MICROTEK MEDICAL WARMING DRAPE

K060200 · Microtek Medical, Inc. · KKX · May 31, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K060200
• Device Name: MICROTEK MEDICAL WARMING DRAPE
• Applicant: Microtek Medical, Inc.
• Product Code: KKX · General, Plastic Surgery
• Decision Date: May 31, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Device consists of non-woven surgical drape with integrated air channel containing holes; designed to facilitate passage of warm air for patient warming. Used in clinical settings during surgeries or procedures. Operates by connecting to external convective air warming source (not provided). Provides thermal regulation to patient during surgical intervention; helps maintain normothermia.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and intended use comparison to legally marketed predicate devices.

Technological Characteristics

Non-woven surgical drape material; integrated air channel with holes for air distribution. Passive device requiring external convective air warming source. Dimensions and specific material standards not provided.

Indications for Use

Indicated for patients undergoing surgeries or procedures in a clinical setting requiring warming.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Cincinnati Sub-Zero Convective Air Warming Blankets
• Nellcor (Tyco) Warmtouch Warming Blankets

Submission Summary (Full Text)

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K060200

# 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:

- 1. Cincinnati Sub-Zero Convective Air Warming Blankets
- 2. 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

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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 [phone]. 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 [phone] or [phone] 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)

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(Division Sign-Off Division of General, Restorative. and Neurological Devices

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KOE0200 510(k) Number_