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-the-counter.

AI/ML Overview

The Perifit is a perineometer designed to treat stress, mild-moderate urge, and mixed urinary incontinence in women by strengthening pelvic floor muscles through exercise. It provides biofeedback via smartphone technology. The Perifit is indicated for adult females and is available over-the-counter.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria	Reported Device Performance and Compliance
Intended Use	Treat stress, mild-moderate urge, and mixed urinary incontinence in women, by strengthening of the pelvic floor muscles through exercise. Provides biofeedback via smartphone technology.	The Perifit has the identical intended use as the predicate device (Analytica Ltd.'s PeriCoach® OTC, K160758). No specific quantitative performance metrics are provided for "treatment" effectiveness within this documentation, but the device's ability to provide biofeedback for muscle strengthening is implied as the mechanism of action.
User Population	Adult females with urinary incontinence; available over-the-counter.	Identical to the predicate device.
Technological Equivalence	Similar technological characteristics to the predicate device, not raising new questions of safety or effectiveness.	Principle of Operation: Identical (probe inserted into the vagina to determine muscle strength, sends signals to external device to indicate contraction strength). Sensing Method: Identical (Output from force sensing resistors, wireless). Parameter Monitored: Identical (Analogue to digital output of uncalibrated force). User Interface: Identical (Smartphone GUI). Anatomical Sites: Identical (Female Pubococcygeus muscle area). The minor differences (sensor placement, external shape (two egg-shaped sensing areas vs. one), shaft length, weight, power source) were deemed not to raise new questions of safety or effectiveness.
Biocompatibility	Patient contacting materials must be safe for intended purpose, tested in accordance with ISO 10993 standards.	Tested in accordance with ISO 10993 standards for Cytotoxicity (ISO 10993-5, 2009), Sensitization (ISO 10993-10, 2010), Vaginal Irritation (ISO 10993-10, 2010), and Systemic Toxicity (ISO 10993-11, 2006). Found to be safe.
Electrical Safety & EMC	Tested in accordance with relevant IEC 60601 standards.	Tested in accordance with IEC 60601-1-2 and IEC 60601-1-11.
Software V&V	Verification and validation in accordance with FDA guidance and IEC 62304:2006.	Software verification and validation conducted in accordance with FDA guidance (Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices) and IEC 62304:2006.
Mechanical Durability	Demonstrated durability and appropriate mechanical behavior.	Mechanical drop testing and durability testing conducted.
Usability/Labeling Comprehension	Users understand key labeling provisions and how to operate the device.	Sensor behavior testing through a questionnaire supports that users understand the key labeling provisions and how to operate the device.
Sterilization	Non-sterile device.	Confirmed as a non-sterile device, identical to the predicate.

2. Sample size used for the test set and the data provenance:

The provided document does not specify a separate "test set" in the context of clinical performance data in the typical sense of evaluating diagnostic accuracy or treatment efficacy with patient outcomes. The performance data focuses on device safety, electrical safety, biocompatibility, software validation, and mechanical durability, which are typically evaluated through engineering tests and specific standards.

Biocompatibility: The ISO 10993 tests would involve specific biological samples or animal models depending on the sub-part (e.g., cell cultures for cytotoxicity, animal models for sensitization/irritation/toxicity). The sample sizes for these specific tests are not detailed.
Mechanical Tests: The number of devices subjected to mechanical drop and durability testing is not specified.
Sensor Behavior/User Comprehension: A "questionnaire" was used, but the sample size of users and data provenance (e.g., country of origin, retrospective/prospective) for this survey are not stated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable or provided in the document. The document describes a 510(k) submission for a perineometer, which is a biofeedback device, not an AI/ML diagnostic or prognostic tool that would typically involve expert-established ground truth for a test set. The "ground truth" for this device relates to its adherence to safety and performance standards (e.g., biocompatibility standards, electrical safety standards, mechanical performance).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. The document does not describe a clinical study requiring adjudication of expert interpretations or diagnoses.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. The Perifit is a perineometer for pelvic floor muscle exercise and biofeedback, not an AI-assisted diagnostic or interpretation system that would involve human "readers" or an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. The Perifit is a physical device that works with a smartphone app for biofeedback. Its performance is intrinsically linked to user interaction and physical measurements. It is not an algorithm that operates "standalone" in a diagnostic or interpretive capacity.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the Perifit's performance is its compliance with established engineering and safety standards and its ability to provide biofeedback, rather than a clinical ground truth like pathology or expert consensus on a diagnosis.

Biocompatibility: ISO 10993 standards define the "ground truth" for material biological safety.
Electrical Safety: IEC 60601 standards define the "ground truth" for electrical safety.
Software Validation: FDA guidance and IEC 62304 define the "ground truth" for software quality and safety.
Mechanical Performance: Internal specifications and durability testing protocols define the "ground truth" for mechanical integrity.
Functionality (Biofeedback): The device's ability to accurately sense pelvic floor muscle contractions and transmit them to the app for user feedback is the functional ground truth, demonstrated through sensor behavior testing.

8. The sample size for the training set:

Not applicable. The device is not an AI/ML model that undergoes "training" in the traditional sense. The development and verification process involves engineering design, testing against standards, and software validation.

9. How the ground truth for the training set was established:

Not applicable. As there is no "training set" for an AI/ML model, there is no ground truth established for such a set.

Summary

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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.

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

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510(k) Number: K221476

K221476

Device Name

Perifit

Indications for Use (Describe)

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)

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510(k) SUMMARY X6 Innovations' Perifit

Submitter

X6 Innovations 128 rue de la Boétie, 75008 Paris, France Phone: +33 6 51 66 55 94 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

Perifit is indicated for an adult female.

Device Description

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:

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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.PeriCoach® OTC(K160758)	Comments

Indications forUse	The Perifit is aperineometer designed totreat stress, mild-moderateurge and mixed urinaryincontinence in women, bystrengthening of the pelvicfloor muscles throughexercise. This deviceprovides biofeedback viasmart phone technology.	The PeriCoach® OTC is aperineometer designed totreat stress, mild-moderateurge and mixed urinaryincontinence in women, bystrengthening of the pelvicfloor muscles throughexercise. This deviceprovides biofeedback viasmart phone technology.	Identical
User Population	Adult females with urinaryincontinence; availableover-the-counter	Adult females with urinaryincontinence; available byprescription and over-the-counter	Identical
Technological Characteristics
Mode of Use	Reusable for single patient	Reusable for single patient	Identical
Principle ofOperation	A probe inserted into thevagina to determine thestrength of the pelvic floormuscles. Probe sendssignals to external deviceto indicate musclecontraction strength toencourage and assist userwith voluntary kegelexercises.	A probe inserted into thevagina to determine thestrength of the pelvic floormuscles. Probe sendssignals to external deviceto indicate musclecontraction strength toencourage and assist userwith voluntary kegelexercises.	Identical
Sensing method	Output from force sensingresistors (wireless).	Output from force sensingresistors.	Identical
	X6 Perifit	Analytica Ltd.PeriCoach® OTC(K160758)	Comments
Sensor'splacement	Inside the rigid plasticenclosure	On the exterior of theplastic enclosure
Materials	Rigid plastic (PC/ABS)structure enclosed within amedical grade siliconeouter layer	Rigid polymer structureenclosed within a medicalgrade silicone outer layer	Similar
Parametermonitored	Analogue to digital outputof uncalibrated forceexerted against externalwalls of device bypubococcygeus andpuborectalis muscles.	Analogue to digital outputof uncalibrated forceexerted against externalwalls of device bypubococcygeus andpuborectalis muscles.	Identical
User Interface	Smartphone GUI	Smartphone GUI	Identical
AnatomicalSites	Female Pubococcygeusmuscle area	Female Pubococcygeusmuscle area	Identical
External shape	Two egg shaped sensingareas	One sensing area
Accessories	None	LiPo charger
Shaft length	90 mm	76 mm
Weight	Probe weight: 54g	Probe weight: 50g
Power Source	Non-rechargeable CR2032Panasonic batteries,Voltage 3.0VDC	Rechargeable Lithium-polymer: Voltage 3.7 VDC
Safety Features	Electronics and internalparts sealed in a medicalgrade silicone shell	Electronics and internalparts sealed in a medicalgrade silicone shell	Identical
Electrical Safety	Tested in accordance withIEC 60601-1-2 and IEC60601-1	Tested in accordance withIEC 60601-1-2 and IEC60601-1	Identical
Biocompatibility	Biocompatible - tested inaccordance with ISO10993standards	Probe outer surfaceconstructed of chemicallyinert materials and tested inaccordance with ISO10993	Identical
Software	Smartphone appcompatible for iOS andAndroid	Smartphone app	Identical
Sterilization	Non-sterile device	Non-sterile device	Identical

Table 1: Substantial Equivalence Table

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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.

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).