(23 days)
The SCHNEIDER GUIDER® Softip® guiding catheter is designed for the intravascular introduction of interventional devices.
The SCHNEIDER GUIDER® guiding catheter is manufactured in four French sizes (6 through 9 FR) and multiple distal stem configurations and lengths. In addition, within each French size, catheters will be offered with differing handling characteristics to allow flexibility in meeting physician preferences.
The submission for the SCHNEIDER GUIDER® Softip® guiding catheter (K981413) does not describe an AI/ML device. Therefore, the requested information regarding acceptance criteria and studies for device performance in the context of AI/ML is not applicable.
The submission is for a conventional medical device, a guiding catheter, and focuses on demonstrating substantial equivalence to a predicate device through comparison of design and verification of materials.
Here's an analysis based on the provided text, focusing on what is present:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Not explicitly stated | Indicated that the modified SCHNEIDER GUIDER® Softip® guiding catheters are equivalent to the currently marketed SCHNEIDER GUIDER® Softip® guiding catheters. (Implies compliance with biocompatibility standards, though specific data not provided in summary). |
| Tip Tensile Pull | Not explicitly stated | Indicated that the modified SCHNEIDER GUIDER® Softip® guiding catheters are equivalent to the currently marketed SCHNEIDER GUIDER® Softip® guiding catheters. (Implies meeting tensile strength requirements, though specific data not provided in summary). |
| Pressure Injection Leak Test | Not explicitly stated | Indicated that the modified SCHNEIDER GUIDER® Softip® guiding catheters are equivalent to the currently marketed SCHNEIDER GUIDER® Softip® guiding catheters. (Implies meeting leak integrity requirements, though specific data not provided in summary). |
| Shape Recovery | Not explicitly stated | Indicated that the modified SCHNEIDER GUIDER® Softip® guiding catheters are equivalent to the currently marketed SCHNEIDER GUIDER® Softip® guiding catheters. (Implies meeting shape recovery requirements, though specific data not provided in summary). |
| Overall Equivalence for Intended Use | Device is safe and effective for intended use, substantially equivalent to predicate. | "The results of design control activities indicated that the modified SCHNEIDER GUIDER® Softip® guiding catheters are equivalent to the currently marketed SCHNEIDER GUIDER® Softip® guiding catheters and are, therefore, safe for the intended use." This statement summarizes the outcome of all testing demonstrating substantial equivalence. |
Missing Information (as per AI/ML prompt, but not applicable to this submission):
- 2. Sample size used for the test set and the data provenance: Not applicable. This is a medical device submission involving physical testing, not a dataset for AI/ML.
- 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. Ground truth for AI/ML algorithms is not relevant here.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- 8. The sample size for the training set: Not applicable.
- 9. How the ground truth for the training set was established: Not applicable.
Study Description (for the conventional device):
The study was a design control activity to demonstrate the equivalence of the modified SCHNEIDER GUIDER® Softip® guiding catheter (with new stem material) to the original, currently marketed predicate device. The "study" involved a series of engineering and material performance tests.
- Tests Conducted: Biocompatibility, tip tensile pull, pressure injection leak test, and shape recovery.
- Objective: To verify that the change in stem material did not adversely affect the safety and effectiveness of the device, thereby proving its substantial equivalence to the predicate device.
- Conclusion: The tests indicated that the modified catheters are equivalent to the currently marketed ones and are safe for the intended use.
§ 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).