(125 days)
Microtek Medical, Inc. Patient Warming Drape is intended to be used to provide patient warming during a variety of surgeries or procedures in the clinical setting.
The Microtek Patient Warming Drape consists of a non-woven surgical drape, similar to other surgical drapes currently being marketed, with the exception of an added channel (with holes) that is adhered to the drape and allows the passage of warm air.
The retrieved document is a 510(k) Premarket Notification for a Patient Warming Drape. This type of device is a physical product used for warming patients, not an AI/ML software device. Therefore, the questions regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, and training sets are not applicable to this document.
The 510(k) summary focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, which is a different regulatory pathway than what would require performance criteria and studies as described in the prompt's questions for an AI/ML device.
Here's the relevant information from the document:
Device Name: Microtek Medical, Inc., Patient Warming Drape
Intended Use: To provide patient warming during a variety of surgeries or procedures in the clinical setting.
Statement of Substantial Equivalence: The Microtek Medical, Inc. Patient Warming Drape is stated to be equivalent to:
- Cincinnati Sub-Zero Convective Air Warming Blankets
- Nellcor (Tyco) Warmtouch Warming Blankets
Since this is not an AI/ML device, the detailed study requirements outlined in your request are not present in this 510(k) submission.
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Premarket (510k) Summary
Submitter Information
MAY 3 1 2006
Microtek Medical, Inc. 512 Lehmberg Road Columbus, Mississippi 39702 662-327-1863 Contact person: Thomas Bonner Date prepared: October 12, 2004
Device Name
Proprietary name: Microtek Medical, Inc., Patient Warming Drape Common name: Patient Warming Drape CDRH Product Regulation: Surgical drape and drape Accessories (21 CFR, 878.4370)
Establishment Registration Number: 1043582 (Microtek Medical, Inc.)
Classification: II
Statement of Substantial Equivalence
Microtek Medical, Inc. Patient Warming Drape equivalent to:
-
- Cincinnati Sub-Zero Convective Air Warming Blankets
-
- Nellcor (Tyco) Warmtouch Warming Blankets
Description of Device
The Microtek Patient Warming Drape consists of a non-woven surgical drape, similar to other surgical drapes currently being marketed, with the exception of an added channel (with holes) that is adhered to the drape and allows the passage of warm air.
Intended Use
Microtek Medical, Inc. Patient Warming Drape is intended to be used to provide patient warming during a variety of surgeries or procedures in the clinical setting.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or other bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 3 1 2006
MicroTek Medical, Inc. % Mr. Thomas Bonner 512 Lehmberg Road Columbus, Mississippi 39702
Re: K060200
Trade/Device Name: Microtek Medical, Inc. Warming Drape Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical drape and drape accessories Regulatory Class: II Product Code: KKX Dated: January 4, 2006 Received: February 10, 2006
Dear Mr. Bonner:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Thomas Bonner
This letter will allow you to begin 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,
Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
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510(k) Number (if known):_____K060200
Device Name: Microtek Medical, Inc. Patient Warming Drape
Indications For Use:
Microtek Medical, Inc. Patient Warming Drape is intended to be used to wrotox modiour, mounday, moriety of surgeries or procedures in the clinical setting.
Prescription Use __ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
el.gmail
(Division Sign-Off Division of General, Restorative. and Neurological Devices
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
KOE0200 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.