BUSSE SURGICAL DRAPES III

K092212 · Busse Hospital Disposables, Inc. · KKX · Oct 9, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K092212
• Device Name: BUSSE SURGICAL DRAPES III
• Applicant: Busse Hospital Disposables, Inc.
• Product Code: KKX · General, Plastic Surgery
• Decision Date: Oct 9, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Intended Use

A Surgical Drape is a protective patient covering, such as to isolate a site of surgical incisions from microbial and other contamination. They are provided sterile using ethylene oxide.

Device Story

Laminated non-woven surgical drapes; single-use; provide absorbent sterile barrier. Available in various sizes; with or without fenestration; with or without adhesive strip/patch. Used in clinical settings to isolate surgical sites from contamination. Protects patients by preventing microbial transfer during procedures. Sterilized via ethylene oxide.

Clinical Evidence

Bench testing only. Biocompatibility evaluation included Kligman Maximization Test, Intracutaneous Injection Test, Systemic Injection Test, Rabbit Pyrogen Test, and L929 Mem Elution Test. All materials met safety requirements.

Technological Characteristics

Laminated non-woven material; single-use; sterile (ethylene oxide). Features include optional fenestration and adhesive patches. No electronic or software components.

Indications for Use

Indicated for use as a protective patient covering to isolate surgical incision sites from microbial and other contamination. Intended for both prescription and over-the-counter use.

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

• Busse Surgical Drapes II (K083424)

Submission Summary (Full Text)

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K092212

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# 510(k) Summary

| Regulatory Affairs Contact: | Muhamad Ansari |
|-----------------------------|----------------------------|
| | Busse Hospital Disposables |
| | PO Box: 11067 |
| | 75 Arkay Dr. |
| | Hauppauge NY 11788 |

Telephone:

631-435-4711 Ext: 254

Fax:

631-435-2849

Date Summary Prepared:

July 15, 2009

Product Trade Name:

Busse Surgical Drapes III

Busse Surgical Drapes II, K083424

Common Name:

Busse Surgical Drapes III

Classification Name: Surgical Drapes III Class II, 21 CFR 878.4370, Product code KKX

Predicate Device:

Device Description:

The Laminated Non-Woven Surgical drapes described in this submission are one piece, single use, designed to provide an absorbent sterile barrier & protection from microbial and other contamination. There are various sizes, with & without fenestration, and with & without adhesive strip/patch.

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# K092212

| Intended Use: | A Surgical Drape is a protective patient covering,<br>such as to isolate a site of surgical incisions from<br>microbial and other contamination. They are<br>provided sterile using ethylene oxide. |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological Characteristics: | The subject device has the same Technological<br>Characteristics as a legally marketed predicate<br>device |
| Summary of Testing: | All materials used in the fabrication of the surgical<br>drapes were evaluated through biological<br>qualification safety tests.<br>The biocompatibility tests performed were:<br>1. Kligman Maximization Test<br>2. Intracutaneous Injection Test<br>3. Systemic Injection Test<br>4. Rabbit Pyrogen Test<br>5. L929 Mem Elution Test<br><br>These materials have met the testing requirements<br>and were found to be acceptable for the intended<br>use. |
| Conclusion: | The above statements are accurate representations<br>of the device Busse intents to market. Based on all<br>the testing and comparison Busse believes the<br>subject device is substantially equivalent to the<br>predicate device. All data and information<br>submitted in this premarket notification is truthful<br>and accurate and no material fact has been omitted. |

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002

Mr. Muhamad Ansari Director of Regulatory Affairs Busse Hospital Disposables, Incorporated 75 Arkay Drive Hauppauge, New York 11788

T - 9 2009

Re: K092212

Trade/Device Name: Busse Surgical Drape II Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: September 10, 2009 Received: September 11, 2009

Dear Mr. Ansari:

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 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. Ansari

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Anthony O. water for
Susan Buckner, D.D.S., M.S.

usan Runner, D.D.S., M.A. Acting 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 STATEMENT

510(k) Number (if known):

Device Name: Busse Surgical Drape III

Indication for Use:

The Busse Surgical Drape is intended to be used as a protective patient covering, such as to isolate a site of surgical incisions from microbial and other contamination. They are provided sterile using Ethylene Oxide. This is the same intended use as a previously cleared for the Busse Surgical Drape II, K083424. The Drapes included in this submission are the following:

687 – Sterile Blue Laminated Non-Woven 22 x 25 Drape with 2 ¼" Fenestration and Adhesive Patch

686 - Sterile Blue Laminated Non-Woven 22 x 25 Drape

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

Over-The-Counter Use X (Per 21 CFR 801Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shale Murphy
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K192212