TRILAMINATE DRAPES/TIBURON

K023419 · Allegiance Healthcare Corp. · KKX · Feb 11, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K023419
• Device Name: TRILAMINATE DRAPES/TIBURON
• Applicant: Allegiance Healthcare Corp.
• Product Code: KKX · General, Plastic Surgery
• Decision Date: Feb 11, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Intended Use

The Convertors®Trilaminate Drapes are devices 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® Trilaminate Drapes function as sterile barriers in surgical environments. Constructed from polyolefin-based nonwoven outer/inner layers and a polyolefin-based film inner layer; some models include clear polyethylene side panels. Drapes are applied by surgical staff to cover patients, isolating incision sites to prevent microbial contamination. Device provides physical barrier protection during procedures; benefits include reduced risk of surgical site contamination.

Clinical Evidence

Bench testing only. Materials evaluated for biocompatibility per ISO 10993 Part-1, including cytotoxicity, sensitization, and intracutaneous reactivity. Materials met all requirements.

Technological Characteristics

Trilaminate construction: outer and inner layers of polyolefin-based nonwovens with an inner layer of polyolefin-based film. Some models include clear polyethylene side panels. Biocompatibility tested per ISO 10993-1.

Indications for Use

Indicated for use as a protective patient covering to isolate surgical incision sites from microbial and other contamination during surgical procedures.

Regulatory Classification

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

• Convertors®Trilaminate Drapes (K023419)

Submission Summary (Full Text)

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K023419

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 resembles a plus sign, but it is made up of many small dots. The symbol is slightly tilted to the left. The word "Allegiance" is written in all capital letters.

FEB 1 1 2003

**Allegiance Healthcare**
1500 Waukegan Road
McGaw Park, IL 60085

**tel** 847.785.3311
**fax** 847.785.2461

# SMDA REQUIREMENTS

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

Sponsor:

Allegiance Healthcare Corporation 1500 Waukegan Road MPWM McGaw Park, IL 60085

| Regulatory Affairs Contact: | Sharon Nichols |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone: | [phone] |
| Date Summary Prepared: | September, 2002 |
| Common Name: | Convertors®Trilaminate Drapes |
| Classification: | Class II per 21CFR § 878.4370 |
| Predicate Device: | Convertors®Trilaminate Drapes |
| Description: | These drapes will be comprised of an outer and<br>inner layer of polyolefin-based nonwovens with<br>an inner layer of polyolefin-based film. Several<br>drapes will also have clear polyethylene side<br>panels on either end of the drapes. |

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K023419

Image /page/1/Picture/1 description: The image shows the logo for Allegiance Health. The logo consists of a stylized cross made up of small squares on the left, followed by the word "Allegiance" in a bold, sans-serif font. The word is slightly slanted to the right, giving it a dynamic appearance.

**Allegiance Healthcare**
1500 Waukegan Road
McGaw Park, IL 60085

tel [phone]
fax [phone]

## SMDA REQUIREMENTS (continued)

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

Intended Use: The Convertors®Trilaminate Drapes are devices intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.

Substantial Equivalence: The Convertors® Trilaminate Drapes are substantially equivalent to the Convertors® trilaminate drape materials in that:

- the intended use is the same
- the performance attributes are similar

Summary of testing: All materials used in the fabrication of the Convertors® Trilaminate drapes were evaluated through biological qualification safety tests as outlined in in ISO 10993 Part-1 "Biological Evaluation of Medical Devices". The biocompatibility tests performed were cytotoxicity, sensitization, and intracutaneous reactivity. These materials also were tested in accordance with industry recognized test methods. These materials have met the requirements of the identified tests and were found to be acceptable for the intended use.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a symbol consisting of three stylized human profiles facing to the right, stacked on top of each other. The profiles are simple and abstract, with only the outline of the face and neck visible.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# FFB 1 1 2003

Ms. Sharon Nichols Regulatory Affairs Manager Allegiance Healthcare Corporation 1500 Waukegan Road, Building WM McGaw Park, Illinois 60085

Re: K023419

Trade/Device Name: Convertors® Trilaminate Drapes Regulation Number: 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: November 14, 2002 Received: November 15, 2002

Dear Ms. Nichols:

We have reviewed your Section 510/k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Nichols

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Susan Rannes

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Image /page/4/Picture/0 description: The image shows the word "Allegiance" in a bold, sans-serif font. To the left of the word is a symbol resembling a plus sign, but it is made up of many small squares. The word "Allegiance" is written in a slightly slanted, italicized style.

Cardinal Health company

**Allegiance Healthcare**
1500 Waukegan Road
McGaw Park, IL 60085

*tel* 847.785.3311
*fax* 847.785.2461

Page 1 of 1

510(k) Number (if known):

K023419

Device Name:

Convertors®Trilaminate Drapes

Indications For Use:

The Convertors®Trilaminate Drapes are devices 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

53

Over-The-Counter Use

Oim S. Cim

(Division Sign-Off) Division of Anesthesiology, General Hospital. Infection Control. Denta

510(k) Number: K023419