(247 days)
Typical applications include: For use where a routine chest tube is required to drain fluids and exudates during surgery or after surgery. The additional lumen allows for application of local anaesthetic to relieve postoperative pain. Caution: The Delivery of local anaesthetic is intended for duration of use, less than 72 hours.
This Axiom Interpleural Anesthesia Catheter is simplicity of design assures effective operation with added convenience. The sterile single patient use component includes the following: 2.1 A conveniently sized two Lumen Catheter made of Silicone round drain with radiopaque line that allows assessment of drain placement after wound closure. Various sizes starting from 18 Fr. up to 28 Fr. will be offered. 2.2 The first Lumen has a bigger inside diameter than the second lumen, and has a series of port openings (Eyes) into a passageway in the catheter wall that terminates at the first Funnel as a fluid outlet (Drainage function). 2.3 The second Lumen connected to the second Funnel as a fluid inlet (Irrigation function) and the Funnel is equipped with a three-way or four-way Stopcock.
This K971851 510(k) submission describes a substantially equivalent determination for a medical device rather than a de novo or PMA submission. Therefore, it does not contain the typical detailed performance study information you would find for novel devices or those requiring higher levels of evidence.
Here's an analysis based on the provided text:
Acceptance Criteria and Device Performance
The document describes a Substantial Equivalence (SE) determination. This means the device, the Axiom Interpleural Anesthesia Catheter, is determined to be as safe and effective as a legally marketed predicate device. The "acceptance criteria" here are not performance metrics in the traditional sense (e.g., sensitivity, specificity, accuracy) but rather the demonstration of substantial equivalence based on material, sterility, intended use, and general function.
| Acceptance Criteria Category | Reported Device Performance (as demonstrated for SE) |
|---|---|
| Sterility | Substantially equivalent to predicate device(s) |
| Material | Substantially equivalent to predicate device(s) |
| Drainage Function | Substantially equivalent to predicate device(s) |
| Indications for Use | Substantially equivalent to predicate device(s) |
| General Operation | Simplicity of design assures effective operation |
Study Information (Based on Substantial Equivalence Claim)
The document does not describe a clinical study with performance criteria like those found for AI/imaging devices. Instead, the "study" is a comparison to predicate devices to establish substantial equivalence.
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Sample size used for the test set and the data provenance: Not applicable. No test set of patient data was used in the way it would be for an AI device. The "test" consists of comparing the new device's characteristics to those of legally marketed predicate devices.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of clinical performance, is not established by experts for this type of submission. The "ground truth" for substantial equivalence is the FDA's determination that the new device shares fundamental characteristics with existing approved devices.
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Adjudication method for the test set: Not applicable. There was no adjudication of performance data. The FDA's review process determines substantial equivalence.
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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 physical medical device (catheter), not an AI-powered diagnostic or assistive tool.
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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.
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The type of ground truth used: Not applicable in the context of clinical performance. For a 510(k) substantial equivalence, the "ground truth" is the established safety and effectiveness profile of the predicate device(s) and the new device's demonstrable similarity.
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The sample size for the training set: Not applicable. This is not an AI/machine learning device requiring a training set.
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How the ground truth for the training set was established: Not applicable.
Summary regarding performance studies for K971851:
The submission for the Axiom Interpleural Anesthesia Catheter is a 510(k) for substantial equivalence. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than on presenting de novo clinical performance data against specific metrics. Therefore, the detailed information typically requested for AI/diagnostic studies (sample sizes for test/training sets, expert ground truth, MRMC studies, etc.) is not present or relevant in this document. The "study" here is the regulatory comparison to predicate devices, focusing on design, materials, manufacturing, and intended use.
§ 868.5120 Anesthesia conduction catheter.
(a)
Identification. An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.(b)
Classification. Class II (performance standards).