FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The VenaTech™ LP Brachial Introducer System (Antecubital) allows for placement of the VenaTech LP Vena Cava Filter by an antecubital vein approach. The antecubital introducer system consists of an introducer sheath and dilator, guidewire, and pusher components. The introducer system is provided sterile.

AI/ML Overview

The provided text describes a 510(k) summary for the VenaTech™ LP Brachial Introducer System (Antecubital). This is a medical device accessory and its evaluation focuses on its ability to deliver an existing vena cava filter, rather than on AI/software performance. Therefore, many of the requested categories related to AI performance, such as sample sizes for test sets, expert ground truth, MRMC studies, standalone performance, and training set information, are not applicable.

Here's a breakdown of the available information:

Acceptance Criteria and Reported Device Performance

Criteria	Reported Device Performance
Ability to reliably deliver and deploy the VenaTech LP Filter (This is the implicit acceptance criterion based on the "Summary of Non-Clinical Testing")	Confirmatory design verification testing was performed and demonstrates that the VenaTech LP Filter can reliably be delivered and deployed through the VenaTech™ LP Brachial Introducer System (Antecubital).

Study Information

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified. The study involved "confirmatory design verification testing," which typically involves engineering tests, not patient data in the sense of a test set for an AI model.
Data Provenance: Not applicable in the context of an AI model. The testing would have been conducted in a lab environment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This is a physical device accessory, not an AI or diagnostic tool requiring expert ground truth for its performance evaluation in this context. The "ground truth" would be the successful physical delivery and deployment of the filter, evaluated by engineers or trained personnel during testing.

4. Adjudication method for the test set:

Not applicable. This concept applies to human interpretation of data for AI model validation, which is not relevant here.

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:

No, an MRMC comparative effectiveness study was not done. This device is an introducer system for a filter, not an AI-powered diagnostic tool. The concept of human readers improving with or without AI assistance is irrelevant here.

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

Not applicable. This is not an algorithm or AI system.

7. The type of ground truth used:

The "ground truth" for this type of device is successful physical deployment and delivery of the vena cava filter by the introducer system, as determined by engineering and performance testing. This is not "expert consensus," "pathology," or "outcomes data" in the typical sense applied to diagnostic tools, but rather functional verification against design specifications.

8. The sample size for the training set:

Not applicable. This is not an AI model requiring a training set.

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

Not applicable. This is not an AI model.

Summary of the Study:

The study proving the device meets its acceptance criteria is summarized as "Confirmatory design verification testing." This testing demonstrated that the VenaTech LP Filter can "reliably be delivered and deployed through the VenaTech™ LP Brachial Introducer System (Antecubital)." The report states that this evaluation was performed through "risk analysis and design verification testing following established Design Control procedures." The focus was on ensuring that the dimensional changes (length) of the introducer, guidewire, and pusher to accommodate the antecubital delivery approach did not raise new questions of safety or effectiveness for the already cleared VenaTech LP Vena Cava Filter.

In essence, the study was an engineering verification to ensure the accessory functioned as intended for its specific purpose of delivering the known filter.

Summary

Regulation Number and Section

§ 870.3375 Cardiovascular intravascular filter.

(a)
Identification. A cardiovascular intravascular filter is an implant that is placed in the inferior vena cava for the purpose of preventing pulmonary thromboemboli (blood clots generated in the lower limbs and broken loose into the blood stream) from flowing into the right side of the heart and the pulmonary circulation.(b)
Classification. Class II. The special controls for this device are:(1) “Use of International Standards Organization's ISO 10993 ‘Biological Evaluation of Medical Devices Part I: Evaluation and Testing,’ ” and
(2) FDA's:
(i) “510(k) Sterility Review Guidance and Revision of 2/12/90 (K90-1)” and
(ii) “Guidance for Cardiovascular Intravascular Filter 510(k) Submissions.”