(72 days)
No
The description focuses on manual control, fixed stimulation frequencies, and standard software verification/validation, with no mention of adaptive algorithms, learning, or AI/ML terms.
Yes
The device is designed to treat a medical condition (urinary incontinence) by applying electrical stimulation to improve muscle strength and support, which are therapeutic actions.
No
The device is described as a non-implanted muscle stimulator designed to treat urinary incontinence by applying stimulation to strengthen pelvic floor muscles. It does not mention any function for diagnosing conditions or diseases.
No
The device description explicitly states it includes an "inflatable probe" with "stainless steel electrodes" and "manual, push-button controls," indicating significant hardware components beyond just software.
Based on the provided information, the ApexM device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- ApexM's Function: The ApexM is a muscle stimulator that is inserted into the vagina to directly stimulate pelvic floor muscles. It does not analyze any biological specimens.
- Intended Use: The intended use is to treat urinary incontinence by strengthening muscles, not to diagnose or analyze a condition based on a sample.
Therefore, the ApexM falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
ApexM is a non-implanted muscle stimulator designed to treat stress, urge and/or mixed urinary incontinence in women. It applies stimulation to the pelvic floor muscles and surrounding structures to improve strength and support.
Product codes (comma separated list FDA assigned to the subject device)
KPI
Device Description
ApexM is a hand-held, home-use device designed to treat female urinary incontinence. The device includes an inflatable probe. The inflatable probe is inserted into the vagina and manually inflated by the end user 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. Muscle stimulation is used to train and strengthen the pelvic floor muscles in a controlled manner. Muscle stimulation is used to improve the ability of muscles to hold a contraction for an extended period of time and is a treatment for urinary incontinence. During a session, high and low frequency stimulation is delivered by the device. The higher frequency stimulation is delivered to specific muscles to encourage their contraction, strengthening the muscles and helping the end user recognize which muscles to activate during self-directed contractions. Lower frequency stimulation calms the detrusor muscle, decreasing symptoms of urgency. The level of electrical stimulation is easily controlled by the end user using manual, push-button controls.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic floor muscles and surrounding structures
Indicated Patient Age Range
Not Found (indicated for "women" but no specific age range given)
Intended User / Care Setting
Home use, Over-the-counter
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Software Verification and Validation Testing: Conducted and documentation 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 to be a "moderate" level of concern, since a failure or latent flaw in the software could directly result in minor injury to the end user. ApexM successfully passed the testing.
- Electrical Safety and Electromagnetic Compatibility Testing: Testing done on the predicates InTone and Apex. 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.
- Biocompatibility Testing: Evaluation completed for InToneMV (K131420). Testing conducted in accordance with International Standard ISO 10993-1. Included tests: Cytotoxicity, Sensitization, Irritation.
- Clinical Testing: A clinical literature evaluation was conducted to provide 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 literature evaluation. The appraisal included an assessment of suitability of each article, a device performance assessment and a device safety assessment.
- Human Factors / Usability Study: Conducted on the predicate device Apex (K141158). Objectives: 1) determine if a subject can self-diagnose using package labeling, 2) self-limit usage if a contraindication is present, and 3) safely use the device referencing only the instructions for use (IFU) provided. Results were favorable leveraging the original packaging and IFU; however, InControl Medical collaborated with the supervising physician to make further labeling enhancements including an educational consumer-focused box, detailed instructions for use, laminated quick reference guide and instructional video. The study found that users can properly self-identify as having stress urinary incontinence (allowing for product use) and self-identify as not having urge urinary incontinence (excluding them from use).
Key results: The non-clinical data on the predicate devices support the safety of the device, and the software verification and validation demonstrates that ApexM performs as intended in the specified use conditions. The clinical literature evaluation, as well as the technological comparison to the predicate device, supports the use of electrical stimulation as an effective treatment of urinary incontinence in women. The usability study completed for the Apex device was designed to ensure that potential users could self-identify as having stress urinary incontinence (allowing for the use of the product) while also self-identify as not having urge urinary incontinence (excluding them from use). The verbiage used in the educational materials was found to be appropriate for this kind of self-identification in a general population of women. Since users of ApexM will be able to properly self-identify as having urinary incontinence (either stress, urge, and/or mixed) as they will not have to exclude themselves from any specific diagnosis, a new human factors / usability study did not need to be performed. The labeling and packaging between ApexM and Apex (K14158) is substantially equivalent, supporting the safety of product labeling for self-diagnosis and use. The data included within this submission supports ApexM as an over-the-counter treatment for stress, urge and/or mixed urinary incontinence in women as safe and effective.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.5320 Nonimplanted electrical continence device.
(a)
Identification. A nonimplanted electrical continence device is a device that consists of a pair of electrodes on a plug or a pessary that are connected by an electrical cable to a battery-powered pulse source. The plug or pessary is inserted into the rectum or into the vagina and used to stimulate the muscles of the pelvic floor to maintain urinary or fecal continence. When necessary, the plug or pessary may be removed by the user. This device excludes an AC-powered nonimplanted electrical continence device and the powered vaginal muscle stimulator for therapeutic use (§ 884.5940).(b)
Classification. Class II (performance standards).
0
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight, composed of three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 9, 2015
InControl Medical, LLC Jessica Andreshak Director of Quality Assurance and Regulatory Affairs 3225 Gateway Road, Suite. 250 Brookfield, WI 53045
Re: K150183 Trade/Device Name: ApexM Regulation Number: 21 CFR 876.5320 Regulation Name: Nonimplanted electrical continence device Regulatory Class: Class II Product Code: KPI 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,
Benjamin R. Fisher -S
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 logo features the word "InControl" in a gray 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.
6. Statement of Indications for Use
510(k) Number (if known) K150183
Device Name
ApexM
Indications for Use
ApexM is a non-implanted muscle stimulator designed to treat stress, urge and/or mixed urinary incontinence in women. It applies stimulation to the pelvic floor muscles and surrounding structures to improve strength and support.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use ____X (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)
3
Image /page/3/Picture/0 description: The image shows the logo for InControl Medical, along with their address. The logo features the company name in a stylized font, with the word "InControl" in a larger font than "Medical". The address is listed as 3225 Gateway Road, Ste. 250, Brookfield, WI 53045.
510(k) Summary
Submission Date
January 26th, 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): | ApexM |
| 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
| 510(k) | Name | Product Code | Manufacturer |
|---|---|---|---|
| K110179 | InTone | KPI | InControl Medical, LLC |
| 3225 Gateway Road, Ste. 250 | |||
| Brookfield, WI 53045 USA | |||
| K141158 | Apex | KPI | InControl Medical, LLC |
| 3225 Gateway Road, Ste. 250 | |||
| Brookfield, 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, along with their address. The logo features the word "InControl" in a dark gray font, with the word "MEDICAL" in a smaller font below it. To the left of the word "InControl" is a light blue circle with white lines inside. The address is listed as 3225 Gateway Road, Ste. 250, Brookfield, WI 53045.
Device Summary
ApexM is a hand-held, home-use device designed to treat female urinary incontinence. The device includes an inflatable probe. The inflatable probe is inserted into the vagina and manually inflated by the end user 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. Muscle stimulation is used to train and strengthen the pelvic floor muscles in a controlled manner. Muscle stimulation is used to improve the ability of muscles to hold a contraction for an extended period of time and is a treatment for urinary incontinence. During a session, high and low frequency stimulation is delivered by the device. The higher frequency stimulation is delivered to specific muscles to encourage their contraction, strengthening the muscles and helping the end user recognize which muscles to activate during self-directed contractions. Lower frequency stimulation calms the detrusor muscle, decreasing symptoms of urgency. The level of electrical stimulation is easily controlled by the end user using manual, push-button controls.
Intended Use
ApexM is a non-implanted muscle stimulator designed to treat stress, urge and/or mixed urinary incontinence in women. It applies stimulation to the pelvic floor muscles and surrounding structures to improve strength and support.
Equivalence Comparison to the Predicate
Electrical muscle stimulation is the technological principle for ApexM and the predicate devices. It is based on the use of the electrical muscle stimulator to strengthen the pelvic floor muscles and surrounding structures. The chart below summarizes the shared and unique technological elements between ApexM and the predicate devices. The intended use, technology, engineering, performance and user interface for ApexM is substantially equivalent to the predicate devices.
| Feature/ Function | K110179 InTone
(Predicate) | K141158 Apex
(Predicate) | ApexM
(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. | Apex is a non-implanted
muscle stimulator designed to
treat female stress urinary
incontinence. It applies
stimulation to the pelvic floor
muscles to improve strength
and support. | ApexM is a non-implanted
muscle stimulator designed to
treat stress, urge and/or
mixed urinary incontinence in
women. It applies stimulation
to the pelvic floor muscles
and surrounding structures to
improve strength and
support. | Substantially
equivalent | None:
These devices apply
electrical stimulation to
strengthen the pelvic floor
muscles, as supported by
literature. |
| Feature/ Function | K110179 InTone
(Predicate) | K141158 Apex
(Predicate) | ApexM
(New Device) | Comparison | Impact on Safety and
Performance |
| | strengthening of pelvic floor
muscles, inhibition of the
detrusor muscle through
reflexive mechanisms. The
biofeedback feature can be
used for muscle re-education
purposes. | | | | |
| Primary Function | Delivery of electrical
stimulation | Delivery of electrical
stimulation | Delivery of electrical
stimulation | Identical | None |
| Warnings or
Precautions | (see product labeling) | (see product labeling) | (see product labeling) | Identical to
Apex | None:
ApexM warnings and
precautions are identical to
Apex, which were defined
according to the FDA
guidance document and
validated through the
Human Factors and
Usability Testing. |
| 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 you are
pregnant
• Do not use if you are
attempting to get pregnant
• Do not use if you have a
cardiac demand pacemaker
or implanted defibrillator
• Do not use if you have
symptoms of active urinary
tract infection, vaginal
infections, or localized
lesions
• Do not use if you have a
diagnosis of extra-urethral
or overflow incontinence
• Do not use if you have
severe urine retention
• Do not use if you have poor
sensation in the pelvic
region
• Do not use if you have
cognitive disabilities, i.e.;
Alzheimer's disease or
dementia
• Do not use if you are
unable to properly insert
the device per instructions
• Do not use if you have
active pelvic cancer
• Do not use if you have an
intestinal clamp
• You must be 6 weeks post-
pelvic surgery or vaginal
childbirth to use this device
• Do not use this device for
diagnostic purposes or
critical patient monitoring
• This device is not (external)
defibrillator-proof | • Do not use if you are
pregnant
• Do not use if you are
attempting to get pregnant
• Do not use if you have a
cardiac demand pacemaker
or implanted defibrillator
• Do not use if you have
symptoms of active urinary
tract infection, vaginal
infections, or localized
lesions
• Do not use if you have a
diagnosis of extra-urethral
or overflow incontinence
• Do not use if you have
severe urine retention
• Do not use if you have poor
sensation in the pelvic
region
• Do not use if you have
cognitive disabilities, i.e.;
Alzheimer's disease or
dementia
• Do not use if you are
unable to properly insert
the device per instructions
• Do not use if you have
active pelvic cancer
• Do not use if you have an
intestinal clamp
• You must be 6 weeks post-
pelvic surgery or vaginal
childbirth to use this device
• Do not use this device for
diagnostic purposes or
critical patient monitoring
• This device is not (external)
defibrillator-proof | Identical to
Apex | None:
ApexM contraindications
are identical to Apex, which
were validated through the
Human Factors and
Usability Testing. |
| Feature/ Function | K110179 InTone
(Predicate) | K141158 Apex
(Predicate) | ApexM
(New Device) | Comparison | Impact on Safety and Performance |
| | 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. | | | | |
| Labeling Summary
Clarity to insure safer
or more effective use | User Manual | User Manual | User Manual | Substantially
equivalent | None:
ApexM user manual was
based on the predicate,
Apex, which was validated
through the Human
Factors/Usability testing. |
| 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 AAA Alkaline battery | 4 AAA Alkaline battery | Identical to
Apex | None:
ApexM battery is identical
to Apex, which leverages 4
AAA Alkaline batteries for
ease of use and acquisition
for the end user. Battery
insertion was validated
through the Apex Human
Factors and Usability
Testing. |
| Method of line
current isolation | N/A (battery) | N/A (battery) | N/A (battery) | Identical | None |
| Patient leakage
current | N/A (battery) | N/A (battery) | N/A (battery) | Identical | None |
| Number of output
modes | 1 | 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 |
| Feature/ Function | K110179 InTone
(Predicate) | K141158 Apex
(Predicate) | ApexM
(New Device) | Comparison | Impact on Safety and
Performance |
| Automatic Overload
Trip? | Yes | No | No | Identical to
Apex | None:
ApexM overload trip is
identical to Apex. Although
there is no overload trip,
ApexM does not introduce
any safety risks because of
the circuit design. The
maximum level of
stimulation is self-limiting
and will not cause end user
injury if maximum output is
applied. |
| Automatic No-Load
Trip? | Yes | No | No | Identical to
Apex | None:
ApexM no-load trip is
identical to Apex. Although
there is no no-load trip,
ApexM does not cause any
safety risks because of the
circuit design. The
maximum level of
stimulation is self-limiting
and will not cause end user
injury if powered with no
load. |
| Automatic Shut Off? | Yes | Yes | Yes | Identical | None |
| Indicator Display
● On/Off Status
● Low Battery | Yes
Yes | Yes (via display illumination)
No | Yes (via display illumination)
No | Identical to
Apex | None:
ApexM indicator display is
identical to Apex. This does
not introduce a safety risk
because the device will
power off when the battery
power is too low. |
| Waveform, shape | Dual phase, rectangular
pulses | Monophasic, alternating
polarity, square pulse | Monophasic, alternating
polarity, square pulse | Identical to
Apex | None:
ApexM waveform shape is
identical to Apex. The
square/rectangular shape
defines the DC component
common with both
waveforms. The dual phase
and monophasic alternating
polarity waveform delivery
both provide a balanced
positive/negative
alternating waveform
delivery. |
| Frequency
● Mixed
● Stress
● Urge | 50 Hz
-
| 50 Hz -
| 13, 50 Hz -
| Substantially
equivalent | None:
ApexM has a combination
of 50Hz and 13Hz
frequency. These
frequencies treat stress,
urge and mixed urinary
incontinence as supported
by literature. |
| Pulse width | 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 | 1 second at 50 Hz
2 seconds no stimulation
2 seconds at 13 Hz
2 second no stimulation | Substantially
equivalent | None:
ApexM time on and off is
identical to Apex for the
50Hz frequency. The
additional time on and off is
to account for a second
frequency of 13Hz. |
| Feature/ Function | K110179 InTone
(Predicate) | K141158 Apex
(Predicate) | ApexM
(New Device) | Comparison | Impact on Safety and
Performance |
| Total Session Time | 12 minutes | Total session time of 10-15
minutes
• 5-10 minutes electrical
stimulation
• 5 minutes self-directed
contraction
(recommended) | Total session time of 10-15
minutes
• 5-10 minutes electrical
stimulation
• 5 minutes self-directed
contraction
(recommended) | Identical to
Apex | None:
ApexM session time is
identical to Apex. Small
variances in session time
are allowed due to end user
preferences. |
| Max output voltage
(500Ω) | 50 Vdc | 40 Vdc | 40 Vdc | Identical to
Apex | None:
This value is identical to
Apex and IEC60601-2-10
requirements are met. |
| Max output current
(500Ω) | 100 mA | 80 mA | 80 mA | Identical to
Apex | None:
This value is identical to
Apex and IEC60601-2-10
requirements are met. |
| Maximum phase
charge (500Ω) | 20 μC | 16 µC | 16 µC | Identical to
Apex | None:
This value is based on the
output current which meets
IEC60601-2-10
requirements. The pulse
width is identical to the
predicates. |
| Electrode surface
area | 10.5 cm² x 2 | 6.00 cm² ± 0.5 cm² (x 2) | 6.00 cm² ± 0.5 cm² (x 2) | Identical to
Apex | None:
ApexM electrode size is the
same as Apex. |
| Max current density | 9.5 mA/cm² | 13.3 mA/cm² | 13.3 mA/cm² | Identical to
Apex | None:
This value is based on the
output current which meets
IEC60601-2-10
requirements. The
electrode surface area is
identical to Apex. |
| Max average power
density (500Ω) | 4.8 mW/cm² | 5.33 mW/cm² | 5.33 mW/cm² | Identical to
Apex | None:
This value is based on the
output current which meets
IEC60601-2-10
requirements. The
electrode surface area,
pulse width and max
frequency are identical to
Apex. |
| Biofeedback | Air pressure, 0 - 2 psi | None | None | Identical to
Apex | None:
Biofeedback is a removed
feature on both Apex and
ApexM. Biofeedback is
strictly an enhanced feature
for neuromuscular re-
education and the omission
of this feature does not
adversely impact the safety
of the device. |
| Dimensions
(Insertion Unit) | Insertion Unit (overall): 12.2"
x 2.5" x 4.0"
Inflatable Probe (avg.
inflated): 5.5" x 2.2" x 2.5" | Insertion Unit (overall): 12.2"
x 2.5" x 4.0"
Inflatable Probe (avg.
inflated): 5.5" x 2.2" x 2.5" | Insertion Unit (overall): 12.2"
x 2.5" x 4.0"
Inflatable Probe (avg.
inflated): 5.5" x 2.2" x 2.5" | Identical | None |
| Feature/ Function | K110179 InTone
(Predicate) | K141158 Apex
(Predicate) | ApexM
(New Device) | Comparison | Impact on Safety and
Performance |
| Control housing
material | ABS plastics | N/A | N/A | Identical to
Apex | None:
ApexM does not include a
control unit, identical to
Apex. The control unit is
intended to store and
review data collected and to
set stimulation levels by the
clinician. Since ApexM is
OTC, there is no need for a
control unit. |
| Insertion material | Silicone, plastics | Silicone, plastics | Silicone, plastics | Identical | None |
| Packaging or
Expiration Dating | 1 year for Insertion Unit | N/A | N/A | Identical to
Apex | None:
The expiration date for
ApexM is identical to Apex.
There is no need for an
expiration date since the
components are stable. |
| 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 | Home use, Over-the-counter | Home use, Over-the-counter | Identical to
Apex | None:
ApexM operation method
for clinical use is identical to
Apex. An over-the-counter
indication does not impact
safety because the
stimulation is controlled by
the end user per end user
response. Additional safety
features are built into the
design of the device for the
maximum frequency and
automatic shut-off. |
| 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 end user can control the
electrical stimulation levels
and the duration of the
stimulation session. | The end user can control the
electrical stimulation levels
and the duration of the
stimulation session. | Identical to
Apex | None:
ApexM patient controlled
functions are identical to
Apex. Stimulation is
controlled by the end user
per individual response.
Additional safety features
are built into the design of
the device for the maximum
frequency and automatic
shut-off. |
| Patient Interaction:
Programming
Capability
Whether the device
can be programmed
and to what extent | None, programming can only
be changed by clinician | Electrical stimulation levels
are set by the end user | Electrical stimulation levels
are set by the end user | Identical to
Apex | None:
ApexM patient
programming capability is
identical to Apex.
Stimulation is controlled by
the end user per individual
response. Additional safety
features are built into the design of the device for the maximum frequency and automatic shut-off. |
| Feature/ Function | K110179 InTone
(Predicate) | K141158 Apex
(Predicate) | ApexM
(New Device) | Comparison | Impact on Safety and
Performance |
| Override | Yes | No | No | Identical to
Apex | None:
ApexM override is identical
to Apex. The predicate,
InTone, includes two units
(Control Unit and Insertion
Unit) and has an override
feature so that the patient
can pause the session on
the Control Unit without
powering the unit off. Apex
and ApexM are single unit
devices (Insertion Unit only)
and therefore do not have
an override option for
suspending the stimulation
function. Apex and ApexM
are designed to be powered
off by the end user to stop
stimulation and improve
ease of use. Powering off
the devices reset the
stimulation level to 0. |
| 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 | Over-the-counter device. No
special knowledge or training
required; instruction manual
provided | Over-the-counter device. No
special knowledge or training
required; instruction manual
provided | Identical to
Apex | None:
ApexM operator
requirements are identical
to Apex. The ApexM device
has been designed to be
more intuitive for use by
the end user without
physician oversight. In both
cases, no special knowledge
or training is required. End
user interaction was
validated by the Apex
Human Factors and
Usability Validation. |
| Software Level of
Concern | Moderate | Moderate | Moderate | Identical | None |
Table 7.3: Substantial Equivalence Comparison Table
5
Image /page/5/Picture/0 description: The image contains the logo for InControl Medical. The logo features the word "InControl" in a large, serif font, with the word "MEDICAL" in a smaller font underneath. To the left of the word "InControl" is a light blue circle. Below the logo is the text "3225 Gateway Road, Ste. 250".
K110179 InTone
Traditional 510(k) Submission
ApexM
apexM
Impact on Safety and
3225 Gateway Road, Ste. 250 Brookfield, WI 53045
K141158 Apex
6
Image /page/6/Picture/0 description: The image shows the logo for InControl Medical. The logo features the text "InControl" in a bold, sans-serif font, with the word "MEDICAL" in a smaller font size underneath. To the left of the text is a circular graphic with a series of curved lines. Below the logo is the text "2225 Gateway Road, Ste. 250".
Image /page/6/Picture/2 description: The image shows the logo for apexM. The text "apex" is in a blue sans-serif font, and the "M" is in a similar font but slightly larger. Above the "ex" in apex is a pink flower with five petals.
3225 Gateway Road, Ste. 250 Brookfield, WI 53045
7
Image /page/7/Picture/0 description: The image shows the logo for InControl Medical, with the words "InControl" in large, bold letters and the word "Medical" in smaller letters below. The logo also includes a light blue circle with curved lines inside. Below the logo is the address "3225 Gateway Road, Ste. 250".
Brookfield, WI 53045
8
Image /page/8/Picture/0 description: The image shows the logo for InControl Medical. The logo features the company name in a bold, sans-serif font, with the word "InControl" stacked above the word "MEDICAL". To the left of the company name is a circular graphic with a series of curved lines. Below the logo is the address "3225 Gateway Road, Ste. 250".
3225 Gateway Road, Ste. 250 Brookfield, WI 53045
9
Image /page/9/Picture/0 description: The image shows the logo for InControl Medical. The logo features the text "InControl" in a bold, sans-serif font, with the word "MEDICAL" in a smaller font below it. To the left of the text is a circular graphic with a series of curved lines. Below the logo is the address "3225 Gateway Road, Ste. 250".
Brookfield, WI 53045
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Image /page/10/Picture/0 description: The image shows the logo for InControl Medical, along with their address. The logo features the word "InControl" in a dark teal color, with the word "MEDICAL" in a smaller font size underneath. The address is listed as 3225 Gateway Road, Ste. 250, Brookfield, WI 53045.
ApexM has the same internal electronics and hardware as the predicate Apex (K141158). ApexM has the same patient contacting materials as InToneMV (K134020).
The predicate device, Apex (K141158), was evaluated for safety when supplied over-the-counter through a human factors / usability study. The device labeling and packaging (which includes an educational consumer-focused box, detailed instructions for use, laminated quick reference guide and instructional video) allow the end user to accurately self-diagnose as having stress urinary incontinence (allowing for the use of the product) while also self-identify as not having urge urinary incontinence (excluding them from use). The verbiage used in the educational materials was found to be appropriate for this kind of self-identification in a general population of women. ApexM labeling and packaging is substantially equivalent to Apex (K14158). Users of ApexM will be able to properly self-identify as having urinary incontinence (either stress, urge, and/or mixed) as they will not have to exclude themselves from any specific diagnosis. Therefore, ApexM is also safe for over-the-counter use.
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Image /page/11/Picture/0 description: The image shows the logo for InControl Medical, along with their address. The logo features the word "InControl" in a stylized font, with the word "MEDICAL" underneath. The address is listed as 3225 Gateway Road, Ste. 250, Brookfield, WI 53045.
Testing Summary
The following performance testing was provided in support of the substantial equivalence. The testing for ApexM included software verification and validation, and ApexM successfully passed the testing. As a result of the similar features between ApexM and the predicates, this claim of substantial equivalence references the electrical safety, and EMC testing performed on the predicates InTone and Apex, and the biocompatibility testing performed on InToneMV (K131420). New electrical safety, EMC, and biocompatibility testing did not need to be performed to demonstrate the equivalent safety and effectiveness of ApexM.
Software Verification and Validation Testing:
Software verification and validation testing were conducted 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 to be a "moderate" level of concern, since a failure or latent flaw in the software could directly result in minor injury to the end user.
Electrical Safety and Electromagnetic Compatibility Testing:
Electrical safety and EMC testing was conducted on the predicates InTone and Apex. 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 ApexM.
Biocompatibility Testing:
The biocompatibility evaluation was completed for InToneMV (K131420). Testing 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 ApexM.
Clinical Testing:
A clinical literature evaluation was conducted to provide 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 literature evaluation. The appraisal included an assessment of suitability of each article, a device performance assessment and a device safety assessment.
A human factors / usability study was conducted on the predicate device Apex (K141158) to assess the safety for over-the-counter use. The human factors / usability study objectives were to: 1) determine if a subject can self-diagnose using package labeling, 2) self-limit usage if a
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Image /page/12/Picture/1 description: The image shows the logo for InControl Medical, followed by their address. The logo is a light blue circle with the word "InControl" in dark gray letters. Below that, the word "MEDICAL" is in smaller, dark gray letters. The address is 3225 Gateway Road, Ste. 250, Brookfield, WI 53045.
contraindication is present, and 3) safely use the device referencing only the instructions for use (IFU) provided. The results were favorable leveraging the original packaging and IFU; however, InControl Medical collaborated with the supervising physician to make further labeling enhancements including an educational consumer-focused box, detailed instructions for use, laminated quick reference guide and instructional video. The human factors / usability study can be applied to ApexM since women using ApexM will be able to properly self-identify as having urinary incontinence (either stress, urge, and/or mixed) as they will not have to exclude themselves from any specific diagnosis. The labeling and packaging for ApexM is substantially equivalent to Apex (K141158).
Risk Management Summary
ApexM has been designed according to InControl Medical's internal procedures with traceability between the design inputs, design outputs, verification and validation activities.
ApexM has been evaluated for risks according to InControl Medical's internal procedures based on ISO14971. The risks associated with ApexM were reduced to as low as possible and the risk/benefit analysis was acceptable.
Conclusion
The non-clinical data on the predicate devices support the safety of the device, and the software verification and validation demonstrates that ApexM performs as intended in the specified use conditions. The clinical literature evaluation, as well as the technological comparison to the predicate device, supports the use of electrical stimulation as an effective treatment of urinary incontinence in women. Like the predicate device Apex (K141158), ApexM is intended for overthe-counter use. The usability study completed for the Apex device was designed to ensure that potential users could self-identify as having stress urinary incontinence (allowing for the use of the product) while also self-identify as not having urge urinary incontinence (excluding them from use). The verbiage used in the educational materials was found to be appropriate for this kind of self-identification in a general population of women. Since users of ApexM will be able to properly self-identify as having urinary incontinence (either stress, urge, and/or mixed) as they will not have to exclude themselves from any specific diagnosis, a new human factors / usability study did not need to be performed. The labeling and packaging between ApexM and Apex (K14158) is substantially equivalent, supporting the safety of product labeling for selfdiagnosis and use. The data included within this submission supports ApexM as an over-thecounter treatment for stress, urge and/or mixed urinary incontinence in women as safe and effective.