(473 days)
The Bioteq Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.
Bioteq Sheath Introducer consists of a sheath introducer with side port extension and stopcock. The sheath hub includes a hemostasis valve and a suture ring. A 4-way stopcock is affixed to the proximal end of the side port extension. The Bioteq Sheath Introducer assembly includes a vessel dilator that rotates securely with the sheath introducer hub and guidewire which is cleared by the Food and Drug Administration (K920884).
The sheath introducer is available in 5 French (F) to 7F sizes in length of 11cm or 23cm. The vessel dilator is tipped specifically to accept either a 0.038 inch or a 0.035 inch diameter guidewire with the length of 45cm or 80cm.
The provided document describes the 510(k) premarket notification for a Sheath Introducer device, demonstrating its substantial equivalence to a legally marketed predicate device. This is not a study proving the device meets acceptance criteria for an AI/ML-based medical device.
The document discusses:
- The device: Sheath Introducer, used for percutaneous introduction of devices into veins/arteries.
- The testing conducted: Sterilization validation, biocompatibility, and various performance tests (e.g., force at break, leakage, radiopacity, insertion force, guidewire compatibility, kink resistance).
- The comparison: The proposed device is compared to the Merit Prelude™ Sheath Introducer (K050962).
- The determination: The FDA found the device substantially equivalent based on intended use, design, technology/principles of operation, and performance.
Therefore, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML device testing (e.g., sample size for test/training sets, expert ground truth, MRMC studies, effect size, standalone performance) cannot be answered from this document.
This document specifically states: "No clinical test data was used to support the decision of the substantial equivalence." and focuses on bench testing and material comparisons.
However, if we interpret "acceptance criteria" and "study" in the context of this specific medical device (a physical sheath introducer) as a substantial equivalence determination, then the information would be as follows:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Bench Test Type) | Reported Device Performance (Summary) |
|---|---|
| Sterilization Validation (Bioburden, Endotoxin, Sterility, EO residual, Pyrogen, Batch release) | Met related requirements. |
| Packaging Validation | Met related requirements. |
| Biocompatibility (Cytotoxicity, Intracutaneous Reactivity, Systemic Injection, Sensitization, Salmonella typhimurium Reverse Mutation, Hemolysis, Thromboresistance, Complement Activation, Material-Mediated Pyrogenicity) | Met related requirements. |
| Performance (Force at Break, Conical Fittings, Liquid Leakage, Chemical Characterization, Radiopacity, Insertion Force, Guidewire Compatibility, External Surface Inspection) | Met related requirements and its intended use. |
| Comparison Performance (Force at Break, Size Designation, Liquid Leakage, Insertion Force, Kink Resistance and Recovery, Minimum Tensile Force to Remove Dilator, Stiffness) | Demonstrated substantial equivalence to predicate device; differences did not raise safety/effectiveness issues. |
2. Sample size used for the test set and the data provenance:
- Sample size: Not explicitly stated for each test, but standard test methods for medical devices typically involve specific sample sizes per ISO/ASTM standards.
- Data provenance: Not specified beyond "A series of tests were performed." The tests are non-clinical, meaning they were conducted in a laboratory setting. No indication of country of origin for the data itself, but the manufacturer is in Taipei, Taiwan. The tests are "retrospective" in the sense that they are conducted on manufactured samples, not "prospective" clinical trials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a physical medical device undergoing bench testing, not an AI/ML algorithm requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for these tests comes from established engineering and material science standards and measurement techniques.
4. Adjudication method for the test set:
- Not applicable. Performance is measured against pre-defined engineering and material standards, not subjective expert judgment.
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 a physical, non-AI medical device. No human-in-the-loop performance or AI assistance involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical, non-AI medical device.
7. The type of ground truth used:
- For the non-clinical tests, the "ground truth" is derived from established engineering and material science standards (e.g., ISO, ASTM standards for medical devices), physical measurements, and chemical analyses. For instance, a "force at break" test's ground truth is the measured force value compared to an acceptable range.
8. The sample size for the training set:
- Not applicable. This is a physical, non-AI medical device. There is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
- Not applicable. There is no training set or machine learning "ground truth" for this device.
§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).