MICROTEK EQUIPMENT DRAPES

K050322 · Microtek Medical, Inc. · KKX · May 17, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K050322
• Device Name: MICROTEK EQUIPMENT DRAPES
• Applicant: Microtek Medical, Inc.
• Product Code: KKX · General, Plastic Surgery
• Decision Date: May 17, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Intended Use

The intended use of this device is to protect equipment from contamination during a variety of procedures throughout the clinical setting.

Device Story

Microtek Medical Equipment Drapes consist of polyurethane film and non-woven materials configured to cover surgical and non-surgical equipment. Used in clinical settings to protect equipment from contamination during procedures. Device acts as a physical barrier; no electronic or active components. Operated by clinical staff during routine equipment preparation.

Clinical Evidence

Bench testing only. Materials tested to ASTM Method F 1671 for Viral Penetration.

Technological Characteristics

Materials: Polyurethane film and non-woven fabric. Sensing/Actuation: None (passive barrier). Connectivity: None. Sterilization: Not specified. Testing: ASTM F 1671 (Viral Penetration).

Indications for Use

Indicated for covering surgical and non-surgical equipment in clinical settings to protect against contamination during procedures.

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

• Medline band Bags and Equipment Drapes (K032065)
• Custom Medical Products Equipment Drapes (K931417)

Submission Summary (Full Text)

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K050322

### Premarket (510k) Summary

#### Submitter Information

Microtek Medical, Inc. 512 Lehmberg Road Columbus, Mississippi 39702 662-327-1863 Contact person: Thomas Bonner Date prepared: January 26, 2005

#### Device Name

Proprietary name: Microtek Medical, Inc., Equipment Drapes Common name: Equipment Drapes. CDRH Product Regulation: Surgical drape and drape Accessories (21 CFR, 878.4370)

#### Owner/Operator Number: 9009921

Establishment Registration Number: 1043582 (Microtek Medical, Inc.)

#### Classification: II

#### Statement of Substantial Equivalence

Microtek Medical, Inc. Equipment Drapes are equivalent to:

- 1. Medline band Bags and Equipment Drapes K032065
- 2. Custom Medical Products Equipment Drapes K931417

#### Description of Device

The Microtek Equipment Drapes consist of poly film and non-woven material, separately and in combination, manufactured to protect a variety of surgical and non-surgical equipment from contamination during various procedures throughout the clinical setting. These equipment drapes are similar to other equipment drapes currently being marketed for the same intended use.

#### Intended Use

The intended use of this device is to protect equipment from contamination during a variety of procedures throughout the clinical setting.

#### Materials

Most of the component materials used in the manufacture of these products are polyurethane film that is cut and configured to specification.

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K050322

## Performance

.

These materials have been tested in other applications to ISO 10993-1 standards, however, since these products are non-patient contact, the material used in these products has been tested to ASTM Method F 1671 for Viral Penetration.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services, USA. The seal features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.

Public Health Service

MAY 1 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Thomas B. Bonner Vice President Regulatory Affairs/Quality Assurance Microtek Medical, Incorporated 512 Lehmberg Road Columbus, Mississippi 39702

Re: K050322

Trade/Device Name: Microter Medical, Inc. Equipment Drapes Regulation Number: 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: April 19, 2005 Received: April 22, 2005

Dear Mr. Bonner:

.

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave to re now a young and have determined the device is substantially equivalent (for the referenced above and in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of Amendinents, or to do rood Cosmetic Act (Act) that do not require approval of a premarket the rederal 1 000; Drag, Drag, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 MA), it hay of subject to the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device earl be roundsh further announcements concerning your device in the Federal Register.

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#### Page 2 - Mr. Bonner

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 modified in the PDP may made and regulations administered by other Federal agencies. or the Act of all + reathar the Act's requirements, including, but not limited to: registration r out intisting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and ifing (2) - set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirence as as electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anon your even finding of substantial equivalence of your device to a premairer notified.com - 12 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), If you desire specific act 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 may overn bare. gMarwacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Cars

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

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# Indications for Use

510(k) Number (if known): Koso322

NICROTEK MEDICAL, INC. EQUIPMENT DRAPES Device Name:

Indications For Use:

MICROTEK MEDICAL EQUIPMENT DRAPES ARE TO BE USED TO COVER A VARIETY OF SURGICAL AND NON-SURGICAL EQUIPMENT IN VARIOUS SETTINGS THE CHOUSE HOUSE THE CUNICAL SETING. THESE DRAPES ARE USED TO PROFECT THE OQUIPMENT FROM CONTAMINATION DURING VARIOUS PROCEOURES.

Prescription Use __ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use __ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shala A. Murphy D

of Anesthesiology, General Hospital, Infection Control. Dental

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510(k) Number.*_*_