(397 days)
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.
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.
The provided document is a 510(k) summary for the InControl InTone device, a non-implantable electrical stimulator for treating female urinary incontinence. The claims are for "substantial equivalence" of the InControl InTone device to predicate devices on the market and do not detail any clinical studies. Therefore, this document does not contain information to answer the bulk of your questions regarding acceptance criteria, study sizes, ground truth establishment, or clinical performance metrics.
However, based on the provided tables comparing the InControl InTone device to its predicate devices (Otto Bock STIWELL med4, MyoTrac Infiniti, and Hollister evadri), we can infer the acceptance criteria were based on demonstrating equivalence in intended use, technology, engineering, and performance specifications.
Here's the information that can be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance:
The acceptance criteria are not explicitly stated with numeric thresholds or targets for device performance. Instead, the "Comparison" column indicates whether the InControl InTone's features are "Identical," "Equivalent," or "Within range" compared to predicate devices. The "Reported Device Performance" for the InControl InTone is simply its listed specifications.
| Feature/Function | Predicate Acceptance Criteria (Inferred from comparison) | InControl InTone (Reported Device Performance) | Comparison to Predicate Devices (Otto Bock, MyoTrac, Hollister) |
|---|---|---|---|
| Intended Use | Equivalent to predicate devices | Treatment of female urinary incontinence, electrical stimulation to pelvic floor, muscle re-education. Acute and ongoing treatment of mixed urinary incontinence. | Equivalent |
| Method of line current Isolation | Battery operated | n/a (battery) | Identical (to Otto Bock, MyoTrac) |
| Patient leakage current | Battery operated | n/a (battery) | Identical (to Otto Bock, MyoTrac) |
| Number of output modes | 1 | 1 | Identical (to all) |
| Number of output channels | 1 | 1 | Identical (to all) |
| Regulated current or Voltage | Regulated current / voltage (equivalent or within range of predicates) | Regulated voltage | Equivalent |
| Firmware controlled | Yes | Yes | Identical (to all) |
| Automatic Overload Trip | Yes | Yes | Identical (to Otto Bock) |
| Automatic No-Load Trip | Yes | Yes | Identical (to Otto Bock) |
| Automatic Shut Off | Yes | Yes | Identical (to Otto Bock) |
| Indicator Display On/Off Status/Low Battery | Yes | Yes | Identical (to Otto Bock, MyoTrac) |
| Waveform, shape | Biphasic symmetrical rectangular / asymmetric balanced pulse / balanced biphasic | dual phase, rectangular pulses | Identical (to Otto Bock, Hollister) |
| Frequency (Mixed, Stress, Urge) | Within range of predicate values | 50 Hz | Identical (to MyoTrac, Hollister specifically mentions 50Hz) / Within range |
| Pulse width (Mixed, Stress, Urge) | Within range of predicate values | 200 µs/phase | Within range |
| Time (On, Off, Total Session Time) | Within range of predicate values | On: 20 secs, Off: 10 secs, Total: 12 mins | Within range |
| Max output voltage (500Ω) | 50 Vdc | 50 Vdc | Identical (to Otto Bock) |
| Max output current (500Ω) | 100 mA | 100 mA | Identical (to Otto Bock) |
| Maximum phase charge (500Ω) | 50-60 µC | 50 µC | Identical |
| Electrode surface area | Equivalent to predicate values | 10.5 cm² x 2 | Equivalent |
| Max current density | Equivalent to predicate values | 4.7 mA/cm² | Identical |
| Maximum power density (500Ω) | Equivalent to predicate values | 14.3 µW/cm² | Equivalent |
| Biofeedback | EMG, pressure, or combination | Air pressure, 0-2 psi | Equivalent (to Hollister) |
| Dimensions | Equivalent to predicate sizes | 8 x 5 x 4 inches | Equivalent |
| Control housing materials | Plastics | ABS plastics | Equivalent |
| Insertion material | Plastics | Silicone, plastics | Equivalent |
| Packaging or Expiration Dating | N/A or 1 year | 1 year for insertion unit | |
| Sterilization | N/A | N/A | |
| Operational Method (Clinical Use) | Clinic or Home use, under direction of physician | Clinic or Home use, under direction of physician | Identical (to all) |
| Patient Interaction: Functions Controllable | Starting/stopping of sessions (auto-stop for completion) | Patient controls start/stop, device auto-stops | Equivalent |
| Patient Interaction: Programming Capability | None, programmed by clinician | None, programming by clinician | Equivalent (to Otto Bock, MyoTrac) |
| Override | Yes | Yes | Identical (to Otto Bock) |
| Patient Interaction: Operator Requirements | No special knowledge/training, instruction manual, physician coaching | No special knowledge/training, instruction manual, physician coaching | Identical (to all) |
| Software Level of Concern | (Not explicitly stated for predicates, but "Moderate" for new device) | Moderate | |
| Environmental Specifications | For indoor use only | For indoor use only | Identical (to all) |
| Power Source | Various (Li-Ion, AAA alkaline, AC power) | Nickel metal hydride battery | Equivalent |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not present in the provided 510(k) summary. The document describes a substantial equivalence submission based on technical features and intended use comparison to predicate devices, not clinical studies with test sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not present in the provided 510(k) summary. No test sets or ground truth establishment by experts are mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not present in the provided 510(k) summary. No test sets or adjudication methods are mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A multi-reader multi-case (MRMC) comparative effectiveness study was not done and is not mentioned in the provided document. The device is a direct patient treatment device, not an AI diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the InControl InTone is an electrical stimulator device, not an AI algorithm. Its performance is related to its physical and electrical specifications, which were assessed through "EMC, electrical, mechanical, safety (operator and patient), temperature/humidity, and software testing."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not present in the provided 510(k) summary for any clinical performance. The "ground truth" for the device's technical performance seems to be established through engineering compliance testing against applicable standards (e.g. EMC, electrical, mechanical safety).
8. The sample size for the training set
This information is not present in the provided 510(k) summary. No training sets are mentioned.
9. How the ground truth for the training set was established
This information is not present in the provided 510(k) summary. No training sets or ground truth establishment for them are mentioned.
{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 250Brookfield, 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, consultant12715 Falcon DrivePh: (262) 957-6797 | Brookfield, Wisconsin 53005 | ||
| Trade Name: | InControl InTone | |||
| Predicate Device: | Otto Bock STIWELL med, K080950MyoTrac Infiniti, K053434Hollister evadri, K050483 | |||
| Common Name: | Stimulator, Electrical, Non-Implantable, for Incontinence | |||
| Classification Name: | ||||
| DeviceClass | ||||
| 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-implantedelectrical stimulator indicated for use inthe treatment of female urinaryincontinence. It applies electricalstimulation to the pelvic floor musculatureand surrounding structures. It is intendedfor acute and ongoing treatment of mixedurinary incontinence where the followingresults may improve urinary control:strengthening of pelvic floor muscles,inhibition of the detrusor muscle throughreflexive mechanisms. The biofeedbackfeature can be used for muscle re-education purposes. | The STIWELL med4 is a neuromuscularelectronic stimulator for use undermedical supervision for adjunctivetherapy in the treatment of medicaldiseases and conditions.As a nonimplanted electrical continencedevice the STIWELL med4 is indicatedfor the following conditions:Acute and ongoing treatment ofstress, urge, or mixed urinaryincontinence and where thefollowing results may improveurinary control: Inhibition of thedetruser muscles through reflexivemechanisms and strengthening ofthe pelvic floor muscles. Incontinence treatment forassessing EMG activity of thepelvic floor and accessorymuscles such as the abdominaland the gluteus muscles. As a biofeedback device the STIWELLmed4 is indicated for the followingconditions:Biofeedback, relaxation andmuscle re-education purposes. | Treatment of urinary incontinenceEMG biofeedbackThe MyoTrac Infiniti system is indicated foracute and ongoing treatment of stress, urge,or mixed urinary incontinence and where thefollowing results may improve urinarycontrol: Inhibition of the detruser musclethrough reflexive mechanisms, strengtheningof pelvic floor muscle. It is also indicatedduring incontinence treatment for assessingEMG activity of the pelvic floor andaccessory muscles such as the abdominal orgluteal muscles. | The evadri Bladder ControlSystem is intended toprovide electricalstimulation orelectromyographic orpressure biofeedback for thetreatment of urinary or fecal(electromyographicbiofeedback) incontinence. | Equivalent |
| (see product labeling) | (see product labeling) | (see product labeling) | (see product labeling) | Equivalent |
Section 5 - 510(k) Summary.doc
K110179
pg. 3 of 7
{3}------------------------------------------------
Section 5 - 510(k) Summary.doc
K110179
Pg. 4 of 7
{4}------------------------------------------------
| 1 |
|---|
| 1P |
| œ0 |
| t1 |
| *** *** |
| 1 |
| 411 |
| œ |
| 71 |
| œ- |
| 27 |
| œœ |
| >0 |
| )œ41 |
| Method of line currentSolation | n/a (battery) | n/a (battery) | n/a (battery) | Identical(to Otto Bock,MyoTrac) | |
|---|---|---|---|---|---|
| Patient leakagecurrent | n/a (battery) | n/a (battery) | n/a (battery) | Identical(to Otto Bock,MyoTrac) | |
| Number of outputmodes | 1 | 1 | 1 | Identical(to all) | |
| Number of outputchannels | 1 | 1 | 1 | Identical(to all) | |
| Regulated current orVoltage? | Regulated voltage | Regulated current | Unknown | Equivalent | |
| Firmware controlled? | Yes | Yes | Yes | Identical(to all) | |
| Automatic OverloadTrip? | Yes | Yes | Unknown | Identical(to Otto Bock) | |
| Automatic No-LoadTrip? | Yes | Yes | Unknown | Identical(to Otto Bock) | |
| Automatic Shut Off? | Yes | Yes | Unknown | Identical(to Otto Bock) | |
| Indicator DisplayOn/Off StatusLow Battery | Yes | Yes | Yes | Identical(to Otto Bock,MyoTrac) | |
| Waveform, shape | dual phase, rectangular pulses | Biphasic symmetrical rectangular | asymmetric, balanced pulse | Balanced biphasic | Identical |
| FrequencyMixedStressUrge | 50 Hz | 35 Hz10 Hz | 12.5, 50, 100, 200 Hz | 10, 12.5, 20, 50, 100, 200Hz | Within range(of MyoTrac,Hollister) |
| Pulse widthMixedStressUrge | 200 µs/phase | 300 µs/phase500 µs/phase | 0.2 ms | 0.3 or 1 ms | Within range |
| TimeOnOff | 20 secs10 secs | 9 - 12 s for Stress, 13 s for Urge7 - 9 s for Stress, 3 s for Urge | 2- 20 secs2- 50 secs | 1 - 80 secs0 - 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 phasecharge (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 powerdensity (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 | EMGpressure, 0 - 350 cm H₂Oor 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 orExpiration 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:FunctionsControllable | 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:ProgrammingCapability | 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:OperatorRequirements | 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 | |||||
| EnvironmentalSpecifications | 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 outputmodes | 1 | 1 | 1 | 1 | Identical(to all) |
| Number of outputchannels | 1 | 1 | 1 | 1 | Identical(to all) |
| Regulated current ofvoltage? | Regulated voltage | Regulated current | Unknown | Unknown | Equivalent |
| Firmware controlled? | Yes | Yes | Yes | Yes | Identical(to all) |
| Automatic OverloadTrip? | Yes | Yes | Unknown | Unknown | Identical(to Otto Bock) |
| Automatic Shut Off? | Yes | Yes | Unknown | unknown | Identical(to Otto Bock) |
| Indicator DisplayOn/Off StatusLow Battery | YesYes | YesYes | YesYes | 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) |
| FrequencyMixedStressUrge | 50Hz | 35 Hz10 Hz | 12.5, 50, 100, 200 Hz | 10, 12.5, 20, 50, 100, 200Hz | Identical(to MyoTrac,Hollister) |
| Pulse widthMixedStressUrge | 200 µs/phase | 300 µs/phase500 µs/phase | 0.2 ms | 0.3 or 1 ms | Within range |
| TimeOnOffTotal Session Time | 20 secs10 sccs12 mins | 9 - 12 s for Stress, 13 s for Urge7- 9 s for Stress, 3 s for Urge5 - 25 mins | 2 - 20 sccs2 - 50 secs0 - 120 mins | 1 - 80 secs0 - 80 secs1 - 30 mins | Within range |
| Max output voltage(500Ω) | 50 Vdc | 50 Vdc | 30 Vdc | 30 Vdc | Within rangeIdentical(to Otto Bock) |
| Max output current(500Ω) | 100 mA | 100 mA | 100 mA | 100 mA | Identical(to Otto Bock) |
| Maximum phasecharge (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 powerdensity (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 H2Oor 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
§ 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).