DRAPE, SURGICAL, X-RAY ELEMENT, MODELS NON STERILE 6120-00, STERILE 704-B, NON STERILE 6124-00X, STERILE 704-BX

K042526 · Medical Action Industries, Inc. · KKX · Apr 25, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K042526
• Device Name: DRAPE, SURGICAL, X-RAY ELEMENT, MODELS NON STERILE 6120-00, STERILE 704-B, NON STERILE 6124-00X, STERILE 704-BX
• Applicant: Medical Action Industries, Inc.
• Product Code: KKX · General, Plastic Surgery
• Decision Date: Apr 25, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Intended Use

Single Use Disposable OR Towel is typically used for draping, body fluid absorption, and hand drying in an OR application

Device Story

Single-use disposable OR towel; used in operating room environments. Functions as a surgical drape accessory for fluid management and hand drying. Operated by clinical staff. Provides passive absorption and barrier protection during surgical procedures. Benefits include infection control and convenience of single-use disposal.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Single-use disposable textile/material; intended for OR use. No electronic, software, or complex mechanical components.

Indications for Use

Indicated for use in operating room (OR) settings for draping, absorption of body fluids, and hand drying.

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.

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 16 2006

Ms. Robin K. Blankenbaker Quality and Compliance Manager Medical Action Industries, Incorporated 25 Hevwood Road Arden, North Carolina 28704

Re: K042526 Trade/Device Name: OR Towel, Sterile and Non Sterile Regulation Number: 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: April 18, 2005 Received: April 18, 2005

Dear Ms. Blankenbaker:

This letter corrects our substantially equivalent letter of April 25, 2005.

We have reviewed vour 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 (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 additional controls. Existing major regulations affecting vour device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition. FDA may publish further announcements concerning vour device in the Federal Register.

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Page-2 Ms. Blankenbaker

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 (OS) 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 continue 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.

little by Michael David

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

## 510(k) Number (if known): K042526

- Station Station Comments Comments of Children Comments of Con-

Device Name: Single Use Disposable OR Towel, Sterile and Non Sterile

Indications For Use: Single Use Disposable OR Towel is typically used for draping, body fluid absorption, and hand drying in an OR application

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use

and the start of the same of the may be in the same

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

## Concurrence of CDRH, Office of Device Evaluation (ODE)

Shula A Murphy
(Division Sign-Off)

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Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K042526