(200 days)
Self-Cath and Self-Cath Plus are intended for use in male, female and pediatric patients (neonates, infants, children, adolescents, and transitional adolescents) requiring bladder drainage as determined by their physician. The devices are indicated for those individuals unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode.
Self-Cath and Self-Cath Plus devices are single-use, sterile catheters for intermittent urinary catheterization. Self-Cath is an uncoated catheter and Self-Cath Plus has a hydrophilic-coating. The catheters are sterilized by ethylene oxide (EO).
The provided text describes the submission for FDA clearance of the "Self-Cath and Self-Cath Plus" devices (K221401).
Since this document is a 510(k) summary for a medical device and not for an AI/ML algorithm, the requested information pertaining to AI/ML specific criteria (such as number of experts for ground truth, adjudication methods, MRMC studies, standalone performance of an algorithm, training set sample size, etc.) is not applicable and therefore not present in the text.
However, I can extract the acceptance criteria and performance data for the device based on the information provided.
1. Table of Acceptance Criteria and Reported Device Performance
This pertains to the physical and chemical properties of the catheters, not an AI/ML algorithm.
| Acceptance Criteria Category | Specific Tests Conducted | Reported Device Performance |
|---|---|---|
| Biocompatibility | Per FDA Guidance: "Use of International Standard ISO 10993-1" (2020) | All tests met pre-determined acceptance criteria. |
| Catheter Performance | ISO 20696:2018 (General Requirements for Intermittent Urethral Catheters) | |
| ASTM F623-99:2013 (Standard Practice for Measuring Maximum Loads of Medical Catheters) | ||
| ASTM D1894:2014 (Standard Test Method for Static and Kinetic Coefficients of Friction of Plastic Film and Sheeting) | All tests met pre-determined acceptance criteria. | |
| Packaging Sterile Barrier Integrity | ISO 11607-1 (Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems) | All tests met pre-determined acceptance criteria. |
| Shelf-Life | ASTM F1980-16 (Standard Guide for Accelerated Aging of Sterile Medical Device Packages) | All tests met pre-determined acceptance criteria. |
Study Information (Based on device testing, not AI/ML algorithm)
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 does not specify the sample size used for performance testing (e.g., number of catheters tested for each criterion) or the data provenance. It states that "Performance testing for Self-Cath and Self-Cath Plus was conducted per applicable sections of non-recognized and recognized voluntary consensus standards, as well as established internal methods."
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)
This question is not applicable as this is a physical medical device clearance, not an AI/ML diagnostic or prognostic tool requiring expert ground truth for image/data interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This question is not applicable for a physical medical device. Performance testing relies on objective measurements against established standards, not subjective expert 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
This question is not applicable as this is a physical medical device, not an AI-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 this is a physical medical device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For a physical medical device like a catheter, the "ground truth" for performance testing is defined by compliance with established international and ASTM standards (e.g., specific tensile strength, elongation, biocompatibility limits, flow rates, etc.) and internal methods, verifiable through objective experimental measurements.
8. The sample size for the training set
This question is not applicable as this is a physical medical device, not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established
This question is not applicable as this is a physical medical device, not an AI/ML algorithm.
§ 876.5130 Urological catheter and accessories.
(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.