BUSSE SURGICAL DRAPES IV

K093909 · Busse Hospital Disposables, Inc. · KKX · May 6, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K093909
• Device Name: BUSSE SURGICAL DRAPES IV
• Applicant: Busse Hospital Disposables, Inc.
• Product Code: KKX · General, Plastic Surgery
• Decision Date: May 6, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Intended Use

Busse Surgical Drape IV 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.

Device Story

Busse Surgical Drape IV is a single-use, one-piece sterile barrier designed to protect patients by isolating surgical incision sites from microbial and other contamination. The device is available in various sizes, with or without fenestrations, and with or without adhesive strips or patches. It is provided sterile via ethylene oxide. The drape is used in clinical or surgical environments to maintain a sterile field during procedures. It functions as a physical barrier to prevent the transfer of contaminants between the patient and the surgical environment.

Clinical Evidence

Bench testing only. Biocompatibility testing included Cytotoxicity (Agar Overlay L929), Sensitization (Buehler Method), and Irritation (Primary Skin ISO). Additional performance testing included Flammability and Lint testing. All materials met testing requirements.

Technological Characteristics

Single-use, one-piece surgical drape. Materials evaluated via biological qualification safety tests. Provided sterile via ethylene oxide. Available in various sizes with optional fenestrations and adhesive strips/patches.

Indications for Use

Indicated for use as a protective patient covering to isolate surgical incision sites from microbial and other contamination. Suitable for use in surgical settings.

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

• KC Surgical Drapes (K083234)

Submission Summary (Full Text)

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# K093909

MAY - 6 2010

l

## Summary of Safety and Effectiveness

Regulatory Affairs Contact:

Muhamad Ansari Busse Hospital Disposables PO Box: 11067 75 Arkay Dr. Hauppauge NY 11788

Telephone:

Fax:

Date Summary Revised:

Product Trade Name:

Common Name:

Classification Name:

Predicate Device:

Device Description:

Intended Use:

Technological Characteristics:

Summary of Testing:

631-435-4711 Ext: 254

631-435-2849

April 16, 2010

Busse Surgical Drapes IV

Surgical Drapes

Surgical Drapes Class II, 21 CFR 878.4370, Product code KKX

KC Surgical Drapes, K083234, Kimberly Clark Corp.

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.

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.

The subject device has the same Technological Characteristics as a legally marketed predicate device

All materials used in the fabrication of the surgical drapes were evaluated through biological qualification safety tests.

The biocompatibility tests performed were:

- Cytotoxicity: Agar Overlay (L929) 1.
- Sensitization: Buehler Method 2.
- Irritation: Primary Skin (ISO) 3.

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Image /page/1/Picture/0 description: The image shows the logo for "busse Hospital Disposables". The word "busse" is written in a bold, sans-serif font, with each letter connected to the next. Below the word "busse" is the phrase "Hospital Disposables" written in a smaller, sans-serif font.

Conclusion:

K093909

- Flammability Test 4.
- 5. Lint Test

These materials have met the testing requirements and were found to be acceptable for the intended use.

The above statements are accurate representations of the device Busse intents to market. Based on all the testing and comparison Busse believes the subject device is substantially equivalent to the predicate device. All data and information submitted in this premarket notification is truthful and accurate and no material fact has been omitted.

Official Correspondent:

Mulo med Qrai. (Signature)

Muhamad Ansari

Title: Director of Regulatory Affairs

Date: _ 4/27/10

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the caduceus in a circular fashion. The logo is black and white.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002

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

MAY - @ 2010

Re: K093909

Trade/Device Name: Busse Surgical Drape IV Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: April 27, 2010 Received: April 29, 2010

Dear Mr. Muhamad 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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. addition, FDA may publish further announcements concerning your device in the Federal Register.

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### Page 2- Mr. Muhamad 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/Resourcesfor You/Industry/default.htm.

Sincerely vours

Susan Fusner

Jen Anthony D. Watson, B.S., M.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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### INDICATION FOR USE STATEMENT

510(k) Number (if known): K093909

Device Name: Busse Surgical Drape IV

Indication for Use:

Busse Surgical Drape IV 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.

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)

Se

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: _ k 093909