(9 days)
Cordis Tempo Angiography Catheters are intended for the delivery of radiopaque contrast medium to selected sites in the vasculature.
The Tempo catheters are single lumen catheters consisting of Polyamide (body, intermediate and distal tip) and Polyurethane (brite tip) materials with a proximal strainrelief and hub. The catheters are available in various diameters and tip configurations. They are compatible with Guidewires with diameters of 0.035" and 0.038".
The provided text describes a submission for a medical device, the "Cordis Tempo™ Angiography Catheters," seeking clearance through the 510(k) pathway. This pathway establishes substantial equivalence to a predicate device rather than proving novel efficacy through detailed performance studies with acceptance criteria in the typical sense for an AI/ML device.
Therefore, many of the requested categories for AI/ML device studies (like sample size for test sets, expert ground truth, MRMC studies, training set details) are not applicable to this type of device submission.
However, I can extract the relevant information regarding the device's intended use and the predicate device it is compared against, which serves as the "acceptance criteria" in a substantial equivalence context.
Here's the information formatted as requested, with "N/A" for inapplicable fields:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from Predicate Device) | Reported Device Performance (Cordis Tempo™ Angiography Catheters) |
|---|---|
| Intended Use: Delivery of radiopaque contrast medium to selected sites in the vasculature. | Intended Use: Delivery of radiopaque contrast medium to selected sites in the vasculature. (Matches predicate) |
| Device Description (Predicate - K973401): Cordis Tempo Catheters (65 to 125 cm length). | Device Description (New Device): Cordis Tempo™ Angiography Catheters (40 to 125 cm length). (Extended length range while maintaining core design and materials) |
| Materials: Polyamide (body, intermediate, distal tip), Polyurethane (brite tip), proximal strain relief and hub. Biocompatible. | Materials: Polyamide (body, intermediate, distal tip), Polyurethane (brite tip), proximal strain relief and hub. Biocompatible. (Matches predicate) |
| Compatibility: Compatible with Guidewires with diameters of 0.035" and 0.038". | Compatibility: Compatible with Guidewires with diameters of 0.035" and 0.038". (Matches predicate) |
| Classification: Class II. | Classification: Class II. (Matches predicate) |
| Performance Standards: No FDA-established performance standards under section 514 (implied for predicate to be accepted). | Performance Standards: No FDA-established performance standards under section 514. (Consistent with predicate) |
| Safety: General controls provisions of the Act (annual registration, listing, good manufacturing practice, labeling, prohibitions against misbranding/adulteration). | Safety: Assumed compliance with Current Good Manufacturing Practice requirements (21 CFR Part 820). General controls provisions apply. (Implied by clearance) |
Study Proving Device Meets Acceptance Criteria:
The study that proves the device meets the "acceptance criteria" is a 510(k) Premarket Notification submission, which establishes substantial equivalence to a previously cleared predicate device.
2. Sample size used for the test set and the data provenance:
- Sample Size: N/A (This is a 510(k) submission for a physical medical catheter, not an AI/ML device requiring a test set of data samples for algorithm performance validation).
- Data Provenance: N/A
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: N/A
- Qualifications of Experts: N/A
4. Adjudication method for the test set:
- Adjudication Method: N/A
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:
- MRMC Study: No.
- Effect Size: N/A
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Performance Study: No.
7. The type of ground truth used:
- Ground Truth Type: N/A. The "ground truth" for this submission is the established safety and effectiveness profile of the predicate device (Cordis Tempo™ Angiography Catheters, K973401), to which the new device is compared for substantial equivalence.
8. The sample size for the training set:
- Training Set Sample Size: N/A
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: N/A
§ 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).