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 Description

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 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.

AI/ML Overview

This document is a 510(k) premarket notification for a modified version of the StimRouter Neuromodulation System. It's a submission to the FDA to demonstrate substantial equivalence to a previously cleared device, not a report of a new clinical study proving effectiveness with specific acceptance criteria in the traditional sense of a clinical trial.

Therefore, many of the requested categories related to clinical study design, ground truth establishment, expert adjudication, and comparative effectiveness studies are not applicable or directly provided in this type of regulatory document. This document focuses on demonstrating that a modification to an already cleared device does not introduce new questions of safety or effectiveness.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a table of quantitative acceptance criteria and reported device performance because it's a 510(k) submission for a modification to a previously cleared device (K190047). The primary "acceptance criterion" for a 510(k) is demonstrating "substantial equivalence" to a predicate device, which largely relies on showing that the modifications do not raise new questions of safety or effectiveness and that the technological characteristics are similar or that any differences do not affect safety or effectiveness.

The document states:

"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."
"The new procedure is being provided for situations in which the surgical field has been previously opened and does not introduce additional risks to the patient. Also, the new method of placing the Lead allows for similarly effective stimulation of target nerve and receipt of stimulation from EPT."
"Bioness Inc. concludes that the Risks vs. Benefits assessment remains unchanged, where the benefits accrued from the use of the device outweigh any identified residual risk."

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not applicable. This document is not a clinical study report with a test set of patients. It's a regulatory submission for a device modification. The assessment is based on design controls and a comparison to a predicate device.
Data Provenance: Not applicable for a traditional test set. The "data" used for this submission are the design specifications, risk analysis, and comparison to the predicate device's existing clearance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. There is no traditional "test set" of medical cases requiring ground truth established by experts in the context of this 510(k) submission for a modification. The assessment of the modification's impact is internal to the manufacturer's design control process and reviewed by the FDA.

4. Adjudication Method for the Test Set:

Not applicable for the same reasons as #3.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically conducted to evaluate diagnostic devices or imaging systems where human readers interpret results, often with and without AI assistance. The StimRouter Neuromodulation System is a therapeutic implantable device, and this submission concerns a change in its implantation procedure.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. The StimRouter is a physical neuromodulation system, not an algorithm, and its use inherently involves human practitioners (implanting physicians and patient interaction with the programmer).

7. The Type of Ground Truth Used:

The "ground truth" implicitly used here relies on the established safety and effectiveness of the predicate device (K190047) and the engineering and clinical assessment that the proposed modification (alternative implantation procedure) does not alter that established safety and effectiveness or introduce new risks. The risk assessment considers potential harms, but clinical outcomes data from a specific study for this modification is not presented as "ground truth."

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that requires a training set of data.

9. How the Ground Truth for the Training Set Was Established:

Not applicable for the same reasons as #8.

In summary: This document is an FDA 510(k) premarket notification for a modification to an existing medical device. It relies on demonstrating substantial equivalence to a predicate device, which is different from a clinical study that establishes performance against specific acceptance criteria for a novel device or AI algorithm. The focus here is on showing that the minor change (an alternative implantation procedure described in updated labeling) does not negatively impact the safety and effectiveness profile already established for the predicate device.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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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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.25103 Rye Canyon LoopValencia, CA 91355 USAPhone Number: (661) 902-5324Fax: (661) 362-4851Email: mercedes.bayani@bioness.com
	Contact:	Sageev GeorgeRegulatory Affairs Manager, ImplantablesPhone Number: (661) 902-5336Fax Number: (661) 362-4851Email: sageev.george@bioness.comMercedes BayaniGlobal Vice-President, Clinical & Regulatory AffairsPhone Number: (661) 902-5324Fax Number: (661) 362-4851Email: mercedes.bayani@bioness.com
	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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Device Description IV.

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.

V. Indications for Use

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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 (ModifiedStimRouter)	Predicate (StimRoutercleared in K190047)	EquivalencyAssessment
Manufacturer	Bioness Inc.	Bioness Inc.	Same
510(k) number	To be Determined	K190047	-
Intended use	The StimRouterNeuromodulation System™is indicated for painmanagement in adults whohave severe intractablechronic pain of peripheralnerve origin, as an adjunct toother modes of therapy (e.g.,medications). TheStimRouter is not intended totreat pain in the craniofacialregion.	The StimRouterNeuromodulation System™is indicated for painmanagement in adults whohave severe intractablechronic pain of peripheralnerve origin, as an adjunct toother modes of therapy (e.g.,medications). TheStimRouter is not intended totreat pain in the craniofacialregion.	Same
	Implantable Lead and Lead Introducer Kit
Packaging
Packaging	No changes	Tray Material: PETGLid Material: 1073B TyvekLid 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
StimRouter LeadReceiver End	No changes	12mm receiver electrode,captures portion of signalgenerated by EPT	Same
StimRouter LeadStimulating End	No changes	3 cylindrical stimulatingelectrodes: Materials:Platinum Iridium, SurfaceArea: 6.3 mm², Max chargeper pulse: 3 µC, Max chargedensity: 15.9 µC/cm²	Same
Introduction method	No changes	Percutaneous	Same
Tunneling Needle andTunneling NeedleStylet	No changes	Stainless steel hollow needleand solid stylet used toimplant receiver end of Lead	Same
	Subject Device (ModifiedStimRouter)	Predicate (StimRoutercleared in K190047)	EquivalencyAssessment
StimRouter Loader	No changes	Stainless Steel Tube withReed Connector	Same
Stimulation Probe	No changes	Stainless steel wire coated w/titanium nitride and insulatedtubing	Same
Stimulation Cable	No changes	2m long Cable for connectingexternal peripheral nervestimulator with StimulationProbe, StimRouter Loader orStimRouter Lead Adaptor	Same
Introducer Set	No changes	11cm long dilator & sheathused for routing stimulationend of Lead from incision totarget stimulation point	Same
Lead Adaptor	No changes	5.5 cm stainless steel cylinderwhich connects to Lead,allowing connection ofStimulation cable	Same
Gel Electrodes	No changes	Nonsterile gel electrodes(5cm diameter) used whenstimulation applied toStimulation Probe orStimulation Lead. Comeswith 1.5m long electrodecable	Same
Clinician Kit
Clinician's Programmer
Hardware	No changes	Vanquisher IP67 8-inchtablet running Window 10Home	Same
Software	No changes	Clinician ProgrammerSoftware used for storingpatient info, session data,logs, patient stimulationprofile, and programming,testing and saving ofstimulation programs ontablet, and downloading ofprograms to PatientProgrammer and EPT	Same
Stimulation Frequenciesavailable for PatientProgrammer and EPTstimulation programs	No changes	1, 2, 5, 10, 12, 15, 20, 30, 40,50, 60, 70, 80, 90, 100, 120,140, 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,Amplitude at Lead: 0-5mA (20% max pick-up ratio)Stimulation Signal:Monopolar, Biphasic, Charge Balanced, RF-based,Pulse Freq: 1-200 Hz, Max Compliance Voltage: 100V,Pulse Width: 70-500 µsec, Charge per phase limit:15 µCRamp 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	Same
	Subject Device (ModifiedStimRouter)	Predicate (StimRoutercleared in K190047)	EquivalencyAssessment
StimRouter Electrodes	No change	Reusable electrodes with gelpad that adhere to skin andtransmit EPT stimulationsignal to StimRouter Lead,Includes 2 snaps for EPTattachment	Same
Labeling: Update to Procedure Manual (MODIFIED FROM PREDICATE)Addition of New Section Detailing Alternative Implantation Procedure for StimRouter LeadSummary: The new section provides details on the implantation of the StimRouter Lead when openimplantation of the Lead is indicated and treating physician believes that the StimRouter System would beuseful in treating the pain associated with target nerve.
Implantation of LeadProcedure	The updated ProcedureManual still includes theminimally invasive procedurefor Lead implantation butincludes an alternate implantprocedure for situations whereopen implantation of the Leadis indicated, for examplewhen the area around thetarget nerve has been exposed(e.g., nerve decompressionprocedures). The newprocedure details how theLead can be placed andfixated next to target nerveand how the TunnelingNeedle and Stylet can be usedto place receiver end of Lead.	The Procedure Manual detailsa minimally invasiveprocedure for implanting theStimRouter Lead using asingle stab incision,Stimulator Probe for targetpoint identification, insertionof the Lead stimulating endusing Introducer Set, andinsertion of Lead receiver endusing Tunneling Needle andStylet.	Similar: The newprocedure is beingprovided forsituations in whichthe surgical fieldhas been previouslyopened and doesnot introduceadditional risks tothe patient. Also,the new method ofplacing the Leadallows for similarlyeffectivestimulation of targetnerve and receipt ofstimulation fromEPT.

Predicate Device Comparison

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Design Control Activities

Bioness Inc. established, and continues to document and maintain, a system for identifying and addressing hazards associated with the design, manufacture and use of a medical device throughout its lifecycle. This system includes procedures for estimating, evaluating, controlling, and/or reducing risk such that the medical benefit outweighs the residual risk associated with the use of the devices that are marketed by Bioness Inc. These procedures address the risk management requirements of ISO 13485, ISO 14971:2012, the Medical Device Directive (MDD) and the Quality System Regulation (QSR).

This system was used to assess the impact of the modifications of the original StimRouter Neuromodulation System and to determine what verification and validation activities may be

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required based on this assessment. The methods and results of the Risks vs. Benefits Assessment are provided in the Design Controls section of this submission. The results of the analysis are as follows:

Verification activities are not required, as there is no change to the design of the ● StimRouter.
Validation activities are not required - lead placement using this alternate approach is visible to the implanting physician due to the open nature of the procedure. The novel component involved during StimRouter lead implantation using this alternate technique is the process of using sutures and/or surgical glue to anchor the lead and prevent migration. These are commonly used surgical procedures employed by trained physicians and are not unique to the StimRouter implantation. As such, these process steps do not require usability testing.
The potential hazardous situation resulting from the alternate surgical approach has been identified as "Undesired motor neuron stimulation, due to poor placement of the lead during implant or migration after implant". The specific harm associated with this failure mode has the same end effect (severity) as overstimulation of contraindicated nerves – a failure mode which is currently listed within the risk documentation (HA-00011) and the current state of the art information. As such, the Risk vs. Benefits assessment remains unchanged, where the benefits accrued from the use of the device outweigh any identified residual risk.

VII. Conclusions

Based on the system maintained by Bioness Inc. for identifying and addressing hazards associated with the design, manufacture and use of a medical device throughout its lifecycle, Bioness Inc. concludes that the Risks vs. Benefits assessment remains unchanged, where the benefits accrued from the use of the device outweigh any identified residual risk. Therefore, the subject device StimRouter Neuromodulation System, which has modifications as compared to the predicate StimRouter Neuromodulation System (cleared in K190047), 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.

Regulation Number and Section

§ 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).