(261 days)
The Reprocessed ViewFlex™ Xtra ICE Catheter is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures, blood flow and other devices within the heart.
The Reprocessed ViewFlex Xtra ICE Catheter is a temporary intracardiac ultrasound catheter intended for use in patients to visualize cardiac structures and blood flow within the heart. The Reprocessed ViewFlex Xtra ICE Catheter is inserted into the heart via intravascular access. The Reprocessed ViewFlex Xtra ICE Catheter shaft is a 9 French catheter with a useable length of 90 cm. The shaft is compatible with a 10 French or larger introducer for insertion into the femoral or jugular veins. The catheter tip is a 64- element linear phased array transducer housed in silicone. The distal portion of the shaft is deflectable in four directions allowing for leftto-right and anterior-to-posterior deflection. The handle of the catheter has two deflection mechanisms that correspond with movement of the distal shaft in the four planes of movement. The Reprocessed ViewFlex Xtra Ice Catheter is compatible with ViewMate Z or ViewMate and Philips CX50 ultrasound consoles via the use of a compatible ViewFlex Catheter interface module.
The provided text is a 510(k) summary for a reprocessed medical device, specifically a Reprocessed ViewFlex Xtra ICE Catheter. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's performance against detailed acceptance criteria for a new AI or diagnostic device.
Therefore, many of the requested elements (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth for training) are not applicable to this document as it describes a reprocessed catheter and not a new diagnostic algorithm or AI system.
However, I can extract the relevant information regarding performance testing that was conducted to demonstrate the reprocessed device's safety and effectiveness.
Here's a breakdown of what can be extracted, and where limitations exist based on the document:
1. A table of acceptance criteria and the reported device performance:
The document describes the types of tests performed to demonstrate that the reprocessed device performs "as originally intended" and is "effectively identical" to the predicate. It does not provide specific quantitative acceptance criteria or detailed numerical performance results for these tests. The conclusion states the device is "at least as safe and effective as the predicate device," implying it met internal standards for each test.
| Test Category | Reported Device Performance | Acceptance Criteria (Not explicitly stated in document) |
|---|---|---|
| Biocompatibility | Passed (implied by conclusion of safety and effectiveness) | (Not detailed, but typically involve ISO 10993 compliance) |
| Validation of Reprocessing | Passed (implied by conclusion of safety and effectiveness) | (Not detailed, but involves demonstrating proper cleaning, disinfection/sterilization, and restoration of function) |
| Sterilization Validation | Passed (implied by conclusion of safety and effectiveness) | (Not detailed, but involves demonstrating sterility assurance level) |
| Functional Performance Tests | "demonstrates that Reprocessed ViewFlex device perform as originally intended." | (Not detailed, would involve specific mechanical and operational parameters) |
| Acoustic Testing | Passed (implied by conclusion of safety and effectiveness) | (Not detailed, would involve ultrasound image quality and output parameters) |
| Electrical Safety Testing | Passed (implied by conclusion of safety and effectiveness) | (Not detailed, but typically involves IEC 60601 standards) |
| Electromagnetic Compatibility Testing | Passed (implied by conclusion of safety and effectiveness) | (Not detailed, but typically involves IEC 60601-1-2 standards) |
| Packaging Validation | Passed (implied by conclusion of safety and effectiveness) | (Not detailed, but involves maintaining sterility and product integrity) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size: Not specified. The document states "Each individual device is tested for appropriate function" during reprocessing, and that bench and laboratory testing was conducted. This implies testing on a statistically relevant sample of reprocessed devices, but the exact number isn't given.
- Data Provenance: Not applicable in the context of this device and the types of tests described. These are laboratory/bench tests, not clinical data sets from patients.
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. This document describes engineering and laboratory testing for a reprocessed catheter, not a diagnostic algorithm that requires expert ground truth for interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are used for interpreting clinical data, particularly in a reader study or when establishing ground truth from multiple experts. This is not relevant for bench testing of a catheter.
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:
- Not applicable. This is a reprocessed catheter, not an AI or diagnostic imaging device. No MRMC study was mentioned or would be relevant for this type of submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. There is no algorithm; this is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. The "ground truth" for these engineering tests would be established by validated test methods, adherence to specifications, and comparison to the original device's performance, as measured by calibrated equipment and documented procedures. For instance, the ground truth for electrical safety is adherence to established electrical safety standards.
8. The sample size for the training set:
- Not applicable. This is a reprocessed physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set for an AI model is involved.
Summary of the Study:
The study described is a series of bench and laboratory tests designed to confirm that the Reprocessed ViewFlex Xtra ICE Catheter is safe and effective and performs "as originally intended," thereby demonstrating substantial equivalence to the predicate device.
The tests included:
- Biocompatibility
- Validation of Reprocessing
- Sterilization Validation
- Functional Performance Tests
- Acoustic Testing
- Electrical Safety Testing
- Electromagnetic Compatibility Testing
- Packaging Validation
The specific detailed results or quantitative acceptance criteria for each test are not provided in this summary document, only the general statement that the testing "demonstrates that Reprocessed ViewFlex device perform as originally intended" and that the device is "at least as safe and effective as the predicate device." The study essentially aims to prove that the reprocessing process does not negatively impact the device's original validated performance and safety characteristics.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).