(64 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a physical device, with no mention of software, data processing, or AI/ML terms.
Yes
The device is indicated for strengthening muscles and correcting urinary incontinence, which are therapeutic actions.
No
The device is described as assisting in strengthening pelvic floor muscles by providing resistance to voluntary contractions, effectively exercising the muscles to correct issues like urinary incontinence. It does not mention any function for diagnosing conditions or measuring physiological parameters.
No
The device description explicitly states it is a "single, reusable, home-use device that comes into contact with the vaginal mucosal membrane" and is "an hourglass-shaped device made from surgical stainless steel." This clearly indicates a physical hardware component, not a software-only device.
Based on the provided information, the Feminine Personal Trainer (FPT) 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, such as blood, urine, or tissue, to provide information about a person's health. These tests are performed outside of the body (in vitro).
- FPT Function: The FPT is a physical device that is inserted into the body (vagina) to provide resistance for muscle strengthening exercises. It does not perform any tests on bodily samples. Its function is mechanical and therapeutic, not diagnostic.
The description clearly indicates the FPT is a device for physical exercise and strengthening of muscles, which falls under the category of a therapeutic or rehabilitation device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Feminine Personal Trainer (FPT) is indicated for the strengthening of the perineal pelvic floor muscles by providing resistance to an individual's voluntary contractions of these muscles. It seeks to correct, through exercise, urinary incontinence in women.
Product codes
HIR
Device Description
The FPT is designed specifically for women for their use in strengthening the pelvic floor musculature. It is a single, reusable, home-use device that comes into contact with the vaginal mucosal membrane for a limited (
§ 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).
0
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 29, 2017
Ralston Group % Jennifer Tillman Business Coordinator Intertek Surveying Services 16441 Space Center Blvd, Suite D-100 Houston, TX 77058
Re: K171896 Trade/Device Name: Feminine Personal Trainer (FPT) Regulation Number: 21 CFR§ 884.1425 Regulation Name: Perineometer Regulatory Class: II Product Code: HIR Dated: June 7, 2017 Received: June 26, 2017
Dear Jennifer Tillman:
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. 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.
1
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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K171896
Device Name
Feminine Personal Trainer (FPT)
Indications for Use (Describe)
The Feminine Personal Trainer (FPT) is indicated for the strengthening of the perineal pelvic floor muscles by providing resistance to an individual's voluntary contractions of these muscles. It seeks to correct, through exercise, urinary incontinence in women.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Registration Use (Part 21 CFR 201.2 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 201.2 Subpart C) |
_ | Prescription Use (Part 21 CFR 801 Subpart D)
|X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
I. SUBMITTER
Ralston Group 656 Lake Lanier Rd. Selma, AL 36701
Phone: 334-875-2298
Contact Person: Russell Ralston Date Prepared: August 16, 2017
II. DEVICE
| Name of Device: | Feminine Personal Trainer (FPT) |
|---|---|
| Common or Usual Name: | Kegel Exercise and Pelvic Floor Workout Device |
| Classification Number: | 21 CFR § 884.1425 |
| Classification Name: | Perineometer |
| Regulatory Class: | II |
| Product Code: | HIR (Perineometer) |
| Classification Panel: | Obstetrics/Gynecology |
III. PREDICATE DEVICE
| 510(k) Number Trade or Proprietary or Model Name | |||
|---|---|---|---|
| K121902 | NatraTone® | Orelle Corporation Ltd |
This predicate has not been subject to a design-related recall.
IV. DEVICE DESCRIPTION
The FPT is designed specifically for women for their use in strengthening the pelvic floor musculature. It is a single, reusable, home-use device that comes into contact with the vaginal mucosal membrane for a limited (