(391 days)
Not Found
Not Found
No
The device description and performance studies focus on a physical, mechanical device for managing urinary leakage. There is no mention of any computational or data-driven components that would suggest the use of AI or ML.
Yes
The device is indicated for the management of urinary leakage in women suffering from stress urinary incontinence (SUI), which constitutes a medical condition. It supports the natural action of muscles to prevent accidental urine loss.
No.
The device is described as an external female continence device for managing urinary leakage, which is a treatment or management function, not a diagnostic one.
No
The device description clearly describes a physical, molded device designed to be placed externally over the female urethra. There is no mention of software as a component of the device itself.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- FemAssist™ Function: The FemAssist™ is a physical device that is placed externally to provide mechanical support and prevent urine leakage. It does not analyze any bodily fluids or tissues.
The description clearly states its purpose is to manage urinary leakage by physically supporting the urethra. This is a mechanical function, not an in vitro diagnostic one.
N/A
Intended Use / Indications for Use
The FemAssist™ is an external female continence device indicated for the management of urinary leakage in women suffering from stress urinary incontinence (SUI).
Product codes (comma separated list FDA assigned to the subject device)
MNG
Device Description
The FemAssist™ device is a small (3.5cm in diameter) cylindrical device with a short profile (2.0cm in height) designed and constructed (molded) to fit over the female urethra, between the labia, posterior to the clitoris and anterior to the vagina. The FemAssist™ supports and reinforces the natural action of the muscles that control urine output and prevents accidental urine loss. The female urethra is located between the vagina and the clitoris, in the center of the area about 3cm in diameter. The FemAssist™ product is place by it's own mild vacuum action.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Female urethra
Indicated Patient Age Range
Adult women
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
At one clinical site, data from 73 women was used to evaluate the effectiveness of the FemAssist™ device in women with SUI. (Women were included in this analysis if they leaked a minimum of 2.0g of wins during the standard one-hour pad weight test® or >1.5 g of urine during the 48 hour pad weight test®.)
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A clinical study was conducted at three (3) US sites to determine if the FemAssist™ device could safely and effectively control urinary leakage in adult women suffering from various degrees of incontinence. The safety analysis was based on all women enrolled at the three sites, however the effectiveness data was based on the data collected from one site.
Clinical Safety:
The study monitored all adverse events on 222 adult women who initially enrolled in the study. 138 patients were followed for at least 30 days. Adverse events were obtained from voiding diaries and physician visits. The following adverse events were recorded during a combined trial involving 222 patients who used FemAssist™ for up to 30 days:
Discomfort: 78 patients (35%)
Urinary Tract Infection: 22 patients (10%)
Urethral Irritation (abrasion, bruising, redness): 14 patients (6%)
Bleeding: 12 patients (5%)
Discharge: 6 patients (3%)
Yeast Infection: 2 patients (1%)
Clinical Effectiveness:
The study used a one-hour standard pad weight test to measure device effectiveness. Each woman was asked to wear a pre-weighed pad for one hour while performing light exercise. After one hour, the pad was removed and weighed again to determine the amount of urine leakage that had occurred during this period. Each woman was then asked to use the device at home for 28 days, then return to the Doctor to repeat the one-hour pad rest while wearing the FemAssist™ device.
Results for 73 women:
100% (no leakage): 24 (32.9%)
75-100%: 22 (30.1%)
50-75%: 10 (13.7%)
0-50%: 6 (8.2%)
Increase in Urine Loss: 11 (15.1%)
76.7% of the women achieved at least a 50% or greater reduction in urine loss. The women were also asked to keep a one-week voiding diary, recording the number of days the FemAssist™ device was worn and the number of dry days experienced while the device was worn. These data demonstrated that the women remained dry for approximately 65.9% of the recorded days.
Conclusion: Based on the indications for use, performance testing, and clinical results, the INSIGHT Medical FemAssist™ device has been shown to be safe and effective for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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.
Not Found
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
11 14
INSIGHT Medical 21 OCT 1997
580 Main St., Bolton, MA 01740 Phone 508-779-6848 FAX 508-779-6927
510(k) Summary
Pursuant to 512(1)(3)(A) of the Food , Drug and Cosmetic Acc, INSIOHT Medical Corp. is required to . areast to box (7)(2)(2) of the an " ... sdequate summary of any information respecting safety and effectiveness or state that information will be made available upon request of any person." INSIGHT Medical chooses to submit a summary of the safety and effectiveness information. The summary is as follows:
| Trade Name: | FemAssist™ Urinary Incontinence Device |
|---|---|
| 510(k) Premarket Notification: | #K963858 |
| Owner/Operator: | INSIGHT Medical Corporation |
| 580 Main St. | |
| Bolton, MA 01740 | |
| Registration # 1221923 | |
| (INSIGHT Medical is a wholly owned subsidiary of Apple Medical | |
| Corp.) | |
| Device Generic Name: | Urethral Clamp |
| Classification: | According to Section 513 of the Federal Food, Drug and Cosmetic |
| Act, the device classification of a urethral clamp is Class I at 21 CFR | |
| 876.5160 (78FHA) by Gastro/Urology. | |
| Also, Appliance, Incontinence, Urosheath Type are classified as Class I | |
| at 21 CFR 876.5250 (78EXJ) by Gastro/Urology. | |
| Predicate Device: | MINIQUARD (Currently called Impress) |
| By Advanced Surgical Intervention | |
| Dana Point, CA (Now Uromed Corp., Needham, MA) | |
| The Miniguard (Impress), similar to the FemAssist™, was cleared for | |
| marketing by the FDA on May 8, 1996 as a new stress urinary | |
| incontinence product. The product is a small triangular shaped | |
| disposable foam pad with a plastic substrate about the size of a quarter, | |
| with an adhesive coating on one side. When placed over the urethra, | |
| the pad forms a seal to help stop urine from leaking. To use, a women | |
| places the adhesive side of the pad over the urinary opening, forming a | |
| seal. | |
| Product Description: | The FemAssist™ device is a small (3.5cm in diameter) cylindrical |
| device with a short profile (2.0cm in height) designed and constructed | |
| (molded) to fit over the female urethra, between the labia, posterior to | |
| the clitoris and anterior to the vagina. | |
| The FemAssist™ supports and reinforces the natural action of the | |
| muscles that control urine output and prevents accidental urine loss. | |
| The female urethra is located between the vagina and the clitoris, in the | |
| center of the area about 3cm in diameter. The FemAssist™ product is |
1
963858
P294
place by it's own mild vacuum action.
The FemAssist™ is an external female continence device indicated for
the management of urinary leakage in women suffering from stress
lications for Use:
ompatibility:
urinary incontinence (SUI). The following biocompatibility tests were performed on the
FemAssist™ device:
FemAssist™ device:
- NAmSA Microbial Limits Preparatory Test
- Staphylococcus Aureus .
- Pseudomonas Aeruginosa .
- Bscherichia Coli .
- Salmonella Typhimurium
- NAmSA Microbial Limits Screening 2.
- NAmSA Ames Salmonella/Mammalian 3. Microsome Mutagenicity Assay for Mutagens
- NAmSA USP Intracutaneous Toxicity Test in Rabbits
-
- NAmSA Delayed Contact Sensitization Study રા
- NAmSA Cytotoxicity Testing By the USP Elution Method ર.
- NAmSA Pyrogen Test T10 7.
-
- NAmSA Hemolysis Test in Vitro
NAmSA Vaginal Mucosal Irritation Study in 9. (Saline Extract) - NAmSA Vaginal Mucosal Irritation Study in the rabbit 10. (Cottonseed Oil Extract)
- USP Muscle Implantation, Two rabbits (4 weeks) v 11. Histopathology
- USP Muscle Implantation, Three rabbits (9 weeks) with 12. Histopathology
- USP Muscle Implantation, Three rabbits (13 weeks) with 13. OSF Musele Implandilon, Till St
Histopathology
The following benchtop safety and performance tests were p on the FemAssist™ device.
- Tensile Test 1.
- Pull Test 2.
- Lift Off Pressure Test 3.
- Vacuum Test ব.
- Water Leakage Test ર્સ
chton Safety and rformance Testing:
2
11963858 Pager
Clinical Results: Safety & Efficacy:
FemAssist™ Clinical Study:
A clinical study was conducted at three (3) US sites to decemine if the FemAssist™ device could safely and effectively control urinary leakage in adult women suffering from various degrees of incontinence. The safety analysis was based on all women excolled at the tires, however the effectiveness data was based on the data collected from one site.
Clinical Safery:
The study monitored all adverse events on 222 schilt women who initially carolled in the study. patients 138 were followed for at least 30 days. Adverse events were obtained from voiding diaries and physician visits. The following adverse evenss were recorded during a combined trial involving 222 patients who used FemAssist™ for up to 30 days:
| Recorded
Event | # of Patients
Recording Event | % of Total
Patients in Trial |
|-------------------------------|----------------------------------|---------------------------------|
| Discomfort | 78 | 35 |
| (patient reported) | | |
| Urinary Tract
Infection | 22 | 10 |
| Urethral Irritation | 14 | 6 |
| (abrasion, bruising, redness) | | |
| Bleeding | 12 | 5 |
| Discharge | 6 | 3 |
| Yeast Infection | 2 | 1 |
Clinical Effectiveness:
The study used a one-hour standard pad weight test to measure device effectiveness. Each women was asked to wear a pre-weighed pad for one hour while performing light exercise. After one how, the pad vas removed and weighed again to determine the amount of urine leakage that had occurred during this period. Each women was then asked to use the device at home for 28 days, then return to the Doctor to repear the one-how pad rest while wearing the FemAssist™ device. At one clinical site, data from 73 women was used to evaluate the effectiveness of the FemAssist™ device in women with SUI. (Women were included in this analysis if they leaked a minimum of 2.0g of wins during the standard one-hour pad weight tess® or >1.5 g of urine during the 48 hour pad weight test®.) "Lose G., Versi E. Pad-wrighing Tests in the Diagnosis and Quantification of Incontinence. Int Urogynecol 1 1992; 3:324-328 "Versi E., Orrego G., Hardy E., et al. Evaluation of the home pad test in the investigation of female urinery incominence. British Journal of Obstetrics and Gynaecology 1996; 103: 162-167
3
K963858 PY of 4
| % Reduction
in Urine Loss | # of Patients (%)
n=73 |
|------------------------------|---------------------------|
| 100% (no leakage) | 24 (32.9%) |
| 75-100% | 22 (30.1%) |
| 50-75% | 10 (13.7%) |
| 0-50% | 6 (8.2%) |
| Increase in Urine Loss | 11 (15.1%) |
As the table indicates, 76.7% of the woman schieved at least a 50% or greater reduction in urine loss. The women were also asked to keep a one-week voiding diary, recording the mumber of days the FemAssist™ device was worn and the number of dry days experienced while the device was worn. These data demonstrated that the women remained dry for approximately 65.9% of the recorded days.
Conclusion:
Based on the indications for use, performance testing, and clinical results, the INSIGHT Medical FemAssist™ device has been shown to be safe and effective for its intended use.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, with three figures in profile facing right, representing health and human services.
APR 2 6 2010
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Mr. Robert W. Schaefer President INSIGHT Medical Corporation 580 Main Street BOLTON MA 01740
Re: K963858 Trade/Device Name: FemAssist™ Regulation Number: 21 CFR §876.5160 Regulation Name: Urological clamp for males Regulatory Class: I Product Code: MNG Dated: October 13, 1997 Received: October 14, 1997
Dear Mr. Schaefer:
This letter corrects our substantially equivalent letter of original SE letter October 21, 1997.
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.
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
5
Page 2 Mr. Robert W. Schaefer K963858
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 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,
Jahine M. Morris
Acting Division Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Page of
510(k) Number (if known): ____K963858
Device Name: Femassiate Personal Urinary Control Device
Indications For Use:
The FemAssist™ is an external female continence device indicated for the management of urinary leakage in women Buffering from strees urinary incontinence (SUI).
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K963858 |
| Prescription Use (Per 21 CFR 801.109) | ✓ |
| OR | |
| Over-The-Counter Use | |
| (Optional Format 1-2-86) |