(325 days)
The Hinson and Hale Medical Technologies, Inc. Next Generation "Infused®" OR Towels, made of synthetic material, both hemmed (Model Number HUCKCR17X27MH) and with binding (Model Number HUCKCR17X27WB), are intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The OR towels are further used as a fluid absorbing towel during surgery or as a device to dry the hands of OR personnel. These towels are provided non-sterile and must be processed before use. These towels may be reprocessed for a total of 100 uses when laundered and sterilized according to the label and instructions provided with the product. Reprocessing instructions are based on industrial laundering procedures and steam sterilization (pre-vacuum sterilizer, 270°F, 4 minutes with 20 minutes drying time).
Hinson and Hale Medical Technologies, Inc. Next Generation "Infused®" OR Towel, made of synthetic material, both hemmed (Model Number HUCKCR17X27MH) and with binding (Model Number HUCKCR17X27WB).
I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or training set details for a medical device.
The document is a 510(k) premarket notification letter from the FDA to Hinson and Hale Medical Technologies, Incorporated, concerning their "Next Generation 'Infused' OR Towel." It states that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices. The letter also includes the "Indications for Use" for the OR towel.
Therefore, I cannot fulfill your request based on the given input.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Hinson and Hale Medical Technologies, Incorporated C/O Jeffrey O. Stull International Personnel Protection, Incorporated 7809 Adelaide Drive Austin, Texas 78739
NOV 1 9 2010
Re: K094016
Trade/Device Name: Hinson and Hale Medical Technologies, Inc. Next Generation "Infused")" OR Towel Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: November 10, 2010 Received: November 15, 2010
Dear Mr. Stull:
We have reviewed your 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 application (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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{1}------------------------------------------------
Page 2- Mr. Stull
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and dental Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
{2}------------------------------------------------
510(k) Number (if known): K094016
Device Name: Hinson and Hale Medical Technologies, Inc. Next Generation "Infused®" OR Towel
Indications for Use:
The Hinson and Hale Medical Technologies, Inc. Next Generation "Infused®" OR Towels, made of synthetic material, both hemmed (Model Number HUCKCR17X27MH) and with binding (Model Number HUCKCR17X27WB), are intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The OR towels are further used as a fluid absorbing towel during surgery or as a device to dry the hands of OR personnel. These towels are provided non-sterile and must be processed before use. These towels may be reprocessed for a total of 100 uses when laundered and sterilized according to the label and instructions provided with the product. Reprocessing instructions are based on industrial laundering procedures and steam sterilization (pre-vacuum sterilizer, 270°F, 4 minutes with 20 minutes drying time).
(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
Prescription Use (Per 21 CFR 801.109)
OR Elaine-Sover-the-Counter Use X
(Division Sign-Off) Division of Anesthesiology of Anesther Infection Control, Dental Devices
510(k) Number: K094016
§ 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.