MSI SURGICAL DRAPES

K974672 · Medical Specialty Innovations, Inc. (Msi) · KKX · Mar 13, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K974672
• Device Name: MSI SURGICAL DRAPES
• Applicant: Medical Specialty Innovations, Inc. (Msi)
• Product Code: KKX · General, Plastic Surgery
• Decision Date: Mar 13, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Intended Use

The MSI Surgical Drapes are intended to be used as a protective patient barrier during surgical procedures to isolate the site of the surgical incisions and assist in protecting the site from microbial and other contamination.

Device Story

MSI Surgical Drapes function as physical barriers in surgical environments. Used by clinical staff to cover patients, these drapes isolate surgical incision sites from the surrounding environment. Primary benefit is the reduction of microbial and other contamination at the surgical site, supporting aseptic technique during procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Surgical drapes designed as physical barriers. Specific materials and ASTM standards not disclosed in the provided documentation.

Indications for Use

Indicated for use as a protective patient barrier during surgical procedures to isolate incision sites and protect against 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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird design, with three overlapping profiles suggesting a sense of community or collaboration. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol.

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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Page 2 - Ms. Kotula

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 [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" (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 [phone] or [phone] 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 _________________________________________________________________________________________________________________________________________________________