PERIFORM

K981277 · Verimed Holdings, Inc. · HIR · Nov 20, 1998 · Obstetrics/Gynecology

Device Facts

• Record ID: K981277
• Device Name: PERIFORM
• Applicant: Verimed Holdings, Inc.
• Product Code: HIR · Obstetrics/Gynecology
• Decision Date: Nov 20, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1425
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Biofeedback/monitoring vaginal probe intended for: - Treatment of stress, urge, and mixed incontinence. . - Facilitation in identification of the pubococcygeus muscles. . - . Strengthening of the pelvic floor muscles through biofeedback-assisted pelvic floor exercises.

Device Story

Periform® is a vaginal perineometric probe for acquiring superficial EMG signals from the human vaginal wall. It functions as a passive sensor; it does not deliver energy. The probe is inserted into the vagina to detect electrical action potentials generated by the pubococcygeus muscle during contraction. These signals are transported to an external biofeedback device for processing. Used in hospitals, clinics, doctor's offices, or home settings under clinician supervision. The output provides biofeedback to the patient, facilitating pelvic floor muscle exercises to improve voluntary control and strength. The device includes a Pelvic Floor Contraction Indicator (PFCI) for qualitative evaluation of musculature. It is a reusable, single-patient device.

Clinical Evidence

Bench testing only. Impedance testing confirmed the probe effectively transports electrical signals with minimal attenuation (approx. 10 ohms) across frequencies relevant to pelvic floor biofeedback (<200 Hz). Biocompatibility testing for body materials (Polystyrene type 564) met USP Class VI requirements; electrodes (Medical Grade Stainless Steel 316S31) were confirmed nontoxic for transient contact.

Technological Characteristics

Passive vaginal probe; no energy delivery. Materials: High Impact Polystyrene (type 564) body, Medical Grade Stainless Steel (316S31) electrodes. Dimensions: 76 mm shaft length, 34 mm width, 28.2 mm flange diameter. Sensing: 2-electrode longitudinal orientation for sEMG. Connectivity: Wired connection to external biofeedback device. Sterilization: Non-sterile; cleaning instructions provided. No software or active electronics.

Indications for Use

Indicated for adult female patients with stress, urge, or mixed urinary incontinence requiring pelvic floor muscle strengthening or identification of pubococcygeus muscles via biofeedback. Contraindicated for pregnant patients, those with menstrual, bladder, or vaginal infections, history of urinary retention, diminished mental/physical capacity, or anatomical structures preventing proper insertion. Do not use with electrical muscle stimulation.

Regulatory Classification

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.

Predicate Devices

• Verimed Electromyographic Perineometer™ (K913912)
• PerryVaginal™ Sensor (K911190)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for Verimed International Inc. The logo is black and white and features a stylized "V" followed by the word "ERIMED" in bold, sans-serif font. Below the word "ERIMED" is the text "International Inc." in a smaller font size.

K98/277

510(k) Summary

# Summary of Safety and Effectiveness

## Periform® Perineometric Probe and Pelvic Floor Contraction Indicator

Manufactured by:

NEEN HealthCare Old Pharmacy Yard, Church Street Dereham, Norfolk NR19 1DJ England, United Kingdom.

Sold by:

Verimed International, Inc. 11950 NW 39 St., Suite D Coral Springs, FL 33065 {USA}

Telephone: [phone] Fax: [phone]

Contact Person:

Signature

Kishore Puppala, Product Manager, Verimed International, Inc.

April 2, 1998.

Date Submitted

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## Name of Device

Trade Name: Periform® Common name: Perineometric Probe Classification: Perineometer (per 21 CFR section 884.1425)

## Identification of Predicate Device

Verimed contends that the Periform® probe is substantially equivalent to the Verimed Electromvographic Perineometer™ [510(k) number K913912] and the PerryVaginal™ Sensor (also known as the PerryMeter Vaginal Perineometer) {510(k) number K911190].

## Description of Device

The Periform® is a vaginal perineometric probe designed specifically for the acquisition of the naturally present superficial EMG signals of the human vaginal wall. Surface electromyography (sEMG) is the technique of measuring and filtering the electrical impulse (action potential) signals generated by muscle fibers during contraction. The probe conducts these signals to a biofeedback device for further processing. The anatomy of the pelvic floor presents a difficulty in obtaining these signals. The use of a perineometric probe overcomes this difficulty.

The purpose of the Periform® is to improve the voluntary control and strength of the pelvic floor muscles with the aid of biofeedback equipment.

#### Intended Uses

#### Indications

- Treatment of stress, urge, and mixed incontinence. �
- Sensor for SEMG behavioral training. �
- Facilitation in identification of the pubococcygeus muscles. �
- � Strengthening of the pelvic floor muscles through biofeedbackassisted pelvic floor exercises.
- � Qualitative evaluation of the pelvic floor musculature using the Pelvic Floor Contraction Indicator.

## Contraindications/ DO NOT USE

- � Do not use during the menstrual period or when pregnant.
- � Do not use if symptoms of a bladder infection are present.
- Do not use if symptoms of a vaginal infection are present. �
- Do not use if patient has a history of urinary retention or symptoms � thereof.
- Do not use with patients who have diminished mental capacity or � physical competence or who cannot handle the device properly.
- Do not use while pregnant or while attempting to become pregnant. �

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- ♦ Do not use if patient has an anatomical vaginal morphology and/or structure that does not permit proper insertion of the probe.
- ◆ Do not use this device in conjunction with electrical muscle stimulation.
- ♦ Do not use if patient is unable or unwilling to use device as directed and indicated.

| | Periform® | Verimed<br>Electromyographic<br>Perineometer™ | PerryVaginal™<br>Sensor |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| 510(k) number | | K913912 | K911190 |
| Mode of Use | Reusable for a single<br>patient | Same. | Same. |
| Parameter monitored | aggregate surface<br>electromyogram | Same. | Same. |
| User feedback | None | None | None |
| Intended Use | To produce<br>biofeedback signals<br>for processing by an<br>external biofeedback<br>device. | Same. | Same. |
| Indications for Use | Treatment of stress<br>and urge incontinence<br>and facilitation of<br>pelvic floor exercises. | Same. | Treatment of stress,<br>urge, and mixed<br>incontinence. |
| Performance<br>Standards | Currently no performance standards exist for sEMG biofeedback<br>perineometric probes. | | |
| Target Population | Adult female urinary<br>incontinence patients. | Same. | Same. |
| Anatomical Sites<br>designated for use. | Female<br>pubococcygeus<br>muscle area. | Same. | Same. |
| Energy used and/ or<br>delivered. | No energy delivered or<br>used, only<br>transported. | Same. | Same. |
| Compatibility with<br>environment and other<br>devices | Probe is not known to<br>conflict with other<br>devices or cause<br>environmental<br>hazards. | Same. | Same. |
| Where used | Hospitals, Clinics,<br>Doctor's offices, or<br>home use under<br>clinician's<br>supervision. | Same. | Same. |
| Sterility | Probe does not need<br>to be sterile.<br>Appropriate cleaning<br>procedure included<br>instructions for use. | Same. | Same. |
| # of Electrode Contacts | 2 | 2 | 3 |
| # of Lead Cables | 2 | 2 | 1 |
| Transducers | None | None | None |
| Body Material | High Impact<br>Polystyrene, type 564 | Plastic: Cycolac ABS-<br>GPM-5600-4500-FGE | N / A |
| Biocompatibility of<br>Body Material | Biocompatible | Biocompatible | Biocompatible |
| | | | 91 |
| Pelvic Floor<br>Contraction Indicator<br>(PFCI) included? | Yes. | No. | No. |
| PFCI Tip and End<br>Material | High Impact<br>Polystyrene 564 | N/A | N/A |
| PFCI Shaft Material | 'Stamylan' low density<br>polyethylene grade<br>2100 TNOO | N/A | N/A |
| Electrode Material | Medical Grade<br>Stainless Steel type<br>316S31 | Series 300 Passivated<br>Stainless Steel | Series 300 Passivated<br>Stainless Steel |
| Biocompatibility of<br>Electrode Material | Biocompatible | Biocompatible | Biocompatible |
| Electrode Orientation | Longitudinal | Circumferential | Longitudinal |
| Construction | 2-piece mold | 3-piece mold | 3-piece mold |
| Sensing Method | sEMG biofeedback<br>recording | Same. | Same. |
| Feedback Modes | No direct feedback to<br>user | Same. | Same. |
| Electrical Safety | Device is passive: Not<br>electrically powered | Same. | Same. |
| Electrodes and<br>Conductive Media | Not applicable. | Not applicable. | Not applicable. |
| Intentional Electrical<br>Current | Warning included in<br>Instructions for Use.<br>Socket type prevents<br>easy intentional<br>connection to AC<br>source. | Warning included in<br>Instructions for Use. | Warning included in<br>Instructions for Use. |
| Unintentional<br>Electrical Current | Probe is to be used<br>with appropriate<br>biofeedback device as<br>stated in Basic Design<br>Description, or with<br>PFCI only. | Probe is to be used<br>with biofeedback<br>devices satisfying<br>criteria listed in Basic<br>Design Description. | Probe is to be used<br>with biofeedback<br>devices satisfying<br>criteria listed in Basic<br>Design Description. |
| Risk of Mechanical<br>Injury | Risk prevention<br>considered in design<br>process (Attached). | Risk prevention<br>considered in design<br>process (Attached). | Unknown. |
| Risk of thermal or<br>Radiation Injury | None: probe does not<br>direct any form of<br>electromagnetic<br>energy or heat. | Same. | Same. |
| Chemical Safety | Body and electrodes<br>constructed of<br>chemically inert<br>materials. | Same. | Same. |
| Shaft Length | 76 mm | 81 mm | 55.9 mm |
| Shaft Diameter | Not applicable (N/A) | 19.1 mm | 17.8 mm |
| Probe Width | 34 mm | N/A | N/A |
| Basal Bulb Diameter<br>(Comparable to<br>Periform's Flange<br>Diameter) | N/A | 63.5 mm | 43.2 mm |
| Flange Diameter | 28.2 mm | N/A | N/A |
| Terminal Bulb<br>Diameter | N/A | 31.8 mm | 33.0 mm |
| Terminal Bulb Length | N/A | 22.7 mm | 26.7 mm |
| Electrode Spacing<br>Distance | N/A | 9.5 mm | 11.4 mm |
| Spacing Type | Axial Incremental | Radial Incremental | Axial Incremental |
| | | | C<br>U- |
| Electrode Surface Area <br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 4.9 cm² x 2 | .5 cm x 2 | 1.2 cm4 x 3 |

#### Device Comparison

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#### Non-Clinical Performance Data

An impedance test was performed to demonstrate that the Periform® is capable of transporting electrical signals with minimal attenuation. Various frequencies were used in order to verify that the Periform® would be effective in the range of frequencies encountered in pelvic floor biofeedback (typically less than 200 Hz). The test shows that the Periform® exhibits the low impedance values (around 10 ohms at all tested frequencies) needed for accurate recording of pelvic floor muscle activity.

## Biocompatibility Testing

The materials used in the Periform® have undergone safety tests and were found to be safe according to the required standards for each test. Tests performed and results were as follows:

| MATERIAL | TEST PERFORMED | RESULTS |
|-------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|
| Polystyrene type 564.<br>Used in Periform® body. | USP tests for Class VI<br>plastics (Systemic Injection,<br>Intracutaneous Toxicity,<br>Implantation Test) | Meets the requirements of<br>USP Class VI Plastic |
| Medical Grade Stainless<br>Steel 316S31.<br>Used for Periform®<br>electrodes. | Standard Item used in the<br>manufacture of medical<br>device to contact human<br>tissue for transient periods<br>(less than 2 hours) | Nontoxic. |
| Polythene.<br>Used in Pelvic Floor<br>Contraction Indicator.<br>Not in contact with<br>patient. | No test performed as this<br>portion is not intended to<br>contact the body. | N/A |

## Conclusion

The Periform® is safe and effective for its intended use and is substantially equivalent to its predicate devices.

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Image /page/5/Picture/0 description: The image shows a logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of a human figure with three flowing lines representing the body and arms. The text "HUMAN SERVICES USA" is arranged in a circular pattern around the figure, indicating the department's focus on human services within the United States.

DEPARTMENT OF HEALTH & HUMAN SERVICES

NOV 20 1908

Kishore Puppala Product Manger Verimed International, Inc. 11950 N.W. 39th Street, Suite D Coral Springs, Florida 33065

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K981277 Periform® Perineometric Probe Dated: August 28, 1998 Received: August 31, 1998 Regulatory Class: II 21 CFR884.1425/Procode: 85 HIR

Dear Mr. Puppala:

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 ensctment 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 (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 requirements, as set forth in the Quality System Regulation (OS) 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsma/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

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Page 1 of 1

510(k) Number (if known): K98 1277

Device Name: Periform® Perineometric Probe

Indications For Use:

Biofeedback/monitoring vaginal probe intended for:

- Treatment of stress, urge, and mixed incontinence. .
- Facilitation in identification of the pubococcygeus muscles. .
- . Strengthening of the pelvic floor muscles through biofeedback-assisted pelvic floor exercises.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Seggern
(Division Sign-Off)

ion Sign-Off) Division of Reproductive, Abdominal, El and Radiological De 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)