The Insertion Unit includes an inflation pump and an inflatable probe. The inflatable probe is inserted into the vagina and the inflation pump is used by the patient to manually inflate the probe, ensuring 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 encourage 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 Software Application allows the clinician to select and lock in the appropriate electrical stimulation level necessary to stimulate pelvic floor contraction.

AI/ML Overview

This document is a 510(k) premarket notification for the InTone device, seeking a determination of substantial equivalence to previously marketed predicate devices (InTone K110179 and InToneMV K134020). The document asserts that the new InTone device is substantially equivalent based on similarities in intended use, technology, engineering, performance, user interface, and prior testing conducted on the predicate devices.

Here's an analysis of the acceptance criteria and study information provided, focusing on what is stated and what is not:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a formal table of "acceptance criteria" for the new InTone device in the sense of predefined thresholds for performance metrics. Instead, it presents a "Substantial Equivalence Comparison Table" (Table 7.3) that compares features and functions of the new InTone with its predicate devices (K110179 and K134020). The reported "performance" is implicitly demonstrated through this comparison, indicating that the new device operates similarly to or within the parameters of the predicate devices. When a feature is "Substantially equivalent" or "Identical," the impact on safety and performance is noted as "None," implying that the new device's performance is acceptable because it matches that of legally marketed devices.

Key performance-related comparisons include:

Feature/Function	New InTone Performance (Comparison to Predicates)	Impact on Safety and Performance
Intended Use	Substantially equivalent	None
Primary Function	Identical to InToneMV	None
Warnings or Precautions	Substantially equivalent	None
Contraindications	Identical to InToneMV	None
Labeling Summary	Substantially equivalent	None
Environmental Specifications	Identical	None
Power Source	Identical	None
Method of line current isolation	Identical	None
Patient leakage current	Identical	None
Number of output modes	Identical	None
Number of output channels	Identical	None
Regulated current or voltage?	Identical	None
Firmware controlled?	Identical	None
Automatic Overload Trip?	Identical to InToneMV	None
Automatic No-Load Trip?	Identical to InToneMV	None
Automatic Shut Off?	Identical	None
Indicator Display On/Off Status / Low Battery	Identical to InToneMV	None
Waveform, shape	Monophasic, alternating polarity, square pulses (Substantially equivalent to dual phase, rectangular pulses)	None
Frequency (Stress, Urge)	50 Hz, 13 Hz (Identical to InToneMV)	None
Pulse width	200 µs/phase (Identical)	None
Time (On, Off)	1s on/2s off at 50Hz, 2s on/2s off at 13Hz (Identical to InToneMV)	None
Total Session Time	Approx. 12 minutes (Identical to InToneMV)	None
Max output voltage (500Ω)	40 Vdc (Substantially equivalent to 50 Vdc)	None
Max output current (500Ω)	80 mA (Substantially equivalent to 100 mA)	None
Maximum phase charge (500Ω)	16 µC (Substantially equivalent to 20 µC)	None
Electrode surface area	6.00 cm² ± 0.5 cm² (x 2) (Substantially equivalent to 10.5 cm² x 2 and 2.5 cm² ± 0.5 cm² (x 2))	None
Max current density	13.3 mA/cm- (Substantially equivalent to 9.5 mA/cm- and 40 mA/cm-)	None
Max average power density (500Ω)	5.33 mW/cm² (Substantially equivalent to 4.8 mW/cm- and 20 mW/cm-)	None
Biofeedback	Manometric, Air pressure, 0-2 psi (Identical to InToneMV)	None
Dimensions	Substantially equivalent	None
Control housing material	Identical	None
Insertion material	Identical	None
Tubing Material	Identical to InTone	None
Packaging or Expiration Dating	Identical to InTone	None
Sterilization	Identical	None
Operational Method: Clinical Use	Identical	None
Patient Interaction: Functions Controllable	Identical	None
Patient Interaction: Programming Capability	Identical	None
Override	Identical	None
Patient Interaction: Operator Requirements	Identical	None
Software Level of Concern	Identical	None

2. Sample size used for the test set and the data provenance:

No specific sample size for a "test set" for the new device is provided. The document states that "New software verification and validation, electrical safety, EMC, and biocompatibility testing did not need to be performed to demonstrate the equivalent safety and effectiveness of this new version of the InTone."
Instead, the reliance is on testing performed on the predicate devices:
- Predicate InToneMV (K134020) for: Software verification and validation, Electrical safety, and EMC testing.
- Predicate InTone (K110179) for: Biocompatibility testing.
Data Provenance: The document does not explicitly state the country of origin or whether the testing data for the predicate devices was retrospective or prospective. It only mentions that the testing was "conducted on the predicate InToneMV" and "for the predicate InTone."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The document relies on engineering and biological testing and a clinical literature review for validation, not on expert-established ground truth from a test set in the conventional sense of a clinical study assessing diagnostic performance.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not applicable/not provided. The document describes technical testing (software V&V, electrical safety, EMC, biocompatibility) and a literature review, not a clinical study involving adjudication of results.

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 MRMC comparative effectiveness study was done as described. The device is for electrical stimulation and biofeedback therapy for urinary incontinence, not an AI-assisted diagnostic tool that would involve human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable in the context of diagnostic algorithms. The InTone device is a therapeutic device (electrical stimulator and biofeedback) with software, not a standalone diagnostic algorithm. The software verification and validation were performed on the predicate device's software, which was considered "moderate" level of concern.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The concept of "ground truth" as typically used in diagnostic algorithm validation is not directly applicable to this submission. The validation relies on:
- Compliance with recognized standards: IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2, ISO 10993-1.
- Software verification and validation: Against specifications and requirements.
- Biocompatibility testing: Chemical/biological safety evaluation.
- Clinical Literature Review: Documented evidence of safety and efficacy of electrical stimulation for female urinary incontinence in published articles and a MAUDE search for adverse events. This implicitly serves as "outcomes data" at a high level, validating the therapy type rather than specific device performance metrics against a gold standard for a new study.

8. The sample size for the training set:

Not applicable/Not provided. The InTone device is not an AI/machine learning model that requires a training set in this context. Its function is based on established electrical stimulation and biofeedback principles.

9. How the ground truth for the training set was established:

Not applicable/Not provided for the same reason as in point 8.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, overlaid on three human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

InControl Medical, LLC. Jessica Andreshak Director of Quality Assurance/Regulatory Affairs 3225 Gateway Road, Ste. 250 Brookfield, Wisconsin 53045

Re: K150180 Trade/Device Name: InTone Regulation Number: 21 CFR 876.5320 Regulation Name: Nonimplanted Electrical Continence Device Regulatory Class: Class II Product Code: KPI, HIR Dated: January 26, 2015 Received: January 27, 2015

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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Herbert P. Lerner -S

for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/2/Picture/0 description: The image shows the logo for InControl Medical, along with their address. The address is 3225 Gateway Road, Ste. 250, Brookfield, WI 53045. The logo features the words "InControl" in a stylized font, with the word "MEDICAL" underneath.

Image /page/2/Picture/2 description: The image shows the logo for InTone. The logo is purple and features the word "InTone" in a sans-serif font. To the left of the word "InTone" is a circular design made up of curved lines. The logo is simple and modern.

6. Statement of Indications for Use

510(k) Number (if known):

Device Name

InTone

Indications for Use

InTone is intended to provide electrical stimulation and/or visual biofeedback (via manometry) for the treatment of female urinary 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)

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Image /page/3/Picture/0 description: The image shows the logo and address of InControl Medical. The logo features the text "InControl" in a sans-serif font, with the word "MEDICAL" in a smaller font below. The address is listed as 3225 Gateway Road, Ste. 250, Brookfield, WI 53045.

Image /page/3/Picture/2 description: The image shows the logo for InTone. The logo features the word "InTone" in a stylized font, with the "I" being larger than the other letters. To the left of the word is a circular design with curved lines. The color scheme is a muted purple.

7. 510(k) Summary

Submission Date

January 26, 2015

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 7.1 Device Information
Type of 510(k):	Traditional 510(k)
Common Name:	Pelvic Floor Muscle Stimulator
Trade Name (proprietary name):	InTone
Classification name:	Stimulator, Electrical, Non-Implantable, For IncontinenceDevice, Perineometer
Classification Regulation:	21 CFR 876.532021 CFR 884.1425
Class:	Class II
Product Code:	KPIHIR

Table 7.1 Device Information

Legally Marketed Device for Substantial Equivalence

510(k)	Name	Product Code	Manufacturer
K110179	InTone	KPI	InControl Medical, LLC3225 Gateway Road, Ste. 250Brookfield, WI 53045 USA
K134020	InToneMV	KPI/HCC	InControl Medical, LLC3225 Gateway Road, Ste. 250Brookfield, WI 53045 USA

Table 7.2 Predicate Device Information

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Image /page/4/Picture/0 description: The image shows the logo for InControl Medical, followed by the address 3225 Gateway Road, Ste. 250, and the city, state, and zip code, Brookfield, WI 53045. The logo is a light blue circle with white lines inside, followed by the word "InControl" in dark gray. Below the word "InControl" is the word "Medical" in a smaller, light gray font. The address is in a dark gray font.

Image /page/4/Picture/2 description: The image shows the logo for InTone. The logo features the word "InTone" in a serif font, with the "I" and "T" capitalized. To the left of the word is a circular design with a pattern of curved lines. The color scheme is a light purple.

Device Summary

The InTone device includes three parts: an Insertion Unit, a Control Unit, and a Software Application for clinicians. Each of these parts are summarized below:

The Insertion Unit includes an inflation pump and an inflatable probe. The inflatable probe is inserted into the vagina and the inflation pump is used by the patient to manually inflate the probe, ensuring 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 encourage 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 Software Application allows the clinician to select and lock in the appropriate electrical stimulation level necessary to stimulate pelvic floor contraction.

Intended Use

InTone is intended to provide electrical stimulation and/or visual biofeedback (via manometry) for the treatment of female urinary incontinence.

Equivalence Comparison to the Predicate

Electrical muscle stimulation and biofeedback are the technological principles for InTone and the predicate devices. It is based on the use of the electrical muscle stimulator and/or biofeedback to strengthen the pelvic floor muscles and surrounding structures. The chart below summarizes the shared and different technological elements. The intended use, technology, engineering, performance and user interface for InTone is substantially equivalent to the predicate devices.

Feature/ Function	InTone(K110179)	InToneMV(K134020)	InTone(New Device)	Comparison	Impact onSafety andPerformance
Intended UseAn explicitdescription of allclinical functionsperformed by thedevice.Indications forUseExplain when thedevice is to beclinically used andthe intendedpatient population	The InControl device is a non-implantedelectrical stimulator indicated for use in thetreatment of female urinary incontinence.It applies electrical stimulation to the pelvicfloor musculature and surroundingstructures. It is intended for acute andongoing treatment of mixed urinaryincontinence where the following resultsmay 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.	InToneMV is intended to provideelectrical stimulation and/or visualbiofeedback (via manometry) forthe treatment of male and femaleurinary and fecal incontinence.	InTone is intended to provideelectrical stimulation and/or visualbiofeedback (via manometry) forthe treatment of female urinaryincontinence.	Substantiallyequivalent	None
Feature/ Function	InTone(K110179)	InToneMV(K134020)	InTone(New Device)	Comparison	Impact onSafety andPerformance
Primary Function	Delivery of electrical stimulation	Delivery of electrical stimulationVisual Biofeedback	Delivery of electrical stimulationVisual Biofeedback	Identicalto InToneMV	None
Warnings orPrecautions	(see product labeling)	(see product labeling)	(see product labeling)	Substantiallyequivalent	None
ContraindicationsExplain when thedevice is not to beclinically used	• This device is not intended for diagnosticpurposes or critical patient monitoring.• The device is not defibrillator proof.• The device should not be used onpatients with cardiac pacemaker,implanted defibrillator, or otherimplanted metallic or electronic device.• Do not use if patient has a history of rateor conductive disturbance.• Do not use if patient has symptoms of anactive urinary tract infection.• Do not use if the patient has vaginalinfections, localized lesions, or otherundiagnosed symptoms.• Do not use if patient has undiagnosedpain.• Do not use if patient has a neurologicaldeficiency that does not permit propersensory perception or stimulation.• Do not use if patient has diminishedmental capacity or physical competencethat limits use of the device orinteraction with the care providerregarding the device settings.• Do not use if patient is currentlypregnant or attempting to get pregnant.• Do not use if patient has anatomicalvaginal structures that do not permitproper and complete placement of theInsertion Unit.• Do not use if the patient has irregularmenstrual bleeding cycles.• Do not use if the patient has a history orsymptoms of urinary retention.• Do not use if the patient has extra-urethra incontinence, (i.e. syrinx,ectopic, urethra).• Do not use if the patient has overflowincontinence caused by evacuationproblems.• Do not use if the patient has severeurine retention in the upper urethras.• Do not use if the patient has completeperipheral denervation of the pelvicfloor.• Do not use if the patient has an intestinalclamp.	• Patients with a pacemaker orimplanted defibrillator requirecardiac clearance beforeelectrical stimulation is offered.• Patients with symptoms ofactive urinary tract infection,vaginal infections, localizedlesions, or other undiagnosedsymptoms.• Patient has extra-urethraincontinence, (i.e. syrinx,ectopic, urethra).• Patient has overflowincontinence caused byevacuation problems.• Patient has severe urineretention in the upper urethraor other symptoms of urineretention.• Patients with neurologicaldeficiency that does not permitproper sensory perception ofstimulation or completedenervation of the pelvic floor.• Patients with cognitivedisabilities, i.e.; Alzheimer'sdisease or dementia.• Patients who are currentlypregnant or attempting to getpregnant.• Patients with anatomical pelvicstructures that do not permitproper and complete placementof the Insertion Unit.• Patients with active pelvicmalignancy.• Patients with an intestinalclamp.• Patients should be 6 weeks post-pelvic surgery or vaginalchildbirth.• Device should not be used fordiagnostic purposes or criticalpatient monitoring.• Device is not (external)defibrillator-proof.	• Patients with a pacemaker orimplanted defibrillator requirecardiac clearance beforeelectrical stimulation is offered.• Patients with symptoms ofactive urinary tract infection,vaginal infections, localizedlesions, or other undiagnosedsymptoms.• Patient has extra-urethraincontinence, (i.e. syrinx,ectopic, urethra).• Patient has overflowincontinence caused byevacuation problems.• Patient has severe urineretention in the upper urethraor other symptoms of urineretention.• Patients with neurologicaldeficiency that does not permitproper sensory perception ofstimulation or completedenervation of the pelvic floor.• Patients with cognitivedisabilities, i.e.; Alzheimer'sdisease or dementia.• Patients who are currentlypregnant or attempting to getpregnant.• Patients with anatomical pelvicstructures that do not permitproper and complete placementof the Insertion Unit.• Patients with active pelvicmalignancy.• Patients with an intestinalclamp.• Patients should be 6 weeks post-pelvic surgery or vaginalchildbirth.• Device should not be used fordiagnostic purposes or criticalpatient monitoring.• Device is not (external)defibrillator-proof.	Identicalto InToneMV	None
LabelingSummaryClarity 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	4/5 AA nickel metal hydridebattery	4/5 AA nickel metal hydridebattery	Identical	None
Method of linecurrent isolation	n/a (battery)	n/a (battery)	n/a (battery)	Identical	None
Feature/ Function	InTone(K110179)	InToneMV(K134020)	InTone(New Device)	Comparison	Impact onSafety andPerformance
Patient leakagecurrent	n/a (battery)	n/a (battery)	n/a (battery)	Identical	None
Number of outputmodes	।	1	1	Identical	None
Number of outputchannels	1	1	1	Identical	None
Regulated currentor voltage?	Regulated voltage	Regulated Voltage	Regulated voltage	Identical	None
Firmwarecontrolled?	Yes	Yes	Yes	Identical	None
AutomaticOverload Trip?	Yes	N/A	N/A	Identicalto InToneMV	None
Automatic No-Load Trip?	Yes	N/A	N/A	ldenticalto InToneMV	None
Automatic ShutOff?	Yes	Yes	Yes	Identical	None
Indicator DisplayOn/OffStatus●Low Battery	YesYes	Yes (via display illumination)Yes	Yes (via display illumination)Yes	Identicalto InToneMV	None
Waveform, shape	Dual phase, rectangular pulses	Dual phase, rectangular pulses	Monophasic, alternating polarity,square pulses	Substantiallyequivalent	None
FrequencyMixedStressUrge	50 Hz	50 Hz13 Hz	50 Hz13 Hz	Identicalto InToneMV	None
Pulse widthMixed●StressUrge	200 µs/phase	200 µs/phase	200 µs/phase	Identical	None
Time●OnOff	20 seconds10 seconds	1 second at 50 Hz2 seconds no stimulation2 seconds at 13 Hz2 second no stimulation(repeating)	1 second at 50 Hz2 seconds no stimulation2 seconds at 13 Hz2 second no stimulation(repeating)	Identicalto InToneMV	None
Total SessionTime	12 mins	Total: approximately 12 minutes• 2 minute volitional contractions• 5 minutes muscle stimulation• 5 minutes volitional contractions	Total: approximately 12 minutes• 2 minute volitional contractions• 5 minutes muscle stimulation• 5 minutes volitional contractions	ldenticalto InToneMV	None
Max outputvoltage (500Ω)	50 Vdc	50 Vdc	40 Vdc	Substantiallyequivalent	None
Max outputcurrent (500Ω)	100 mA	100 mA	80 mA	Substantiallyequivalent	None
Maximum phasecharge (500Ω)	20 μC	20 μC	16 µC	Substantiallyequivalent	None
Electrode surfacearea	10.5 cm² x 2	2.5 cm² ± 0.5 cm² (x 2)	6.00 cm2 ± 0.5 cm2 (x 2)	Substantiallyequivalent	None
Max currentdensity	9.5 mA/ cm-	40 mA/ cm-	13.3 mA/cm-	Substantiallyequivalent	None
Max averagepower density(500Ω)	4.8 mW/cm-	20 mW/cm-	5.33 mW/cm²	Substantiallyequivalent	None
Biofeedback	Air pressure, 0 - 2 psi	ManometricAir pressure, 0 - 2 psi	ManometricAir pressure, 0 - 2 psi	Identicalto InToneMV	None
Feature/ Function	InTone(K110179)	InToneMV(K134020)	InTone(New Device)	Comparison	Impact onSafety andPerformance
Dimensions	Control Unit: 4.88" x 2.38" x 1.07"Insertion Unit (overall): 12.2" x 2.5" x 4.0"Inflatable Probe (avg. inflated): 5.5" x 2.2" x2.5"	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	Control Unit: 4.88" x 2.38" x 1.07"Insertion Unit (overall): 12.2" x2.5" x 4.0"Inflatable Probe (avg. inflated):5.5" x 2.2" x 2.5"	Substantiallyequivalent	None
Control housingmaterial	ABS plastics	ABS plastics	ABS plastics	Identical	None
Insertion material	Silicone, plastics	Silicone, plastics	Silicone, plastics	Identical	None
Tubing Material	NA	Silicone	N/A	Identicalto InTone	None
Packaging orExpiration Dating	1 year for Insertion Unit	N/A	N/A	Identicalto InToneMV	None
Sterilization	N/A	N/A	N/A	Identical	None
OperationalMethod: ClinicalUsee.g., ambulatoryuse, home use	Clinic or Home use, under direction ofphysician	Clinic or Home use, under directionof physician	Clinic or Home use, under directionof physician	Identical	None
PatientInteraction:FunctionsControllable: Anexplanation ofhow the deviceinteracts with thepatient.	The patient can control the starting andstopping of each session. However, thedevice will stop on its own once the sessionin normally completed.	The patient can control the startingand stopping of each session.However, the device will stop onits own once the session innormally completed.	The patient can control the startingand stopping of each session.However, the device will stop onits own once the session innormally completed.	Identical	None
PatientInteraction:ProgrammingCapabilityWhether thedevice can beprogrammed andto what extent	None, programming can only be changedby clinician	None, programming can only bechanged by clinician	None, programming can only bechanged by clinician	Identical	None
Override	Yes	Yes	Yes	Identical	None
PatientInteraction:OperatorRequirementsKnowledge ortraining requiredof the operator,	Intended as part of a complete therapyprogram with physician coaching. Nospecial knowledge or training; instructionmanual provided	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 manual	Identical	None
Software Level ofConcern	Moderate	Moderate	Moderate	Identical	None

Table 7.3 Substantial Equivalence Comparison Table

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Image /page/5/Picture/0 description: The image shows the logo for InControl Medical. The logo features the word "InControl" in a serif font, with the word "MEDICAL" in a smaller, sans-serif font underneath. To the left of the word "InControl" is a light blue circle with a pattern of curved lines inside.

Image /page/5/Picture/2 description: The image shows the word "INTONE" in a stylized font. The letters are a dark purple color. To the left of the word is a light purple circle with white lines inside.

3225 Gateway Road, Ste. 250 Brookfield, WI 53045

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Image /page/6/Picture/0 description: The image shows the logo for InControl Medical. The logo features the text "InControl" in a dark teal color, with the word "MEDICAL" in a smaller font size underneath. To the left of the text is a light teal circle. Below the logo is the text "2225 Gateway Road, Ste. 250".

Image /page/6/Picture/2 description: The image shows the word "INTONE" in a stylized font. The letters are purple, and there is a purple circle with white lines to the left of the word. The word is written in all capital letters, and the letters are slightly spaced apart.

3225 Gateway Road, Ste. 250 Brookfield, WI 53045

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Image /page/7/Picture/0 description: The image shows the logo for InControl Medical. The logo features the company name in a dark gray, sans-serif font. The word "InControl" is on the top line, and the word "MEDICAL" is on the bottom line in a smaller font. To the left of the company name is a light blue circle with a series of curved lines inside.

Image /page/7/Picture/2 description: The image shows the logo for InTone. The logo features the word "InTone" in a purple sans-serif font. To the left of the word is a circular design with curved lines, also in purple. The letters are bold and slightly spaced apart.

3225 Gateway Road, Ste. 2 Brookfield, WI 53045

The new InTone has the same internal electronics, stimulation waveform/algorithm, internal firmware, and external software application as the predicate InToneMV (K134020). The new InTone has the same patient contacting materials as the predicate InTone (K110179).

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Image /page/8/Picture/0 description: The image shows the logo for InControl Medical, followed by the address 3225 Gateway Road, Ste. 250, and the city, state, and zip code Brookfield, WI 53045. The logo features the word "InControl" in a dark blue sans-serif font, with the word "MEDICAL" in a smaller, lighter blue font underneath. To the left of the word "InControl" is a light blue circle with curved lines inside.

Image /page/8/Picture/2 description: The image shows the logo for InTone. The logo is purple and features the word "InTone" in a stylized font. There is a circular design to the left of the word "InTone" that has a series of curved lines. The letters are all capitalized except for the "TM" symbol in the upper right corner.

Testing Summary

As a result of the similar features between the new InTone and the predicate InTone (K110179) and InToneMV (K134020), this claim of substantial equivalence references the software verification and validation, electrical safety, and EMC testing performed on the predicate InToneMV, and the biocompatibility testing performed on the predicate InTone. New software verification and validation, electrical safety, EMC, and biocompatibility testing did not need to be performed to demonstrate the equivalent safety and effectiveness of this new version of the InTone.

Software Verification and Validation Testing:

Software verification and validation testing were conducted on the predicate InToneMV and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw in the software could directly result in minor injury to the patient or operator. New software verification and validation testing did not need to be performed to demonstrate the equivalent safety and effectiveness of this new version of the InTone.

Electrical Safety and Electromagnetic Compatibility Testing:

Electrical safety and EMC testing was conducted on the predicate InToneMV. The device complies with the IEC 60601-1 and IEC 60601-2-10 standards for safety and the IEC 60601-1-2 standard for EMC. New electrical safety and EMC testing did not need to be performed to demonstrate the equivalent safety and effectiveness of this new version of the InTone.

Biocompatibility Testing:

The biocompatibility evaluation for the predicate InTone was conducted in accordance with International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process," as recognized by FDA. The inflatable probe on the Insertion Unit is considered tissue contacting for a duration of less than 24 hours. The biocompatibility testing included the following tests:

Cytotoxicity
. Sensitization
. Irritation

New biocompatibility testing did not need to be performed to demonstrate the equivalent safety and effectiveness of this new version of the InTone.

Clinical Literature Review:

The clinical literature review, which is included to provide additional supporting evidence of InTone safety and effectiveness, consisted of a published article search and a MAUDE search. The published article search included documented evidence of the safety and efficacy of electrical stimulation for the treatment of female urinary incontinence. An appraisal of each article was completed as part of the search. The appraisal included an assessment of suitability of each article, a device performance assessment and a device safety assessment. The MAUDE search included reviewing risk associated with currently marketed devices classified as an "electrical muscle stimulator."

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Image /page/9/Picture/0 description: The image shows the logo for InControl Medical, along with their address. The logo features the text "InControl Medical" in a dark blue font. Below the logo is the address "3225 Gateway Road, Ste. 250, Brookfield, WI 53045".

Image /page/9/Picture/2 description: The image shows the word "InTone" in a stylized font. The word is purple and has a trademark symbol next to it. To the left of the word is a purple circle with white lines inside.

Risk Management Summary

InTone has been designed according to InControl Medical's internal procedures with traceability between the design inputs, design outputs verification and validation activities.

InTone has been evaluated for risks according to InControl Medical's internal procedures based on ISO 14971. The risks associated with InTone were reduced to as low as possible and the risk/benefit analysis was acceptable.

Conclusion

Both the InTone and the predicates are indicated for the treatment of female urinary incontinence. As a result of the similarities in design and construction between the new InTone and the predicates, the bench testing performed on the predicate InTone and InToneMV continue to support the safety and effectiveness of this new device version. The literature review further supports the use of electrical stimulation in the treatment of urinary incontinence in women. The InTone is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 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).