(57 days)
Not Found
No
The description focuses on electrical stimulation, biofeedback via pressure sensing, and data storage/display. There is no mention of algorithms that learn or adapt based on data, which are characteristic of AI/ML.
Yes
The device is intended to provide electrical stimulation and visual biofeedback for the treatment of male and female urinary and fecal incontinence. Treatment is a hallmark of a therapeutic device.
No
Explanation: The device description states its purpose is to provide electrical stimulation and/or visual biofeedback for the treatment of urinary and fecal incontinence, not for diagnosis. While it records results and provides biofeedback, these are for monitoring treatment and muscle retraining, fitting within a therapeutic or rehabilitative function rather than establishing a diagnosis.
No
The device description clearly outlines hardware components: an insertion unit (probe, inflation bulb, tubing, electrodes, pressure sensor) and a control unit with user keys and a display. While there is a software application, it is only one part of a multi-component system that includes physical hardware.
Based on the provided information, the InToneMV device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The InToneMV device is used to provide electrical stimulation and biofeedback directly to the patient's pelvic floor muscles via insertion into the vagina or rectum. It does not analyze any biological samples (like blood, urine, or tissue).
- The intended use is for treatment. The primary purpose of InToneMV is to treat urinary and fecal incontinence through electrical stimulation and biofeedback, not to diagnose a condition by analyzing a sample.
- The device description focuses on physical interaction with the body. The components described (insertion unit, control unit, software) are designed for delivering stimulation and monitoring muscle activity within the body, not for processing biological specimens.
Therefore, based on the definition of an IVD, the InToneMV device does not fit that category. It is a therapeutic device used for physical treatment and monitoring.
N/A
Intended Use / Indications for Use
InToneMV is intended to provide electrical stimulation and/or visual biofeedback (via manometry) for the treatment of male and female urinary and fecal incontinence.
Product codes (comma separated list FDA assigned to the subject device)
KPI, HCC
Device Description
The InToneMV device includes three parts: an insertion unit, control unit, and a software application for clinicians. Each of these parts are summarized below:
- The insertion unit includes (1) an inflation bulb, (2) the customizable inflatable probe, and (3) the flexible tubing connecting the inflation bulb and the inflatable probe. The inflatable probe is inserted into the vagina or rectum and manually inflated by the patient to ensure a customized fit. Electrical stimulation is delivered via stainless steel electrodes on the inflatable probe to induce a contraction of the pelvic floor muscles. Biofeedback is monitored via a pressure sensor within the insertion unit which records changes in pressure related to volitional muscle contraction.
- The control unit includes user keys to initiate and control treatment sessions, and a visual biofeedback graph to provide muscle re-training. The control unit is designed to record and store results of the electrical stimulation and biofeedback sessions for clinician review at follow-up visits.
- The software application is utilized by the clinician to program the control unit and display the results of electrical stimulation and biofeedback sessions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinic or Home use, under direction of physician
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)
The testing for InToneMV included performance, software, electrical safety, EMC and biocompatibility. InToneMV successfully passed all testing.
Clinical evaluations for InToneMV have been completed to support the device as safe and effective according to the intended use.
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
§ 876.5320 Nonimplanted electrical continence device.
(a)
Identification. A nonimplanted electrical continence device is a device that consists of a pair of electrodes on a plug or a pessary that are connected by an electrical cable to a battery-powered pulse source. The plug or pessary is inserted into the rectum or into the vagina and used to stimulate the muscles of the pelvic floor to maintain urinary or fecal continence. When necessary, the plug or pessary may be removed by the user. This device excludes an AC-powered nonimplanted electrical continence device and the powered vaginal muscle stimulator for therapeutic use (§ 884.5940).(b)
Classification. Class II (performance standards).
0
FEB 25 2014
Traditional 510(k) Submission
IN TONE MV
INCON 3225 Gateway Road, Ste. 2 Brookfield, WI 53045
7. 510(k) Summary
Submission Date
December 27th, 2013
Submitter Information
Jessica Andreshak Director of Quality Assurance and Regulatory Affairs InControl Medical, LLC 3225 Gateway Road, Ste. 250, Brookfield, WI 53045 USA Phone: (262) 373.0422 Fax: (262) 373.0463 Email: jandreshak@incontrolmedical.com
Device Information
Table 4. Device Information
| Type of 510(k): | Traditional 510(k) |
|---|---|
| Common Name: | Pelvic Floor Muscle Stimulator |
| Trade Name (proprietary name): | InToneMV |
| Classification name: | Stimulator, Electrical, Non-Implantable, For Incontinence |
| Classification Regulation: | 21 CFR 876.5320 |
| Class: | Class II |
| Product Code: | KPI |
Legally Marketed Device for Substantial Equivalence
| Table 5. Predicate Device Information | |||||
|---|---|---|---|---|---|
| --------------------------------------- | -- | -- | -- | -- | -- |
| 510(k) | Name | Product Code | Manufacturer |
|---|---|---|---|
| K110179 | InTone | KPI | InControl Medical, LLC |
| 3225 Gateway Road, Ste. 250 | |||
| Brookfield, WI 53045 USA | |||
| K050483 | evadri Bladder | ||
| Control Systems | KPI | HOLLISTER, Inc. | |
| 2000 Hollister Dr. | |||
| Libertyville, IL 60048 USA |
1
3225 Gateway Road, Brookfield, WI 53045 Traditional 510(k) Submission IN TONEMV
Device Summary
The InToneMV device includes three parts: an insertion unit, control unit, and a software application for clinicians. Each of these parts are summarized below:
- The insertion unit includes (1) an inflation bulb, (2) the customizable inflatable probe, . and (3) the flexible tubing connecting the inflation bulb and the inflatable probe. The inflatable probe is inserted into the vagina or rectum and manually inflated by the patient to ensure a customized fit. Electrical stimulation is delivered via stainless steel electrodes on the inflatable probe to induce a contraction of the pelvic floor muscles. Biofeedback is monitored via a pressure sensor within the insertion unit which records changes in pressure related to volitional muscle contraction.
- The control unit includes user keys to initiate and control treatment sessions, and a . visual biofeedback graph to provide muscle re-training. The control unit is designed to record and store results of the electrical stimulation and biofeedback sessions for
- clinician review at follow-up visits.
- The software application is utilized by the clinician to program the control unit and display the results of electrical stimulation and biofeedback sessions.
Intended Use
InToneMV is intended to provide electrical stimulation and/or visual biofeedback (via manometry) for the treatment of male and female urinary and fecal incontinence.
Equivalence Comparison to the Predicate
The intended use, technology, engineering, performance and user interface for InToneMV is substantially equivalent to the predicate devices as summarized in the chart below.
| Feature/ Function | InTone
(K110179) | evadri Bladder Control Systems
(K050483) | InToneMV
(New Device) | Comparison | Impact on
Safety and
Performance |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|----------------------------------------|
| Intended Use
An explicit
description of all
clinical functions
performed by the
device,
Indications for Use
Explain when the
device is to be
clinically used and
the intended
patient population | The InControl device is a non-
implanted electrical stimulator
indicated for use in the treatment of
female urinary incontinence. It
applies electrical stimulation to the
pelvic floor musculature and
surrounding structures. It is
intended for acute and ongoing
treatment of mixed urinary
incontinence where the following
results may improve urinary control:
strengthening of pelvic floor
muscles, inhibition of the detrusor
muscle through reflexive
mechanisms. The biofeedback
feature can be used for muscle re-
education purposes. | The evadri Bladder Control System
is intended to provide electrical
stimulation or electromyographic
or pressure feedback for the
treatment of urinary and fecal
(electromyographic biofeedback)
incontinence. | InToneMV is intended to be used
in males and females for the
treatment of urinary and fecal
incontinence. | Substantially
equivalent | None |
| Feature/ Function | InTone
(K110179) | evadri Bladder Control Systems
(K050483) | InToneMV
(New Device) | Comparison | Impact on
Safety and
Performance |
| Primary Function | Delivery of electrical stimulation | Delivery of electrical stimulation
EMG Biofeedback | Delivery of electrical stimulation
Visual Biofeedback | Substantially
equivalent | None |
| Warnings or
Precautions | (see product labeling) | (see product labeling) | (see product labeling) | Substantially
equivalent | None |
| Labeling Summary
Clarity to insure
safer or more
effective use | User Manual | User Manual | User Manual | Substantially
equivalent | None |
| Environmental
Specifications | For indoor use only | For indoor use only | For indoor use only | Identical | None |
| Power Source | 4/5 AA nickel metal hydride battery | Isolated AC to DC power adapter,
115/230VAC switchable input to
6VDC output | 4/5 AA nickel metal hydride
battery | Substantially
equivalent | None |
| Method of line
current isolation | n/a (battery) | Unknown | n/a (battery) | Substantially
equivalent | None |
| Patient leakage
current | n/a (battery) | Unknown | n/a (battery) | Substantially
equivalent | None |
| Number of output
modes | 1 | 1 | 1 | Substantially
equivalent | None |
| Number of output
channels | 1 | 1 | 1 | Substantially
equivalent | None |
| Regulated current
or voltage? | Regulated voltage | Unknown | Regulated voltage | Substantially
equivalent | None |
| Firmware
controlled? | Yes | Yes | Yes | Identical | None |
| Automatic
Overload Trip? | Yes | Unknown | N/A | Substantially
equivalent | None |
| Automatic No-Load
Trip? | Yes | Unknown | N/A | Substantially
equivalent | None |
| Automatic Shut
Off? | Yes | Unknown | Yes | Substantially
equivalent | None |
| Indicator Display
On/Off Status
Low Battery | Yes
Yes | Unknown | Yes (via display illumination)
Yes | Substantially
equivalent | None |
| Waveform, shape | Dual phase, rectangular pulses | Balanced biphasic, no DC
component | Dual phase, rectangular pulses | Substantially
equivalent | None |
| Frequency
Mixed
Stress
Urge | 50 Hz | 10, 12.5, 20, 50, 100, 200 HZ | 0 - 50 Hz | Substantially
equivalent | None |
| Pulse width
Mixed
Stress
Urge | 200 µs/phase | 0.3, 1 ms | 200 µs/phase | Substantially
equivalent | None |
| Time
On
Off | 20 seconds
10 seconds | 1-80 seconds
0-80 seconds | 0 - 20 seconds
0 - 20 seconds | Substantially
equivalent | None |
| Total Session Time | 12 mins | 1 - 30 minutes | 0-30 minutes | Substantially
equivalent | None |
| Max output voltage
(5000) | 50 Vdc | 0-30 Vdc | 50 Vdc | Substantially
equivalent | None |
| Feature/ Function | InTone
(K110179) | evadri Bladder Control Systems
(K050483) | InToneMV
(New Device) | Comparison | Impact on
Safety and
Performance |
| Max output current
(500Ω) | 100 mA | 100 Vdc | 100 mA | Substantially
equivalent | None |
| Maximum phase
charge (500Ω) | 50 μC | Unknown | 50 μC | Substantially
equivalent | None |
| Electrode surface
area | 10.5 cm² x 2 | Various | 2.5 cm² ± 0.5 cm² (x 2) | Substantially
equivalent | None |
| Max current
density | 4.7 mA/ cm² | Unknown | 20 mA/ cm² | Substantially
equivalent | None |
| Max average
power density
(500Ω) | 2.38 mW/cm² | Unknown | 10 mW/cm² | Substantially
equivalent | None |
| Biofeedback | Air pressure, 0 - 2 psi | EMG
Pressure, 0 - 350 cm H2O or
combination | Manometric
Air pressure, 0 - 2 psi | Substantially
equivalent | None |
| Dimensions | 8 x 5 x 4 inches (Inflatable Probe,
uninflated) | 100 x 70 x 130 mm | Control Unit: 4.8" x 2.4" x 1.1" (+/-
1.0")
Inflation bulb: 7.7" x 2.3" x 3.9"
(+/- 2.0")
Inflatable Probe (with handle): 4.8"
x 1.0" x 1.5" (+/- 1.5")
Tubing: Maximum 41" long | Substantially
equivalent | None |
| Control housing
material | ABS plastics | Plastics | ABS plastics | Substantially
equivalent | None |
| Insertion material | Silicone, plastics | Plastics | Silicone, plastics | Substantially
equivalent | None |
| Tubing Material | NA | N/A | Silicone | Substantially
equivalent | None |
| Packaging or
Expiration Dating | 1 year for insertion unit | N/A | N/A | Substantially
equivalent | None |
| Sterilization | N/A | N/A | N/A | Identical | None |
| Operational
Method: Clinical
Use
e.g., ambulatory
use, home use | Clinic or Home use, under direction
of physician | Unknown | Clinic or Home use, under direction
of physician | Substantially
equivalent | None |
| Patient Interaction:
Functions
Controllable: An
explanation of how
the device interacts
with the patient. | The patient can control the starting
and stopping of each session.
However, the device will stop on its
own once the session in normally
completed. | Unknown | The patient can control the starting
and stopping of each session.
However, the device will stop on
its own once the session in
normally completed. | Substantially
equivalent | None |
| Patient Interaction:
Programming
Capability
Whether the device
can be
programmed and to
what extent | None, programming can only be
changed by clinician | Unknown | None, programming can only be
changed by clinician | Substantially
equivalent | None |
| Override | Yes | Unknown | Yes | Substantially
equivalent | None |
| Patient Interaction:
Operator
Requirements
Knowledge or
training required of
the operator, | Intended as part of a complete
therapy program with physician
coaching. No special knowledge or
training; instruction manual
provided | Intended as part of a complete
therapy program with physician
coaching. No special knowledge or
training; instruction manual
provided. | Intended as part of a complete
therapy program with physician
coaching. No special knowledge or
training; instruction manual
provided | Substantially
equivalent | None |
| Software Level of | Moderate | Unknown | Moderate | Substantially
equivalent | None |
Confidential
2
INCONTRONT
Traditional 510(k) Submission
IN TONE MV
.
....
K134020 Page 3 of 5
3225 Gateway Road, Ste. 250 Brookfield, WI 53045
11 | Page
:
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INCONT 3225 Gateway Road, Ste. 250
Brookfield, WI 53045
Traditional 510(k) Submission
K134020 Page 4 of 5
INTONE MV
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4
INCON 3225 Gateway Road, Ste Brookfield, WI 53045
N TONEMV
Testing Summary
The testing for InToneMV included performance, software, electrical safety, EMC and biocompatibility. InToneMV successfully passed all testing.
Clinical evaluations for InToneMV have been completed to support the device as safe and effective according to the intended use.
Risk Management Summary
InToneMV has been designed according to InControl Medical's internal procedures with clear traceability between the design inputs, design outputs verification and validation activities.
InToneMV has been evaluated for risks according to InControl Medical's internal procedures based on ISO 14971. The risks associated with InToneMV were reduced to as low as possible and the risk/benefit analysis was acceptable.
Conclusion
InTone is substantially equivalent to the predicate devices. The data collected and documented throughout this submission provides objective evidence that InToneMV performs as well as or better than the predicate devices for the treatment of incontinence.
5
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 25, 2014
InControl Medical, LLC Jessica Andreshak Director of Quality Assurance and Regulatory Affairs 3225 Gateway Road, Suite 250 Brookfield, WI 53045
- Re: K134020
Trade/Device Name: InToneMV Regulation Number: 21 CFR§ 876.5320 Regulation Name: Nonimplanted electrical continence device Regulatory Class: II Product Code: KPI, HCC Dated: January 4, 2014 Received: February 5, 2014
Dear Jessica Andreshak,
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.
6
Page 2 - Jessica Andreshak
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/gefault.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 Small Manufacturers, International and Consumer Assistance 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,
Image /page/6/Picture/6 description: The image shows the name "Herbert P. Lerner -S" in a simple, sans-serif font. The letters are black against a white background, creating a clear contrast. The "P. Lerner" part of the name is stylized with some decorative elements around the letters. The overall impression is clean and professional.
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
7
Image /page/7/Picture/0 description: The image shows the logo and address of InControl Medical. The logo features the company name in bold, capitalized letters, with the word "MEDICAL" in smaller font beneath "CONTROL". The address is listed as 3225 Gateway Road, Ste. 250, Brookfield, WI 53045.
6. Statement of Indications for Use
510(k) Number (if known): K134020
Device Name
InToneMV
Indications for Use
InToneMV is intended to provide electrical stimulation and/or visual biofeedback (via manometry) for the treatment of male and female urinary and fecal incontinence.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)