(295 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 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.
This document is a 510(k) Premarket Notification from Bioness Inc. for their StimRouter Neuromodulation System. It's a submission to the FDA requesting clearance to market a modified version of an already cleared device. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on demonstrating substantial equivalence to a predicate device, rather than proving clinical efficacy from scratch as one might for a novel AI device or drug.
Based on the provided text, the device is a neuromodulation system for pain management, not an AI/ML diagnostic tool. Therefore, the questions related to AI/ML specific criteria (number of experts, MRMC studies, ground truth for training/test sets, effect size of human readers with/without AI, standalone performance) are not directly applicable.
However, I can extract information related to the device's technical specifications and the testing performed to demonstrate its safety and effectiveness, which are the "acceptance criteria" in the context of a 510(k) submission for a medical device modification.
Device: StimRouter Neuromodulation System (modified version)
Type of Submission: 510(k) Premarket Notification for a modification to a previously cleared device (K142432).
Key Goal of the Study: To demonstrate substantial equivalence of the modified StimRouter Neuromodulation System to its predicate device (original StimRouter, K142432) in terms of safety and effectiveness. This is achieved by showing that the modifications do not raise new questions of safety or effectiveness and that the device performs as intended.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the safety and performance standards expected for an implanted peripheral nerve stimulator and the comparison to the predicate device. The "reported device performance" is demonstrated through various verification and validation activities and comparison of technical characteristics.
| Acceptance Criteria (Implicit from 510(k) Process) | Reported Device Performance (as demonstrated by comparison and testing) |
|---|---|
| Functional Equivalence to Predicate Device | Most technical characteristics are "Same" as the predicate (e.g., intended use, manufacturer, lead design, number of electrodes, electrode shape, materials, lead length, body diameter, implantation method, stimulation probe, cables, introducer set, lead adaptor, gel electrodes, EPT power source, EPT location, EPT communication, EPT pulse frequency, EPT pulse width, waveform, stimulation modality, patient programmer programs, patient selectable programs, programmer communication, software driven, multiple stim modes, GUI, StimRouter Electrodes) |
| Safety of Modified Components/Parameters: | |
| - Packaging (consolidation of kits, material change) | Similar; New packaging is consolidation; PETE (new material) confirmed equivalent through qualification, has better impact resistance than PETG (old material). |
| - Tray Lid Adhesive | Similar; New adhesive confirmed equivalent through qualification. |
| - Increased Maximum Charge per Pulse (Lead) & Maximum Charge Density (Lead) | Similar; Safety maintained because of limits on max current (30mA) and max pulse duration (500µsec). Values are lower than other similar devices and comply with safety requirements. Detailed comparison table shows values are within safe ranges of reference predicate devices (Medtronic PNS, Renew System). |
| - Tunneling Needle Material (removal of nickel plating) | Similar; Safety maintained; Nickel was previously used for soldering ease, but adequate soldering without nickel was confirmed by the vendor for the subject device. Addresses nickel allergy warning. |
| - Clinician's Programmer Hardware (new off-the-shelf tablet) | Similar; Physically larger but runs substantially equivalent software (recompiled). |
| - Clinician Programmer Operating System (Windows Mobile 5 to Windows 10 Home) | Similar; Same code can run in Windows 10 Home. |
| - Clinician Programmer GUI (adjusted to fit larger screen) | Similar; Same GUI contents. |
| - Added Stimulation Frequencies (12, 15 Hz) | Similar; New frequencies are within the original stimulation range. |
| - Patient Log Export Function (software enhancement) | Similar; Minor change that just adds a function. |
| - Miscellaneous Clinician Software Enhancements (obsolete buffering, co-installation) | Similar; Minor enhancements to code that do not change function. |
| - Ramp Down Feature (EPT) | Similar; Provides smooth transition for patient comfort. Expected to have same paresthesia effect. |
| - Maximum Compliance Voltage (EPT: 90V to 100V) | Similar; Safety maintained because of limits on max current (30mA) and max EPT external temperature (41°C). Aims to treat patients with high skin impedance or requiring higher current. |
| - Charge per Phase Limit (EPT: 10 µC to 15 µC due to rechargeable batteries) | Similar; Safety maintained because of limits on max current (30mA) and max pulse duration (500µsec). The previous 10 µC limit was due to non-rechargeable battery needs, which are no longer supported. |
| - Miscellaneous EPT Software Enhancements (transistor disconnection, impedance) | Similar; Updates provide better detection of conditions and unnecessary termination of stimulation. |
| - Miscellaneous Patient Programmer Software Enhancements (interfering EPTs, buggy RF channels) | Similar; Software updates improve reliability of connection with EPT. |
| Verification & Validation Testing Compliance | Risk Analysis methods were used to assess impact of modifications and determine required V&V activities. Extensive bench tests were conducted, including: Bioburden, Sterilization & Shelf-life, Biocompatibility, Shelf Life, Shipping Validation, Package Integrity (Bubble Leak, Seal Strength), Functional V&V, Label Validation, Printing Verification, MRI Compatibility, Implant Heating, and Software V&V Testing. |
2. Sample Size Used for the Test Set and the Data Provenance:
- Sample Size: Not explicitly stated as a number of devices/patients for a clinical trial. For a 510(k) modification where substantial equivalence is demonstrated through bench testing and comparison, the "sample size" refers to the number of units tested for each specific bench test (e.g., a certain number of devices for shelf-life testing, a certain number for functional testing). These specific numbers are not provided in this summary.
- Data Provenance: The document does not specify a country of origin for any human data (as no clinical trial data is summarized). The data primarily comes from bench testing and technical comparisons against historical predicate device data and reference devices. The submission indicates that these tests were "originally developed under the design control process of the StimRouter Neuromodulation System cleared in K142432," suggesting these are in-house engineering and lab tests. The nature of the submission (Special 510(k)) indicates that new clinical data is generally not required if performance is demonstrated through other means.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- This is not applicable as the submission relates to a physical medical device modification, not an AI/ML algorithm requiring expert annotation for ground truth. Ground truth for device performance is established through engineering specifications, material science, and safety standards, not subjective expert assessment of images or clinical outcomes in the same way as an AI diagnostic.
4. Adjudication Method for the Test Set:
- Not applicable for a device modification validated through bench testing and technical comparison. Clinical study adjudication methods (e.g., 2+1, 3+1) are for human-in-the-loop diagnostic studies or clinical outcome studies.
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. This is a medical device (neuromodulation system) and not an AI-assisted diagnostic tool. No MRMC study was conducted or required for this type of submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm. Its "standalone performance" is related to its physical and functional operation as a stimulator, which is evaluated through the listed bench tests.
7. The Type of Ground Truth Used:
- The "ground truth" for this submission are the performance specifications, safety limits (e.g., charge density, current limits), and accepted medical device standards (e.g., biocompatibility standards, sterilization standards, electrical safety standards).
- For the comparative analysis, the performance characteristics of the cleared predicate device (K142432) and other reference devices (Medtronic PNS, Renew System) serve as the "ground truth" or benchmark for substantial equivalence.
8. The Sample Size for the Training Set:
- Not applicable. This is not an AI/ML algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable.
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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 (1-800-638-2041 or 301-796-7100).
Sincerely.
Pamela D. Scott -S
Pamela Scott Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for Bioness. The logo consists of an orange sun-like symbol on the left, followed by the word "Bioness" in gray. The "i" in Bioness is dotted with an orange circle, matching the color of the sun symbol. A small registration mark is present to the right of the word.
510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:
| I. | Submitter Information | |
|---|---|---|
| Company: | Bioness Inc. | |
| 25103 Rye Canyon Loop | ||
| Valencia, CA 91355 USA | ||
| Phone Number: (661) 902-5324 | ||
| Fax: (661) 362-4851 | ||
| Email: mercedes.bayani@bioness.com | ||
| Contact: | Sageev George | |
| Senior Regulatory Affairs Specialist | ||
| Phone Number: (661) 902-5336 | ||
| Fax Number: (661) 362-4851 | ||
| Email: sageev.george@bioness.com | ||
| Mercedes Bayani | ||
| Global Director, Clinical & Regulatory Affairs | ||
| Phone Number: (661) 902-5324 | ||
| Fax Number: (661) 362-4851 | ||
| Email: mercedes.bayani@bioness.com | ||
| Date Prepared: | January 7, 2019 | |
| II. | Name of Device | |
| Device Trade Name: | StimRouter Neuromodulation System | |
| Classification Name: | Implantable peripheral nerve stimulator for pain relief | |
| Common Name: | Implantable Neurostimulator | |
| Product Code: | GZF | |
| Regulation Number: | 21 CFR §882.5870 | |
| Device Class: | Class II | |
| Panel Identification: | Neurology | |
| III. | Predicate Device | |
| Predicate Manufacturer: | Bioness Inc. | |
| Predicate Trade Name: | StimRouter Neuromodulation System | |
| Predicate 510(k): | K142432 | |
| Reference Devices: | ||
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Image /page/4/Picture/0 description: The image shows the logo for Bioness. The logo consists of an orange sun-like symbol on the left and the word "Bioness" in gray on the right. The sun-like symbol has eight orange lines radiating from a central point. The word "Bioness" is in a sans-serif font, and there is a registered trademark symbol next to the last "s".
| Predicate Manufacturer: | Medtronic |
|---|---|
| Predicate Trade Name: | PNS |
| Predicate 510(k): | K904409/A, K920567, K982902 |
| Predicate Manufacturer: | ANS |
| Predicate Trade Name: | Renew |
| Predicate 510(k): | K000582 |
IV. Device Description
The StimRouter Neuromodulation System consists of two main parts - the implantable lead, and the external (to the body) accessories for the StimRouter include a clinician programmer with software (CPS), a patient programmer, disposable hydrogel electrode patch, external pulse transmitter (EPT), and an EPT stimulation tester (EPTT).
The Bioness StimRouter Neuromodulation System is intended to provide electrical stimulation via an implanted lead to a target peripheral nerve, for aid in the management of severe, intractable, chronic pain of peripheral nerve origin in adults, as an adjunct to other modes of therapy (e.g. medications). The StimRouter is not intended to treat pain in the craniofacial region.
The complete StimRouter System consists of three kits: A Lead and Lead Introducer Kit, a Clinician Kit and User Kit. The Lead Kit contains the StimRouter implantable multielectrode lead with integrated receiver, used for peripheral nerve stimulation. The Lead receives an electrical signal transmitted transcutaneously by the EPT which is mounted on an electrode patch on the skin and delivers that electrical signal down the lead's length to a target peripheral nerve. The Lead is supplied in Lead Loader that is used during intraoperative testing of the lead and to verify proper placement during implantation.
The Lead and lead Introducer Kit consists of two stimulation probes, two stimulation cables, and introducer set, a lead adapter, a Tunneling Needle and a Tunneling Needle Stylet. The included tools and components allow for insertion of the StimRouter Lead and confirmation of optimal location of the stimulation electrode contacts of the StimRouter Lead.
The Clinician Kit is used for the programming of the StimRouter patient programmer and the EPT. The components of the Clinician Kit are a tablet PC with programming software and the accessories for connecting to the Patient Programmer and the EPT.
The User Kit contains the patient-use components of the StimRouter System. The components are the Patient Programmer and the EPT. After the EPT is programmed, the StimRouter electrode interfaces with the EPT and function to delivery stimulation to the implanted lead receiver.
V. Indications for Use
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Image /page/5/Picture/0 description: The image contains the logo for Bioness. The logo consists of an orange star-like symbol on the left and the word "Bioness" in gray on the right. The star-like symbol is made up of several orange lines that converge towards the center. The word "Bioness" is written in a sans-serif font, with a small orange dot above the "i".
The StimRouter Neuromodulation System is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy (e.g., medications). The StimRouter is not intended to treat pain in the craniofacial region.
Comparison of Technological Characteristics VI.
The subject device is a modified version of the StimRouter Neuromodulation System previously cleared in K142432. A comparison of the technological characteristics of the two is presented below:
| Subject Device (ModifiedStimRouter) | Predicate (OriginalStimRouter) | EquivalencyAssessment | |
|---|---|---|---|
| Manufacturer | Bioness Inc. | Bioness Inc. | Same |
| 510(k) number | To be Determined | K142432 | - |
| Intended use | The StimRouterNeuromodulation System™is indicated for painmanagement in adults whohave severe intractablechronic pain of peripheralnerve origin, as an adjunctto other modes of therapy(e.g., medications). TheStimRouter is not intendedto treat pain in thecraniofacial region. | The StimRouterNeuromodulation System™is indicated for painmanagement in adults whohave severe intractablechronic pain of peripheralnerve origin, as an adjunctto other modes of therapy(e.g., medications). TheStimRouter is not intendedto treat pain in thecraniofacial region. | Same |
| Packaging | |||
| Packaged Kit(s) | "Implantable Lead and LeadIntroducer Kit" | "Lead Kit" and "SurgicalKit" | Similar*New packaging is justconsolidation of LeadKit and Surgical Kit |
| Inner Tray Material | Blue tinted PETE(PolyethyleneTerephthalate): Largehistory of use in medicaldevice industry | Blue tinted PETG(Polyethylene TerephthalateGlycol): Large history ofuse in medical deviceindustry | Similar*Contract manufacturerconfirmed equivalencethru qualification(PETE has betterimpact resistance) |
| Tray Lid | 1073B Tyvek (DuPont) | 1073B Tyvek (DuPont) | Same |
| Tray Lid Adhesive | Heat Seal CoatedTPT-021C adhesive: Largehistory of use in medicaldevice industry | Heat Seal CoatedCR-27 adhesive: Largehistory of use in medicaldevice industry | Similar*Contract manufacturerconfirmed equivalencethru qualification |
| StimRouter Lead | |||
| Number of stimulatingelectrodes | 3 | Same | Same |
| Electrode shape | Cylindrical | Same | Same |
| Estimated electrodesurface area, perelectrode | $6.3 mm^2$ | Same | Same |
| Maximum charge perpulse (lead) | $3 \mu C$ | $2 \mu C$ | SimilarSafety is maintainedbecause of limit onmax current (30mA)and max pulseduration (500µsec).Max value is lowerthan that of similardevices, and complieswith safetyrequirements. |
| Maximum chargedensity (lead) | $15.9 \mu C/cm^2$ | $10.6 \mu C/cm^2$ | SimilarSafety is maintainedbecause of limit onmax current (30mA)and max pulseduration (500µsec).Max value is lowerthan that of similardevices, and complieswith safetyrequirements. |
| Materials (electrode /Insulator | Platinum IridiumSilicone Rubber | Same | Same |
| Location of stimulationreceiver | Implanted, RF lead receivertransmitter | Same | Same |
| Design features | Helical coil designSingle silicone insulatorsheath | Same | Same |
| Anchors | Yes | Same | Same |
| Lead Length | 15 cm | Same | Same |
| Lead body diameter | 1.2 mm | Same | Same |
| Implantation / PlacerTools | StimRouter Surgical ToolKit | Same | Same |
| Introduction method | Percutaneous | Same | Same |
| Tunneling Needle and Tunneling Needle Stylet | |||
| Tunneling NeedleMaterial | 304 Stainless Steel(SST 304)(No Nickel warning, unlikepredicate) | SST 304 with nickel platingon handles/hubs (Presenceof nickel required Nickelallergy warning in labeling) | SimilarNickel was used tomake soldering easierbetween needle andhandle/hub inpredicate. Adequatesoldering withoutnickel was confirmedby vendor in subjectdevice |
| 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-inchtablet (off-the-shelf) withnew charger and connectorcable with Micro-SD Cardstorage | Hewlett Packard iPAQ 210Enterprise Handheld PDA(off-the-shelf) with SD Cardstorage | Similar*IP67 is physicallylarger than the PDAand runs substantiallyequivalent software(recompiled for IP67Operating System) |
| Clinician ProgrammerOperating System | Microsoft® Windows 10Home | Microsoft® WindowsMobile® 5 | Similar*Same code can run inWindows 10 Home |
| Location of programmer | External | Same | Same |
| Software driven? | Yes | Same | Same |
| Size of programmer | Hand-held | Same | Same |
| Multiple stim modes? | Yes | Same | Same |
| Graphical User Interface(GUI) | Original GUI adjusted to fita larger area (8") of screen | Yes | Similar*Same GUI contents |
| Stimulation Frequencies | 1, 2, 5, 10, 12 , 15 , 20, 30,40, 50, 60, 70, 80, 90, 100,120, 140, 160, 180, 200 Hz | 1, 2, 5, 10, 20, 30, 40, 50,60, 70, 80, 90, 100, 120,140, 160, 180, 200 Hz | SimilarAdded frequencies(12, 15 Hz) w/inoriginal stimulationrange |
| Patient Log ExportFunction in the software | Yes | No | Similar*Minor change that justadds a function |
| Miscellaneous SoftwareEnhancements | Updates to remove obsoleteevent buffering procedure,to allow co-installation ofCPS software with H200and L300 Go software | Software did not have theseenhancements | Similar*Minor enhancementsto code that do notchange function |
| Tester | No changes | Same | Same |
| User Kit | |||
| External Pulse Transmitter (EPT) | |||
| Power source | One lithium polymer,rechargeable battery | Same | Same |
| Location of transmitter | External | Same | Same |
| Amplitude current | 0-5 mA(estimate based on 20%max pick-up ratio, maxoutput of EPT of 30 mA) | Same | Same |
| Communication method | RF | Same | Same |
| Pulse frequency | 1-200 Hz | Same | Same |
| Stimulation Frequencies | 1, 2, 5, 10, 12 , 15 , 20, 30,40, 50, 60, 70, 80, 90, 100,120, 140, 160, 180, 200 Hz | 1, 2, 5, 10, 20, 30, 40, 50,60, 70, 80, 90, 100, 120,140, 160, 180, 200 Hz | SimilarAdded frequencies(12, 15 Hz) w/inoriginal stimulationrange |
| Ramp Down Feature | PresentProvides smooth transitionfor patient where pulseamplitude is slowlydecreased over time forcomfort | Not present | Similar*Stimulation pulse withramp down has sameparesthesia effect andmay provide morecomfort |
| Maximum ComplianceVoltage | 100V (higher voltage totreat patients w/ high skinimpedance or who needhigher current settings toachieve therapeutic effect) | 90V | Similar*Safety is maintainedbecause of limit onmax current (30mA)and max EPT externaltemperature (41°C) |
| Pulse width | 70-500 μsec | Same | Same |
| Charge per phase limit | 15 μCNon-rechargeable batteriesare no longer supported socharge limitation is notrequired | 10 μCIncluded in original designto support non-rechargeablebatteries (preventeddepletion) | Similar*Safety is maintainedbecause of limit onmax current (30mA)and max pulseduration (500µsec) |
| Wave form | Biphasic, charge balanced | Same | Same |
| Stimulation modality | Monopolar | Same | Same |
| Miscellaneous SoftwareEnhancements | Software update to preventfalse positive detection oftransistor disconnection andimprove impedancemeasurement of electrodes | Original software did nothave enhancements | Similar*Update provides betterdetection of conditionsand unnecessarytermination ofstimulation |
| Patient Programmer | |||
| Stimulation Frequencies | 1, 2, 5, 10, 12 , 15 , 20, 30,40, 50, 60, 70, 80, 90, 100,120, 140, 160, 180, 200 Hz | 1, 2, 5, 10, 20, 30, 40, 50,60, 70, 80, 90, 100, 120,140, 160, 180, 200 Hz | Similar12 Hz and 15 Hz areboth within the originalstimulation range |
| Number of programs | 8 | Same | Same |
| Programs patientselectable? | Yes | Same | Same |
| Programmercommunication methodwith EPT | RF | Same | Same |
| Location of programmer | External | Same | Same |
| Software driven? | Yes | Same | Same |
| Multiple stim modes? | Yes | Same | Same |
| Graphical User Interface(GUI) | Yes | Same | Same |
| Miscellaneous SoftwareEnhancements | Updates to preventconnection with interferingEPTs, to prevent use ofbuggy RF channels | Original software did nothave enhancements | Similar*Software updatesimprove reliability ofconnection with EPT |
| StimRouter Electrodes | No change | Same | Same |
Predicate Device Comparison
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Image /page/6/Picture/0 description: The image shows the logo for Bioness. The logo consists of an orange sun-like symbol on the left and the word "Bioness" in gray on the right. The "i" in Bioness has an orange dot above it.
Special 510(k) Notification Supplement
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Image /page/7/Picture/0 description: The image shows the logo for Bioness. The logo consists of an orange sun-like symbol on the left and the word "Bioness" in gray on the right. The sun-like symbol is made up of several orange lines that radiate outward from a central point. The word "Bioness" is written in a sans-serif font, and there is a small orange dot above the "i" in "Bioness".
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- This technology change does not impact the intended use or the operating principles or mechanism of action of the system
Comparison of Revised Stimulation Parameters
As noted in the above Predicate Device Comparison Matrix, certain stimulation parameters have increased values. However, the subject device uses parameters that are within the safe ranges of the predicates of the original StimRouter cleared in K142432, and which are used as reference devices in this submission. The following table illustrates these parameters and how the subject device falls within these safe ranges:
| Receivers andTransmitters | StimRouterImplantableNeurostimulator(currentversion) | StimRouterImplantableNeurostimulator(as submitted inK142432) | REFERENCE 1Medtronic PNS(K904409/A,K920567,K982902) | REFERENCE 2Renew System(K000852) |
|---|---|---|---|---|
| Number ofstimulatingelectrodes | 3 | 3 | 4 | 4 |
| Surface area perelectrode | 6.3 mm² | 6.3 mm² | 12 mm² | 13 mm² |
| Total area ofstimulatingelectrodes | 18.9 mm² | 18.9 mm² | 48 mm² | 52 mm² |
| Amplitudecurrent | 0-6mA(estimate basedon 20% maxpick-up ratio,max output ofEPT of 30 mA) | 0-6mA(estimate basedon 20% maxpick-up ratio,max output ofEPT of 30 mA) | Up to 20 mA | 24 mA(estimate basedon 12V maxoutput, 500Ωload) |
| Pulse frequency | 1-200 Hz | 1-200 Hz | 5-240 Hz(Mattrix) | 10-1,500 Hz |
| Pulse width | 70-500 µsec | 70-500 µsec | 60-450 µsec | 50-500 µsec |
| Maximumaverage current | 1.2 mA | 1.2 mA | 4.3 mA | Information notpubliclyavailable |
| Receivers andTransmitters | StimRouterImplantableNeurostimulator(currentversion) | StimRouterImplantableNeurostimulator(as submitted inK142432) | REFERENCE 1Medtronic PNS(K904409/A,K920567,K982902) | REFERENCE 2Renew System(K000852) |
| Maximumcurrent (rms) | 2.7 mA | 2.7 mA | 9.3 mA | Information notpubliclyavailable |
| Maximumaverage currentdensity | 6.3 mA/cm² | 6.3 mA/cm² | 9.0 mA/cm² | Information notpubliclyavailable |
| Maximumaverage powerdensity (into 500Ohm load) | 19.2 mW/cm² | 19.2 mW/cm² | 90.1 mW/cm² | Information isnot available |
| Maximum chargeper pulse | 3 µC(estimate basedon 20% maxpick-up ratio,max output ofEPT of 30 mA) | 3 µC(estimate basedon 20% maxpick-up ratio,max output ofEPT of 30 mA) | 20 µC | 12 µC(estimate basedon 12V maxoutput, 500Ωload) |
| Maximum chargedensity | 15.9 µC/cm²(estimate basedon 20% maxpick-up ratio,max output ofEPT of 30 mA) | 15.9 µC/cm²*(estimate basedon 20% maxpick-up ratio,max output ofEPT of 30 mA) | 160 µC/cm²(X-trel) | 92.3 µC/cm² |
| Wave form | Biphasic, chargebalanced | Biphasic, chargebalanced | Rectangular,biphasic currentoutputs | Information notpubliclyavailable |
| Stimulationmodality | Monopolar | Monopolar | Bipolar | Bipolar |
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Performance Data
Risk Analysis methods were used to assess the impact of the modifications of the original StimRouter Neuromodulation System and to determine the verification and validation activities required based on the Risk Analysis. The Risk Analysis methods, the verification and validation activities required, including methods and tests used and their acceptance criteria applied, are provided in the Design Controls section of this submission. The verification and validation activities required the following bench tests, originally developed under the design control process of the StimRouter Neuromodulation System cleared in K142432:
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- Bioburden
- Sterilization & Shelf-life Testing ●
- Biocompatibility Testing ●
- Shelf Life
- Shipping Validation
- Package Integrity (Bubble Leak Testing, Seal Strength Testing)
- Functional Verification and Validation
- Label Validation
- Printing Verification
- MRI Compatibility
- Implant Heating ●
- Software Verification and Validation Testing
VII. Conclusions
The verification and validation activities described above demonstrate that the subject device StimRouter Neuromodulation System, which has modifications as compared to the predicate StimRouter Neuromodulation System (cleared in K142432), is substantially equivalent to the predicate device in terms of safety and effectiveness for its indication of pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy (e.g., medications). The subject device continues to not be intended to treat pain in the craniofacial region.
§ 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).