(220 days)
Single Use Disposable OR Towel is typically used for draping, body fluid absorption, and hand drying in an OR application
Single Use Disposable OR Towel, Sterile and Non Sterile
I apologize, but this document is a 510(k) clearance letter from the FDA for a surgical towel (OR Towel, Sterile and Non Sterile). It confirms that the device is substantially equivalent to a legally marketed predicate device.
This type of document does not contain information about acceptance criteria or a study proving performance in the context of advanced AI/ML algorithms, clinical trials, or rigorous performance metrics typically associated with modern medical device approvals for complex diagnostic or treatment tools.
Therefore, I cannot extract the information you've requested regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, ground truth, or MRMC studies, as these concepts are not applicable to the content of this specific regulatory letter for a surgical drape accessory.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the top half of the circle. In the center of the seal is an abstract image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 16 2006
Ms. Robin K. Blankenbaker Quality and Compliance Manager Medical Action Industries, Incorporated 25 Hevwood Road Arden, North Carolina 28704
Re: K042526 Trade/Device Name: OR Towel, Sterile and Non Sterile Regulation Number: 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: April 18, 2005 Received: April 18, 2005
Dear Ms. Blankenbaker:
This letter corrects our substantially equivalent letter of April 25, 2005.
We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 (PMA), it may be subject to additional controls. Existing major regulations affecting vour device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition. FDA may publish further announcements concerning vour device in the Federal Register.
{1}------------------------------------------------
Page-2 Ms. Blankenbaker
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to continue marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
little by Michael David
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known): K042526
- Station Station Comments Comments of Children Comments of Con-
Device Name: Single Use Disposable OR Towel, Sterile and Non Sterile
Indications For Use: Single Use Disposable OR Towel is typically used for draping, body fluid absorption, and hand drying in an OR application
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use
and the start of the same of the may be in the same
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shula A Murphy
(Division Sign-Off)
Page 1 of 1
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K042526
§ 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.