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 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.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the Contiplex Continuous® Nerve Block Set. This document focuses on demonstrating substantial equivalence to a predicate device (Contiplex® Stim Continuous Nerve Block Set, K063282) rather than presenting a performance study with detailed acceptance criteria and results as would be typical for a new, non-substantially equivalent device.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert qualifications, and ground truth establishment are not available in this type of submission. The primary method of "proving" the device meets acceptance criteria in a 510(k) is to show it performs at least as well as an already legally marketed device with similar intended use.

Here's a breakdown of what can be extracted and what is missing:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence Claim)

Acceptance Criteria Category	Reported Device Performance (Contiplex Continuous® Nerve Block Set)
Intended Use	Same intended use as the predicate device (continuous/intermittent infusion of local anesthetics/analgesics near a nerve for perineural anesthesia and pain management).
Components	Contains similar components as the predicate device (e.g., insulated stimulating needles, polyamide catheter).
Safety and Effectiveness	Functional performance and biocompatibility testing completed to verify no new issues of safety or effectiveness compared to the predicate device.
Technical Characteristics	Utilizes insulated stimulating needles to locate targeted nerve bundles by electrical stimulation, similar to the predicate.

Study Information (Based on Available Text)

Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document states "Biocompatibility and functional performance testing have been completed," but does not provide details on the number of units or cases tested for functional performance. Biocompatibility testing typically involves material samples, not patient data.
- Data Provenance: Not specified. Given the nature of a 510(k) for substantial equivalence based on functional and biocompatibility testing (rather than a clinical trial), it's highly unlikely that patient data (country, retrospective/prospective) was involved in proving this specific iteration's equivalence. It would involve lab-based or bench testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. As no clinical study or diagnostic performance assessment is described, there's no "ground truth" establishment by experts in the context of diagnostic accuracy. "Ground truth" would refer to established performance derived from testing, likely by engineers or lab personnel.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. No clinical test set or diagnostic performance requiring adjudication is described.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This device is a medical instrument (nerve block set), not an AI/software device. Therefore, no MRMC study or AI assistance is relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For biocompatibility: Likely standard ISO/ASTM testing standards for material safety, which form the "ground truth" for material biological interaction.
- For functional performance: Likely engineering specifications and performance benchmarks for characteristics like needle insulation, catheter strength, and electrical stimulation properties. The "ground truth" would be established by meeting these pre-defined specifications.
- No clinical "ground truth" (e.g., pathology, outcomes) is described as being used to establish performance for this 510(k).
The sample size for the training set:
- Not Applicable. This device is a physical instrument, not an AI model, so there is no "training set."
How the ground truth for the training set was established:
- Not Applicable. (See above)

Summary

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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: (610) 596-2354 Fax: (610) 266-4962 E-mail: lisa.giaquinto@bbraun.com

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® 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:

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 (800) 638-2041 or (240) 276-3150 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)

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

Regulation Number and Section

§ 868.5140 Anesthesia conduction kit.

(a)
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.(b)
Classification. Class II (performance standards).