(243 days)
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No
The device description and performance studies focus on a physical, external continence device and its clinical efficacy, with no mention of AI or ML technologies.
Yes
The device is described as an external female continence device designed to prevent or decrease episodes of stress incontinence, aiming to improve conditions such as urine leakage, perceived severity of leakage, and quality of life. This direct therapeutic intent to alleviate a medical condition classifies it as a therapeutic device.
No
The Miniguard is described as a continence device applied to the urinary opening to prevent or decrease episodes of stress incontinence, making it a treatment or management device, not a diagnostic one.
No
The device description clearly states it is a physical pad with adhesive, which is a hardware component.
Based on the provided information, the Miniguard device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The Miniguard is an external device applied to the urinary opening. It does not analyze or test any biological samples.
- The intended use is to physically prevent or decrease urine leakage. This is a mechanical function, not a diagnostic one.
- The performance studies focus on the physical effects of the device (reducing leakage episodes, quantity, and improving quality of life) and its safety when applied externally. They do not involve analyzing biological markers or performing diagnostic tests.
The Miniguard is a medical device intended for the management of stress incontinence, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Miniguard is an external female continence device that is applied to the urinary opening to prevent or decrease episodes of stress incontinence occurs when intraabdominal pressure exceeds urethral resistance as a result of physical stress such as coughing, laughing, or lifting heavy objects. The Miniguard is designed for women who experience urine leakage under conditions of physical stress.
Product codes (comma separated list FDA assigned to the subject device)
MNG
Device Description
The Miniguard female continence device consists of a small pad that is coated on one side with a biocompatible polymer adhesive. The Miniguard is an external management device that is applied to the urinary opening to prevent or decrease episodes of stress incontinence. The Miniguard's function is to provide occlusion of the urinary opening by creating a seal over the urinary opening. The foam pad backing is intended to facilitate application and removal and for user comfort.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
urinary opening, intralabial mucosa
Indicated Patient Age Range
Not Found
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
The Miniguard device has been extensively tested for its safety and efficacy in decreasing the number of urinary leakage episodes in women with incontinence. All testing results indicate that use of the Miniguard imparts minimal risk. yet provides significant benefit for women in controlling urinary leakage.
Clinical testing on the Miniguard was completed on over 350 women from 12 investigative centers in the United States. Women used the Miniguard during a device usage period of 12 weeks to test four efficacy hypotheses which demonstrate the Miniguards ability to 1) decrease the number of leakage episodes; 2) reduce the perceived severity of urinary leakage; 3) reduce the impact of incontinence on quality of life: and 4) reduce the quantity of urine leakage. Testing materials used were: 1) a voiding diary, 2) a svmptom questionnaire; 3) an incontinence impact questionnaire; and 4) a 12-hour home pad-weight test. All testing materials were derived from published sources on incontinence testing and management. Efficacy parameters were statistically analyzed using graphical analyses, paired-1 analyses (Prob>(T)) and repeated-measures (MANOVA) analyses.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical testing on the Miniguard was completed on over 350 women from 12 investigative centers in the United States. Women used the Miniguard during a device usage period of 12 weeks to test four efficacy hypotheses which demonstrate the Miniguards ability to 1) decrease the number of leakage episodes; 2) reduce the perceived severity of urinary leakage; 3) reduce the impact of incontinence on quality of life: and 4) reduce the quantity of urine leakage. Analyses' results demonstrate, in each of the four hypothesis, a statistically and clinically significant improvement for participants. The table below details the average values before using the Miniguard (Control) and after 12 weeks of device use (Trial 17).
- No. of Leakage Episodes (per week): Control 14.18, Trial 17 4.89, % Improvement 65.5%, Prob> T ≤0.0001
- Perceived Severity of Leakage: Control 11.00, Trial 17 3.18, % Improvement 71.1%, Prob> T T T
§ 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
510(k) Summary ASI Miniguard Female Continence Device
| 1. | Name: | Advanced Surgical Intervention |
|---|---|---|
| Address: | P.O. Box 3134 | |
| Dana Point, CA 92629 | MAY - 8 1996 | |
| Phone: | (714) 240-5899 | |
| Contact: | Robert Rosenblut, PhD | |
| 2. | Device Name: | Female Continence Device |
| Proprietary Name: | Miniguard | |
| Classification Name: | Unknown | |
| 3. | Predicate Devices: | Dacomed C³ Male Continence Device |
| Diamed External Urinary Appliance | ||
| Xtramedics Fresh 'n Fit Padette |
4. Device Description
The Miniguard female continence device consists of a small pad that is coated on one side with a biocompatible polymer adhesive. The Miniguard is an external management device that is applied to the urinary opening to prevent or decrease episodes of stress incontinence. The Miniguard's function is to provide occlusion of the urinary opening by creating a seal over the urinary opening. The foam pad backing is intended to facilitate application and removal and for user comfort.
5. Intended Use
The Miniguard is an external female continence device that is applied to the urinary opening to prevent or decrease episodes of stress incontinence occurs when intraabdominal pressure exceeds urethral resistance as a result of physical stress such as coughing, laughing, or lifting heavy objects. The Miniguard is designed for women who experience urine leakage under conditions of physical stress.
6. Technological Characteristics Comparison
The Miniguard female continence device is substantially equivalent in function to the Dacomed C' Male Continence Device. Both the Miniguard und the Dacomed device achieve the intended use (to prevent or decrease episodes of incontinence) by occlusion of the urethra. The Miniguard is substantially equivalent in design characteristics to the Diamed External Urinary Appliance. The design characteristics are equivalent to the Diarred device in that both utilize an adhesive seal on the intralabial mucosa The Miniguard also has technological similarities to the Xtramedics device in that both are worn intralabially, over the urethral opening. The materials used in the Miniguard have extensive histories in a variety of biomedic including oral, ocular, vaginal and wound care devices
7. Nonclinical Tests
The Miniguard and it constituent materials were .ested for biocompatibility, toxicity, bacteriostasis/fungistasis, and skin sensitivity. The testing exceeds the guidelines per the FDA tripartite and ISO 194 for a device that is chronically used on intact mucous membrane. The results of these tests demonstrated that the materials and the whole device are biocompatible, non-toxic and well tolerated by cutaneous and subculaneous tissue. In addition, bacteriological testing indicated that the materials do not support growth of common urologic pathogens.
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8. Clinical Tests
The Miniguard device has been extensively tested for its safety and efficacy in decreasing the number of urinary leakage episodes in women with incontinence. All testing results indicate that use of the Miniguard imparts minimal risk. yet provides significant benefit for women in controlling urinary leakage.
Clinical testing on the Miniguard was completed on over 350 women from 12 investigative centers in the United States. Women used the Miniguard during a device usage period of 12 weeks to test four efficacy hypotheses which demonstrate the Miniguards ability to 1) decrease the number of leakage episodes; 2) reduce the perceived severity of urinary leakage; 3) reduce the impact of incontinence on quality of life: and 4) reduce the quantity of urine leakage. Testing materials used were: 1) a voiding diary, 2) a svmptom questionnaire; 3) an incontinence impact questionnaire; and 4) a 12-hour home pad-weight test. All testing materials were derived from published sources on incontinence testing and management. Efficacy parameters were statistically analyzed using graphical analyses, paired-1 analyses (Prob>(T)) and repeated-measures (MANOVA) analyses. Analyses' results demonstrate, in each of the four hypothesis, a statistically and clinically significant improvement for participants. The table below details the average values before using the Miniguard (Control) and after 12 weeks of device use (Trial 17).
| Hypothesis | Control | Trial 17 | % Improvement | Prob> T |
|---|---|---|---|---|
| 1. No. of Leakage Episodes (per week) | 14.18 | 4.89 | 65.5% | ≤0.0001 |
| 2. Perceived Severity of Leakage | 11.00 | 3.18 | 71.1% | m device usage. |
The sole adverse event which may be associated with Miniguard usage was a minor increase in the incidence of subject reported symptoms of iritation, characteristic of subjective perceptions of minor irritation associated with use of any topical device. Of the women who reported symptoms of vestibular irritation, the majority experienced one c continued using the Miniguard with no further symptoms and no required intervention from the investigator.
To further assess the safety data, ASI submitted study data to teams of physicians for analysis. Bladder function data were assessed by leading urologists and urogynecologists, microbiology data were assessed by a corc laboratory at the U iversity of Washington specializing in urogenital microflora; dermatology data were assessed by an expert in dermatology and gynecology at Emory University. These independent reports confirmed ASI's analyses results and are included in the 510(k) in Sections 10-14. Statistical analy:ses were completed on bladder function data and to assess the incidence rates for bacterial vaginosis and urinary tract infection. The results of these analyses (t-tests and McNemar's analyse:) showed no statistically significant differences between the control period and device usage periods.
9. Conclusions
The safety of the Miniguard female continence device was demonstrated by the extensive positive experience of the materials in medical applications and the nonclinical and clinical testing. Further, technological characteristics do not raise new types of safety and effectiveness questions relative to the predicate devices. The clinical in estigation demonstrated that Miniguard usage did not effect bladder function and did not appear o effect the incidence rates for urinary tract or vaginal infection. The Miniguard was well tolerated by the intralabial mucosa and there were no significant dermatologic effects associated with device usage. The efficacy of the Miniguard was demonstrated by the clinical testing that included both subjective measures. The clinical data showed that statistically significan improvement was obtained by study subjects when using the Miniguard In summary, these data provide reasonable assurance that the Miniguard female continence device is a safe anc effective alternative for women requiring stress incontinence management and is substantially equivalent to the predicate devices.
References
- 1 Burns PA et af, A Companson of Effectiveness of Biolecdback and Peter Muscle Exercise Treatment of Stress Incontinence in Older Community-Dwelling Wornen. J Gerontol, Medical Sciences, 48 4):M167-M174, 1993.
2 Ostergard DR. Bent AE, eds: Urogynecology & Urodynamics. Williams & Wilkins, Battimore, MD. P209-211, 1991.
3 Letter KF, Wagner DB; Incontinent In U.S. Antress Home · · 1 survey of 30,900 · posple. Josenations Society. 38,379-183, 1990
4 Wyman JF, et al; Psychosocial Ininary Incominence in Women. 1) stel Gynevol. Vol 70, 1987
5 Stergard DR. Bent AE. eds. Urogynecology & Urodynamics. Williams & Wilkins. Haltimore. MD. P211-213, 1991.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
APR 2 6 2010
Robert F. Rosenbluth, Ph.D. Advanced Surgical Intervention P.O. Box 3134 DANA POINT CA 92629
Re: K954215
Trade/Device Name: Miniguard Regulation Number: 21 CFR§ 876.5160 Regulation Name: Urological clamp for males Regulatory Class: I Product Code: MNG Dated: April 26, 1996 Received: April 29, 1996
Dear Dr. Rosenbluth:
This letter corrects our substantially equivalent letter of May 8, 1996.
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.
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Page 2 Robert F. Rosenbluth, Ph.D. K954215
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/Resourcesfor You/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