B. BRAUN NERVE BLOCK CATHETER

K030830 · B.Braun Medical, Inc. · MEB · Jul 15, 2003 · General Hospital

Device Facts

• Record ID: K030830
• Device Name: B. BRAUN NERVE BLOCK CATHETER
• Applicant: B.Braun Medical, Inc.
• Product Code: MEB · General Hospital
• Decision Date: Jul 15, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The B. Braun Nerve Block Catheter is a device intended to provide, via percutaneous administration, continuous and/or intermittent infusion of local anesthetics near a nerve for regional anesthesia and pain management during the pre-operative, perioperative and postoperative periods associated with general and orthopedic surgery.

Device Story

Catheter for percutaneous administration of local anesthetics; used for regional anesthesia and pain management. Input: local anesthetic solution; Output: infusion near nerve. Used in pre-operative, perioperative, and postoperative clinical settings; operated by healthcare professionals. Device consists of polyamide tubing (18G-24G, 400mm-1010mm) with open or closed rounded tip; soft tip version features welded Pebax tip. Facilitates continuous or intermittent nerve block to manage surgical pain; benefits patient through targeted anesthesia delivery.

Clinical Evidence

Bench testing only.

Technological Characteristics

Polyamide tubing; optional welded Pebax soft tip. Sizes 18G to 24G; lengths 400mm to 1010mm. Open or closed rounded tip configurations. Non-electronic, mechanical infusion accessory.

Indications for Use

Indicated for patients undergoing general or orthopedic surgery requiring regional anesthesia or pain management via continuous or intermittent percutaneous infusion of local anesthetics near a nerve.

Regulatory Classification

Identification

An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

Predicate Devices

• B. Braun Medical Inc. Soft Tip Epidural Catheter Kit (K971233)
• B. Braun Medical Inc. Perifix® Set for Epidural Anesthesia with Tuohy Needle and Catheter (K813186)
• I-Flow Corporation Nerve Block Infusion Kit (K984502)
• I-Flow Corporation Intra Op Catheter (K991543)

Submission Summary (Full Text)

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## JUL 15 2003 8.0 510(k) Summary

| SUBMITTER: | B. Braun Medical Inc.<br>901 Marcon Boulevard<br>Allentown, PA 18109-9341<br>[phone], ext. 2280<br>Contact: Patricia D. Wilson, Regulatory Affairs Specialist |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE NAME: | B. Braun Nerve Block Catheter |
| COMMON OR USUAL<br>NAME: | Nerve Block Catheter / Elastomeric Infusion Pump Accessory |
| DEVICE<br>CLASSIFICATION: | Class II, 21 CFR 868.5120 (Anesthetic Conduction Catheter) and<br>21 CFR § 880.5725 (Elastomeric Infusion Pump) |
| PREDICATE DEVICE: | B. Braun Medical Inc. Soft Tip Epidural Catheter Kit (K971233)<br>B. Braun Medical Inc. Perifix® Set for Epidural Anesthesia with<br>Tuohy Needle and Catheter (K813186)<br>I-Flow Corporation Nerve Block Infusion Kit (K984502)<br>I-Flow Corporation Intra Op Catheter (K991543) |
| DESCRIPTION: | The B. Braun Nerve Block Catheter consists of polyamide tubing<br>with an open or closed rounded tip, and will be available in sizes<br>ranging from 18 G to 24 G, with a length ranging from 400 mm to<br>1010 mm. A soft tip version of the catheter (with a Pebax soft tip<br>welded to the catheter body) will also be available in a closed tip<br>configuration. |
| ●<br>INTENDED USE: | The B. Braun Nerve Block Catheter is a device intended to provide,<br>via percutaneous administration, continuous and/or intermittent<br>infusion of local anesthetics near a nerve for regional anesthesia and<br>pain management during the pre-operative, perioperative and<br>postoperative periods associated with general and orthopedic surgery. |
| SUBSTANTIAL<br>EQUIVALENCE: | The B. Braun Nerve Block Catheter has the same materials,<br>method of construction, and similar design as the Perifix® Epidural<br>Catheters that are marketed under the B. Braun Medical Inc.<br>Premarket Notifications K971233 and K813186. The<br>B. Braun Nerve Block Catheter differs from the Perifix Epidural<br>Catheter in the intended use, the location of catheter markings, and<br>the size range. |

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SUBSTANTIAL EQUIVALENCE (continued):

.

The indications for the B. Braun Nerve Block Catheter are similar to the indications for the Nerve Block Infusion Kit and the Intra Op Catheter that are marketed by I-Flow Corporation under the Premarket Notifications K984502 and K991543.

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Image /page/2/Picture/1 description: The image is a black and white circular logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the top half of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Patricia D. Wilson Regulatory Affairs Specialist B. Braun Medical Incorporated 901 Marcon Boulevard Allentown, Pennsylvania 18109

Re: K030830

Trade/Device Name: B. Braun Nerve Block Catheter Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: CFR Product Code: II Dated: June 11, 2003 Received: June 18, 2003

Dear: Ms. Wilson

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 vour 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.

JUL 15 2003

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Page 2 - Ms. Wilson

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/dsma/dsmamain.html

Sincerely yours.

Suser Pumm

Susan Runner, DDDS, 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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## 2.0 Indications for Use Statement

Page

| 510(k) Number (if known): | K030830 |
|---------------------------|-------------------------------|
| Device Name: | B. Braun Nerve Block Catheter |

Indications For Use:

The B. Braun Nerve Block Catheter is a device intended to provide, via percutaneous administration, continuous and/or intermittent infusion of local anesthetics near a nerve for regional anesthesia and pain management during the pre-operative and postoperative and postoperative periods associated with general and orthopedic surgery.

Susan Runo!

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

510(k) Number:

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

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ (Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

B. Braun Medical Inc. 510(k) Premarket Notification B. Braun Nerve Block Catheter

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