(224 days)
Self-Cath Closed System is intended for use in male adult patients requiring bladder drainage as determined by their physician. The device is 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.
The Self-Cath Closed System is a disposable single-use, catheter designed for intermittent catheterization integrated with a urine collection bag. The device is sterilized with ethylene oxide (EO) sterilization. The catheter is made with PVC with DEHT as a plasticizer. The Self-Cath catheter used in the system is identical to the catheter recently cleared in K221401.The catheter is provided with a gel lubricant that is placed inside a urine bag, which is closed off with a protection cap (introducer tip cap). During use, the protection cap is removed, and the catheter is pushed out of the urine bag through the introducer tube and tip. The drainage end of the catheter is inside the bag allowing urine to be drained directly into the bag. The urine bag has a tear off section to open the urine bag for emptying. The Self-Cath Closed System includes gloves, swab sticks, a wipe, and a drape in addition to the components above.
The provided text is a 510(k) premarket notification for a medical device called the "Self-Cath Closed System." It primarily focuses on demonstrating substantial equivalence to a predicate device. This type of document is generally for medical device clearances and does not typically involve AI/ML technology or human performance studies in the way you've outlined.
Therefore, many of the specific questions you've asked regarding AI device performance, sample sizes for training sets, expert qualifications for ground truth, MRMC studies, and standalone AI performance are not applicable to this document.
However, I can extract information related to the acceptance criteria and performance testing conducted for this non-AI medical device.
1. A table of acceptance criteria and the reported device performance
The document states: "All tests met the pre-determined acceptance criteria." However, the specific quantitative acceptance criteria and detailed reported performance values are not explicitly listed in the provided text. The document refers to meeting performance per applicable sections of voluntary consensus standards and internal methods.
| Test Category | Acceptance Criteria (General) | Reported Device Performance (General) |
|---|---|---|
| Biocompatibility | Based on chemical analysis according to ISO 10993-1:2018 and FDA Guidance "Use of International Standard ISO 10993-1" (2020) | Met the pre-determined acceptance criteria. |
| Catheter Performance | According to ISO 20696:2018 (e.g., Effective Length, Verification of Catheter Surface Finish, Verification of Catheter Effective Shaft Length) | Met the pre-determined acceptance criteria. |
| Urine Collection Bags | According to EN ISO 8669-2:1996 (Rated Volume, Strength of Attachment of the inlet tubing) | Met the pre-determined acceptance criteria. |
| Packaging Sterile Barrier Integrity | Per ISO 11607-1 | Met the pre-determined acceptance criteria. |
| Shelf-life | Accelerated and Real Time aged shelf-life testing according to ASTM F1980-16. Intended shelf life is 3 years. | Met the pre-determined acceptance criteria (demonstrating a 3-year shelf life). |
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 sizes used for the various performance tests (e.g., how many catheters were tested for effective length or surface finish). It also does not mention the data provenance in terms of country of origin or whether the tests were retrospective or prospective, as these are typically laboratory-based engineering and material performance tests.
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 medical device, not an AI/ML diagnostic tool requiring clinical expert ground truth for interpretation. The "ground truth" for these tests comes from adherence to established international standards and laboratory testing protocols.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. As this is not an AI/ML diagnostic or measurement device, there is no need for expert adjudication methods in this context. Performance is determined by standardized test results.
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 intermittent catheter, not an AI system. No MRMC study was conducted or is 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.)
The "ground truth" for the device's performance is established by compliance with recognized international standards (e.g., ISO 10993-1 for biocompatibility, ISO 20696 for catheter performance, EN ISO 8669-2 for urine bags, ISO 11607-1 for sterile barrier, ASTM F1980-16 for shelf-life). These standards define the test methods and the expected performance criteria.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device.
§ 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.