(176 days)
No
The device description details a simple mechanical suction device. There is no mention of AI, ML, image processing, or any computational elements that would suggest the use of such technologies. The performance studies focus on clinical outcomes related to the mechanical function of the device.
Yes
The device is indicated for the prevention or decrease of episodes of urine leakage in women with stress incontinence, which directly addresses a medical condition.
No
The device is indicated for prevention or decrease of episodes of urine leakage, which is a therapeutic rather than diagnostic function. It physically occludes the meatus to prevent leakage, it does not analyze or detect a medical condition.
No
The device description clearly describes a physical, non-invasive suction cup that adheres to the body, indicating it is a hardware device, not software only.
Based on the provided information, the Restore device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Restore Device Function: The Restore device is a physical, non-invasive device that is applied externally to the body (over the urinary meatus) to prevent urine leakage. It does not analyze any biological samples.
- Intended Use: The intended use is for the prevention or decrease of episodes of urine leakage, which is a physical intervention, not a diagnostic test.
- Device Description: The description details a mechanical device that uses suction to create a physical barrier.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information.
Therefore, the Restore device falls under the category of a medical device used for treatment or management of a condition, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Restore device is indicated for the prevention or decrease of episodes of urine leakage in women with stress incontinence.
Product codes (comma separated list FDA assigned to the subject device)
78MNG
Device Description
Restore Female Continence device is a simple, noninvasive suction cup which fits over the urinary meatus. Air is squeezed out of the device's cap while it is positioned over the urinary meatus. When the cap is released, the device self-adheres to the anterior vaginal wall over the meatus via suction. If inadequate suction occurs. Aquaphor or a petroleum based ointment can be applied to the outside rim of the device to enhance suction. The suction or negative pressure created by the device causes coaptation and occlusion of the meatus and, therefore, increased urethral resistance. The amount of negative pressure generated by the device is optimized to counteract increases in intraabdominal and intravesical pressure during valsalva, thereby decreasing or preventing leakage.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary meatus, anterior vaginal wall
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)
The Restore device has been extensively tested for its safety and efficacy in decreasing or preventing incontinence episodes in women (see K971359). All testing results indicate that the Restore device provides minimal risk yet provides significant benefit for women in controlling urinary leakage.
Clinical testing was completed on 100 women from 8 Investigational Sites in the U.S. Women used the Restore device during a device usage period of 12 weeks to test the efficacy hypothesis that the Restore Continence device will: 1) decrease or prevent incontinence episodes and 2) reduce the impact of incontinence on quality of life. Objective testing included Pad Weight Test (PdWt) and Provocative Stress Test (PST). Subjective testing included a voiding diary documenting the number of incontinence episodes per day (IEPD), an incontinence impact questionnaire and a Satisfaction Survey. Efficacv parameters were statistically analyzed using paired t-test analysis, repeated-measures analysis and Wilcoxon signed rank testing. Analysis demonstrates a statistically significant improvement in all objective and subjective efficacy measures. The Table below details the average measurements before device use (Control) and at the Week 12 Device Utilization Visit.
| Test | Control | Week 12 | %Improvement | P |
|---|---|---|---|---|
| PdWt | 6.67gm | .19gm | 97% | .0001 |
| PST | 2 | 0 | 100% | .0001 |
| IEPD | 3.4 | .3 | 91% | .0001 |
| I-QOL | 62.3 | 90.4 | 45% | .0001 |
Breakdown by Visits demonstrated that the effect was immediate with continued improvement as patients became more proficient with device placement.
The women in the Study were stratified into categories of mild (0-2gm), moderate (2-8gm) and severe (greater than 8gm) urinary incontinence based on Baseline PdWt. Analysis of PdWt results demonstrate a statistically significant improvement in urine loss for each subpopulation of subjects.
A 22 question incontinence impact questionnaire (I-QOL) with a maximum score of 110 evaluated subjects before and during device usage. Subjects demonstrated a significant improvement in their quality of life during device use.
Patient Satisfaction Surveys specifically evaluated Restore's ease of placement and removal and overall patient satisfaction with performance. The Rate of Positive Response (RPR) was calculated as the percent of responses that were equal to or greater than neutral. i.e.satisfied with that aspect of device function. Question 2 evaluated the ease of device placement. Ninety percent of patients found the device easy to place at the first study visit and 95% at 3 months. Question 3 evaluated the ease of device removal. One hundred percent of patients found the device easy to remove during the study. Noting that correct device placement is critical to performance, Question 7 evaluated overall patient satisfaction with Restore. Ninety three percent of patients were satisfied with device performance at the first study visit and 98% at 3 months. This data confirms that Restore is easy to place and remove and that patients are satisfied with device performance. Furthermore, patients found the device convenient, able to remain in place during activity, improved their enjoyment of life and self confidence. Finally, patients demonstrated a high degree of satisfaction with device comfort.
A six week Post Device Utilization Period assessed subjects degree of urine loss after device discontinuation. PdWt, PST and IEPD testing demonstrated statistically significant improvement in urine loss during this period compared to the Baseline control. This response, however, deserves further investigation before any long term therapeutic claims can be made.
To provide clinical safety assurance of the Restore Continence device. objective assessment of Safety included 1) urine cultures 2) imitation questionnaire and 3) periodic physical examinations.
Frequent urine cultures revealed a 1.5% prevalence and 3% incidence of positive urine cultures during device usage.
Satisfaction Survey Question 8 quantitates vaginal irritation. The Mean Response and Rate of Positive Response were relatively high throughout the Study signifying that the Restore device was well tolerated in the vast majority of patients.
Adverse events on physical examination were few, minimal, and self limited. No therapeutic intervention was required in any patients and no complications or sequelae occurred.
Analysis of patients Withdrawing from the Study demonstrated that the most common reason cited was inability to keep scheduled visits. Only 5% withdrew because of vaginal irritation. Furthermore, PdWt and PST demonstrated a statistically significant improvement in urine loss in this subgroup during device use which was equivalent to subjects completing the Study.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
PdWt: 97% Improvement (6.67gm to .19gm)
PST: 100% Improvement (2 to 0)
IEPD: 91% Improvement (3.4 to .3)
I-QOL: 45% Improvement (62.3 to 90.4)
Rate of Positive Response (Ease of Placement): 90% (first visit), 95% (3 months)
Rate of Positive Response (Ease of Removal): 100%
Rate of Positive Response (Overall Satisfaction): 93% (first visit), 98% (3 months)
Prevalence of positive urine cultures: 1.5%
Incidence of positive urine cultures: 3%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Impress Soft Patch (Uromed Inc) K974600
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Restore (NEBL Inc.) K971359
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
3/5/99
510(K) Summary NEBL Restore Female Incontinence Device
-
- Name: NEBL, Inc. Address: 44 Terrace Drive Worcester, MA 01609 Phone: 781-322-4501 Contact: Jeffrey Dann M.D. Date Prepared: September 1, 1998
-
- Device Name:
Proprietary Name: Restore (a.k.a. Re/Stor) Common Name: Female Incontinence Device Classification Name: Device, urethral occlusion for incontinence Classification Code: 78MNG
- Predicate Devices: Impress Soft Patch (Uromed Inc) K974600 3. Restore (NEBL Inc.) K971359
-
- Device Description
Restore Female Continence device is a simple, noninvasive suction cup which fits over the urinary meatus. Air is squeezed out of the device's cap while it is positioned over the urinary meatus. When the cap is released, the device self-adheres to the anterior vaginal wall over the meatus via suction. If inadequate suction occurs. Aquaphor or a petroleum based ointment can be applied to the outside rim of the device to enhance suction. The suction or negative pressure created by the device causes coaptation and occlusion of the meatus and, therefore, increased urethral resistance. The amount of negative pressure generated by the device is optimized to counteract increases in intraabdominal and intravesical pressure during valsalva, thereby decreasing or preventing leakage.
-
- Intended Use
The Restore device is indicated for the prevention or decrease of episodes of urine leakage in women with stress incontinence.
- Intended Use
1
6. Indications for Use
The Restore device is indicated for the prevention or decrease of episodes of urine leakage in women with stress incontinence.
7. Substantial Equivalence Companson
The Restore device is substantially equivalent in function, features and indications to the Impress Soft Patch (UroMed, Inc.). Both devices have the same Indications For Use to prevent or decrease episodes of urine leakage in women with stress urinary incontinence. Both devices are worn intralabially over the meatus and occlude the urethral meatus by creating a seal over the urethral opening. Both are applied by patients to the same anatomical position with ease by utilizing similar techniques of device placement. Both are removed to urinate and reapplied after urination is completed.
Restore has several important advantages compared to Impress Soft Patch. First, it does not require a medical adhesive to function; therefore, it should be easier to manipulate into the correct anatomical position or to reapply if initially incorrectly positioned. Secondly, it naturally migrates to the midline of the antenor vaginal wall and, therefore, over the meatus even if slightly malpositioned. Third, there is no risk of mucosal contact or irritation from an adhesive. Fourth, there are fewer restrictions in use such as showering, bathing and swimming since Restore is not composed of hydrophilic material. In summary, Restore appears easier to place, less wasteful and cumbersome to reposition and reapply if inadequately placed, and requires fewer restrictions in use compared to the Impress Soft Patch. Restore also provides protection if inappropriately used by a patient with urgency incontinence secondary to uninhibited bladder contractions since the device easily "props-off" under this clinical condition.
8. Nonclinical Tests
Restore and its component material has been tested for biocompatibility, Delayed Contact Sensitization, Vaginal Cytotoxicity. Irritation Study. Bacteriostatic Fungistasis, 90 Day Muscle Implantation Study, Microbial Limits Screening, Microbial Limits Prepatory Testing, Bioburden Recovery and Zone of Inhibition Testing. The results indicate the materials and product are biocompatible, nontoxic and well tolerated by tissues.
2
Summary of Clinical Testing റ്റ.
The Restore device has been extensively tested for its safety and efficacy in decreasing or preventing incontinence episodes in women (see K971359). All testing results indicate that the Restore device provides minimal risk yet provides significant benefit for women in controlling urinary leakage.
Effectiveness A.
Clinical testing was completed on 100 women from 8 Investigational Sites in the U.S. Women used the Restore device during a device usage period of 12 weeks to test the efficacy hypothesis that the Restore Continence device will: 1) decrease or prevent incontinence episodes and 2) reduce the impact of incontinence on quality of life. Objective testing included Pad Weight Test (PdWt) and Provocative Stress Test (PST). Subjective testing included a voiding diary documenting the number of incontinence episodes per day (IEPD), an incontinence impact questionnaire and a Satisfaction Survey. Efficacv parameters were statistically analyzed using paired t-test analysis, repeatedmeasures analysis and Wilcoxon signed rank testing. Analysis demonstrates a statistically significant improvement in all objective and subjective efficacy measures. The Table below details the average measurements before device use (Control) and at the Week 12 Device Utilization Visit.
| Test | Control | Week 12 | %Improvement | P |
|---|---|---|---|---|
| PdWt | 6.67gm | .19gm | 97% | .0001 |
| PST | 2 | 0 | 100% | .0001 |
| IEPD | 3.4 | .3 | 91% | .0001 |
| I-QOL | 62.3 | 90.4 | 45% | .0001 |
Breakdown by Visits demonstrated that the effect was immediate with continued improvement as patients became more proficient with device placement.
The women in the Study were stratified into categories of mild (0-2gm), moderate (2-8gm) and severe (greater than 8gm) urinary incontinence based on Baseline PdWt. Analysis of PdWt results demonstrate a statistically significant improvement in urine loss for each subpopulation of subjects.
3
The impact of urinary incontinence on quality of life is a measure of the patient's perception of the degree to which leakage has a negative effect on various aspects of daily living. A 22 question incontinence impact questionnaire (I-QOL) with a maximum score of 110 evaluated subjects before and during device usage. Subjects demonstrated a significant improvement in their quality of life during device use.
Patient Satisfaction Surveys specifically evaluated Restore's ease of placement and removal and overall patient satisfaction with performance. The Rate of Positive Response (RPR) was calculated as the percent of responses that were equal to or greater than neutral. i.e.satisfied with that aspect of device function. Question 2 evaluated the ease of device placement. Ninety percent of patients found the device easy to place at the first study visit and 95% at 3 months. Question 3 evaluated the ease of device removal. One hundred percent of patients found the device easy to remove during the study. Noting that correct device placement is critical to performance, Question 7 evaluated overall patient satisfaction with Restore. Ninety three percent of patients were satisfied with device performance at the first study visit and 98% at 3 months. This data confirms that Restore is easy to place and remove and that patients are satisfied with device performance. Furthermore, patients found the device convenient, able to remain in place during activity, improved their enjoyment of life and self confidence. Finally, patients demonstrated a high degree of satisfaction with device comfort.
A six week Post Device Utilization Period assessed subjects degree of urine loss after device discontinuation. PdWt, PST and IEPD testing demonstrated statistically significant improvement in urine loss during this period compared to the Baseline control. This response, however, deserves further investigation before any long term therapeutic claims can be made.
в. Safety
.
To provide clinical safety assurance of the Restore Continence device. objective assessment of Safety included 1) urine cultures 2) imitation questionnaire and 3) periodic physical examinations.
Frequent urine cultures revealed a 1.5% prevalence and 3% incidence of positive urine cultures during device usage. Based on literature review of the age-specific prevalence of bacteriuria in incontinent females, this low prevalence rate is significantly below historic figures of 10-38%.
Satisfaction Survey Question 8 quantitates vaginal irritation. The Mean Response and Rate of Positive Response were relatively high throughout the Study signifying that the Restore device was well tolerated in the vast majority of patients.
4
Adverse events on physical examination were few, minimal, and self No therapeutic intervention was required in any patients and no limited. complications or sequelae occurred.
Analysis of patients Withdrawing from the Study demonstrated that the most common reason cited was inability to keep scheduled visits. Only 5% withdrew because of vaginal irritation. Furthermore, PdWt and PST demonstrated a statistically significant improvement in urine loss in this subgroup during device use which was equivalent to subjects completing the Study.
். Conclusions
The safety of the Restore device was demonstrated by extensive nonclinical and clinical testing. Technological characteristics do not raise new types of safety and effectiveness questions relative to predicate devices. The Clinical Study demonstrated that the Restore device did not effect the incidence or prevalence of significant bacteriuria. The device was well tolerated by the vast majority of patients. The efficacy of the Restore device was demonstrated by both objective and subjective measures. The clinical data showed that statistically significant improvement was obtained by subjects using Restore. Satisfaction Surveys demonstrated that the device is easy to place and remove with high patient satisfaction with device performance. In summary, these data orovide reasonable assurance that the Restore Female Continence Device is a safe and effective alternative for women requiring stress incontinence management and is statistically equivalent to the predicate device.
5
Clinical/Market Experience 10.
Confirming the safety data reported in its clinical study, NEBL has received no significant adverse event reports since the product's release.
Physicians associated with the clinical study and/or with clinical expertise using Restore have attested that patients can adequately self select and use Restore on a non-prescription, over-the-counter basis based on its Instructions Furthermore, patients have also supported the concept of non-For Use. prescription OTC access to the product.
11. Conclusions
The safety and efficacy of Restore has been demonstrated by nonclinical and clinical testing. Comparison with Impress Soft Patch shows that both devices are substantially equivalent in function and indications and that Restore appears to be easier to place and utilize. Clinical experience derived from patients and physicians confirm that Restore can be used over-the-counter based on its product labelings. This data, supports NEBL's claim that Restore is equivalent to its predicate device and therefore should receive non-prescription, over-the-counter market approval.
6
Public Health Service
Image /page/6/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is positioned to the right of a circular text element. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" and is arranged around the circumference of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
APR 2 6 2010
Jeffrey A. Dann, M.D. NEBL, Inc. 44 Terrace Drive WORCESTER MA 01609
Re: K983164
Trade/Device Name: Restore (Re/stor) Female Incontinence Device Regulation Number: 21 CFR& 876.5160 Regulation Name: Urological clamp for males Regulatory Class: I Product Code: MNG Dated: December 9, 1998 Received: December 10, 1998
Dear Dr. Dann:
This letter corrects our substantially equivalent letter of March 5, 1999.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
7
Page 2 Dr. Jeffrey A. Dann K983164
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
| -10(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ | |
|---|---|
| -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -- |
Device Name: ____ NEBL, Inc. Restone Device
Indications For Use:
The Restore device is indicated for the prevention or decrease of episodes of urine leakage in women with stress incontinence.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Usc 21 CFR 801.109) }.
OR
Over-The-Counter Use
(Optional Formal 1-2-96)