(126 days)
The Medtronic model 6248VAL adjustable valve is intended to minimize blood loss during percutaneous catheter procedures used to place cardiac leads and implant accessories such as guide wires and subselecting catheters.
The 6248VAL Adjustable Valve is a single use valve designed to reduce blood loss during percutaneous catheter procedures. The valve sealing diameter is adjustable so it may be tightened or loosened to provide an appropriate seal around devices such as leads, guidewires, and catheters, which are passed through the main valve port. Blood flow through the valve is reduced as the valve is closed.
Here's an analysis of the provided text regarding the 6248VAL Adjustable Valve:
It's important to note that this document is a 510(k) summary for a medical device (an adjustable valve), not an AI/ML-driven device. Therefore, many of the typical acceptance criteria and study components for AI/ML devices, such as performance metrics like sensitivity/specificity, sample sizes for test sets, ground truth establishment by experts, MRMC studies, or training sets, are not applicable here.
The summary focuses on demonstrating "substantial equivalence" to predicate devices through traditional engineering and biocompatibility testing.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Visual requirements | Met |
| Mechanical requirements | Met |
| Performance requirements | Met |
| Biocompatibility consistent with ISO 10993-1:2003 | Conducted |
| Sterilization process validated (gamma radiation) | Will be sterilized using a validated gamma radiation process |
Study Details (as inferable from the document)
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document states "Device verification testing was performed to demonstrate the valve meets established performance criteria." This typically involves a defined number of units or test samples, but the specific quantity is not reported.
- Data Provenance: Not specified, but implied to be internal laboratory testing conducted by Medtronic (the manufacturer). This would be prospective testing of newly manufactured devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. For a physical device like a valve, "ground truth" is typically defined by engineering specifications, material standards, and functional requirements. Expert medical consensus or pathology is not relevant for this type of testing.
4. Adjudication method for the test set:
- Not applicable. This concept pertains to resolving discrepancies in interpretations, usually for image-based or diagnostic AI/ML systems. For mechanical testing, results are typically objective measurements against a defined specification.
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 physical device, not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used:
- Engineering Specifications and Performance Standards: The "ground truth" for this device's performance would be the pre-defined engineering design specifications, functional requirements (e.g., ability to reduce blood loss, seal effectively), and compliance with relevant standards (like ISO 10993-1 for biocompatibility).
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device; there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device; there is no "training set."
Overall Conclusion from the Document:
The 510(k) summary for the 6248VAL Adjustable Valve demonstrates substantial equivalence to predicate devices based on:
- Similar intended use.
- Equivalent design, function, materials, and method of operation.
- Successful completion of visual, mechanical, and performance testing, indicating all design and performance requirements were met.
- Biocompatibility testing consistent with ISO 10993-1.
- Validated sterilization process.
The document does not provide the detailed raw data or specific quantitative results from these tests, but rather states that the criteria were "met" and "conducted," which is typical for a 510(k) summary demonstrating substantial equivalence for a non-AI/ML device.
§ 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
(a)
Identification. A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.