(3 days)
The EN Snare Endovascular Snare and Catheter is intended for use in the cardiovascular system or hollow viscous to retrieve and manipulate foreign objects. Manipulation procedures include indwelling venous catheter repositioning, indwelling venous catheter fibrin sheath stripping, and central venous access veni-puncture procedure assistance.
The EN Snare ® Endovascular Snare System consists of four individual components: snare; catheter; snare introducer; and torque device. The snare is comprised of 3 cable loops which are secured to a shaft wire. The construction of the snare enables it to be introduced through a catheter and manipulated by use of an external torque device. A snare introducer is also included for optional back-end loading of the snare into a pre-placed catheter.
This document is a 510(k) Premarket Notification for the EN Snare® Endovascular Snare System. It aims to demonstrate substantial equivalence to a predicate device, rather than providing a study proving a device meets specific acceptance criteria in the context of diagnostic performance (e.g., sensitivity, specificity, AUC).
Therefore, many of the requested categories are not applicable or cannot be answered from the provided text, as this type of submission focuses on demonstrating equivalence in design, materials, and intended use, not on a clinical performance study with predefined acceptance criteria for diagnostic accuracy.
Here's an analysis based on the provided text, addressing the applicable points:
1. A table of acceptance criteria and the reported device performance
This information is not present in the document. The submission is for a medical device that aims to be substantially equivalent to a predicate device, not a device that reports performance against specific diagnostic acceptance criteria. The document explicitly states: "No safety or performance testing is required to establish the safety and efficacy of the subject device" due to its identical nature to the predicate.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. No performance study with a test set was conducted or reported for this 510(k) submission.
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. No ground truth establishment by experts was part of this submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No test set or adjudication method was 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 not an AI-assisted device, and no MRMC study was conducted or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical instrument (snare system), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth was established as no performance study was conducted.
8. The sample size for the training set
Not applicable. This is a medical instrument, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
Summary of the document's approach:
The core of this 510(k) submission (K097343) for the EN Snare® Endovascular Snare System is to demonstrate substantial equivalence to a previously cleared predicate device (K021606). The key argument for substantial equivalence is that the subject device is "manufactured with identical design, materials and processes as that of the currently marketed EN Snare® Endovascular Snare System."
Therefore, the "acceptance criteria" for this submission are met by demonstrating that:
- Intended Use is identical: "The EN Snare Endovascular Snare and Catheter is intended for use in the cardiovascular system or hollow viscous to retrieve and manipulate foreign objects."
- Technological Characteristics are identical: "There are no technological differences between the subject and predicate devices. The system is manufactured with identical design, materials and processes..."
- Safety & Performance Testing: The submission explicitly states, "No safety or performance testing is required to establish the safety and efficacy of the subject device," because it is identical to a device already on the market with a proven safety and efficacy profile.
In essence, the "study" proving the device meets its "acceptance criteria" here is the analysis demonstrating identicality to the predicate device, which itself was cleared based on its own safety and performance pathway.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).