VARIOUS STERILE AND NON-STERILE SURGICAL DRAPES, (I.E., DISPOSABLES MINOR PROCEDURE DRAPES, LARGE APERTURE DRAPES, ABSOR

K994199 · Custom Medical Products, Inc. · KKX · Jun 9, 2000 · General, Plastic Surgery

Device Facts

• Record ID: K994199
• Device Name: VARIOUS STERILE AND NON-STERILE SURGICAL DRAPES, (I.E., DISPOSABLES MINOR PROCEDURE DRAPES, LARGE APERTURE DRAPES, ABSOR
• Applicant: Custom Medical Products, Inc.
• Product Code: KKX · General, Plastic Surgery
• Decision Date: Jun 9, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Intended Use

Surgical Drapes are single use and shall be used by medical professionals in an operating room or healthcare setting for patient protective covering.

Device Story

Device consists of various sterile and non-sterile surgical drapes, including minor procedure drapes, large aperture drapes, absorbent angiography sheets, cesarean birth sheets, and poly-u-drapes. Used by medical professionals in operating rooms or healthcare settings to provide a protective barrier for patients during surgical or medical procedures. Single-use disposables designed to prevent cross-contamination between patient and environment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Single-use surgical drapes; various configurations including aperture and absorbent sheets. Materials and construction intended for patient protective covering in clinical settings.

Indications for Use

Indicated for use by medical professionals in operating rooms or healthcare settings as a single-use patient protective covering.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 9 2000

Custom Medical Products, Incorporated C/O Mr. Steve Woody Quality Assurance Coordinator Integrated Quality Systems 1 Holiday Inn Drive, Building E Asheville, North Carolina 28806

K994199 Re :

Various Sterile and Non-Sterile Surgical Trade Name: Drapes, (i.e., Disposables Minor Procedure Drapes, Large Aperture Drapes, Absorbent Angiography Sheet, Cesarean Birth Sheet and Poly-u-Drape) Requlatory Class: II Product Code: KKX March 21, 2000 Dated: Received: March 23, 2000

Dear Mr. Woody:

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, Drug, 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does 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 regulations.

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Page 2 - Mr. Woody

This letter will allow you to begin 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 requlation (21 CFR Part 801 and additionally 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" (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 Radiological Health

Enclosure

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Custom Medical Products, Inc.

Appendix B

Indication for Use Statement

| 510(k) Number (if known): | K994199 |
|---------------------------|---------|
|---------------------------|---------|

Device Name: Various Sterile and Non-Sterile Surgical Drapes, DISPOSABLES
MINOR PROCEDURE DRAPES, LARGE APERTURE DRAPE, ABSORBANT ANG'IO GRAPHY SHEET, CEGEAREAN BIRTH SHEET
AND POLY-U-DRAPE

Indications for Use:

Surgical Drapes are single use and shall be used by medical professionals in an operating
room or healthcare setting for patient protective covering.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Dental, Infection Control,
and General Hospital Devices

| 510(k) Number | K994199 |
|---------------|---------|
|---------------|---------|

OR

Prescription Use

(Per 21 CFR 801.109)

Over-The Counter Use

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