(116 days)
The CROSSER 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, high frequency Transducer, and single-use CROSSER 14 Catheter. The CROSSER 14 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 14 Catheter. The main body of the catheter is constructed from Pebax and a hydrophilic coating which covers the distal 90cm of the catheter.
The provided text describes the FlowCardia CROSSER System and its 510(k) submission (K062868). It primarily focuses on demonstrating substantial equivalence to a predicate device, the Intraluminal Therapeutics (ILT) Safe-Cross System, through technological characteristics, physical test data, and clinical study data.
However, the document does not contain specific acceptance criteria, detailed device performance metrics, or the full study design typically expected for a comprehensive report on device performance against acceptance criteria. It mentions that "the FlowCardia CROSSER System met the acceptance criteria and performed similarly to the predicate device" in physical tests and that a "clinical study... demonstrated substantially equivalent safety and effectiveness," but it does not elaborate on what those criteria were or the specific results.
Therefore, much of the requested information cannot be extracted directly from the provided text. I will provide what can be inferred or explicitly stated.
Acceptance Criteria and Device Performance Study Data - FlowCardia CROSSER System (K062868)
The provided 510(k) summary indicates that various tests were conducted to demonstrate the substantial equivalence of the FlowCardia CROSSER System to its predicate device. While it states that the system "met the acceptance criteria," it does not specify what those acceptance criteria were in quantitative terms for most of the tests. Similarly, detailed device performance metrics are not reported.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The provided document states that the device "met the acceptance criteria" but does not explicitly define these criteria or report specific performance values against them. The information below is inferred from the types of tests mentioned.
| Test Category | Acceptance Criteria (Inferred from text) | Reported Device Performance (as stated in text) |
|---|---|---|
| Physical Tests | Adherence to design specifications, material properties, and functional requirements, and performance similar to the predicate device. | Met the acceptance criteria; performed similarly to the predicate device. |
| Dimensional Verification | Specific dimensions (e.g., working length around 146cm vs. 175cm for predicate). | Not explicitly stated, but implies verification occurred. |
| Tensile Strength | Sufficient strength to withstand typical forces during use. | Met the acceptance criteria. |
| Torque Strength | Sufficient strength to withstand torquing actions. | Met the acceptance criteria. |
| Torqueability | Ability to transmit torque effectively. | Met the acceptance criteria. |
| Tip Flexibility | Appropriate flexibility for navigation within coronary arteries. | Met the acceptance criteria. |
| Coating Adherence/Integrity | Hydrophilic coating remains intact and functional. | Met the acceptance criteria. |
| Biocompatibility | Biologically safe for intended use. | Met the acceptance criteria. |
| Bench top Simulated Efficiency | Efficient operation in a simulated environment. | Met the acceptance criteria. |
| Catheter Fatigue Testing | Durability over repeated use or simulated life. | Met the acceptance criteria. |
| Shelf Life | Maintains integrity and functionality over its specified shelf life. | Met the acceptance criteria. |
| Package Integrity Testing | Packaging protects the device until use. | Met the acceptance criteria. |
| Clinical Study | Demonstration of substantially equivalent safety and effectiveness to the predicate device in facilitating guidewire placement beyond CTOs. | Demonstrated substantially equivalent safety and effectiveness to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided text. The document only mentions "clinical study of the FlowCardia CROSSER System" without detailing the number of patients or cases.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective nature). The text simply refers to a "clinical study."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the given text.
4. Adjudication Method for the Test Set
This information is not provided in the given text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not provided in the given text. The study mentioned is a "clinical study" to demonstrate substantial equivalence, but it's not described as an MRMC study comparing human readers with and without AI assistance. The device itself is a percutaneous catheter, not an AI-powered diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is not applicable as the device is a physical medical instrument (percutaneous catheter), not an algorithm or AI system for standalone performance evaluation without human intervention. The "Generator" is an electronic component that powers the catheter, not a diagnostic algorithm.
7. Type of Ground Truth Used
For the "clinical study," the ground truth would likely be based on clinical outcomes (e.g., successful crossing of chronic total occlusions, patient safety, absence of major adverse cardiac events) as assessed by interventional cardiologists or relevant medical professionals during the procedure and follow-up. However, the specific method for establishing this ground truth (e.g., expert consensus, pathology, long-term outcomes data) is not detailed in the provided text.
8. Sample Size for the Training Set
This information is not applicable as the device is a physical medical instrument and not an AI/machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above (not an AI/ML model).
§ 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).