BUSSE EPIDURAL CATHETER KIT

K093920 · Busse Hospital Disposables · BSO · Aug 6, 2010 · Anesthesiology

Device Facts

• Record ID: K093920
• Device Name: BUSSE EPIDURAL CATHETER KIT
• Applicant: Busse Hospital Disposables
• Product Code: BSO · Anesthesiology
• Decision Date: Aug 6, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5120
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Busse Epidural Catheter Kit is a sterile, single-use device for delivering local anesthetics into the epidural space. Components include clear tubing with a black radiopaque stripe, thread assist guide, connector gasket, and Tuohy Borst adapter. Catheter features 20-gauge sizing, 36-inch length, and is available in open or closed-tip configurations with 3 eyes. Depth markings are provided at 1 cm increments up to 20 cm for accurate placement. A safety marking at the tip confirms complete removal after use. The device is intended for clinical use by healthcare professionals. It functions as a conduit for anesthetic delivery; performance is verified through leakage, flow rate, tensile, and kink testing. The device is designed for short-term use, with a recommended replacement interval of 72 hours.

Clinical Evidence

Bench testing only. No clinical data provided. Performance verified through biocompatibility testing (Kligman Maximization, Intracutaneous Injection, Systemic Injection, Rabbit Pyrogen, L929 Mem Elution, Hemolysis, Subacute Toxicity) and mechanical performance testing (Liquid Leakage, Kink Test, Flow Rate, General Tensile Testing, Pull Test).

Technological Characteristics

20-gauge epidural catheter, 36-inch length, radiopaque stripe, Tuohy Borst adapter. Available in open or closed-tip (3 eyes) configurations. Materials evaluated via biocompatibility standards. Mechanical features include depth markings (1-20 cm). Non-powered, manual device.

Indications for Use

Indicated for the administration of local anesthetics into the epidural space in 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)

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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 close together. Below the word "busse" is the phrase "Hospital Disposables" in a smaller, sans-serif font. The logo is black and white.

K093920

AUG 0 6 2010

# 510(k) Summary

Regulatory Affairs Contact:

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

Telephone:

Fax:

Date Summary Prepared:

Product Trade Name:

Common Name:

Classification Name:

Predicate Device:

December 17, 2009

631-435-2849

631-435-4711 Ext: 254

Busse Epidural Catheter Kit

Epidural Catheter

Class II, 21 CFR 868.5120, Product code BSO

Micor Conduction Catheter, K001717, Micor Inc.

Device Description:

The Epidural Catheter kit consists of clear tubing with a black radiopaque stripe, a Thread assist guide, a Connector Gasket, and a Tuohy Borst adapter catheter connection. All inserted in a Polvethylene bag. The catheter is marked at 5 cm from the tip with 1 cm increments up to 20 cm. The 10 cm mark is indicated by two marks, the 15 cm by three marks, and the 20 cm by four marks. The Catheter will be available 20 Gauge, with a nominal length of 36 inches. It will be available in open tip or closed tip with 3 eyes. As an extra safety feature, the tip of the catheter is incorporated with a marking to assure the completed catheter has been removed.

Intended Use:

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

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busse

Technological Characteristics:

The design of the proposed Catheter is the same as the predicate device, except for the minor changes in the material used. The material does not effect the performance of the device, as attached testing demonstrate.

#### Summary of Testing:

All materials used in the fabrication of the epidural catheter were evaluated through biological qualification safety tests.

The biocompatibility tests performed were:

- 1. Kligman Maximization Test
- 2. Intracutaneous Injection Test
- 3. Systemic Injection Test
- Rabbit Pyrogen Test 4.
- റ്റ് L929 Mem Elution Test
- ം. Hemolysis Test
- Subacute Toxicity 7.

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

Summary of Performance Testing:

Busse Epidural Catheter has been tested for the following performance tests:

- 1. Liquid Leakage
- 2. Kink Test
- 3. Flow Rate
- 4. General Tensile Testing
- 5. Pull Test

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

Conclusion:

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:

Mihraef Ohen. (Signature)

Muhamad Ansari

Title: Director of Regulatory Affairs

**Date:** 6/24/10

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

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

# AUG 0.6 2010

Re: K093920

Trade/Device Name: Busse Hospital Disposable Epidural Catheter Kit Regulation Number: 21 CFR 868.5120 Regulation Name: Anesthesia Conduction Catheter Regulatory Class: II Product Code: BSO Dated: July 29, 2010 Received: July 30, 2010

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. 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. 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/ReportalProblem/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 yours,

ht for

Anthony D. Watson, B.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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FDA 510(k) Premarket Notification Busse Hospital Disposables - Epidural Catheter Kit

### INDICATIONS FOR USE

K093920

AUG & 6 2010

510(k) Number (if known):

Device Name: Busse Hospital Disposable Epidural Catheter Kit.

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

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Concurrence of CDRH Office of Device Evaluation (ODE)

L. Schultze

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

4693920 510(k) Number:

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use_