DRAPES WITH ABSORBENT REINFORCEMENT

K023425 · Allegiance Healthcare Corp. · KKX · Nov 6, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K023425
• Device Name: DRAPES WITH ABSORBENT REINFORCEMENT
• Applicant: Allegiance Healthcare Corp.
• Product Code: KKX · General, Plastic Surgery
• Decision Date: Nov 6, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

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 consist of a base layer of nonwoven material with a laminated absorbent reinforcement structure. Used in surgical settings as a sterile barrier to isolate incision sites from microbial and other contamination. Protects patients by preventing fluid and pathogen transfer during procedures. Operated by surgical staff in clinical environments.

Clinical Evidence

Bench testing only. Biocompatibility testing included cytotoxicity and primary skin irritation. Materials tested in accordance with industry-recognized methods and found acceptable.

Technological Characteristics

Nonwoven base layer with laminated absorbent reinforcement structure. Natural or synthetic materials. Class II device per 21 CFR 878.4370.

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 Surgical Drapes (K023425)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the word "Allegiance" in a bold, sans-serif font. To the left of the word is a cluster of small squares arranged in a cross shape. The word is in black and the background is white. The image appears to be a logo or brand name.

a Cardinal Health company

6 2002 NOV

1500 Waukegan Road McGaw Park, IL 60085

tel [phone] fax [phone]

# SMDA REQUIREMENTS

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

| Sponsor: | Allegiance Healthcare Corporation<br>1500 Waukegan Road MPWM<br>McGaw Park, IL 60085 |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Sharon Nichols |
| Telephone: | [phone] |
| Date Summary Prepared: | October, 2002 |
| Common Name: | Convertors®Surgical Drapes |
| Classification: | Class II per 21CFR § 878.4370 |
| Predicate Device: | Convertors Surgical Drapes |
| Description: | The drapes are comprised of a base layer of<br>nonwoven material to which the absorbent<br>reinforcement structure is laminated. |
| Intended Use: | The Convertors®Surgical Drapes are devices<br>made of natural or synthetic materials intended to<br>be used as a protective patient covering, such as<br>to isolate a site of surgical incision from microbial<br>and other contamination. |

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K 023425

Image /page/1/Picture/1 description: The image shows the word "Allegiance" in a stylized font. To the left of the word is a symbol that looks like a plus sign made up of small dots. The word is in black and the background is white. The font is bold and slightly italicized.

a Cardinal Health company

1500 Waukegan Road McGaw Park, IL 60085

tel [phone] fax [phone]

## 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 currently marketed<br>Allegiance drapes in that:<br>- the intended use is the same<br>- the performance attributes are<br>similar |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of testing: | The biocompatibility test performed were cytotoxicity<br>and primary skin irritation. These materials also were<br>tested in accordance with industry recognized test<br>methods and were found to be acceptable for the |

intended use.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

#### NOV 6 2002

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

Re: K023425

Trade/Device Name: Convertors® Surgical Drapes Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: October 10, 2002 Received: October 11, 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 and additionally 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Timothy J. Ulatowski

Tim 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 stylized, bold, black font. To the left of the word is a symbol resembling a plus sign, but it is made up of many small dots. The font of the word "Allegiance" is slightly slanted to the right, giving it a dynamic appearance.

**Cardinal Health** company

1500 Waukegan Road
McGaw Park, IL 60085

*tel* 847.785.3311
*fax* 847.785.2461

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510(k) Number (if known):

Device Name:

Indications for Use

K 0 2 3 4 25

Convertors®Surgical Drapes

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)

29

Prescription Use (Per 21 CFR 801.109)

or

Over-The Counter Use

Qum S. Lin

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

510(k) Number: K023425