(231 days)
The Chase Medical Femoral Access Cannulation Set is intended for use in situations which require rapid femoral venous and arterial access for short term cardiopulmonary bypass. Venous and arterial access is left to the discretion of the physician.
Not Found
The provided text describes a 510(k) premarket notification for the Chase Femoral Access Cannulation Set. The cornerstone of the submission is the claim of substantial equivalence to an existing predicate device, the RMI Femoral Access Cannulation Set (K891576). Therefore, the study proving the device meets acceptance criteria is not a typical performance study with defined acceptance criteria and statistical analysis, but rather a direct comparison demonstrating identical characteristics to the predicate device.
Here's the breakdown of the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance | Study/Evidence |
|---|---|---|
| Identical Physical Form | Identical to RMI device | Direct component comparison; supplied by same vendor. |
| Identical Material Composition | Identical to RMI device | Direct component comparison; supplied by same vendor. |
| Identical Functional Characteristics | Non-differentiable from RMI device | Direct component comparison; supplied by same vendor. |
| Equivalent Sterilization Process | 100% EtO (same as predicate) | Chase Medical's sterilization information (Section 7). |
| Biocompatibility | Identical materials to predicate device | Section 5 of submission. |
| Packaging Integrity | Validated after sterilization, simulated transportation, and two-year accelerated heat aging. | Section 6 of submission. |
| Two-year Expiration Date | Labeled with a two-year expiration date. | Section 6 of submission. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the traditional sense of a "test set" for a performance study. The "test set" is essentially the Chase Femoral Access Cannulation Set itself, compared directly to the RMI predicate device. No statistical sample size for performance evaluation is mentioned.
- Data Provenance: The comparison is based on the design, materials, and manufacturing specifications of both the Chase Medical device and the RMI device, which are claimed to be identical. The RMI device has been marketed worldwide for 6 years (retrospective information about the predicate). The Chase device implicitly uses prospective validation for packaging integrity.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. The "ground truth" for this submission is established by the identity of the components and manufacturing processes between the new device and the predicate device, as supplied by the same vendor. No independent expert panel was involved in establishing a "ground truth" for a performance test.
4. Adjudication Method for the Test Set
- Not applicable. There's no performance "test set" requiring adjudication in the context of clinical outcomes or diagnostic accuracy. The adjudication is essentially the FDA's review of the documentation supporting the claim of substantial equivalence.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This is not a diagnostic imaging device, and therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is a medical device (cannulation set), not an algorithm or AI system. Its performance is inherent to its physical characteristics and functionality, not a computational output.
7. The Type of Ground Truth Used
- The "ground truth" is the demonstrated identity (physical form, material composition, functional characteristics, sterilization, biocompatibility, packaging) between the Chase Medical Femoral Access Cannulation Set and its predicate device, the RMI Femoral Access Cannulation Set. This is a technical and manufacturing "ground truth" rather than a clinical or diagnostic one.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/machine learning device. There is no "training set" in the context of this 510(k) submission.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set.
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).