(57 days)
InToneMV is intended to provide electrical stimulation and/or visual biofeedback (via manometry) for the treatment of male and female urinary and fecal incontinence.
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.
The provided text describes the InToneMV device, an electrical stimulator for incontinence, and its 510(k) submission to the FDA. However, it does not contain a study that proves the device meets specific acceptance criteria in terms of performance metrics.
Instead, the submission focuses on demonstrating substantial equivalence to existing predicate devices (InTone K110179 and evadri Bladder Control Systems K050483) through a comparison of features, functions, and safety aspects. The "Testing Summary" section broadly states that "InToneMV successfully passed all testing" and "Clinical evaluations for InToneMV have been completed to support the device as safe and effective according to the intended use," but no specific performance acceptance criteria or results from these evaluations are provided.
Therefore, many of the requested details about acceptance criteria and study design are not available in the provided text.
Here's a breakdown of what can and cannot be answered based on the input:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Explicitly Stated for Performance | The document states "InToneMV successfully passed all testing" and "Clinical evaluations... have been completed to support the device as safe and effective according to the intended use." However, no specific performance metrics (e.g., success rates, percentage reduction in incontinence episodes, specific biofeedback accuracy thresholds) are provided as acceptance criteria nor are their corresponding measured performance values. |
| Substantial Equivalence (General) | The device is deemed "Substantially Equivalent" to predicate devices for its intended use, technology, engineering, performance, and user interface. This is the primary "acceptance criterion" articulated. |
| Electrical Safety | Passed electrical safety testing. |
| EMC (Electromagnetic Compatibility) | Passed EMC testing. |
| Biocompatibility | Passed biocompatibility testing. |
| Software Functionality | Passed software testing. |
| Risk Management | Risks reduced to "as low as possible" and "risk/benefit analysis was acceptable" according to ISO 14971. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document only mentions "Clinical evaluations... have been completed" without providing details on the number of participants.
- Data Provenance (Country of Origin): Not specified.
- Retrospective or Prospective: Not specified.
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 provided. The term "ground truth" and details about expert review are not mentioned in the context of performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not provided.
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
- No, an MRMC comparative effectiveness study was not done. The device (InToneMV) is an electrical stimulator and biofeedback device for incontinence, not an imaging or diagnostic AI device that would typically involve "human readers" or "AI assistance" in the sense of image interpretation. The study mentioned is a "clinical evaluation" which is likely a clinical trial to assess safety and effectiveness of the therapeutic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable in the context of this device. The InToneMV is a medical device for treatment, not an algorithm for diagnosis that would have standalone performance. Its function inherently involves patient interaction (insertion, self-inflation, muscle contraction) and clinician programming.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not explicitly stated. Given the nature of the device for treating incontinence, "outcomes data" (e.g., reduction in incontinence episodes, improved quality of life, strength of pelvic floor muscles) would be the most likely form of ground truth for its efficacy in a clinical evaluation. However, the document does not specify how "ground truth" was established or what specific metrics were used.
8. The sample size for the training set
- This is not applicable as the device is a physical medical device, not an AI/machine learning algorithm requiring a "training set" in the computational sense.
9. How the ground truth for the training set was established
- This is not applicable for the same reason as above (not an AI/machine learning algorithm).
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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, LLC3225 Gateway Road, Ste. 250Brookfield, WI 53045 USA |
| K050483 | evadri BladderControl Systems | KPI | HOLLISTER, Inc.2000 Hollister Dr.Libertyville, IL 60048 USA |
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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 onSafety andPerformance |
|---|---|---|---|---|---|
| Intended UseAn explicitdescription of allclinical functionsperformed by thedevice,Indications for UseExplain when thedevice is to beclinically used andthe intendedpatient population | The InControl device is a non-implanted electrical stimulatorindicated for use in the treatment offemale urinary incontinence. Itapplies electrical stimulation to thepelvic floor musculature andsurrounding structures. It isintended for acute and ongoingtreatment of mixed urinaryincontinence where the followingresults may improve urinary control:strengthening of pelvic floormuscles, inhibition of the detrusormuscle through reflexivemechanisms. The biofeedbackfeature can be used for muscle re-education purposes. | The evadri Bladder Control Systemis intended to provide electricalstimulation or electromyographicor pressure feedback for thetreatment of urinary and fecal(electromyographic biofeedback)incontinence. | InToneMV is intended to be usedin males and females for thetreatment of urinary and fecalincontinence. | Substantiallyequivalent | None |
| Feature/ Function | InTone(K110179) | evadri Bladder Control Systems(K050483) | InToneMV(New Device) | Comparison | Impact onSafety andPerformance |
| Primary Function | Delivery of electrical stimulation | Delivery of electrical stimulationEMG Biofeedback | Delivery of electrical stimulationVisual Biofeedback | Substantiallyequivalent | None |
| Warnings orPrecautions | (see product labeling) | (see product labeling) | (see product labeling) | Substantiallyequivalent | None |
| Labeling SummaryClarity to insuresafer or moreeffective use | User Manual | User Manual | User Manual | Substantiallyequivalent | None |
| EnvironmentalSpecifications | 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 to6VDC output | 4/5 AA nickel metal hydridebattery | Substantiallyequivalent | None |
| Method of linecurrent isolation | n/a (battery) | Unknown | n/a (battery) | Substantiallyequivalent | None |
| Patient leakagecurrent | n/a (battery) | Unknown | n/a (battery) | Substantiallyequivalent | None |
| Number of outputmodes | 1 | 1 | 1 | Substantiallyequivalent | None |
| Number of outputchannels | 1 | 1 | 1 | Substantiallyequivalent | None |
| Regulated currentor voltage? | Regulated voltage | Unknown | Regulated voltage | Substantiallyequivalent | None |
| Firmwarecontrolled? | Yes | Yes | Yes | Identical | None |
| AutomaticOverload Trip? | Yes | Unknown | N/A | Substantiallyequivalent | None |
| Automatic No-LoadTrip? | Yes | Unknown | N/A | Substantiallyequivalent | None |
| Automatic ShutOff? | Yes | Unknown | Yes | Substantiallyequivalent | None |
| Indicator DisplayOn/Off StatusLow Battery | YesYes | Unknown | Yes (via display illumination)Yes | Substantiallyequivalent | None |
| Waveform, shape | Dual phase, rectangular pulses | Balanced biphasic, no DCcomponent | Dual phase, rectangular pulses | Substantiallyequivalent | None |
| FrequencyMixedStressUrge | 50 Hz | 10, 12.5, 20, 50, 100, 200 HZ | 0 - 50 Hz | Substantiallyequivalent | None |
| Pulse widthMixedStressUrge | 200 µs/phase | 0.3, 1 ms | 200 µs/phase | Substantiallyequivalent | None |
| TimeOnOff | 20 seconds10 seconds | 1-80 seconds0-80 seconds | 0 - 20 seconds0 - 20 seconds | Substantiallyequivalent | None |
| Total Session Time | 12 mins | 1 - 30 minutes | 0-30 minutes | Substantiallyequivalent | None |
| Max output voltage(5000) | 50 Vdc | 0-30 Vdc | 50 Vdc | Substantiallyequivalent | None |
| Feature/ Function | InTone(K110179) | evadri Bladder Control Systems(K050483) | InToneMV(New Device) | Comparison | Impact onSafety andPerformance |
| Max output current(500Ω) | 100 mA | 100 Vdc | 100 mA | Substantiallyequivalent | None |
| Maximum phasecharge (500Ω) | 50 μC | Unknown | 50 μC | Substantiallyequivalent | None |
| Electrode surfacearea | 10.5 cm² x 2 | Various | 2.5 cm² ± 0.5 cm² (x 2) | Substantiallyequivalent | None |
| Max currentdensity | 4.7 mA/ cm² | Unknown | 20 mA/ cm² | Substantiallyequivalent | None |
| Max averagepower density(500Ω) | 2.38 mW/cm² | Unknown | 10 mW/cm² | Substantiallyequivalent | None |
| Biofeedback | Air pressure, 0 - 2 psi | EMGPressure, 0 - 350 cm H2O orcombination | ManometricAir pressure, 0 - 2 psi | Substantiallyequivalent | 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 | Substantiallyequivalent | None |
| Control housingmaterial | ABS plastics | Plastics | ABS plastics | Substantiallyequivalent | None |
| Insertion material | Silicone, plastics | Plastics | Silicone, plastics | Substantiallyequivalent | None |
| Tubing Material | NA | N/A | Silicone | Substantiallyequivalent | None |
| Packaging orExpiration Dating | 1 year for insertion unit | N/A | N/A | Substantiallyequivalent | None |
| Sterilization | N/A | N/A | N/A | Identical | None |
| OperationalMethod: ClinicalUsee.g., ambulatoryuse, home use | Clinic or Home use, under directionof physician | Unknown | Clinic or Home use, under directionof physician | Substantiallyequivalent | None |
| Patient Interaction:FunctionsControllable: Anexplanation of howthe device interactswith the patient. | The patient can control the startingand stopping of each session.However, the device will stop on itsown once the session in normallycompleted. | Unknown | The patient can control the startingand stopping of each session.However, the device will stop onits own once the session innormally completed. | Substantiallyequivalent | None |
| Patient Interaction:ProgrammingCapabilityWhether the devicecan beprogrammed and towhat extent | None, programming can only bechanged by clinician | Unknown | None, programming can only bechanged by clinician | Substantiallyequivalent | None |
| Override | Yes | Unknown | Yes | Substantiallyequivalent | None |
| Patient Interaction:OperatorRequirementsKnowledge ortraining required ofthe operator, | Intended as part of a completetherapy program with physiciancoaching. No special knowledge ortraining; instruction manualprovided | Intended as part of a completetherapy program with physiciancoaching. No special knowledge ortraining; instruction manualprovided. | Intended as part of a completetherapy program with physiciancoaching. No special knowledge ortraining; instruction manualprovided | Substantiallyequivalent | None |
| Software Level of | Moderate | Unknown | Moderate | Substantiallyequivalent | None |
Confidential
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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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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.
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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.
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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
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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)
Herbert P. Lerne 2014.02.25 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).