(65 days)
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No
The device description and performance studies focus on the physical properties and biological safety of a mechanical compression device, with no mention of AI or ML technologies.
Yes
The device is described as a "two piece compression device for males with urinary incontinence" intended to "provide a temporary means of urinary continence," which directly addresses a medical condition.
No
The device description indicates it is a compression device intended to provide a temporary means of urinary continence, not to diagnose a condition.
No
The device description clearly states it is a "two piece compression device" consisting of a "silicone gel filled penile compression wrap" and a "silicone ring," indicating it is a physical hardware device.
Based on the provided information, 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.
- Device Function: The Mentor Urology Triple Rib Occlusion Wrap is a physical compression device applied externally to the penis to control urinary incontinence. It does not analyze any biological samples.
- Intended Use: The intended use clearly states it's for managing urinary incontinence in males, not for diagnosing or monitoring a condition through laboratory testing.
Therefore, this device falls under the category of a medical device but not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Mentor Urology Triple Rib Occlusion Wrap for Male Incontinence is indicated for any male, who has urinary incontinence, either on a temporary or long term basis. It is also indicated for those patients who have an adverse reaction to natural latex rubber.
Product codes
78FHA
Device Description
The Mentor Urology Triple Rib Occlusion Wrap for Male Incontinence is a two piece compression device for males with urinary incontinence. The device consists of a silicone gel filled penile compression wrap for occlusion of the urethra and a silicone ring. It is intended for users who would prefer a reusable soft sided device instead of a rigid clamping device. The device is intended for users with moderate to heavy urinary incontinence to provide a temporary means of urinary continence.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 876.5160 Urological clamp.
(a)
Identification. A urological clamp for males is a device used to close the urethra of a male to control urinary incontinence or to hold anesthetic or radiography contrast media in the urethra temporarily. It is an external clamp.(b)
Classification. Class I (general controls). Except when intended for internal use, 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.
0
P152
SUMMARY OF SAFETY AND EFFECTIVENESS
MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCE (510K SUMMARY)
1. Submitter's Data
Mentor Urology, Inc. 1615 West River Road North Minneapolis, MN 5541 1
Date Prepared: 23 January 1997
2. Device Name. Classification
Name: Mentor Urology Triple Rib Occlusion Wrap for Male Incontinence
Trade Name: To be determined
FDA Classification: Class I per 21CFR876.5250, Urological Clamp for Males, Code 78FHA.
3. Identification of Substantially Equivalent Device
Bard Cunningham Incontinence Clamp, #K884426
4. Device Description
The Mentor Urology Triple Rib Occlusion Wrap for Male Incontinence is a two piece compression device for males with urinary incontinence. The device consists of a silicone gel filled penile compression wrap for occlusion of the urethra and a silicone ring. It is intended for users who would prefer a reusable soft sided device instead of a rigid clamping device. The device is intended for users with moderate to heavy urinary incontinence to provide a temporary means of urinary continence.
5. Indications for Use
The Mentor Urology Triple Rib Occlusion Wrap for Male Incontinence is indicated for any male, who has urinary incontinence, either on a temporary or long term basis. It is also indicated for those patients who have an adverse reaction to natural latex rubber.
1
6. Contraindications for Use
Clinical contraindications for use of the Mentor Urology Triple Rib Occlusion Wrap for Male Incontinence include:
Use on patients with broken or poor skin quality.
Use on patients with adverse reactions to any component of the system.
7. Warnings, Precautions
Patient skin must be clean and dry before use.
The correct size must be used. Physician advise may be helpful
8. Biological Safety Testing
Mentor Urology has performed biological safety testing on all components used in this device. These rests meet or exceed Tripartite and ISO 10993 standards. All tests were satisfactory.
9. Physical Testing, Design Verification
Mentor Urology has performed various physical tests on this device and its components to show that the device and its design are adequate for the use intended ..