← Product Code [KKX](/submissions/SU/subpart-e%E2%80%94surgical-devices/KKX) · K993795

# CONVERTORS SURGICAL DRAPES (K993795)

_Allegiance Healthcare Corp. · KKX · Jan 12, 2000 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/KKX/K993795

## Device Facts

- **Applicant:** Allegiance Healthcare Corp.
- **Product Code:** [KKX](/submissions/SU/subpart-e%E2%80%94surgical-devices/KKX.md)
- **Decision Date:** Jan 12, 2000
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4370
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery

## Intended Use

The Convertors® Surgical Drapes are devices made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.

## Device Story

Convertors® Surgical Drapes are single-layer, degradable, spunlaced nonwoven fabric sheets; designed to isolate surgical incision sites from microbial/environmental contamination. Used in clinical surgical settings; applied by healthcare personnel as a sterile barrier. Materials are water-soluble at temperatures above approximately 190°F. Device provides a physical barrier to protect patients during surgery.

## Clinical Evidence

No clinical data. Bench testing only. Biocompatibility evaluated per ISO 10993-1 (cytotoxicity, sensitization, irritation/intracutaneous reactivity). Materials tested per industry-recognized methods.

## Technological Characteristics

Single-layer degradable spunlaced nonwoven fabric; water-soluble at temperatures >190°F. Biocompatibility per ISO 10993-1. Non-electronic, passive barrier device.

## Regulatory Identification

A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.

## Special Controls

*Classification.* Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

## Predicate Devices

- Isolyser Enviroguard Drapes

## Submission Summary (Full Text)

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>
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### JAN 1 2 2000

Image /page/0/Picture/1 description: The image shows the word "Allegiance" in a bold, sans-serif font. To the left of the word is a symbol that looks like a plus sign made up of small dots. The word is slightly slanted to the right, giving it a dynamic appearance.

cGaw Park. Illinois 60085-6787 X- 847 785 2461

K993795

## SMDA REQUIREMENTS

#### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Convertors® Surgical Drapes

Manufacturer:

Allegiance Healthcare Corporation One Butterfield Trail El Paso, Texas 79906

- Regulatory Affairs Contact:
Sharon Robbins 1500 Waukegan Road MPWM McGaw Park, IL 60085 (847) 785-3311

Telephone:

September, 1999 Date Summary Prepared:

Common Name: Convertors® Surgical Drapes

Class II per 21CFR § 878.4370 Classification:

Predicate Device: Isolyser Enviroguard Drapes.

Description: The drapes are comprised of a sing e layer of degradable spunlaced nonwoven fabric with various reinforcements. The fiber is water soluble in temperatures above approximate v 190 degrees F.

Intended Use:

The Convertors® Surgical Drapes are devices made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.

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Image /page/1/Picture/0 description: The image shows the word "Allegiance" in a bold, italicized font. To the left of the word is a graphic of a cluster of dots arranged in a cross-like shape. The word is in black and the background is white.

Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500 FAX: 847.785.2461

# SMDA REQUIREMENTS (continued)

#### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Convertors® Surgical Drapes

| Substantial Equivalence: | The Convertors® Surgical drapes are<br>substantially equivalent to the Isolyser<br>Enviroguard drapes in that: |
|--------------------------|----------------------------------------------------------------------------------------------------------------|
|--------------------------|----------------------------------------------------------------------------------------------------------------|

- the intended use is the same
- the performance attributes are similar
- All materials used in the fabrication of this Summary of testing: Convertors® Surgical drapes were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 "Biological Evaluation of Medical Devices". The biocompatibility tests performed were cytotoxicity, sensitization, and irritation/ intracutaneous reactivity. These materials also were tested in accordance with industry recognized test methods and were found to be acceptable for the intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with three curved lines above them, resembling a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 2 2000

Ms. Sharon Robbins Requlatory Affairs Manager Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787

Re : K993795

> Convertors® Surgical Drapes Trade Name: Requlatory Class: II Product Code: KKX Dated: November 8, 1999 November 9, 1999 Received:

Dear Ms. Robbins:

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 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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In 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

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Paqe 2 - Ms. Robbins

obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA findinq 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

> Sincerely yours, Timotiny A. Ulatowski

Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Allegiance

Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 347.473.1500 FAX: 847.785.2461

510(k) Number (if known):

Device Name:

Convertors® Surgical Drapes

Unknown

Indications For Use:

The Convertors® Surgical Drapes are devices made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) or

Over-The Counter Use

unter Use X

Qlin S. him
11

(Division Sign-Off) Division of Dental, Infection Con and General Hospi 510(k) Numbe

116

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