HVO, INC., DISPOSABLE NON-STERILE SURGICAL DRAPES

K050508 · Haywood Vocational Opportunities · KKX · Apr 27, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K050508
• Device Name: HVO, INC., DISPOSABLE NON-STERILE SURGICAL DRAPES
• Applicant: Haywood Vocational Opportunities
• Product Code: KKX · General, Plastic Surgery
• Decision Date: Apr 27, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Intended Use

HVO surgical drapes are 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. They are designed to be repackaged and/or sterilized before use. This single use product is a disposable non-sterile drape designed to be re-packaged and/or sterilized prior to use. This product may be sterilized using Ethylene Oxide (EO) following the Validation and Routine Control under ANSI/AMMI/ISO 11135. For more information about sterilization of this product, contact HVO, Inc.

Device Story

Disposable non-sterile surgical drapes; used as protective patient coverings to isolate surgical incision sites from contamination. Materials include SMS, LDPE, nonwoven cellulose, Airtex, Sontara, Krayton, medical-grade tapes, polyfoam, Velcro, polyester mesh, and adhesives. Supplied non-sterile; intended for customer-performed sterilization via Ethylene Oxide (EO) per ANSI/AAMI/ISO 11135. Used in clinical/surgical settings by medical professionals. Provides a physical barrier to reduce microbial transfer during surgical procedures.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Materials: SMS, micro-embossed/clear LDPE, nonwoven (wetlaid cellulose), Airtex, Sontara, Krayton, medical-grade single/double coated tapes, bridging, polyfoam, Velcro, polyester mesh, hot melt, cold glue, coated medical-grade liners. Form factor: Various surgical drapes (table covers, OB/GYN, general surgery, orthopedic, ENT/EENT, drape sheets, cystoscopy, craniotomy, angiography, fluid pouches, instrument covers). Sterilization: Non-sterile; validated for ETO sterilization per ANSI/AAMI/ISO 11135.

Indications for Use

Indicated for use by medical professionals as protective patient coverings to isolate surgical incision sites from microbial and other contamination. Intended for single use; must be sterilized by the customer prior to use in a sterile setting.

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.

Submission Summary (Full Text)

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# APR 2 7 2005

K050508

#### Haywood Vocational Opportunities, Inc. Various Disposable Non-Sterile Surgical Drapes

510(k) Summary

Summary of the Safety and Effectiveness Information Upon Which An Equivalence Could Be Based

#### SPONSOR INFORMATION

Haywood Vocational Opportunities, Inc. Name: P.O. Box 7 Address: Hazelwood, N.C. 28738 Telephone: [phone] [phone] Fax:

#### DEVICE NAMES

HVO, Inc., Various Disposable Non-Sterile Surgical Drapes Name: Surgical Drapes Common/Usual Name: Classifications Name (if known): Surgical and Drape Accessories Device Names: Table Covers, OB GYN, General Surgery, Orthopedic, ENT and EENT, Drape Sheets, Cystoscopy, Craniotomy, Angiography, Fluid Pouches, and Instrument Covers.

#### PREDICATE OR LEGALLY MARKETED DEVICES

There are several predicate devices currently on the market that have similar function and are made from same or similar materials.

#### DEVICE DESCRIPTION

The proposed HVO, Inc. Various Disposable Non-Sterile Surgical Drapes function in the same manner as predicate devices in that they are intended to be used as protective patient coverings, such as used to isolate a site of surgical incision from microbial and other contamination.

Device Design/ Materials Used/ Physical Properties: The HVO, Inc. Various Disposable Non-Sterile Surgical Drapes are made of materials commonly used for their purpose. The primary material components are SMS, Micro-embossed LDPE, Clear LDPE, Nonwoven (wetlaid cellulose), Airtex, Sontara, Krayton, Medical Grade Single and Double Coated Tapes, Bridging, Polyfoam, Velcro, Polyester Mesh, Hot Melt, Cold Glue and Coated Medical Grade Liners.

Primarily all of our drapes are offered in the color blue, which is the common color for medical device materials, but some materials are offered in white or with white backing. These materials include Nonwovens, SMS, Airtex, Sontara, Polyfoam, Back Table Covers, Bridging, and LDPE's. All other materials are clear plastics or adhesives, which are not colored, but natural.

#### DEVICE INTENDED USE

The HVO, Inc. Various Non-Sterile Surgical Drapes are intended to be used as protective patient covering, such as to isolate surgical incisions from microbial and other contamination. These proposed devices are intended to undergo sterilization by the customer prior to use in the sterile setting. These products can be sterilized by ETO. The products may be sterilized using Ethylene Oxide following the Validation and Routine Control under ANSVAAMI/ISO 11135, see section 12 for more details on sterilization.

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### Haywood Vocational Opportunities, Inc. Various Disposable Non-Sterile Surgical Drapes

510(k) Summary

## TECHNOLOGICAL COMPARISON WITH PREDICATE OR LEGALLY MARKETED DEVICE(S)

| Characteristics | HVO, Inc. Devices | Other Devices |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Materials | SMS, Micro-Embossed LDPE, Clear<br>LDPE, Sontara, Nonwoven, Krayton,<br>Airtex, Polyfoam, Medical Grade Single<br>And Double Coated Tapes, Velcro, Cold<br>Glue, Hot Melt, Bridging, Polyester Mesh<br>Coated Medical Grade Liners | Same or similar materials |
| Absorbency | Absorbent and Non-Absorbent | Same |
| Packaging | Bulk and Single Use | Bulk and Single Use |
| Disposable | Yes | Yes |
| Sterility | Non-Sterile | Non-Sterile and Sterile |

Page 2

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APR 2 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Tim Kelley Director of Regulatory Affairs Haywood Vocational Opportunities, Incorporated 56 Scates Street Waynesville, North Carolina 28786

Re: K050508

Trade/Device Name: Various Disposable Non-Sterile Surgical Drapes (Table Covers, OB GYN, General Surgery, Orthopedic, ENT and ENNT, Drape Sheets, Cystoscopy, Craniotomy, Angiography, Fluid Pouches, and Instrument Covers) Regulation Number: 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: April 19, 2005 Received: April 20, 2005

Dear Mr. Kelley:

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 - Mr. Kelley

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,

Sultie Y. Michie Omd.

Chr. Livia Ph.D.

Chíu 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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## Indication for Use

510(k) Number: K050508

Device Name: HVO, Inc. Various Disposable Non-Sterile Surgical Drapes (Table Covers, OB GYN, General Surgery, Orthopedic, ENT and ENNT, Drape Sheets, Cystoscopy, Craniotomy, Angiography, Fluid Pouches, and Instrument Covers).

Indications For Use:

HVO surgical drapes are 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. They are designed to be repackaged and/or sterilized before use.

This single use product is a disposable non-sterile drape designed to be re-packaged and/or sterilized prior to use. This product may be sterilized using Ethylene Oxide (EO) following the Validation and Routine Control under ANSI/AMMI/ISO 11135. For more information about sterilization of this product, contact HVO, Inc.

Prescription Use X (Part 21 CFR 801 Subpart D) and/or

Over-The-Counter Use (21 CFR 807 Subpart C)

Laird H. Mingay 13

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sion of Anesthesiology, General Hospital, rection Control. Dental Devices

:(k) Number. 4656508