(454 days)
BIOTEQ® DOUBLE PIGTAIL URETERAL STENT SET is intended to facilitate the temporary internal drainage of urine from the kidney to the bladder via placement endoscopically by a trained physician.
The BIOTEQ® DOUBLE PIGTAIL URETERAL STENT SET consist of a ureter stent that is completely radiopaque, coiled cylindrical or open tip with drainage holes at intervals of 5-20 mm, centimeter graduations, continuous black positioning line to indicate the direction in which the catheter tip coils, and black marking at the catheter end. The Pusher Catheter (Introducer sheath) is approximately 45cm long. The Guide Wire (Spiral stylet) is made of stainless steel with PTFE coating and a flexible safety tip and a marked rigid tip and is approximately 120 cm long. The plastic dispenser is used to protect the Guide Wire (Spiral stylet). There are also plastic clips in the set.
The provided text describes a 510(k) summary for the BIOTEQ® DOUBLE PIGTAIL URETERAL STENT SET. For medical devices, particularly those submitted under 510(k), the "acceptance criteria" and "study" typically refer to demonstrating substantial equivalence to a legally marketed predicate device through bench testing, performance testing, and adherence to relevant standards, rather than clinical studies with human participants that establish a device's performance in terms of diagnostic accuracy or effect sizes.
Based on the provided text, here's an analysis of the requested information:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Specific Criteria/Standard Adhered To | Reported Device Performance / Compliance |
|---|---|---|
| Physical Specification | Applicable standards (unspecified detail) | "conforms to applicable standards" |
| Chemical Specification | Applicable standards (unspecified detail) | "conforms to applicable standards" |
| Sterilization Specification | ISO 11135 (Sterilization of health care products - Ethylene oxide), ISO 11607-1 (Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems), USP Pyrogenic standards, & related standards | "conforms to applicable standards" |
| Biocompatibility | ISO 10993 series (Biological evaluation of medical devices) | "conforms to applicable standards" |
| Substantial Equivalence | Same intended use and similar technological characteristics as predicate device (Rusch Ureter Stent Integral Set and Rusch Ureter DD Stent Sets - K982974). Any differences in technological characteristics do not raise new questions of safety or effectiveness. | "The BIOTEQ® DOUBLE PIGTAIL URETERAL STENT SET have the same intended use and similar technological characteristics as the Rusch Ureter Stent Integral Set and Rusch Ureter DD Stent Sets (K982974) marketed by RUSCH INTL.. Moreover, bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness." |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify a "sample size" in the context of a traditional test set with individual patient cases or data points. The assessment is based on bench testing and adherence to standards for the device itself and its material properties.
- Data Provenance: Not applicable in the context of clinical data. The "data" refers to the results of the bench tests and compliance with international standards for manufacturing, materials, and sterilization.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable to this 510(k) submission. The "ground truth" for a medical device cleared via 510(k) is typically established by demonstrating that the device meets engineering specifications, material standards, biocompatibility requirements, and sterilization efficacy, which are evaluated by technical experts, engineers, and regulatory bodies against established standards, not clinical experts establishing diagnostic "ground truth" for a dataset.
4. Adjudication method for the test set:
- Not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies, particularly for diagnostic devices, to resolve discrepant expert opinions on case classifications. This 510(k) relies on bench testing and adherence to standards, which do not involve such adjudication.
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:
- No, an MRMC comparative effectiveness study was NOT done. This type of study is relevant for diagnostic imaging devices, especially those incorporating AI, where the performance of human readers with and without AI assistance is evaluated across multiple cases. The BIOTEQ® DOUBLE PIGTAIL URETERAL STENT SET is an implantable medical device, not a diagnostic imaging or AI-enabled device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was NOT done. This device is a physical medical instrument (ureteral stent) and does not involve an algorithm.
7. The type of ground truth used:
- The "ground truth" in this context is defined by engineering specifications, material safety and performance standards (e.g., ISO, USP), and biocompatibility requirements. It's about meeting pre-defined physical, chemical, and biological performance benchmarks, not clinical outcomes or pathology.
8. The sample size for the training set:
- Not applicable. There is no "training set" as this device does not utilize machine learning or AI algorithms. The device undergoes manufacturing processes and quality controls to ensure each unit meets the required specifications.
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set involving algorithms, there is no ground truth to be established for it. The "ground truth" for the device's design and manufacturing is established through adherence to recognized international and national standards and regulatory requirements.
§ 876.4620 Ureteral stent.
(a)
Identification. A ureteral stent is a tube-like implanted device that is inserted into the ureter to provide ureteral rigidity and allow the passage of urine. The device may have finger-like protrusions or hooked ends to keep the tube in place. It is used in the treatment of ureteral injuries and ureteral obstruction.(b)
Classification. Class II (performance standards).