StimRouter Neuromodulation System

K190047 · Bioness, Inc. · GZF · Oct 31, 2019 · Neurology

Device Facts

• Record ID: K190047
• Device Name: StimRouter Neuromodulation System
• Applicant: Bioness, Inc.
• Product Code: GZF · Neurology
• Decision Date: Oct 31, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5870
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

StimRouter Neuromodulation System provides electrical stimulation to peripheral nerves for chronic pain management. System components: implantable multielectrode lead with integrated receiver, external pulse transmitter (EPT), clinician programmer (tablet PC with software), patient programmer, and disposable hydrogel electrode patch. Physician implants lead percutaneously; EPT mounts on skin via electrode patch. EPT transmits electrical signals transcutaneously to lead receiver, which delivers stimulation to target nerve. Clinician uses tablet software to program stimulation parameters (frequency, amplitude, pulse width). Patient uses patient programmer to control stimulation settings within clinician-defined limits. Device operates via RF communication between programmers and EPT. Stimulation is biphasic, charge-balanced, and monopolar. System aids in pain management, potentially reducing reliance on other therapies like medications.

Clinical Evidence

Bench testing only. No clinical data presented. Verification and validation activities included bioburden, sterilization, shelf-life, biocompatibility, package integrity, functional verification, label/printing validation, MRI compatibility, implant heating, and software verification.

Technological Characteristics

Implantable lead: 3 platinum-iridium electrodes, silicone rubber insulator, helical coil design, 15cm length, 1.2mm diameter. EPT: lithium polymer rechargeable battery, RF communication, 0-6mA current, 1-200Hz frequency, 70-500µsec pulse width. Clinician programmer: Windows 10 tablet. Packaging: PETE tray, Tyvek lid. Sterilization: Not specified. Software: Rule-based control of stimulation parameters.

Indications for Use

Indicated for adults with severe intractable chronic pain of peripheral nerve origin as an adjunct to other therapies. Not for craniofacial pain.

Regulatory Classification

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.

Predicate Devices

• StimRouter Neuromodulation System (K142432)
• Medtronic PNS (K904409/A, K920567, K982902)
• Renew (K000582)

Submission Summary (Full Text)

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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

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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 [phone] 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

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# 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)

| <div> <span> <span style="font-size:16px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|--------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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: [phone] |
| | | Fax: [phone] |
| | | Email: [e-mail] |
| | Contact: | Sageev George |
| | | Senior Regulatory Affairs Specialist |
| | | Phone Number: [phone] |
| | | Fax Number: [phone] |
| | | Email: [e-mail] |
| | | Mercedes Bayani |
| | | Global Director, Clinical & Regulatory Affairs |
| | | Phone Number: [phone] |
| | | Fax Number: [phone] |
| | | Email: [e-mail] |
| | 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<br>StimRouter) | Predicate (Original<br>StimRouter) | Equivalency<br>Assessment |
|-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Bioness Inc. | Bioness Inc. | Same |
| 510(k) number | To be Determined | K142432 | - |
| Intended use | The StimRouter<br>Neuromodulation System™<br>is indicated for pain<br>management in adults who<br>have severe intractable<br>chronic pain of peripheral<br>nerve origin, as an adjunct<br>to other modes of therapy<br>(e.g., medications). The<br>StimRouter is not intended<br>to treat pain in the<br>craniofacial region. | The StimRouter<br>Neuromodulation System™<br>is indicated for pain<br>management in adults who<br>have severe intractable<br>chronic pain of peripheral<br>nerve origin, as an adjunct<br>to other modes of therapy<br>(e.g., medications). The<br>StimRouter is not intended<br>to treat pain in the<br>craniofacial region. | Same |
| Packaging | | | |
| Packaged Kit(s) | "Implantable Lead and Lead<br>Introducer Kit" | "Lead Kit" and "Surgical<br>Kit" | Similar*<br>New packaging is just<br>consolidation of Lead<br>Kit and Surgical Kit |
| Inner Tray Material | Blue tinted PETE<br>(Polyethylene<br>Terephthalate): Large<br>history of use in medical<br>device industry | Blue tinted PETG<br>(Polyethylene Terephthalate<br>Glycol): Large history of<br>use in medical device<br>industry | Similar*<br>Contract manufacturer<br>confirmed equivalence<br>thru qualification<br>(PETE has better<br>impact resistance) |
| Tray Lid | 1073B Tyvek (DuPont) | 1073B Tyvek (DuPont) | Same |
| Tray Lid Adhesive | Heat Seal Coated<br>TPT-021C adhesive: Large<br>history of use in medical<br>device industry | Heat Seal Coated<br>CR-27 adhesive: Large<br>history of use in medical<br>device industry | Similar*<br>Contract manufacturer<br>confirmed equivalence<br>thru qualification |
| StimRouter Lead | | | |
| Number of stimulating<br>electrodes | 3 | Same | Same |
| Electrode shape | Cylindrical | Same | Same |
| Estimated electrode<br>surface area, per<br>electrode | $6.3 mm^2$ | Same | Same |
| Maximum charge per<br>pulse (lead) | $3 \mu C$ | $2 \mu C$ | <b>Similar</b><br>Safety is maintained<br>because of limit on<br>max current (30mA)<br>and max pulse<br>duration (500µsec).<br>Max value is lower<br>than that of similar<br>devices, and complies<br>with safety<br>requirements. |
| Maximum charge<br>density (lead) | $15.9 \mu C/cm^2$ | $10.6 \mu C/cm^2$ | <b>Similar</b><br>Safety is maintained<br>because of limit on<br>max current (30mA)<br>and max pulse<br>duration (500µsec).<br>Max value is lower<br>than that of similar<br>devices, and complies<br>with safety<br>requirements. |
| Materials (electrode /<br>Insulator | Platinum Iridium<br>Silicone Rubber | Same | Same |
| Location of stimulation<br>receiver | Implanted, RF lead receiver<br>transmitter | Same | Same |
| Design features | Helical coil design<br>Single silicone insulator<br>sheath | Same | Same |
| Anchors | Yes | Same | Same |
| Lead Length | 15 cm | Same | Same |
| Lead body diameter | 1.2 mm | Same | Same |
| Implantation / Placer<br>Tools | StimRouter Surgical Tool<br>Kit | Same | Same |
| Introduction method | Percutaneous | Same | Same |
| Tunneling Needle and Tunneling Needle Stylet | | | |
| Tunneling Needle<br>Material | 304 Stainless Steel<br>(SST 304)<br>(No Nickel warning, unlike<br>predicate) | SST 304 with nickel plating<br>on handles/hubs (Presence<br>of nickel required Nickel<br>allergy warning in labeling) | <b>Similar</b><br>Nickel was used to<br>make soldering easier<br>between needle and<br>handle/hub in<br>predicate. Adequate<br>soldering without<br>nickel was confirmed<br>by vendor in subject<br>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<br>tablet (off-the-shelf) with<br>new charger and connector<br>cable with Micro-SD Card<br>storage | Hewlett Packard iPAQ 210<br>Enterprise Handheld PDA<br>(off-the-shelf) with SD Card<br>storage | Similar*<br>IP67 is physically<br>larger than the PDA<br>and runs substantially<br>equivalent software<br>(recompiled for IP67<br>Operating System) |
| Clinician Programmer<br>Operating System | Microsoft® Windows 10<br>Home | Microsoft® Windows<br>Mobile® 5 | Similar*<br>Same code can run in<br>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<br>(GUI) | Original GUI adjusted to fit<br>a larger area (8") of screen | Yes | Similar*<br>Same GUI contents |
| Stimulation Frequencies | 1, 2, 5, 10, <b>12</b> , <b>15</b> , 20, 30,<br>40, 50, 60, 70, 80, 90, 100,<br>120, 140, 160, 180, 200 Hz | 1, 2, 5, 10, 20, 30, 40, 50,<br>60, 70, 80, 90, 100, 120,<br>140, 160, 180, 200 Hz | Similar<br>Added frequencies<br>(12, 15 Hz) w/in<br>original stimulation<br>range |
| Patient Log Export<br>Function in the software | Yes | No | Similar*<br>Minor change that just<br>adds a function |
| Miscellaneous Software<br>Enhancements | Updates to remove obsolete<br>event buffering procedure,<br>to allow co-installation of<br>CPS software with H200<br>and L300 Go software | Software did not have these<br>enhancements | Similar*<br>Minor enhancements<br>to code that do not<br>change function |
| Tester | No changes | Same | Same |
| User Kit | | | |
| External Pulse Transmitter (EPT) | | | |
| Power source | One lithium polymer,<br>rechargeable battery | Same | Same |
| Location of transmitter | External | Same | Same |
| Amplitude current | 0-5 mA<br>(estimate based on 20%<br>max pick-up ratio, max<br>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, <b>12</b> , <b>15</b> , 20, 30,<br>40, 50, 60, 70, 80, 90, 100,<br>120, 140, 160, 180, 200 Hz | 1, 2, 5, 10, 20, 30, 40, 50,<br>60, 70, 80, 90, 100, 120,<br>140, 160, 180, 200 Hz | Similar<br>Added frequencies<br>(12, 15 Hz) w/in<br>original stimulation<br>range |
| Ramp Down Feature | Present<br>Provides smooth transition<br>for patient where pulse<br>amplitude is slowly<br>decreased over time for<br>comfort | Not present | Similar*<br>Stimulation pulse with<br>ramp down has same<br>paresthesia effect and<br>may provide more<br>comfort |
| Maximum Compliance<br>Voltage | 100V (higher voltage to<br>treat patients w/ high skin<br>impedance or who need<br>higher current settings to<br>achieve therapeutic effect) | 90V | Similar*<br>Safety is maintained<br>because of limit on<br>max current (30mA)<br>and max EPT external<br>temperature (41°C) |
| Pulse width | 70-500 μsec | Same | Same |
| Charge per phase limit | 15 μC<br>Non-rechargeable batteries<br>are no longer supported so<br>charge limitation is not<br>required | 10 μC<br>Included in original design<br>to support non-rechargeable<br>batteries (prevented<br>depletion) | Similar*<br>Safety is maintained<br>because of limit on<br>max current (30mA)<br>and max pulse<br>duration (500µsec) |
| Wave form | Biphasic, charge balanced | Same | Same |
| Stimulation modality | Monopolar | Same | Same |
| Miscellaneous Software<br>Enhancements | Software update to prevent<br>false positive detection of<br>transistor disconnection and<br>improve impedance<br>measurement of electrodes | Original software did not<br>have enhancements | Similar*<br>Update provides better<br>detection of conditions<br>and unnecessary<br>termination of<br>stimulation |
| Patient Programmer | | | |
| Stimulation Frequencies | 1, 2, 5, 10, <b>12</b> , <b>15</b> , 20, 30,<br>40, 50, 60, 70, 80, 90, 100,<br>120, 140, 160, 180, 200 Hz | 1, 2, 5, 10, 20, 30, 40, 50,<br>60, 70, 80, 90, 100, 120,<br>140, 160, 180, 200 Hz | Similar<br>12 Hz and 15 Hz are<br>both within the original<br>stimulation range |
| Number of programs | 8 | Same | Same |
| Programs patient<br>selectable? | Yes | Same | Same |
| Programmer<br>communication method<br>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<br>(GUI) | Yes | Same | Same |
| Miscellaneous Software<br>Enhancements | Updates to prevent<br>connection with interfering<br>EPTs, to prevent use of<br>buggy RF channels | Original software did not<br>have enhancements…