(208 days)
No
The device description details a passive system that converts pressure changes into a visual signal using LEDs, with no mention of AI or ML algorithms for data processing or interpretation.
No.
The device is described as a "passive device" that allows the patient to visually monitor exercise progress but does not actively provide therapy. Its function is to assist in exercising pelvic muscles, not to provide treatment directly.
No.
The device is described as a "passive device" that allows visual monitoring of pelvic muscle exercise progress. Its primary function is to provide biofeedback, not to detect, diagnose, or treat a medical condition.
No
The device description explicitly includes hardware components: a vaginal probe (silicone shaft, balloon, connector tube) and a Perineometer (biofeedback monitor with LEDs and rechargeable batteries). The system description details the interaction between these physical components.
Based on the provided text, this 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.
- Device Function: The description clearly states that this device is used to assist the patient in exercising their pelvic muscles by providing visual feedback on muscle activity. It measures pressure changes within the vaginal probe due to muscle contractions.
- No Sample Analysis: The device does not analyze any biological samples taken from the patient. It directly interacts with the patient's body to monitor a physiological process (muscle contraction).
Therefore, this device falls under the category of a medical device used for biofeedback and exercise assistance, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
85 HIR
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Pelvic muscles, vagina
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)
Not Found
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.
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.
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
§ 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).
0
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.
1
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}
2
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.
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.
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".
3
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.
4
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
5
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).
6
14970145
.
し
SAFETY & EFFECTIVENESS SUMMARY Biosearch Medical Products, Inc. PERINEOMETER & VAGINAL PROBE
| MATERIAL | TEST DATE | TEST PERFORMED | RESULTS |
|---|---|---|---|
| Perineometer | |||
| Model #20 | NA | Device is identical to legally | |
| marked device known as | |||
| Biosearch Biofeedback | |||
| monitor #5 | Previous 510(k) | ||
| K902843 | |||
| Anorectal Probe | |||
| Assembly | 11/11/91 | Tested entire device for | |
| Cytotoxicity - MEM Elution | Nontoxic | ||
| Glue used to | |||
| assemble the | |||
| Anorectal probe | Vendor | ||
| Provided | FDA Master File | Nontoxic | |
| Silicone used in | |||
| Anorectal Probe | Vendor | ||
| Provided | USP tests for Class VI | ||
| Plastics. (Hemolysis, | |||
| Pyrogenicity, Intracutaneous | |||
| Toxicity, Intramuscular | |||
| implant for 90 days) | Meets the | ||
| requirements of | |||
| USP Class VI | |||
| Plastic | |||
| Polyurethane | |||
| Tubing | |||
| Not inserted into | |||
| patient. | Vendor | ||
| Provided | USP tests for Class VI | ||
| Plastics. (Cytotoxicity | |||
| Agarose overlay, Hemolysis, | |||
| Intracutaneous Toxicity, | |||
| Implantation Test) | Meets the | ||
| requirements of | |||
| USP Class VI | |||
| Plastic | |||
| Luer Connectors | |||
| Not inserted into | |||
| patient. | Vendor | ||
| Provided | USP tests for Class VI | ||
| Plastics. (Acute Systemic | |||
| toxicity , Intracutaneous | |||
| Toxicity, Implantation Test) | Meets the | ||
| requirements of | |||
| USP Class VI | |||
| Plastic | |||
| Molded Tube | |||
| Adapter | |||
| Not inserted into | |||
| patient. | Vendor | ||
| Provided | USP tests for Class VI. | ||
| (Acute Systemic toxicity , | |||
| Hemolysis-Direct & | |||
| Extraction, Intracutaneous | |||
| Toxicity, Muscle | |||
| Implantation Test, | |||
| Cytotoxicity - MEM | |||
| Elution) | Meets the | ||
| requirements of | |||
| USP Class VI | |||
| Plastic | |||
| Check Valve | Vendor | ||
| Provided | ANSI/HIMA MD 70.1 | ||
| British BS 5081,176 | Meets the | ||
| requirements |
7
K970148 વ્યુવ
SAFETY & EFFECTIVENESS SUMMARY Biosearch Medical Products, Inc. PERINEOMETER & VAGINAL PROBE
EQUIVALENCE MATRIX (COMPARING USE AND TYPE)
| NAME &
510(k) No. | PROBE
(BALLOON
TYPE) | PROBE
(RING
TYPE) | PROBE
(EMG)
EXERCISING | CAN BE
USED WITH
SENSOR
STIMULATOR
(OPTIONAL) | USED FOR
MALE
BLADDER
CONTROL | USED FOR
FEMALE
BLADDER
CONTROL | PROBE
INSERTED
IN THE
RECTUM | PROBE
INSERTED
IN THE
VAGINA |
|--------------------------------------------------------------------|----------------------------|-------------------------|------------------------------|-----------------------------------------------------------|----------------------------------------|------------------------------------------|---------------------------------------|---------------------------------------|
| BIOSEARCH
"PERINOMETER &
VAGINAL PROBE"
{This Submission} | YES | NO | YES | YES | NO | YES | NO | YES |
| BIOSEARCH
"ANORECTAL
BIOFEEDBACK
SYSTEM #5"
{K902843} | YES | NO | YES | YES | NO | NO | YES | NO |
| BIOSEARCH
"ANORECTAL
BIOFEEDBACK
SYSTEM #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 |
| HOLLISTER
CONTIMED II"
{K891774} | YES | NO | YES | YES | YES | YES | YES | YES |
7
8
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
9
| 510(k) Number (if known): | K970145 |
|---|---|
| Device Name: | Permeometer & Vaginal Probe (Biofeedback Monitor #20 and Vaginal Probe) |
| Indications For Use: |
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.
(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.
OR
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
of