(205 days)
Not Found
No
The description focuses on manual control and standard electrical stimulation, with no mention of adaptive algorithms, learning, or data processing that would indicate AI/ML.
Yes
The device is designed to treat a medical condition (female stress urinary incontinence) by applying electrical stimulation to improve muscle strength and support, which falls under the definition of a therapeutic device.
No
The device description states that Apex is a "muscle stimulator designed to treat female stress urinary incontinence" and it "applies stimulation to the pelvic floor muscles to improve strength and support." This indicates a therapeutic or treatment function rather than a diagnostic one.
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, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Apex Function: Apex is a muscle stimulator that applies electrical stimulation directly to the pelvic floor muscles within the body. It is a therapeutic device designed to treat a condition (stress urinary incontinence) by strengthening muscles, not by analyzing biological samples.
The description clearly states its purpose is to "apply stimulation to the pelvic floor muscles" and "induce a contraction of the pelvic floor muscles." This is a direct physical intervention, not an in vitro test.
N/A
Intended Use / Indications for Use
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.
Product codes
KPI
Device Description
Apex is a hand-held, home-use device designed to treat female stress 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, stimulation is delivered to specific muscles to encourage their contraction. This contraction strengthens the muscles and also helps the end user recognize which muscles to activate during self-directed contractions. 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
Indicated Patient Age Range
Not Found
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
A clinical literature evaluation was conducted to provide evidence of the safety and efficacy of electrical stimulation for the treatment of female stress 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 to assess the safety of the Apex device for over-the-counter use. The human factors / usability study objectives were to: 1) determine if a subject can self-identify as having stress urinary incontinence using package labeling 2) self-limit usage if a contraindication is present 3) safely use the Apex device using 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.
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).
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a symbol. The symbol is a stylized representation of three human profiles facing right, stacked on top of each other. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 26, 2014
InControl Medical, LLC Jessica Andreshak Director of Quality Assurance and Regulatory Affairs 3225 Gateway Road, Suite 250 Brookfield. WI 53045
Re: K141158 Trade/Device Name: Apex Regulation Number: 21 CFR 876.5320 Regulation Name: Nonimplanted Electrical Continence Device Regulatory Class: Class II Product Code: KPI Dated: October 13, 2014 Received: October 23, 2014
Dear Jessica Andreshak,
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. 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 Fisher 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 bold, 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)
Device Name
Арех
Indications for Use
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.
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)
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ap
7. 510(k) Summary
Submission Date
May 2nd, 2014
Submitter Information
Jessica Andreshak Director of Quality Assurance and Regulatory Affairs InControl Medical, LLC 3225 Gateway Road, Ste. 250, Brookfield, WI 53045 USA Phone: (262) 373.0422 Fax: (262) 373.0463 Email: jandreshak@incontrolmedical.com
Device Information
Table 4. Device Information
| Type of 510(k): | Traditional 510(k) |
|---|---|
| Common Name: | Pelvic Floor Muscle Stimulator |
| Trade Name (proprietary name): | Apex |
| 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 |
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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, Brookfield, WI 53045. The logo is in gray and features the text "InControl" above the word "Medical". To the left of the text is a circular design with curved lines.
Image /page/4/Picture/1 description: The image shows the text "Traditional 510(k) Submission" in a bold, sans-serif font. The text is centered on the image and appears to be the title or heading of a document. The words are arranged on a single line, with "Traditional" being the first word and "Submission" being the last.
Device Summary
Apex is a hand-held, home-use device designed to treat female stress 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, stimulation is delivered to specific muscles to encourage their contraction. This contraction strengthens the muscles and also helps the end user recognize which muscles to activate during self-directed contractions. The level of electrical stimulation is easily controlled by the end user using manual, push-button controls.
Intended Use
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.
Apex for over-the-counter use was evaluated for safety 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 and use the product to treat stress urinary incontinence.
Equivalence Comparison to the Predicate
Electrical muscle stimulation is the technological principle for both Apex and the predicate device, InTone (K110179). It is based on the use of the electrical muscle stimulator to strengthen the pelvic floor muscles. The chart below summarizes the shared and unique technological elements between the InTone and Apex devices. The intended use, technology, engineering, performance and user interface for Apex is substantially equivalent to the predicate devices.
| Feature/ Function | K110179 InTone
(Predicate) | Apex
(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. | 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. | Substantially
equivalent | None:
Both devices apply electrical
stimulation to strengthen the
pelvic floor muscles, as
supported by literature, see
Appendix 13. |
| Primary Function | Delivery of electrical stimulation | Delivery of electrical stimulation | Identical | None |
| Feature/ Function | K110179 InTone
(Predicate) | Apex
(New Device) | Comparison | Impact on Safety and
Performance |
| Warnings or Precautions | (see product labeling) | (see product labeling) | Substantially
equivalent | None:
The warnings and precautions
were based on the predicate,
InTone, but were reworded for
Apex to improve end user
understanding for over-the-
counter use. The warning and
precautions were re-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 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. | • 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 | Substantially
equivalent | None:
The contraindications are based
on the predicate, InTone, but
were reworded and reordered
for Apex to improve end user
understanding for over-the-
counter use. The ability to
understand the
contraindications was validated
through collaboration with the
supervising physician from the
Human Factors and Usability
Testing. |
| Feature/ Function | K110179 InTone
(Predicate) | Apex
(New Device) | Comparison | Impact on Safety and
Performance |
| Labeling Summary
Clarity to insure safer or more
effective use | User Manual | User Manual | Substantially
equivalent | None:
The user manual is based on the
predicate, InTone, but was
reworded for Apex to improve
end user understanding for
over-the-counter use. The
manual was validated through
collaboration with the
supervising physician from the
Human Factors and Usability
Testing. |
| Environmental Specifications | For indoor use only | For indoor use only | Identical | None |
| Power Source | 4/5 AA nickel metal hydride battery | 4 AAA Alkaline battery | Substantially
equivalent | None:
Both devices are battery
powered. Both devices operate
at 3.3V (processor) and 5V
(waveform generator);
however, the Apex device
leverages 4 AAA Alkaline
batteries for ease of use and
acquisition for the end user.
Battery insertion was validated
through the Human Factors and
Usability Testing. |
| Method of line current
isolation | N/A (battery) | N/A (battery) | Identical | None |
| Patient leakage current | N/A (battery) | N/A (battery) | Identical | None |
| Number of output modes | 1 | 1 | Identical | None |
| Number of output channels | 1 | 1 | Identical | None |
| Regulated current or voltage? | Regulated voltage | Regulated voltage | Identical | None |
| Firmware controlled? | Yes | Yes | Identical | None |
| Automatic Overload Trip? | Yes | No | Substantially
equivalent | None:
Although there is no overload
trip, Apex 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 | Substantially
equivalent | None:
Although there is no no-load
trip, Apex 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 | Identical | None |
| Indicator Display
• On/Off Status
• Low Battery | Yes
Yes | Yes (via display illumination)
No | Substantially
equivalent | None:
Apex does not have a low
battery indicator. This does not
introduce a safety risk because
the device will power off when
the battery power is too low. |
| Waveform, shape | Monophasic, alternating polarity, square
pulse | Monophasic, alternating polarity,
square pulse | Identical | None |
| Feature/ Function | K110179 InTone
(Predicate) | Apex
(New Device) | Comparison | Impact on Safety and
Performance |
| | | | | incontinence as supported by
literature, see Appendix 13. |
| Pulse width | 200 $\mu$ s/phase | 200 $\mu$ s/phase | Identical | None |
| Time
On Off | 1 second at 50 Hz
2 seconds no stimulation
2 seconds at 13 Hz
2.1 second no stimulation | 1 second at 50 Hz
2 seconds no stimulation | Substantially
equivalent | None:
The time on and time off are
identical for the 50Hz treatment
algorithm. |
| Total Session Time | 12 minutes | Total session time of 10-15
minutes
5-10 minutes electrical
stimulation 5 minutes self-directed
contraction (recommended) | Substantially
equivalent | None:
With Apex, small variances in
session time are allowed due to
end user preferences. |
| Max output voltage (500Ω) | 34.7 V | 34.2 V | Substantially
equivalent | None:
Apex has a slightly lower output
voltage than the predicate. A
1% deviation from the predicate
is within the variation of circuit
component tolerance. |
| Max output current (500Ω) | 69.1 mA | 68.2 mA | Substantially
equivalent | None:
Apex has a slightly lower max
output current than the
predicate. A 1% deviation from
the predicate is within the
variation of circuit component
tolerance. |
| Maximum phase charge (500Ω) | 13.8 $\mu$ C | 13.6 $\mu$ C | Substantially
equivalent | None:
Apex has a slightly lower max
phase charge than the
predicate. A 1% deviation from
the predicate is within the
variation of circuit component
tolerance. |
| Electrode surface area | 5.88 cm² | 5.88 cm² | Identical | None |
| Max current density | 11.8 mA/cm² | 11.6 mA/cm² | Substantially
equivalent | None:
Apex has a slightly lower max
current density than the
predicate. Less than 2%
deviation from the predicate is
within the variation of circuit
component tolerance. |
| Max average power density
(500Ω) | 4.05 mW/cm² | 3.95 mW/cm² | Substantially
equivalent | None:
Apex has a slightly lower max
average power density than the
predicate. Less than 2%
deviation from the predicate is
within the variation of circuit
component tolerance. |
| Biofeedback | Air pressure, 0 - 2 psi | None | Feature
removed | None:
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) | Overall Insertion Unit: 12.2"x 2.5"x 4.0" | Overall Insertion Unit: 12.2"x 2.5"x
4.0" | Identical | None |
| Control housing material | ABS plastics | N/A | Feature
Removed | None:
Apex does not include a control
unit. The control unit is |
| Feature/ Function | K110179 InTone
(Predicate) | Apex
(New Device) | Comparison | Impact on Safety and
Performance |
| Insertion material | Silicone, plastics | Silicone, plastics | Identical | None |
| Packaging or Expiration Dating | 1 year for insertion unit | NA | Substantially
equivalent | None:
Expiration dating is not needed
based on the stability of the
materials chosen. |
| Sterilization | 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 | Substantially
equivalent | None:
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. | Substantially
equivalent | None:
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 | Substantially
equivalent | None:
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. |
| Override | Yes | No | Substantially
equivalent | None:
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 is a
single unit device (insertion unit
only) and therefore does not
have an override option for
suspending the stimulation
function. Apex is designed to be
powered off by the end user to
stop stimulation and improve
ease of use. Powering off the
device resets 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 | Substantially
equivalent | None:
The Apex device has been
designed to be more intuitive
for use by the end user without
physician oversight. In both
cases, no special knowledge or |
| Feature/ Function | K110179 InTone
(Predicate) | Apex
(New Device) | Comparison | Impact on Safety and
Performance |
| | | | | training is required. End user
interaction was validated by the
Human Factors and Usability
Validation. |
| Software Level of Concern | Moderate | Moderate | Identical | None |
Table 6. 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 text "InControl" in a bold, sans-serif font, with the word "Medical" in a smaller font below. The logo also includes the address "3225 Gateway Road, Ste. 250".
Image /page/5/Picture/2 description: The image contains the word "apex" in a blue sans-serif font. To the right of the word is a stylized flower-like design in a light orange color. The flower has six petals arranged in a circular pattern.
Brookfield, WI 53045
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Image /page/6/Picture/0 description: The image shows the logo for InControl Medical, along with their address. The logo features the company name in a gray, sans-serif font, with the word "MEDICAL" in a smaller font size below "CONTROL". The address is listed as 3225 Gateway Road, Ste. 250, Brookfield, WI 53045.
Image /page/6/Picture/2 description: The image shows the word "apex" in a blue sans-serif font. To the right of the word is a light orange flower-like design. The flower has six petals and a small circle in the center.
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Image /page/7/Picture/0 description: The image shows the logo for InControl Medical, followed by their address. The logo is a light green circle with the word "InControl" in dark gray letters. Below the logo is the word "Medical" in smaller, dark gray letters. The address is 3225 Gateway Road, Ste. 250, Brookfield, WI 53045.
Image /page/7/Picture/2 description: The image shows the word "apex" in a sans-serif font. The word is in lowercase letters and is a teal color. To the right of the word is a light orange flower-like design.
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Image /page/8/Picture/0 description: The image shows the logo for InControl Medical, along with their address. The logo features the word "InControl" in a bold, sans-serif font, with the word "MEDICAL" in a smaller font underneath. The address is listed as 3225 Gateway Road, Ste. 250, Brookfield, WI 53045.
Image /page/8/Picture/2 description: The image shows the word "apex" in a sans-serif font. The word is in a teal color. To the right of the word is a flower-like design in a light orange color.
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Image /page/9/Picture/0 description: The image shows the logo and address of InControl Medical. The logo features the word "InControl" in a bold, 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.
Testing Summary
The following performance testing was provided in support of the substantial equivalence. The testing for Apex included software, electrical safety, biocompatibility and clinical. Apex successfully passed all testing.
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 as 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 were conducted on 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:
The biocompatibility evaluation for Apex 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 Insertion Unit is considered tissue contacting for a duration of less than 24 hours. The biocompatibility testing completed included the following 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 stress 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 to assess the safety of the Apex device for over-the-counter use. The human factors / usability study objectives were to: 1) determine if a subject can self-identify as having stress urinary incontinence using package labeling 2) self-limit usage if a contraindication is present 3) safely use the Apex device using 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
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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 stylized font, with the word "Medical" underneath. The address is listed as 3225 Gateway Road, Ste. 250, Brookfield, WI 53045.
Image /page/10/Picture/2 description: The image shows the word "apex" in a sans-serif font. The letters are a light blue color. To the right of the word is a light orange flower-like design. The design has six petals.
enhancements including an educational consumer-focused box, detailed instructions for use, laminated quick reference guide and instructional video.
Risk Management Summary
Apex has been designed according to InControl Medical's internal procedures with traceability between the design inputs, design outputs, verification and validation activities.
Apex has been evaluated for risks according to InControl Medical's internal procedures based on ISO 14971. The risks associated with Apex were reduced to as low as possible and the risk/benefit analysis was acceptable.
Conclusion
The non-clinical data supports the safety of the device, and the hardware and software verification and validation demonstrates that Apex 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 stress urinary incontinence in women. Given that Apex is intended for over-the-counter use, whereas the predicate is intended for prescription use, a human factors / usability study was completed to support the safety of the product labeling for self-diagnosis and use. The data included within this submission supports the use of Apex for over-the-counter as safe and effective.