The FemAssist™ is an external female continence device indicated for the management of urinary leakage in women suffering from stress urinary incontinence (SUI).

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the FemAssist™ Urinary Incontinence Device, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria (Measured Outcome)	Reported Device Performance
Clinical Effectiveness: Achieve at least a 50% reduction in urine loss during a one-hour standard pad weight test.	76.7% of women achieved at least a 50% or greater reduction in urine loss.
Clinical Effectiveness: Maintain dryness for a high percentage of days while using the device (as recorded in a one-week voiding diary).	Women remained dry for approximately 65.9% of the recorded days.
Clinical Safety: Low incidence of reported adverse events such as discomfort, urinary tract infection, urethral irritation, bleeding, discharge, and yeast infection over 30 days of use.	Discomfort: 35% Urinary Tract Infection: 10% Urethral Irritation: 6% Bleeding: 5% Discharge: 3% Yeast Infection: 1%
Biocompatibility Testing: Device materials must pass a range of biocompatibility tests to ensure safety for human contact (e.g., microbial limits, mutagenicity, toxicity, sensitization, cytotoxicity, pyrogen, hemolysis, mucosal irritation, muscle implantation with histopathology).	NAmSA Microbial Limits Preparatory Test (Staphylococcus Aureus, Pseudomonas Aeruginosa, Escherichia Coli, Salmonella Typhimurium), NAmSA Microbial Limits Screening, NAmSA Ames Salmonella/Mammalian Microsome Mutagenicity Assay, NAmSA USP Intracutaneous Toxicity Test, NAmSA Delayed Contact Sensitization Study, NAmSA Cytotoxicity Testing, NAmSA Pyrogen Test, NAmSA Hemolysis Test in Vitro, NAmSA Vaginal Mucosal Irritation Study (Saline and Cottonseed Oil Extracts), USP Muscle Implantation (4, 9, and 13 weeks with Histopathology).
Benchtop Safety & Performance Testing: Device must withstand specified mechanical and functional tests (e.g., tensile test, pull test, lift off pressure test, vacuum test, water leakage test) to ensure structural integrity and proper function.	Tensile Test, Pull Test, Lift Off Pressure Test, Vacuum Test, Water Leakage Test. (Specific pass/fail criteria or quantitative results not provided in the summary, only that these tests were performed.)

Study Details

Sample size used for the test set and the data provenance:
- Clinical Efficacy Test Set: Data from 73 women from one clinical site.
- Clinical Safety Test Set: 222 women initially enrolled. 138 patients were followed for at least 30 days. Data was collected at three (3) US sites.
- Data Provenance: United States (US sites), prospective clinical study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number or qualifications of experts used to establish ground truth for the clinical study. The effectiveness measure (pad weight test) and adverse event reporting would likely have involved clinical personnel (doctors, nurses) at the study sites, but their specific roles in "ground truth establishment" are not detailed.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- The document does not describe any specific adjudication method for the clinical test set data. Adverse events were "obtained from voiding diaries and physician visits," and pad weight tests are objective measurements.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This was not an AI-based device, nor was it a multi-reader, multi-case study. It's a medical device for urinary incontinence.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable as the device is a physical, external medical device and not an algorithm or AI system. Its performance is tested entirely standalone (device only) as it's designed to be used by the patient without the need for human intervention or interpretation beyond initial fitment and instructions.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Clinical Effectiveness: Objective measurements - urine leakage measured by the change in pad weight (standardized one-hour pad weight test) and patient self-reported dryness days from voiding diaries.
- Clinical Safety: Patient self-reported adverse events (from voiding diaries) and physician observations during visits.
- Biocompatibility/Benchtop: Pass/fail criteria established by recognized standards (NAmSA, USP) for laboratory tests.
The sample size for the training set:
- The concept of a "training set" is not applicable here as this is a physical medical device, not a machine learning model.
How the ground truth for the training set was established:
- Not applicable (see point 7).

Summary

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K963858

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 Corporation580 Main St.Bolton, MA 01740Registration # 1221923(INSIGHT Medical is a wholly owned subsidiary of Apple MedicalCorp.)
Device Generic Name:	Urethral Clamp
Classification:	According to Section 513 of the Federal Food, Drug and CosmeticAct, the device classification of a urethral clamp is Class I at 21 CFR876.5160 (78FHA) by Gastro/Urology.Also, Appliance, Incontinence, Urosheath Type are classified as Class Iat 21 CFR 876.5250 (78EXJ) by Gastro/Urology.
Predicate Device:	MINIQUARD (Currently called Impress)By Advanced Surgical InterventionDana Point, CA (Now Uromed Corp., Needham, MA)
	The Miniguard (Impress), similar to the FemAssist™, was cleared formarketing by the FDA on May 8, 1996 as a new stress urinaryincontinence product. The product is a small triangular shapeddisposable 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 womenplaces the adhesive side of the pad over the urinary opening, forming aseal.
Product Description:	The FemAssist™ device is a small (3.5cm in diameter) cylindricaldevice with a short profile (2.0cm in height) designed and constructed(molded) to fit over the female urethra, between the labia, posterior tothe clitoris and anterior to the vagina.
	The FemAssist™ supports and reinforces the natural action of themuscles that control urine output and prevents accidental urine loss.The female urethra is located between the vagina and the clitoris, in thecenter of the area about 3cm in diameter. The FemAssist™ product is

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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
1. 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:

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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:

RecordedEvent	# of PatientsRecording Event	% of TotalPatients in Trial
Discomfort	78	35
(patient reported)
Urinary TractInfection	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

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K963858 PY of 4

% Reductionin 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.

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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

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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

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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)

Regulation Number and Section

§ 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.