(53 days)
The Hollister Self Retaining Male External Catheter is a urosheath type incontinence device intended to be used as an external catheter to collect urine from urinary incontinent males.
The Hollister Self Retaining Male External Urinary Catheter is a condom-like device made from Natural Rubber Latex. The device features a unique inner flap that aids in the protection of the penile skin from irritation due to backwash of urine and helps to maximize wear time. The external catheter is presented on a plastic collar to enable easy application and maintain the catheter shape integrity during shipping.
Here's an analysis of the provided 510(k) summary regarding the Hollister Self Retaining Male External Urinary Catheter, focusing on the requested acceptance criteria and study details.
Based on the provided text, there is no specific acceptance criteria table or a detailed study description with performance metrics that would typically be found for AI/ML-driven devices. The document is for a physical medical device (urinary catheter) and focuses on substantial equivalence, biocompatibility, and intended use rather than algorithmic performance.
Therefore, for many of your specific questions related to AI/ML studies, the answer will be that the information is not applicable or not provided in this document.
Here's an attempt to answer your questions based on the available information, noting where details are missing or irrelevant to an AI/ML context:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Biocompatibility | Considered biocompatible and suitable for intended use. |
| Substantial Equivalence | Concluded to be substantially equivalent to predicate devices. |
| Safety and Effectiveness | Concluded to be safe and effective for its intended use. |
| Functionality (Retention) | Designed to be retained on the penis solely by its shape (elastic sheath substantially matching penile diameter in extended position). |
| Functionality (Protection) | Unique inner flap aids in protection of penile skin from irritation due to backwash of urine and helps maximize wear time. |
| Functionality (Application Ease) | Presented on a plastic collar to enable easy application. |
| Functionality (Shape Integrity) | Plastic collar helps maintain catheter shape integrity during shipping. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. This type of detail is not typically included in 510(k) summaries for non-AI/ML devices. The "tests" mentioned are primarily biocompatibility assessments, not clinical performance studies with specific patient sample sizes in the context of device performance metrics.
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 / Not provided. The "ground truth" for this device is based on material science (biocompatibility) and functional design principles. Expert consensus in the sense of clinicians interpreting data for AI models is not relevant here. The biocompatibility assessments were based on established guidelines (EN 30993, G95-1, USP) which likely involve material scientists and toxicologists, but specific numbers and qualifications are not listed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. Adjudication methods are typically for resolving discrepancies in expert interpretations of data, as in clinical trials or AI model evaluations. This is not relevant for the type of assessments described.
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 study is for a physical male external urinary catheter, not an AI/ML diagnostic or assistive device. Therefore, MRMC studies and "human readers improving with AI assistance" are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth for biocompatibility was based on established regulatory standards and guidelines from agencies like the European Commission (EN 30993), United States FDA (G95-1), and United States Pharmacopeia (USP).
- The ground truth for functionality (e.g., retention, protection, ease of application) is based on engineering design principles and presumably internal testing/validation that ensures the device operates as intended.
8. The sample size for the training set
- Not applicable. This device does not involve a "training set" in the context of AI/ML.
9. How the ground truth for the training set was established
- Not applicable. This device does not involve a "training set" or AI/ML-related ground truth.
§ 876.5250 Urine collector and accessories.
(a)
Identification. A urine collector and accessories is a device intended to collect urine. The device and accessories consist of tubing, a suitable receptacle, connectors, mechanical supports, and may include a means to prevent the backflow of urine or ascent of infection. The two kinds of urine collectors are:(1) A urine collector and accessories intended to be connected to an indwelling catheter, which includes the urinary drainage collection kit and the closed urine drainage system and drainage bag; and
(2) A urine collector and accessories not intended to be connected to an indwelling catheter, which includes the corrugated rubber sheath, pediatric urine collector, leg bag for external use, urosheath type incontinence device, and the paste-on device for incontinence.
(b)
Classification —(1)Class II (special controls) for a urine collector and accessories intended to be connected to an indwelling catheter. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.(2)
Class I (general controls). For a urine collector and accessories not intended to be connected to an indwelling catheter, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.