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The intended use of the subject device is for the administration of local anesthetics into intra-operative sites for post-operative pain management and for regional anesthesia outside of the epidural space. Routes of administration may be intra-operative, subcutaneous or percutaneous.
The intended use of the subject device is equivalent to the predicates K003966 and K003611

The subject device is available as a closed end with multiple holes, fenestrated area, located radially along the lateral surface at the distal end of the device.
The subject device is radiopaque and is available in 19g and 20g sizes.

This document is a 510(k) premarket notification for a Conduction Catheter. It indicates substantial equivalence to predicate devices rather than presenting a study demonstrating it meets specific acceptance criteria based on performance. Therefore, most of the requested information regarding acceptance criteria and performance studies is not available in this document.

Here's what can be extracted based on the provided text:

1. A table of acceptance criteria and the reported device performance

This document does not present specific quantitative acceptance criteria or reported device performance in terms of clinical metrics. The basis for clearance is substantial equivalence to existing predicate devices. The document states:

• "No new issues of safety and effectiveness are raised by the design of the subject device."
• "The subject device is substantially equivalent in its performance to predicate K003966 and in its intended use to predicates K003966 and K003611."
• "The design, performance, materials, intended use and safety and effectiveness of the subject device is substantially equivalent to the cited predicate devices."

Therefore, the "acceptance criteria" are implicitly met by demonstrating this substantial equivalence through comparison of technological characteristics, materials, and intended use to previously cleared devices.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document describes a 510(k) submission based on substantial equivalence, not a clinical study with a test set of patient data. Therefore, this information is not applicable and not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as no clinical study with a test set of patient data requiring expert-established ground truth is presented.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical study with a test set of patient data requiring adjudication is presented.

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

Not applicable. This is a medical device for drug delivery, not an AI-assisted diagnostic device where MRMC studies would typically be performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable, as no clinical study with a ground truth is presented. The "ground truth" for this 510(k) submission is the pre-existing FDA clearance of predicate devices, against which the new device's characteristics are compared for substantial equivalence.

8. The sample size for the training set

Not applicable, as no algorithm requiring a training set is involved.

9. How the ground truth for the training set was established

Not applicable, as no algorithm requiring a training set is involved.

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