(266 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the device description focuses on sensor-based biofeedback.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "designed to treat stress, mild-moderate urge and mixed urinary incontinence in women, by strengthening of the pelvic floor muscles through exercise." This direct claim of treating a medical condition classifies it as a therapeutic device.
No
The device is described as a perineometer designed to treat urinary incontinence by strengthening pelvic floor muscles through exercise, providing biofeedback to the user. It is not indicated for diagnosing a condition, but rather for treating it.
No
The device description explicitly states it consists of a "rigid probe covered in a silicone sheath" with "sensors located under the sheath," which are physical hardware components. The software is used to provide feedback from these hardware components.
No, the Perifit device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Perifit's Function: The Perifit is a perineometer that is inserted into the vagina to directly measure the strength of pelvic floor muscles. It provides biofeedback based on this physical measurement, not on the analysis of a biological sample.
The description clearly states the device's function is to measure muscle strength and provide biofeedback for exercise, which is a physical therapy/rehabilitation function, not an in vitro diagnostic function.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
HIR
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.
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 females
Intended User / Care Setting
Over-The-Counter Use
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)
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.
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.
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
§ 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).
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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 (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
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)
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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
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.
PeriCoach® OTC
(K160758) | Comments |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| | | | |
| 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. | The PeriCoach® OTC 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. | Identical |
| User Population | Adult females with urinary
incontinence; available
over-the-counter | Adult females with urinary
incontinence; available by
prescription and over-the-
counter | Identical |
| Technological Characteristics | | | |
| Mode of Use | Reusable for single patient | Reusable for single patient | Identical |
| Principle of
Operation | A probe inserted into the
vagina to determine the
strength of the pelvic floor
muscles. Probe sends
signals to external device
to indicate muscle
contraction strength to
encourage and assist user
with voluntary kegel
exercises. | A probe inserted into the
vagina to determine the
strength of the pelvic floor
muscles. Probe sends
signals to external device
to indicate muscle
contraction strength to
encourage and assist user
with voluntary kegel
exercises. | Identical |
| Sensing method | Output from force sensing
resistors (wireless). | Output from force sensing
resistors. | Identical |
| | X6 Perifit | Analytica Ltd.
PeriCoach® OTC
(K160758) | Comments |
| Sensor's
placement | Inside the rigid plastic
enclosure | On the exterior of the
plastic enclosure | |
| Materials | Rigid plastic (PC/ABS)
structure enclosed within a
medical grade silicone
outer layer | Rigid polymer structure
enclosed within a medical
grade silicone outer layer | Similar |
| Parameter
monitored | Analogue to digital output
of uncalibrated force
exerted against external
walls of device by
pubococcygeus and
puborectalis muscles. | Analogue to digital output
of uncalibrated force
exerted against external
walls of device by
pubococcygeus and
puborectalis muscles. | Identical |
| User Interface | Smartphone GUI | Smartphone GUI | Identical |
| Anatomical
Sites | Female Pubococcygeus
muscle area | Female Pubococcygeus
muscle area | Identical |
| External shape | Two egg shaped sensing
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
Panasonic batteries,
Voltage 3.0VDC | Rechargeable Lithium-
polymer: Voltage 3.7 VDC | |
| Safety Features | Electronics and internal
parts sealed in a medical
grade silicone shell | Electronics and internal
parts sealed in a medical
grade silicone shell | Identical |
| Electrical Safety | Tested in accordance with
IEC 60601-1-2 and IEC
60601-1 | Tested in accordance with
IEC 60601-1-2 and IEC
60601-1 | Identical |
| Biocompatibility | Biocompatible - tested in
accordance with ISO10993
standards | Probe outer surface
constructed of chemically
inert materials and tested in
accordance with ISO10993 | Identical |
| Software | Smartphone app
compatible for iOS and
Android | 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.