CIV-FLEX HOLSTER COVER, MODEL STERILE, LATEX-FREE

K002546 · CIVCO Medical Instruments Co., Inc. · KNW · Oct 31, 2000 · Gastroenterology, Urology

Device Facts

• Record ID: K002546
• Device Name: CIV-FLEX HOLSTER COVER, MODEL STERILE, LATEX-FREE
• Applicant: CIVCO Medical Instruments Co., Inc.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Oct 31, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

The CIV-Flex™ Holster Cover is a protective cover for a mechanical breast biopsy device reusable holster / cable assembly that helps prevent contamination [blood, body fluids, ultrasound gel, etc.] of the holster control buttons, and thus allowing for reprocessing of the holster between patient uses; covers are single use, disposable.

Device Story

CIV-Flex™ Holster Cover provides thin, conformal, transparent polyurethane sleeve for Ethicon Endo-Surgery Mammotome® mechanical breast biopsy device; protects reusable holster/cable assembly from contamination (blood, body fluids, ultrasound gel) during procedures; allows for holster reprocessing between patients. Device is single-use, disposable; secured with latex-free Kraton® thermoplastic elastomer bands. Clinician applies cover to holster before use; transparent material allows visualization of control buttons. Benefits include reduced contamination of non-sterile holster components, enabling effective cleaning/reprocessing protocols.

Clinical Evidence

Bench testing only. Performance demonstrated via mechanical testing for strength and elasticity (comparable to predicate) and barrier effectiveness testing using viral penetration methods adapted from surgical glove/endoscope sheath standards. Biocompatibility testing (ISO 10993-1) confirms non-toxic, non-sensitizing, non-irritating, non-hemolytic, and non-pyrogenic properties.

Technological Characteristics

Material: Polyurethane film (0.002" thickness). Design: One-piece sleeve, open-ended, tapered fit. Securing mechanism: Latex-free Kraton® thermoplastic elastomer bands. Manufacturing: Extruded/blown film, heat-sealed, packaged in Class 10,000 cleanroom (Fed Std 209e). Sterilization: Ethylene oxide (EtO) per ANSI/AAMI/ISO 11135 (SAL 10^-6).

Indications for Use

Indicated for use as a protective barrier for mechanical breast biopsy device reusable holster/cable assemblies to prevent contamination from blood, body fluids, and ultrasound gel, facilitating device reprocessing between patient uses. Single-use, disposable.

Regulatory Classification

Identification

A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Predicate Devices

• Poly [CIV-Flex™] Ultrasound Transducer Cover (K970513)

Submission Summary (Full Text)

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K002546

# 510(k) SUMMARY OF SAFETY & EFFECTIVENESS

(As required by 21 CFR 807.92)

## CIV-Flex™ Holster Cover

## A. General Information

| Submitter's Name: | CIVCO Medical Instruments Company, Inc. |
|-------------------|------------------------------------------------|
| Address: | 102 First Street South, Kalona, IA 52247 |
| Telephone No.: | phone [phone] fax: [phone] |
| Contact Person: | J. William Jones, Manager - Regulatory Affairs |

Date Prepared:

16 August 2000

1937223 Establishment Registration Number: CIVCO Medical Instruments is registered as a medical device manufacturer.

Device Trade: Device Common: Device Classification Name: CIV-Flex™ Holster Cover Biopsy Device Accessory Biopsy Instrument Cover

Classification: Classification Panel: Classification Procode: Class II under 21 CFR 876.1075 Gastroenterology 78 KNW

Performance Standards: No applicable performance standards have been issued under Section 514 of the Food, Drug and Cosmetic Act.

## B. Device Description

The CIV-Flex™ Holster Cover device provides a thin, conformal protective covering for the disposable probe / reusable holster and cable assembly components of the Ethicon Endo-Surgery Mammotome® mechanical breast biopsy device. The cover is manufactured as a one-piece sleeve design that is open on both ends with a tapered fit to the holster / probe geometry. The cover material is transparent for visualization of the holster control buttons during use.

Cover material is polyurethane film. Material system is free of any latex natural rubber. The polyurethane material was introduced into CIVCO products as CIV-Flex™ Ultrasound Transducer Covers in 1987. This polyurethane material has been used in CIVCO ultrasound transducer cover applications for over ten (10) years. Thus, this material can fall under a "GRAS" (Generally Recognized As Safe) classification.

Covers are packaged sterile in a pouch for single patient / procedure, disposable use. Cover is supplied with latex free Kraton® thermoplastic elastomer bands for use in securing the cover to the holster and cable.

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K002546 Page 274

# C. Intended Use / Indications for Use

The CIV-Flex™ Holster Cover is a protective cover for a mechanical breast biopsy The CIV-Plex -- Thoister Gover 16 a provent contamination [blood, body fluids, ultrasound gel, etc.] of the holster control buttons, and thus allowing for hulds, ultrasound get, etc.] of the holor oonlier batterie, a are single use, disposable.

#### D. Predicate Device

The CIV-Flex™ Holster Cover device is identified as substantially equivalent to CIVCO Medical's currently, legally marketed Poly [CIV-Flex™] Ultrasound Transducer Covers:

Predicate Device(s) Poly [CIV-Flex™] Ultrasound Transducer Cover

510(k) Reference K970513

Manufacturer CIVCO Medical

## E. Substantial Equivalence Summary

The CIV-Flex™ Holster Cover is substantially equivalent in safety and effectiveness to the CIVCO Poly [CIV-Flex™] Ultrasound Transducer Cover. The comparison table on the following pages demonstrates this substantial equivalence.

#### F. Conclusions

Ethicon Endo-Surgery User's Manual for the Mammotome® Hand-Held System indicates the holster / cable device is a non-sterile instrument and cannot be reprocessed between the norsel 7 cable do not is a non exercion methods. Reducing the contamination level pations allows for reprocessing of the holster device by the instructed cleaning by covening allowe for reploseaaked with enzymatic detergent / removing residual methou of wiping with a clear-ended sleeve type cover is not intended to be a sterile downlor. The holster is required to be cleaned after every use regardless of whether a sterile cover was used or not. Testing of the cover system has demonstrated satisfactory performance for contamination reduction.

This premarket submission for the CIV-Flex™ Holster Cover has demonstrated Substantial Equivalence as defined and understood in the Federal Food, Drug and Cosmetic act and various guidance documents issued by the Center for Devices and Radiological Health.

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CIVCO Medical Instruments 08/16/00

CIV-Flex™ Holster Cover

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Kov 2546 Page 3 of 4

# Comparison of Device to Substantially Equivalent, Legally Marketed Device

| Parameter | CIV-Flex™ Holster Cover | Predicate Device<br>CIVCO Poly Ultrasound<br>Transducer Cover (K970513) |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use /<br>Indications for<br>Use | Same, except subject device is a<br>mechanical breast biopsy reusable<br>holster / cable assembly instead of an<br>ultrasound transducer. | A protective cover that helps prevents<br>contamination [blood, body fluids,<br>ultrasound gel, etc.] and thus allowing<br>for reprocessing of the device between<br>patient uses. Covers are single use,<br>disposable. |
| Design | Same. | One-piece, geometry conforming cover. |
| Material | Same. | polyurethane, thermoplastic. CIVCO trade name CIV-Flex™. effectively used for over 10 years. |
| Manufacturing | Same. | extruded / blown thin film sheet. cut / heat seal fabricated & packaged in a Class 10,000 cleanroom per Federal Std 209e. sterile packaging material system per ANSI / AAMI / ISO 11607. sterilized by ethylene oxide gas. |
| Quality Systems | Same. | FDA/QSR cGMP 21CFR Part 820. ISO 9001 / EN46001 / ISO 13485. |
| Sterility | Same. | sterilization by 100% EtO method. validated ANSI / AAMI / ISO 11135. SAL 10-6. |
| Device Body<br>Contact Category | Same. | surface devices, intact skin / mucosal membranes / breached surfaces; limited contact duration (< 24 hours). |
| Parameter | CIV-Flex™ Holster Cover | Predicate Device<br>CIVCO Poly Ultrasound<br>Transducer Cover (K970513) |
| Safety | Same. | Biocompatibility tests for acute systemic<br>toxicity, irritation, sensitization,<br>hemolysis, material mediated pyrogen,<br>and ethylene oxide sterilization residuals<br>have demonstrated the polyurethane<br>[CIV-Flex™] material / cover device is:<br>non-toxic. non-sensitizing. non-irritating. non-hemolytic. non-pyrogenic. Testing is in accordance with -<br>ISO 10993-Part 1 Biological Evaluation<br>of Medical Devices, FDA Blue Book<br>Memorandum #G95-1, and FDA-Good<br>Laboratory Practices (GLP). |
| Effectiveness | Same.<br>Mechanical testing for CIV-Flex™<br>Holster Covers has shown that the<br>material is adequate for the intended<br>use:<br>a) during application and removal of<br>cover from holster, b) during use as<br>intended.<br>Strength and elastic characteristics<br>are the same as that of the<br>ultrasound cover allowing use<br>without tearing or pinholing. same cover thickness of .002". | Experience and testing has shown that<br>polyurethane covers:<br>polyurethane has sufficient strength<br>and elasticity for the intended use. Nominal cover thickness is .002". Provides an effective barrier to the<br>prevention of microbial migration as<br>demonstrated using protocol<br>adapted from that used to evaluate<br>the barrier properties / resistance of<br>surgical gloves and endoscope<br>sheaths to penetration by<br>bloodborne pathogens using viral<br>penetration as a test method. |

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## Comparison of Device to Substantially Equivalent, Legally Marketed Device cont.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 3 1 2000

Mr. J. William Jones Regulatory Affairs Manager CIVCO Medical Instruments Co, Inc. 102 First Street South KALONA IA 52247-9589

Re: K002546 CIVCO Medical, CIV-Flex™ Holster Cover Dated: August 16, 2000 Received: August 17, 2000 Regulatory Class: II 21 CFR §876.1075/Procode: 78 KNW

Dear Mr. Jones:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and problibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation regulatory action. Jn addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal faws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours.

Daniel G. Schultz, M.D.

Captain, USPHS Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure (s)

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# INDICATIONS FOR USE STATEMENT

Page 1 of 1

K002546 510(k) Number (if known):

CIV-Flex™ Holster Cover Device Name:

Indications For Use:

A protective cover for a mechanical breast biopsy device reusable A procetive oover assembly that helps prevent contamination [blood, holor / Sablo assend gel, etc.] of the holster control buttons, and body flande, and as a reprocessing of the holster between patient uses; covers are single use, disposable.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE 1F NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

Thos A. Serson

OR

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K002546

CIV-Flex™ Holster Cover