(53 days)
K#940269
None
No
The device description and intended use are purely mechanical and do not mention any computational or analytical capabilities that would suggest AI/ML.
No
The device is described as an "incontinence device intended to be used as an external catheter to collect urine," which is a collection and management function, not a therapeutic treatment for a disease or condition.
No
Explanation: The device is described as an external catheter for collecting urine, indicating it is a therapeutic or collection device, not one used for diagnosis.
No
The device description clearly states it is a physical, condom-like device made from Natural Rubber Latex, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
- Device Function: The Hollister Self Retaining Male External Catheter is a device that is applied externally to the body to collect urine. It does not perform any tests on the urine or provide diagnostic information about the patient's health. Its purpose is purely for collection and management of incontinence.
The provided information clearly describes a device for external urine collection, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for 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.
Product codes
Not Found
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penis
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K#940269, Mentor Active Cath Self Adhesive Male External Urinary Catheter
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
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.
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:
-
- 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
-
- A self adhesive catheter that is designed with an adhesive that has been applied to the inside of the urosheath.
1
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).