(20 days)
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.
Medline ASEP™ Plus Reusable Surgical Drapes (Mayo Stand Cover and Back Table Cover)
The provided text is a 510(k) premarket notification approval letter for the Medline ASEP™ Plus Reusable Surgical Drapes. This document indicates the FDA's decision that the device is "substantially equivalent" to legally marketed predicate devices.
Crucially, this document is a regulatory approval letter and not a study report. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other technical details requested in your prompt. The FDA's substantial equivalence determination for this type of device (surgical drapes) typically relies on material characteristics and performance against established industry standards for barrier properties, durability, and biological safety, rather than a "study that proves the device meets the acceptance criteria" in the way one would analyze a diagnostic or AI-driven device.
Therefore, I cannot provide the requested information from the provided text. To answer your prompt, I would need a detailed study report or technical data sheet for the Medline ASEP™ Plus Reusable Surgical Drapes.
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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 (301) 594-4618. 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" (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 (800) 638-2041 or (301) 443-6597 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
§ 878.4370 Surgical drape and drape accessories.
(a)
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.(b)
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.