(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.
§ 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).