PERINEOMETER & VAGINAL PROBE (BIOFEEDBACK MONITOR #20 AND VAGINAL PROBE)

{0} K970145 AUG 11 1997 # bi5search MEDICAL PRODUCTS INC. ## >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 Dyck *(Handwritten signature above printed name)* Vice President of Operations, New Product Development Coordinator *(Handwritten signature above printed name)* 1/15/97 date submitted Biosearch Medical Products, Inc. P.O. Box 1700 Somerville, NJ. 08876-1276 (USA) TEL: 908-722-5000 FAX: 908-722-5024 BIO5SEARCH {1} K970145 3/8 # SAFETY & EFFECTIVENESS SUMMARY ## Biosearch Medical Products, Inc. ### PERINEOMETER & VAGINAL PROBE **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 in the majority of cases lead to increased bladder control. (Figure showing vaginal probe inserted)  {2} K970145 # 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 polyurethane connector tube. The silicone balloon is mounted in such a way that when pressure is applied to it, air will be displaced through its connector tubing. This air displacement is being monitored by the biofeedback monitor which 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 vaginal 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 inserted the balloon 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.  Vaginal Probe  Perineometer 2 {3} K970145 4/8 # SAFETY & EFFECTIVENESS SUMMARY ## Biosearch Medical Products, Inc. ### PERINEOMETER & VAGINAL PROBE **Why do pelvic muscle exercises (Kegal exercise):** Without the strength and support of the pelvic floor muscles, urinary continence is difficult to maintain. Female urinary incontinence is usually associated with anatomical, neurological pelvic floor dysfunction. Presently many Urologist/Gynecologists are recommending pelvic muscle exercises to their female patients since these exercises will serve to enhance the strength and pelvic muscle control for the patient and in many cases improve urinary continence. **What need does this device address:** The Perineometer (Biofeedback Monitor) and Vaginal Probe makes it possible for the patient to visualize their pelvic muscle activity. This is otherwise extremely difficult for the patient to monitor, due to the anatomical location of these muscles. This procedure must be performed at regular intervals as prescribed by the physician.  {4} K970145 5/8 # SAFETY & EFFECTIVENESS SUMMARY ## Biosearch Medical Products, Inc. ### PERINEOMETER & VAGINAL PROBE ## BIOCOMPATIBILITY DATA AND MATERIAL SPECIFICATIONS:  VAGINAL PROBE shown above is similar (except that the proximal balloon has been removed.) to the Anorectal probe which has been previously approved via the following Biosearch Medical 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. 4 {5} K920145 6/8 # SAFETY & EFFECTIVENESS SUMMARY ## Biosearch Medical Products, Inc. ### PERINEOMETER & VAGINAL PROBE Cont. **BIOCOMPATIBILITY DATA AND MATERIAL SPECIFICATIONS:**  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). 5 {6} K970145 # 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} K970145 8/8 # SAFETY & EFFECTIVENESS SUMMARY ## Biosearch Medical Products, Inc. ### PERINEOMETER & VAGINAL PROBE ## EQUIVALENCE MATRIX (COMPARING USE AND TYPE) | NAME & 510(k) No. | PROBE (BALANCE TYPE) | PROBE (CIRC TYPE) | USED FOR REQUIREMENT | CAN BE USED WITH REQUIREMENT OF OTHER RECOGNIZER (OPTIONAL) | USED FOR MALE REQUIREMENT CONTROL | USED FOR FEMALE REQUIREMENT CONTROL | PROBE INSERVED IN THE RECIPIENT | PROBE INSERVED IN THE VAGIN | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 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 | {8} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 11 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 indications for use stated in the enclosure) to 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). 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 (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. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product 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 vitro 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,  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 Enclosure {9} Page ___ of ___ 510(k) Number (if known): K970145 Device Name: Perineometer & 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) Colin M Pollard (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number K970145 Prescription Use ☑ (Per 21 CFR 801.109) OR Over-The-Counter Use ☐ (Optional Format 1-2-96)