(74 days)
The Fetch Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system and coronary vasculature.
The FETCH Aspiration Catheter is a rapid exchange, low-profile tip, dual lumen catheter that uses a 0.014" (0.36 mm) guide wire to track to the target site. It is used for aspiration of fresh, soft emboli and thrombi Its outer diameter 0.052" (1.33 mm) or 4F allows advancement to the target site through a 6F (0.070" I.D.) guiding catheter. A radiopaque marker is located about 2 mm from the distal tip. FETCH is provided with an extension line, 30 cc syringe, one-way stopcock and a 40 micron collection basket. This basket can be used to filter aspirated blood for laboratory analysis of collected thrombus.
This looks like a 510(k) summary for a medical device called the "Fetch® Aspiration Catheter." This type of document is generally for regulatory submission to demonstrate substantial equivalence to a legally marketed predicate device, rather than a study proving the device meets specific acceptance criteria in the way a clinical trial would for a new drug or novel medical device.
Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria, as typically seen in clinical performance evaluations.
Here's why and what information is present:
- 510(k) Submissions Focus on Substantial Equivalence: The primary goal of a 510(k) summary is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and the same technological characteristics as the predicate device, or if it has different technological characteristics, that information submitted to FDA does not raise new questions of safety and effectiveness.
- Lack of Performance Metrics/Acceptance Criteria: The document mentions "mechanical testing, biocompatibility testing, and sterility assessment" were performed, but it does not provide specific acceptance criteria (e.g., "device must achieve X% successful thrombus removal") or the quantitative results of these tests against such criteria.
- No Clinical Study Details: There is no description of a clinical study (like a standalone or MRMC study) with human subjects, sample sizes for test/training sets, expert adjudication, or ground truth establishment relevant to clinical performance (e.g., efficacy in thrombus removal in patients).
Based on the provided text, I cannot complete the requested tables and information because the document describes a regulatory submission for substantial equivalence, not a clinical study proving performance against specific acceptance criteria.
The available information is limited to:
- Device Name: Fetch® Aspiration Catheter
- Intended Use: Removal of fresh, soft emboli and thrombi from vessels in the arterial system and coronary vasculature.
- Predicate Devices: The Fetch Aspiration Catheter - K062172 and K070363 (meaning this submission is likely for a modification or new size of an existing device).
- Testing Mentioned (without results or criteria): Mechanical testing, biocompatibility testing, and sterility assessment.
To answer your specific questions, the document would need to be a clinical study report, a performance study report, or similar, which it is not.
§ 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).