(25 days)
The Ultraflex™ EV Hemostasis Introducers are designed for the introduction of angiographic catheters, closed end catheters, balloon catheters and electrodes into a vessel where minimizing blood loss is essential.
The Ultraflex™ EV (9-12F) Hemostasis Introducers are introducers designed to provide easy access to the vascular system while providing convenient temporary closure of a standard indwelling introducer access site. The introducers include a sheath, hub, hemostasis valve, sideport for 3-way stopcock, and dilator. The introducers are provided sterile, and are intended for single-use only.
This 510(k) summary (K012922) pertains to the St. Jude Medical, Daig Division's Ultraflex™ EV Hemostasis Introducer. The device is a "Catheter Introducer" and its intended use is for "the introduction of angiographic catheters, closed end catheters, balloon catheters and electrodes into a vessel where minimizing blood loss is essential."
Critically, this submission is a claim of substantial equivalence to a predicate device (Ultraflex™ Hemostasis Introducer) and does not contain specific acceptance criteria for performance, nor does it detail a study proving the device meets such criteria. Instead, it relies on the assertion that its "technological characteristics... are substantially equivalent to the predicate device including product design, sterilization, and labeling."
Therefore, I cannot provide the requested information in the format given, as the underlying document does not contain a study with performance metrics, sample sizes, expert ground truth establishment, or comparative effectiveness.
However, I can extract the relevant information regarding the basis of the substantial equivalence claim:
1. A table of acceptance criteria and the reported device performance:
This document does not contain any specific acceptance criteria or reported device performance metrics from a study. It asserts substantial equivalence to a predicate device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No test set or associated data provenance is mentioned as this is a substantial equivalence claim based on technological characteristics rather than a new performance study.
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 test set requiring expert ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no test set requiring adjudication 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 is a medical device (catheter introducer), not an AI-assisted diagnostic tool.
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 concensus, pathology, outcomes data, etc):
Not applicable, as no ground truth for a performance study is mentioned.
8. The sample size for the training set:
Not applicable, as a training set for a performance study is not described.
9. How the ground truth for the training set was established:
Not applicable, as a training set for a performance study is not described.
Summary of the document's argument:
The 510(k) submission states that the Ultraflex™ EV Hemostasis Introducer is substantially equivalent to the predicate device, Ultraflex™ Hemostasis Introducers, based on shared "product design, sterilization, and labeling." This implies that the new device is considered safe and effective because its fundamental characteristics match an already legally marketed device with a known safety and effectiveness profile. The FDA's letter concurs with this substantial equivalence.
§ 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).