PeriCoach

K143580 · Analytica, Ltd. · HIR · Mar 18, 2015 · Obstetrics/Gynecology

Device Facts

• Record ID: K143580
• Device Name: PeriCoach
• Applicant: Analytica, Ltd.
• Product Code: HIR · Obstetrics/Gynecology
• Decision Date: Mar 18, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1425
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The PeriCoach® 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 is a perineometer for pelvic floor muscle strengthening. Device consists of a rigid probe with a medical-grade silicone sheath; inserted vaginally by the patient. Sensors under the sheath measure force exerted by pubococcygeus and puborectalis muscles during voluntary Kegel exercises. Data is transmitted wirelessly to a smartphone application. The app provides real-time biofeedback by displaying relative magnitudes of muscle contraction or normalized sensor output. Used in home or clinical settings under prescription. Biofeedback assists users in performing exercises correctly, potentially improving muscle strength and reducing incontinence symptoms.

Clinical Evidence

Bench testing only. Biocompatibility testing per ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization, vaginal irritation), and ISO 10993-11 (systemic toxicity). Electrical safety and EMC testing per IEC 60601-1:2005, IEC 60601-1-2:2007, and IEC 60601-1-11:2010. Mechanical testing included drop, durability, immersion/cleaning, and sensor behavior testing. Software verification and validation conducted per IEC 62304:2006.

Technological Characteristics

Rigid polymer structure with medical-grade silicone outer sheath. Sensing via force-sensing resistors. Wireless connectivity to smartphone. Dimensions: 30-35 mm width, 76 mm shaft length. Single-patient reusable. Biocompatible materials per ISO 10993. Electrical safety per IEC 60601-1 series. Software validation per IEC 62304.

Indications for Use

Indicated for adult women with stress, mild-moderate urge, or 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

• Neen Healthcare Periform (K002617)

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

March 18, 2015

Analytica Ltd % Tracey Bullivant Consultant Brandwood Biomedical 408, 460 Pacific Highway St Leonards, NSW 2065 AU

Re: K143580

> Trade/Device Name: PeriCoach Regulation Number: 21 CFR 884.1425 Regulation Name: Perineometer Regulatory Class: Class II Product Code: HIR Dated: December 12, 2014 Received: December 18, 2014

Dear Tracey Bullivant,

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. 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

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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 yours,

Joyce M. Whang -S

for Benjamin Fisher 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) K143580

Device Name PeriCoach

Indications for Use (Describe)

The PeriCoach 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.

Type of Use (*Select one or both, as applicable*)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) Summary

| Date Prepared: | 13 December, 2014 |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Owner: | Analytica Pty Ltd<br>320 Adelaide Street,<br>Brisbane, QLD 4000,<br>Australia<br>Tel: [phone] |
| Official Contact: | Tracey Bullivant<br>408, 460 Pacific Highway<br>St Leonards NSW 2065<br>Australia<br>Tel: [phone]<br>Fax: [phone]<br>[e-mail] |
| Trade Name: | PeriCoach® |
| Common Name: | Perineometer |
| Classification Name: | (21CFR 884.1425) Perineometer |
| Product Code: | HIR |
| Predicate: | Neen Healthcare Periform (K002617) |
| Intended Use: | The PeriCoach® 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® device consists of a rigid probe covered in a silicone<br>sheath that is temporarily inserted into the vagina. Sensors located<br>under the sheath measure the strength of contraction of the user's pelvic<br>floor muscles. This information is then transmitted wirelessly to a<br>smartphone application in order to provide real-time feedback to the<br>user. It is a single patient, reusable device to be supplied under<br>prescription only. |
| Non-clinical Testing: | The patient contacting materials in the PeriCoach have been tested in<br>accordance with ISO 10993 standards and found to be safe for the |

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intended purpose. Biocompatibility testing includes 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 60601-1:2005, IEC 60601-1-2:2007, and IEC 60601-1-11:2010 to establish the safety of the device. Software verification and validation testing has also been conducted in accordance with IEC 62304:2006.

In addition, various mechanical tests have been conducted to establish substantial equivalence including mechanical drop testing, durability testing, immersion/long term cleaning exposure, and sensor behavior testing. The results of these tests indicate that the device is effective for the intended use.

#### Predicate: Periform PeriCoach Parameters (K002617) (New device) Mode of Use Reusable for single patient Same Target Population Adult female urinary incontinence Same patients Principle of A probe inserted into the vagina to Same Operation 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. Electrode/sensor Longitudinal Same orientation Sensing method sEMG biofeedback recording (wired Output from force sensing electrode). resistors (wireless). Parameter Aqqreqate surface electromyogram Analoque to digital output of monitored (sEMG). uncalibrated force exerted against external walls of device by pubococcyqeus and puborectalis muscles.

## Summary of Basis for Substantial Equivalence:

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| Parameters | Predicate: Periform<br>(K002617) | PeriCoach<br>(New device) |
|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| User Feedback | The Periform does not provide feedback<br>directly to the user; a separate external<br>feedback device is required. | The PeriCoach is designed to<br>provide real-time feedback, via an<br>application on the user's<br>Smartphone. The Smartphone<br>application displays the relative<br>magnitudes of pelvic muscle<br>contraction or graphically displays<br>the normalized analogue to digital<br>sensor output depending on<br>which option is selected. |
| Anatomical Sites | Female Pubococcygeus muscle area | Same |
| Where used | Hospitals, Clinics, Doctors' offices or<br>home use under Clinician supervision | Same |
| Energy used<br>and/or delivered | No energy used or delivered, only<br>transported1 | The device is not intended to<br>deliver energy to the patient.<br>Energy is used to operate the<br>device and communicate with the<br>Smartphone Application. |
| Compatibility with<br>environment and<br>other devices | Probe is not known to conflict with other<br>devices or cause environmental<br>hazards | Same - the PeriCoach device has<br>been tested in accordance with<br>IEC60601-1-2 (2007) |
| Sterility | Probe does not need to be sterile.<br>Appropriate cleaning procedure<br>included in instructions for use. | Same |
| Body Materials | BP Empera Impact Polystyrene Type<br>514 | Medical grade silicone |
| Biocompatibility of<br>body material | Biocompatible | Same - tested in accordance with<br>ISO10993 standards |
| Electrical Safety | Unknown | Tested in accordance with<br>IEC60601-1-2 (2007) and<br>IEC60601-1(2005) |
| Chemical Safety | Body and electrodes constructed of<br>chemically inert materials | Probe outer surface constructed<br>of chemically inert materials and<br>tested in accordance with<br>ISO10993 standards. |
| Construction | Two mouldings enclosing two<br>electrodes, ultrasonically welded<br>together | Rigid polymer structure enclosed<br>within a medical grade silicone<br>outer layer |
| Shaft length | 76 mm | Same |
| Parameters | Predicate: Periform<br>(K002617) | PeriCoach<br>(New device) |
| Width across<br>electrodes/<br>sensors | 34 mm | 30-35 mm, across region<br>containing sensor |
| Maximum flange<br>dimension | 28.2 mm | 30-35 mm |
| Electrode surface<br>area | 4.9cm2 x 2 | Sensor surface area is 11.8cm2 |
| Prescription only<br>device | Yes | Same |

¹ Wording taken directly from 510(k) summary for Periform, K002617

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- Conclusion: Both devices share common indications for use, usage environments and general principle of operation. The devices are both single patient reusable, nonsterile and are available by prescription only.
The main differences between the devices are the way the pelvic floor muscle activity is determined, the materials used and the method of feedback to the user. Non-clinical testing demonstrates that the PeriCoach device raises no new safety or efficacy concerns and is therefore substantially equivalent to the legally marketed predicate device.