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.

Device Description

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.

AI/ML Overview

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.

Summary

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K968900 SEP 16

Hollister Incorporated Hollister Self Retaining Male External Urinary Catheter

510(k) Summary

1. Submitter's Name. Address and Contact Person

Submitter Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60048 Contact Person Joseph S. Tokarz Manager. Regulatory Affairs Phone (847) 680-2849 (847) 918-3860 Fax

Date Summary Prepared - September 13, 1996

2. Name of Device:

Hollister Self Retaining Male External Urinary Catheter

3. Name of Predicate Device(s)

Hollister Non-Rolled Male External Urinary Catheter K#940269 Mentor Active Cath Self Adhesive Male External Urinary Catheter

4. Description of Device

5. Statement of Intended Use

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.

6. Statement of Technological Characteristics of the Device

Currently, there are two basic types of male external catheters in commercial distribution:

1. A two-piece catheter that relies on a strip of adhesive to be placed on the penis and the urosheath adhered to the adhesive strip. There is also a two-piece catheter that relies on a velcro strip or other material to be wrapped around the urosheath after it has been placed on the penis, and
1. A self adhesive catheter that is designed with an adhesive that has been applied to the inside of the urosheath.

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Hollister Incorporated Hollister Self Retaining Male External Urinary Catheter

The proposed device differs from these types of external catheters in that it is not a twopiece system nor does it rely on an adhesive for securement. Instead the proposed device is retained on the penis of the wearer solely by virtue of its designed shape. The proposed device is designed to contain the portion of the penis exclusive of the glans in an elastic sheath which substantially matches the diameter of the penis in its extended position so that the penis provides its own outward force against the walls of the elastic sheath which results in the retaining of the device upon the penis.

7. Biocompatibility Assessment

Material Biocompatibility: Issues of biomaterial safety or biocompatibility have been addressed based upon the biomaterial history or in separate in-vitro or in-vivo evaluations using licensed commercial reference laboratories. Each assessment was conducted based on principles and guidelines established by various governmental and standard setting organizations among these are the following:

-- EN 30993. European Commission (EC) Standard
-- General Program Memorandum #G95-1, United States FDA Office of Device Evaluation
-- United Stated Pharmacopeia (USP)

The materials used to construct the Hollister Self Retaining Male External Urinary Catheter are considered biocompatible and suitable for their intended use.

8. Conclusion

Based on the information presented above and within the body of the 510(k) premarket notification, it is concluded that the Hollister Self Retaining Male External Urinary Catheter Device is safe and effective for its intended use. The Hollister Self Retaining Male External Urinary Catheter is substantially equivalent to the predicate device(s).

Regulation Number and Section

§ 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.