B. BRAUN CONTIPLEX CONTINUOUS NERVE BLOCK SET

K090995 · B.Braun Medical, Inc. · CAZ · Aug 14, 2009 · Anesthesiology

Device Facts

• Record ID: K090995
• Device Name: B. BRAUN CONTIPLEX CONTINUOUS NERVE BLOCK SET
• Applicant: B.Braun Medical, Inc.
• Product Code: CAZ · Anesthesiology
• Decision Date: Aug 14, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5140
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The B. Braun Contiplex® Continuous Nerve Block Set is intended to provide, via percutaneous administration, continuous and/or intermittent infusion of local anesthetics and analgesics near a nerve for perineural anesthesia and pain management during the pre-operative, perioperative and post-operative periods associated with general and orthopedic surgery. The route of administration is perineural (peripheral nerve block). The Contiplex® Catheter may remain indwelling for up to 72 hours.

Device Story

Set includes 18G insulated needle, sideport valve, 20G polyamide catheter, threading assist guide, and catheter connector. Used by clinicians for regional anesthesia and pain therapy. Needle tip transfers electrical impulses from external nerve stimulators (e.g., Stimuplex series) to localize nerve bundles. Once localized, catheter is placed percutaneously to facilitate continuous/intermittent infusion of anesthetics/analgesics. Indwelling up to 72 hours. Benefits include precise nerve localization and sustained pain management during pre-, peri-, and post-operative periods.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Components: 18G insulated stainless steel needle (Tuohy or straight tip), 20G polyamide catheter, sideport valve, clamp connector. Energy source: External nerve stimulator (electrical impulse). Sterilization: Not specified. Connectivity: None (mechanical/manual).

Indications for Use

Indicated for patients undergoing general or orthopedic surgery requiring perineural anesthesia and pain management via continuous or intermittent infusion of local anesthetics/analgesics near a nerve. Catheter indwelling time up to 72 hours.

Regulatory Classification

Identification

An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.

Predicate Devices

• Contiplex® Stim Continuous Nerve Block Set (K063282)

Reference Devices

• Stimuplex® DIG Nerve Stimulator
• Stimuplex® DIG RC Nerve Stimulator
• Stimuplex® HNS 11 Nerve Stimulator
• Stimuplex® HNS 12 Nerve Stimulator

Submission Summary (Full Text)

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K050995-

B. Braun Medical, Inc. 510(k) Premarket Notification August 13, 2009

### 5. 510(k) SUMMARY

# AUG 1 4 2009

SUBMITTER:

B. Braun Medical Inc. 901 Marcon Boulevard Allentown, PA 18109-9341 610-266-0500

Contact: Lisa Giaquinto, Sr. Analyst, Regulatory Affairs Phone: [phone] Fax: [phone] E-mail: [e-mail]

DEVICE NAME:

Contiplex Continuous® Nerve Block Set

COMMON OR USUAL NAME:

Anesthesia Conduction Kit

DEVICE CLASSIFICATION: Class II, Product Code CAZ, 868.5140

PREDICATE DEVICES:

Contiplex® Stim Continuous Nerve Block Set, B. Braun Medical, Inc., K063282, class II, CAZ, 868.5140

DESCRIPTION:

The Contiplex® Continuous Nerve Block Set consists of an 18 gauge insulated needle, a sideport valve assembly, a 20 gauge polyamide catheter with threading assist guide, and a clamp style catheter connector. The set is used to facilitate the continuous delivery of anesthetics or analgesics through a catheter during regional anesthesia and pain therapy procedures. The Contiplex insulated 18G needles contained in each set are available in four different lengths with a Tuohy shaped tip, and three different lengths with a straight tip. The needles are designed for precise localization of a nerve by transferring electrical impulses through a thinly coated stainless steel tip.

The Contiplex® needles can be used with the Stimuplex® DIG, the Stimuplex® DIG RC Nerve Stimulator, or the Stimuplex® HNS 11 and HNS 12 Nerve Stimulators.

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B. Braun Medical, Inc. 510(k) Premarket Notification

#### INTENDED USE:

The B. Braun Contiplex® Continuous Nerve Block Set is intended to provide, via percutaneous administration, continuous and/or intermittent infusion of local anesthetics and analgesics near a nerve for perineural anesthesia and pain management during the pre-operative, perioperative and post-operative periods associated with general and orthopedic surgery. The route of administration is perineural (peripheral nerve block). The Contiplex® Catheter may remain indwelling for up to 72 hours.

# SUBSTANTIAL EQUIVALENCE:

The Contiplex® Continuous Nerve Block Set has the same intended use and contains similar components as the Contiplex® Stim Continuous Nerve Block Set (K063282). Both sets utilize insulated stimulating needles to locate by stimulation, targeted nerve bundles, in order to perform peripheral nerve block procedures. Biocompatibility and functional performance testing have been completed to verify there are no differences between the proposed and predicate device, which raise new issues of safety or effectiveness.

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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 depiction of an eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the eagle.

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

Ms. Lisa Giaquinto Senior Analyst, Regulatory Affairs B. Braun Medical, Incorporated 901 Marcon Boulevard Allentown, Pennsylvania 18109-9341

AUG 1 4 2009

Re: K090995

Trade/Device Name: B. Braun Contiplex ® Continuous Nerve Block Set Regulation Number: 21 CFR 868.5140 Regulation Name: Anesthesia Conduction Kit Regulatory Class: II Product Code: CAZ Dated: August 3, 2009 Received: August 6, 2009

Dear Ms. Giaquinto:

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- Ms. Giaquinto

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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

Anthony D. Montanaro

Susan Runner, D.D.S., M.A. Acting Division 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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B. Braun Medical, Inc. 510(k) Premarket Notification

#### INDICATIONS FOR USE STATEMENT 4.

Page _________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

B. Braun Contiplex® Continuous Nerve Block Set

Indications For Use:

The B. Braun Continuous Nerve Block Set is intended to provide, via percutaneous administration, continuous and/or intermittent infusion of local anesthetics and analgesiss near a nerve for perineural anesthesia and pain management during the pre-operative, perioperative and post-operative periods associated with general and orthopedic surgery. The route of induction is perineural (peripheral nerve block). The Contiplex Catheter may remain indwelling for up to 72 hours.

Prescription Use X (Per 21 CFR 801.109)

OR

Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schultze

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

510(k) Number: 4090795