(99 days)
This system is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The system is not intended to treat pain in the craniofacial region.
The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.
This submission will add 4 stimulation contact options to the predicate Nalu Neurostimulation System (also referred to as the "Nalu PNS System"). The Nalu PNS System is used for peripheral nerve stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The Nalu PNS System incorporates a miniature implanted neurostimulator, powered by an externally worn Therapy Disc device. The Nalu Neurostimulation therapy utilizes pulsed electrical current to create an energy field that acts on the peripheral nerves to inhibit the transmission of pain signals to the brain. The Nalu PNS System may be implanted following a successful trial period using the Nalu PNS trial system.
The leads that were cleared with the Nalu PNS System featured 8 stimulation contacts. This submission will provide an optional use of leads with 4 stimulation contacts.
This document is a 510(k) premarket notification for a medical device called the "Nalu Neurostimulation System for PNS" (specifically, the 4-contact version). The purpose of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This document does NOT present a study that proves the device meets specific acceptance criteria through clinical performance data. Instead, it argues for substantial equivalence based on non-clinical performance testing because the changes are considered minor.
Therefore, many of the requested items related to clinical studies, ground truth establishment, expert adjudication, and MRMC studies are not applicable to this submission. The "acceptance criteria" here are demonstrating substantial equivalence through non-clinical testing.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The core "acceptance criteria" for this 510(k) submission revolve around demonstrating substantial equivalence to a predicate device, primarily the Nalu Neurostimulation System (K183579). This is achieved by showing that the new device (4 Contact PNS System) has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.
The document demonstrates this through comparative tables and statements rather than a traditional pass/fail clinical study.
| Acceptance Criterion (Implicit for Substantial Equivalence) | Reported Device Performance (4 Contact PNS System) |
|---|---|
| Intended Use: Same as predicate. | Same: Indicated for pain management in adults with severe intractable chronic pain of peripheral nerve origin. Not for craniofacial region. Trial devices for stimulation (max 30 days). |
| Technological Characteristics: Similar to predicate, with differences not affecting safety/effectiveness. | Differences: - Number of Electrodes: 4 (vs. 8 in primary predicate). - Lead Length: 25 cm, 40 cm (vs. 40 cm, 60 cm in primary predicate). - Electrode Array Length: 21 mm (vs. 52 mm in primary predicate). - Electrode Spacing: 3.0 mm (vs. 4.0 mm in primary predicate). - Cable Features: Coiled Wires (vs. Multilumen tube in primary predicate). - Lead Anchor: Integrated Lead Tines (vs. Separate molded silicone anchor with Ti locking mechanism in primary predicate). Performance: All differences are stated to "not affect safety and effectiveness of intended use" and are within parameters of other reference devices. Tested through non-clinical means. |
| Therapeutic Attributes: Same as predicate. | Same: All parameters like pulse frequency, pulse width, current/voltage regulation, output current/voltage, waveform, pulse shape, maximum phase charge/density, net charge, average phase power/density, pulse delivery mode, current path options, software level of concern, program cycle, pulse pattern, dosage time, transmit frequency are identical to the predicate (K183579). |
| Biocompatibility: Meet standards. | Met: Same biocompatibility reports as predicate supported this device. Materials and processes previously assessed. |
| Sterilization: Meet standards. | Met: Ethylene Oxide sterilization, same as predicate. |
| Electrical & Mechanical Performance: Meet specifications, safe, and effective. | Met: Verification testing included electrical and mechanical tests. Validation, performance, and usability testing demonstrated device meets user needs. Conforms to applicable standards (ISO 14708-1, ISO 14708-3, IEC 62366-1, EN ISO 14971, ISO 11607, ISO 11135-1, CISPR 11). |
| Software Level of Concern: Moderate. | Met: Same as predicate (moderate). |
| Human Factors and Usability: Tested and met. | Met: Testing performed. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. This submission relies on non-clinical performance testing (bench testing, verification, validation, biocompatibility) and a comparative analysis to a predicate device, as opposed to a clinical test set with a specific sample size of patients/cases.
- Data Provenance: Not applicable. There is no clinical data from patients/cases mentioned. The testing is internal (Nalu Medical) and presumably took place in the U.S.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not applicable. As there is no clinical test set requiring ground truth establishment by experts (e.g., for disease diagnosis or outcome evaluation), this information is not provided nor needed for this type of submission.
4. Adjudication Method for the Test Set
- Not applicable. No clinical test set or human interpretation requiring adjudication.
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 device is an implanted neurostimulator, not an AI-assisted diagnostic imaging device for human readers. No MRMC study was conducted or is relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not a standalone algorithm.
7. The Type of Ground Truth Used
- For Non-Clinical Testing: The "ground truth" implicitly used for non-clinical testing (electrical, mechanical, biocompatibility, sterilization) is based on established engineering principles, international standards (e.g., ISO, IEC, CISPR), and pre-defined specifications/tolerances for the device's performance. For biocompatibility, it's compliance with ISO 10993-1. For substantial equivalence, the "ground truth" is the established safety and effectiveness of the legally marketed predicate device.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" as this is not a machine learning/AI device.
9. How the Ground Truth for the Training Set Was Established
- Not applicable.
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September 6, 2019
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Nalu Medical, Inc. Michele Chin-Purcell VP Regulatory Affairs and Quality Assurance 2320 Faraday Ave. Suite 100 Carlsbad, California 92008
Re: K191435
Trade/Device Name: IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4 Regulation Number: 21 CFR 882.5870 Regulation Name: Implanted Peripheral Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: GZF Dated: August 5, 2019 Received: August 7, 2019
Dear Michele Chin-Purcell:
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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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,
Robert Kang, PharmD Acting 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) K191435
Device Name Nalu Neurostimulation System for PNS
Indications for Use (Describe)
This system is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The system is not intended to treat pain in the craniofacial region.
The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.
| 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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Submission Sponsor
Nalu Medical, Incorporated 2320 Faraday Ave., Suite 100 Carlsbad, CA 92008 Phone: (760) 448-2360 Fax: (760) 448-2377 Contact: Michele Chin-Purcell, Vice President of Regulatory Affairs and Quality Assurance
Date Prepared
August 30, 2019
Device Identification
Trade/Proprietary Name: Nalu Neurostimulation System, 4 Contact PNS System Common/Usual Name: Peripheral Nerve Stimulator Product Code: GZF Regulation number: 21 CFR 882.5870: Stimulator, peripheral nerve, implanted (Pain Relief) Class: Class II Device Classification Panel: Neurology
Legally Marketed Predicate Device(s)
Nalu Neurostimulation System for Peripheral Nerve Stimulation (K183579)
For areas where slight differences occur between the Nalu Neurostimulation system and the primary predicate (K183579), substantial equivalence to other reference devices in this same product code is demonstrated. These reference devices were used as part of the predicate history to the primary predicate in this submission. The history of the predicates is summarized in Table below:
Predicate history of the proposed primary predicate
| Device | 510(k) | Predicate(s) used for clearance |
|---|---|---|
| StimQ Peripheral NerveStimulator (PNS) System(Reference Devices) | K152178 | Stimwave Freedom SCS (K150517)Medtronic Mattrix 3271/3272 (K934065)Medtronic Xtrel, 3425 (K883780) |
| StimQ Peripheral NerveStimulator (PNS) System(Reference Devices) | K171366 | K152178 |
| Nalu Neurostimulation Systemfor PNS | K183579 | K171366 |
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| Device | 510(k) | Predicate(s) used for clearance |
|---|---|---|
| (Primary Predicate) |
The 510(k) history of the StimQ PNS System includes design changes over time. The original Medtronic devices are part of the predicate history of the StimO PNS System and are also used as reference devices in this document.
Device Description
This submission will add 4 stimulation contact options to the predicate Nalu Neurostimulation System (also referred to as the "Nalu PNS System"). The Nalu PNS System is used for peripheral nerve stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The Nalu PNS System incorporates a miniature implanted neurostimulator, powered by an externally worn Therapy Disc device. The Nalu Neurostimulation therapy utilizes pulsed electrical current to create an energy field that acts on the peripheral nerves to inhibit the transmission of pain signals to the brain. The Nalu PNS System may be implanted following a successful trial period using the Nalu PNS trial system.
The leads that were cleared with the Nalu PNS System featured 8 stimulation contacts. This submission will provide an optional use of leads with 4 stimulation contacts.
| 1. | 4 ContactNaluImplantablePulseGenerator | The implantable pulse generator (IPG) provides electricalstimulation pulses that are transmitted through the leads to thedesired peripheral nerve. The IPG is available in two differentimplant architectures: an “integrated” system with a single pre-attached lead (available in two lengths) and a "ported" system wherea single lead (available in two effective lengths) may be attached,via connector ports. The hermetic IPG housing includes a ceramicenclosure and a feedthrough connected internally to a printed circuitboard assembly. Wires leaving the IPG are encapsulated inpolyurethane and a silicone over mold forms the final biocompatiblesurface of the IPG for direct patient tissue contact. |
|---|---|---|
| 2. | 4 ContactLeads/LeadExtension | Leads are implantable and are designed to deliver electrical pulses tothe peripheral nerve via an array of four cylindrical electrodes at thedistal end. Leads may be integrated with or connected to the IPG.The leads use polyurethane insulation with Pt/Ir electrodes. Theleads are secured in place with tines designed into the lead body. A4 contact Lead Extension is also available which connects to theproximal end of the lead to extend the lead subcutaneously. |
The 4 Contact PNS System include the following subject devices in this submission:
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Indications for Use Statement
"This system is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The system is not intended to treat pain in the craniofacial region.
The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device."
The Indications for Use statement for the 4 Contact PNS System are identical to the predicate Nalu Neurostimulation System. The intended use is unchanged from the predicate.
Substantial Equivalence Discussion
The following tables compare the 4 Contact PNS System to the predicate device with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.
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| 4 Contact PNSSystem(SubjectDevice) | NaluNeurostimulation System(PrimaryPredicate) | StimQPNSSystem(ReferenceDevice) | StimQPNSSystem(ReferenceDevice) | Medtronic Mattrix3271/3272(Reference Device) | Medtronic Xtrel3425(Reference Device) | Analysis ofTechnologicalDifferencesfromPrimaryPredicate | |
|---|---|---|---|---|---|---|---|
| 510(k) | K191435 | K183579 | K171366 | K152178 | K934065 | K883780 | NA |
| ProductCode andclass | GZF, Class II | Same | Same | Same | GZF andGZB | GZB | Same |
| Regulationnumber | 21 CFR§882.5870 | Same | Same | Same | Same,plus 21CFR882.5880 | Same | Same |
| Classification name | Stimulator,PeripheralNerve,Implanted(pain relief) | Same | Same | Same | SameplusStimulator, SpinalCord,Implanted (PainRelief) | Same | Same |
| IntendedUse | Stimulation ofperipheralnerves forchronic,intractablepain | Same | Same | Same | Same,plusStimulation ofspinalcord forchronic,intractable pain | Same | Same |
| Indicationsfor Use | This system isindicated forpainmanagementin adults whohave severeintractablechronic painof peripheralnerve origin,as the solemitigatingagent, or as anadjunct toother modesof therapyused in amultidisciplina | Same | The StimQ PeripheralNerve Stimulator(PNS) System isindicated for painmanagement inadults who havesevere intractablechronic pain ofperipheral nerveorigin, as the solemitigating agent, oras an adjunct to othermodes of therapyused in amultidisciplinaryapproach. The StimQPNS System is notintended to treat | The StimQ PeripheralNerve Stimulator(PNS) System isindicated for painmanagement inadults who havesevere intractablechronic pain ofperipheral nerveorigin, as the solemitigating agent, oras an adjunct to othermodes of therapyused in amultidisciplinaryapproach. The StimQPNS System is notintended to treat | Indicated as an aide inthe management ofchronic, intractablepain of the trunk orlimbs | Indicated as an aide inthe management ofchronic, intractablepain of the trunk orlimbs | Same |
| 4 Contact PNSSystem(SubjectDevice) | NaluNeurostimulation System(PrimaryPredicate) | StimQPNSSystem(ReferenceDevice) | StimQPNSSystem(ReferenceDevice) | Medtronic Mattrix3271/3272(Reference Device) | Medtronic Xtrel3425(Reference Device) | Analysis ofTechnologicalDifferencesfromPrimaryPredicate | |
| ry approach.The system isnot intendedto treat painin thecraniofacialregion.The trialdevices aresolely used fortrialstimulation(no longerthan 30 days)to determineefficacybeforerecommendation for apermanent(long term)device. | pain in thecraniofacial region.The StimQ Trial LeadKit is only used inconjunction with theStimQ StimulatorReceiver Kit. The trialdevices are solelyused for trialstimulation (nolonger than 30 days)to determine efficacybeforerecommendation fora permanent (longterm) device. | ||||||
| PrescriptionUse? | Yes | Same | Same | Same | Same | Same | Same |
| Implant site | Peripheralnerves,excludingcraniofacialregion | Same | Same | Same | Same | Same | Same |
| Environmental Use | Hospital,Home | Same | Same | Same | Same | Same | Same |
| IntendedClinician | Orthopedic,NeurosurgeonAnesthesiologist | Same | Same | Same | Same | Same | Same |
| IntendedUser | Physician,Layperson | Same | Same | Same | Same | Same | Same |
| Mode ofAction | RadioFrequency(RF) wirelesstransmissionof energy toproducestimulation atstimulatorelectrodes. | Same | Same | Same | Same | Same | Same |
| 4 Contact PNSSystem(SubjectDevice) | NaluNeurostimulation System(PrimaryPredicate) | StimQPNSSystem(ReferenceDevice) | StimQPNSSystem(ReferenceDevice) | Medtronic Mattrix3271/3272(Reference Device) | Medtronic Xtrel3425(Reference Device) | Analysis ofTechnologicalDifferencesfromPrimaryPredicate | |
| SoftwareLevel ofConcern | Moderate | Same | Same | Same | Unreported | Unreported | Same |
| Sterilization | EthyleneOxide | Same | Same | Same | Same | Same | Same |
Table: Substantial Equivalence Table – General and Implanted Components
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| 4 ContactPNSSystem(SubjectDevice) | NaluNeurostimulation System(K183579)(PrimaryPredicate) | StimQ PNSSystem(K171366)(ReferencePredicate) | StimQ PNSSystem(K152178)(Reference Device) | Medtronic Mattrix3271/3272(K934065)(Reference Device) | Medtronic Xtrel3425(K883780)(Reference Device) | Analysis ofTechnologicalDifferencesfromPrimaryPredicate | |
|---|---|---|---|---|---|---|---|
| ElectrodeMaterial | Platinum-iridium90:10 | Same | Same | Same | Same | Same | Same |
| InsulationBodyMaterial | Pellethane 2363-55D | Same | Same | Same | Same | Same | Same |
| Cablefeatures | CoiledWires | Multilumen tube | Multilumen tube | Multilumen tube | CoiledWires | CoiledWires | Differencesdo not affectsafety andeffectivenessof intendeduse |
| Leadlength | 25 cm, 40cm | 40 cm, 60 cm | 44 cm | 45 cm | 30 to 110cm | 30 to 110cm | Differencesdo not affectsafety andeffectivenessof intendeduse |
| Diameter | 1.30 mm | 1.30 mm | 1.35 mm | 1.35 mm | 1.3 mm | 1.3 mm | Same |
| ElectrodeArraylength | 21 mm | 52 mm | 24 mm(FRE-4)52 mm(FRE-8) | 24 mm | 24 mm | 24 mm | Differencesdo not affectsafety andeffectivenessof intendeduse |
| No. ofElectrodes, per lead | 4 | 8 | 4 (FRE-4)8 (FRE-8) | 4 | Same | Same | Differencesdo not affectsafety andeffectivenessof intendeduse |
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| 4 ContactPNSSystem(SubjectDevice) | NaluNeurostimulation System(K183579)(PrimaryPredicate) | StimQ PNSSystem(K171366)(ReferencePredicate) | StimQ PNSSystem(K152178)(Reference Device) | Medtronic Mattrix3271/3272(K934065)(Reference Device) | Medtronic Xtrel3425(K883780)(Reference Device) | Analysis ofTechnologicalDifferencesfromPrimaryPredicate | |
|---|---|---|---|---|---|---|---|
| IndividualElectrodelength | 3.0 mm | Same | Same | Same | Same | Same | Same |
| Electrodespacing | 3.0 mm | 4.0 mm | 4.0 mm | 4.0 mm | 4.0 mm | 4.0 mm | Differencesdo not affectsafety andeffectivenessof intendeduse |
| Electrodesurfacearea | 12.25 mm² | 12.25 mm² | 12.72 mm² | 12.72 mm² | 12.25 mm² | 12.25 mm² | Same |
| Leadextension | Leadextensionavailable | Lead extensionavailable | NA | NA | Leadextensionavailable | Leadextensionavailable | Differencesdo not affectsafety andeffectivenessof intendeduse |
| LeadAnchor | Integrated LeadTines | Separate moldedsilicone anchorwith Ti lockingmechanism | IntegratedLead TinesSeparateSutureSleeveCap,Pellethane55-D,placedoverproximalend ofstimulator | SutureSleeveCap,Pellethane55-D,placedoverproximalend ofstimulator | Moldedsiliconeanchor | Moldedsiliconeanchor | Differencesdo not affectsafety andeffectivenessof intendeduse |
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Table: Substantial Equivalence Table - Therapy
| 4 Contact PNS System(Subject Device) | NaluNeurostimulationSystem(K183579)(Predicate) | Analysis ofTechnologicalDifferences | |
|---|---|---|---|
| Pulse Frequency | 2 Hz to 1500 Hz | Same | Same |
| Pulse Width | 12 µs to 1000 µs | Same | Same |
| Current/Voltage Regulated | Current | Same | Same |
| Output Voltage (300Ohms) | 0 to 3.1 V | Same | Same |
| Output Voltage (500Ohms) | 0 to 5.1 V | Same | Same |
| Output Voltage (800Ohms) | 0 to 8.2 V | Same | Same |
| Output Current (300Ohms) | 0 to 10.2 mA | Same | Same |
| Output Current (500Ohms) | 0 to 10.2 mA | Same | Same |
| Output Current (800Ohms) | 0 to 10.2 mA | Same | Same |
| Waveform | Charge balanced (delayed) biphasicasymmetrical | Same | Same |
| Pulse Shape | Decaying Exponential | Same | Same |
| Maximum phase charge(300 Ohms) | 10.2 µC/pulse | Same | Same |
| Maximum phase charge(500 Ohms) | 10.2 µC/pulse | Same | Same |
| Maximum phase charge(800 Ohms) | 10.2 µC/pulse | Same | Same |
| Maximum charge density(300 Ohm) | 83.3 µC/cm² | Same | Same |
| Maximum charge density(500 Ohm) | 83.3 µC/cm² | Same | Same |
| Maximum charge density(800 Ohm) | 83.3 µC/cm² | Same | Same |
| Maximum current density(300 Ohm) | 83.3 mA/cm² | Same | Same |
| Maximum current density(500 Ohm) | 83.3 mA/cm² | Same | Same |
| Maximum current density(800 Ohm) | 83.3 mA/cm² | Same | Same |
| Net Charge | 0 µC | Same | Same |
| Average Phase Power (300Ohms) | 0.031 W/phase | Same | Same |
| Average Phase Power (500Ohms) | 0.052 W/phase | Same | Same |
| Average Phase Power (800Ohms) | 0.083 W/phase | Same | Same |
| Average Phase Powerdensity (300 Ohms) | 0.25 W/cm²/phase | Same | Same |
| Average Phase Powerdensity (500 Ohms) | 0.51 W/cm²/phase | Same | Same |
| 4 Contact PNS System(Subject Device) | NaluNeurostimulationSystem(K183579)(Predicate) | Analysis ofTechnologicalDifferences | |
| Average Phase Powerdensity (800 Ohms) | 0.55 W/cm²/phase | Same | Same |
| Pulse Delivery Mode | Continuous | Same | Same |
| Current Path options | Bipolar | Same | Same |
| Software level of Concern | Moderate | Same | Same |
| Program Cycle | Cycle through programs | Same | Same |
| Pulse Pattern | Fine tuning of pulse patterns(On/Off; If On, spans from 12 µs to1000 µs) | Same | Same |
| Dosage Time | Allows for stimulation to be appliedin periodic doses (On/Off; If On,spans from 1 ms to 25 ms) | Same | Same |
| Transmit Frequency | 40.68 MHz | Same | Same |
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All of the physical and therapeutic attributes for the 4 Contact PNS System are the same as the parameters in the predicate devices. There are no significant differences in these characteristics that would raise different questions of safety or effectiveness.
The main difference between the subject device and the primary predicate is the number and spacing of electrical contacts, integrated tines, and a coiled lead design. This reduced number of contacts reduces the stimulation area, allowing the physician to target a smaller affected area, if needed. The integrated tines eliminate the need for a separate anchor making the system more convenient to be placed in peripheral location. All of the physical attributes for the 4 Contact PNS System are within the parameters seen in the predicate and reference devices, or the differences are minor and do not affect the safe and effective use of the devices.
Nonclinical Performance Testing
Nalu Medical performed a range of testing to gather data supporting the safety and performance of the 4 Contact PNS System prior to use. Nalu follows the Design Controls section of 21 CFR 820.30, ISO 14971, and ISO 13485:2016. These procedures ensure that all designs are appropriately planned, defined, transferred to production, and ongoing changes are reviewed for impact on safety and effectiveness and appropriately evaluated and tested. The system is designed and tested to ensure that it meets all applicable standards and guidance documents. Bench testing includes design verification and validation, sterilization validation, and biocompatibility testing. Human factors and usability testing were also performed on the device. Validation and performance testing demonstrate that the device meets user needs as reflected in the functional specification.
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Applicable Standards and Guidance Documents
The testing for the 4 Contact PNS System includes the following test standards and guidance:
| Standard Number | Title |
|---|---|
| ISO 14708-1:2014 | Implants for surgery -- Active implantable medical devices -- Part 1:General requirements for safety, marking and for information to beprovided by the manufacturer |
| ISO 14708-3:2017 | Implants for surgery -- Active implantable medical devices -- Part 3:Implantable neurostimulators |
| IEC 62366-1:2015 | Medical Devices -- Part 1: Application of usability engineering to medicaldevices |
| ISO 10993-1:2009 | Biological evaluation of medical devices -- Part 1: Evaluation and testingwithin a risk management process |
| EN ISO 14971:2012 | Medical devices -- Application of risk management to medical devices |
| ISO 14971:2007 | |
| ISO 11607-1:2006/Amd1:2014 and -2:2006/Amd1:2014 | Packaging for terminally sterilized medical devices -- Part 1: Requirementsfor materials, sterile barrier systems and packaging systems, Part 2:Validation requirements for forming, sealing and assembly processes |
| ISO 11135-1:2014 | Sterilization of health-care products -- Ethylene oxide -- Requirements forthe development, validation and routine control of a sterilization processfor medical devices |
| CISPR 11 | Industrial, scientific and medical equipment - Radio-frequency disturbancecharacteristics - Limits and methods of measurement |
Table: Standards and Guidance Documents
Biocompatibility testing
The biocompatibility testing followed the International Standard ISO 10993-1: 2009 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process," as well as Guidance for Industry and Food and Drug Administration Staff Document entitled "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process," issued on: June 16, 2016.
The same biocompatibility reports that supported the Nalu Neurostimulation System also support the 4 Contact PNS System in this submission. The materials and processes involved in producing the 4 Contact PNS System were already assessed in the previous test reports. No additional testing was necessary.
Animal Testing
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Additional animal testing was not necessary to support the addition of the 4 Contact PNS System to this system.
Summary of Nonclinical Performance Testing
Verification testing of the 4 Contact PNS System included electrical and mechanical tests to show that the device met its target specifications over a range of operating and storage conditions. Validation, performance, and usability testing demonstrated that the device met user needs as reflected in the functional specification.
Clinical Performance Data
Nalu Medical determined that bench and non-clinical testing are sufficient to demonstrate that the 4 Contact PNS System is as safe and effective as the predicate device.
Conclusions
The bench and non-clinical data support the safety of the device, and the verification and validation demonstrated that the 4 Contact PNS System performs as intended in the specified use conditions. The results do not raise different questions of safety and 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).