(79 days)
The Medtronic Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guiding catheter is intended to be used in the coronary or peripheral vascular system.
The 6F Taiga™ Guiding Catheter is a single lumen catheter with an atraumatic tip, which provides a pathway for therapeutic devices to be introduced into the coronary or peripheral vascular system.
The provided text describes the 510(k) summary for the Medtronic 6F Taiga™ Guiding Catheter, which is a medical device, not an AI/ML-enabled diagnostic device. Therefore, the requested information regarding acceptance criteria, study details, and AI-specific metrics (like MRMC studies, standalone performance, training sets) is not applicable to this document.
The document explicitly states: "No clinical investigation has been performed for this device."
Instead, the submission for this device relies on non-clinical data and demonstrating substantial equivalence to a predicate device.
Here's a breakdown of what is relevant from the provided text:
1. A table of acceptance criteria and the reported device performance:
Since this is not an AI/ML diagnostic device, there are no "acceptance criteria" in the sense of performance metrics like sensitivity, specificity, or AUC. The acceptance criteria for this device would have been related to engineering and non-clinical performance (e.g., integrity, deliverability, lubricity), which are summarized as:
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Design verification and validation testing | Successfully passed all design verification and validation testing. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. No clinical investigation or test set for performance evaluation was conducted. The evaluation was based on non-clinical (engineering) tests.
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. There was no clinical test set requiring expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No clinical test set.
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 not an AI/ML-enabled device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/ML-enabled device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable for clinical performance. The "ground truth" for this device's evaluation would be defined by engineering standards and specifications, confirmed through non-clinical testing.
8. The sample size for the training set:
Not applicable. This is not an AI/ML-enabled device.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/ML-enabled device.
Study that proves the device meets the acceptance criteria:
The study proving the device meets the acceptance criteria is summarized as "Non-clinical Data: passed all design verification and validation testing." This indicates a series of engineering tests (e.g., mechanical tests, material compatibility, dimensional verification, flow rate, torque response, etc.) were conducted to ensure the device performs as intended and meets its specifications. The specific reports for these tests are not detailed in this summary but would be part of the full 510(k) submission.
Conclusion from Data:
Medtronic Vascular concluded that the 6F Taiga™ Guiding Catheter is substantially equivalent to the predicate devices based on its indications for use and fundamental scientific technology, supported by the successful completion of non-clinical design verification and validation testing.
§ 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).