(211 days)
The CROSSER S6 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 S6 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 S6 System consists of a re-usable electronic Generator, Foot Switch, high-frequency Transducer, and single-use CROSSER S6 Catheter.
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 stainless steel 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.
This document describes the FlowCardia CROSSER S6 System, a medical device designed to assist in navigating guidewires beyond chronic total occlusions in peripheral arteries. The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting a standalone clinical study with detailed acceptance criteria and performance metrics.
Based on the provided information, a clinical study proving the device meets specific acceptance criteria in the context of human performance, as would be typical for an AI/ML device, was not conducted or reported in this 510(k) summary. This summary focuses on physical and bench testing to demonstrate substantial equivalence to previously cleared devices.
Here's an breakdown of the information that can be extracted and what is NOT available:
1. Table of acceptance criteria and reported device performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Design analysis | Met relevant guidance documents to demonstrate substantial equivalence to predicate device. | Performed similarly to predicate device. |
| Bench testing | Met relevant guidance documents to demonstrate substantial equivalence to predicate device. | Performed similarly to predicate device. |
| Biocompatibility testing | Met relevant guidance documents to demonstrate substantial equivalence to predicate device. | Met acceptance criteria. |
| Dimensional Verification | Not explicitly stated, but implied to meet design specifications. | Not explicitly stated, but implied to meet design specifications. |
| Tensile Strength | Not explicitly stated, but implied to meet safety and performance standards. | Tested |
| Torque Strength | Not explicitly stated, but implied to meet safety and performance standards. | Tested |
| Torqueability | Not explicitly stated, but implied to meet safety and performance standards. | Tested |
| Tip Flexibility | Not explicitly stated, but implied to meet safety and performance standards. | Tested |
| Coating Adherence/Integrity | Not explicitly stated, but implied to meet safety and performance standards. | Tested |
| Bench top Simulated Efficiency | Not explicitly stated, but implied to meet safety and performance standards. | Tested |
| Catheter Fatigue Testing | Not explicitly stated, but implied to meet safety and performance standards. | Tested |
| Shelf Life Testing | Not explicitly stated, but implied to meet safety and performance standards. | Tested |
| Animal studies (using predicate device) | Established initial safety and performance. | Performed (with CROSSER LP predicate device). |
Note: The acceptance criteria are broadly described as meeting "relevant guidance documents" and performing "similarly to the predicate device." Specific numerical or qualitative targets for each test are not provided in this summary.
Regarding a "study that proves the device meets the acceptance criteria" in the context of an AI/ML device (which this is not) or human clinical performance, the following points are largely absent or not applicable:
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 for a clinical test set in this 510(k) summary. The testing documented here is primarily physical and bench testing. Animal studies were conducted with a predicate device, but no details on sample size or provenance are provided for those.
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 for this 510(k) summary. This type of information would be relevant for clinical studies involving expert interpretation, which is not the focus here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for this 510(k) summary. Adjudication methods are typically used in clinical trials to establish ground truth for ambiguous cases, which is not 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:
- No MRMC comparative effectiveness study was done or reported. This device is a physical catheter system, not an AI/ML diagnostic tool meant to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical device (catheter system), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the physical tests, the "ground truth" would be established by engineering specifications, material science standards, and performance characteristics of the predicate device.
- For animal studies (with the predicate device), the ground truth for safety and performance would have been established through direct observation, physiological measurements, and potentially necropsy, but no details are provided.
8. The sample size for the training set:
- Not applicable. This is a physical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set.
In summary: The provided document is a 510(k) summary for a physical medical device. It details a series of physical, bench, and biocompatibility tests designed to demonstrate substantial equivalence to predicate devices, rather than a clinical study evaluating human-machine interaction or AI performance against specific clinical acceptance criteria. The acceptance criteria are generally framed as meeting relevant guidance documents and performing similarly to the predicate.
§ 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).