(397 days)
Not Found
No
The document describes a standard electrical stimulator with biofeedback and data storage capabilities, but there is no mention of AI or ML algorithms being used for analysis, decision-making, or adaptation beyond basic biofeedback and data logging.
Yes
The device is explicitly indicated for use in the treatment of female urinary incontinence, which is a medical condition. It applies electrical stimulation and has a biofeedback feature aimed at improving urinary control by strengthening muscles and inhibiting the detrusor muscle.
No
The device is indicated for treatment (electrical stimulation, muscle re-education) of urinary incontinence, not for diagnosis. The "biofeedback" feature is for muscle re-education, not to diagnose a condition.
No
The device description explicitly states it includes hardware components: an insertion probe with electrodes and a hand-held control unit.
Based on the provided information, the InControl InTone 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.
- InControl InTone Function: The InControl InTone device is an electrical stimulator that applies electrical stimulation directly to the pelvic floor muscles. It is used for treatment and muscle re-education, not for analyzing samples taken from the body.
- Intended Use: The intended use clearly states it's for the treatment of female urinary incontinence by applying electrical stimulation and providing biofeedback. This is a therapeutic and rehabilitative function, not a diagnostic one.
Therefore, the InControl InTone device falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The InControl InTone 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.
Product codes (comma separated list FDA assigned to the subject device)
KPI
Device Description
The device includes three parts; an insertion probe and a hand-held control unit. The insertion The device includes three parts, an inoortion provides more adaptable fit for intra-vaginal use. The probe includes stainless steel electrodes to deliver electro-stimulation. The hand-held control probe includes stainless steel clours and displays the results of electro-stimulation and patient and ulsplay device records, storos, and alspiary one to select and lock in the correct amount generated pervic noor excressor from to the contraction. It also stores data on contraction of current necessary to stimulate pervice noor ochination to select and lock in the correct amount of current necessary to stimulate pelvic floor contraction.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic floor musculature and surrounding structures
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)
Complete EMC, electrical, mechanical, safety (operator and patient), temperature/humidity, and software testing demonstrate compliance with applicable standards. The results demonstrate that the InControl InTone device is in compliance with the guidelines and standards referenced in the FDA reviewer's guides, and that it performed within its specifications and functional requirements for 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
§ 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
K110179
pg. 1 of 7
510(k) Summary for InControl InTone
| Submitter: | InControl Medical, LLC | FEB 2 2 2012 | ||
|---|---|---|---|---|
| Address: | 3225 Gateway Road, Suite 250 | |||
| Brookfield, Wisconsin 53045 | ||||
| Corporate Contact: | InControl Medical, LLC | Herschel Peddicord, President | ||
| Telephone: | Ph: (414) 429-2625 | |||
| Establishment Registration #: | to be registered following 510(k) | |||
| Submission Contact: | Michael J. Leigh, consultant | |||
| 12715 Falcon Drive | ||||
| Ph: (262) 957-6797 | Brookfield, Wisconsin 53005 | |||
| Trade Name: | InControl InTone | |||
| Predicate Device: | Otto Bock STIWELL med, K080950 | |||
| MyoTrac Infiniti, K053434 | ||||
| Hollister evadri, K050483 | ||||
| Common Name: | Stimulator, Electrical, Non-Implantable, for Incontinence | |||
| Classification Name: | ||||
| Device | ||||
| Class | ||||
| Jon-implanted electrical continen | II |
Device Description:
The device includes three parts; an insertion probe and a hand-held control unit. The insertion The device includes three parts, an inoortion provides more adaptable fit for intra-vaginal use. The probe includes stainless steel electrodes to deliver electro-stimulation. The hand-held control probe includes stainless steel clours and displays the results of electro-stimulation and patient and ulsplay device records, storos, and alspiary one to select and lock in the correct amount generated pervic noor excressor from to the contraction. It also stores data on contraction of current necessary to stimulate pervice noor ochination to select and lock in the correct amount of current necessary to stimulate pelvic floor contraction.
device
Intended Use:
d Use:
The InControl InTone device is a non-implanted indicated for use in the treatment of The InControl In One device is a non-inplanted electrical stimulation has and manufacture and female urinaly incontinence. It applies electrial only of mixed urinary incontinent surrounding structures. It is intended for active and strengthening of pelvic floor muscles and where the following results may improve unflary bonnery bonnel of the biofeedback feature can be used for muscle re-education purposes.
1
K110179
. pg. 2 of 7
Performance Data:
Complete EMC, electrical, mechanical, safety (operator and patient), temperature/humidity, and software testing demonstrate compliance with applicable standards. The results demonstrate that the InControl InTone device is in compliance with the guidelines and standards referenced in the FDA reviewer's guides, and that it performed within its specifications and functional requirements for the device.
This summary of 510(k) safety and effectiveness information is being submitted in accordance with FDA requirements.
2
| InControl InTone
(new device) | Otto Bock STIWELL med4
(K080950) | MyoTrac Infiniti
(K053434) | Hollister evadri
(K050483) | Comparison |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 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 STIWELL med4 is a neuromuscular
electronic stimulator for use under
medical supervision for adjunctive
therapy in the treatment of medical
diseases and conditions.
As a nonimplanted electrical continence
device the STIWELL med4 is indicated
for the following conditions:
Acute and ongoing treatment of
stress, urge, or mixed urinary
incontinence and where the
following results may improve
urinary control: Inhibition of the
detruser muscles through reflexive
mechanisms and strengthening of
the pelvic floor muscles. Incontinence treatment for
assessing EMG activity of the
pelvic floor and accessory
muscles such as the abdominal
and the gluteus muscles. As a biofeedback device the STIWELL
med4 is indicated for the following
conditions:
Biofeedback, relaxation and
muscle re-education purposes. | Treatment of urinary incontinence
EMG biofeedback
The MyoTrac Infiniti system is indicated for
acute and ongoing treatment of stress, urge,
or mixed urinary incontinence and where the
following results may improve urinary
control: Inhibition of the detruser muscle
through reflexive mechanisms, strengthening
of pelvic floor muscle. It is also indicated
during incontinence treatment for assessing
EMG activity of the pelvic floor and
accessory muscles such as the abdominal or
gluteal muscles. | The evadri Bladder Control
System is intended to
provide electrical
stimulation or
electromyographic or
pressure biofeedback for the
treatment of urinary or fecal
(electromyographic
biofeedback) incontinence. | Equivalent |
| (see product labeling) | (see product labeling) | (see product labeling) | (see product labeling) | Equivalent |
Section 5 - 510(k) Summary.doc
K110179
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3
Section 5 - 510(k) Summary.doc
K110179
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4
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| Method of line current
Solation | n/a (battery) | n/a (battery) | n/a (battery) | | Identical
(to Otto Bock,
MyoTrac) |
|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| Patient leakage
current | n/a (battery) | n/a (battery) | n/a (battery) | | Identical
(to Otto Bock,
MyoTrac) |
| Number of output
modes | 1 | 1 | 1 | | Identical
(to all) |
| Number of output
channels | 1 | 1 | 1 | | Identical
(to all) |
| Regulated current or
Voltage? | Regulated voltage | Regulated current | Unknown | | Equivalent |
| Firmware controlled? | Yes | Yes | Yes | | Identical
(to all) |
| Automatic Overload
Trip? | Yes | Yes | Unknown | | Identical
(to Otto Bock) |
| Automatic No-Load
Trip? | Yes | Yes | Unknown | | Identical
(to Otto Bock) |
| Automatic Shut Off? | Yes | Yes | Unknown | | Identical
(to Otto Bock) |
| Indicator Display
On/Off Status
Low Battery | Yes | Yes | Yes | | Identical
(to Otto Bock,
MyoTrac) |
| Waveform, shape | dual phase, rectangular pulses | Biphasic symmetrical rectangular | asymmetric, balanced pulse | Balanced biphasic | Identical |
| Frequency
Mixed
Stress
Urge | 50 Hz | 35 Hz
10 Hz | 12.5, 50, 100, 200 Hz | 10, 12.5, 20, 50, 100, 200
Hz | Within range
(of MyoTrac,
Hollister) |
| Pulse width
Mixed
Stress
Urge | 200 µs/phase | 300 µs/phase
500 µs/phase | 0.2 ms | 0.3 or 1 ms | Within range |
| Time
On
Off | 20 secs
10 secs | 9 - 12 s for Stress, 13 s for Urge
7 - 9 s for Stress, 3 s for Urge | 2- 20 secs
2- 50 secs | 1 - 80 secs
0 - 80 secs | Equivalent |
| | | 5 - 25 mins | 0 - 120 mins | 1 - 30 mins | Within range |
| Total Session Time | 12 mins | | | | Identical
(to Otto Bock) |
| Max output voltage
(500Ω) | 50 Vdc | 50 Vdc | 30 Vdc | 30 Vdc | Identical |
| Max output current
(500Ω) | 100 mA | 100 mA | 100 mA | 100 mA | Identical
(to Otto Bock) |
| Maximum phase
charge (500Ω) | 50 µC | 50 μC | 60 µC | Unknown | Equivalent |
| Electrode surface area | 10.5 cm² x 2 | 21.2 cm² | Various, 1.53 cm² to 10.5 cm² | unknown | Identical
(to Otto Bock) |
| Max current density | 4.7 mA/cm² | 4.7 mA/cm² | Various, 4.7 mA/cm² to 32 mA/cm² | | Equivalent. |
| Maximum power
density (500Ω) | 14.3 µW/cm² | 23.5 µW/cm² | Various, 11.32 µW/cm² to 22.84 μW/cm² | Unknown | Equivalent |
| Biofeedback | Air pressure, 0-2 psi | EMG | EMG | EMG
pressure, 0 - 350 cm H₂O
or combination | Equivalent
(to Hollister) |
| Materials | | | | | |
| | | 175 x 95 x 30 mm | 102 x 152 x 51 mm | 100 x 70 x 130 mm | Equivalent |
| Dimensions | 8 x 5 x 4 inches | | | | |
| Control housing | ABS plastics | plastics | plastics | plastics | Equivalent |
| Insertion material | Silicone, plastics | plastics | plastics | plastics | Equivalent |
| Packaging or
Expiration Dating | 1 year for insertion unit | N/A | N/A | N/A | |
| Sterilization | N/A | N/A | N/A | N/A | |
| User Interaction and Software | | | | | |
| Operational Method:
Clinical Use
(e.g., ambulatory use, home use) | Clinic or Home use, under direction of physician | Clinic or Home use, under direction of physician | Clinic or Home use, under direction of physician | Clinic or Home use, under direction of physician | Identical
(to all) |
| Patient Interaction:
Functions
Controllable | 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. | | | | Equivalent |
| An explanation of how the device interacts with the patient. | | | | | |
| Patient Interaction:
Programming
Capability | None, programming can only be changed by clinician | None, programming is locked by clinician | None, programming is locked by clinician | | Equivalent
(to Otto Bock, MyoTrac) |
| Whether the device can be programmed and to what extent | | | | | |
| Override | Yes | Yes | | | Identical
(to Otto Bock) |
| Patient Interaction:
Operator
Requirements | 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 | Intended as part of a complete therapy program with physician coaching. No special knowledge or training; instruction manual provided | Identical
(to all) |
| Knowledge or training required of the operator | | | | | |
| Software Level of Concern | Moderate | | | | |
| A statement indicating the Level of Concern and a description of the rationale for that level | | | | | |
| Feature/ Function | InControl InTone
(new device) | Otto Bock STIWELL med4
(K080950) | MyoTrac Infiniti
(K053434) | Hollister evadri
(K050483) | Comparison |
| Technology, Engineering, and Performance | | | | | |
| Environmental
Specifications | For indoor use only | For indoor use only | For indoor use only | For indoor use only | Identical
(to all) |
| Power Source | Nickel metal hydride battery | Li-Ion battery | Four AAA 1.5V alkaline batteries | AC power supply | Equivalent |
| Number of output
modes | 1 | 1 | 1 | 1 | Identical
(to all) |
| Number of output
channels | 1 | 1 | 1 | 1 | Identical
(to all) |
| Regulated current of
voltage? | Regulated voltage | Regulated current | Unknown | Unknown | Equivalent |
| Firmware controlled? | Yes | Yes | Yes | Yes | Identical
(to all) |
| Automatic Overload
Trip? | Yes | Yes | Unknown | Unknown | Identical
(to Otto Bock) |
| Automatic Shut Off? | Yes | Yes | Unknown | unknown | Identical
(to Otto Bock) |
| Indicator Display
On/Off Status
Low Battery | Yes
Yes | Yes
Yes | Yes
Yes | unknown | Identical
(to Otto Bock,
MyoTrac) |
| Waveform, shape | dual phase, rectangular pulses | Biphasic symmetrical rectangular | asymmetric, balanced pulse | Balanced biphasic | Identical
(to Otto Bock,
Hollister) |
| Frequency
Mixed
Stress
Urge | 50Hz | 35 Hz
10 Hz | 12.5, 50, 100, 200 Hz | 10, 12.5, 20, 50, 100, 200
Hz | Identical
(to MyoTrac,
Hollister) |
| Pulse width
Mixed
Stress
Urge | 200 µs/phase | 300 µs/phase
500 µs/phase | 0.2 ms | 0.3 or 1 ms | Within range |
| Time
On
Off
Total Session Time | 20 secs
10 sccs
12 mins | 9 - 12 s for Stress, 13 s for Urge
7- 9 s for Stress, 3 s for Urge
5 - 25 mins | 2 - 20 sccs
2 - 50 secs
0 - 120 mins | 1 - 80 secs
0 - 80 secs
1 - 30 mins | Within range |
| Max output voltage
(500Ω) | 50 Vdc | 50 Vdc | 30 Vdc | 30 Vdc | Within range
Identical
(to Otto Bock) |
| Max output current
(500Ω) | 100 mA | 100 mA | 100 mA | 100 mA | Identical
(to Otto Bock) |
| Maximum phase
charge (500Ω) | 50 µC | 50 µC | 60 µC | Unknown | Identical |
| Electrode surface area | 10.5 cm² x 2 | 21.2 cm² | Various, 1.53 cm² to 10.5 cm² | unknown | Equivalent |
| Max current density | 4.7 mA/cm² | 4.7 mA/cm² | Various, 4.7 mA/ cm² to 32 mA/cm² | unknown | Identical |
| Maximum power
density (500Ω) | 14.3 µW/cm² | 23.5 µW/cm² | Various, 11.32 µW/ cm² to 22.84 µW/cm² | Unknown | Equivalent |
| Biofeedback | Air pressure, 0.2 psi | EMG | EMG | pressure, 0 - 350 cm H2O
or combination | Equivalent
(to Hollister) |
K110179
Pg 5 of 7
5
Section 5 - 510(K) Summary.doc
K110179
pg. 6 of 7
6
Section 5 - 510(k) Summary.doc
K110179
pg. 7 of 7
7
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/Picture/1 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002
InControl Medical, LLC % Mr. Michael J. Leigh Consultant 12715 Falcon Drive BROOKFIELD WI 53005
FEB 2 2 2012
Re: K110179
Trade/Device Name: InControl InTone Regulation Number: 21 CFR§ 876.5320 Regulation Name: Nonimplanted electrical continence device Regulatory Class: II Product Code: KPI Dated: January 24, 2011 Received: January 31, 2012
Dear Mr. Leigh:
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 for association 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 I ou may were revelsions 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 your de roo 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 r load of act how a a determination that your device complies with other requirements of the Act that I DTPhas intatutes and regulations administered by other Federal agencies. You must or unf I edolul StatuteD and regurements, including, but not limited to: registration and listing confirs min an an and 110 room g (21 CFR Part 801); medical device reporting of medical
8
Page 2-
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/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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Benjamin R. Twichell
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
9
Indications for Use
510(k) Number (if known): K110179
InControl InTone Device Name:
Indications For Use:
The InControl InTone device is a non-implanted electrical stimulator indicated for use in the the incontrol in the devious is a non-mail.com income electrical stimulation to the pelvic floor treatment of lemale unnery incontinents. It is intended for acute and ongoing treatment of mixed urinary incontinence where the following results may improve urinary control: mixed "unlary" incontinence" whole the religition of the detrusor muscle through reflexive strengthening of powle feature can be used for muscle re-education purposes.
Federal (USA) law restricts this device to sale by or on the order of a physician.
Prescription Use (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)
Helmut Kohl
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K110179
Page 1 of _ 1