SURGICAL DRAPES

K061422 · Austin Medical, Inc. · KKX · Sep 25, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K061422
• Device Name: SURGICAL DRAPES
• Applicant: Austin Medical, Inc.
• Product Code: KKX · General, Plastic Surgery
• Decision Date: Sep 25, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Intended Use

Surgical drapes 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. These are provided non-sterile to kit packers, who then may sterilize the drape as part of a kit.

Device Story

Non-sterile, disposable surgical drapes; various configurations including table covers, OB/GYN, general surgery, orthopedic, ENT, cystoscopy, craniotomy, angiography, fluid pouches, and instrument covers. Used by medical professionals in hospitals, physician offices, and sub-acute institutions to isolate surgical sites from contamination. Provided to kit packers for subsequent sterilization as part of a surgical kit. Materials include micro-embossed LDPE, clear LDPE, Sontara, non-woven fabrics, Airtex, polyfoam, and medical-grade tape. Device acts as a physical barrier to prevent cross-contamination during surgical procedures.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Materials: micro-embossed LDPE, clear LDPE, Sontara, non-woven, Airtex, polyfoam, medical grade tape, and liners. Disposable, non-sterile (intended for sterilization by kit packers). Available in various configurations and absorbency levels.

Indications for Use

Indicated for use as protective coverings to isolate surgical incision sites from contamination. Intended for any individual patient population. Used by medical professionals in physician offices, hospitals, and sub-acute institutions. No contraindications.

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

• Webster Enterprises (K864899)

Submission Summary (Full Text)

{0}------------------------------------------------

Premarket Notification 510(k) Section 5 -- 510(k) Summary

<061422 Austin Medical

# Non-Confidential Summary of Safety and Effectiveness

Page 1 of 2 22-May-06

SEP 2 5 2006

| Austin Medical, Inc.<br>1578 Prairie Road<br>Enterprise, FL 32725 | Tel – [phone]<br>Fax – [phone] |
|-------------------------------------------------------------------|----------------------------------------------|
| Official Contact: | Tim Hutto, Owner |
| Proprietary or Trade Name: | Surgical Drapes |
| Common/Usual Name: | Surgical Drapes |
| Classification Name: | Surgical drapes |
| Device: | Various types of surgical drapes |
| Predicate Devices: | Webster Enterprises – K864899 |

Austin Medical offers a series of non-sterile surgical drapes for various surgical procedure applications, i.e., table covers, OB/GYN, General Surgery, Orthopedic, ENT and ENNT, Drape Sheets, Cystoscopy, Craniotomy, Angiography, Fluid Pouches, Instrument Covers, U Drapes, Minor procedure drapes, and pediatric drapes.

| Indications for Use: | |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indicated Use -- | Non-sterile surgical drapes made from natural and synthetic<br>materials intended to be used by medical professionals as<br>protective coverings, such as a patient covering to isolate a site<br>for surgical incision from contamination. These are provided<br>non-sterile to kit packers, who then may sterilize the drape as<br>part of a kit. |
| Patient Population -- | Any individual |
| Environment of Use -- | Physician office, hospital, sub-acute institutions |
| Contraindications -- | None |

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## Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 22-May-06

### Device Attributes:

| Features | Predicate<br>Webster - K864899 | Austin<br>Proposed |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|
| Indications for use | Surgical drapes made from natural and<br>synthetic materials intended to be used by<br>medical professionals as protective coverings,<br>such as a patient covering to isolate a site for<br>surgical incision from contamination | Same |
| Environment of Use | Physician offices, Hospital, Sub-acute<br>Institutions | Same |
| Patient Population | No limitations | Same |
| Contraindications | None | None |
| Sterility | Non-sterile<br>Sterile | Non-sterile |
| Configurations | Many | Many |
| Absorbency | Absorbent and non-absorbent | Same |
| Materials in patient<br>contact | Micro-embossed LDPE, Clear LDPE,<br>Sontara, non-woven, Airtex, Polyfoam,<br>Medical grade tape, liners | Identical |
| Disposable | Yes | Yes |

# Differences Between Other Legally Marketed Predicate Devices

The Austin Medical surgical drapes are viewed as substantially equivalent to the following predicate device. Webster, K864899.

There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## EP 2 5 2006

Austin Medical, Incorporated Mr. Paul E. Dryden President ProMedic, Incorporated 3460 Pointe Creek Court # 102 Bonita Springs, Florida 34134-2015

Re: K061422

Trade/Device Name: Surgical Drapes Regulation Number: 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKK Dated: September 14, 2006 Received: September 15, 2006

Dear Mr. Dryden:

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. Dryden

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 notifioation" (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 vours.

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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#### 4 Indications for Use Statement

Page 1 of 1

#### koby 22 (To be assigned) 510(k) Number:

### Device Name:

Surgical Drapes. Various disposable, non-sterile surgical drapes (Table covers, OB/GYN, General Surgery, Orthopedic, ENT and ENNT, Drape Sheets, Cystoscopy, Craniotomy, Anglogiaphy, Flaid Poaches, and Instrument Covers)

### Indications for Use:

Surgical drapes 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. These are provided non-sterile to kit packers, who then may sterilize the drape as part of a kit.

**Prescription Use**
(Part 21 CFR 801 Subpart D)

or

Over-the-counter use 7 (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)

Shila A. Murphy, 40

n of Anesthesiology, General Hospital, n Control, Dental Devices

Number: K011422