BUSSE EPIDURAL CATHETER

K070465 · Busse Hospital Disposables, Inc. · BSO · Jul 19, 2007 · Anesthesiology

Device Facts

• Record ID: K070465
• Device Name: BUSSE EPIDURAL CATHETER
• Applicant: Busse Hospital Disposables, Inc.
• Product Code: BSO · Anesthesiology
• Decision Date: Jul 19, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5120
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Epidural Catheter is intended for administration of local anesthetics into the epidural space. Busse recommends the removal and/or replacement of the catheter every 72 hours. The epidural catheter will be sold sterile individually packaged, and as part of a sterile kit. The Catheter will also be sold as a non-sterile product to kit packers, who then may sterilize the catheter as part of a kit.

Device Story

Busse Epidural Catheter is a single-use, sterile device designed for the administration of local anesthetics into the epidural space. It is supplied either individually packaged or as a component within a sterile procedure kit; it is also available non-sterile for third-party kit packers. The device is intended for use by healthcare professionals in clinical settings. The catheter requires removal or replacement every 72 hours to maintain safety. By providing a reliable conduit for anesthetic delivery, the device facilitates regional anesthesia, potentially reducing systemic drug exposure and improving patient comfort during surgical or pain management procedures.

Clinical Evidence

Bench testing only. Biocompatibility testing performed included L929 MEM Elution Test, Kligman Maximization Test, Intracutaneous Injection Test, Systemic Injection Test, Salmonella Typhimurium and Escherichia Coli Reverse Mutation Assay, Hemolysis (Rabbit Blood), 14-day repeat dose intravenous toxicity study, and intramuscular implantation test (ISO).

Technological Characteristics

Single-use epidural conduction catheter. Materials evaluated for biocompatibility per ISO standards. Device is provided sterile or non-sterile for kit assembly. No electronic or software components.

Indications for Use

Indicated for the administration of local anesthetics into the epidural space for patients requiring epidural anesthesia.

Regulatory Classification

Identification

An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.

Predicate Devices

• Micor - Conduction Catheter (K001717)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image shows the logo for "busse Hospital Disposables". The word "busse" is in a bold, sans-serif font, with the letters slightly overlapping each other. Below the word "busse", the words "Hospital Disposables" are written in a smaller, less bold, sans-serif font. The logo is in black and white.

K070465

# SUMMARY

#### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS BUSSE EPIDURAL CATHETER

| Regulatory Affairs Contact: | Muhamad Ansari<br>Busse Hospital Disposables<br>PO Box: 11067<br>75 Arkay Dr.<br>Hauppauge NY 11788 | JUL 19 2007 |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Telephone: | 631-435-4711 Ext: 254 | |
| Fax: | 631-435-2849 | |
| Date Summary Prepared: | February 8th 2007 | |
| Product Trade Name: | Busse Epidural Catheter | |
| Common Name: | Epidural Catheter | |
| Classification Name: | Anesthesia Conduction Catheter | |
| Classification: | Class II, 21 CFR 868.5120 | |
| Product Code: | BSO | |
| Predicate Device: | Micor - Conduction Catheter -- (K001717) | |
| Device Description: | The Busse Epidural Catheter is a single use device,<br>which is sold as sterile individually packaged and<br>sterile packaged inside a kit/procedure tray. | |
| Intended Use: | The Epidural Catheter is intended for administration of<br>local anesthetics into the epidural space. Busse<br>recommends the removal and/or replacement of the<br>catheter every 72 hours.<br>The epidural catheter will be sold sterile individually<br>packaged, and as part of a sterile kit.<br>The Catheter will also be sold as a non-sterile product<br>to kit packers, who then may sterilize the catheter as<br>part of a kit. | |

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the logo for "busse Hospital Disposables". The word "busse" is in a bold, stencil-like font, with the letters close together. Below the word "busse" is the phrase "Hospital Disposables" in a smaller, regular font. The logo is black and white.

### 510(k) SUMMARY OF SUBSTANTIAL EQUIVALENCE

| Summary of Testing: | All materials used in the fabrication of the epidural catheter<br>were evaluated through biological qualification safety tests.<br>The biocompatibility tests performed were L929 Men Elution<br>Test, Kligman Maximization Test,<br>Intracutaneous Injection Test, Systemic Injection Test,<br>Salmonella Typhimurium; and Escherichia Coli Reverse<br>Mutation Assay, Hemolysis - Rabbit Blood, 14 Day Repeat<br>Dose Intravenous Toxicity Study (Sub - Chronic),<br>Intramuscular Implantation Test - ISO<br>These materials have met the testing requirements and were<br>found to be acceptable for the intended use. |
|---------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological Characteristics:<br>[21 CFR 807.92(a)(6)] | The subject device has the same Technological<br>Characteristics as a legally marketed predicate device. |
| Conclusion:<br>[21 CFR 807.92(b)(3)] | The above statements are accurate representations of the device<br>Busse intents to market.<br>Based on all the testing and comparison Busse believes the<br>subject device is substantially equivalent to the predicate<br>device<br>All data and information submitted in this premarket<br>notification is truthful and accurate and no material fact has<br>been omitted. |

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 1 9 2007

Mr. Muhamad Ansari Director of Regulatory Affairs Busse Hospital Disposables P.O. Box 11067 Hauppauge, New York 11788

Re: K070465

Trade/Device Name: Busse Epidural Catheter Regulation Number: 21 CFR 868.5120 Regulation Name: Anesthesia Conduction Catheter Regulatory Class: II Product Code: BSO Dated: July 6, 2007 Received: July11, 2007

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 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.

{3}------------------------------------------------

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); 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/industry/support/index.html.

Sincerely vours.

Cars

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

{4}------------------------------------------------

#### INDICATIONS FOR USE

510(k) Number (if known): __k ك ك ك ك

Device Name: Busse Epidural Catheter.

Indication for Use: The Epidural Catheter is intended for administration of local anesthetics into the epidural space. Busse recommends the removal and/or replacement of the catheter every 72 hours.

Prescription Use X (Per 21 CFR 801Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE – CONINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Null J. Dadel

al Color Sign-Olt)
Division of Anesthesiology, General Hospital
infection Control, Dental Devices infection of Anesthesiology, Gene

510(k) Number: K070465