INTENDED USE STATEMENT: The Perineometer (Biofeedback monitor) and vaginal probe are intended to be used to assist the patient in exercising her pelvic muscles (referred to Kegal exercises) which may lead to increased bladder control.

Device Description

The PERINEOMETER & VAGINAL PROBE , is a passive device which will allow the patient to visually monitor their Kegal exercise progress.

The Vaginal probe is a Single patient use only device comprised of a medical grade Silicone shaft with a silicone balloon (Inflatable to enlarge to accomodate various vaginal sizes.) and a oolvurethane connector tube. The silicone balloon is mounted in such a way that when pressure is applied to it, air will be displaced through it's connector tubing. This air displacement is being monitored by the biofeedback monitor will cause the LED lights to turn on in proportion to the pressure exerted. This probe is similar to the legally marketed probe via 510(k) numbers (K902843) and (K913736) except that in this case we are inflating the balloon to provide gentle pressure to the vaginal wall. This will allow the probe to be customized for the patients individual vaqinal size.

The Perineometer (Biofeedback Monitor) is powered by rechargeable batteries. To prevent a potential shock hazard this unit will not function while it is being recharged. The Perineometer is identical to the biofeedback monitor which had been 510(k) approved for use in fecal incontinence (K902843). Thus, in the case of this 510(k) submission, we only seek to expand its use for general Kegal exercises.

SYSTEM DESCRIPTION: The patient inserts the vaginal probe which is connected to the Perineometer. Once the probe is inflated until it provides gentle pressure to the vaginal wall. As the pelvic muscles expand and contract (Kegal exercises) the pressure in the probe changes and these pressure changes are converted into a visual signal on the Perineometer (biofeedback monitor). The visual signal on the Perineometer is a series of LEDs (lights) which provide the patient with a real time representation of pelvic muscle activity.

AI/ML Overview

This submission describes the Biosearch Medical Products, Inc. "PERINEOMETER & VAGINAL PROBE" for assisting patients with pelvic muscle exercises to improve bladder control. The device consists of a Perineometer (biofeedback monitor) and a vaginal probe.

Here's an analysis of the acceptance criteria and supporting studies based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly define quantitative acceptance criteria for the "PERINEOMETER & VAGINAL PROBE" in terms of performance metrics like sensitivity, specificity, or accuracy. Instead, the focus is on demonstrating substantial equivalence to legally marketed predicate devices through material biocompatibility and functional similarity.

Therefore, the "acceptance criteria" can be inferred as meeting the safety and material requirements of similar devices and demonstrating comparable functionality.

Acceptance Criteria (Inferred)	Reported Device Performance
Biocompatibility: Materials in patient contact are safe.	Vaginal Probe Components:
	- Silicone Probe & Silicone Marker Ring: USP Class VI Silicone (Meets requirements).
	- Anorectal Probe Assembly (entire device): Tested for Cytotoxicity (MEM Elution), reported as Nontoxic.
	- Glue used to assemble Anorectal probe: Vendor Provided (FDA Master File), reported as Nontoxic.
	- Polyurethane Tubing: USP Class VI Plastics tests (Cytotoxicity Agarose overlay, Hemolysis, Intracutaneous Toxicity, Implantation Test), reported as Meets the requirements.
	Components Not Inserted into Body Cavity (Luer Lock Connector, Medical Grade Tubing, Molded Tube Adapter, Luer Connector & Dual Port Adapter, Balloon Inflation Valve/Port): Made of Medical grade plastic, assumed safe due to no direct patient contact. Some were also tested against USP Class VI Plastics (e.g., Luer Connectors, Molded Tube Adapter).
Functional Equivalence: Device functions similarly to legally marketed devices for its intended use.	Perineometer (Biofeedback Monitor): Identical to Biosearch Biofeedback monitor #5 (K902843), already 510(k) approved for fecal incontinence.
	Vaginal Probe: Similar to legally marketed probes (K902843, K913736) but with an inflatable balloon to customize to patient's vaginal size. Demonstrates comparable operation by converting pressure changes from pelvic muscle activity into a visual LED signal.
	Equivalence Matrix: The "Equivalence Matrix" table (page 7) shows the "BIOSEARCH "PERINOMETER & VAGINAL PROBE" (This Submission) has similar features (Balloon Type Probe, EMG Exercising, Can be used with Sensor Stimulator, Used for Female Bladder Control, Probe Inserted in the Vagina) to predicate devices like "MILEX "PERINEAL EXERCISER" (K862410) and "CARDIO DESIGN "PERITRON" (K945611).

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a specific clinical "test set" in the way typically expected for performance claims (e.g., a cohort of patients randomized to use the device). The device's performance is primarily established through:

Substantial Equivalence: Comparison to existing, legally marketed predicate devices.
Material Biocompatibility Testing: Conducted on components (e.g., Anorectal Probe Assembly, Silicone, Polyurethane Tubing). The "sample size" for these tests would refer to the number of material samples tested, but this detail is not provided.
Data Provenance: The biocompatibility tests are listed with "Test Date" (e.g., 11/11/91 for Anorectal Probe Assembly) or "Vendor Provided." This indicates the data is from laboratory testing of materials and components, likely retrospective given the dates. There is no information about the country of origin for the data or whether it was prospective or retrospective in a clinical sense.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

There is no mention of experts establishing a "ground truth" in a clinical context for a test set. The submission relies on:

Regulatory Standards: USP Class VI for plastics, ANSI/HIMA MD 70.1, British BS 5081,176 for check valve.
Previous Approvals: The Perineometer's equivalence to existing 510(k)-approved devices (K902843, K913736).
Expertise in Biocompatibility: The "Nontoxic" and "Meets requirements" results imply assessment by experts in material science and biocompatibility testing, but their specific qualifications or number are not detailed.

4. Adjudication Method for the Test Set

As there is no described clinical "test set" or human assessment of device performance for the purpose of establishing clinical efficacy or accuracy in this submission, there is no adjudication method mentioned. The primary "adjudication" is the FDA's review of the substantial equivalence claim based on the provided material and functional comparisons.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No MRMC comparative effectiveness study was done or reported in this submission. The effectiveness of the device is inferred from its similarity to predicate devices already on the market and the general understanding that pelvic muscle exercises improve bladder control. There is no mention of human readers or AI assistance, let alone an effect size.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done

This device, the "PERINEOMETER & VAGINAL PROBE," is a biofeedback system that provides a visual signal (LED lights) in proportion to pressure exerted by pelvic muscles. It is an interactive device used by the patient (human-in-the-loop) to guide their exercises. Therefore, the concept of a "standalone (algorithm only)" performance assessment does not apply to this type of medical device. Its function is to facilitate human action, not to perform an automated diagnostic or therapeutic task independently.

7. The Type of Ground Truth Used

The "ground truth" in this submission is primarily based on:

Established Biocompatibility Standards: USP Class VI, ISO standards, and previous FDA approvals for material safety.
Functional Similarity to Legally Marketed Predicate Devices: The reference to previous 510(k) clearances (K902843, K913736, K945611, K862410, K891774) indicates that the performance of these devices in assisting pelvic muscle exercises and improving bladder control is the benchmark.
Scientific Consensus: The statement "Presently many Orologists of the country are recommending pelvic muscle exercises to their female patients since the exercises improve urinary continence" implies a general medical consensus on the efficacy of the underlying therapy (Kegal exercises).

8. The Sample Size for the Training Set

There is no "training set" in the context of machine learning or AI models described in this document. The device is a mechanical/electronic biofeedback tool, not an AI or algorithm-based system that requires training data.

9. How the Ground Truth for the Training Set Was Established

As there is no training set, this question is not applicable.

Summary

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AUG 1-11 1997

Image /page/0/Picture/2 description: The image shows the logo for Biosearch Medical Products Inc. The logo is in black and white and features the word "biosearch" in a bold, sans-serif font. The "o" in "biosearch" is stylized to resemble a flask. Below the word "biosearch" is the phrase "MEDICAL PRODUCTS INC." in a smaller, sans-serif font. The logo has a registered trademark symbol.

510(k) SUMMARY SAFETY & EFFECTIVENESS SUMMARY

PERINEOMETER & VAGINAL PROBE

Manufactured / Sold by:

Biosearch Medical Products, Inc. 35 Industrial Parkway P.O. Box 1700 Somerville, NJ. 08876 {USA}

Telephone : 1-908-722-5000 Fax : 1-908-722-5024

Contact Person:

Martin Rych

Martin Dyck

Vice President of Operations, New Product Development Coordinator

1/15/97

date submitted

Image /page/0/Picture/15 description: The image shows a black and white graphic of a banner with the text "ISO 9001" written on it. The banner is curved and has pointed ends. The text is in a sans-serif font and is centered on the banner. The image is simple and clear, with no other details or elements present.

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SAFETY & EFFECTIVENESS SUMMARY Biosearch Medical Products, Inc. PERINEOMETER & VAGINAL PROBE

INTENDED USE STATEMENT: The Perineometer (Biofeedback monton) and vaginal probes (referred to Kegal INTENDED USE STATEMENT: In exercising her periormer (since musels) and mores (referred to Kegal
intended to be used to assist the patient in exercising her pelvic museles (re intended to be used to assist the "patient in excruments" por por por por of.

Image /page/1/Picture/3 description: This image shows a figure of a vaginal probe inserted. The image shows a cross section of the female anatomy. The vaginal probe is inserted into the vagina. The uterus and other organs are also visible in the image.

{Figure showing vaginal probe inserted}

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SAFETY & EFFECTIVENESS SUMMARY Biosearch Medical Products. Inc. PERINEOMETER & VAGINAL PROBE

DESCRIPTION OF THE DEVICE:

The PERINEOMETER & VAGINAL PROBE , is a passive device which will allow the patient to visually monitor their Kegal exercise progress.

Image /page/2/Picture/7 description: The image shows a white ultrasound probe on a black background, with a coin placed near the probe's head for size comparison. The probe has a long, slender body that widens into a rounded head, and a cable extends from the opposite end. The coin is a US dime, and it is placed to the left of the probe's head. The image is likely intended to illustrate the size and shape of the ultrasound probe.

Vaginal Probe

Image /page/2/Picture/9 description: The image shows a device labeled as a "Perineometer". The device has a bio search logo on the top left. The device has a dial labeled "ZERO ADJ" and a power button labeled "PWR".

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SAFETY & EFFECTIVENESS SUMMARY Biosearch Medical Products, Inc. PERINEOMETER & VAGINAL PROBE

Why do pelvic muscle exercises (Kegal exercise); Without the strength and support of Why do pelvic muscles, urinary continence is difficult to maintain. Female urinary the pelvic floor muscals, unnaly continence to annomical, nelvic floor dysfunction.
incontinence is usually associated with anatomical, nelvic exercises to incontinence is usually associated with a recommending pelvic muscle exercises to their Presently many Orologists of the countinents "Personal on the strength and pelvic muscle termale patients since the exercises improve urinary continence.

What need does this device address: The Perineometer (Biofeelback Monitor) and What need does this device address. The investize their pevic muscle activity. This is Vaginal Probe makes it possible for the patient to moritor, due to the anatomical location of these
otherwise extremely difficult for the patient to mornalisation on proscri otherwise extremely unficult for the patient to neer, r intervals as prescribed by the physician.

Image /page/3/Picture/4 description: The image shows a strip chart recorder, a perineometer, a vaginal probe, a connector to the perineometer, and a balloon inflation port. The strip chart recorder is a device that records data on a long strip of paper. The perineometer is a device that measures the strength of the pelvic floor muscles. The vaginal probe is inserted into the vagina to measure the pressure of the pelvic floor muscles. The connector to the perineometer connects the vaginal probe to the perineometer. The balloon inflation port is used to inflate the balloon in the vaginal probe.

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SAFETY & EFFECTIVENESS SUMMARY Biosearch Medical Products, Inc. PERINEOMETER & VAGINAL PROBE

BIOCOMPATIBILITY DATA AND MATERIAL SPECIFICATIONS:

Image /page/4/Figure/2 description: The image shows a diagram of a medical device with several labeled components. The device includes a Luer lock connector to monitor, a dual port adapter, and a balloon inflation valve/port. Other labeled parts are the Luer connector, medical grade tubing, silicone probe, distal balloon, marker ring, and a molded tube adapter.

VAGINAL PROBE shown above is similar (except that the proximal balloon has been VAGINAL FRODE Showntaboro which has been previously approved via the femoved.) to the Anorooal products 510(k)'s : K902843 (System #5 & Anorectal Probe) and K913736 (System #10 & Anorectal Probe).

*) LUER LOCK CONNECTOR -> (Not inserted into a body cavity) The material used is a Medical grade plastic.

*) MEDICAL GRADE TUBING -> (Not inserted into a body cavity) The material used is a Medical grade plastic.

*) MOLDED TUBE ADAPTER -> (Not inserted into a body cavity) The material used is a Medical grade plastic.

*) SILICONE PROBE & SILICONE MARKER RING -> The material used is USP class VI Silicone.

*) LUER CONNECTOR & DUAL PORT ADAPTER -> (Not inserted into a body cavity) The material used is a Medical grade plastic.

*) BALLOON INFLATION VALVE/PORT -> (Not inserted into a body cavity) The materials used are Medical grade plastics.

1970145

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K970145 6/4

SAFETY & EFFECTIVENESS SUMMARY Biosearch Medical Products, Inc. PERINEOMETER & VAGINAL PROBE

Cont. BIOCOMPATIBILITY DATA AND MATERIAL SPECIFICATIONS:

Image /page/5/Picture/3 description: The image shows a "Perineometer" device, which is a medical instrument used to measure the strength of the pelvic floor muscles. The device has a bio-search logo on the top left corner. The device has a series of buttons and knobs, including a "ZERO ADJ" knob, which is used to calibrate the device. There is also a power button at the bottom of the device.

THIS IS A HAND HELD MONITOR. IT DOES NOT COME INTO CONTACT WITH MUCUS MEMBRANES OR BODY FLUIDS.

SPECIAL NOTE : PERINEOMETER has been previously approved via the following Biosearch Medical Products 510(k) : K902843 (System #5 & Anorectal Probe).

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14970145

し

SAFETY & EFFECTIVENESS SUMMARY Biosearch Medical Products, Inc. PERINEOMETER & VAGINAL PROBE

MATERIAL	TEST DATE	TEST PERFORMED	RESULTS
PerineometerModel #20	NA	Device is identical to legallymarked device known asBiosearch Biofeedbackmonitor #5	Previous 510(k)K902843
Anorectal ProbeAssembly	11/11/91	Tested entire device forCytotoxicity - MEM Elution	Nontoxic
Glue used toassemble theAnorectal probe	VendorProvided	FDA Master File	Nontoxic
Silicone used inAnorectal Probe	VendorProvided	USP tests for Class VIPlastics. (Hemolysis,Pyrogenicity, IntracutaneousToxicity, Intramuscularimplant for 90 days)	Meets therequirements ofUSP Class VIPlastic
PolyurethaneTubingNot inserted intopatient.	VendorProvided	USP tests for Class VIPlastics. (CytotoxicityAgarose overlay, Hemolysis,Intracutaneous Toxicity,Implantation Test)	Meets therequirements ofUSP Class VIPlastic
Luer ConnectorsNot inserted intopatient.	VendorProvided	USP tests for Class VIPlastics. (Acute Systemictoxicity , IntracutaneousToxicity, Implantation Test)	Meets therequirements ofUSP Class VIPlastic
Molded TubeAdapterNot inserted intopatient.	VendorProvided	USP tests for Class VI.(Acute Systemic toxicity ,Hemolysis-Direct &Extraction, IntracutaneousToxicity, MuscleImplantation Test,Cytotoxicity - MEMElution)	Meets therequirements ofUSP Class VIPlastic
Check Valve	VendorProvided	ANSI/HIMA MD 70.1British BS 5081,176	Meets therequirements

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K970148 વ્યુવ

SAFETY & EFFECTIVENESS SUMMARY Biosearch Medical Products, Inc. PERINEOMETER & VAGINAL PROBE

EQUIVALENCE MATRIX (COMPARING USE AND TYPE)

NAME &510(k) No.	PROBE(BALLOONTYPE)	PROBE(RINGTYPE)	PROBE(EMG)EXERCISING	CAN BEUSED WITHSENSORSTIMULATOR(OPTIONAL)	USED FORMALEBLADDERCONTROL	USED FORFEMALEBLADDERCONTROL	PROBEINSERTEDIN THERECTUM	PROBEINSERTEDIN THEVAGINA
BIOSEARCH"PERINOMETER &VAGINAL PROBE"{This Submission}	YES	NO	YES	YES	NO	YES	NO	YES
BIOSEARCH"ANORECTALBIOFEEDBACKSYSTEM #5"{K902843}	YES	NO	YES	YES	NO	NO	YES	NO
BIOSEARCH"ANORECTALBIOFEEDBACKSYSTEM #10"{K913736}	YES	NO	YES	YES	NO	NO	YES	NO
CARDIO DESIGN"PERITRON"{K945611}	YES	NO	YES	NO	YES	YES	YES	YES
MILEX"PERINEAL EXERCISER"{K862410}	YES	NO	YES	YES	NO	YES	NO	YES
HOLLISTERCONTIMED II"{K891774}	YES	NO	YES	YES	YES	YES	YES	YES

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Image /page/8/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG | | 1997

Mr. Martin Dyck Vice President of Operations. New Product Development Coordinator Biosearch Medical Products, Inc. P.O. Box 1700 Somerville, New Jersey 08876-1276

Re: K970145 PERINEOMETER & VAGINAL PROBE (Biofeedback Monitor #20 and Vaginal Probe) Dated: May 13, 1997 Received: May 15, 1997 Regulatory class: II 21 CFR §884.1425/Product code: 85 HIR

Dear Mr. Dyck:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the intel in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in yitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

h. Lillian Yin, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (if known):	K970145
Device Name:	Permeometer & Vaginal Probe (Biofeedback Monitor #20 and Vaginal Probe)
Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
Qhis in Rulle

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K97 0145

Image /page/9/Picture/6 description: The image shows the text "Prescription Use" with a check mark above a line. Below the line, the text "(Per 21 CFR 801.109)" is visible. The check mark indicates that the prescription use option has been selected.

Over-The-Counter Use

(Optional Format 1-2-96)

ﺮ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤ

Regulation Number and Section

§ 884.1425 Perineometer.

(a)
Identification. A perineometer is a device consisting of a fluid-filled sack for intravaginal use that is attached to an external manometer. The devices measure the strength of the perineal muscles by offering resistence to a patient's voluntary contractions of these muscles and is used to diagnose and to correct, through exercise, uninary incontinence or sexual dysfunction.(b)
Classification. Class II (performance standards).