(269 days)
The Ancora Nerve Block Catheter Set is indicated for surgical pain management during the pre-operative, perioperative and post-operative periods associated with general and orthopedic surgery. The device allows physicians to locate peripheral nerves by transferring electrical impulses from a nerve stimulator and/or through ultrasound visualization of the device. The catheter may remain in dwelling for up to 72 hours.
The Ancora Nerve Block Catheter Set is a sterile, single-use, disposable device, intended for delivery of local anesthetic for continuous peripheral nerve blocks, in adult patients. The Ancora Nerve Block Catheter Set is intended to be placed with the use of nerve stimulation and/or ultrasound guidance. The device has a catheter-over-needle design, which consists of a 21-gauge needle and 18-gauge catheter with a twist lock connection between them. The device design includes an anchor and decoupler to help maintain the catheter position. Both the needle and catheter have NRFit connection for infusion. The device set includes two sizes of dressings.
The medical device in question is the "Ancora Nerve Block Catheter Set," which is designed for surgical pain management via continuous peripheral nerve blocks. The document provided outlines the device's characteristics, intended use, and a comparison to a predicate device (Braun Contiplex® C).
Here's an analysis based on the provided text, focusing on acceptance criteria and the study proving the device meets them:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly present a table of "acceptance criteria" with numerical targets and reported specific clinical performance metrics (like sensitivity, specificity, or improvement in pain scores). Instead, it describes a series of non-clinical performance tests and their compliance with relevant ISO and ASTM standards. The overarching acceptance criterion for the premarket notification (510(k)) is demonstrating substantial equivalence to a predicate device, meaning it's as safe and effective as a legally marketed device.
Here's a summary of the non-clinical performance areas and the general reported outcome:
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Performance Testing | Meets applicable sections of referenced standards (ISO 20698, EN 13868, ISO 7864, ISO 10555-1, ISO 10555-5, ASTM D4169-16, ISO 80369-6:2016, ANSI/AAMI/ISO 11135:2014) for: |
- Electrical performance (continuity, current transfer)
- Flow rate
- Occlusion
- Kink resistance
- Resistance to breakage
- Joint bond strength
- Leakage
- Penetration force
- Echogenicity
- Corrosion resistance |
| Biocompatibility | Materials used are safe for their intended use, based on ISO 10993-1 requirements for externally communicating devices with tissue contact (limited duration for needle assembly, prolonged duration for catheter/decoupler, skin contact for dressing). |
| Sterilization | Meets requirements as per ANSI/AAMI/ISO 11135:2014 (Ethylene oxide sterilization). |
| Shelf-life | Performed, results not detailed but implied to be acceptable for substantial equivalence. |
| Substantial Equivalence | Concluded to be substantially equivalent to the predicate device, as differences in technological characteristics do not raise different questions of safety and effectiveness. |
2. Sample size used for the test set and the data provenance:
The document does not mention any clinical study or human test set. The evaluation relies entirely on non-clinical performance data (bench testing) and a comparison of technological characteristics to a predicate device. Therefore, information about sample size for a test set and data provenance (country, retrospective/prospective) is not applicable here as no patient data was used for a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as there was no clinical test set requiring expert interpretation or establishment of ground truth. The "ground truth" for the non-clinical tests would be the specifications and requirements defined in the referenced industry standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This is not applicable as there was no clinical test set requiring adjudication.
5. 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:
This is not applicable. The device is a physical medical device (catheter set), not an AI algorithm or imaging diagnostic tool that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable as the device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For this device, the "ground truth" in the context of demonstrating safety and effectiveness for substantial equivalence is primarily based on:
- Industry Standards: Compliance with recognized international and national standards (ISO, EN, ASTM) for characteristics like material safety, electrical performance, mechanical integrity (kink resistance, bond strength), and sterilization.
- Predicate Device Equivalence: The performance and characteristics of the legally marketed predicate device (Braun Contiplex® C) serve as a de-facto "ground truth" for what constitutes an acceptably safe and effective device in this product category. The new device must demonstrate it is at least as safe and effective.
8. The sample size for the training set:
This is not applicable as there was no AI model or complex algorithm requiring a training set developed. The device is a physical product.
9. How the ground truth for the training set was established:
This is not applicable as there was no AI model or complex algorithm requiring a training set.
§ 868.5150 Anesthesia conduction needle.
(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).