MEDLINE ASEP PLUS SURGICAL DRAPES

K023432 · Medline Industries, Inc. · KKX · Nov 4, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K023432
• Device Name: MEDLINE ASEP PLUS SURGICAL DRAPES
• Applicant: Medline Industries, Inc.
• Product Code: KKX · General, Plastic Surgery
• Decision Date: Nov 4, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Intended Use

The ASEP™ Plus Back Surgical Drapes are used to cover accessory tables in the operating room The fluid repellent properties of the drapes aid in the control of microbial and other contamination.

Device Story

Medline ASEP™ Plus Reusable Surgical Drapes consist of Mayo stand covers and back table covers. Used in operating rooms to cover accessory tables; provide fluid-repellent barrier; aid in control of microbial and other contamination. Device is a passive physical barrier; no electronic or software components. Intended for clinical use by surgical staff.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

Reusable surgical drapes (Mayo stand and back table covers). Material provides fluid repellency to serve as a microbial barrier. Non-sterile, reusable design.

Indications for Use

Indicated for use in the operating room to cover accessory tables (Mayo stands and back tables) to provide a fluid-repellent barrier for the control of microbial and other contamination.

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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## DEPARTMENT OF HEALTH & HUMAN

Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850

NOV 4 2002

·Ms. Andrea Haferkamp Corporate Director of Regulatory Affairs Medline Industries, Incorporated One Medline Place Mundelein, Illinois 60060-4486

Re: K023432

Trade/Device Name: Medline ASEP™ Plus Reusable Surgical Drapes (Mayo Stand Cover and Back Table Cover) Regulation Number: 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: October 14, 2002 Received: October 15, 2002

Dear Ms. Haferkamp:

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 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 your device in the Federal Register.

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## Page 2 - Ms. Haferkamp

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,

[signature]

Timothy A. Ulatowski 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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K.023432 510(k) Number (if known): Device Name: Medline ASEP™ Plus Surgical Drapes {Reusable ASEP Plus Mayo Stand Cover and Back Table Cover]

Indications for Use:

The ASEP™ Plus Back Surgical Drapes are used to cover accessory tables in the operating room The fluid repellent properties of the drapes aid in the control of microbial and other contamination.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Over-the-Counter Use Prescription Use OR (Per 21 CFR 801.109)

(Optional Format 12-96)

Olin S. Lin

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

510(k) Number: K023432