STERI-DRAPE SURGICAL DRAPES

K031287 · 3M Company · KKX · Sep 10, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K031287
• Device Name: STERI-DRAPE SURGICAL DRAPES
• Applicant: 3M Company
• Product Code: KKX · General, Plastic Surgery
• Decision Date: Sep 10, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Intended Use

3M Steri-Drape™ Surgical Fabric Drapes are used to create a sterile field for a surgical procedure. They are provided sterile using ethylene oxide or gamma irradiation, and intended for external use only. 3M Steri-Drape™ non-sterile fabric drapes are provided to other manufacturers for further processing using ethylene oxide. 3M provides information on compatibility with ethylene oxide processing.

Device Story

Steri-Drape™ Fabric Surgical Drapes are single-use, disposable sheets providing an absorbent sterile barrier during surgery. Drapes consist of absorbent nonwoven fabric backed with a protective film to prevent fluid strike-through. Available in various sizes and shapes to accommodate different surgical fields. Used in clinical settings by surgical teams to cover patients and maintain a sterile environment. Benefits include protection against fluid contamination during procedures.

Clinical Evidence

Bench testing only. Biocompatibility testing performed including cytotoxicity, primary skin irritation, and sensitization testing. All results indicated the drapes are biocompatible and acceptable for the intended use.

Technological Characteristics

Single-use, disposable, nonwoven fabric sheet with a protective film backing. Sterilization via ethylene oxide or gamma irradiation. No electronic components or software.

Indications for Use

Indicated for creating a sterile field during surgical procedures. Intended for external use only. Applicable to patients undergoing surgical procedures requiring a sterile barrier.

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

• Steri-Drape™ Fabric Surgical Drapes (K031287)

Submission Summary (Full Text)

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# SEP 1 0 2003

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## Steri-Drape™ Fabric Drape Summary of Safety and Effectiveness

#### General Information

Manufacturer:

Requlatory Contact:

3M Health Care 3M Center St. Paul, MN 55144-1000 [phone]

Scott Sardeson Sr. Regulatory Affairs Associate

Date:

Dietary Name:

Steri-Drape™ Fabric Surgical Drape Proprietary Name:

March 21, 2003

Common Name: Sterile and Non-Sterile Surgical Drape

Steri-Drape™ Fabric Surgical Drapes Predicate Device: (Class II, KKX)

#### Device Description

The Steri-Drape™ Fabric Drapes described in this submission are onepiece, single use disposable sheets designed to provide an absorbent sterile barrier during surgical procedures. The drapes cover the patient and are made of an absorbent nonwoven fabric backed with a protective film that stops fluid strike-through.

Steri-Drape™ Fabric Drapes are provided in various sizes and shapes to meet the surgeon's needs. In general, the surgeon delineates the proposed field of surgery and charges the nursing team with the responsibility of draping the patient using different types of drapes.

#### Indication for Use

3M Steri-Drape™ Surgical Fabric Drapes are used to create a sterile field for a surgical procedure. They are provided sterile using ethylene oxide or gamma irradiation, and intended for external use only.

3M Steri-Drape™ non-sterile fabric drapes are provided to other manufacturers for further processing using ethylene oxide. 3M provides information on compatibility with ethylene oxide processing.

#### Substantial Equivalence

The Steri-Drape™ fabric drapes described in this submission are substantially equivalent to the currently marketed Steri-Drape™ fabric drapes. These drapes have the same intended use as the currently marketed Steri-Drape™ Fabric Drapes.

### Description of Testing

In addition to performance testing in accordance with industry recognized test methods, these drapes were tested for biocompatibility using

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cytotoxicity, primary skin irritation tests, and sensitization testing. All testing indicated that the drapes described above were biocompatible and acceptable for the intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

SEP 1 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Scott S. Sardeson Senior Regulatory Affairs Associate 3M Center, Bldg. 275-5W-06 Street Paul, Minnesota 55144-1000

Re: K031287

Trade/Device Name: Steri- Drape Surgical Drapes Regulation Number: 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: July 24, 2003 Received: July 28, 2003

Dear Mr. Sardeson:

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 vour 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. Sardeson

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/dsma/dsmamain.html

Sincerely yours,

Susan Russe

Susan Runner, DDS, MA Interim 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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# 510(k) Number (if known): K031287

Device Name: 3M Steri-Drape™ Surgical Fabric Drapes

Indications for Use:

3M Steri-Drape™ Surgical Fabric Drapes are used to create a sterile field for a surgical procedure. They are provided sterile using ethylene oxide or gamma irradiation, and intended for external use only.

3M Steri-Drape™ non-sterile fabric drapes are provided to other manufacturers for further processing using ethylene oxide. 3M provides information on compatibility with ethylene oxide processing.

Susabunne

(Division Sian-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental D

510(k) Number: K031287

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

concurrence of CDRH, Office of Device Evaluation (ODE)