StimRouter Neuromodulation System

K200482 · Bioness, Inc. · GZF · Mar 27, 2020 · Neurology

Device Facts

• Record ID: K200482
• Device Name: StimRouter Neuromodulation System
• Applicant: Bioness, Inc.
• Product Code: GZF · Neurology
• Decision Date: Mar 27, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5870
• Device Class: Class 2
• Attributes: Therapeutic

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.

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); patient programmer; clinician programmer; disposable hydrogel electrode patch. EPT mounts on skin via electrode patch; transmits electrical signals transcutaneously to implanted lead receiver; lead delivers stimulation to target nerve. Clinician uses tablet-based software to program stimulation parameters (frequency, amplitude, pulse width). Patient uses handheld programmer to start/stop stimulation and adjust intensity. Used in clinical settings for implantation; patient manages therapy at home. Modification allows open surgical implantation (e.g., during nerve decompression) in addition to percutaneous approach. Benefits include pain relief; risks managed via standard surgical fixation techniques (sutures/glue).

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design control activities, risk assessment, and the determination that the alternative surgical implantation procedure utilizes standard, well-understood surgical techniques that do not alter the device's safety or performance profile.

Technological Characteristics

Implantable lead: helical coil design, silicone insulator, platinum-iridium electrodes (6.3 mm² surface area). EPT: rechargeable lithium battery, RF-based communication. Stimulation: monopolar, biphasic, charge-balanced, 1-200 Hz, 70-500 µsec pulse width, max 30mA output. Connectivity: wireless RF between patient programmer and EPT. Sterilization: not specified. Software: Windows 10-based clinician programmer.

Indications for Use

Indicated for adults with severe intractable chronic pain of peripheral nerve origin as an adjunct to other therapies (e.g., medications). 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 (K190047)

Submission Summary (Full Text)

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March 27, 2020

Bioness Inc. Sageev George Senior Regulatory Affairs Specialist 25103 Rye Canyon Loop Valencia, California 91355

Re: K200482

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: February 25, 2020 Received: February 27, 2020

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/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

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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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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) K200482

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)

| <span style="font-family: Arial, sans-serif;"> <span style="font-size: 10pt;"> <span style="font-style: normal;"> <span style="font-variant-ligatures: normal;"> <span style="font-variant-caps: normal;"> <span style="font-weight: 400;"> <span style="letter-spacing: normal;"> <span style="orphans: 2;"> <span style="text-align:start;"> <span style="text-indent: 0px;"> <span style="text-transform: none;"> <span style="white-space: normal;"> <span style="widows: 2;"> <span style="word-spacing: 0px;"> <span style="-webkit-text-stroke-width: 0px;"> <span style="text-decoration-thickness: initial;"> <span style="text-decoration-style: initial;"> <span style="text-decoration-color: initial;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> |
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| <span style="font-family: Arial, sans-serif;"> <span style="font-size: 10pt;"> <span style="font-style: normal;"> <span style="font-variant-ligatures: normal;"> <span style="font-variant-caps: normal;"> <span style="font-weight: 400;"> <span style="letter-spacing: normal;"> <span style="orphans: 2;"> <span style="text-align:start;"> <span style="text-indent: 0px;"> <span style="text-transform: none;"> <span style="white-space: normal;"> <span style="widows: 2;"> <span style="word-spacing: 0px;"> <span style="-webkit-text-stroke-width: 0px;"> <span style="text-decoration-thickness: initial;"> <span style="text-decoration-style: initial;"> <span style="text-decoration-color: initial;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> |

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Image /page/3/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. There is also a small orange dot above the "i" in "Bioness".

# 3. 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.<br>25103 Rye Canyon Loop<br>Valencia, CA 91355 USA<br>Phone Number: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| | Contact: | Sageev George<br>Regulatory Affairs Manager, Implantables<br>Phone Number: [phone]<br>Fax Number: [phone]<br>Email: [e-mail]<br><br>Mercedes Bayani<br>Global Vice-President, Clinical & Regulatory Affairs<br>Phone Number: [phone]<br>Fax Number: [phone]<br>Email: [e-mail] |
| | Date Prepared: | February 25, 2020 |
| II. | Name of Device | |
| | Device Trade Name: | StimRouter Neuromodulation System |
| | Classification Name: | Implantable peripheral nerve stimulator for pain relie |
| | 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): | K190047 |

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Image /page/4/Picture/0 description: The image shows the logo for Bioness. The logo consists of an orange starburst-like symbol on the left, followed by the word "Bioness" in gray, with an orange dot above the "i". There is a registered trademark symbol to the right of the word.

#### Device Description IV.

The StimRouter Neuromodulation System consists of two main parts - the implantable lead, and the external (to the body) accessories. 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 StimRouter Neuromodulation System is provided with three labeling documents: the Clinician's Guide, the Procedure Manual and the User's Guide. Only the Procedure Manual has been modified to include an alternative implantation procedure for situations in which an open implantation of the implantable StimRouter Lead is indicated

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

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.

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Image /page/5/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 star-like symbol is made up of several curved lines that converge in the center. The word "Bioness" is written in a sans-serif font, and there is a small circle above the "s" at the end of the word.

#### Comparison of Technological Characteristics VI.

The subject device is a modified version of the StimRouter Neuromodulation System previously cleared in K190047. A comparison of the technological characteristics of the two is presented below. As noted in the Predicate Device Comparison Matrix below, other than the update of the Procedure Manual to include an alternative implantation procedure for situations in which an open implantation of the implantable StimRouter Lead is indicated, there are no other modifications with respect to the K190047 predicate all other technological characteristics are equivalent.

| | Subject Device (Modified<br>StimRouter) | Predicate (StimRouter<br>cleared in K190047) | Equivalency<br>Assessment |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Bioness Inc. | Bioness Inc. | Same |
| 510(k) number | To be Determined | K190047 | - |
| 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 to<br>other modes of therapy (e.g.,<br>medications). The<br>StimRouter is not intended to<br>treat pain in the craniofacial<br>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 to<br>other modes of therapy (e.g.,<br>medications). The<br>StimRouter is not intended to<br>treat pain in the craniofacial<br>region. | Same |
| | Implantable Lead and Lead Introducer Kit | | |
| Packaging | | | |
| Packaging | No changes | Tray Material: PETG<br>Lid Material: 1073B Tyvek<br>Lid Adhesive: TPT-021C | Same |
| StimRouter Lead | | | |
| StimRouter Lead | No changes | Implanted Lead: Length:<br>15cm, Diameter: 1.2mm,<br>Helical coil design, Anchors,<br>silicone insulator sheathe | Same |
| StimRouter Lead<br>Receiver End | No changes | 12mm receiver electrode,<br>captures portion of signal<br>generated by EPT | Same |
| StimRouter Lead<br>Stimulating End | No changes | 3 cylindrical stimulating<br>electrodes: Materials:<br>Platinum Iridium, Surface<br>Area: 6.3 mm², Max charge<br>per pulse: 3 µC, Max charge<br>density: 15.9 µC/cm² | Same |
| Introduction method | No changes | Percutaneous | Same |
| Tunneling Needle and<br>Tunneling Needle<br>Stylet | No changes | Stainless steel hollow needle<br>and solid stylet used to<br>implant receiver end of Lead | Same |
| | Subject Device (Modified<br>StimRouter) | Predicate (StimRouter<br>cleared in K190047) | Equivalency<br>Assessment |
| StimRouter Loader | No changes | Stainless Steel Tube with<br>Reed Connector | Same |
| Stimulation Probe | No changes | Stainless steel wire coated w/<br>titanium nitride and insulated<br>tubing | Same |
| Stimulation Cable | No changes | 2m long Cable for connecting<br>external peripheral nerve<br>stimulator with Stimulation<br>Probe, StimRouter Loader or<br>StimRouter Lead Adaptor | Same |
| Introducer Set | No changes | 11cm long dilator & sheath<br>used for routing stimulation<br>end of Lead from incision to<br>target stimulation point | Same |
| Lead Adaptor | No changes | 5.5 cm stainless steel cylinder<br>which connects to Lead,<br>allowing connection of<br>Stimulation cable | Same |
| Gel Electrodes | No changes | Nonsterile gel electrodes<br>(5cm diameter) used when<br>stimulation applied to<br>Stimulation Probe or<br>Stimulation Lead. Comes<br>with 1.5m long electrode<br>cable | Same |
| Clinician Kit | | | |
| Clinician's Programmer | | | |
| Hardware | No changes | Vanquisher IP67 8-inch<br>tablet running Window 10<br>Home | Same |
| Software | No changes | Clinician Programmer<br>Software used for storing<br>patient info, session data,<br>logs, patient stimulation<br>profile, and programming,<br>testing and saving of<br>stimulation programs on<br>tablet, and downloading of<br>programs to Patient<br>Programmer and EPT | Same |
| Stimulation Frequencies<br>available for Patient<br>Programmer and EPT<br>stimulation programs | No changes | 1, 2, 5, 10, 12, 15, 20, 30, 40,<br>50, 60, 70, 80, 90, 100, 120,<br>140, 160, 180, 200 Hz | Same |
| | Subject Device (Modified StimRouter) | Predicate (StimRouter cleared in K190047) | Equivalency Assessment |
| Tester | No changes | Used to confirm EPT is delivering stimulation by providing audio feedback when stimulation is applied | Same |
| | User Kit | | |
| External Pulse Transmitter (EPT) | | | |
| External Pulse Transmitter Description | No change | Generates stimulation signals, transmitting them transcutaneously through StimRouter Electrode to StimRouter Lead. Responds to wireless commands from Patient Programmer. Snaps onto StimRouter Electrode, Rechargeable lithium battery | Same |
| EPT Stimulation | No Change | EPT Max output: 30mA,<br>Amplitude at Lead: 0-5mA (20% max pick-up ratio)<br>Stimulation Signal:<br>Monopolar, Biphasic, Charge Balanced, RF-based,<br>Pulse Freq: 1-200 Hz, Max Compliance Voltage: 100V,<br>Pulse Width: 70-500 µsec, Charge per phase limit:15 µC<br>Ramp Up/Down feature | Same |
| EPT 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 |
| Patient Programmer | | | |
| Patient Programmer Description | No change | Communicates wirelessly (RF) with EPT to do the following: start/stop stimulation, adjust stimulation intensity, selection of one of 8 possible stimulation programs | Same |
| Patient Programmer 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…