OPERATING ROOM TOWELS

K981823 · Baldur Systems Corp. · KKX · Aug 11, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K981823
• Device Name: OPERATING ROOM TOWELS
• Applicant: Baldur Systems Corp.
• Product Code: KKX · General, Plastic Surgery
• Decision Date: Aug 11, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Intended Use

INTENDED BE USED P COUERIN ﺮ INCISIO A SITE SURGICAL From AND other MICROBIAN CONTAMINATION

Device Story

Sterile operating room towels used as protective barriers in surgical settings; function as covers for incision sites to prevent microbial contamination; intended for over-the-counter use.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Sterile textile-based operating room towels; Class II device (Product Code KKX).

Indications for Use

Indicated for use as a surgical drape or cover for incision sites to protect against microbial 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG / 1 1998

Baldur Systems Corporation C/O Mr. Steve Woody Submission Correspondent Integrated Quality Systems 25 Heritage Drive Asheville, North Carolina 28806

Re: K981823 Sterile Operating Room Towels, Blue Trade Name: Requlatory Class: II Product Code: KKX Dated: July 8, 1998 Received: July 9, 1998

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 Requlations, 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 regulation 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

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Page 2 - Mr. Woody

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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,

S. Sutman for

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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Page_ I of_

**510(k) Number (if known):** K981823

**Device Name:** OPERATION ROOM TOWELS (BWE)

Indications For Use:

XXE INTENDED BE USED P COUERIN ﺮ INCISIO A SITE SURGICAL From AND other MICROBIAN CONTAMINATION

(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 K981823

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

(Optional Format 1-2-96)