(90 days)
Not Found
No
The summary describes a biofeedback device that measures muscle contractions and transmits data to a smartphone app for real-time feedback. There is no mention of AI, ML, or any related concepts like training/test sets, image processing, or complex algorithms beyond basic data transmission and display.
Yes
The device is designed to treat urinary incontinence by strengthening pelvic floor muscles through exercise, which is a therapeutic purpose.
No
The device is designed to treat urinary incontinence by strengthening pelvic floor muscles through exercise and providing biofeedback. While it measures muscle contraction strength, its primary purpose is therapeutic and not diagnostic of a disease or condition.
No
The device description explicitly states it consists of a "rigid probe covered in a silicone sheath" with "sensors located under the sheath" that are "temporarily inserted into the vagina." This describes a physical hardware component, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- PeriCoach Function: The PeriCoach is a device that is inserted into the body to measure muscle contractions and provide biofeedback for therapeutic purposes (strengthening pelvic floor muscles). It does not analyze samples taken from the body.
The description clearly indicates the device's function is to measure physical activity (muscle contractions) within the body for treatment, not to analyze biological samples for diagnostic purposes.
N/A
Intended Use / 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.
Product codes
HIR
Device Description
The PeriCoach® 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 contraction 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 under prescription only.
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
Not Found
Intended User / Care Setting
Hospitals, Clinics, Doctors' offices or home use under Clinician supervision
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)
Non-clinical Testing: The patient contacting materials in the PeriCoach have been tested in accordance with ISO 10993 standards and found to be safe for the 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Neen Healthcare Periform (K002617)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
0
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
1
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 (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 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 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 |
| 320 Adelaide Street, | |
| Brisbane, QLD 4000, | |
| Australia | |
| Tel: +61 (0) 732781950 | |
| Official Contact: | Tracey Bullivant |
| 408, 460 Pacific Highway | |
| St Leonards NSW 2065 | |
| Australia | |
| Tel: +61(0) 299062984 | |
| Fax: +61(0) 285804613 | |
| tracey@brandwoodbiomedical.com | |
| 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- |
| 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 Description: | The PeriCoach® 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 contraction 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 under | |
| prescription only. | |
| Non-clinical Testing: | The patient contacting materials in the PeriCoach have been tested in |
| accordance with ISO 10993 standards and found to be safe for the |
4
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:
5
| Parameters | Predicate: Periform
(K002617) | PeriCoach
(New device) |
|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| User Feedback | The Periform does not provide feedback
directly to the user; a separate external
feedback device is required. | The PeriCoach is designed to
provide real-time feedback, via an
application on the user's
Smartphone. The Smartphone
application displays the relative
magnitudes of pelvic muscle
contraction or graphically displays
the normalized analogue to digital
sensor output depending on
which option is selected. |
| Anatomical Sites | Female Pubococcygeus muscle area | Same |
| Where used | Hospitals, Clinics, Doctors' offices or
home use under Clinician supervision | Same |
| Energy used
and/or delivered | No energy used or delivered, only
transported1 | The device is not intended to
deliver energy to the patient.
Energy is used to operate the
device and communicate with the
Smartphone Application. |
| Compatibility with
environment and
other devices | Probe is not known to conflict with other
devices or cause environmental
hazards | Same - the PeriCoach device has
been tested in accordance with
IEC60601-1-2 (2007) |
| Sterility | Probe does not need to be sterile.
Appropriate cleaning procedure
included in instructions for use. | Same |
| Body Materials | BP Empera Impact Polystyrene Type
514 | Medical grade silicone |
| Biocompatibility of
body material | Biocompatible | Same - tested in accordance with
ISO10993 standards |
| Electrical Safety | Unknown | Tested in accordance with
IEC60601-1-2 (2007) and
IEC60601-1(2005) |
| Chemical Safety | Body and electrodes constructed of
chemically inert materials | Probe outer surface constructed
of chemically inert materials and
tested in accordance with
ISO10993 standards. |
| Construction | Two mouldings enclosing two
electrodes, ultrasonically welded
together | Rigid polymer structure enclosed
within a medical grade silicone
outer layer |
| Shaft length | 76 mm | Same |
| Parameters | Predicate: Periform
(K002617) | PeriCoach
(New device) |
| Width across
electrodes/
sensors | 34 mm | 30-35 mm, across region
containing sensor |
| Maximum flange
dimension | 28.2 mm | 30-35 mm |
| Electrode surface
area | 4.9cm2 x 2 | Sensor surface area is 11.8cm2 |
| Prescription only
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.