(102 days)
The B. Braun Contiplex® FX Continuous Nerve Block Set is intended to provide continuous and/or intermittent infusion of local anesthetics and analgesics for peripheral plexus anesthesia and pain management. The Contiplex FX catheter may remain indwelling for up to 72 hours.
The B. Braun Continuous Nerve Block Set consists of one 17 gauge Tuohy needle, one 19 gauge springwound catheter with threading assist guide, one sideport valve assembly, and one clamp style catheter connector. The set is used to facilitate the continuous delivery of anesthetics or analgesics to the patient for pain management during regional anesthesia procedures.
The provided text is a 510(k) Premarket Notification for the B. Braun Contiplex FX Continuous Nerve Block Set. It describes the device, its intended use, and indicates that performance testing and biocompatibility testing were conducted to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Standard | Reported Device Performance |
|---|---|
| ISO 9626: "Stainless steel needle tubing for the manufacture of medical devices." | Met applicable sections of the standard. |
| ISO 7864: "Sterile hypodermic needles for single use." | Met applicable sections of the standard. |
| ISO 594-1: "Conical Fittings with a 6 % Luer taper for syringes, needles and certain other medical equipment - Part I: General Requirements." | Met applicable sections of the standard. |
| ISO 594-2: "Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment- Part 2: Lock fittings." | Met applicable sections of the standard. |
| EN 1618: "Catheters Other Than Intravascular Catheters - Test Methods for Common Properties." | Met applicable sections of the standard. |
| ISO 10993-1: "Biological evaluation of medical devices -- Part I: Evaluation and testing within a risk management process." (Biocompatibility) | Materials are safe for intended use. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for performance or biocompatibility testing. It also does not provide information on data provenance (e.g., country of origin, retrospective or prospective). The testing appears to be primarily benchtop/laboratory-based for device characteristics rather than clinical data from human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The "ground truth" for this medical device's performance is established by its adherence to internationally recognized engineering and biocompatibility standards, rather than expert consensus on clinical images or diagnoses.
4. Adjudication Method for the Test Set
This information is not applicable as the evaluation relies on objective measurements against engineering standards, not subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This device is a medical instrument (nerve block set), not an AI diagnostic tool or imaging system that would typically undergo such a study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device is a physical medical tool, not an AI algorithm. Its performance is evaluated through physical and material testing, not algorithmic output.
7. The Type of Ground Truth Used
The "ground truth" for establishing the safety and effectiveness of the Contiplex FX Continuous Nerve Block Set is adherence to international consensus standards for medical device design, manufacturing, and biocompatibility. This includes:
- Engineering standards (e.g., ISO 9626, ISO 7864, ISO 594-1, ISO 594-2, EN 1618) for physical properties and functional performance of the needle and catheter components.
- Biocompatibility standards (ISO 10993-1) for the materials used.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" in the context of this device's evaluation, as it's not an AI/machine learning product. The testing is based on device characteristics against predetermined standards.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
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B. Braun Medical Inc. 510(k) Premarket Notification Contiplex FX Continuous Nerve Block Set December 19, 2011
ડ. 510(k) SUMMARY
SUBMITTER:
B. Braun Medical Inc. 901 Marcon Boulevard Allentown, PA 18109-9341 610-266-0500
Contact: Lisa Giaquinto, Specialist, Regulatory Affairs Phone: (610) 596-2354 Fax: (610) 266-4962 E-mail: lisa.giaquinto@bbraun.com
DEVICE NAME:
Contiplex® FX Continuous Nerve Block Set
COMMON OR USUAL NAME:
SUBSTANTIAL
EQUIVALENCE:
Anesthesia Conduction Kit
DEVICE CLASSIFICATION:
Contiplex® Continuous Nerve Block Set, Braun Medical Inc., PREDICATE DEVICES: K090995, Class II, CAZ, 868.5140.
Class II, Product Code CAZ, 868.5140
DESCRIPTION: The B. Braun Continuous Nerve Block Set consists of one 17 gauge Tuohy needle, one 19 gauge springwound catheter with threading assist guide, one sideport valve assembly, and one clamp style catheter connector. The set is used to facilitate the continuous delivery of anesthetics or analgesics to the patient for pain management during regional anesthesia procedures.
INTENDED USE: The B. Braun Continlex® FX Continuous Nerve Block Set is intended to provide continuous and/or intermittent infusion of local anesthetics and analgesics for peripheral plexus anesthesia and pain management. The Contiplex FX catheter may remain indwelling for up to 72 hours.
The Contiplex® FX Continuous Nerve Block Set has the same intended use and contains similar components as the Contiplex Continuous Nerve Block Set cleared under premarket notification # K090995. Both sets include a Tuohy needle, catheter with threading assist guide, sideport valve assembly, and clamp style catheter connector. The primary differences between the proposed Contiplex FX Continuous Nerve Block Set and the predicate Contiplex
JAN 2 4 2012
K 113059
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B. Braun Medical Inc. 510(k) Premarket Notification Contiplex FX Continuous Nerve Block Set December 19, 2011
Continuous Nerve Block Set relate to the Tuohy needle and catheter. The predicate device contains a coated, stimulating Tuohy needle, while the proposed device contains an uncoated, nonstimulating Tuohy needle. Additionally, the predicate device also includes a polyamide catheter, while the proposed device includes a polyamide catheter with inner springwound coil.
Biocompatibility and functional performance testing have been completed with the proposed Tuohy needle and springwound catheter to verify there are no differences between the proposed and predicate device, which would raise new issues of safety or effectiveness.
Performance Testing
The following performance standards have been utilized in the evaluation of the Tuohy needle included in the proposed Contiplex FX Continuous Nerve Block Set:
ISO 9626: "Stainless steel needle tubing for the manufacture of medical devices. "
ISO 7864: "Sterile hypodermic needles for single use."
ISO 594-1: "Conical Fittings with a 6 % Luer taper for syringes, needles and certain other medical equipment - Part I: General Requirements. "
ISO 594-2: "Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment- Part 2: Lock fittings. "
The following performance standards has been utilized in the evaluation of the springwound catheter included in the proposed Contiplex FX Continuous Nerve Block Set:
EN 1618: "Catheters Other Than Intravascular Catheters - Test Methods for Common Properties."
Results of performance testing indicate that the needle and catheter in the Contiplex FX Continuous Nerve Block Set meet applicable sections of the standards referenced and are safe and effective for their intended use.
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B. Braun Medical Inc. 510(k) Premarket Notification Contiplex FX Continuous Nerve Block Set December 19, 2011
Biocompatibility
Biocompatibility testing was performed based on the nature and duration of patient contact outlined in ISO 10993-1: "Biological evaluation of medical devices -- Part I: Evaluation and testing within a risk management process." Results of testing demonstrates that the materials used in the construction of the needle and catheter in the proposed Contiplex FX Continuous Nerve Block Set are safe for their intended use.
Conclusion
Based on the results of performance and biocompatibility testing, the proposed nerve block set is considered similar to the predicate device identified above, and is safe and effective for it's intended use.
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Image /page/3/Picture/1 description: The image is a circular seal for the Department of Health & Human Services USA. The seal features the department's name in a circular arrangement around the edge. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
Ms. Lisa Giaquinto Regulatory Affairs Specialist B. Braun Medical, Incorporated 901 Marcon Boulevard Allentown, Pennsylvania 18109
JAN 2 4 2012
Re: K113059
Trade/Device Name: Contiplex FX Continuous Nerve Block Set Regulation Number: 21 CFR 868.5140 Regulation Name: Anesthesia Conduction Kit Regulatory Class: II Product Code: CAZ Dated: December 20, 2011 Received: December 21, 2011
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. 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 - 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/MedicalDevices/Safety/ReportaProblem/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Wh 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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B. Braun Medical Inc. 510(k) Premarket Notification Contiplex FX Continuous Nerve Block Set
4. INDICATIONS FOR USE STATEMENT
Page _________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Names:
Contiplex FX Continuous Nerve Block Set
Indications For Use:
The B. Braun Contiplex® FX Continuous Nerve Block Set is intended to provide continuous and/or intermittent infusion of local anesthetics and analgesics for peripheral plexus anesthesia and pain management. The Contiplex FX 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. Shullins
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
K113059 510(k) Number:
§ 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).