KLINIDRAPE SURGICAL DRAPES

K031131 · Molnlycke Health Care · KKX · Jun 10, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K031131
• Device Name: KLINIDRAPE SURGICAL DRAPES
• Applicant: Molnlycke Health Care
• Product Code: KKX · General, Plastic Surgery
• Decision Date: Jun 10, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Intended Use

The Klinidrape® Surgical Drapes are devices intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.

Device Story

Klinidrape® Surgical Drapes are protective coverings used in surgical settings to isolate incision sites from contamination. The device consists of a 2- or 3-laminate structure composed of nonwoven material, polyethylene film, and white tissue. These drapes act as a physical barrier to prevent microbial transfer and fluid penetration during surgery. They are intended for use by healthcare professionals in clinical surgical environments.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included biological evaluation (ISO 10993), synthetic blood penetration (ASTM F1670-98), viral penetration (ASTM F1671-97b), flammability (16 CFR 1610), tensile strength/elongation (ASTM D 882), and breaking strength (ASTM D 5034).

Technological Characteristics

Materials: 2- or 3-laminate nonwoven, polyethylene film, and white tissue. Standards: ISO 10993 (biocompatibility), ASTM F1670-98 (synthetic blood penetration), ASTM F1671-97b (viral penetration), 16 CFR 1610 (flammability), ASTM D 882 (tensile strength/elongation), ASTM D 5034 (breaking strength). Form factor: Surgical drape.

Indications for Use

Indicated for use as a protective patient covering to isolate surgical incision sites from microbial and other contamination during surgical procedures.

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

• Klinidrape® Surgical Drapes (K000906)

Submission Summary (Full Text)

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# JUN 1 0 2003

### 510(k) SUMMARY

长031131

| Applicant: | Mölnlycke Health Care, Inc.<br>826 Newtown-Yardley Road<br>Newtown, PA 18940 |
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| | Contact Person: Miguel A. Negron<br>Vice President,<br>Quality & Regulatory Affairs - North America<br>Tel.: [phone]<br>Fax: [phone] |
| Device Name: | Proprietary Name: Klinidrape® Surgical Drapes<br>Common/Usual Name: Surgical Drapes<br>Device Classification: Class II – 21 CFR 878.4370 |
| Substantial<br>Equivalence: | For the purpose of Section 510(k) of the Federal Food, Drug and<br>Cosmetic Act, Mölnlycke Health Care considers the new Klinidrape®<br>Surgical Drapes are substantially equivalent in function and intended<br>use to our original Klinidrape® Surgical Drapes (K000906). |
| Intended Use: | The Klinidrape® Surgical Drapes are devices intended to be used as a<br>protective patient covering, such as to isolate a site of surgical incision<br>from microbial and other contamination. |
| Description: | The Klinidrape® Surgical Drapes are composed of a 3-laminate or 2-<br>laminate composed of nonwoven, polyethylene film and white tissue. |
| Summary of<br>Testing: | The Klinidrape® Surgical Drapes have been found non-toxic and non-<br>irritant when tested by the above biological tests in accordance with<br>the ISO 10993, Part I: Biological Evaluation of Medical Devices. The<br>materials used in the manufacturing of Klinidrape® Surgical Drapes<br>have been tested in accordance with applicable standards and was<br>determined to pass the Resistance of Materials Used in Protective<br>Clothing to Penetration by Synthetic Blood (ASTM-F1670-98) and the<br>Viral Penetration testing (ASTM-F1671-97b). These materials were<br>tested in accordance with 16 CFR 1610 and meet Class 1. The<br>Klinidrape® Surgical Drapes have been tested and pass Tensile<br>Strength and Elongation (ASTM D 882) and Breaking Strength<br>(ASTM D 5034). |

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Mõlnlycke Health Care, Inc.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

JUN 1 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Miguel A. Negron Vice President Mölnlycke Health Care, Incorporated 826 Newtown-Yardley Road Newtown, Pennsylvania 18940

Re: K031131

Trade/Device Name: Klinidrape® Surgical Drapes Regulation Number: 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: April 14, 2003 Received: April 15, 2003

Dear Mr. Negron:

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. Negron

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 (OS) 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 Runoe

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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#### Indications for Use Statement Section 9:

### PREMARKET NOTIFICATION

## INDICATIONS FOR USE STATEMENT

KO31131 Unassigned

510(k) Number:

Mölnlycke Health Care, Inc.

Device Name:

Klinidrape® Surgical Drapes

Indications for Use:

The Klinidrape® Surgical Drapes are devices intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <img alt="Salim" src="signature.png"/> |
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| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital, | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K031131 |

Prescription Use (Per 21 CFR 801.109) Or Over-The-Counter Use

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