(81 days)
INTENDED BE USED P COUERIN ﺮ INCISIO A SITE SURGICAL From AND other MICROBIAN CONTAMINATION
Not Found
The provided text is a 510(k) premarket notification approval letter for "Sterile Operating Room Towels, Blue" (K981823) from the FDA to Baldur Systems Corporation. This document is a regulatory approval and does not contain information about acceptance criteria or a study proving device performance as it pertains to AI/ML or diagnostic devices.
The information requested in the prompt (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) are characteristic of the data typically provided in submissions for AI/ML-powered medical devices or diagnostic devices that require performance evaluation studies.
Since the device in question is "Sterile Operating Room Towels," a low-risk product, the FDA approval is based on substantial equivalence to a predicate device rather than on detailed performance metrics from a clinical study as would be required for more complex devices or AI/ML technologies.
Therefore, I cannot provide the requested information based on the input document. The document simply states the intended use as: "XXE INTENDED BE USED P COUERIN ﺮ INCISIO A SITE SURGICAL From AND other MICROBIAN CONTAMINATION" (intended to be used for covering an incision site during surgery from microbial contamination).
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, composed of several curved lines that suggest the shape of a bird in flight.
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 (301) 594-4692. 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,
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)
§ 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.