(56 days)
No
The summary describes a physical device for occluding the male meatus with material changes for comfort, and explicitly states no performance data was used for substantial equivalence. There is no mention of AI, ML, image processing, or data sets.
Yes
The device is designed to prevent urinary leakage in men with urinary incontinence, which addresses a medical condition and provides a therapeutic benefit.
No
Explanation: The device is designed to prevent urinary leakage, which is a treatment or management function, not a diagnostic one. There is no mention of the device being used to identify or determine a medical condition.
No
The device description explicitly states it is a physical product ("occlude the male meatus") and discusses material changes, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "effectively occlude the male meatus thereby preventing urinary leakage." This is a physical action on the body to manage a symptom (urinary incontinence).
- Device Description: The description focuses on the physical design and materials of the device.
- Lack of Diagnostic Elements: There is no mention of the device being used to:
- Examine specimens derived from the human body (blood, urine, tissue, etc.).
- Provide information for the diagnosis, monitoring, or treatment of a disease or condition.
- Perform any kind of test or analysis on biological samples.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. This device is a physical barrier applied to the body.
N/A
Intended Use / Indications for Use
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.
Product codes
Not Found
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
male meatus
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
The determination of substantial equivalence is not based on an assessment of any performance date, clinical or non-clinical.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
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.
1
Indications for Use
、
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 in
male incontinence | Prevent urine leakage in
male incontinence |
| Mode of
Operation | External device which
occludes the distal urethra | External device which
occludes the distal urethra |
| Application | 1. adheres to the glans
penis
2. a shallow closed ended
trough occludes the meatus
3. Patient removes device
to void and re-applies a
new device after each void | 1. adheres to the glans
penis
2. a shallow closed ended
trough occludes the meatus
3. Patient removes device
to void and re-applies a
new device after each void |
| Material | 1. Kraton Thermoplastic
elastomer G-2706
2. C-Flex Thermoplastic
elastomer - CPT Technologies
3. medical grade pressure
sensitive skin adhesive
Dow Corning Bio PSA 7-4500 | 1. Kraton Thermoplastic
elastomer G-2705
2. medical grade pressure
sensitive skin adhesive
Polyken Technologies #DFPE 170
or 3M Healthcare polyethylene
film #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