(56 days)
The NEBL CAP-AID (Improved) is designed to effectively occlude the male meatus thereby preventing urinary leakage.
The product prevents urinary leakage in men with urinary incontinence.
The CAP-AID (Improved) is exactly similar in indications, design and features to the original CAP-AID device. Only the materials are different. The material changes requested in the "Improved" version allow additional comfort and ease of use for the patient.
This looks like a 510(k) submission for a penile clamp device, not an AI/ML powered device. As such, the typical acceptance criteria and study design elements requested in your prompt (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies) are not applicable.
The submission focuses on demonstrating substantial equivalence to a predicate device, primarily through material changes for improved comfort and ease of use, rather than a performance study as would be seen for an AI algorithm.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Details on sample sizes, data provenance, ground truth establishment, or expert involvement.
- Information on MRMC studies or standalone algorithm performance.
The provided text simply states that "The determination of substantial equivalence is not based on an assessment of any performance data, clinical or non-clinical."
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1964580
JAN | 0 |997
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CPR 807.92.
The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________
Submitted By: Jeffrey A. Dann, M.D. President NEBL Inc. 44 Terrace Drive Worcester, MA 01609 Phone (508) 342-2224 Fax: (508) 345-0137
Date Prepared: 11/14/96
Device Name
Proprietary Name: NEBL, Inc. CAP-AID (Improved)
Common Name: Male Incontinence Cap
Classification Name: Penile Clamp
Substantial Equivalence
The NEBL CAP-AID (Improved) is exactly similar in indications, design and features to NEBL's original CAP-AID device.
Device Description
The CAP-AID (Improved) is exactly similar in indications, design and features to the original CAP-AID device. Only the materials are different. The material changes requested in the "Improved" version allow additional comfort and ease of use for the patient.
Intended Use
The NEBL CAP-AID (Improved) is designed to effectively occlude the male meatus thereby preventing urinary leakage.
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Indications for Use
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The product prevents urinary leakage in men with urinary incontinence.
Substantial Equivalence Comparison
| NEBL Inc. CAP-AID(Improved) | NEBL Inc. CAP-AID(original) K954959 | |
|---|---|---|
| Indication | Prevent urine leakage inmale incontinence | Prevent urine leakage inmale incontinence |
| Mode ofOperation | External device whichoccludes the distal urethra | External device whichoccludes the distal urethra |
| Application | 1. adheres to the glanspenis2. a shallow closed endedtrough occludes the meatus3. Patient removes deviceto void and re-applies anew device after each void | 1. adheres to the glanspenis2. a shallow closed endedtrough occludes the meatus3. Patient removes deviceto void and re-applies anew device after each void |
| Material | 1. Kraton Thermoplasticelastomer G-27062. C-Flex Thermoplasticelastomer - CPT Technologies3. medical grade pressuresensitive skin adhesiveDow Corning Bio PSA 7-4500 | 1. Kraton Thermoplasticelastomer G-27052. medical grade pressuresensitive skin adhesivePolyken Technologies #DFPE 170or 3M Healthcare polyethylenefilm #1509 |
| Sterility | Sterile/disposable | Sterile/disposable |
The determination of substantial equivalence is not based on an assessment of any performance date, clinical or non-clinical.
Submitters Signature
Date
11/4/80
§ 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.