rev. E

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RevisionRev. ARev. BRev.CRev. DRev. E

ECO#ECO-1316ECO-1403ECO-1695ECO-1762ECO-1839

Date Released12-12-053-20-0612-13-062-23-073-9-07

This Document Contains Tags - Do Not Edit

1. PURPOSE

This document defines the design input for the Sanarus Visica II Treatment System.2. SCOPE

This document applies to the complete Visica II Treatment System including the cart, cryogen, userinterface, and probes.

3. REFERENCES

No. Description Doc Number

[1]

Sanarus Quality Manual QAM-00-0001

[2]

FDA Medical Device Quality System 21 CFR 820

[3]

Electrosurgical cutting and coagulation device and accessories. 21 CFR 878-4400

[4]

Standard Guide for Heated System Surface Conditions That ProduceASTM C1055-03Contact Burn Injuries

[5]

Graphical symbols for use in the labeling of medical devices EN 980:2003

6]

FDA Blue Book Memos - Device Labeling Guidance G91-1 :1991

[7]

Medical Electrical Equipment General Requirements for SafetyIEC 60601-1:2005-

12[8]

General requirements for safety - Collateral standard: Electromagnetic IEC 60601-1-compatibility - Requirements and tests

2:2004-11

[9]

Appliance couplers for household and similar general purposesIEC 60320-1:2001-

06[10]

Biological evaluation of medical devices -- Part 1: Evaluation and testingISO 10993-1 :2003

[11 ]

Symbols to be used with medical device labels, labeling and informationISO 15223:2000/to be supplied

Amd.2:2004(E)

[12]

Standard Practice for Performance Testing of Shipping Containers andASTM D 4169-05Systems

[13]

FDA Blue Book Memo - Use of ISO-1 0993, Biological evaluation ofG95-1:1995medical devices -- Part 1: Evaluation and testing

[14]

Standard Performance and Safety Specification for Cryosurgical MedicalASTM 882-84Instruments.

(2002)

[15]

Sterilization of health care products-Radiation-Part 2: Establishing theANSI/AAMI/ISOdose.

11137 -2:2006

Confidential and Proprietary


Title: Product Specification, Visica IIThis Document Contains Tags - Do Not Edit

4. DEFINITIONS

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Term Definition

Active probe

A probe that is receiving cryogen or electric energy.

Button

User interface feature used to control behavior of equipment by pressingwith a finger or the like. Can be implemented as a mechanical device oras a defined area on a display.Cart

Wheeled enclosure housing removable cryogen reservoir and allelectronic, pneumatic, and user interface components needed to operatethe probe according to the Instructions for UseWarm

Application of electrical energy to warm the probe tip to facilitate removalfrom the ice ball.FA

Fibroadenoma

High freeze

Operating mode characterized by maximum cryogen flow to produce thedesired isotherms as quickly as possible.IFU

Instructions for Use

Low freeze

Operating mode characterized by reduced cryogen flow to maintain iceballsize.Probe

Handheld cryogenic device operated by the cart intended to secure andfreeze the target tissue.System

Combination of cart, cryogen reservoir, and probe.

Thaw

Period of time between High freezes in a single procedure.

Idle

No energy or material flow to the probe.

5. DOCUMENT CONVENTIONS

The first several top level document sections provide background information and qualitativedescriptions. Explicit requirement specifications begin with the section titled Requirements.Requirements are indicated by use ofthe word "shall". Sentences lacking the word "shall" are not tobe construed as requirements.

6. INTENDED USE

The Sanarus Vi sica II Treatment System is intended primarily to treat fibroadenomas (FA) bysubjecting them to controlled exposures to subfreezing temperatures. The system may also beappropriate for cryo assisted localization (CAL) and cancer ablation (CA) procedures. Visica II isintended for use in hospital operating rooms as well as for outpatient procedures performed in doctoroffices.

The 51O(k) Indications for Use will be the same as that ofthe current Visica system.7. PRODUCT DESCRIPTION

The Visica II Treatment System comprises a cart that houses a cryogen, a means to convey thecryogen out to a treatment probe, a control algorithm to manage cryogenic system temperatures andpressures, and a user interface that provides a means for the user to operate the device.

Visica II will incorporate appropriate safety measures to protect the patient, operator, andenvironment from hazards arising from the use, and reasonably foreseeable misuse of the system.




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Visica II will use liquid nitrogen as the cryogen because it is readily available and because its thermalcharacteristics are well suited to this application.

8. REGULATORY CLASSIFICATION

The Sanarus Visica II system is a Class II device per 21 CFR Part 878.4400.

9. REQUIREMENTS

9.1 Compliance to Standards

The Visica II system shall comply with the following standards:

FDA Blue Book memorandum, G95-1, Use ofInternational Standard ISO-10993, BiologicalEvaluation of Medical Devices, Part 1: Evaluation and Testing.

ASTM International C 1055-03, Standard Guide for Heated System Surface Conditions ThatProduce Contact Bum Injuries.

ASTM 882-84(2002), Standard Performance and Safety Specification for Cryosurgical MedicalInstruments.

IEC 60601-1-2:2004-11, Medical Electrical Equipment - Part 1-2, General requirements forsafety - Collateral standard: Electromagnetic compatibility - Requirements and tests.

lEC 60601-1 :2005-12, Medical Electrical Equipment General Requirements for Safetyincluding Amendment 1 (1991) and amendment 2 (1995).

ANSI/AAMI/ISO 11137-2:2006, Sterilization of health care products-Radiation-Part 2:Establishing the dose.

9.2 Sterilization Requirements

Visica II probes shall be provided to the end user in a sterile condition (SAL of 10-6)

9.3 Biocompatibility RequirementsVisica II patient contact materials shall be either generally recognized as biocompatible, ortested per ISO 10993-1 :2003 requirements for an "external communicating device" in "Limitedcontact" with "Tissue/bone/dentin".

9.4 Safety Requirements

9.4.1 UL ApprovalThe Vi sica II system shall be designed such that it can be certified by UnderwritersLaboratory (UL).

9.4.2 General SafetyThe Visica II system shall comply with the applicable safety requirements stated inlEC 60601-1:2005-12.

The Visica II system shall provide a means to indicate to the operator that adetectable fault condition has occurred.

The Visica II system shall provide a means to stop the flow of cryogen and electricalenergy to the probe if a detectable fault could result in a hazardous condition.

9.4.3 Cryogen SafetyThe Vi sica II system shall be designed such that the cryogen dewar can bereplenished by a lay person with instructions.




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The Visica II system shall prevent the actively driven flow of liquid cryogen from thecart probe connector unless an approved probe is connected according to the IFU.

The Vi sica II system shall provide a means to prevent actively driven liquid cryogenflow out of the cart cryogen connector in the event the operator disconnects the probe.

The Visica II system shall provide a means to prevent actively driven liquid cryogenflow out of the probe cryogen connector in the event the operator disconnects theprobe.

The Vi sica II system shall require a successful probe test result before operating theprobe.

The Visica II system shall provide a means for the operator to stop cryogen flow andbegin a warm cycle with a single button push.

The Vi sica II system shall provide a means for the operator to stop the flow ofcryogen to the probe with a single button push.

The Vi sica II system shall provide a means for the operator to stop the flow ofelectrical energy to the probe with a single button push.

9.4.4 Minimum Surface Temperatures

The Visica II system shall be designed such that the probe handle and the portion ofthe exposed probe shaft from its proximal end to a point 1.0 cm proximal to the iceball remain at or above 1.5 °C for the duration of a 10 minute high freeze.

9.4.5 Tipping

The Vi sica II Cart shall be designed such that, when the cryogen reservoir is full, itdoes not overbalance when tilted through an angle of 10° per IEC 60601-1 :200 512clause 24. 1.

The Visica II Cart shall be designed such that, when the cryogen reservoir is empty, itdoes not overbalance when tilted through an angle of 10° per IEC 60601-1 :200512clause 24. 1.

9.5 Labeling

Visica II system labeling shall comply with ISO 15223, EN 980, and FDA Blue Book MemoG91-1.

9.6 Physical Requirements

9.6.1 Unitized SystemThe Vi sica II system shall be designed such that all components except for theprobe(s) and their associated connecting hose(s) required for a supported medicalprocedure are either contained within or firmly attached to the cart.

9.6.2 Weight and DimensionsVi sica Cart dimensions shall not exceed 50 cm in width, 65 cm in length, and 160 cmin height.

Visica Cart weight shall not exceed 150 kg when configured for the maximumnumber of freeze minutes.




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9.6.3 Power Cord

The Vi sica II system shall provide a connector for an IEC 60320-1 :2001-06compliant mains power cord.

The Visica II system mains power cord shall be at least 3 m long.

The Visica II system mains power cord shall remain connected to the cart and able topower the system for normal operation when pulled on with a normal force of 100 N.

9.6.4 Probe Holder

The Vi sica II system shall provide a means to hold one approved probe such that it issecurely retained.

The Vi sica II system shall provide a sterile accessory that will fit over the probeholder.

9.7 Functional Requirements

9.7.1 Confirmation of Function

The Visica II system shall provide a visual indication that an attached, active probe isperforming the commanded function.

Note: Commanded functions include high freeze, low freeze, warm, thaw, and idle.

9.7.2 Manual Mode

The Vi sica II system shall provide a means for the operator to switch among the highfreeze, low freeze, warm, and idle operating states with a single button push.

9.7.3 Automatic Mode

The Vi sica II system shall provide an automatic mode of operation in which thesystem cycles through the states of first freeze, thaw, second freeze, warm, accordingto an elapsed time algorithm based on lesion size.

The Visica II system shall provide a means for the operator to adjust automatic modeelapsed times.

9.7.4 Active Probe Heater

The Visica II system shall provide a means to operate an active probe heater.

The Visica II system shall limit the maximum probe surface temperature during warmmode to no more than 50°C per ASTM C10SS-03.

9.7.5 Probe Identification

The Vi sica II system shall provide a means to determine if an attached probe is amodel that is approved for use with the system.

9.8 Performance Requirements

9.8.1 Isotherm Performance

The Visica II system shall engulf the major and minor lesion diameters in -20°C asspecified in the following table(s):3.4 mm Probe Table




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3.4mm ProbeMinor diameter (1)

Major diameterTime to reach

(em)diameter (minutes)

0.8

1.01

1.2.

1.51.5

1.5

2.02

1.9

2.53

2.3

3.04

2.7

3.56

3.1

4.08

(1) Minor diameter is measured normal to the probe shaft surface.

9.8.2 Extraction Performance

The Visica II system shall provide a means to release the probe from the ice ball in nomore than 60 s.

9.8.3 Cryogen CapacityThe Visica II system shall provide sufficient integral cryogen storage for at least thefollowing procedures:

The appropriate procedure for a lesion with a major diameter of3.5cm followinga storage period not to exceed 6 hours at a temperature not to exceed 27C.

The appropriate procedure for a lesion with a major diameter of 4.0cm.

9.9 Environmental Requirements

9.9.1 TransportThe Visica II system, when packed for transport, shall be fully operational aftertransport under the following environmental conditions:• Ambient temperature range of -20°C to +55 °c with a maximum time of24hours at either temperature extreme ..

Relative humidity range of 10% to 90%, non-condensingAtmospheric pressure range of 500 hPa to 1013 hPa with a maximum time of 24

hours at 500 hPa.

The Visica II system shipping enclosure shall be designed such that the enclosedVisica II system is fully operational after being tested according to the ASTM 416905, DC 2.

9.9.2 Operation/StorageThe Visica II system shall be capable of operation and storage under the followingenvironmental conditions:

Ambient temperature range of + 15°C to + 30 °C.Relative humidity range of 10 % to 90 % non-condensing.Atmospheric pressure range of 700 hPa to 1013 hPa




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9.11.1

9.9.3 Electromagnetic CompatibilityThe Visica II system shall comply with the radiated emission requirementscontained in IEC 60601-1-2:2004-11clause 36.201.1.

The Visica II system shall comply with the conducted emission requirementscontained in IEC 60601-1-2:2004-11 clause 36.201.1.

The Visica II system shall comply with the harmonic distortion requirementscontained in IEC 60601-1-2:2004-11 clause 36.201.3.1.

The Visica II system shall comply with the voltage fluctuation and flickerrequirements contained in IEC 60601-1-2:2004-11 clause 36.201.3.2.

The Visica II system shall comply with the electrostatic discharge requirementscontained in IEC 60601-1-2:2004-11 clause 36.202.2.

The Vi sica II system shall comply with the radiated immunity requirementscontained in IEC 60601-1-2:2004-11 clause 36.202.3.

The Visica II system shall comply with the electrical fast transient and burstimmunity requirements contained in IEC 60601-1-2:2004-11 clause 36.202.4.

The Visica II system shall comply with the surge immunity requirements containedin IEC 60601-1-2:2004-11 clause 36.202.5.

9.10 Maintenance Requirements

The Visica II cart shall be designed such that recommended product maintenance occurs at aminimum interval of 24 months.

The Visica II system shall sustain no physical or cosmetic damage when exterior surfaces arelightly wiped with a cloth dampened with the following products:• mild detergent

70% isopropyl alcohol

9.11 Human Factors Requirements

Probe Connection

Visica II system probe connections shall be designed such that the probe can beattached to the cart with one hand.

Visica II system probe connections shall provide tactile feedback to the operator toindicate that the probe is properly connected to the cart.

9.12 User Interface Requirements

9.12.1 System Function SelectionThe Visica II system shall provide a means for the operator to make the followingselections:

power on/offprobe test start/abortmanual modeautomatic mode

• lesion size

• start automatic mode procedure




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9.12.2 Information Display

The Visica II system shall provide a means to display the following information:power on/offlow freeze activelow freeze time in minutes and secondshigh freeze activehigh freeze time in minutes and secondswarm activewarm time in minutes and seconds

• thaw activethaw time in minutes and secondsidle activeidle time in minutes and secondsprobe test activeprobe test time remainingautomatic mode procedure time remainingprobe temperature (qualitative temperature indication is sufficient)probe test result

9.13 Accessories

9.13.1 Multiple Dewar Holder

The Visica II system shall provide a means to safely transport and store up to six fulldewars in a single container that, when filled to capacity, can be handled by oneperson.


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