(231 days)
Not Found
No
The description focuses on manual controls, electrical stimulation, and biofeedback via manometry. There is no mention of AI, ML, or any adaptive algorithms based on data.
Yes
The device is intended for the "treatment of stress, urge, or mixed urinary incontinence," which indicates a therapeutic purpose.
No
The device is a muscle stimulator intended for treatment, not for diagnosing conditions. While it uses biofeedback, this is for treatment effectiveness, not for initial diagnosis.
No
The device description explicitly states that the ApexMV device is a "non-implantable muscle stimulator" and describes physical components such as a "hand held control unit with bio-feedback and inflation pump attached to a customizable inflatable probe via flexible tubing." It also mentions the kit includes batteries, gel, a screwdriver, and a travel bag, all of which are hardware components. While software is mentioned in the performance studies section, the device itself is clearly a physical medical device with embedded software, not a software-only device.
Based on the provided information, the ApexMV device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples from the human body. IVDs are designed to examine specimens like blood, urine, tissue, etc., to provide information about a person's health.
- ApexMV is a therapeutic device. The ApexMV device is a muscle stimulator intended to treat urinary and/or fecal incontinence through electrical stimulation and biofeedback. It directly interacts with the body to provide therapy, rather than analyzing a sample.
The description clearly outlines its function as a non-implantable muscle stimulator for therapeutic purposes.
N/A
Intended Use / Indications for Use
ApexMV is a non-implantable muscle stimulator intended to provide electrical stimulation and/or visual biofeedback (via manometry) for the treatment of stress, urge, or mixed urinary incontinence in adult women.
Product codes (comma separated list FDA assigned to the subject device)
KPI
Device Description
The ApexMV device is a non-implantable muscle stimulator intended to provide electrical stimulation and/or visual biofeedback (via manometry) for the treatment of stress, urge, or mixed urinary incontinence and/or fecal incontinence in adult women for Over-the-Counter use. The ApexMV device is to be distributed as a kit that contains the following items:
- 1 ApexMV device
- 1 4 pack of AA batteries
- 1 2 oz. tube of InControl Medical Electrode Gel**
- 1 ApexMV IFU/ User Manual
- 1 ApexMV Quick Reference Card
- 1 Screw driver
- 1 Travel Bag
- 1 Animation Video
The ApexMV device consists of a hand held control unit with bio-feedback and inflation pump attached to a customizable inflatable probe via flexible tubing. The customizable inflatable probe is inserted vaginally or rectally 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 also used to improve the ability of the muscles to hold a contraction for an extended period of time for the treatment of stress, urge, or mixed urinary and/or fecal incontinence in adult women. 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
Indicated Patient Age Range
Adult women
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: Software verification and validation testing were conducted. The software for this device was considered to be a "moderate" level of concern. The device successfully passed all testing.
- Electrical Safety and Electromagnetic Compatibility Testing: Electrical safety and EMC testing was conducted. The ApexMV device complies with the IEC 60601-1, IEC 60601-2-10, IEC 60601-1-11, and IEC 60601-1-2 standards for safety and the standard for EMC.
- Biocompatibility Testing: Not performed for the ApexMV device as the materials are the same as previously cleared predicate devices. Previous testing for predicate devices was conducted in accordance with International Standard ISO 10993-1 and included Cytotoxicity, Sensitization, and Irritation tests.
- Clinical Testing (Clinical Literature Evaluation): A clinical literature evaluation was conducted on the predicates ApexM (150183) and InToneMV (K134020) to provide evidence of the safety and efficacy of electrical stimulation for the treatment of female urinary incontinence and treatment of male urinary or fecal incontinence. The appraisal included assessment of suitability, device performance, and device safety.
- Clinical Testing (Human Factors Usability Study): A Human Factors Usability Study was conducted on the ApexMV device to assess the safety for over-the-counter use. Objectives were to determine if a user/subject can self-identify as having urinary and/or fecal incontinence using package labeling, self-limit usage if a contraindication is present, safely use the ApexMV device using only package labeling, manual and patient card, and determine subject's ability to complete critical tasks successfully. The study objectives were met. The study feedback supported the availability of a training video.
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.
Not Found
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 15, 2019
InControl Medical, LLC Jennifer Koch Director of Quality & Regulatory Affairs 3225 Gateway Road Suite 250 Brookfield. WI 53045
K182022 Re: Trade/Device Name: ApexMV Regulation Number: 21 CFR§ 876.5320 Regulation Name: Nonimplanted Electrical Continence Device Regulatory Class: II Product Code: KPI Dated: February 5, 2019 Received: February 7, 2019
Dear Jennifer Koch:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Glenn B. Bell -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
2
Indications for Use
510(k) Number (if known) K182022
Device Name ApexMV
Indications for Use (Describe)
ApexMV is a non-implantable muscle stimulator intended to provide electrical stimulation and/or visual biofeedback (via manometry) for the treatment of stress, urge, or mixed urinary incontinence in adult women.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/1 description: The image shows the logo for InControl Medical, followed by their address. The address is 3225 Gateway Road, Ste. 250 in Brookfield, WI 53045. The logo is a light blue circle with the word "InControl" in dark blue letters. The word "MEDICAL" is in smaller, dark blue letters to the right of "InControl".
Image /page/3/Picture/3 description: The image contains the logo for ApexMV. The logo features the text "apexMV" in a sans-serif font, with the "apex" portion in a lighter gray and the "MV" portion in a darker gray. Above the "apex" portion of the text is a green, stylized flower-like graphic with six petals.
7. 510(k) Summary
Date Prepared
Friday, March 15th, 2019
Submitter Information
Corey Olson Regulatory Affairs Manager InControl Medical, LLC 3225 Gateway Road, Suite 250, Brookfield, WI 53045 USA Phone: (262) 373.0422 Fax: (262) 373.0463 Email: colson@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): | ApexMV |
| Classification name: | Nonimplanted Electrical Continence Device |
| Classification Regulation: | 21 CFR 876.5320 |
| Class: | Class II |
| Product Code: | KPI |
Legally Marketed Device for Substantial Equivalence
Table 7.2: Predicate Device Information
| 510(k) | Name | Product Code | Owner |
|---|---|---|---|
| K134020 | InToneMV | KPI | InControl Medical, LLC |
| 3225 Gateway Road, Ste. 250 | |||
| Brookfield, WI 53045 USA | |||
| K150183 | ApexM | KPI | InControl Medical, LLC |
| 3225 Gateway Road, Ste. 250 | |||
| Brookfield, WI 53045 USA |
4
Traditional 510(k) Subm
Image /page/4/Picture/2 description: The image shows the logo and address of InControl Medical. The logo features the text "InControl MEDICAL" in a serif font, with the word "MEDICAL" in a smaller font size. The address is "3225 Gateway Road, Ste. 250 Brookfield, WI 53045".
Device Summary
The ApexMV device is a non-implantable muscle stimulator intended to provide electrical stimulation and/or visual biofeedback (via manometry) for the treatment of stress, urge, or mixed urinary incontinence and/or fecal incontinence in adult women for Over-the-Counter use. The ApexMV device is to be distributed as a kit that contains the following items:
- · 1 ApexMV device
- 1 4 pack of AA batteries
- · 1 2 oz. tube of InControl Medical Electrode Gel**
- 1 ApexMV IFU/ User Manual
- · 1 ApexMV Quick Reference Card
- 1 Screw driver
- 1 Travel Bag
- 1 Animation Video
**The InControl Medical Electrode Gel is privately labeled for InControl Medical. It is a Pre-Amendment Class II Medical Device under D039725.
The kit contents are substantially equivalent to the ApexM (K150183) and InToneMV (K134020) that are distributed on the market by InControl Medical. The inclusion of the screw driver in the ApexMV kit is for the screw that holds the battery cover panel in place on the back side of the control unit.
The ApexMV device consists of a hand held control unit with bio-feedback and inflation pump attached to a customizable inflatable probe via flexible tubing. The customizable inflatable probe is inserted vaginally or rectally 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 also used to improve the ability of the muscles to hold a contraction for an extended period of time for the treatment of stress, urge, or mixed urinary and/or fecal incontinence in adult women. 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.
Indications for Use
ApexMV is a non-implantable muscle stimulator intended to provide electrical stimulation and/or visual biofeedback (via manometry) for the treatment of stress, urge, or mixed urinary incontinence and/or fecal incontinence in adult women.
5
Image /page/5/Picture/1 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 circular design with curved lines. Below the logo is the address "3225 Gateway Road, Ste. 250".
Image /page/5/Picture/3 description: The image shows the logo for ApexMV. The logo is in a light gray color, with the letters "apexMV" written in a simple, sans-serif font. Above the "x" in "apex" is a small, stylized flower or starburst design in a teal color. The logo is clean and modern in appearance.
Brookfield, WI 53045
Equivalence Comparison to the Predicate
Electrical muscle stimulation is the technological principle for ApexMV and the predicate devices, ApexM (K150183) and InToneMV (134020). It is based on the use of electrical muscle stimulation to strengthen the pelvic floor muscles and surrounding structures. The chart below summarizes the shared and unique technological elements between ApexMV and the predicate devices, ApexM (K150183) and InToneMV (K134020). The intended use, technology, engineering, and performance for the ApexMV is substantially equivalent to the predicate devices, ApexM (K150183) and InToneMV (134020).
| Feature/
Function | K134020 InToneMV
(Predicate)
manufactured by
InControl Medical,
LLC. | K150183 ApexM
(Predicate)
manufactured by
InControl Medical,
LLC. | ApexMV | 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 | InToneMV is intended
to provide electrical
stimulation and/or
visual biofeedback
(via manometry) for
the treatment of
male and female
urinary and fecal
incontinence | 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
to improve strength
and support. | ApexMV is a non-
implantable muscle
stimulator intended to
provide electrical
stimulation and/or
visual biofeedback (via
manometry) for the
treatment of stress,
urge, or mixed urinary
incontinence and/or
fecal incontinence in
adult women. | Substantially
equivalent | None:
These devices
apply the same
electrical
stimulation to
strengthen the
pelvic floor
muscles, as
supported by
literature. |
| Primary
Function | Delivery of electrical
stimulation
Visual biofeedback | Delivery of electrical
stimulation | 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:
ApexMV
warnings and
precautions are
identical to
ApexM and
InToneMV,
which were |
| Feature/
Function | K134020 InToneMV
(Predicate)
manufactured by
InControl Medical,
LLC. | K150183 ApexM
(Predicate)
manufactured by
InControl Medical,
LLC. | ApexMV | Comparison | Impact on
Safety and
Performance |
| | | | | | defined in
accordance
with the FDA
guidance
document and
validated
through the
Human Factors
Usability
Testing. |
| Contraindications
Explain when
the device is
not to be
clinically used | • 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 | • 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.: | • 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
electrical device
• 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 | Substantially
Equivalent | None |
| Feature/
Function | K134020 InToneMV
(Predicate)
manufactured by
InControl Medical,
LLC. | K150183 ApexM
(Predicate)
manufactured by
InControl Medical,
LLC. | ApexMV | Comparison | Impact on
Safety and
Performance |
| | • 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. | 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
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 | | |
| Feature/
Function | K134020 InToneMV
(Predicate)
manufactured by
InControl Medical,
LLC. | K150183 ApexM
(Predicate)
manufactured by
InControl Medical,
LLC. | ApexMV | Comparison | Impact on
Safety and
Performance |
| Labeling
Summary
Clarity to
ensure safer or
more effective
use | User Manual and
Quick Reference
Patient Guide Card | User Manual and
Quick Reference
Patient Guide Card | User Manual and
Quick Reference
Patient Guide Card | Identical to
predicates | None:
ApexMV User
Manual and
Quick
Reference
Patient Guide
Card user were
based on the
labeling and
use for ApexM
for Over-The-
Counter use
and was
validated
through the
Human Factors
Usability
Testing. |
| Environmental
Specifications | For indoor use only | For indoor use only | For indoor use only | Identical to
predicates | None |
| Power Source | 4/5 AA nickel metal
hydride battery | 4-AAA Alkaline
battery | 4 -AA Alkaline battery | Substantially
equivalent | None |
| Method of line
current
isolation | N/A (battery) | N/A (battery) | N/A (battery) | Identical to
predicates | None |
| Patient
leakage
current | N/A (battery) | N/A (battery) | N/A (battery) | Identical to
predicates | None |
| Number of
output modes | 1 | 1 | 1 | Identical to
predicates | None |
| Number of
output
channels | 1 | 1 | 1 | Identical to
predicates | None |
| Regulated
current or
voltage? | Regulated voltage | Regulated voltage | Regulated voltage | Identical to
predicates | None |
| Firmware
controlled? | Yes | Yes | Yes | Identical to
predicates | None |
| Automatic
Overload Trip? | No | No | No | Identical to
predicates | None |
| Feature/
Function | K134020 InToneMV
(Predicate)
manufactured by
InControl Medical,
LLC. | K150183 ApexM
(Predicate)
manufactured by
InControl Medical,
LLC. | ApexMV | Comparison | Impact on
Safety and
Performance |
| Automatic No-
Load Trip? | No | No | No | Identical to
predicates | None |
| Automatic
Shut Off? | Yes | Yes | Yes | Identical to
predicates | None |
| Indicator
Display
• On/Off
Status
• Low
Battery | Yes (via display
illumination)
Yes | Yes (via display
illumination)
No | Yes
Yes (via on screen
warning) | Substantially
equivalent to
InToneMV | None |
| Waveform,
shape | Monophasic,
alternating polarity,
square pulse | Monophasic,
alternating polarity,
square pulse | Monophasic,
alternating polarity,
square pulse | Identical to
predicates | None |
| Waveform
Frequency
• Urge
• Stress
• Mixed | 13 Hz - Urge
Incontinence
50 Hz - Stress
Incontinence
13/50 Hz - Mixed | 13 Hz - Urge
Incontinence
50 Hz - Stress
Incontinence
13/50 Hz - Mixed | 13 Hz - Urge
Incontinence
50 Hz - Stress
Incontinence
13/50 Hz - Mixed | Identical to
predicates | None |
| Waveform
Pulse width | 200 µs/phase | 200 µs/phase | 200 µs/phase | Identical
predicates | None |
| Waveform
Pattern | 1 second at 50 Hz
2 seconds no
stimulation
2 seconds at 13 Hz
2 second no
stimulation | 1 second at 50 Hz
2 seconds no
stimulation
2 seconds at 13 Hz
2 second no
stimulation | 1 second at 50 Hz
2 seconds no
stimulation
2 seconds at 13 Hz
2 second no
stimulation | Identical to
predicates | None |
Table 7.3: Substantial Equivalence Comparison Table
6
Image /page/6/Picture/1 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 "3225 Gateway Road, Ste. 250, Brookfield, WI 53045".
Image /page/6/Picture/3 description: The image shows the logo for ApexMV. The logo is in gray and features a stylized flower above the letters "exMV". The flower has a green color.
7
K182022
Page 5 of 15
Image /page/7/Picture/1 description: The image shows the logo for InControl Medical. The logo features the company name in a stylized font, with the word "InControl" in a larger, bolder font than the word "Medical." There is a circular graphic to the left of the company name. Below the logo is the address "3225 Gateway Road, Ste. 250".
Traditional 510(k) Submission
Image /page/7/Picture/3 description: The image contains the word "Submission" at the top. Below that is the logo for apexMV, which is written in a sans-serif font. The "M" and "V" are slightly larger than the "apex" part of the logo. Above the "apex" part of the logo is a green flower-like design.
3225 Gateway Road, Ste. 250 Brookfield, WI 53045
8
Image /page/8/Picture/1 description: The image shows the logo and address of InControl Medical. The logo features the text "InControl" in a stylized font, with the word "Medical" below it. The address is listed as 3225 Gateway Road, Ste. 250, Brookfield, WI 53045.
Image /page/8/Picture/3 description: The image shows the logo for ApexMV. The logo features the text "apexMV" in a sans-serif font. Above the text is a green, stylized flower-like graphic with six petals and a small droplet at the bottom.
9
Image /page/9/Picture/1 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" in a darker shade and "Medical" in a lighter shade. 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".
Brookfield, WI 53045
Image /page/9/Picture/3 description: The image contains the logo for apexMV. The logo features the text "apexMV" in a sans-serif font, with the "apex" portion in a lighter shade of gray and the "MV" portion in a darker shade of gray. Above the "apex" portion of the text is a green floral design with a water droplet in the center.
10
K182022
Page 8 of 15
Image /page/10/Picture/1 description: The image shows the logo for InControl Medical. The logo features the company name in a stylized font, with the word "InControl" in a larger font than the word "Medical". There is also an address listed below the logo, which reads "3225 Gateway Road, Ste. 250".
Image /page/10/Picture/3 description: The image shows the logo for apexMV. The logo is in gray and features a stylized flower above the 'x' in 'apex'. The flower has six petals and a small droplet in the center.
| MEDICA | |
|---|---|
| 3225 Gateway Road, Ste. 250 | |
| Brookfield, WI 53045 |
| Feature/
Function | K134020 InToneMV
(Predicate)
manufactured by
InControl Medical,
LLC. | K150183 ApexM
(Predicate)
manufactured by
InControl Medical,
LLC. | ApexMV | Comparison | Impact on
Safety and
Performance |
|-----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Total Session
Time | Total session time of
approximately 12
minutes
2 minutes of
volitional
stimulation5 minutes of
muscles
stimulation5 minutes of
volitional
contractions. | Total session time of
10-15 minutes
5-10 minutes
electrical
stimulation5 minutes self-
directed
contractions
(recommended) | Total session time of
approximately 11
minutes
7 minutes of
electrical
stimulation3.5 minutes of
self-directed
contractions
(recommended) | Substantially
equivalent to
predicates | None |
| Max output
voltage (500Ω) | 40.0 V peak | 40.0 V peak | 40.0 V peak | Identical to
predicates | None |
| Max output
current (500Ω) | 80.0 mA peak | 80.0 mA peak | 80.0 mA peak | Identical to
predicates | None |
| Maximum
phase charge
(500Ω) | 16.0 µC | 16.0 µC | 16.0 µC | Identical to
predicates | None |
| Electrode
surface area | 2.5 cm² ± 0.1 cm² x 2 | 5.9 cm² ± 0.1 cm² x 2 | 3.9 cm² ± 0.1 cm² x 2 | Substantially
equivalent to
predicates | None |
| Max current
density | 32.0 mA/cm² | 13.6 mA/cm² | 20.5 mA/cm² | Substantially
equivalent to
predicates | None |
| Max average
power density
(500Ω) | 12.8 mW/ cm² | 5.4 mW/cm² | 8.2 mW/cm² peak | Substantially
equivalent to
predicates | None |
| Biofeedback | Manometric Air
pressure, .01 - 2 psi | None | Manometric Air
pressure, .01 - 2 psi | Substantially
equivalent to
predicates | None |
| Feature/
Function | K134020 InToneMV
(Predicate)
manufactured by
InControl Medical,
LLC. | K150183 ApexM
(Predicate)
manufactured by
InControl Medical,
LLC. | ApexMV | Comparison | Impact on
Safety and
Performance |
| Dimensions
(Insertion Unit) | Control Unit: 4.8" x
2.4" x 1.1" (+/- 0.1")
Inflation bulb: 7.7" x
2.3" x 3.9" (+/- 0.1")
Uninflated Probe:
2.7" x 0.5" x 0.9" (+/-
0.1")
Inflated Probe (2.0
PSI):
2.4" x 1.4" x 1.7" (+/-
0.1")
Tubing: 40.0" (+/-
1.0") long | Overall Insertion
Unit: 11.8"x 2.3"x
3.9" (+/- 0.1")
Uninflated Probe:
5.1" x 1.2" x 1.5" (+/-
0.1")
Inflated Probe: 5.0" x
1.6" x 2.1" (+/- 0.1") | Control Unit:
6.2"x3.3"x 1.8" (+/-
0.1")
Uninflated Probe: 4.1"
x 0.5" x 0.8" (+/- 0.1")
Inflated Probe: 3.9" x
1.4" x 1.7" (+/- 0.1")
Tubing: 40.0" (+/-
1.0") long | Substantially
equivalent to
InToneMV | None |
| Control
housing
material | ABS plastics | N/A | ABS plastics, TPE over
molded gaskets and
hand grip | Substantially
equivalent | A TPE over
molded gasket
was added to
the plastic
housing to
comply with
electrical safety
standards for
home use
devices (H20
ingress). |
| Insertion probe
material | Silicone, stainless
steel | Silicone, stainless
steel | Silicone, stainless steel | Identical | None |
| Expiration
Dating | N/A | N/A | N/A for the ApexMV
insertion unit.
4 year shelf life for the
electrode gel | Identical | The electrode
gel supplied in
the kits for
InToneMV,
ApexM and
ApexMV has a
4 year shelf life
that was not
stated in the
original
submissions. |
| Overall Device
Weight | ~ 0.8lbs. | ~ 0.8 lbs. | ~ 0.8 lbs. | Identical | None |
| Feature/
Function | K134020 InToneMV
(Predicate)
manufactured by
InControl Medical,
LLC. | K150183 ApexM
(Predicate)
manufactured by
InControl Medical,
LLC. | ApexMV | Comparison | Impact on
Safety and
Performance |
| Packaging
(Overall
Weight) | ~ 2.6 lbs. | ~ 2.0 lbs. | ~ 2.2 lbs. | Substantially
equivalent | The InToneMV,
ApexM and the
ApexMV are all
packaged with
the same
customized
foam that
surrounds the
device, and
same
corrugated
cardboard
exterior box for
the Patient
Unit. |
| Sterilization | N/A | N/A | N/A | Identical to
predicates | None |
| Operational
Method:
Clinical Use
e.g.,
ambulatory
use, home use | Clinic or Home use,
under direction of a
Physician or health
care provider. | Home use, Over-the-
counter | Home use, Over-the-
counter | Identical to
ApexM | None |
| Operating
Conditions: | Temperature: 32 -
130°F (0-54°C)
Relative Humidity:
15-95%, non-
condensing | Temperature: 32 -
130°F (0-54°C)
Relative Humidity:
15-95%, non-
condensing | Temperature: 41 - 104
°F (5-40°C)
Relative Humidity: 15-
95%, non-condensing | Substantially
equivalent to
predicates | None |
| Storage and
Transportation
Conditions: | Temperature: -4-
150°F (-20 -65°C)
Relative Humidity:
10-95%, non-
condensing | Temperature: -4-
150°F (-20 -65°C)
Relative Humidity:
10-95%, non-
condensing | Temperature: -13 -
158°F (-25 -70°C)
Relative Humidity: 10-
95%, non-condensing | Substantially
equivalent to
predicates | None |
| Feature/
Function | K134020 InToneMV
(Predicate)
manufactured by
InControl Medical,
LLC. | K150183 ApexM
(Predicate)
manufactured by
InControl Medical,
LLC. | ApexMV | Comparison | Impact on
Safety and
Performance |
| 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
automatically on its
own once the session
is complete. | 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 starting and
stopping of each
session. However, the
device will
automatically stop on
its own once the
session is complete. | Substantially
equivalent to
the predicates | None |
| Patient
Interaction:
Programming
Capability
Whether the
device can be
programmed
and to what
extent | None, stimulation
level settings can only
be changed by a
Physician or health
care provider. | Electrical stimulation
levels are set by the
end user | Electrical stimulation
levels are set by the
end user | Identical to
ApexM | None |
| Override | Yes | No | Yes | Identical to
InToneMV | 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 | 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
ApexM | None |
| Software Level
of Concern | Moderate | Moderate | Moderate | ldentical to
predicates | None |
11
Image /page/11/Picture/1 description: The image shows the logo for InControl Medical. The logo features the company name in a gray sans-serif font, with the word "InControl" in a larger font size than the word "Medical." To the left of the company name is a light blue circle with a series of curved lines inside. Below the logo is the address "3225 Gateway Road, Ste. 250".
Brookfield, WI 53045
Image /page/11/Picture/3 description: The image shows the logo for ApexMV. The logo consists of the word "apexMV" in a sans-serif font. Above the "x" in "apex" is a green flower-like symbol with a water droplet in the center.
12
Image /page/12/Picture/1 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 "3225 Gateway Road, Ste. 250, Brookfield, WI 53045".
Image /page/12/Picture/3 description: The image shows the logo for ApexMV. The logo features the text "apexMV" in a sans-serif font, with the "apex" portion in a lighter shade of gray and the "MV" portion in a darker shade of gray. Above the "apex" portion of the text is a stylized flower-like graphic in a teal color.
13
Image /page/13/Picture/1 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. To the left of the words is a circular graphic with a series of curved lines. Below the logo is the address "3225 Gateway Road, Ste. 250".
Brookfield, WI 53045
Traditional 510(k) Submission
Image /page/13/Picture/3 description: The image shows the logo for apexMV. The logo features a stylized flower or asterisk-like symbol in a teal color above the text "apexMV" in a gray sans-serif font. The logo appears to be clean and modern in design.
ApexMV Design Modifications Compared To Predicates
-
- The modifications to the insertion unit includes: a longer in length inflatable probe of 4.0 inches in place of the 2.7 inch probe on the InToneMV (K134020) device. The inflatable probe is inserted into either the vagina or rectum and manually inflated by the end user to ensure a customized fit. Electrical stimulation is delivered via stainless steel electrodes on the probe to induce a contraction of the pelvic floor muscles. This portion of the device has been modified from the predicate device, InToneMV (K134020).
14
Image /page/14/Picture/1 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" in a larger size than 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".
Image /page/14/Picture/3 description: The image contains the logo for ApexMV. The logo features the text "apexMV" in a sans-serif font, with the "apex" portion in a darker shade of gray and the "MV" portion in a lighter shade of gray. Above the "apex" portion of the text is a green, stylized flower-like graphic with a droplet shape in the center.
- Brookfield, WI 53045
- 2. The attached hand-held control unit includes user keys to initiate and control the treatment sessions. The control unit is designed to provide the stimulation pulses as well as visual biofeedback response. The modifications to the hand-held control unit include:
- Use of a new microprocessor. The stimulation output will operate under the o same specifications as the previous InToneMV device (use of the same frequency (13/50Hz), pulse width (200uS), maximum voltage (40V), and maximum current (80mA). The pulse delivery on/off time shall also be identical.
- The stimulation output characteristics as noted above will be replicated o identical to the predicate devices. The electrode surface area of the ApexMV falls between the InToneMV (smaller surface area) and the ApexM (larger surface area) making the ApexMV substantially equivalent in current density compared to the predicates.
- Addition of an LED indicator that will illuminate when the stimulation is active O on the electrodes. The LEDs will only illuminate when sufficient current is conducting from one electrode to another, or will require tissue to bridge between the electrodes (create a current conducing path) in order to illuminate the LEDs.
- Addition of an OLED display allows users to see the following visual cues: o
- I Timer for duration of stimulation session
- . Pressure gauge to illustrate the optimal balloon pressure range to begin the self-directed contractions to maximize the LED biofeedback bar graph response.
- Visual cues during the self-directed contractions to guide the user when to contract and relax, as well as an integrated timer to illustrate length of contraction/relaxation.
- o Omission of audio, no verbal session guidance will be offered for the ApexMV.
- 2. The attached hand-held control unit includes user keys to initiate and control the treatment sessions. The control unit is designed to provide the stimulation pulses as well as visual biofeedback response. The modifications to the hand-held control unit include:
These changes do not change the fundamental technology, operating principle or primary function of the ApexMV device. Software/Firmware verification, electrical safety and EMC testing, Human Factors Usability Study and performance validation was performed in accordance with InControl Medical's risk management process and external standards. A summary of the results from this testing is found in Testing Summary, pages 21-22 of this document.
The table below is a summary of why each predicate was chosen for the ApexMV device design.
| Attribute | Predicate |
|---|---|
| Smaller in size Probe | InToneMV |
| Visual Biofeedback | InToneMV |
| Over-the-Counter Use | ApexM |
| Fecal and Urinary Incontinence in men | |
| and women | InToneMV |
| Stress, Urge or Mixed Urinary | |
| Incontinence in women | ApexM |
| End user sets their own stimulation | ApexM |
Table 7.4: Substantial Equivalence Comparison Table
15
Image /page/15/Picture/1 description: The image shows the logo for InControl Medical, with the company name in a stylized font. Below the logo is the address "3225 Gateway Road, Ste. 250 Brookfield, WI 53045".
Image /page/15/Picture/3 description: The image shows the logo for ApexMV. The logo consists of the word "apexMV" in a light gray sans-serif font. Above the "x" in "apex" is a green, stylized flower-like design with six petals and a small drop in the center. The overall design is clean and modern.
The ApexMV was designed with the smaller insertion probe, substantially equivalent to the InToneMV to accommodate anal insertion for urinary or fecal incontinence and for certain women who have smaller physical anatomies. The smaller probe aids in either rectal or vaginal insertion. The visual biofeedback that was added to the ApexMV, is substantially equivalent to the predicate, InToneMV. It allows the end user of the ApexMV to visually see the LED bars illuminate when they contract their pelvic floor muscles against the inflated balloon during the self-directed contraction portion of the session, which aids in their treatment.
By combining the smaller probe with the biofeedback, the ApexMV device is then able to treat stress, urge or mixed urinary and/or fecal incontinence in adult women as the electrical technology is identical to the predicates. The over-the-counter use allows the end user to self-diagnose their own incontinence and use the device to specifically treat that incontinence, same as the ApexM. Where as the InToneMV had data review and a controlled treatment session by the clinician/medical professional. The ApexMV doesn't have this data review or controlled treatment session by a clinician/medical professional. The end user of the ApexMV set's their own stimulation as they can with ApexM.
The device labeling and packaging (which includes an educational consumer-focused box, detailed IFU/user manual, laminated quick reference guide/patient card and an instructional video included in the packaging and available via InControl Medical's website) allows the end user to accurately self-diagnose and use the product. ApexMV labeling and packaging is substantially equivalent to the predicate, ApexM (K150183), and is therefore safe for over-thecounter use. This intended use is substantially equivalent to the predicate devices, ApexM (K150183) and InToneMV (K134020). The ApexMV labeling and the predicate labeling for ApexM (150183) and InToneMV (K134020) is found in Appendix 11 – Predicate and ApexMV Labeling.
16
Image /page/16/Picture/1 description: The image shows the logo and address of InControl Medical. The logo features the text "InControl Medical" in a stylized font, with a circular graphic to the left. Below the logo is the address "3225 Gateway Road, Ste. 250, Brookfield, WI 53045".
Image /page/16/Picture/3 description: The image contains the logo for apexMV. The logo is gray, and there is a green flower above the 'x' in apexMV. The flower has six petals and a water droplet in the center.
Testing Summary
The following testing is provided in support of the substantial equivalence. The testing for ApexMV included software/firmware verification, electrical safety and EMC, Human Factors Usability Study and performance validation, in which the ApexMV device successfully passed all of this testing. Since the ApexMV device uses the same grade, type, color, and manufacturing processes for the silicone parts as the predicates and the previously cleared InTone device (K150180), manufactured by InControl Medical, LLC, the biocompatibility testing was not performed for the ApexMV device to demonstrate the equivalent safety and effectiveness. The biocompatibility testing was previously submitted with the ApexM submission under K150183 and with the InToneMV submission under K134020, there for the data is not attached to this submission for ApexMV.
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. Testing data is found in Appendix 4 – Risk Management File.
Electrical Safety and Electromagnetic Compatibility Testing:
Electrical safety and EMC testing was conducted. The ApexMV device complies with the IEC 60601-1, IEC 60601-2-10, IEC 60601-1-11, and IEC 60601-1-2 standards for safety and the standard for EMC. Testing data is found in Appendix 7 – SGS EMC and Electrical Safety.
Biocompatibility Testing:
The biocompatibility evaluation was completed and submitted previously as stated above under the Testing Summary, therefore it was not tested for the ApexMV device. Above, under Testing Summary, contains the rationale. When the biocompatibility testing was performed for the predicates, it 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 the FDA. The inflatable probe on the ApexMV device and predicates is considered tissue contacting for a duration of less than 24 hours. The biocompatibility testing included the following tests:
- Cytotoxicity
- Sensitization
- . Irritation
Clinical Testing:
A clinical literature evaluation was conducted on the predicates ApexM (150183) and InToneMV (K134020) to provide evidence of the safety and efficacy of electrical stimulation for the treatment of female urinary incontinence and treatment of male urinary or fecal 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.
17
Image /page/17/Picture/1 description: The image shows the logo and address of InControl Medical. The logo features the company name in a stylized font, with the word "InControl" in a larger, bolder font and the word "Medical" in a smaller font below. The address is listed as 3225 Gateway Road, Ste. 250, Brookfield, WI 53045.
Image /page/17/Picture/3 description: The image contains the logo for ApexMV. The logo features the text "apexMV" in a simple, sans-serif font. The "apex" portion of the text is in a lighter color, while the "MV" portion is in a darker shade of gray. Above the text is a small, stylized graphic that resembles a flower or asterisk in a teal color.
A Human Factors Usability Study was conducted on the ApexMV device to assess the safety for over-the-counter use. The Human Factors Usability Study objectives were to: 1) determine if a user/subject can self-identify as having urinary and / or fecal incontinence using package labeling, 2) self-limit usage, if a contraindication is present, 3) safely use the ApexMV device using only package labeling, manual and patient card, and 4) determine subject's ability to complete critical tasks successfully. The study was conducted with collaboration with a supervising physician to ensure the product labeling, IFU, and video provided were suitable for over-the-counter use. The study objectives were met as the subject/end users were able to properly self-identify as having either urinary incontinence (either stress, urge, and/or mixed) or fecal incontinence. The labeling and packaging for the ApexMV device is substantially equivalent to the predicates ApexM (K150183) and InToneMV (K134020). The study feedback supported the availability of a training video. The Clinical Literature Review and Human Factors Usability Study results are found in Appendix 9 – Clinical Literature and Human Factors Usability Study Test.
Risk Management Summary
ApexMV has been designed according to InControl Medical's internal procedures with traceability between the design inputs, design outputs, verification and validation activities.
ApexMV has been evaluated for risks according to InControl Medical's internal procedures based on ISO14971. The risks associated with ApexMV 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 ApexMV device. The software verification, performance validation, electrical safety, EMC testing and Human Factors Usability Study demonstrates that the ApexMV device is safe and effective for an over-thecounter treatment of stress, urge, or mixed urinary incontinence and/or fecal incontinence in adult women.