Perifit

K221476 · X6 Innovations · HIR · Feb 10, 2023 · Obstetrics/Gynecology

Device Facts

• Record ID: K221476
• Device Name: Perifit
• Applicant: X6 Innovations
• Product Code: HIR · Obstetrics/Gynecology
• Decision Date: Feb 10, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1425
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Perifit is a perineometer designed to treat stress, mild-moderate urge and mixed urinary incontinence in women, by strengthening of the pelvic floor muscles through exercise. This device provides biofeedback via smart phone technology.

Device Story

Perifit is a reusable, single-patient intravaginal perineometer for home use. Device consists of a rigid PC/ABS probe encased in medical-grade silicone, containing force-sensing resistors and a Bluetooth transmitter. User inserts probe into vagina; sensors measure contraction force of pubococcygeus and puborectalis muscles. Data transmits wirelessly to a smartphone application, providing real-time visual biofeedback to guide voluntary Kegel exercises. Output allows users to monitor muscle strength and progress over time. Device is powered by a non-rechargeable CR2032 battery. Intended to treat urinary incontinence by facilitating pelvic floor muscle strengthening.

Clinical Evidence

Bench testing only. No clinical data provided. Evidence includes biocompatibility (ISO 10993-5, -10, -11), electrical safety/EMC (IEC 60601-1, -1-2, -1-11), software verification/validation (IEC 62304), and mechanical testing (drop, durability, sensor behavior). User questionnaire confirmed ability to understand labeling and operate the device.

Technological Characteristics

Intravaginal probe with rigid PC/ABS structure and medical-grade silicone sheath. Sensing via force-sensing resistors. Connectivity via Bluetooth to smartphone app. Power: 3.0VDC CR2032 battery. Dimensions: 90mm shaft length. Non-sterile. Biocompatibility per ISO 10993. Electrical safety per IEC 60601-1/1-2/1-11.

Indications for Use

Indicated for adult females with stress, mild-moderate urge, or mixed urinary incontinence to strengthen pelvic floor muscles via exercise-based biofeedback.

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

• PeriCoach® OTC (K160758)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out next to it.

February 10, 2023

X6 Innovations % Lina Kontos Partner Hogan Lovells US LLP 555 13th Street NW Washington, DC 20016

Re: K221476 Trade/Device Name: Perifit Regulation Number: 21 CFR§ 884.1425 Regulation Name: Perineometer Regulatory Class: II Product Code: HIR Dated: January 9, 2023 Received: January 9, 2023

Dear Lina Kontos:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

{1}------------------------------------------------

You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Jason Roberts -S

for Jessica K. Nguyen, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

510(k) Number: K221476

K221476

Device Name

Perifit

Indications for Use (Describe)

The Perifit is a perineometer designed to treat stress, mild-moderate urge and mixed urinary incontinence in women, by strengthening of the pelvic floor muscles through exercise. This device provides biofeedback via smart phone technology.

Perifit is indicated for an adult female.

Type of Use (Select one or both, as applicable)

□ Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 510(k) SUMMARY X6 Innovations' Perifit

## Submitter

X6 Innovations 128 rue de la Boétie, 75008 Paris, France Phone: [phone] Contact Person: Artem Rodionov Date Prepared: May 20, 2022

Name of Device: Perifit

Common or Usual Name: Perineometer

Classification Name: (21CFR 884.1425) Perineometer

Regulatory Class: Class II

Product Code: HIR

## Predicate Devices:

Analytica Ltd.'s PeriCoach® OTC (K160758)

#### Intended Use / Indications for Use

The Perifit is a perineometer designed to treat stress, mild-moderate urge and mixed urinary incontinence in women, by strengthening of the pelvic floor muscles through exercise. This device provides biofeedback via smart phone technology.

Perifit is indicated for an adult female.

#### Device Description

The Perifit device consists of a rigid probe covered in a silicone sheath that is temporarily inserted into the vagina. Sensors located under the sheath measure the strength of the user's pelvic floor muscles. This information is then transmitted wirelessly to a smartphone application in order to provide real-time feedback to the user. It is a single patient, reusable device to be supplied over-thecounter.

#### Summary of Technological Characteristics

Pelvic floor muscle contraction and instantaneous feedback to the user's smartphone is the technological principle for both the subject and predicate devices. An intravaginal device with embedded force sensors is used to monitor the contraction force of the user's pelvic floor muscles. This information is transmitted to the patient's smartphone via bluetooth and is displayed on the screen. The subject and predicate devices are based on the following same technological elements:

{4}------------------------------------------------

- an intravaginal probe with external silicone shell
- force sensors and bluetooth transmitter embedded inside the probe
- a smartphone with a dedicated App

The minor technological differences between the Perifit and the predicate device do not raise different questions of safety or effectiveness. A table comparing the key features of the subject and predicate devices is provided below.

| | X6 Perifit | Analytica Ltd.<br>PeriCoach® OTC<br>(K160758) | Comments |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| | | | |
| Indications for<br>Use | The Perifit is a<br>perineometer designed to<br>treat stress, mild-moderate<br>urge and mixed urinary<br>incontinence in women, by<br>strengthening of the pelvic<br>floor muscles through<br>exercise. This device<br>provides biofeedback via<br>smart phone technology. | The PeriCoach® OTC is a<br>perineometer designed to<br>treat stress, mild-moderate<br>urge and mixed urinary<br>incontinence in women, by<br>strengthening of the pelvic<br>floor muscles through<br>exercise. This device<br>provides biofeedback via<br>smart phone technology. | Identical |
| User Population | Adult females with urinary<br>incontinence; available<br>over-the-counter | Adult females with urinary<br>incontinence; available by<br>prescription and over-the-<br>counter | Identical |
| Technological Characteristics | | | |
| Mode of Use | Reusable for single patient | Reusable for single patient | Identical |
| Principle of<br>Operation | A probe inserted into the<br>vagina to determine the<br>strength of the pelvic floor<br>muscles. Probe sends<br>signals to external device<br>to indicate muscle<br>contraction strength to<br>encourage and assist user<br>with voluntary kegel<br>exercises. | A probe inserted into the<br>vagina to determine the<br>strength of the pelvic floor<br>muscles. Probe sends<br>signals to external device<br>to indicate muscle<br>contraction strength to<br>encourage and assist user<br>with voluntary kegel<br>exercises. | Identical |
| Sensing method | Output from force sensing<br>resistors (wireless). | Output from force sensing<br>resistors. | Identical |
| | X6 Perifit | Analytica Ltd.<br>PeriCoach® OTC<br>(K160758) | Comments |
| Sensor's<br>placement | Inside the rigid plastic<br>enclosure | On the exterior of the<br>plastic enclosure | |
| Materials | Rigid plastic (PC/ABS)<br>structure enclosed within a<br>medical grade silicone<br>outer layer | Rigid polymer structure<br>enclosed within a medical<br>grade silicone outer layer | Similar |
| Parameter<br>monitored | Analogue to digital output<br>of uncalibrated force<br>exerted against external<br>walls of device by<br>pubococcygeus and<br>puborectalis muscles. | Analogue to digital output<br>of uncalibrated force<br>exerted against external<br>walls of device by<br>pubococcygeus and<br>puborectalis muscles. | Identical |
| User Interface | Smartphone GUI | Smartphone GUI | Identical |
| Anatomical<br>Sites | Female Pubococcygeus<br>muscle area | Female Pubococcygeus<br>muscle area | Identical |
| External shape | Two egg shaped sensing<br>areas | One sensing area | |
| Accessories | None | LiPo charger | |
| Shaft length | 90 mm | 76 mm | |
| Weight | Probe weight: 54g | Probe weight: 50g | |
| Power Source | Non-rechargeable CR2032<br>Panasonic batteries,<br>Voltage 3.0VDC | Rechargeable Lithium-<br>polymer: Voltage 3.7 VDC | |
| Safety Features | Electronics and internal<br>parts sealed in a medical<br>grade silicone shell | Electronics and internal<br>parts sealed in a medical<br>grade silicone shell | Identical |
| Electrical Safety | Tested in accordance with<br>IEC 60601-1-2 and IEC<br>60601-1 | Tested in accordance with<br>IEC 60601-1-2 and IEC<br>60601-1 | Identical |
| Biocompatibility | Biocompatible - tested in<br>accordance with ISO10993<br>standards | Probe outer surface<br>constructed of chemically<br>inert materials and tested in<br>accordance with ISO10993 | Identical |
| Software | Smartphone app<br>compatible for iOS and<br>Android | Smartphone app | Identical |
| Sterilization | Non-sterile device | Non-sterile device | Identical |

# Table 1: Substantial Equivalence Table

{5}------------------------------------------------

{6}------------------------------------------------

# Performance Data

The patient contacting materials in the Perifit have been tested in accordance with ISO 10993 standards and was found to be safe for the intended purpose. Biocompatibility testing included Cytotoxicity (ISO 10993-5, 2009), Sensitization (ISO 10993-10, 2010), Vaginal Irritation (ISO 10993-10, 2010), and Systemic Toxicity (ISO 10993-11, 2006). Electrical safety and electromagnetic compatibility testing have been conducted in accordance with IEC 60601-1-2, and IEC 60601-1-11 to establish the safety of the device. Software verification and validation testing has also been conducted in accordance with FDA guidance (Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices) and IEC 62304:2006. In addition, various mechanical tests have been conducted which support substantial equivalence including mechanical drop testing, durability testing, and sensor behavior testing through a questionnaire supports that users understand the key labeling provisions and how to operate the device.

#### Conclusions

The Perifit is as safe and effective as the PeriCoach® OTC. The Perifit has the same intended use and similar indications for use, technological characteristics, and principles of operation as the predicate device. In addition, the minor technological differences between the Perifit and the predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the Perifit is as safe and effective as the PeriCoach® OTC. Thus, the Perifit is substantially equivalent.