(136 days)
This device is composed of 100% natural cotton fiber. The intended uses of an operating room towel are the absorption of fluids, including blood and body fluids while being used as patient drape at the incision site, or serving as a general use sterile towel for drying hands. The product is intended for single use and is disposable. This product is not intended to be used as a protective barrier.
This device is composed of 100% natural cotton fiber.
This document is a 510(k) premarket notification letter from the FDA to Broadline Medical Industries, Incorporated, regarding their "Broadline O.R. Towels." It indicates that the device has been found substantially equivalent to legally marketed predicate devices.
Crucially, this document does not contain information about acceptance criteria, device performance, study details, or ground truth establishment for a medical device that uses an algorithm or AI functionality.
The "Broadline O.R. Towels" are described as being made of 100% natural cotton fiber and intended for absorption of fluids during surgery (blood, body fluids as a patient drape at the incision site, or a general use sterile towel for drying hands). They are for single use and disposable. The document explicitly states: "This product is not intended to be used as a protective barrier."
Therefore, I cannot answer your specific questions related to acceptance criteria, study methodologies, sample sizes, expert qualifications, or ground truth for an AI/algorithm-based device, as this product does not appear to be such a device.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 7 1999
Ms. Anna M. Ramza Quality Assurance Manager Broadline Medical Industries, Incorporated 923 North State Street 60123 Elgin, Illinois
K991667 Re: Broadline O.R. Towels Trade Name: Requlatory Class: II KKX Product Code: Dated: July 22, 1999 Received: July 23, 1999
Dear Ms. Ramza:
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. ਖ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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
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Page 2 - Ms. Ramza
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) 594-4690. 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,
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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510 (k) NUMBER (IF KNOWN) : 991667
Broadline O.R. Towels
INDICATIONS FOR USE:
DEVICE NAME:
This device is composed of 100% natural cotton fiber. The intended uses of an operating room towel are the absorption of fluids, including blood and body fluids while being used as patient drape at the incision site, or serving as a general use sterile towel for drying hands. The product is intended for single use and is disposable. This product is not intended to be used as a protective barrier.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED. )
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter-Use$\frac{\land}{1-2}$
(Optional Format
Olin S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospit 510(k) Number
§ 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.