(129 days)
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.
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.
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)
§ 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).