FOOTHILLS SURGICAL DRAPES

K041224 · Foothills Industries, Inc. · KKX · Feb 3, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K041224
• Device Name: FOOTHILLS SURGICAL DRAPES
• Applicant: Foothills Industries, Inc.
• Product Code: KKX · General, Plastic Surgery
• Decision Date: Feb 3, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Intended Use

Foothills Surgical Drapes are devices made from natural and synthetic materials intended to be used by medical professionals as protective coverings, such as a patient covering to isolate a site for surgical incision from contamination and to cover accessories in the operating room. These disposable single-use drapes are designed to be repackaged and sterilized before use by the user using a 100% EtO cycle that has been validated to achieve a SAL of 10-6 in accordance with ANSI/AAMI/ISO 11135:1994. Sterilization residual limits should meet the requirements of the ANSI/AAMI/ISO 10993-9:1995.

Device Story

Disposable surgical and utility drapes; composed of natural and synthetic materials. Used by medical professionals in operating rooms to provide protective barriers; isolate surgical sites; cover equipment. Drapes supplied non-sterile; intended for user-performed sterilization via 100% EtO cycle. Benefit: reduction of contamination risk during surgical procedures.

Clinical Evidence

No clinical data. Substantial equivalence based on technological characteristics and performance comparisons to legally marketed predicate devices.

Technological Characteristics

Disposable surgical/utility drapes; natural and synthetic materials. Sterilization: 100% EtO cycle validated to SAL 10-6 per ANSI/AAMI/ISO 11135:1994. Sterilization residuals compliant with ANSI/AAMI/ISO 10993-9:1995.

Indications for Use

Indicated for use by medical professionals as protective coverings for patients to isolate surgical incision sites from contamination and to cover operating room accessories.

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

• 3M Steri Drape (K031287)
• Alcon (K830822)

Submission Summary (Full Text)

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FEB - 3 2005

K041224

## Summary of Safety and Effectiveness

Submitted by:

Jov Shuford Foothills Industries 172 Lukfin Street Marion, NC 28752

Date Summary Prepared: December 6, 2004

Proposed Devices: Surgical drapes and utility drapes

### Classification Name: Surgical Drape and Drape Accessories

#### Comparison Devices:

Foothills Industries surgical drapes and utility drapes are substantially equivalent to surgical drapes and utility drapes currently marketed by 3M Steri Drape (K031287) and Alcon (K830822).

#### Description of Device:

Foothills Industries disposable surgical drapes and utility covers are devices made from natural and synthetic materials intended to be used by medical professionals as protective coverings.

#### Intended Use:

Foothills Industries disposable surgical drapes and utility covers are devices made from natural and synthetic materials intended to be used by medical professionals as protective coverings, such as patient covering to isolate a site for surgical incision from contamination and to cover accessories in the operating room.

These disposable single-use drapes are designed to be repackaged and sterilized before use by the user using a 100% EtO cycle that has been validated to achieve a SAL of 10-6 in accordance with ANSI/AAMI/ISO 11135:1994. Sterilization residual limits should meet the requirements of the ANSI/AAMI/ISO 10993-9:1995.

#### Technological Characteristics:

Foothills Industries surgical and utility drapes are made from the same materials and designs as other currently marketed surgical drapes. They provide the same absorbency, packaging, and other performance characteristics and are similarly labeled as disposable and non-sterile.

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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized caduceus, a symbol of medicine and health, with a double helix representing DNA.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 3 2005

Ms. Joy Shuford Chief Executive Foothills Industries, Incorporated 172 Lukin Street Marion, North Carolina 28752

Re: K041224

Trade/Device Name: Foothills Surgical Drapes Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: January 19, 2005 Received: January 21, 2005

Dear Ms. Shuford:

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.

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Page 2 - Ms. Shuford

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 vou 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,

Chiu 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): K041224

Device Name: Foothills Surgical Drapes

Indications For Use:

Foothills Surgical Drapes are devices made from natural and synthetic materials intended to be used by medical professionals as protective coverings, such as a patient covering to isolate a site for surgical incision from contamination and to cover accessories in the operating room.

These disposable single-use drapes are designed to be repackaged and sterilized before use by the user using a 100% EtO cycle that has been validated to achieve a SAL of 10-6 in accordance with ANSI/AAMI/ISO 11135:1994. Sterilization residual limits should meet the requirements of the ANSI/AAMI/ISO 10993-9:1995.

Cichosio D.P. for Loretta Michael 2/1/05, Acting Branch Chief

on Figh-6 Ston of Anesthesiology, General Hospital, Interior Control, Dental Devices

Number: K041224

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

Over-The-Counter Use X (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)