(244 days)
No
The summary describes a neuromodulation system with hardware components and programming software, but there is no mention of AI or ML capabilities in the device description, intended use, or performance studies.
Yes
The device is indicated for "pain management in adults who have severe intractable chronic pain of peripheral nerve origin," which is a treatment of a disease or condition.
No
The device is indicated for "pain management" and delivers electrical signals to a peripheral nerve for therapeutic purposes, rather than to diagnose a condition.
No
The device description clearly outlines multiple hardware components, including an implantable lead, external pulse transmitter, electrode patch, and a tablet PC, in addition to the software.
Based on the provided information, the StimRouter Neuromodulation System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "pain management in adults who have severe intractable chronic pain of peripheral nerve origin." This is a therapeutic indication, not a diagnostic one.
- Device Description: The device description details an implantable lead and external components that deliver electrical stimulation to a peripheral nerve. This is a treatment mechanism, not a method for analyzing biological samples to diagnose a condition.
- Lack of IVD Characteristics: The description does not mention any components or processes related to:
- Collecting or analyzing biological samples (blood, urine, tissue, etc.).
- Detecting or measuring substances in biological samples.
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on the analysis of biological samples.
The StimRouter is a neuromodulation system designed to treat pain by directly stimulating a nerve, which falls under the category of therapeutic devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The StimRouter Neuromodulation System is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy (e.g., medications). The StimRouter is not intended to treat pain in the craniofacial region.
Product codes
GZF
Device Description
The StimRouter Neuromodulation System consists of two main parts - the implantable lead, and the external (to the body) accessories for the StimRouter include a clinician programmer with software (CPS), a disposable hydrogel electrode patch, an external pulse transmitter, an external pulse transmitter stimulation tester and a device used by the patient to wirelessly control the external pulse transmitter. The StimRouter Neuromodulation System is provided with three labeling documents: the Clinician's Guide, the Procedure Manual and the User's Guide.
The Bioness StimRouter Neuromodulation System is intended to provide electrical stimulation via an implanted lead to a target peripheral nerve, for aid in the management of severe, intractable, chronic pain of peripheral nerve origin in adults, as an adjunct to other modes of therapy (e.g. medications). The StimRouter is not intended to treat pain in the craniofacial region.
The complete StimRouter System consists of three kits: a Lead and Lead Introducer Kit, a Clinician Kit and User Kit. The Lead Kit contains the StimRouter implantable multielectrode lead with integrated receiver, used for peripheral nerve stimulation. The Lead receives an electrical signal transmitted transcutaneously by the external pulse transmitter which is mounted on an electrode patch on the skin and delivers that electrical signal down the lead's length to a target peripheral nerve. The Lead is supplied in Lead Loader that is used during intraoperative testing of the lead and to verify proper placement during implantation.
The Lead and Lead Introducer Kit consists of two stimulation probes, two stimulation cables, and introducer set, a lead adapter, a Tunneling Needle, and a Tunneling Needle Stylet. The included tools and components allow for insertion of the StimRouter Lead and confirmation of optimal location of the stimulation electrode contacts of the StimRouter Lead.
The Clinician Kit is used for the programming of the external pulse transmitter. The components of the Clinician Kit are a tablet PC with programming software that is capable of connecting to and configuring the external pulse transmitter.
The User Kit contains the patient-use components of the StimRouter System. The components are the External Electric Field Conductor (E-EFC), an external pulse transmitter, with included charger and the StimRouter Electrode Carrying Case. After the E-EFC is programmed, the E-EFC can be connected to the StimRouter Electrode through which it can deliver stimulation transcutaneously to the implanted lead receiver.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral nerve, craniofacial region (not intended to treat pain in this area)
Indicated Patient Age Range
adults
Intended User / Care Setting
Not Found
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)
Performance Testing:
- Electrical compatibility and safety
- Wireless coexistence
- Biocompatibility Testing
- Shipping and storage
- Shelf life
- Functional Verification
- Usability
- Software Verification and Validation Testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5870 Implanted peripheral nerve stimulator for pain relief.
(a)
Identification. An implanted peripheral nerve stimulator for pain relief is a device that is used to stimulate electrically a peripheral nerve in a patient to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed around a peripheral nerve and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.(b)
Classification. Class II (performance standards).
0
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February 22, 2022
Bioness Inc. Sageev George, Ph.D. Regulatory Affairs Manager, Implantables 25103 Rye Canyon Loop Valencia, California 91355
Re: K211965
Trade/Device Name: StimRouter Neuromodulation System Regulation Number: 21 CFR 882.5870 Regulation Name: Implanted Peripheral Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: GZF Dated: January 21, 2022 Received: January 24, 2022
Dear Dr. Sageev George:
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. 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
1
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Amber Ballard, Ph.D. Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211965
Device Name StimRouter Neuromodulation System
Indications for Use (Describe)
The StimRouter Neuromodulation System is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy (e.g., medications). The StimRouter is not intended to treat pain in the craniofacial region.
Type of Use (Select one or both, as applicable):
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the logo for LiveOn. The word "Live" is in gray, and the word "On" is in orange. There is a trademark symbol in the upper right corner of the word "On".
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:
| I. | Submitter Information | |
|---|---|---|
| Company: | Bioness Inc. | |
| 25103 Rye Canyon Loop | ||
| Valencia, CA 91355 USA | ||
| Phone Number: (661) 388-9303 | ||
| Fax: (661) 362-4851 | ||
| Email: sageev.george@bioness.com | ||
| Contact: | Sageev George | |
| Senior Regulatory Affairs Manager, Implantables | ||
| Bioness Inc. | ||
| Phone Number: (661) 388-9303 | ||
| Fax Number: (661) 362-4851 | ||
| Email: sageev.george@bioness.com | ||
| Sharon Klugewicz | ||
| Sr. Vice President, Quality & Regulatory Affairs | ||
| Bioventus Inc. | ||
| Phone Number: (516) 425-4446 | ||
| Email: sklugewicz@misonix.com | ||
| Date Prepared: | January 21, 2022 | |
| II. | Name of Device | |
| Device Trade Name: | ||
| Classification Name: | StimRouter Neuromodulation System | |
| Implantable peripheral nerve stimulator for pain | ||
| relief | ||
| Common Name: | Implantable Neurostimulator | |
| Product Code: | GZF | |
| Regulation Number: | 21 CFR §882.5870 | |
| Device Class: | ||
| Panel Identification: | Class II | |
| Neurology | ||
| III. | Predicate Device | |
| Predicate Manufacturer: | Bioness Inc. |
4
Image /page/4/Picture/0 description: The image shows the logo for Bioness. The logo consists of an orange sun-like symbol on the left and the word "Bioness" in gray on the right. The "i" in Bioness has an orange dot above it. There is a registered trademark symbol to the right of the word Bioness.
Predicate Trade Name: Predicate 510(k):
StimRouter Neuromodulation System K200482
IV. Device Description
The StimRouter Neuromodulation System consists of two main parts - the implantable lead, and the external (to the body) accessories for the StimRouter include a clinician programmer with software (CPS), a disposable hydrogel electrode patch, an external pulse transmitter, an external pulse transmitter stimulation tester and a device used by the patient to wirelessly control the external pulse transmitter. The StimRouter Neuromodulation System is provided with three labeling documents: the Clinician's Guide, the Procedure Manual and the User's Guide.
The Bioness StimRouter Neuromodulation System is intended to provide electrical stimulation via an implanted lead to a target peripheral nerve, for aid in the management of severe, intractable, chronic pain of peripheral nerve origin in adults, as an adjunct to other modes of therapy (e.g. medications). The StimRouter is not intended to treat pain in the craniofacial region.
The complete StimRouter System consists of three kits: a Lead and Lead Introducer Kit, a Clinician Kit and User Kit. The Lead Kit contains the StimRouter implantable multielectrode lead with integrated receiver, used for peripheral nerve stimulation. The Lead receives an electrical signal transmitted transcutaneously by the external pulse transmitter which is mounted on an electrode patch on the skin and delivers that electrical signal down the lead's length to a target peripheral nerve. The Lead is supplied in Lead Loader that is used during intraoperative testing of the lead and to verify proper placement during implantation.
The Lead and Lead Introducer Kit consists of two stimulation probes, two stimulation cables, and introducer set, a lead adapter, a Tunneling Needle, and a Tunneling Needle Stylet. The included tools and components allow for insertion of the StimRouter Lead and confirmation of optimal location of the stimulation electrode contacts of the StimRouter Lead.
The Clinician Kit is used for the programming of the external pulse transmitter. The components of the Clinician Kit are a tablet PC with programming software that is capable of connecting to and configuring the external pulse transmitter.
The User Kit contains the patient-use components of the StimRouter System. The components are the External Electric Field Conductor (E-EFC), an external pulse transmitter, with included charger and the StimRouter Electrode Carrying Case. After the E-EFC is programmed, the E-EFC can be connected to the StimRouter Electrode through which it can deliver stimulation transcutaneously to the implanted lead receiver.
V. Indications for Use
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Image /page/5/Picture/0 description: The image shows the logo for Bioness. The logo consists of an orange sun-like symbol on the left and the word "Bioness" in gray on the right. There is an orange dot above the "i" in Bioness. There is a registered trademark symbol next to the last "s" in Bioness.
The StimRouter Neuromodulation System is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy (e.g., medications). The StimRouter is not intended to treat pain in the craniofacial region.
LiveOn™
VI. Comparison of Technological Characteristics
The table below compares the principles of operation and operational/technological characteristics for the subject device and the predicate device. These comparisons confirm that the subject and predicate devices have very similar overall principles of operation and operational/technological characteristics, thereby support the substantial equivalence of the subject device to the predicate. Except for three accessories, the subject device is identical to the predicate. The three accessories, the External Electrical Field Conductor, the MAPP Smartphone Application, and a modified version of the Clinician's Programming Software, are newer versions of three accessories of the predicate, the External Pulse Transmitters, the Patient Programmer, and the original Clinician's Programming Software. These new accessories will replace the accessories in the system. The table below confirms that the three new subject device accessories have equivalent functionality to the predicate's accessories that they will replace.
| | Subject Device (Modified
StimRouter) | Predicate (StimRouter
cleared in K200482) | Equivalency
Assessment |
|------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Bioness Inc. | Bioness Inc. | Same |
| 510(k) number | K211965 | K200482 | - |
| Intended use | The StimRouter
Neuromodulation System™
is indicated for pain
management in adults who
have severe intractable
chronic pain of peripheral
nerve origin, as an adjunct to
other modes of therapy (e.g.,
medications). The
StimRouter is not intended to
treat pain in the craniofacial
region. | The StimRouter
Neuromodulation System™
is indicated for pain
management in adults who
have severe intractable
chronic pain of peripheral
nerve origin, as an adjunct to
other modes of therapy (e.g.,
medications). The
StimRouter is not intended to
treat pain in the craniofacial
region. | Same |
| Implantable Lead and Lead Introducer Kit | | | |
| Packaging | No changes | Tray Material: PETG
Lid Material: 1073B Tyvek
Lid Adhesive: TPT-021C | Same |
| StimRouter Lead | | | |
| StimRouter
Lead | No changes | Implanted Lead: Length:
15cm, Diameter: 1.2mm,
Helical coil design, Anchors,
silicone insulator sheathe | Same |
| | Subject Device (Modified
StimRouter) | Predicate (StimRouter
cleared in K200482) | Equivalency
Assessment |
| StimRouter
Lead Receiver
End | No changes | 12mm receiver electrode,
captures portion of signal
generated by EPT | Same |
| StimRouter
Lead
Stimulating
End | No changes | 3 cylindrical stimulating
electrodes: Materials:
Platinum Iridium, Surface
Area: $6.3 \text{ mm}^2$ , Max charge
per pulse: $3 \mu\text{C}$ , Max charge
density: $15.9 \mu\text{C/cm}^2$ | Same |
| Introduction
method | No changes | Percutaneous | Same |
| Tunneling
Needle and
Tunneling
Needle Stylet | No changes | Stainless steel hollow needle
and solid stylet used to
implant receiver end of Lead | Same |
| StimRouter
Loader | No changes | Stainless Steel Tube with
Reed Connector | Same |
| Stimulation
Probe | No changes | Stainless steel wire coated w/
titanium nitride and insulated
tubing | Same |
| Stimulation
Cable | No changes | 2m long Cable for connecting
external peripheral nerve
stimulator with Stimulation
Probe, StimRouter Loader or
StimRouter Lead Adaptor | Same |
| Introducer
Set | No changes | 11cm long dilator & sheath
used for routing stimulation
end of Lead from incision to
target stimulation point | Same |
| Lead Adaptor | No changes | 5.5 cm stainless steel cylinder
which connects to Lead,
allowing connection of
Stimulation cable | Same |
| Gel
Electrodes | No changes | Nonsterile gel electrodes
(5cm diameter) used when
stimulation applied to
Stimulation Probe or
Stimulation Lead. Comes
with 1.5m long electrode
cable | Same |
| | Subject Device (Modified StimRouter) | Predicate (StimRouter cleared in K200482) | Equivalency Assessment |
| External Pulse Generator | No changes | Implantation requires the use of a 510(k) cleared External Pulse Generator (such as Dakmed 750 DPNS, cleared in K791047) to verify correct placement of StimRouter lead | Same |
| | User Kit | | |
| Name | External Electrical Field Conductor (E-EFC) | External Pulse Transmitter (EPT) | Similar. The different product names do not affect safety and effectiveness of intended use. |
| EWD Description | Generates stimulation signals, transmitting them transcutaneously through StimRouter Electrode to StimRouter Lead. Responds to wireless commands MAPP or CPS, or configuration requests from CPS. Snaps onto StimRouter Electrode; contains a rechargeable lithium battery. | Generates stimulation signals, transmitting them transcutaneously through StimRouter Electrode to StimRouter Lead. Responds to wireless commands from Patient Programmer or CPS, or to configuration requests from CPS. Snaps onto StimRouter Electrode; contains a rechargeable lithium battery. | Similar. The E-EFC is substantially equivalent to the EPT for actions including generation of stimulation signals, transmission of signals through Electrode to Lead. Minor differences in hardware are discussed below. |
| EWD Electronics | E-EFC uses a printed circuit board assembly (PCBA) that includes STMicroelectronics STM32L151 Microcontroller and Nordic Semiconductors nRF52832 Bluetooth LE Module. PCBA-based circuitry generates and transmits electrical stimulation current with embedded waveform parameter settings. | EPT uses a PCBA that includes Texas Instrument TI CC2510F32 DS (26 MHz) and a module that allows for encrypted 2.4 GHz wireless communication. PCBA-based circuitry generates and transmits electrical stimulation current with embedded waveform parameter settings. | Similar. The E-EFC PCBA can generate similar electrical stimulation current output as the EPT (symmetrical / asymmetrical, pulse width, pulse frequency, and pulse amplitude). Differences do not affect safety and effectiveness of intended use. |
| | Subject Device (Modified
StimRouter) | Predicate (StimRouter
cleared in K200482) | Equivalency
Assessment |
| EWD
Software | STMicroelectronics
STM32L151
Microcontroller-specific
firmware. In addition to
controlling the PCBA-based
circuitry, the firmware
processes and executes
wireless commands sent
from MAPP and Clinician
Programmer and received by
the Nordic Semiconductors
nRF52832 Bluetooth LE
Module | In addition to controlling the
PCBA-based circuitry, the
Texas Instrument TI
CC2510F32 DS-specific
firmware processes and
executes wireless commands
sent from Patient
Programmer and Clinician
Programmer | Similar. The E-EFC
firmware is able to
provide substantially
equivalent safety,
efficacy and
functionality as was
provided by EPT
firmware. |
| EWD Wireless
Protocol | BLE wireless protocol | Proprietary 2.4 GHz wireless
protocol | Similar. Bluetooth Low
Energy (BLE) used by
the E-EFC is a widely
adopted wireless
protocol that can use the
2.4 GHz radio
frequency and can
provide encryption of
transmitted data. The
proprietary 2.4 GHz
protocol of the EPT was
written in-house and
also provides
encryption of
transmitted data. |
| EWD Wireless
Control and
Programming | 2.4 GHz BLE
communication used for
control of E-EFC by
Wireless Remote (MAPP)
and control and
programming of E-EFC by
CPS. | Proprietary 2.4 GHz RF
communication used for
control of EPT by Wireless
Remote (Patient
Programmer) and control and
programming of EPT by
Clinician Programmer
Software (CPS) | Similar. The
functionality of the EPT
(control by wireless
remote and control and
programming by CPS)
has been duplicated in
the E-EFC using BLE.
The differences do not
affect safety and
effectiveness of
intended use. |
| EWD
Electrical
Signal
Transmitter | E-EFC has PCBA-based
circuitry that is functionally
equivalent to that of the EPT | EPT has PCBA-based
circuitry that generates and
transmits the therapeutic
electrical signal | Similar. The E-EFC
circuitry is functionally
equivalent to the EPT
circuitry. The
differences do not affect
safety and effectiveness
of intended use. |
| | Subject Device (Modified
StimRouter) | Predicate (StimRouter
cleared in K200482) | Equivalency
Assessment |
| EWD Charger
Port | E-EFC uses USB-C charging
port | EPT uses Barrel Charging
port | Similar. The USB-C-
type charging port is
functionally equivalent
to the EPT barrel port.
The differences do not
affect safety and
effectiveness of
intended use. |
| EWD Built-in
Control
Interface | E-EFC has integrated controls
(buttons) that allow the user to
turn the device on/off, turn the
stimulation on/off, increase or
decrease therapy levels. | EPT has no onboard buttons
for controlling EPT. | Similar. With the
exception of the On/Off
button, all other
functions provided by
the E-EFC integrated
button controls were
previously provided by
the EPT's Patient
Programmer. Therefore,
the addition of
integrated button
controls does not affect
safety and effectiveness
of intended use |
| EWD Status
Indicators | E-EFC has an LED built into
one of the multi-functional
built-in buttons. The LED can
indicate charging, standby
mode, stimulation mode, low
battery, error, action required
and pairing mode. | EPT has an integrated LED
indicator to indicate when
charging is occurring. | Similar. The new
functions of the E-EFC
were previously
provided by the Patient
Programmer. Therefore,
these differences do not
affect safety and
effectiveness of
intended use |
| EWD
Enclosure:
Externally
Contacting
Materials | E-EFC:
Housing: TritanTM
Copolyester MX731
Button overlay: Polycarbonate
polyform
Snap connector: CDA 260
Brass 200 Series S.S | ABS/PC-PBT | Similar. As with the
EPT ABS/PC-PBT
externally contacting
enclosure material, the
E-EFC enclosure
material was confirmed
to be biocompatible for
the type and duration of
contact as per ISO
10993-1. |
| EWD
Enclosure:
Size and
Weight | E-EFC: 5.7 x 3.7 x 1.2 cm,
28g | EPT: 5.7 x 3.2 x 1.2 cm, 20g | Similar. The E-EFC is
slightly larger and
slightly heavier than the
EPT, but the differences
do not affect safety and
effectiveness of
intended use. |
| | Subject Device (Modified
StimRouter) | Predicate (StimRouter
cleared in K200482) | Equivalency
Assessment |
| EWD Delivery
of Energy | E-EFC delivers
transcutaneous electrical
pulses via hydrogel patch
attached to the skin over the
implanted receiver. | EPT delivers transcutaneous
electrical pulses via hydrogel
patch attached to the skin
over the implanted receiver. | Same. The delivery of
energy remains
unchanged. |
| EWD
Stimulation | E-EFC Max output: 30mA
Monopolar, Biphasic, Charge
Balanced,
Pulse Freq: 1-200 Hz,
Max Compliance Voltage:
130V,
Charge per phase limit:15 µC
Ramp Up/Down feature
Amplitude at Lead: 0-5mA
(20% max pick-up ratio)
Stimulation Signal:
Monopolar | EPT Max output: 30mA
Monopolar, Biphasic, Charge
Balanced,
Pulse Freq: 1-200 Hz,
Max Compliance Voltage:
100V,
Charge per phase limit:15 µC
Ramp Up/Down feature
Amplitude at Lead: 0-5mA
(20% max pick-up ratio)
Stimulation Signal:
Monopolar | Similar
E-EFC max compliance
voltage increased to
130V.
Since both the EPT and
E-EFC are current
controlled stimulators,
the maximal delivered
current or other
stimulation parameters
did not change. Increase
in max compliance
voltage allows delivery
of the required current
into higher impedance,
thus providing the
therapy to a wider range
of patient skin
impedances. This
difference in hardware
does not affect safety
and effectiveness of the
intended use. |
| | Subject Device (Modified
StimRouter) | Predicate (StimRouter
cleared in K200482) | Equivalency
Assessment |
| EWD Phase
Duration | Pulse Width: 100-500 $\mu$ sec
(Positive Phase Duration
Values: 100, 200, 300, 400,
500 $\mu$ sec)
Negative Phase Duration for
Asymmetric Waveforms:
Three times positive phase
duration | Pulse Width: 70-500 $\mu$ sec
(Positive Phase Duration
Values: 70, 100, 150, 200,
250, 300, 350, 400, 450, 500
$\mu$ sec)
Negative Phase Duration for
Asymmetric Waveforms:
Four times positive phase
duration | The reduction in
number of positive
phase duration values
(due to a simplified
code base) does not
affect safety and
effectiveness of the
intended use because
minor adjustments can
be made to other
parameters to create
therapeutic programs
equivalent to those
provided by the EPT.
The change in relative
duration of the negative
phase of asymmetric
waveforms does not
affect the safety or
effectiveness because of
the following:
- Because E-EFC
stimulation is still
charged balanced ,the
physiological response
range/impact is
equivalent to that of the
predicate. - The positive phase
remains physiologically
dominant. - Fine tuning of
amplitude parameters to
create therapeutic
programs is equivalent
to those provided by
EPT. |
| EWD
Stimulation
Frequencies | No change | 1, 2, 5, 10, 12, 15, 20, 30, 40,
50, 60, 70, 80, 90, 100, 120,
140, 160, 180, 200 Hz | Same |
| Wireless Remote Control: Accessory for Controlling EWD | | | |
| | Subject Device (Modified
StimRouter) | Predicate (StimRouter
cleared in K200482) | Equivalency
Assessment |
| Electronic
Platform | Smartphone operating
system running MAPP
software with a graphical
user interface to change E-
EFC therapy programs and
parameters via 2.4 GHz BLE
protocol. E-EFC therapy
| PCBA running firmware and
button interface to change
EPT therapy programs and
parameters via 2.4 GHz
proprietary wireless protocol.
EPT therapy programs are
loaded by CPS into Patient
Programmer in case EPT
needs to be replaced. | Similar. MAPP
software uses a
graphical user interface
to allow changes to the
E-EFC therapy
programs via a BLE
protocol that reproduces
the functions of the
EPT. Differences do not
affect safety and
effectiveness of the
intended use. |
| Wireless
Protocol | Smartphone running MAPP
software uses 2.4 GHz BLE
protocol to communicate
with E-EFC | Patient Programmer uses 2.4
GHz proprietary wireless
protocol to communicate
with EPT | Similar. The BLE
protocol provides the
same functionality as
the 2.4 GHz proprietary
protocol (i.e., effective
wireless communication
and encrypted data).
Differences do not
affect safety and
effectiveness of the
intended use. |
| Software /
Firmware
Capabilities | Smartphone running MAPP
can select one of 8 pre-set
therapy programs, start/stop
therapy on E-EFC, increase /
decrease amplitude of
therapy signal and provide
status readout for paired E-
EFC. | Patient Programmer can
select one of 8 pre-set
therapy programs, start/stop
therapy on EPT, increase /
decrease amplitude of
therapy signal and provide
status readout for paired EPT. | Similar. Smartphone
running MAPP software
replicates all of Patient
Programmers
capabilities. Differences
do not affect safety and
effectiveness of the
intended use. |
| Remote
Control
Required? | Optional | Required | Similar. Because of the
integrated control
buttons of the E-EFC,
the use of MAPP is
optional, but it is as
functional as the Patient
Programmer.
Differences do not
affect safety and
effectiveness of the
intended use. |
| | Subject Device (Modified
StimRouter) | Predicate (StimRouter
cleared in K200482) | Equivalency
Assessment |
| StimRouter
Electrodes | No change | Reusable electrodes with gel
pad that adhere to skin and
transmit EPT stimulation
signal to StimRouter Lead,
Includes 2 snaps for EPT
attachment | Same. |
| Clinician Kit | | | |
| Clinician's Programmer | | | |
| Electronic
Platform | Clinician Programmer
Software (CPS) runs on
Vanquisher IP67 8-inch
tablet running Window 10
Home. Built-in Bluetooth
functionality is used. | Clinician Programmer
Software (CPS) runs on
Vanquisher IP67 8-inch
tablet running Window 10
Home. Built-in Bluetooth
functionality is not used. | Similar. The new
version of the CPS runs
on the same electronic
platform, although now
the Bluetooth
functionality of the
tablet is used.
Differences in software
do not affect safety and
effectiveness of the
intended use. |
| Wireless
Protocol | 2.4 GHz Bluetooth Low
Energy (BLE) protocol used
to program E-EFC directly | CPS uses attached Patient
Programmer and proprietary
2.4 GHz RF protocol to
program EPT | Similar. The CPS can
now program the E-
EFC directly where
previously, it needed to
be connected to the
Patient Programmer.
Differences do not
affect safety and
effectiveness of
intended use. |
| Software | Updated Clinician
Programmer Software can
perform the same functions
as the original CPS but uses
BLE to send wireless
commands directly to the E-
EFC. | The Clinician Programmer
Software is used for storing
patient info, session data,
logs, patient stimulation
profile, programming,
testing, and saving of
stimulation programs on
tablet. In addition, the CPS
allows for downloading of
programs to the EPT using
wireless commands sent via
the Patient Programmer using
proprietary 2.4 GHz RF | Similar, but differences
do not affect safety and
effectiveness of
intended use: - BLE vs. 2.4 GHz
proprietary protocol:
Equivalent capabilities. - Although fewer
positive phase duration
values are available in
new CPS, substantially
equivalent therapies can
be created using other
available parameters. |
| | Subject Device (Modified
StimRouter) | Predicate (StimRouter
cleared in K200482) | Equivalency
Assessment |
| EWD Tester | No changes | The EPT Tester is used to
confirm that the EPT is
delivering stimulation by
providing audio feedback
when stimulation is applied. | Same. The same EPT
Tester can be used,
unchanged, to confirm
that the E-EFC is
delivering stimulation
via audio feedback. |
Predicate Device Comparison Matrix
6
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Performance Testing
The StimRouter Neuromodulation System was qualified through the following :
- Electrical compatibility and safety ●
- Wireless coexistence
- Biocompatibility Testing
- Shipping and storage
- Shelf life ●
- Functional Verification ●
- Usability ●
- Software Verification and Validation Testing ●
VII. Conclusions
Bioness concludes that the StimRouter Neuromodulation System is substantially equivalent to its predicate, the StimRouter Neuromodulation System cleared in K200482, and does not raise any new issues or concerns of safety or effectiveness.