(115 days)
Not Found
No
The description focuses on biofeedback and real-time data transmission, with no mention of AI or ML terms or concepts like training/test sets.
Yes
The intended use explicitly states that the device is "designed to treat stress, mild-moderate urge and mixed urinary incontinence in women, by strengthening of the pelvic floor muscles through exercise."
No
The device is described as a perineometer designed to treat urinary incontinence by strengthening pelvic floor muscles through exercise and providing biofeedback. It measures the strength of muscle contractions to provide real-time feedback for exercise, not to diagnose a condition.
No
The device description explicitly states it consists of a "rigid probe covered in a silicone sheath" with "sensors located under the sheath," which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- PeriCoach® OTC Function: The PeriCoach® OTC is a device that is inserted into the body (vagina) to measure muscle contractions. It provides biofeedback based on these physical measurements. It does not analyze samples taken from the body.
The device's function is to provide biofeedback for strengthening muscles, which is a therapeutic and monitoring function, not a diagnostic one based on in vitro analysis.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
HIR
Device Description
The PeriCoach® OTC 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 over-the-counter.
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
Adult female urinary incontinence patients
Intended User / Care Setting
Over-The-Counter Use
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized symbol that resembles three human profiles facing to the right, stacked on top of each other, with a wing-like shape extending above them.
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.
1
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 (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 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 |
| 320 Adelaide Street, | |
| Brisbane, QLD 4000, | |
| Australia | |
| Tel: +61 (0) 732781950 | |
| Application Contact: | Tammy Ahmadzada |
| Suite 5, 1 Chandos St | |
| St Leonards NSW 2065 | |
| Australia | |
| Tel: +61(0) 299062984 | |
| Fax: +61(0) 285804613 | |
| tammy@brandwoodbiomedical.com | |
| 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- |
| 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® OTC 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 over-the-counter. | |
| Non-clinical Testing: | Biocompatibility |
| The patient contacting material in the PeriCoach® OTC have been | |
| tested in accordance with ISO 10993 standards and found to be safe | |
| for the intended purpose. Biocompatibility testing included |
5—1
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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.
5
Summary of Basis for Substantial Equivalence:
| Parameters | Predicate: PeriCoach®
(K143580) | PeriCoach® OTC
(Proposed device) |
|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| Mode of Use | Reusable for single
patient | Same |
| Target Population | Adult female urinary
incontinence patients | Same |
| Principle of
Operation | A probe inserted into the
vagina to 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. | Same |
| Sensing method | Output from force
sensing resistors. | Same |
| Parameter
monitored | Analogue to digital output
of uncalibrated force
exerted against external
walls of device by
pubococcygeus and
puborectalismuscles. | Same |
| User Feedback | Provides real-time
feedback, via an
application on the user's
Android or iOS
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. | Same |
| Anatomical Sites | Female
Pubococcygeusmuscle
area | Same |
| Over the Counter | No, prescription only | Yes |
| Energy used
and/or delivered | The device is not
intended to deliver
energy to the patient.
Energy is used to operate
the device and
communicate the results. | Same |
| Compatibility with
environment and
other devices | Probe is not known to
conflict with other devices
or cause environmental
hazards and tested in
accordance with
IEC60601-1-2 (2007) | Same |
| Sterility | Non-sterile device | Same |
| Body Materials | Medical grade silicone | Same |
| Biocompatibility of
body material | Biocompatible in
accordance with
ISO10993 | Same |
| Electrical Safety | Tested in accordance
withIEC60601-1-2 (2007)
andIEC60601-1(2005) | Same |
| Chemical Safety | Probe outer surface
constructed of chemically
inert materials and tested
in accordance with
ISO10993 | Same |
| Construction | Rigid polymer structure
enclosed within a medical
grade silicone outer layer | Same |
5—3
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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
5—4
7
new safety or efficacy concerns and is therefore substantially equivalent to the legally marketed predicate devices.