PeriCoach OTC

K160758 · Analytica, Ltd. · HIR · Jul 11, 2016 · Obstetrics/Gynecology

Device Facts

• Record ID: K160758
• Device Name: PeriCoach OTC
• Applicant: Analytica, Ltd.
• Product Code: HIR · Obstetrics/Gynecology
• Decision Date: Jul 11, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1425
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

PeriCoach OTC is a perineometer for pelvic floor muscle training. Device consists of a rigid probe with a medical-grade silicone sheath; inserted vaginally by the user. Internal sensors measure contraction strength of pubococcygeus and puborectalis muscles. Data is transmitted wirelessly to a smartphone application. App provides real-time biofeedback, displaying relative contraction magnitudes or graphical representations of sensor output to guide user through Kegel exercises. Intended for over-the-counter, single-patient, reusable use. Benefits include improved pelvic floor muscle strength and management of urinary incontinence symptoms. Healthcare providers may use the output to monitor patient progress.

Clinical Evidence

No clinical trials were required. Evidence consists of a post-market user survey demonstrating that the device is well-understood and easy to use without supervision, supporting the OTC classification. Bench testing included biocompatibility (ISO 10993: cytotoxicity, sensitization, irritation, systemic toxicity), electrical safety/EMC (IEC 60601-1, 60601-1-2, 60601-1-11, 62133), and mechanical testing (drop, durability, immersion/cleaning, sensor behavior).

Technological Characteristics

Rigid polymer probe with medical-grade silicone sheath. Sensing via force-sensing resistors. Wireless data transmission to smartphone. Non-sterile, reusable, single-patient device. Electrical safety per IEC 60601-1, 60601-1-2, 60601-1-11, 62133. Biocompatibility per ISO 10993.

Indications for Use

Indicated for women with stress, mild-moderate urge, and mixed urinary incontinence to strengthen pelvic floor muscles via exercise.

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® (K143580)

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

July 11, 2016

Analytica Ltd. % Tammy Ahmadzada Senior Consultant Brandwood Biomedical Suite 5, Level 9, 1 Chandos Street St. Leonards, NSW 2065 Australia

Re: K160758

> Trade/Device Name: PeriCoach OTC Regulation Number: 21 CFR§ 884.1425 Regulation Name: Perineometer Regulatory Class: II Product Code: HIR Dated: March 29, 2016 Received: April 12, 2016

Dear Tammy Ahmadzada:

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.

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 (reporting of medical device-related 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 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 at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

# Joyce M. Whang -S

for

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) K160758

Device Name PeriCoach OTC

Indications for Use (Describe)

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.

Prescription Use (Part 21 CFR 801 Subpart D)

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

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| Date Prepared: | 29 February 2016 |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Owner: | Analytica Pty Ltd<br>320 Adelaide Street,<br>Brisbane, QLD 4000,<br>Australia<br>Tel: [phone] |
| Application Contact: | Tammy Ahmadzada<br>Suite 5, 1 Chandos St<br>St Leonards NSW 2065<br>Australia<br>Tel: [phone]<br>Fax: [phone]<br>[e-mail] |
| Trade Name: | PeriCoach® OTC |
| Common Name: | Perineometer |
| Classification Name: | (21CFR 884.1425) Perineometer |
| Product Code: | HIR |
| Predicate: | PeriCoach® (K143580) |
| Intended Use: | The PeriCoach® OTC is a perineometer designed to treat stress, mild-<br>moderate urge and mixed urinary incontinence in women, by<br>strengthening of the pelvic floor muscles through exercise. This device<br>provides biofeedback via smart phone technology. |
| Device Description: | The PeriCoach® OTC device consists of a rigid probe covered in a<br>silicone sheath that is temporarily inserted into the vagina. Sensors<br>located under the sheath measure the strength of contraction of the<br>user's pelvic floor muscles. This information is then transmitted<br>wirelessly to a smartphone application in order to provide real-time<br>feedback to the user. It is a single patient, reusable device to be<br>supplied over-the-counter. |
| Non-clinical Testing: | Biocompatibility<br>The patient contacting material in the PeriCoach® OTC have been<br>tested in accordance with ISO 10993 standards and found to be safe<br>for the intended purpose. Biocompatibility testing included |

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Cytotoxicity, Sensitization, Vaginal Irritation, and Systemic Toxicity.

#### Software

The software used in the PeriCoach OTC was evaluated in accordance with the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005.

## Electrical Safety and EMC

The PeriCoach OTC was evaluated in accordance with the following standards IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, and IEC 62133. The PeriCoach OTC meets the respective standards for electrical safety and EMC to establish the safety of the device.

### Bench testing

Various mechanical tests have also been conducted to establish the safety of the device. The following bench tests were completed:

- Drop test
- Durability test
- Immersion/long term cleaning exposure
- Sensor behavior test

The bench testing established that the PeriCoach OTC met all of the acceptance criteria needed to demonstrate substantial equivalence.

### Clinical Testing: A post market user survey to substantiate the safety and effectiveness of the subject device for OTC use was provided. Although this type of information is not typically required for the review of OTC perineometer devices, the survey information was reviewed to further substantiate the substantial equivalence determination. The post market user survey demonstrated that the subject device is generally well understood and easy to use without supervision. The survey does not raise any concerns with OTC use of the device.

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# Summary of Basis for Substantial Equivalence:

| Parameters | Predicate: PeriCoach®<br>(K143580) | PeriCoach® OTC<br>(Proposed device) |
|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| Mode of Use | Reusable for single<br>patient | Same |
| Target Population | Adult female urinary<br>incontinence patients | Same |
| Principle of<br>Operation | A probe inserted into the<br>vagina to determine the<br>strength of the pelvic<br>floor muscles. Probe<br>sends signals to external<br>device to indicate muscle<br>contraction strength to<br>encourage and assist<br>user with voluntary kegel<br>exercises. | Same |
| Sensing method | Output from force<br>sensing resistors. | Same |
| Parameter<br>monitored | Analogue to digital output<br>of uncalibrated force<br>exerted against external<br>walls of device by<br>pubococcygeus and<br>puborectalismuscles. | Same |
| User Feedback | Provides real-time<br>feedback, via an<br>application on the user's<br>Android or iOS<br>smartphone. The<br>smartphone application<br>displays the relative<br>magnitudes of pelvic<br>muscle contraction or<br>graphically displays the<br>normalized analogue to<br>digital sensor output<br>depending on which<br>option is selected. | Same |
| Anatomical Sites | Female<br>Pubococcygeusmuscle<br>area | Same |
| Over the Counter | No, prescription only | Yes |
| Energy used<br>and/or delivered | The device is not<br>intended to deliver<br>energy to the patient.<br>Energy is used to operate<br>the device and<br>communicate the results. | Same |
| Compatibility with<br>environment and<br>other devices | Probe is not known to<br>conflict with other devices<br>or cause environmental<br>hazards and tested in<br>accordance with<br>IEC60601-1-2 (2007) | Same |
| Sterility | Non-sterile device | Same |
| Body Materials | Medical grade silicone | Same |
| Biocompatibility of<br>body material | Biocompatible in<br>accordance with<br>ISO10993 | Same |
| Electrical Safety | Tested in accordance<br>withIEC60601-1-2 (2007)<br>andIEC60601-1(2005) | Same |
| Chemical Safety | Probe outer surface<br>constructed of chemically<br>inert materials and tested<br>in accordance with<br>ISO10993 | Same |
| Construction | Rigid polymer structure<br>enclosed within a medical<br>grade silicone outer layer | Same |

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- Conclusion: The predicate and proposed devices share indications for use, usage environments, outer construction materials and general principle of operation. The devices are all single patient, reusable and non-sterile.
The primary differences between the predicate device and the proposed device are:

- . the original PeriCoach® predicate device was prescription use only and the new PeriCoach® OTC device will be available as an over the counter device;
- . Software and firmware upgrades have been made to improve functionality

A Post Market Surveillance Report supports the decision to change the availability of the PeriCoach® device from prescription to over-the-counter. Non-clinical testing demonstrates that the PeriCoach® OTC device raises no

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new safety or efficacy concerns and is therefore substantially equivalent to the legally marketed predicate devices.