(20 days)
The Hollister Urine Collection Pouch is intended to collect urine from incontinent men by encompassing the penis
The Hollister Urine Collection Pouch is a one-piece disposable system which collects urine by encompassing the penis. The pouch is made from odor-barrier film and features a synthetic skin barrier adhesive which aids in the protection of the skin. If required the precut opening in the barrier may be enlarged to accommodate the anatomy of the user. Strips of adhesive microporous tape may be used for additional security.
The provided document is a 510(k) summary for the Hollister Urine Collection Pouch. It describes a medical device and compares it to a predicate device for regulatory approval. This document does not contain any information about a study with acceptance criteria, reported device performance, sample sizes, expert ground truth, or adjudication methods in the context of an AI/ML device.
The document discusses:
- Device Description: A one-piece disposable system to collect urine from incontinent men.
- Predicate Device: Hollister Female Urine Collection Pouch, K862934.
- Technological Characteristics Comparison: A table comparing characteristics like intended use, barrier adhesive, barrier backing, barrier thickness, pouch film, drain valve, and drain valve tubing between the proposed and predicate devices.
- Biocompatibility: Assessment based on ISO 10993, FDA guidelines (G95-1), and USP. Materials were found biocompatible.
- Conclusion: The device is safe, effective, and substantially equivalent to the predicate device.
Therefore, I cannot fulfill your request as the information you are asking for (acceptance criteria and study details for an AI/ML device) is not present in the provided text. This document is from 1997 and pertains to a physical medical device, not an AI/ML system.
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Image /page/0/Picture/0 description: The image shows the Hollister company logo. To the left of the company name is a geometric shape that resembles a snowflake. The company name is written in a serif font.
Hollister Incorporated 2000 Hollister Drive Libertyville, Illinois 60048-3781
P192
K970443
Hollister Incorporated Urine Collection Pouch
510(k) Summary
FEB 2 5 1997
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 Ph (847)680-2849 (847)918-3860 Fax
Date Summary Prepared - February 3, 1997
2. Name of Device:
Hollister Urine Collection Pouch
3. Name of Predicate Device(s)
Hollister Female Urine Collection Pouch, K862934
4. Description of Device
The Hollister Urine Collection Pouch is a one-piece disposable system which collects urine by encompassing the penis. The pouch is made from odor-barrier film and features a synthetic skin barrier adhesive which aids in the protection of the skin. If required the precut opening in the barrier may be enlarged to accommodate the anatomy of the user. Strips of adhesive microporous tape may be used for additional security.
5. Statement of Intended Use
The Hollister Urine Collection Pouch is intended to collect urine from incontinent men by encompassing the penis
6. Statement of Technological Characteristics of the Device
The proposed device is substantially equivalent to the predicate device. The following is a chart comparing the two devices.
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Image /page/1/Picture/0 description: The image shows handwritten text on a white background. The first line reads 'K970443', with each character clearly written. Below this, the second line reads 'P 2 of 2', indicating a page number or a similar reference. The handwriting appears to be consistent across both lines.
Image /page/1/Picture/1 description: The image shows the Hollister brand logo. The logo consists of a geometric symbol on the left and the word "Hollister" on the right. The geometric symbol is a stylized cross shape made up of intersecting bars, and the word "Hollister" is written in a serif font.
Hollister Incorporated Urine Collection Pouch
Comparison of the Proposed Urine Collection Pouch and the Predicate Device
| Characteristic | Hollister Urine Collection Pouch | Hollister Female Urinary Pouch |
|---|---|---|
| PremarketNotification | Current Submission | K862934 |
| Intended Use | to collect urine from incontinent men | to collect urine from incontinent women |
| Barrier Adhesive | Hydrocolloid Synthetic Skin Barrier | Hydrocolloid Synthetic Skin Barrier |
| Barrier Backing | Non-woven Polyethylene Fabric | Closed-Cell Ethylene Copolymer Foam |
| Barrier Thickness | .045 inch nominal | .064 inch nominal |
| Pouch Film | Polyethylene/Vinylidene Chloride, VinylChloride Copolymer/ PolyethyleneLaminate Odor Barrier Film | Polyethylene/Vinylidene Chloride, VinylChloride Copolymer/ PolyethyleneLaminate Odor Barrier Film |
| Drain Valve | Molded Polyethylene Resin | Molded Polyethylene Resin |
| Drain Valve Tubing | Molded Polyvinylchloride Resin | Molded Polyvinylchloride Resin |
8. Biocompatibility
The biocompatibility of the Urine Collection Pouch as a nonsterilized configuration was assessed based on principles and guidelines established by various governmental and standard setting organizations, such as:
- -- ISO 10993, International Standards Organization (ISO) Standard
- -- General Program Memorandum #G95-1. United States FDA Office of Device Evaluation
- -- United Stated Pharmacopeia (USP)
Material biocompatibility issues have been addressed based upon biomaterial history or in separate in vitro or in vivo laboratory evaluations using licensed commercial reference laboratories. Specific test methodology has been chosen, where appropriate, from test protocols established or recommended by the aforementioned agencies or organizations, Product use conditions have been mimicked in testing procedures where possible. These evaluations have been contracted either by Hollister or the suppliers of the materials.
Based upon the results of this assessment, the materials used to fabricate the Urine Collection Pouch are considered biocompatible and appropriate for their intended use.
8. Conclusion -
Based upon the information presented above it is concluded that the proposed Urine Collection Device is safe and effective for its intended use and is substantially equivalent to the predicate device.
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§ 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.