(295 days)
No
The summary does not mention AI, ML, or any related technologies in the device description, intended use, or performance studies. The focus is on electrical stimulation and programming of the device.
Yes
The device is indicated for "pain management in adults who have severe intractable chronic pain of peripheral nerve origin" and provides "electrical stimulation via an implanted lead to a target peripheral nerve, for aid in the management of severe, intractable, chronic pain." This directly indicates a therapeutic purpose.
No
The device is indicated for pain management and provides electrical stimulation; it does not diagnose a condition.
No
The device description clearly outlines multiple hardware components including an implantable lead, external pulse transmitter, and a tablet PC, in addition to the software.
Based on the provided information, the StimRouter Neuromodulation System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- StimRouter Function: The StimRouter Neuromodulation System is an implantable medical device that delivers electrical stimulation directly to a peripheral nerve to manage chronic pain. It does not involve the analysis of specimens taken from the body.
- Intended Use: The intended use clearly states it's for "pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy." This is a therapeutic application, not a diagnostic one based on in vitro analysis.
- Device Description: The description details an implantable lead and external components for delivering electrical pulses. There is no mention of collecting or analyzing biological samples.
Therefore, the StimRouter Neuromodulation System falls under the category of an active implantable medical device used for therapeutic purposes, not an In Vitro Diagnostic device.
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 (comma separated list FDA assigned to the subject device)
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 patient programmer, disposable hydrogel electrode patch, external pulse transmitter (EPT), and an EPT stimulation tester (EPTT).
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 EPT 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 StimRouter patient programmer and the EPT. The components of the Clinician Kit are a tablet PC with programming software and the accessories for connecting to the Patient Programmer and the EPT.
The User Kit contains the patient-use components of the StimRouter System. The components are the Patient Programmer and the EPT. After the EPT is programmed, the StimRouter electrode interfaces with the EPT and function to delivery stimulation 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, not in the craniofacial region
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)
Risk Analysis methods were used to assess the impact of the modifications of the original StimRouter Neuromodulation System and to determine the verification and validation activities required based on the Risk Analysis. The Risk Analysis methods, the verification and validation activities required, including methods and tests used and their acceptance criteria applied, are provided in the Design Controls section of this submission. The verification and validation activities required the following bench tests, originally developed under the design control process of the StimRouter Neuromodulation System cleared in K142432:
- Bioburden
- Sterilization & Shelf-life Testing ●
- Biocompatibility Testing ●
- Shelf Life
- Shipping Validation
- Package Integrity (Bubble Leak Testing, Seal Strength Testing)
- Functional Verification and Validation
- Label Validation
- Printing Verification
- MRI Compatibility
- Implant Heating ●
- Software Verification and Validation Testing
The verification and validation activities described above demonstrate that the subject device StimRouter Neuromodulation System, which has modifications as compared to the predicate StimRouter Neuromodulation System (cleared in K142432), is substantially equivalent to the predicate device in terms of safety and effectiveness for its indication of 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 subject device continues to not be intended to treat pain in the craniofacial region.
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.
K142432, K904409/A, K920567, K982902, K000582
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.
K904409/A, K920567, K982902, K000852
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
§ 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).
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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below.
October 31, 2019
Bioness Inc. Sageev George Senoir Regulatory Affairs Specialist 25103 Rye Canyon Loop Valencia, California 91355
Re: K190047
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: September 30, 2019 Received: October 1, 2019
Dear 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/cfpmr/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 mediation-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.
Pamela D. Scott -S
Pamela Scott 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) K190047
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) |
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Image /page/3/Picture/0 description: The image shows the logo for Bioness. The logo consists of an orange sun-like symbol on the left, followed by the word "Bioness" in gray. The "i" in Bioness is dotted with an orange circle, matching the color of the sun symbol. A small registration mark is present to the right of the word.
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) 902-5324 | ||
| Fax: (661) 362-4851 | ||
| Email: mercedes.bayani@bioness.com | ||
| Contact: | Sageev George | |
| Senior Regulatory Affairs Specialist | ||
| Phone Number: (661) 902-5336 | ||
| Fax Number: (661) 362-4851 | ||
| Email: sageev.george@bioness.com | ||
| Mercedes Bayani | ||
| Global Director, Clinical & Regulatory Affairs | ||
| Phone Number: (661) 902-5324 | ||
| Fax Number: (661) 362-4851 | ||
| Email: mercedes.bayani@bioness.com | ||
| Date Prepared: | January 7, 2019 | |
| II. | Name of Device | |
| Device Trade Name: | StimRouter Neuromodulation System | |
| Classification Name: | Implantable peripheral nerve stimulator for pain relief | |
| Common Name: | Implantable Neurostimulator | |
| Product Code: | GZF | |
| Regulation Number: | 21 CFR §882.5870 | |
| Device Class: | Class II | |
| Panel Identification: | Neurology | |
| III. | Predicate Device | |
| Predicate Manufacturer: | Bioness Inc. | |
| Predicate Trade Name: | StimRouter Neuromodulation System | |
| Predicate 510(k): | K142432 | |
| Reference Devices: | ||
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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 sun-like symbol has eight orange lines radiating from a central point. The word "Bioness" is in a sans-serif font, and there is a registered trademark symbol next to the last "s".
| Predicate Manufacturer: | Medtronic |
|---|---|
| Predicate Trade Name: | PNS |
| Predicate 510(k): | K904409/A, K920567, K982902 |
| Predicate Manufacturer: | ANS |
| Predicate Trade Name: | Renew |
| Predicate 510(k): | K000582 |
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 patient programmer, disposable hydrogel electrode patch, external pulse transmitter (EPT), and an EPT stimulation tester (EPTT).
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 EPT 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 StimRouter patient programmer and the EPT. The components of the Clinician Kit are a tablet PC with programming software and the accessories for connecting to the Patient Programmer and the EPT.
The User Kit contains the patient-use components of the StimRouter System. The components are the Patient Programmer and the EPT. After the EPT is programmed, the StimRouter electrode interfaces with the EPT and function to delivery stimulation to the implanted lead receiver.
V. Indications for Use
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Image /page/5/Picture/0 description: The image contains the logo for Bioness. The logo consists of an orange star-like symbol on the left and the word "Bioness" in gray on the right. The star-like symbol is made up of several orange lines that converge towards the center. The word "Bioness" is written in a sans-serif font, with a small orange dot above the "i".
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.
Comparison of Technological Characteristics VI.
The subject device is a modified version of the StimRouter Neuromodulation System previously cleared in K142432. A comparison of the technological characteristics of the two is presented below:
| | Subject Device (Modified
StimRouter) | Predicate (Original
StimRouter) | Equivalency
Assessment |
|-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Bioness Inc. | Bioness Inc. | Same |
| 510(k) number | To be Determined | K142432 | - |
| 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 |
| Packaging | | | |
| Packaged Kit(s) | "Implantable Lead and Lead
Introducer Kit" | "Lead Kit" and "Surgical
Kit" | Similar*
New packaging is just
consolidation of Lead
Kit and Surgical Kit |
| Inner Tray Material | Blue tinted PETE
(Polyethylene
Terephthalate): Large
history of use in medical
device industry | Blue tinted PETG
(Polyethylene Terephthalate
Glycol): Large history of
use in medical device
industry | Similar*
Contract manufacturer
confirmed equivalence
thru qualification
(PETE has better
impact resistance) |
| Tray Lid | 1073B Tyvek (DuPont) | 1073B Tyvek (DuPont) | Same |
| Tray Lid Adhesive | Heat Seal Coated
TPT-021C adhesive: Large
history of use in medical
device industry | Heat Seal Coated
CR-27 adhesive: Large
history of use in medical
device industry | Similar*
Contract manufacturer
confirmed equivalence
thru qualification |
| StimRouter Lead | | | |
| Number of stimulating
electrodes | 3 | Same | Same |
| Electrode shape | Cylindrical | Same | Same |
| Estimated electrode
surface area, per
electrode | $6.3 mm^2$ | Same | Same |
| Maximum charge per
pulse (lead) | $3 \mu C$ | $2 \mu C$ | Similar
Safety is maintained
because of limit on
max current (30mA)
and max pulse
duration (500µsec).
Max value is lower
than that of similar
devices, and complies
with safety
requirements. |
| Maximum charge
density (lead) | $15.9 \mu C/cm^2$ | $10.6 \mu C/cm^2$ | Similar
Safety is maintained
because of limit on
max current (30mA)
and max pulse
duration (500µsec).
Max value is lower
than that of similar
devices, and complies
with safety
requirements. |
| Materials (electrode /
Insulator | Platinum Iridium
Silicone Rubber | Same | Same |
| Location of stimulation
receiver | Implanted, RF lead receiver
transmitter | Same | Same |
| Design features | Helical coil design
Single silicone insulator
sheath | Same | Same |
| Anchors | Yes | Same | Same |
| Lead Length | 15 cm | Same | Same |
| Lead body diameter | 1.2 mm | Same | Same |
| Implantation / Placer
Tools | StimRouter Surgical Tool
Kit | Same | Same |
| Introduction method | Percutaneous | Same | Same |
| Tunneling Needle and Tunneling Needle Stylet | | | |
| Tunneling Needle
Material | 304 Stainless Steel
(SST 304)
(No Nickel warning, unlike
predicate) | SST 304 with nickel plating
on handles/hubs (Presence
of nickel required Nickel
allergy warning in labeling) | Similar
Nickel was used to
make soldering easier
between needle and
handle/hub in
predicate. Adequate
soldering without
nickel was confirmed
by vendor in subject
device |
| Tunneling Needle Size | 12 Gauge | 12 Gauge | Same |
| StimRouter Loader | No changes | Same | Same |
| Stimulation Probe | No changes | Same | Same |
| Stimulation Cable | No changes | Same | Same |
| Introducer Set | No changes | Same | Same |
| Lead Adaptor | No changes | Same | Same |
| Gel Electrodes | No changes | Same | Same |
| Clinician Kit | | | |
| Clinician's Programmer | | | |
| Hardware | Vanquisher IP67 8-inch
tablet (off-the-shelf) with
new charger and connector
cable with Micro-SD Card
storage | Hewlett Packard iPAQ 210
Enterprise Handheld PDA
(off-the-shelf) with SD Card
storage | Similar*
IP67 is physically
larger than the PDA
and runs substantially
equivalent software
(recompiled for IP67
Operating System) |
| Clinician Programmer
Operating System | Microsoft® Windows 10
Home | Microsoft® Windows
Mobile® 5 | Similar*
Same code can run in
Windows 10 Home |
| Location of programmer | External | Same | Same |
| Software driven? | Yes | Same | Same |
| Size of programmer | Hand-held | Same | Same |
| Multiple stim modes? | Yes | Same | Same |
| Graphical User Interface
(GUI) | Original GUI adjusted to fit
a larger area (8") of screen | Yes | Similar*
Same GUI contents |
| Stimulation Frequencies | 1, 2, 5, 10, 12 , 15 , 20, 30,
40, 50, 60, 70, 80, 90, 100,
120, 140, 160, 180, 200 Hz | 1, 2, 5, 10, 20, 30, 40, 50,
60, 70, 80, 90, 100, 120,
140, 160, 180, 200 Hz | Similar
Added frequencies
(12, 15 Hz) w/in
original stimulation
range |
| Patient Log Export
Function in the software | Yes | No | Similar*
Minor change that just
adds a function |
| Miscellaneous Software
Enhancements | Updates to remove obsolete
event buffering procedure,
to allow co-installation of
CPS software with H200
and L300 Go software | Software did not have these
enhancements | Similar*
Minor enhancements
to code that do not
change function |
| Tester | No changes | Same | Same |
| User Kit | | | |
| External Pulse Transmitter (EPT) | | | |
| Power source | One lithium polymer,
rechargeable battery | Same | Same |
| Location of transmitter | External | Same | Same |
| Amplitude current | 0-5 mA
(estimate based on 20%
max pick-up ratio, max
output of EPT of 30 mA) | Same | Same |
| Communication method | RF | Same | Same |
| Pulse frequency | 1-200 Hz | Same | Same |
| Stimulation Frequencies | 1, 2, 5, 10, 12 , 15 , 20, 30,
40, 50, 60, 70, 80, 90, 100,
120, 140, 160, 180, 200 Hz | 1, 2, 5, 10, 20, 30, 40, 50,
60, 70, 80, 90, 100, 120,
140, 160, 180, 200 Hz | Similar
Added frequencies
(12, 15 Hz) w/in
original stimulation
range |
| Ramp Down Feature | Present
Provides smooth transition
for patient where pulse
amplitude is slowly
decreased over time for
comfort | Not present | Similar*
Stimulation pulse with
ramp down has same
paresthesia effect and
may provide more
comfort |
| Maximum Compliance
Voltage | 100V (higher voltage to
treat patients w/ high skin
impedance or who need
higher current settings to
achieve therapeutic effect) | 90V | Similar*
Safety is maintained
because of limit on
max current (30mA)
and max EPT external
temperature (41°C) |
| Pulse width | 70-500 μsec | Same | Same |
| Charge per phase limit | 15 μC
Non-rechargeable batteries
are no longer supported so
charge limitation is not
required | 10 μC
Included in original design
to support non-rechargeable
batteries (prevented
depletion) | Similar*
Safety is maintained
because of limit on
max current (30mA)
and max pulse
duration (500µsec) |
| Wave form | Biphasic, charge balanced | Same | Same |
| Stimulation modality | Monopolar | Same | Same |
| Miscellaneous Software
Enhancements | Software update to prevent
false positive detection of
transistor disconnection and
improve impedance
measurement of electrodes | Original software did not
have enhancements | Similar*
Update provides better
detection of conditions
and unnecessary
termination of
stimulation |
| Patient Programmer | | | |
| Stimulation Frequencies | 1, 2, 5, 10, 12 , 15 , 20, 30,
40, 50, 60, 70, 80, 90, 100,
120, 140, 160, 180, 200 Hz | 1, 2, 5, 10, 20, 30, 40, 50,
60, 70, 80, 90, 100, 120,
140, 160, 180, 200 Hz | Similar
12 Hz and 15 Hz are
both within the original
stimulation range |
| Number of programs | 8 | Same | Same |
| Programs patient
selectable? | Yes | Same | Same |
| Programmer
communication method
with EPT | RF | Same | Same |
| Location of programmer | External | Same | Same |
| Software driven? | Yes | Same | Same |
| Multiple stim modes? | Yes | Same | Same |
| Graphical User Interface
(GUI) | Yes | Same | Same |
| Miscellaneous Software
Enhancements | Updates to prevent
connection with interfering
EPTs, to prevent use of
buggy RF channels | Original software did not
have enhancements | Similar*
Software updates
improve reliability of
connection with EPT |
| StimRouter Electrodes | No change | Same | Same |
Predicate Device Comparison
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Image /page/6/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.
Special 510(k) Notification Supplement
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Image /page/7/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 sun-like symbol is made up of several orange lines that radiate outward from a central point. The word "Bioness" is written in a sans-serif font, and there is a small orange dot above the "i" in "Bioness".
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Image /page/8/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 sun-like symbol has eight orange lines radiating from the center. The word "Bioness" is in a sans-serif font, and there is a small circle above the "ss".
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Image /page/9/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 sun-like symbol has eight orange rays emanating from a central point. The word "Bioness" is in a sans-serif font, with a small orange dot above the "i". There is a registered trademark symbol next to the word "Bioness".
- This technology change does not impact the intended use or the operating principles or mechanism of action of the system
Comparison of Revised Stimulation Parameters
As noted in the above Predicate Device Comparison Matrix, certain stimulation parameters have increased values. However, the subject device uses parameters that are within the safe ranges of the predicates of the original StimRouter cleared in K142432, and which are used as reference devices in this submission. The following table illustrates these parameters and how the subject device falls within these safe ranges:
| Receivers and
Transmitters | StimRouter
Implantable
Neurostimulator
(current
version) | StimRouter
Implantable
Neurostimulator
(as submitted in
K142432) | REFERENCE 1
Medtronic PNS
(K904409/A,
K920567,
K982902) | REFERENCE 2
Renew System
(K000852) |
|------------------------------------------------------------|--------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|-----------------------------------------------------------------|
| Number of
stimulating
electrodes | 3 | 3 | 4 | 4 |
| Surface area per
electrode | 6.3 mm² | 6.3 mm² | 12 mm² | 13 mm² |
| Total area of
stimulating
electrodes | 18.9 mm² | 18.9 mm² | 48 mm² | 52 mm² |
| Amplitude
current | 0-6mA
(estimate based
on 20% max
pick-up ratio,
max output of
EPT of 30 mA) | 0-6mA
(estimate based
on 20% max
pick-up ratio,
max output of
EPT of 30 mA) | Up to 20 mA | 24 mA
(estimate based
on 12V max
output, 500Ω
load) |
| Pulse frequency | 1-200 Hz | 1-200 Hz | 5-240 Hz
(Mattrix) | 10-1,500 Hz |
| Pulse width | 70-500 µsec | 70-500 µsec | 60-450 µsec | 50-500 µsec |
| Maximum
average current | 1.2 mA | 1.2 mA | 4.3 mA | Information not
publicly
available |
| Receivers and
Transmitters | StimRouter
Implantable
Neurostimulator
(current
version) | StimRouter
Implantable
Neurostimulator
(as submitted in
K142432) | REFERENCE 1
Medtronic PNS
(K904409/A,
K920567,
K982902) | REFERENCE 2
Renew System
(K000852) |
| Maximum
current (rms) | 2.7 mA | 2.7 mA | 9.3 mA | Information not
publicly
available |
| Maximum
average current
density | 6.3 mA/cm² | 6.3 mA/cm² | 9.0 mA/cm² | Information not
publicly
available |
| Maximum
average power
density (into 500
Ohm load) | 19.2 mW/cm² | 19.2 mW/cm² | 90.1 mW/cm² | Information is
not available |
| Maximum charge
per pulse | 3 µC
(estimate based
on 20% max
pick-up ratio,
max output of
EPT of 30 mA) | 3 µC
(estimate based
on 20% max
pick-up ratio,
max output of
EPT of 30 mA) | 20 µC | 12 µC
(estimate based
on 12V max
output, 500Ω
load) |
| Maximum charge
density | 15.9 µC/cm²
(estimate based
on 20% max
pick-up ratio,
max output of
EPT of 30 mA) | 15.9 µC/cm²*
(estimate based
on 20% max
pick-up ratio,
max output of
EPT of 30 mA) | 160 µC/cm²
(X-trel) | 92.3 µC/cm² |
| Wave form | Biphasic, charge
balanced | Biphasic, charge
balanced | Rectangular,
biphasic current
outputs | Information not
publicly
available |
| Stimulation
modality | Monopolar | Monopolar | Bipolar | Bipolar |
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Image /page/10/Picture/0 description: The image shows the logo for Bioness. The logo consists of an orange star-like symbol on the left and the word "Bioness" in gray on the right. The dot over the "i" in "Bioness" is orange, matching the color of the star-like symbol.
Performance Data
Risk Analysis methods were used to assess the impact of the modifications of the original StimRouter Neuromodulation System and to determine the verification and validation activities required based on the Risk Analysis. The Risk Analysis methods, the verification and validation activities required, including methods and tests used and their acceptance criteria applied, are provided in the Design Controls section of this submission. The verification and validation activities required the following bench tests, originally developed under the design control process of the StimRouter Neuromodulation System cleared in K142432:
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- Bioburden
- Sterilization & Shelf-life Testing ●
- Biocompatibility Testing ●
- Shelf Life
- Shipping Validation
- Package Integrity (Bubble Leak Testing, Seal Strength Testing)
- Functional Verification and Validation
- Label Validation
- Printing Verification
- MRI Compatibility
- Implant Heating ●
- Software Verification and Validation Testing
VII. Conclusions
The verification and validation activities described above demonstrate that the subject device StimRouter Neuromodulation System, which has modifications as compared to the predicate StimRouter Neuromodulation System (cleared in K142432), is substantially equivalent to the predicate device in terms of safety and effectiveness for its indication of 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 subject device continues to not be intended to treat pain in the craniofacial region.