(244 days)
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 consists of two main parts - the implantable lead, and the external (to the body) accessories for the StimRouter include a clinician programmer with software (CPS), a disposable hydrogel electrode patch, an external pulse transmitter, an external pulse transmitter stimulation tester and a device used by the patient to wirelessly control the external pulse transmitter. The StimRouter Neuromodulation System is provided with three labeling documents: the Clinician's Guide, the Procedure Manual and the User's Guide. The complete StimRouter System consists of three kits: a Lead and Lead Introducer Kit, a Clinician Kit and User Kit. The Lead Kit contains the StimRouter implantable multielectrode lead with integrated receiver, used for peripheral nerve stimulation. The Lead receives an electrical signal transmitted transcutaneously by the external pulse transmitter which is mounted on an electrode patch on the skin and delivers that electrical signal down the lead's length to a target peripheral nerve. The Lead is supplied in Lead Loader that is used during intraoperative testing of the lead and to verify proper placement during implantation. The Lead and Lead Introducer Kit consists of two stimulation probes, two stimulation cables, and introducer set, a lead adapter, a Tunneling Needle, and a Tunneling Needle Stylet. The included tools and components allow for insertion of the StimRouter Lead and confirmation of optimal location of the stimulation electrode contacts of the StimRouter Lead. The Clinician Kit is used for the programming of the external pulse transmitter. The components of the Clinician Kit are a tablet PC with programming software that is capable of connecting to and configuring the external pulse transmitter. The User Kit contains the patient-use components of the StimRouter System. The components are the External Electric Field Conductor (E-EFC), an external pulse transmitter, with included charger and the StimRouter Electrode Carrying Case. After the E-EFC is programmed, the E-EFC can be connected to the StimRouter Electrode through which it can deliver stimulation transcutaneously to the implanted lead receiver.
The provided text describes a 510(k) premarket notification for the StimRouter Neuromodulation System, arguing for its substantial equivalence to a previously cleared predicate device (K200482). The submission primarily focuses on comparing the technological characteristics of the new device (modified StimRouter) with the predicate, rather than presenting a study with specific acceptance criteria and performance data for a standalone algorithmic device.
Therefore, many of the requested details about acceptance criteria, specific device performance metrics, sample sizes for test/training sets, ground truth establishment, and multi-reader multi-case studies are not available in the provided document. The document describes a comparison study, not a standalone performance study as would be typical for an AI/ML device.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document as specific numerical acceptance criteria and corresponding reported device performance for an algorithm's classification or prediction capabilities. The document describes a comparison of technical characteristics between the modified StimRouter and its predicate, rather than reporting performance against predefined acceptance criteria.
The "Equivalency Assessment" column in the table on pages 5-6 indicates similarity to the predicate and states that differences do not affect safety and effectiveness of intended use. For example:
- EWD Electrical Signal Transmitter: "Similar. The E-EFC circuitry is functionally equivalent to the EPT circuitry. The differences do not affect safety and effectiveness of intended use."
- EWD Phase Duration: "The reduction in number of positive phase duration values (due to a simplified code base) does not affect safety and effectiveness of the intended use because minor adjustments can be made to other parameters to create therapeutic programs equivalent to those provided by the EPT."
- EWD Max Compliance Voltage: The E-EFC's maximum compliance voltage increased to 130V from the predicate's 100V. The assessment states: "This difference in hardware does not affect safety and effectiveness of the intended use."
2. Sample size used for the test set and the data provenance
Not applicable/Not provided. This document does not describe a study involving a test set of data for evaluating an AI/ML algorithm's performance. The "performance testing" mentioned on page 15 refers to electrical compatibility, wireless coexistence, biocompatibility, shipping, storage, shelf life, functional verification, usability, and software verification/validation—these are not related to a data-driven performance evaluation with a test set in the context of AI.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. As there is no described test set or ground truth establishment in the context of an AI/ML algorithm's performance, this information is not present.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable/Not provided. This submission is for a neuromodulation system, not an AI/ML diagnostic or assistive device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable/Not provided. The device described is a physical neuromodulation system, not a standalone algorithm. The software components are for controlling the device (CPS, MAPP app) and are evaluated through software verification and validation, not standalone diagnostic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable/Not provided.
8. The sample size for the training set
Not applicable/Not provided. No AI/ML training is described.
9. How the ground truth for the training set was established
Not applicable/Not provided.
Summary of the Study Performed (as described in the document):
The "study" described in the 510(k) submission is a comparison of technological characteristics and performance testing to demonstrate substantial equivalence to a predicate device (StimRouter Neuromodulation System cleared in K200482).
The core of the submission (pages 5-6) is a detailed table comparing the "Subject Device (Modified StimRouter)" to the "Predicate (StimRouter cleared in K200482)" across numerous technical attributes, including:
- Manufacturer, 510(k) number, Intended use (all identical)
- Implantable Lead and Lead Introducer Kit components (packaging, lead characteristics, introduction method, tools) - indicated as "No changes" or "Same"
- User Kit accessories (External Electrical Field Conductor (E-EFC) vs. External Pulse Transmitter (EPT), MAPP Smartphone Application vs. Patient Programmer)
- Clinician Kit accessories (Modified Clinician's Programming Software (CPS) vs. original CPS)
The "Equivalency Assessment" column justifies why any differences (e.g., changes in electronics, wireless protocol, charging port, integrated controls, maximum compliance voltage, or phase duration values) do not affect the safety and effectiveness of the intended use, arguing that similar functionality is maintained or improved.
Performance Testing Mentioned (page 15):
The document lists "Performance Testing" categories that the StimRouter Neuromodulation System was qualified through:
- Electrical compatibility and safety
- Wireless coexistence
- Biocompatibility Testing
- Shipping and storage
- Shelf life
- Functional Verification
- Usability
- Software Verification and Validation Testing
These tests are standard for medical devices and demonstrate the device's adherence to relevant standards and its functional capabilities, rather than an AI/ML algorithm's data-driven performance. The document concludes that based on these comparisons and performance tests, the modified StimRouter is substantially equivalent to its predicate and does not raise new safety or effectiveness concerns.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and 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 square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 22, 2022
Bioness Inc. Sageev George, Ph.D. Regulatory Affairs Manager, Implantables 25103 Rye Canyon Loop Valencia, California 91355
Re: K211965
Trade/Device Name: StimRouter Neuromodulation System Regulation Number: 21 CFR 882.5870 Regulation Name: Implanted Peripheral Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: GZF Dated: January 21, 2022 Received: January 24, 2022
Dear Dr. Sageev George:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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,
Amber Ballard, Ph.D. Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211965
Device Name StimRouter Neuromodulation System
Indications for Use (Describe)
The StimRouter Neuromodulation System is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy (e.g., medications). The StimRouter is not intended to treat pain in the craniofacial region.
Type of Use (Select one or both, as applicable):
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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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) 388-9303Fax: (661) 362-4851Email: sageev.george@bioness.com | |
| Contact: | Sageev GeorgeSenior Regulatory Affairs Manager, ImplantablesBioness Inc.Phone Number: (661) 388-9303Fax Number: (661) 362-4851Email: sageev.george@bioness.com | |
| Sharon KlugewiczSr. Vice President, Quality & Regulatory AffairsBioventus Inc.Phone Number: (516) 425-4446Email: sklugewicz@misonix.com | ||
| Date Prepared: | January 21, 2022 | |
| II. | Name of Device | |
| Device Trade Name:Classification Name: | StimRouter Neuromodulation SystemImplantable peripheral nerve stimulator for painrelief | |
| Common Name: | Implantable Neurostimulator | |
| Product Code: | GZF | |
| Regulation Number: | 21 CFR §882.5870 | |
| Device Class:Panel Identification: | Class IINeurology | |
| III. | Predicate Device | |
| Predicate Manufacturer: | Bioness Inc. |
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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 "i" in Bioness has an orange dot above it. There is a registered trademark symbol to the right of the word Bioness.
Predicate Trade Name: Predicate 510(k):
StimRouter Neuromodulation System K200482
IV. Device Description
The StimRouter Neuromodulation System consists of two main parts - the implantable lead, and the external (to the body) accessories for the StimRouter include a clinician programmer with software (CPS), a disposable hydrogel electrode patch, an external pulse transmitter, an external pulse transmitter stimulation tester and a device used by the patient to wirelessly control the external pulse transmitter. The StimRouter Neuromodulation System is provided with three labeling documents: the Clinician's Guide, the Procedure Manual and the User's Guide.
The Bioness StimRouter Neuromodulation System is intended to provide electrical stimulation via an implanted lead to a target peripheral nerve, for aid in the management of severe, intractable, chronic pain of peripheral nerve origin in adults, as an adjunct to other modes of therapy (e.g. medications). The StimRouter is not intended to treat pain in the craniofacial region.
The complete StimRouter System consists of three kits: a Lead and Lead Introducer Kit, a Clinician Kit and User Kit. The Lead Kit contains the StimRouter implantable multielectrode lead with integrated receiver, used for peripheral nerve stimulation. The Lead receives an electrical signal transmitted transcutaneously by the external pulse transmitter which is mounted on an electrode patch on the skin and delivers that electrical signal down the lead's length to a target peripheral nerve. The Lead is supplied in Lead Loader that is used during intraoperative testing of the lead and to verify proper placement during implantation.
The Lead and Lead Introducer Kit consists of two stimulation probes, two stimulation cables, and introducer set, a lead adapter, a Tunneling Needle, and a Tunneling Needle Stylet. The included tools and components allow for insertion of the StimRouter Lead and confirmation of optimal location of the stimulation electrode contacts of the StimRouter Lead.
The Clinician Kit is used for the programming of the external pulse transmitter. The components of the Clinician Kit are a tablet PC with programming software that is capable of connecting to and configuring the external pulse transmitter.
The User Kit contains the patient-use components of the StimRouter System. The components are the External Electric Field Conductor (E-EFC), an external pulse transmitter, with included charger and the StimRouter Electrode Carrying Case. After the E-EFC is programmed, the E-EFC can be connected to the StimRouter Electrode through which it can deliver stimulation transcutaneously to the implanted lead receiver.
V. Indications for Use
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Image /page/5/Picture/0 description: The image shows the logo for Bioness. The logo consists of an orange sun-like symbol on the left and the word "Bioness" in gray on the right. There is an orange dot above the "i" in Bioness. There is a registered trademark symbol next to the last "s" in Bioness.
The StimRouter Neuromodulation System is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy (e.g., medications). The StimRouter is not intended to treat pain in the craniofacial region.
LiveOn™
VI. Comparison of Technological Characteristics
The table below compares the principles of operation and operational/technological characteristics for the subject device and the predicate device. These comparisons confirm that the subject and predicate devices have very similar overall principles of operation and operational/technological characteristics, thereby support the substantial equivalence of the subject device to the predicate. Except for three accessories, the subject device is identical to the predicate. The three accessories, the External Electrical Field Conductor, the MAPP Smartphone Application, and a modified version of the Clinician's Programming Software, are newer versions of three accessories of the predicate, the External Pulse Transmitters, the Patient Programmer, and the original Clinician's Programming Software. These new accessories will replace the accessories in the system. The table below confirms that the three new subject device accessories have equivalent functionality to the predicate's accessories that they will replace.
| Subject Device (ModifiedStimRouter) | Predicate (StimRoutercleared in K200482) | EquivalencyAssessment | |
|---|---|---|---|
| Manufacturer | Bioness Inc. | Bioness Inc. | Same |
| 510(k) number | K211965 | K200482 | - |
| 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 | No changes | Tray Material: PETGLid Material: 1073B TyvekLid Adhesive: TPT-021C | Same |
| StimRouter Lead | |||
| StimRouterLead | No changes | Implanted Lead: Length:15cm, Diameter: 1.2mm,Helical coil design, Anchors,silicone insulator sheathe | Same |
| Subject Device (ModifiedStimRouter) | Predicate (StimRoutercleared in K200482) | EquivalencyAssessment | |
| StimRouterLead ReceiverEnd | No changes | 12mm receiver electrode,captures portion of signalgenerated by EPT | Same |
| StimRouterLeadStimulatingEnd | No changes | 3 cylindrical stimulatingelectrodes: Materials:Platinum Iridium, SurfaceArea: $6.3 \text{ mm}^2$ , Max chargeper pulse: $3 \mu\text{C}$ , Max chargedensity: $15.9 \mu\text{C/cm}^2$ | Same |
| Introductionmethod | No changes | Percutaneous | Same |
| TunnelingNeedle andTunnelingNeedle Stylet | No changes | Stainless steel hollow needleand solid stylet used toimplant receiver end of Lead | Same |
| StimRouterLoader | No changes | Stainless Steel Tube withReed Connector | Same |
| StimulationProbe | No changes | Stainless steel wire coated w/titanium nitride and insulatedtubing | Same |
| StimulationCable | No changes | 2m long Cable for connectingexternal peripheral nervestimulator with StimulationProbe, StimRouter Loader orStimRouter Lead Adaptor | Same |
| IntroducerSet | 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 |
| GelElectrodes | No changes | Nonsterile gel electrodes(5cm diameter) used whenstimulation applied toStimulation Probe orStimulation Lead. Comeswith 1.5m long electrodecable | Same |
| Subject Device (Modified StimRouter) | Predicate (StimRouter cleared in K200482) | Equivalency Assessment | |
| External Pulse Generator | No changes | Implantation requires the use of a 510(k) cleared External Pulse Generator (such as Dakmed 750 DPNS, cleared in K791047) to verify correct placement of StimRouter lead | Same |
| User Kit | |||
| Name | External Electrical Field Conductor (E-EFC) | External Pulse Transmitter (EPT) | Similar. The different product names do not affect safety and effectiveness of intended use. |
| EWD Description | Generates stimulation signals, transmitting them transcutaneously through StimRouter Electrode to StimRouter Lead. Responds to wireless commands MAPP or CPS, or configuration requests from CPS. Snaps onto StimRouter Electrode; contains a rechargeable lithium battery. | Generates stimulation signals, transmitting them transcutaneously through StimRouter Electrode to StimRouter Lead. Responds to wireless commands from Patient Programmer or CPS, or to configuration requests from CPS. Snaps onto StimRouter Electrode; contains a rechargeable lithium battery. | Similar. The E-EFC is substantially equivalent to the EPT for actions including generation of stimulation signals, transmission of signals through Electrode to Lead. Minor differences in hardware are discussed below. |
| EWD Electronics | E-EFC uses a printed circuit board assembly (PCBA) that includes STMicroelectronics STM32L151 Microcontroller and Nordic Semiconductors nRF52832 Bluetooth LE Module. PCBA-based circuitry generates and transmits electrical stimulation current with embedded waveform parameter settings. | EPT uses a PCBA that includes Texas Instrument TI CC2510F32 DS (26 MHz) and a module that allows for encrypted 2.4 GHz wireless communication. PCBA-based circuitry generates and transmits electrical stimulation current with embedded waveform parameter settings. | Similar. The E-EFC PCBA can generate similar electrical stimulation current output as the EPT (symmetrical / asymmetrical, pulse width, pulse frequency, and pulse amplitude). Differences do not affect safety and effectiveness of intended use. |
| Subject Device (ModifiedStimRouter) | Predicate (StimRoutercleared in K200482) | EquivalencyAssessment | |
| EWDSoftware | STMicroelectronicsSTM32L151Microcontroller-specificfirmware. In addition tocontrolling the PCBA-basedcircuitry, the firmwareprocesses and executeswireless commands sentfrom MAPP and ClinicianProgrammer and received bythe Nordic SemiconductorsnRF52832 Bluetooth LEModule | In addition to controlling thePCBA-based circuitry, theTexas Instrument TICC2510F32 DS-specificfirmware processes andexecutes wireless commandssent from PatientProgrammer and ClinicianProgrammer | Similar. The E-EFCfirmware is able toprovide substantiallyequivalent safety,efficacy andfunctionality as wasprovided by EPTfirmware. |
| EWD WirelessProtocol | BLE wireless protocol | Proprietary 2.4 GHz wirelessprotocol | Similar. Bluetooth LowEnergy (BLE) used bythe E-EFC is a widelyadopted wirelessprotocol that can use the2.4 GHz radiofrequency and canprovide encryption oftransmitted data. Theproprietary 2.4 GHzprotocol of the EPT waswritten in-house andalso providesencryption oftransmitted data. |
| EWD WirelessControl andProgramming | 2.4 GHz BLEcommunication used forcontrol of E-EFC byWireless Remote (MAPP)and control andprogramming of E-EFC byCPS. | Proprietary 2.4 GHz RFcommunication used forcontrol of EPT by WirelessRemote (PatientProgrammer) and control andprogramming of EPT byClinician ProgrammerSoftware (CPS) | Similar. Thefunctionality of the EPT(control by wirelessremote and control andprogramming by CPS)has been duplicated inthe E-EFC using BLE.The differences do notaffect safety andeffectiveness ofintended use. |
| EWDElectricalSignalTransmitter | E-EFC has PCBA-basedcircuitry that is functionallyequivalent to that of the EPT | EPT has PCBA-basedcircuitry that generates andtransmits the therapeuticelectrical signal | Similar. The E-EFCcircuitry is functionallyequivalent to the EPTcircuitry. Thedifferences do not affectsafety and effectivenessof intended use. |
| Subject Device (ModifiedStimRouter) | Predicate (StimRoutercleared in K200482) | EquivalencyAssessment | |
| EWD ChargerPort | E-EFC uses USB-C chargingport | EPT uses Barrel Chargingport | Similar. The USB-C-type charging port isfunctionally equivalentto the EPT barrel port.The differences do notaffect safety andeffectiveness ofintended use. |
| EWD Built-inControlInterface | E-EFC has integrated controls(buttons) that allow the user toturn the device on/off, turn thestimulation on/off, increase ordecrease therapy levels. | EPT has no onboard buttonsfor controlling EPT. | Similar. With theexception of the On/Offbutton, all otherfunctions provided bythe E-EFC integratedbutton controls werepreviously provided bythe EPT's PatientProgrammer. Therefore,the addition ofintegrated buttoncontrols does not affectsafety and effectivenessof intended use |
| EWD StatusIndicators | E-EFC has an LED built intoone of the multi-functionalbuilt-in buttons. The LED canindicate charging, standbymode, stimulation mode, lowbattery, error, action requiredand pairing mode. | EPT has an integrated LEDindicator to indicate whencharging is occurring. | Similar. The newfunctions of the E-EFCwere previouslyprovided by the PatientProgrammer. Therefore,these differences do notaffect safety andeffectiveness ofintended use |
| EWDEnclosure:ExternallyContactingMaterials | E-EFC:Housing: TritanTMCopolyester MX731Button overlay: PolycarbonatepolyformSnap connector: CDA 260Brass 200 Series S.S | ABS/PC-PBT | Similar. As with theEPT ABS/PC-PBTexternally contactingenclosure material, theE-EFC enclosurematerial was confirmedto be biocompatible forthe type and duration ofcontact as per ISO10993-1. |
| EWDEnclosure:Size andWeight | E-EFC: 5.7 x 3.7 x 1.2 cm,28g | EPT: 5.7 x 3.2 x 1.2 cm, 20g | Similar. The E-EFC isslightly larger andslightly heavier than theEPT, but the differencesdo not affect safety andeffectiveness ofintended use. |
| Subject Device (ModifiedStimRouter) | Predicate (StimRoutercleared in K200482) | EquivalencyAssessment | |
| EWD Deliveryof Energy | E-EFC deliverstranscutaneous electricalpulses via hydrogel patchattached to the skin over theimplanted receiver. | EPT delivers transcutaneouselectrical pulses via hydrogelpatch attached to the skinover the implanted receiver. | Same. The delivery ofenergy remainsunchanged. |
| EWDStimulation | E-EFC Max output: 30mAMonopolar, Biphasic, ChargeBalanced,Pulse Freq: 1-200 Hz,Max Compliance Voltage:130V,Charge per phase limit:15 µCRamp Up/Down featureAmplitude at Lead: 0-5mA(20% max pick-up ratio)Stimulation Signal:Monopolar | EPT Max output: 30mAMonopolar, Biphasic, ChargeBalanced,Pulse Freq: 1-200 Hz,Max Compliance Voltage:100V,Charge per phase limit:15 µCRamp Up/Down featureAmplitude at Lead: 0-5mA(20% max pick-up ratio)Stimulation Signal:Monopolar | SimilarE-EFC max compliancevoltage increased to130V.Since both the EPT andE-EFC are currentcontrolled stimulators,the maximal deliveredcurrent or otherstimulation parametersdid not change. Increasein max compliancevoltage allows deliveryof the required currentinto higher impedance,thus providing thetherapy to a wider rangeof patient skinimpedances. Thisdifference in hardwaredoes not affect safetyand effectiveness of theintended use. |
| Subject Device (ModifiedStimRouter) | Predicate (StimRoutercleared in K200482) | EquivalencyAssessment | |
| EWD PhaseDuration | Pulse Width: 100-500 $\mu$ sec(Positive Phase DurationValues: 100, 200, 300, 400,500 $\mu$ sec)Negative Phase Duration forAsymmetric Waveforms:Three times positive phaseduration | Pulse Width: 70-500 $\mu$ sec(Positive Phase DurationValues: 70, 100, 150, 200,250, 300, 350, 400, 450, 500$\mu$ sec)Negative Phase Duration forAsymmetric Waveforms:Four times positive phaseduration | The reduction innumber of positivephase duration values(due to a simplifiedcode base) does notaffect safety andeffectiveness of theintended use becauseminor adjustments canbe made to otherparameters to createtherapeutic programsequivalent to thoseprovided by the EPT.The change in relativeduration of the negativephase of asymmetricwaveforms does notaffect the safety oreffectiveness because ofthe following:1. Because E-EFCstimulation is stillcharged balanced ,thephysiological responserange/impact isequivalent to that of thepredicate.2. The positive phaseremains physiologicallydominant.3. Fine tuning ofamplitude parameters tocreate therapeuticprograms is equivalentto those provided byEPT. |
| EWDStimulationFrequencies | No change | 1, 2, 5, 10, 12, 15, 20, 30, 40,50, 60, 70, 80, 90, 100, 120,140, 160, 180, 200 Hz | Same |
| Wireless Remote Control: Accessory for Controlling EWD | |||
| Subject Device (ModifiedStimRouter) | Predicate (StimRoutercleared in K200482) | EquivalencyAssessment | |
| ElectronicPlatform | Smartphone operatingsystem running MAPPsoftware with a graphicaluser interface to change E-EFC therapy programs andparameters via 2.4 GHz BLEprotocol. E-EFC therapy | PCBA running firmware andbutton interface to changeEPT therapy programs andparameters via 2.4 GHzproprietary wireless protocol.EPT therapy programs areloaded by CPS into PatientProgrammer in case EPTneeds to be replaced. | Similar. MAPPsoftware uses agraphical user interfaceto allow changes to theE-EFC therapyprograms via a BLEprotocol that reproducesthe functions of theEPT. Differences do notaffect safety andeffectiveness of theintended use. |
| WirelessProtocol | Smartphone running MAPPsoftware uses 2.4 GHz BLEprotocol to communicatewith E-EFC | Patient Programmer uses 2.4GHz proprietary wirelessprotocol to communicatewith EPT | Similar. The BLEprotocol provides thesame functionality asthe 2.4 GHz proprietaryprotocol (i.e., effectivewireless communicationand encrypted data).Differences do notaffect safety andeffectiveness of theintended use. |
| Software /FirmwareCapabilities | Smartphone running MAPPcan select one of 8 pre-settherapy programs, start/stoptherapy on E-EFC, increase /decrease amplitude oftherapy signal and providestatus readout for paired E-EFC. | Patient Programmer canselect one of 8 pre-settherapy programs, start/stoptherapy on EPT, increase /decrease amplitude oftherapy signal and providestatus readout for paired EPT. | Similar. Smartphonerunning MAPP softwarereplicates all of PatientProgrammerscapabilities. Differencesdo not affect safety andeffectiveness of theintended use. |
| RemoteControlRequired? | Optional | Required | Similar. Because of theintegrated controlbuttons of the E-EFC,the use of MAPP isoptional, but it is asfunctional as the PatientProgrammer.Differences do notaffect safety andeffectiveness of theintended use. |
| Subject Device (ModifiedStimRouter) | Predicate (StimRoutercleared in K200482) | EquivalencyAssessment | |
| StimRouterElectrodes | No change | Reusable electrodes with gelpad that adhere to skin andtransmit EPT stimulationsignal to StimRouter Lead,Includes 2 snaps for EPTattachment | Same. |
| Clinician Kit | |||
| Clinician's Programmer | |||
| ElectronicPlatform | Clinician ProgrammerSoftware (CPS) runs onVanquisher IP67 8-inchtablet running Window 10Home. Built-in Bluetoothfunctionality is used. | Clinician ProgrammerSoftware (CPS) runs onVanquisher IP67 8-inchtablet running Window 10Home. Built-in Bluetoothfunctionality is not used. | Similar. The newversion of the CPS runson the same electronicplatform, although nowthe Bluetoothfunctionality of thetablet is used.Differences in softwaredo not affect safety andeffectiveness of theintended use. |
| WirelessProtocol | 2.4 GHz Bluetooth LowEnergy (BLE) protocol usedto program E-EFC directly | CPS uses attached PatientProgrammer and proprietary2.4 GHz RF protocol toprogram EPT | Similar. The CPS cannow program the E-EFC directly wherepreviously, it needed tobe connected to thePatient Programmer.Differences do notaffect safety andeffectiveness ofintended use. |
| Software | Updated ClinicianProgrammer Software canperform the same functionsas the original CPS but usesBLE to send wirelesscommands directly to the E-EFC. | The Clinician ProgrammerSoftware is used for storingpatient info, session data,logs, patient stimulationprofile, programming,testing, and saving ofstimulation programs ontablet. In addition, the CPSallows for downloading ofprograms to the EPT usingwireless commands sent viathe Patient Programmer usingproprietary 2.4 GHz RF | Similar, but differencesdo not affect safety andeffectiveness ofintended use:1. BLE vs. 2.4 GHzproprietary protocol:Equivalent capabilities.2. Although fewerpositive phase durationvalues are available innew CPS, substantiallyequivalent therapies canbe created using otheravailable parameters. |
| Subject Device (ModifiedStimRouter) | Predicate (StimRoutercleared in K200482) | EquivalencyAssessment | |
| EWD Tester | No changes | The EPT Tester is used toconfirm that the EPT isdelivering stimulation byproviding audio feedbackwhen stimulation is applied. | Same. The same EPTTester can be used,unchanged, to confirmthat the E-EFC isdelivering stimulationvia audio feedback. |
Predicate Device Comparison Matrix
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Performance Testing
The StimRouter Neuromodulation System was qualified through the following :
- Electrical compatibility and safety ●
- Wireless coexistence
- Biocompatibility Testing
- Shipping and storage
- Shelf life ●
- Functional Verification ●
- Usability ●
- Software Verification and Validation Testing ●
VII. Conclusions
Bioness concludes that the StimRouter Neuromodulation System is substantially equivalent to its predicate, the StimRouter Neuromodulation System cleared in K200482, and does not raise any new issues or concerns of safety or effectiveness.
§ 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).