(88 days)
The MSI Surgical Drapes are intended to be used as a protective patient drape during surgical procedures to isolate the site of the surgical incisions and assist in protecting the site from microbial and other contamination.
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I am sorry, but the provided text does not contain the information required to answer your request. The text is a 510(k) clearance letter from the FDA for "MSI Surgical Drapes" and describes the regulatory approval process and indications for use. It does not include acceptance criteria, details of a study on device performance, sample sizes, information about experts or ground truth, or details about AI or MRMC studies.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 3 1998
Medical Specialty Innovations, Incorporated C/O Ms. Carolann Kotula Vice President RA/QA MDI Consultants, Incorporated 55 Northern Boulevard Great Neck, New York 11021
Re: K974672 MSI Surgical Drapes Trade Name: Requlatory Class: II Product Code: KKX February 10, 1998 Dated: February 12, 1998 Received:
Dear Ms. Kotula:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A ................................................... substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does
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not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to beqin marketing your device as described in your 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 809.10 for in vitro diaqnostic 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): _ K974672
Device Name: Medical Specialty Innovations, Inc. Surgical Drapes
Indications for Use:
The MSI Surgical Drapes are intended to be used as a protective patient The Nibe Burgical procedures to isolate the site of the surgical incisions and assist in protecting the site from microbial and other contamination.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Olin S. Lin
Prescription Use (per 21 CFR 801.109) OR
Over the Counter Use _________________________________________________________________________________________________________________________________________________________
§ 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.