EQUIPMENT SLUSH DRAPE

K053495 · Advance Medical Designs, Inc. · KKX · Mar 16, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K053495
• Device Name: EQUIPMENT SLUSH DRAPE
• Applicant: Advance Medical Designs, Inc.
• Product Code: KKX · General, Plastic Surgery
• Decision Date: Mar 16, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Intended Use

Advance Medical Designs equipment drapes are used to cover a variety of surgical and non-surgical equipment in various clinical settings. It is to be used in general and Endoscopic surgery for use with saline.

Device Story

Equipment slush drape; polyurethane film; sterile barrier pouch. Used to cover surgical/non-surgical equipment in clinical settings; specifically general and endoscopic surgery involving saline. Protects equipment from contamination. Operated by surgical staff.

Clinical Evidence

Bench testing only. Material tested to ASTM F 1671 for viral penetration and 16 CFR Part 1610 for flammability.

Technological Characteristics

Polyurethane film; sterile barrier pouch. Tested to ASTM F 1671 (viral penetration) and 16 CFR Part 1610 (flammability).

Indications for Use

Indicated for use as an equipment cover for surgical and non-surgical equipment in general and endoscopic surgical settings involving saline.

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

• MicroTek Equipment Drapes

Submission Summary (Full Text)

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ATTACHMENT 2

K053495

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# Substantial Equivalence 510(k) Summary

## Advance Medical Designs, Inc Equipment Slush Drape

To Whom It May Concern:

Date: 02/27/2006

Submitter/ Contact Name and Address William Slevin Advance Medical Designs, Inc. 1241 Atlanta Industrial Drive Marietta, GA 30066

Tel: [phone]

Trade Name: Advance Medical Designs, Inc Equipment Slush Drape

Classification Name: Drape, Surgical

Common/ Usual Name: Equipment Slush Drape

Predicate Legally Marketed Device: MicroTek Equipment Drapes

Intended Use:

Advance Medical Designs equipment drapes are used to cover a variety of surgical and non-surgical equipment in various clinical settings. It is to be used in general and Endoscopic surgery for use with saline.

Description of the Device:

The Advance Medical Designs, Inc Equipment Drapes consist of polyurethane film that is cut and configured to specification. Packaged in a pouch to act as a sterile barrier. These equipment drapes are equivalent to other equipment drapes currently being marketed for the same intended use

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### Performance

The material used in this product has been tested to ASTM Mcthod F 1671 for Viral Penetration and to 16 CFR Part 1610 for Flammability.

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Image /page/2/Picture/1 description: The image shows a circular seal with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA". The symbol in the center consists of three curved lines that appear to be stylized representations of a human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 16 2008

Mr. William Slevin Ouality Assurance Regulatory Affairs Advance Medical Designs, Incorporated 1241 Atlanta Industrial Drive Marietta, Georgia 30066

Re: K053495

Trade/Device Name: Equipment Slush Drape Regulation Number: 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: March 10, 2006 Received: March 13, 2006

Dear Mr. Slevin:

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 Eederal Register.

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#### Page 2 -- Mr. Slevin

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.

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/industry/support/index.html.

Sincerely yours,

Cluts
Chin Lin, Ph.D.

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): 长 053495

Device Name: Slush Drape

Indications For Use:

Advance Medical Designs Slush Drapes are equipment covers used to cover a variety of surgical and non surgical equipment in various clinical settings. It is to be used in General and Endoscopic surgery for use with Saline.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (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) | Page 1 of 1 |
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| Division of Anesthesiology, General Hospital, | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K053495 |

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