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The FETCH™ Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral 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.

The provided text is related to an FDA 510(k) premarket notification for the "FETCH Aspiration Catheter." It details the regulatory approval process and includes a brief device description and indications for use. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trial reports or detailed performance studies.

The document states: "Preclinical animal testing supported the substantial equivalency of the FETCH Aspiration Catheter to the predicate device for the indicated use." This indicates that animal testing was performed, but no details of the study design, acceptance criteria, or results are provided. The FDA 510(k) clearance process often relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive new clinical efficacy studies for many Class II devices.

Therefore, I cannot fulfill your request for the following information based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not available.
2. Sample size used for the test set and the data provenance: Not available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
4. Adjudication method for the test set: Not available.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not available.
6. If a standalone performance study was done: "Preclinical animal testing" was mentioned, but no study details are provided to assess if it was a standalone performance study in the context of your request (e.g., in a human clinical setting or with detailed metrics).
7. The type of ground truth used: Not available beyond the mention of "preclinical animal testing."
8. The sample size for the training set: Not applicable/available, as this appears to be a medical device clearance, not an AI/algorithm-based device in the context of your question about training sets.
9. How the ground truth for the training set was established: Not applicable/available.

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The FETCH™ Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from 2 mm or larger vessels in the arterial system.

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 45 allows advancement to the target site through a 6F (0.070" I.D.) guiding catherer. A radiopaque marker is located about 2 mm from the distal tip. FETCH is provided with an exterpsion line, 30 cc syringe, one-way stopcock and a 40 micron collection basket. This backet can be used to filter aspirated blood for laboratory analysis of collected three " the

The provided text is a 510(k) premarket notification for the FETCH Aspiration Catheter, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing robust clinical trial data with acceptance criteria and performance metrics described in medical AI/device studies. Therefore, much of the requested information cannot be directly extracted from this document.

However, I can extract information related to the device description and the type of testing performed to support substantial equivalence.

Based on the provided document:

1. A table of acceptance criteria and the reported device performance:

The document does not specify quantitative acceptance criteria or detailed performance metrics in the way a clinical study for a new AI/diagnostic device would. The approval is based on "substantial equivalence" to a predicate device.

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

• The document mentions "Bench, biocompatibility, animal, packaging and sterilization testing."
• It does not specify specific sample sizes for these tests, nor does it detail data provenance (e.g., country of origin, retrospective/prospective).
• Given the nature of the device (catheter for aspiration), the test set would likely refer to the number of devices or animal subjects used in the non-clinical tests mentioned. These are not typically human clinical data in the context of substantial equivalence.

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

• This is not applicable as the document describes an embolectomy catheter, not a diagnostic or AI device that requires expert-established ground truth for a test set. The validation relies on engineering and biological testing rather than interpretation of data by experts.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• This is not applicable for the same reason as point 3.

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:

• This is not applicable. The device is an aspiration catheter, not an AI or imaging diagnostic tool.

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

• This is not applicable. The device is a physical medical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• For the non-clinical tests (bench, biocompatibility, animal), the "ground truth" would be established by standard engineering measurements, material science evaluations, and observed biological responses (e.g., tissue reaction, effectiveness of clot removal in animal models). This is not expert consensus, pathology, or outcomes data in the typical sense for a diagnostic device.

8. The sample size for the training set:

• This is not applicable as the device is a physical catheter, not an AI model that requires a training set.

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

• This is not applicable for the same reason as point 8.

Summary of available information from the document regarding the device and its testing:

• Device Name: FETCH Aspiration Catheter
• Indications For Use: Removal of fresh, soft emboli and thrombi from 2 mm or larger vessels in the arterial system.
• Regulatory Basis: Substantial equivalence (510(k)) to predicate devices, specifically the Pronto Extraction Catheter (K042937) and other embolectomy catheters.
• Supporting Information (Testing): Bench, biocompatibility, animal, packaging, and sterilization testing. No specific details on sample sizes or detailed results are provided in this summary document, as the focus is on the regulatory determination of substantial equivalence.

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