(28 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.
Medtronic 6F Taiga Guiding Catheter is an intravascular catheter that is supplied sterile and intended for single use only. The primary function of the 6F Taiga Guiding Catheter is to provide a pathway through which therapeutic devices are introduced. Medtronic 6F Taiga Guiding Catheter has a 6F outer diameter (0.082") and is be available in variety of curves and lengths, identical to the predicate Medtronic Taiga Guide Catheter. The various curves and lengths available, will allow the catheter to accommodate the varying patient vascular system anatomies
The Medtronic 6F Taiga Guiding Catheter is a physical medical device, not an AI/ML device. Therefore, the questions related to AI/ML specific aspects such as human readers, AI assistance, training sets, and ground truth for AI algorithms are not applicable.
Based on the provided text, the acceptance criteria and the study that proves the device meets them are as follows:
1. Table of Acceptance Criteria and Reported Device Performance
The device is a modified version of a legally marketed predicate device (Medtronic 6F Taiga™ Guiding Catheter - K083422). The modification involves a specification related to the soft tip component. Therefore, the acceptance criteria are generally based on demonstrating substantial equivalence to the predicate device through performance/bench testing and biocompatibility testing. The specific acceptance criteria for each test are not explicitly detailed in the provided summaries (e.g., specific thresholds for tensile strength or kink resistance). Instead, the document states that tests were conducted "in accordance to the relevant FDA guidance to demonstrate substantial equivalence."
For the modified soft tip component, two specific tests were performed on the subject device to demonstrate substantial equivalence to the predicate:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Demonstrate substantial equivalence to predicate device for Modified Soft Tip Component: | Tests were performed on the subject device to demonstrate substantial equivalence to the predicate Taiga device for the modification in this premarket notification. |
| * Soft Tip Tensile Strength* | Performance met criteria for substantial equivalence to the predicate. |
| * Soft Tip Compression* | Performance met criteria for substantial equivalence to the predicate. |
| Overall Device Performance: (Based on 32 bench tests performed on the predicate, and through inference, the subject device is expected to meet these as well for substantial equivalence) | The performance testing along with biocompatibility testing demonstrated that the modified Taiga Guide Catheters are substantially equivalent to the predicate device. |
| Examples of bench tests listed (acceptance criteria not detailed in document): | |
| Shaft Inner Diameter | Performance met criteria for substantial equivalence. |
| Shaft Outer Diameter | Performance met criteria for substantial equivalence. |
| Segments Outer Diameter | Performance met criteria for substantial equivalence. |
| Pressure and Leak Resistance | Performance met criteria for substantial equivalence. |
| Inner Lubricity | Performance met criteria for substantial equivalence. |
| Biocompatibility: | Met all requirements as per ISO 10993-1. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size (number of units) used for each specific bench test. It mentions that "Performance/Bench Testing" was conducted, and "biocompatibility tests were conducted." The testing is described as non-clinical data. The provenance of the data is from Medtronic Vascular, the manufacturer. The data is retrospective in the sense that it's reported after the tests were conducted for the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable as the device is a physical medical device and its performance is evaluated through objective bench testing and biocompatibility assessments, not through expert-driven ground truth establishment for an AI/ML algorithm.
4. Adjudication Method for the Test Set
This question is not applicable for the same reasons as point 3. Bench tests have objective measurements and pass/fail criteria, not subjective adjudication by experts.
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
This question is not applicable as the device is a physical medical device and not an AI/ML-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a physical medical device and not an AI/ML algorithm.
7. The Type of Ground Truth Used
For a physical device, the "ground truth" for performance is typically defined by:
- Engineering Specifications/Standards: Each bench test will have predefined acceptance limits or ranges derived from engineering design specifications and relevant industry standards (e.g., ISO, ASTM) and FDA guidance for catheters.
- Predicate Device Performance: For substantial equivalence, the performance of the subject device is compared against the established performance characteristics of the predicate device.
- Biocompatibility Standards: Ground truth for biocompatibility is established by international standards like ISO 10993-1, which outlines the requirements for biological evaluation of medical devices.
8. The Sample Size for the Training Set
This question is not applicable as the device is a physical medical device and does not involve AI/ML requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as the device is a physical medical device and does not involve AI/ML requiring a training set or its associated ground truth establishment.
§ 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).