(28 days)
The CROSSER® System is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions. The device is contraindicated for use in carotid arteries.
The CROSSER® Catheter is only intended for use with the CROSSER Electronics System. Refer to the CROSSER Electronics System Manual of Operations for proper use.
The CROSSER® System consists of a re-usable electronic Generator, Foot Switch, highfrequency Transducer, and single-use CROSSER Catheter. The CROSSER Over the Wire Catheter is available in two variations:
- CROSSER 14P OTW (014 guidewire compatible flexible), .
- CROSSER 14S OTW (014 guidewire compatible supportive). .
Each Catheter is connected to the electronic Generator through the Transducer. The Foot Switch is used to activate the system. The Generator and Transducer convert AC power into high frequency mechanical vibrations which are propagated through a Nitinol core wire to the Titanium tip of the CROSSER Catheter. The main body of the catheter is constructed from Pebax and a hydrophilic coating which covers the distal end of the catheter.
Here's a breakdown of the acceptance criteria and study information for the FLOWCARDIA, INC. CROSSER System, based on the provided text:
Acceptance Criteria and Device Performance
The documents do not provide a table with specific numerical or quantified acceptance criteria for each test (e.g., "Tensile Strength must be > X Newtons"). Instead, they state that the tests were conducted "to demonstrate that the FlowCardia CROSSER Over the Wire Catheters met the acceptance criteria and performed similarly to the predicate device."
Therefore, the table below reflects the types of tests performed and the general statement of meeting criteria, rather than specific performance metrics.
| Acceptance Criterion (Test Type) | Reported Device Performance |
|---|---|
| Dimensional Verification | Met acceptance criteria (implicitly, as it passed testing) |
| Tensile Strength | Met acceptance criteria |
| Torque Strength | Met acceptance criteria |
| Torqueability | Met acceptance criteria |
| Tip Flexibility | Met acceptance criteria |
| Coating Adherence/Integrity | Met acceptance criteria |
| Benchtop Simulated Efficiency | Met acceptance criteria |
| Catheter Fatigue Testing | Met acceptance criteria |
| Biocompatibility | Met acceptance criteria |
| Shelf Life Testing | Met acceptance criteria |
| Similarity to Predicate Device | Performed similarly to the predicate device |
Study Details
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Sample size used for the test set and the data provenance:
- The document mentions "Design analysis, bench, and biocompatibility testing," but does not specify the sample sizes for these tests.
- The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. It appears to be bench testing performed by the manufacturer.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The testing appears to be primarily engineering and physical testing, not dependent on expert medical interpretation for ground truth.
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Adjudication method for the test set:
- This information is not provided, as the tests are physical/bench tests rather than clinical evaluations requiring adjudication of expert opinions.
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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:
- No MRMC comparative effectiveness study was done. This device is a mechanical catheter system, not an AI-powered diagnostic or assistive technology for human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. The device is a mechanical catheter and does not involve an algorithm for standalone performance.
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The type of ground truth used:
- For the physical tests, the "ground truth" would be established by engineering specifications, standard test methods, and potentially the performance of the predicate device. For biocompatibility, it would be based on established international standards (e.g., ISO 10993).
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The sample size for the training set:
- This question is not applicable. This device is a mechanical catheter and does not involve a "training set" in the context of machine learning or AI.
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How the ground truth for the training set was established:
- This question is not applicable for the reasons mentioned above.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).