(236 days)
This product is to assist in the percutaneous introduction of diagnostic or therapeutic devices into a vessel.
The TFX Medical Introducer Kit consists of a Sheath/Dilator Assembly, Needle with indicator, Syringe, Guide-wire Tray
The provided text is a 510(k) summary for the TFX Medical Introducer Kit. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than providing extensive clinical study data with acceptance criteria for device performance in the way a novel AI or diagnostic device might.
Therefore, many of the requested data points (acceptance criteria, specific study details, sample sizes, ground truth establishment, MRMC studies, standalone performance) are not typically included in a 510(k) summary for a device like an introducer kit. The evaluation is based on comparison to existing devices with established safety and effectiveness.
Here's an analysis based on the provided text, addressing the points where information is available or explaining why it's not present:
Acceptance Criteria and Study for TFX Medical Introducer Kit (K991647)
This 510(k) summary for the TFX Medical Introducer Kit does not report specific quantitative acceptance criteria or a detailed study designed to measure the device's performance against such criteria. Instead, the submission relies on demonstrating substantial equivalence to existing legally marketed predicate devices. The "acceptance criteria" in this context are implicitly met if the device has "basic features, designs and intended uses" that are the same as the predicate and the "differences... raise no new issues of safety and effectiveness."
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Equivalence to Predicate Device | The device's basic features, designs, and intended uses are the same as legally marketed predicate devices. Differences must not raise new issues of safety and effectiveness. | The TFX Medical Introducer Kits are "substantially equivalent" to the Burron Tear-Away Sheath Introducers and Daig Corporation Introducer Sets. The submitter explicitly states: "the basic features, designs and intended uses are the same. The differences between the TFX Medical, Incorporated devices and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function or intended use of the devices." |
2. Sample size used for the test set and the data provenance
Not applicable. This 510(k) summary does not describe a clinical "test set" or a study involving human subjects or data collection for performance measurement. The submission is a comparison to predicate devices, focusing on design and intended use specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No "ground truth" establishment by experts for a test set is described, as the submission relies on substantial equivalence.
4. Adjudication method for the test set
Not applicable. No test set or adjudication method is described.
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 device is an introducer kit, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study, human readers, or AI assistance is relevant or discussed in this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an introducer kit, not an algorithm, and does not have a "standalone" or "human-in-the-loop" performance component.
7. The type of ground truth used
Not applicable. As discussed, the submission relies on demonstrating substantial equivalence to predicate devices, not on proving performance against a specific "ground truth" derived from pathology, outcomes data, or expert consensus for the TFX Medical Introducer Kit itself. The "ground truth" is effectively the established safety and effectiveness of the predicate devices.
8. The sample size for the training set
Not applicable. This submission does not involve machine learning or AI models, so there is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no corresponding ground truth to establish.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).