(48 days)
Not Found
No
The description focuses on electrical stimulation, biofeedback via pressure sensing, and software for clinician programming and data display. There is no mention of algorithms that learn or adapt based on data.
Yes
The device is intended to treat female urinary incontinence, which is a medical condition, making it a therapeutic device.
No
The device is intended to provide electrical stimulation for treatment and visual biofeedback for muscle re-training, not primarily for diagnosis. While it monitors changes in pressure, this is for biofeedback during treatment rather than for identifying a medical condition.
No
The device description clearly outlines hardware components (Insertion Unit with probe, pump, electrodes, pressure sensor; Control Unit with user keys and display) in addition to the software application.
Based on the provided information, the InTone device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
- InTone's Function: The InTone device works by providing electrical stimulation and biofeedback directly to the pelvic floor muscles within the body. It is a therapeutic device used for treatment, not a diagnostic device used for testing samples.
- Intended Use: The intended use clearly states "treatment of female urinary incontinence," which is a therapeutic purpose.
- Device Description: The description details components for delivering stimulation and monitoring muscle activity in vivo, not for analyzing samples in vitro.
Therefore, the InTone device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
InTone is intended to provide electrical stimulation and/or visual biofeedback (via manometry) for the treatment of female urinary incontinence.
Product codes
KPI, HIR
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic floor musculature, vagina
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
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."
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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
1
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 Incontinence |
| Device, Perineometer | |
| Classification Regulation: | 21 CFR 876.5320 |
| 21 CFR 884.1425 | |
| Class: | Class II |
| Product Code: | KPI |
| HIR |
Table 7.1 Device Information
Legally Marketed Device for Substantial Equivalence
| 510(k) | Name | Product Code | Manufacturer |
|---|---|---|---|
| K110179 | InTone | KPI | InControl Medical, LLC |
| 3225 Gateway Road, Ste. 250 | |||
| Brookfield, WI 53045 USA | |||
| K134020 | InToneMV | KPI/HCC | InControl Medical, LLC |
| 3225 Gateway Road, Ste. 250 | |||
| Brookfield, WI 53045 USA |
Table 7.2 Predicate Device Information
4
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 on
Safety and
Performance |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|----------------------------------------|
| Intended Use
An explicit
description of all
clinical functions
performed by the
device.
Indications for
Use
Explain when the
device is to be
clinically used and
the intended
patient population | The InControl device is a non-implanted
electrical stimulator indicated for use in the
treatment of female urinary incontinence.
It applies electrical stimulation to the pelvic
floor musculature and surrounding
structures. It is intended for acute and
ongoing treatment of mixed urinary
incontinence where the following results
may improve urinary control:
strengthening of pelvic floor muscles,
inhibition of the detrusor muscle through
reflexive mechanisms. The biofeedback
feature can be used for muscle re-
education purposes. | InToneMV is intended to provide
electrical stimulation and/or visual
biofeedback (via manometry) for
the treatment of male and female
urinary and fecal incontinence. | InTone is intended to provide
electrical stimulation and/or visual
biofeedback (via manometry) for
the treatment of female urinary
incontinence. | Substantially
equivalent | None |
| Feature/ Function | InTone
(K110179) | InToneMV
(K134020) | InTone
(New Device) | Comparison | Impact on
Safety and
Performance |
| Primary Function | Delivery of electrical stimulation | Delivery of electrical stimulation
Visual Biofeedback | Delivery of electrical stimulation
Visual Biofeedback | Identical
to InToneMV | None |
| Warnings or
Precautions | (see product labeling) | (see product labeling) | (see product labeling) | Substantially
equivalent | None |
| Contraindications
Explain when the
device is not to be
clinically used | • This device is not intended for diagnostic
purposes or critical patient monitoring.
• The device is not defibrillator proof.
• The device should not be used on
patients with cardiac pacemaker,
implanted defibrillator, or other
implanted metallic or electronic device.
• Do not use if patient has a history of rate
or conductive disturbance.
• Do not use if patient has symptoms of an
active urinary tract infection.
• Do not use if the patient has vaginal
infections, localized lesions, or other
undiagnosed symptoms.
• Do not use if patient has undiagnosed
pain.
• Do not use if patient has a neurological
deficiency that does not permit proper
sensory perception or stimulation.
• Do not use if patient has diminished
mental capacity or physical competence
that limits use of the device or
interaction with the care provider
regarding the device settings.
• Do not use if patient is currently
pregnant or attempting to get pregnant.
• Do not use if patient has anatomical
vaginal structures that do not permit
proper and complete placement of the
Insertion Unit.
• Do not use if the patient has irregular
menstrual bleeding cycles.
• Do not use if the patient has a history or
symptoms 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 overflow
incontinence caused by evacuation
problems.
• Do not use if the patient has severe
urine retention in the upper urethras.
• Do not use if the patient has complete
peripheral denervation of the pelvic
floor.
• Do not use if the patient has an intestinal
clamp. | • Patients with a pacemaker or
implanted defibrillator require
cardiac clearance before
electrical stimulation is offered.
• Patients with symptoms of
active urinary tract infection,
vaginal infections, localized
lesions, or other undiagnosed
symptoms.
• Patient has extra-urethra
incontinence, (i.e. syrinx,
ectopic, urethra).
• Patient has overflow
incontinence caused by
evacuation problems.
• Patient has severe urine
retention in the upper urethra
or other symptoms of urine
retention.
• Patients with neurological
deficiency that does not permit
proper sensory perception of
stimulation or complete
denervation of the pelvic floor.
• Patients with cognitive
disabilities, i.e.; Alzheimer's
disease or dementia.
• Patients who are currently
pregnant or attempting to get
pregnant.
• Patients with anatomical pelvic
structures that do not permit
proper and complete placement
of the Insertion Unit.
• Patients with active pelvic
malignancy.
• Patients with an intestinal
clamp.
• Patients should be 6 weeks post-
pelvic surgery or vaginal
childbirth.
• Device should not be used for
diagnostic purposes or critical
patient monitoring.
• Device is not (external)
defibrillator-proof. | • Patients with a pacemaker or
implanted defibrillator require
cardiac clearance before
electrical stimulation is offered.
• Patients with symptoms of
active urinary tract infection,
vaginal infections, localized
lesions, or other undiagnosed
symptoms.
• Patient has extra-urethra
incontinence, (i.e. syrinx,
ectopic, urethra).
• Patient has overflow
incontinence caused by
evacuation problems.
• Patient has severe urine
retention in the upper urethra
or other symptoms of urine
retention.
• Patients with neurological
deficiency that does not permit
proper sensory perception of
stimulation or complete
denervation of the pelvic floor.
• Patients with cognitive
disabilities, i.e.; Alzheimer's
disease or dementia.
• Patients who are currently
pregnant or attempting to get
pregnant.
• Patients with anatomical pelvic
structures that do not permit
proper and complete placement
of the Insertion Unit.
• Patients with active pelvic
malignancy.
• Patients with an intestinal
clamp.
• Patients should be 6 weeks post-
pelvic surgery or vaginal
childbirth.
• Device should not be used for
diagnostic purposes or critical
patient monitoring.
• Device is not (external)
defibrillator-proof. | Identical
to InToneMV | None |
| Labeling
Summary
Clarity to insure
safer or more
effective use | User Manual | User Manual | User Manual | Substantially
equivalent | None |
| Environmental
Specifications | For indoor use only | For indoor use only | For indoor use only | Identical | None |
| Power Source | 4/5 AA nickel metal hydride battery | 4/5 AA nickel metal hydride
battery | 4/5 AA nickel metal hydride
battery | Identical | None |
| Method of line
current isolation | n/a (battery) | n/a (battery) | n/a (battery) | Identical | None |
| Feature/ Function | InTone
(K110179) | InToneMV
(K134020) | InTone
(New Device) | Comparison | Impact on
Safety and
Performance |
| Patient leakage
current | n/a (battery) | n/a (battery) | n/a (battery) | Identical | None |
| Number of output
modes | । | 1 | 1 | Identical | None |
| Number of output
channels | 1 | 1 | 1 | Identical | None |
| Regulated current
or voltage? | Regulated voltage | Regulated Voltage | Regulated voltage | Identical | None |
| Firmware
controlled? | Yes | Yes | Yes | Identical | None |
| Automatic
Overload Trip? | Yes | N/A | N/A | Identical
to InToneMV | None |
| Automatic No-
Load Trip? | Yes | N/A | N/A | ldentical
to InToneMV | None |
| Automatic Shut
Off? | Yes | Yes | Yes | Identical | None |
| Indicator Display
On/Off
Status
●
Low Battery | Yes
Yes | Yes (via display illumination)
Yes | Yes (via display illumination)
Yes | Identical
to InToneMV | None |
| Waveform, shape | Dual phase, rectangular pulses | Dual phase, rectangular pulses | Monophasic, alternating polarity,
square pulses | Substantially
equivalent | None |
| Frequency
Mixed
Stress
Urge | 50 Hz | 50 Hz
13 Hz | 50 Hz
13 Hz | Identical
to InToneMV | None |
| Pulse width
Mixed
●
Stress
Urge | 200 µs/phase | 200 µs/phase | 200 µs/phase | Identical | None |
| Time
●
On
Off | 20 seconds
10 seconds | 1 second at 50 Hz
2 seconds no stimulation
2 seconds at 13 Hz
2 second no stimulation
(repeating) | 1 second at 50 Hz
2 seconds no stimulation
2 seconds at 13 Hz
2 second no stimulation
(repeating) | Identical
to InToneMV | None |
| Total Session
Time | 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 | ldentical
to InToneMV | None |
| Max output
voltage (500Ω) | 50 Vdc | 50 Vdc | 40 Vdc | Substantially
equivalent | None |
| Max output
current (500Ω) | 100 mA | 100 mA | 80 mA | Substantially
equivalent | None |
| Maximum phase
charge (500Ω) | 20 μC | 20 μC | 16 µC | Substantially
equivalent | None |
| Electrode surface
area | 10.5 cm² x 2 | 2.5 cm² ± 0.5 cm² (x 2) | 6.00 cm2 ± 0.5 cm2 (x 2) | Substantially
equivalent | None |
| Max current
density | 9.5 mA/ cm- | 40 mA/ cm- | 13.3 mA/cm- | Substantially
equivalent | None |
| Max average
power density
(500Ω) | 4.8 mW/cm- | 20 mW/cm- | 5.33 mW/cm² | Substantially
equivalent | None |
| Biofeedback | Air pressure, 0 - 2 psi | Manometric
Air pressure, 0 - 2 psi | Manometric
Air pressure, 0 - 2 psi | Identical
to InToneMV | None |
| Feature/ Function | InTone
(K110179) | InToneMV
(K134020) | InTone
(New Device) | Comparison | Impact on
Safety and
Performance |
| 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" x
2.5" | 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" x
2.5" x 4.0"
Inflatable Probe (avg. inflated):
5.5" x 2.2" x 2.5" | Substantially
equivalent | None |
| Control housing
material | ABS plastics | ABS plastics | ABS plastics | Identical | None |
| Insertion material | Silicone, plastics | Silicone, plastics | Silicone, plastics | Identical | None |
| Tubing Material | NA | Silicone | N/A | Identical
to InTone | None |
| Packaging or
Expiration Dating | 1 year for Insertion Unit | N/A | N/A | Identical
to InToneMV | None |
| Sterilization | N/A | N/A | N/A | Identical | None |
| Operational
Method: Clinical
Use
e.g., ambulatory
use, home use | Clinic or Home use, under direction of
physician | Clinic or Home use, under direction
of physician | Clinic or Home use, under direction
of physician | Identical | None |
| Patient
Interaction:
Functions
Controllable: An
explanation of
how the device
interacts with the
patient. | The patient can control the starting and
stopping of each session. However, the
device will stop on its own once the session
in normally completed. | 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. | 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. | Identical | None |
| Patient
Interaction:
Programming
Capability
Whether the
device can be
programmed and
to what extent | None, programming can only be changed
by clinician | None, programming can only be
changed by clinician | None, programming can only be
changed by clinician | Identical | None |
| Override | Yes | Yes | Yes | Identical | None |
| Patient
Interaction:
Operator
Requirements
Knowledge or
training required
of the operator, | Intended as part of a complete therapy
program with physician coaching. No
special knowledge or training; instruction
manual provided | Intended as part of a complete
therapy program with physician
coaching. No special knowledge or
training; instruction manual
provided | Intended as part of a complete
therapy program with physician
coaching. No special knowledge or
training; instruction manual
| Identical | None |
| Software Level of
Concern | 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
6
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
7
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).
8
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.