(111 days)
For Spinal Cord Stimulation: This system is indicated as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain. 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.
For Peripheral Nerve Stimulation: 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 day) to determine efficacy before recommendation for a permanent (long term) device.
The Nalu Neurostimulation System has been cleared by the FDA for spinal cord stimulation, and peripheral nerve stimulation (K201618), to provide therapeutic relief for chronic, intractable pain of the trunk and/or limbs including unilateral, bilateral nerve pain. The Nalu Neurostimulation therapy utilizes pulsed electrical current to create an energy field that acts on nerves in the spinal cord or peripheral nerve to inhibit the transmission of pain signals to the brain. The Nalu System is implanted only following a successful trial period using the Nalu Neurostimulation trial system. The Nalu Neurostimulation System consists of several components. The implantable pulse generator (IPG) provides electrical stimulation pulses that are transmitted through the leads, to the desired location, either on the spinal cord or peripheral nerve site. The leads are implantable and designed to deliver electrical pulses to the nerves via an array of four or eight cylindrical electrodes at the distal end. The Trial Therapy Disc or the Therapy Disc houses the battery and electronics for RF power and controls the IPG for therapy delivery via the remote programmer. Implantation of the Nalu IPG and lead components for spinal cord stimulation (SCS) or peripheral nerve stimulation (PNS) is performed via standard surgical tools and techniques, as described in (K201618).
Here's a breakdown of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria or performance metrics in the way one might expect for a diagnostic or AI-based device's clinical performance. Instead, the submission describes the Nalu Neurostimulation System and its substantial equivalence to predicate devices, focusing on technical specifications and safety rather than a measurable clinical outcome in a performance study.
The closest to "acceptance criteria" are the parameters defining the device's operational range, and the "reported device performance" is that these parameters are within acceptable limits compared to predicate devices, demonstrating substantial equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Pulse Width Range | Subject Device: 12 to 2000 µs (Predicate: 12 to 1000 µs; Reference: 50 to 1000 µs) - Analysis: Available programmable pulse width will be capped to maintain Maximum Phase Charge and Maximum Charge Density within limits of Medtronic Xtrel reference device limit. No impact to safety and effectiveness. |
| Maximum Phase Charge (300 Ohms) | Subject Device: 18.0 µC/pulse (Predicate: 10.2 µC/pulse; Reference: 18.0 µC/pulse) - Analysis: Same as Medtronic Xtrel reference device. |
| Maximum Phase Charge (500 Ohms) | Subject Device: 18.0 µC/pulse (Predicate: 10.2 µC/pulse; Reference: 14.2 µC/pulse) - Analysis: Same as Medtronic Xtrel reference device at 300 Ohms. Maximum Phase Charge constant in current controlled system and enforced below maximum reference device value (at 300 Ohms). No impact to safety and effectiveness. |
| Maximum Phase Charge (800 Ohms) | Subject Device: 18.0 µC/pulse (Predicate: 10.2 µC/pulse; Reference: 10.5 µC/pulse) - Analysis: Same as Medtronic Xtrel reference device at 300 Ohms. Maximum Phase Charge constant in current controlled system and enforced below maximum reference device value (at 300 Ohms). No impact to safety and effectiveness. |
| Maximum Charge Density (300 Ohm) | Subject Device: 146.94 µC/cm² (Predicate: 83.3 µC/cm²; Reference: 150.0 µC/cm²) - Analysis: Within maximum limit as set by Medtronic Xtrel reference device. |
| Maximum Charge Density (500 Ohm) | Subject Device: 146.94 µC/cm² (Predicate: 83.3 µC/cm²; Reference: 118.3 µC/cm²) - Analysis: Same as Medtronic Xtrel reference device at 300 Ohms. Maximum Phase Charge constant in current controlled system and enforced below maximum reference device value (at 300 Ohms). No impact to safety and effectiveness. |
| Maximum Charge Density (800 Ohm) | Subject Device: 146.94 µC/cm² (Predicate: 83.3 µC/cm²; Reference: 87.5 µC/cm²) - Analysis: Same as Medtronic Xtrel reference device at 300 Ohms. Maximum Phase Charge constant in current controlled system and enforced below maximum reference device value (at 300 Ohms). No impact to safety and effectiveness. |
| Dosage Time Range | Subject Device: On spans 1 ms to 1000 ms, Off spans 1 ms to 2000 ms (Predicate: On spans 1 ms to 25 ms) - Analysis: This parameter has no impact on safety and effectiveness. Increasing the range allows the clinician to offer more flexibility to accommodate patient preferences. |
| All other parameters (Frequency, Current/Voltage Regulated, Output Voltage/Current, Waveform, Pulse Shape, Maximum Current Density, Net Charge, Average Phase Power/Density, Pulse Delivery Mode, Current Path Options, Program Cycle, Pulse Pattern, Daily Therapy Time, Transmit Frequency) | All "Same as predicate." or "Same as predicate/reference." indicating compliance with established safe and effective parameters. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical performance study with a "test set" from real patient data in the context of an AI/diagnostic device. Instead, it refers to "testing" performed to support the safety and performance of the device. This testing appears to be primarily non-clinical (bench/laboratory) testing of electrical and software parameters.
Therefore, there is no mention of a sample size for a test set of patient data, nor data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable and not provided. The study focuses on evaluating technical parameters against established medical device safety standards and comparison to predicate devices, not on a ground truth established by medical experts for diagnostic accuracy.
4. Adjudication Method
This information is not applicable and not provided, as the submission does not involve expert review or adjudication of clinical cases for diagnostic or performance accuracy.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This device is a neurostimulation system for pain relief, not a diagnostic imaging or AI-assisted diagnostic tool that would typically undergo MRMC studies to assess human reader improvement. The submission focuses on demonstrating substantial equivalence in technical characteristics and safety.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable. The "device" itself (Nalu Neurostimulation System) is a therapeutic electrical stimulator. The "software" changes described are modifications to its operational parameters. The performance testing referenced is likely to evaluate the hardware and software functionality as an integrated system, ensuring it operates within safe and effective limits. There isn't an "algorithm only" component in the sense of an AI interpreting inputs to provide diagnostic outputs.
7. The type of ground truth used
The "ground truth" for this submission appears to be regulatory and engineering standards, and the specifications and performance characteristics of legally marketed predicate and reference devices. The evaluation focuses on whether the subject device's technical specifications and functionality (particularly the updated software parameters) fall within the established safe and effective ranges of these comparable devices.
8. The sample size for the training set
This information is not applicable and not provided. The device is not an AI/ML model that would train on a dataset. The software changes are operational programming changes for the neurostimulator.
9. How the ground truth for the training set was established
This information is not applicable and not provided, as there is no "training set" for an AI/ML model.
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Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below.
March 25, 2021
Nalu Medical, Inc. Pauline Lieu Principle Regulatory Affairs Associate 2320 Faraday Ave. Suite 100 Carlsbad, California 92008
Re: K203547
Trade/Device Name: Nalu Neurostimulation System Regulation Number: 21 CFR 882.5880 Regulation Name: Implanted spinal cord stimulator for pain relief Regulatory Class: Class II Product Code: GZB, GZF Dated: December 4, 2020 Received: December 4, 2020
Dear Pauline Lieu:
(NOTE: Reprocessed SUD device types require a separate attachment of the list of all models cleared in the submission. A corrected SE letter will be required if the attachment is omitted.)
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
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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 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,
Jitendra Virani 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) K203547
Device Name Nalu Neurostimulation System
Indications for Use (Describe) For Spinal Cord Stimulation
This system is indicated as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain. 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.
For Peripheral Nerve Stimulation
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 day) 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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510(k) Summary
K203547
1. Submission Sponsor
Nalu Medical, Incorporated 2320 Faraday Ave., Suite 100 Carlsbad, CA 92008 Phone: (858) 442-6370 Fax: (760) 448-2377 Contact Pauline Lieu, Ph.D. Principle Regulatory Affairs Associate
Date Prepared: March 23吋, 2021
2. Device Names and Classification
| Primary Product Code | |
|---|---|
| Proprietary Name | Nalu Neurostimulation System |
| Common Names | Stimulator, Spinal-Cord Implanted (Pain Relief); |
| Class | II |
| Classification Regulation | 21 CFR 882.5880; Stimulator, Implanted Spinal-cord (PainRelief) |
| Product Code | GZB |
| Review Panel | Division of Neurological and Physical Medicine Devices |
| Secondary Product Code | |
|---|---|
| Proprietary Name | Nalu Neurostimulation System |
| Common Names | Stimulator, Peripheral Nerve, Implanted (Pain Relief); |
| Class | II |
| Classification Regulation | 21 CFR 882.5870 Stimulator, Peripheral Nerve Stimulator(Pain Relief) |
| Product Code | GZF |
| Review Panel | Division of Neurological and Physical Medicine Devices |
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3. Predicate and Reference Devices:
Predicate Device: Nalu Neurostimulation System (K201618)
Reference Devices: Medtronic Xtrel Model 3425 (K883780 and K982902)
4. Device Description
The Nalu Neurostimulation System has been cleared by the FDA for spinal cord stimulation, and peripheral nerve stimulation (K201618), to provide therapeutic relief for chronic, intractable pain of the trunk and/or limbs including unilateral, bilateral nerve pain. The Nalu Neurostimulation therapy utilizes pulsed electrical current to create an energy field that acts on nerves in the spinal cord or peripheral nerve to inhibit the transmission of pain signals to the brain. The Nalu System is implanted only following a successful trial period using the Nalu Neurostimulation trial system.
The Nalu Neurostimulation System consists of several components. The implantable pulse generator (IPG) provides electrical stimulation pulses that are transmitted through the leads, to the desired location, either on the spinal cord or peripheral nerve site. The leads are implantable and designed to deliver electrical pulses to the nerves via an array of four or eight cylindrical electrodes at the distal end. The Trial Therapy Disc or the Therapy Disc houses the battery and electronics for RF power and controls the IPG for therapy delivery via the remote programmer. Implantation of the Nalu IPG and lead components for spinal cord stimulation (SCS) or peripheral nerve stimulation (PNS) is performed via standard surgical tools and techniques, as described in (K201618).
5. Indications for Use
Spinal Cord Stimulation (SCS)
This system is indicated as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain.
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.
Peripheral Nerve Stimulation (PNS)
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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.
6. Comparison with the Predicate and Reference Device:
The following tables illustrate the substantial equivalence between the subject, predicate, and reference devices.
| NaluNeurostimulationSystem(Subject Device) | NaluNeurostimulationSystem(PredicateDevice, K201618) | Medtronic XtrelModel 3425(ReferenceDevice, K883780and K982902) | Analysis ofTechnologicalDifferences fromPredicate | |
|---|---|---|---|---|
| 510(k) | K203547 | K201618 (SCS andPNS) | K883780 (SCS)K982902 (PNS) | NA |
| Product Code andclass | GZB and GZF,Class II | GZB and GZF,Class II | GZB and GZF, ClassII | Same |
| Regulationnumber | 21 CFR 882.5880(GZB)21 CFR 882.5870(GZF) | 21 CFR 882.5880(GZB)21 CFR 882.5870(GZF) | 21 CFR 882.5880(GZB)21 CFR 882.5870(GZF) | Same |
| Classificationname | Implanted spinalcord stimulatorfor pain relief.(GZB)Implantedperipheral nervestimulator forpain relief (GZF) | Same | Same | Same |
| Intended Use | Stimulation ofspinal cord forchronic,intractable pain(GZB)Stimulation ofperipheral nervesfor chronic | Same | Same | Same |
| NaluNeurostimulationSystem(Subject Device) | NaluNeurostimulationSystem(PredicateDevice, K201618) | Medtronic XtrelModel 3425(ReferenceDevice, K883780and K982902) | Analysis ofTechnologicalDifferences fromPredicate | |
| intractable pain(GZF) | ||||
| Indications forUse | SCS:The NaluNeurostimulationSystem isindicated as thesole mitigatingagent, or as anadjunct to othermodes of therapyused in amultidisciplinaryapproach forchronic,intractable painof the trunkand/or limbs,includingunilateral orbilateral pain.PNS:This system isindicated for painmanagement inadults who havesevere intractablechronic pain ofperipheral nerveorigin, as the solemitigating agent,or as an adjunctto other modesof therapy usedin amultidisciplinaryapproach. Thesystem is notintended to treatpain in thecraniofacialregion.Both SCS andPNS:The trial devicesare solely usedfor trialstimulation (nolonger than 30days) to | Same | The X-trelTransmitter is partof a system forSpinal CordStimulation orPeripheral nerveStimulation. Thesystem isindicated in themanagement ofchronic,intractable pain ofthe trunk or limbs | Same |
| NaluNeurostimulationSystem(Subject Device) | NaluNeurostimulationSystem(PredicateDevice, K201618) | Medtronic XtrelModel 3425(ReferenceDevice, K883780and K982902) | Analysis ofTechnologicalDifferences fromPredicate | |
| determineefficacy beforerecommendationfor a permanent(long term)device. | ||||
| Prescription Use? | Yes | Same | Same | Same |
| Implant site, leads | Epidural space(SCS) orperipheral nerveareas (PNS) | Same | Same | Same |
| EnvironmentalUse | Hospital, Home | Same | Same | Same |
| Intended Clinician | Orthopedic,Neurosurgeon,Anesthesiologist | Same | Same | Same |
| Intended User | Physician,Layperson | Same | Same | Same |
| Mode of Action | Radio Frequency(RF) wirelesstransmission ofenergy toproducestimulation atstimulatorelectrodes. | Same | Same | Same |
| Software Level ofConcern | Moderate | Moderate | Unreported | Same |
| Comparator | NaluNeurostimulationSystem(Subject Device) | NaluNeurostimulationSystem(Predicate Device,K201618) | Medtronic XtrelModel 3425(Reference Device,K883780 andK982902) | Analysis ofTechnologicalDifferences fromPredicate |
| PulseFrequency | 2 Hz to 1500 Hz | 2 Hz to 1500 Hz | 5 to 1400 Hz | Same as predicate |
| Pulse Width | 12 to 2000 µs | 12 to 1000 µs | 50 to 1000 µs | Availableprogrammable pulsewidth will be cappedto maintain MaximumPhase Charge andMaximum ChargeDensity within limitsof Medtronic Xtrelreference device limit.No impact to safetyand effectiveness. |
| Current/Voltage Regulated | Current | Same | Voltage | Same as predicate |
| OutputVoltage (300Ohms) | 0 to 3.1 V | 0 to 3.1 V | 0 to 5.4 V | Same as predicate |
| OutputVoltage (500Ohms) | 0 to 5.1 V | 0 to 5.1 V | 0 to 7.1 V | Same as predicate |
| OutputVoltage (800Ohms) | 0 to 8.2 V | 0 to 8.2 V | 0 to 8.4 V | Same as predicate |
| OutputCurrent (300Ohms) | 0 to 10.2 mA | 0 to 10.2 mA | 0 to 18.0 mA | Same as predicate |
| OutputCurrent (500Ohms) | 0 to 10.2 mA | 0 to 10.2 mA | 0 to 14.2 mA | Same as predicate |
| OutputCurrent (800Ohms) | 0 to 10.2 mA | 0 to 10.2 mA | 0 to 10.5 mA | Same as predicate |
| Comparator | NaluNeurostimulationSystem(Subject Device) | NaluNeurostimulationSystem(Predicate Device,K201618) | Medtronic XtrelModel 3425(Reference Device,K883780 andK982902) | Analysis ofTechnologicalDifferences fromPredicate |
| Waveform | charge balanced(delayed) biphasicasymmetrical | Same | Same | Same as predicate |
| Pulse Shape | DecayingExponential | Same | Same | Same as predicate |
| Maximumphase charge(300 Ohms) | 18.0 µC/pulse | 10.2 µC/pulse | 18.0 µC/pulse | Same as MedtronicXtrel reference device |
| Maximumphase charge(500 Ohms) | 18.0 µC/pulse | 10.2 µC/pulse | 14.2 µC/pulse | Same as MedtronicXtrel reference deviceat 300 Ohms.Maximum PhaseCharge constant incurrent controlledsystem and enforcedbelow maximumreference device value(at 300 Ohms). Noimpact to safety andeffectiveness. |
| Maximumphase charge(800 Ohms) | 18.0 µC/pulse | 10.2 µC/pulse | 10.5 µC/pulse | Same as MedtronicXtrel reference deviceat 300 Ohms.Maximum PhaseCharge constant incurrent controlledsystem and enforcedbelow maximumreference device value(at 300 Ohms). Noimpact to safety andeffectiveness. |
| Maximumcharge density(300 Ohm) | 146.94 µC/cm² | 83.3 µC/cm² | 150.0 µC/cm² | Within maximum limitas set by MedtronicXtrel reference device. |
| Comparator | NaluNeurostimulationSystem(Subject Device) | NaluNeurostimulationSystem(Predicate Device,K201618) | Medtronic XtrelModel 3425(Reference Device,K883780 andK982902) | Analysis ofTechnologicalDifferences fromPredicate |
| Maximumcharge density(500 Ohm) | 146.94 µC/cm² | 83.3 µC/cm² | 118.3 µC/cm² | Same as MedtronicXtrel reference deviceat 300 Ohms.Maximum PhaseCharge constant incurrent controlledsystem and enforcedbelow maximumreference device value(at 300 Ohms). Noimpact to safety andeffectiveness. |
| Maximumcharge density(800 Ohm) | 146.94 µC/cm² | 83.3 µC/cm² | 87.5 µC/cm² | Same as MedtronicXtrel reference deviceat 300 Ohms.Maximum PhaseCharge constant incurrent controlledsystem and enforcedbelow maximumreference device value(at 300 Ohms). Noimpact to safety andeffectiveness. |
| Maximumcurrentdensity (300Ohm) | 83.3 mA/cm² | 83.3 mA/cm² | 150.0 mA/cm² | Same as predicate |
| Maximumcurrentdensity (500Ohm) | 83.3 mA/cm² | 83.3 mA/cm² | 118.3 mA/cm2 | Same as predicate |
| Maximumcurrentdensity (800Ohm) | 83.3 mA/cm² | 83.3 mA/cm² | 87.5 mA/cm² | Same as predicate |
| Net Charge | 0 μC | Same | Same | Same as predicate |
| Average PhasePower (300Ohms) | 0.031 W/phase | 0.031 W/phase | 0.068 W/phase | Same as predicate |
| Comparator | NaluNeurostimulationSystem(Subject Device) | NaluNeurostimulationSystem(Predicate Device,K201618) | Medtronic XtrelModel 3425(Reference Device,K883780 andK982902) | Analysis ofTechnologicalDifferences fromPredicate |
| Average PhasePower (500Ohms) | 0.052 W/phase | 0.052 W/phase | 0.074 W/phase | Same as predicate |
| Average PhasePower (800Ohms) | 0.083 W/phase | 0.083 W/phase | 0.066 W/phase | Same as predicate. |
| Average PhasePower density(300 Ohms) | 0.25 $W/cm^2$ /phase | 0.25 $W/cm^2$ /phase | 0.57 $W/cm^2$ /phase | Same as predicate. |
| Average PhasePower density(500 Ohms) | 0.51 $W/cm^2$ /phase | 0.51 $W/cm^2$ /phase | 0.62 $W/cm^2$ /phase | Same as predicate. |
| Average PhasePower density(800 Ohms) | 0.55 $W/cm^2$ /phase | 0.55 $W/cm^2$ /phase | 0.55 $W/cm^2$ /phase | Same as predicate. |
| Pulse DeliveryMode | Continuous | Same | Same | Same as predicate. |
| Current Pathoptions | Bipolar | Same | Same | Same as predicate. |
| Program Cycle | Cycle throughprograms | Same | Details unavailable | Same as predicate. |
| Pulse Pattern | Fine tuning ofpulse patterns(On/Off; If On,spans from 12 $\mu$ sto 1000 $\mu$ s) | Same | Details unavailable | Same as predicate. |
| Dosage Time | Allows forstimulation to beapplied in periodicdoses (On/Off; IfOn, spans from 1ms to 1000 ms, IfOff, spans from 1ms to 2000 ms) | Allows forstimulation to beapplied in periodicdoses (On/Off; IfOn, spans from 1ms to 25 ms) | Same (CycleON/OFF) | This parameter has noimpact on safety andeffectivenessconsiderations.Increasing the rangeallows the clinician tooffer more flexibilityto accommodatepatient preferences |
| Comparator | NaluNeurostimulationSystem(Subject Device) | NaluNeurostimulationSystem(Predicate Device,K201618) | Medtronic XtrelModel 3425(Reference Device,K883780 andK982902) | Analysis ofTechnologicalDifferences fromPredicate |
| Daily TherapyTime | Limits the numberof hours in a daythat stimulationmay be used(Seconds to hours) | Same | Details unavailable | Same as predicate. |
| TransmitFrequency | 40.68 MHz | 40.68 MHz | 1.6 MHz | Same as predicate |
Table 6.1. Primary Predicate and Reference Device Summary
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The Implanted Pulse Generator, Leads, all surgical implant accessories and all external accessories are unchanged from the predicate Nalu Neurostimulation System. The only difference between the subject devices and the predicate devices is the change in the software. The Nalu Neurostimulation System uses the same software for both SCS and PNS. A table below details the impact of those changes in comparison with the predicate and reference devices.
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Table 6.2. Predicate and Reference Device comparison with the Nalu Neurostimulation therapy delivery
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7. Technological Characteristics
All of the physical and therapeutic attributes for the proposed Nalu Neurostimulation System and the predicate and reference devices share the same technological characteristics and have no differences that would impact safety or effectiveness.
8. Summary of Performance Testing
Nalu Medical performed a range of testing to gather data supporting the safety and performance of the Nalu Neurostimulation 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 evaluated and tested. The system is designed and tested to ensure that it meets all applicable standards and guidance documents. The subject device of this 510(k) has the same technological and performance criteria which have not changed from the predicate device. The proposed changes on the software specifications to increase therapy options are within the limits that have been previously cleared in predicate and reference devices. Validation and performance testing demonstrate that the device meets the performance criteria as reflected in the functional specifications. All of the required testing and results from the predicate device (K201618) remain applicable to the subject device of this 510(k) except for the updated software and firmware verification testing to support the proposed changes that are included in this submission.
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9. Conclusions
The subject device of this 510(k) is substantially equivalent to the predicate since it has identical intended use and the change in software and differences in technological characteristics do not raise new questions of safety and effectiveness.
§ 882.5880 Implanted spinal cord stimulator for pain relief.
(a)
Identification. An implanted spinal cord stimulator for pain relief is a device that is used to stimulate electrically a patient's spinal cord to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed on the patient's spinal cord and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.(b)
Classification. Class II (performance standards).