Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the probe's function in acquiring and transmitting sEMG signals for biofeedback, with no mention of AI or ML for processing or interpretation.

Therapeutic

Yes

The device is intended for the treatment of various types of incontinence and for strengthening pelvic floor muscles through biofeedback-assisted exercises, all of which are therapeutic interventions.

Diagnostic

No

The device is described as a biofeedback/monitoring probe intended for treatment, facilitation, and strengthening of muscles. While it acquires signals, its stated purpose is to improve voluntary control and strength of muscles with the aid of biofeedback equipment, rather than to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "vaginal perineometric probe" and describes its physical function of acquiring EMG signals, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, 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. They are used to provide information for diagnosis, monitoring, or screening.
Device Function: The Periform® probe is a biofeedback/monitoring device. It measures electrical signals (sEMG) from the pelvic floor muscles in vivo (within the body) to help patients learn to control and strengthen those muscles. It does not analyze samples taken from the body.
Intended Use: The intended use is for treatment of incontinence, muscle identification, and muscle strengthening through biofeedback-assisted exercises. These are therapeutic and training applications, not diagnostic testing of samples.

The device is a medical device, but it falls under the category of devices used for therapy and monitoring, not in vitro diagnosis.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

85 HIR

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Female pubococcygeus muscle area.

Indicated Patient Age Range

Adult female urinary incontinence patients.

Intended User / Care Setting

Hospitals, Clinics, Doctor's offices, or home use under clinician's supervision.

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)

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.

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.

K913912, K911190

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.

Not Found

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

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).

Summary

0

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: (954) 344-2454 Fax: (954) 340-8812

Contact Person:

Signature

Kishore Puppala, Product Manager, Verimed International, Inc.

April 2, 1998.

Date Submitted

1

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. �

2

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

Device Comparison

3

4

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

Conclusion

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

5

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 (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/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

6

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)