(94 days)
The CROSSER LP System is indicated in coronary arteries to facilitate the intra-luminal placement of conventional guidewires beyond chronic total occlusions.
The CROSSER System consists of a re-usable electronic Generator, Foot Switch, highfrequency Transducer, and single-use CROSSER LP 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 LP Catheter. The main body of the catheter is constructed from Pebax and a hydrophilic coating which covers the distal end of the catheter.
The provided document is a 510(k) summary for the FlowCardia CROSSER LP System, a medical device used to facilitate the placement of guidewires beyond chronic total occlusions in coronary arteries. It primarily focuses on demonstrating substantial equivalence to a predicate device through physical and functional testing, rather than an AI-powered diagnostic system.
Therefore, many of your requested categories are not applicable to the information contained within this document. The document describes a traditional medical device (catheter system), not an AI algorithm.
Here's a breakdown of the applicable and non-applicable information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document outlines functional tests performed, which serve as the acceptance criteria for the device's performance. However, it does not provide a table format with specific numerical acceptance criteria and a corresponding numerical reported performance for each test. Instead, it states that "the FlowCardia CROSSER LP System met the acceptance criteria and performed similarly to the predicate device."
| Acceptance Criteria (Functional Tests Performed) | Reported Device Performance |
|---|---|
| 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 |
| Biocompatibility | Met acceptance criteria |
| Bench top Simulated Efficiency | Met acceptance criteria |
| Catheter Fatigue Testing | Met acceptance criteria |
| Shelf Life | Met acceptance criteria |
| Package Integrity Testing | Met acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated for each functional test. The document mentions "Design analysis, bench, and biocompatibility testing were conducted."
- Data Provenance: Not applicable in the context of an AI study. These are bench and lab tests, not clinical data sets from specific countries.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Not Applicable. This device is proven through physical and functional testing, not through expert-labeled data sets for an AI algorithm.
4. Adjudication Method for the Test Set:
- Not Applicable. Again, this refers to expert consensus for AI ground truth, which is not relevant here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This type of study is for evaluating human readers with and without AI assistance. The FlowCardia CROSSER LP System is a physical medical device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Not Applicable. This is not an AI algorithm.
7. Type of Ground Truth Used:
- For the functional and bench tests, the "ground truth" is defined by the engineering specifications and performance requirements for a catheter system.
- Animal studies were also conducted "to establish initial safety and performance," which serves as an in-vivo form of ground truth for safety and general performance.
8. Sample Size for the Training Set:
- Not Applicable. This is not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. This is not an AI algorithm.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.