(103 days)
Flexor® Introducers and Guiding Sheaths are intended to introduce therapeutic devices into the vasculature, excluding coronary and neuro vasculature.
The Flexor® Tuohy-Borst Side-Arm Introducers Shuttle Select® are composed of an introducer sheath and a dilator. These devices will be manufactured in 5.0 and 6.0 French and in a length of 90 cm.
The provided text describes a 510(k) premarket notification for a medical device (Flexor® Tuohy-Borst Side-Arm Introducers Shuttle Select®) and its comparison to a predicate device. The information focuses on the physical and performance characteristics of the device rather than diagnostic or AI-driven performance. Therefore, many of the requested categories (like ground truth, expert opinions, AI assistance, effect size, etc.) are not applicable or cannot be extracted from this type of regulatory submission.
Here's a breakdown of the available and inapplicable information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Acute Performance: Acceptable performance parameters for clinical use. | Verified that performance parameters were acceptable for clinical use. The predetermined acceptance criterion was met. |
| Biocompatibility: In conformance with AAMI/ANSI/ISO 10993-1:2009 (cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, pyrogenicity, hemocompatibility, complement activation, and partial thromboplastin time). | Demonstrated that the device is biocompatible. The predetermined acceptance criteria were met. |
| Coating Integrity and Device Compatibility: Absence of defects in coating appearance before and after simulated use. | Verified that the coating appearance was absent of defects before and after simulated use. (Implicitly, acceptance criterion met). |
| Dilator and Introducer Sheath Liquid Leakage: Shall not leak when tested in accordance with BS EN ISO 11070:1999, Annex D and E, under proper clinical use. | Verified that under proper clinical use, each test article shall not leak. The predetermined acceptance criteria were met. |
| Dilator and Introducer Sheath Lubricity: While hydrated and subjected to a 300 gram normal force, the peak force over a 10 centimeter stroke shall be less than 100 grams during the course of 10 cycles. | Verified that during the course of 10 cycles, the peak force over a 10 centimeter stroke was less than 100 grams. The predetermined acceptance criteria were met. |
| Dilator and Introducer Sheath Tensile Testing: Peak load values shall be in accordance with the applicable values of BS EN ISO 11070:1999, under proper clinical use. | Verified that under proper clinical use, the peak load values were in accordance with the applicable values of BS EN ISO 11070:1999. The predetermined acceptance criteria were met. |
| Dimensional Verification: Component compatibility and dimensional tolerances. | Verified component compatibility and dimensional tolerances. (Implicitly, acceptance criterion met). |
| Thromboresistance Testing: 0% to 25% estimated patency impact due to thrombus associated with the test articles. | Verified that there would be 0% to 25% estimated patency impact due to thrombus associated with the test articles. The predetermined acceptance criterion was met. |
| Torque Strength Testing: Device could withstand one full rotation without failure under proper clinical use. | Verified that under proper clinical use, the device could withstand one full rotation without failure. (Implicitly, acceptance criterion met). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document lists "Test Data" and the types of tests performed (e.g., Acute performance Testing, Biocompatibility testing). It does not specify the sample size for these tests or the data provenance (e.g., country of origin, retrospective/prospective). These are typically internal validation tests conducted by the manufacturer.
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. This is a physical device, and its performance is evaluated through engineering and biological tests, not by expert interpretation of diagnostic images or data for ground truth establishment in that context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in diagnostic studies involving human readers, which is not the nature of this submission.
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 device is an introducer sheath, not a diagnostic imaging device or an AI algorithm. Therefore, no MRMC study or assessment of AI assistance for human readers would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the context of diagnostic "ground truth." For this device, "ground truth" refers to the established engineering specifications, material properties, and biological safety standards (e.g., ISO, ASTM, internal specifications) that the device must meet through testing.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of a physical medical device being evaluated for substantial equivalence through performance and safety testing.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" or "ground truth" in the AI/diagnostic sense for this device.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).