Feminine Personal Trainer (FPT)

K171896 · Ralston Group · HIR · Aug 29, 2017 · Obstetrics/Gynecology

Device Facts

• Record ID: K171896
• Device Name: Feminine Personal Trainer (FPT)
• Applicant: Ralston Group
• Product Code: HIR · Obstetrics/Gynecology
• Decision Date: Aug 29, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1425
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Feminine Personal Trainer (FPT) is a reusable, hourglass-shaped, surgical stainless steel (grade 303) vaginal exerciser for home use. Device is inserted into the vagina; held in place by voluntary pelvic floor muscle contractions. Resistance is provided by the device's weight; user controls resistance level via body angle during exercise. Device moves upward and inward upon correct muscle contraction. Intended to strengthen pelvic floor muscles to correct urinary incontinence. Operated by the patient; no clinician involvement required for daily use. Benefits include improved pelvic floor muscle strength and potential reduction of incontinence symptoms.

Clinical Evidence

No clinical data. Bench testing only. Biocompatibility testing performed per ISO 10993-5:2009 (cytotoxicity) and ISO 10993-10:2010 (irritation and sensitization) confirmed the device is non-cytotoxic, non-irritating, and non-sensitizing.

Technological Characteristics

Hourglass-shaped resistive vaginal exerciser. Material: Surgical stainless steel grade 303. Available in three sizes (standard, small, petite) with varying weights (340g-450g) to provide resistance. Non-sterile. No electronic components, software, or energy source.

Indications for Use

Indicated for women with mild urinary incontinence to strengthen perineal pelvic floor muscles via resistance to voluntary muscle contractions.

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

• NatraTone® (K121902)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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) |
|-------------------------------------------------|
|-------------------------------------------------|

| <span></span> Registration Use (Part 21 CFR 201.2 Subpart D) |
|--------------------------------------------------------------|
| <span></span> 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: [phone]

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 (< 24 hours) duration per each use.

The FPT is an hourglass-shaped device made from surgical stainless steel. The FPT is available in three sizes: standard, small and petite.

The FPT is inserted into the vagina and is held in place by contracting the pelvic floor muscles. The hourglass shape ensures automatic positioning so that the appropriate muscles are targeted. The weight of the FPT provides resistance as it is gently lifted with each contraction of

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the pelvic floor muscles. When utilized correctly, the device will move upward and inward when the user contracts her pelvic floor muscles. The body's angle while exercising controls the level of resistance.

## V. 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.

## VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

| Device Name | Feminine Personal Trainer (FPT) | NatraTone® | Device<br>Comparison |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| 510(k) Number | K171896 | K021115 | Not applicable |
| Regulation<br>Number | 21 CFR § 884.1425 | 21 CFR § 884.1425 | Same |
| Product Code | HIR | HIR | Same |
| Classification<br>Name | Perineometer | Perineometer | Same |
| Indications for<br>Use | The Feminine Personal Trainer<br>(FPT) is indicated for the<br>strengthening of the perineal pelvic<br>floor muscles by providing<br>resistance to an individual's<br>voluntary contractions of these<br>muscles. It seeks to correct,<br>through exercise, urinary<br>incontinence in women. | NatraTone® is indicated for the<br>strengthening of the perineal pelvic<br>floor muscles by providing<br>resistance to an individual's<br>voluntary contractions of these<br>muscles. It seeks to correct,<br>through exercise, Urinary<br>Incontinence in women. | Same |
| Over the<br>Counter (OTC) | Yes | Yes | Same |
| Feature | Resistive vaginal exerciser | Resistive vaginal exerciser | Same |
| Target<br>Population | Women with mild incontinence | Women with mild incontinence | Same |
| Anatomical Site | Vagina | Vagina | Same |
| Single Patient<br>Device | Yes | Yes | Same |
| Reusable | Yes | Yes | Same |
| Sterile | Clean, but not sterile | Clean, but not sterile | Same |
| Device Design | Hourglass-shaped | Symmetrically S-shaped | Same |
| Materials | Surgical stainless steel grade 303 | Molded medical grade<br>polycarbonate | Different |

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| Device Name | Feminine Personal Trainer (FPT) | NatraTone® | Device<br>Comparison |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Dimensions | Standard FPT:<br>Large end diameter: 1.628 in<br>Small end diameter: 1.248 in<br>Length: 3.503 in<br>Weight: 450 g.<br>Small FPT:<br>Large end diameter: 1.500 in<br>Small end diameter: 1.125 in<br>Length: 3.500 in<br>Weight: 340 g<br>Petite FPT:<br>Large end diameter: 1.250 in<br>Small end diameter: 1.100 in | Length: 3.25 in<br>Width at bulbous base end: 1.35 in<br>Weight: 1 oz (28 q) | Different |
| | Length: 4.564 in<br>Weight: 340 g. | | |
| Packaging | The FPT device is packaged in a<br>velveteen bag inside a clear plastic<br>tube with instructions and exercise<br>chart. | NatraToner intra-vaginal training aid<br>is packaged inside of a translucent<br>carry-case; an instruction book with<br>activity diary and a personal training<br>DVD are all provided in a cardboard<br>box. | Same |
| Operating<br>Principle | Resistive pelvic floor strengthener | Resistive pelvic floor strengthener | Same |
| Resistive<br>Component | Weight | Symmetrically S-shaped | Different |
| Instructions for<br>Use | Manual and video link | Manual | Same |

Except for materials, dimensions, and resistive component, all the other device attributes are the same as the predicate device. Nonclinical performance testing has been done to indicate the materials are safe. By using weight as the resistive component, the FPT devices have different dimensions to provide different levels of resistance to individuals instead of a single level of resistance from the predicate device. The minor differences in the technological characteristics between the FPT and the predicate device do not raise different questions of safety or effectiveness.

## VII. Non-clinical Performance Testing

Non-clinical performance testing was done utilizing the following standards:

- . ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity

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- ISO 10993-10:2010 Biological Evaluation of Medical Devices Part 10: Tests for . Irritation and Skin Sensitization, Vaginal Irritation and Guinea Pig Maximization Sensitiziation
Test results from the tests listed above supported that the device is not cytotoxic, not irritating, and not sensitizing. The FPT device has been demonstrated to be biocompatible.

### VIII. CONCLUSIONS

The FPT device has the same intended use as the predicate. Performance testing of the device supports that the FPT device is as safe and effective as the predicate. Therefore, the FPT device is substantially equivalent to the predicate.