(29 days)
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 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)
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 Nalu Neurostimulation System has been cleared by the FDA for spinal cord stimulation (SCS; K203547) and peripheral nerve stimulation (PNS; K203547) 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 five (5) 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 (4) or eight (8) 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 (K203547).
This looks like a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and performance metrics for a novel AI device. The document mostly highlights the similarities between the subject device (K221376) and its predicate (K203547).
Based on the provided text, there is no specific AI component or algorithm mentioned, nor are there acceptance criteria or a study described to demonstrate the performance of such a component. The device is a "Nalu Neurostimulation System" which appears to be a hardware device for spinal cord and peripheral nerve stimulation. The changes referenced are related to "Clinician Programmer" software differences for therapy configuration, rather than an AI/ML algorithm that interprets data or makes diagnostic decisions.
Therefore, most of the questions you've asked about acceptance criteria, study details, ground truth, sample sizes, and involvement of experts/AI effectiveness are not applicable to this submission as it doesn't describe an AI/ML device in the context of the typical information provided if it were an AI/ML device.
Here's an attempt to answer your questions based only on the provided text, highlighting where the information is absent because the device does not appear to be an AI/ML product as you seem to be assuming:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in the form of performance metrics (e.g., sensitivity, specificity, AUC) that would be expected for an AI device. Instead, it demonstrates an acceptance of "substantial equivalence" to a predicate device by showing that the technological characteristics and indications for use are the same, and that non-clinical testing confirms safety and performance within established limits.
The tables (Table 1, Table 2, Table 3) provided in the document compare the technological characteristics and therapeutic parameters of the subject device (K221376) and its predicate device (K203547). The "reported device performance" in this context is that these characteristics are "Same as predicate" or that any differences "do not impact the safety and effectiveness of the device."
Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):
| Acceptance Criteria Category | Specific Criteria (Implicitly Met by Predicate Equivalence) | Reported Device Performance (Subject Device K221376) |
|---|---|---|
| Product Code and Class | GZB and GZF, Class II (for SCS and PNS) | Same as predicate (K203547) |
| Regulation Number | 21 CFR 882.5880 (GZB), 21 CFR 882.5870 (GZF) | Same as predicate (K203547) |
| Classification Name | Implanted spinal cord stimulator for pain relief / Implanted peripheral nerve stimulator for pain relief | Same as predicate (K203547) |
| Trade Name | Nalu Neuromodulation System | Same as predicate (K203547) |
| Manufacturer | Nalu Medical, Inc. | Same as predicate (K203547) |
| Intended Use | Stimulation of spinal cord/peripheral nerves for chronic intractable pain | Same as predicate (K203547) |
| Indications for Use | For chronic, intractable pain of the trunk and/or limbs (SCS); For severe intractable chronic pain of peripheral nerve origin (PNS) | Same as predicate (K203547) |
| Clinical Application | Treatment of chronic, intractable pain | Same as predicate (K203547) |
| Prescription Use | Yes | Same as predicate (K203547) |
| Environmental Use | Hospital, Home | Same as predicate (K203547) |
| Intended Clinician | Orthopedic, Neurosurgeon, Anesthesiologist | Same as predicate (K203547) |
| Intended User | Physician, Layperson | Same as predicate (K203547) |
| Implant Site, Leads | Epidural space (SCS) or peripheral nerve areas (PNS) | Same as predicate (K203547) |
| Principle of Operation | Stimulation of spinal cord/peripheral nerve to provide therapeutic relief | Same as predicate (K203547) |
| Mode of Action | RF wireless transmission of energy to deliver stimulation | Same as predicate (K203547) |
| Software Level of Concern | Moderate | Same as predicate (K203547) |
| Therapeutic Electrical Parameters (e.g., Pulse Frequency, Pulse Width, Current, Voltage, Waveform, Charge/Current Density, Net Charge, Power, Pulse Delivery Mode, etc.) | Within specified ranges and identical to predicate | Same as predicate (K203547) |
| Clinician Programmer Software | Software to communicate to Trial Therapy or Therapy Disc; Manual control of current and optional model-based allocation; Safety parameters (charge per phase, charge density, current density) unchanged and within limits. | Differences do not impact safety and effectiveness. New method is an option for faster programming, with patient feedback for effectiveness. |
| Patient Remote Control Software | Software to pair with Trial Therapy or Therapy Disc; SW update to reflect Clinician Programmer changes | No impact on safety or effectiveness (implied by lack of further analysis). |
| Externally Worn Devices Firmware | Firmware update to reflect Clinician Programmer and Remote Control changes | No impact on safety or effectiveness (implied by lack of further analysis). |
| Labeling | Updated to support Clinical Programmer Current Steering options | Differences to labeling do not impact safety and effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document states, "Nalu Medical determined that bench and non-clinical testing are sufficient to demonstrate that the Nalu Neurostimulation system is as safe and effective as the predicate device." No clinical data (which might involve a test set, sample size, or patient data provenance) was required or submitted for this 510(k) submission, as the device's substantial equivalence was established through non-clinical testing and comparison to the predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. As no clinical study or test set for an AI/ML algorithm was conducted/submitted, there was no need for experts to establish ground truth. The device is a neurostimulation system, not an AI diagnostic or interpretive tool.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring adjudication was used.
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 not an AI-assisted diagnostic or interpretive tool, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an AI algorithm. Its functionality involves hardware for neurostimulation, with software controlling the programming and delivery of stimulation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. Ground truth for an AI algorithm is not relevant here as the device is not an AI/ML product. The "ground truth" for this submission is implicitly the established safety and effectiveness of the predicate device, validated through non-clinical engineering and performance testing.
8. The sample size for the training set
Not applicable. No AI/ML model training was described or performed for this device.
9. How the ground truth for the training set was established
Not applicable. As no training set for an AI/ML model was used, no ground truth needed to be established for it.
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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-USA seal. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
June 10, 2022
Nalu Medical, Inc. Chelsea Gutierrez VP Regulatory and Quality 2320 Faraday Avenue, Suite 100 Carlsbad, California 92008
Re: K221376
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: May 12, 2022 Received: May 12, 2022
Dear Chelsea Gutierrez:
We have reviewed vour 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
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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-reporting-
combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Amber Ballard, PhD 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) K221376
Device Name Nalu Neurostimulation System
Indications for Use (Describe)
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 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)
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) |
|---|
| ------------------------------------------------- |
| ☑ Research that is Part 21 CFR 58 Subject to Bioresearch Monitoring Program |
|---|
| ☐ One Time Contracted (to Part 21 CFR 58) Study |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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1. Submission Sponsor
Nalu Medical, Incorporated 2320 Faraday Ave., Suite 100 Carlsbad, CA 92008 Phone: (714) 401-0608 Fax: (760) 448-2377 Contact: Chelsea Gutierrez Vice President of Regulatory Affairs and Quality Assurance
2. Date Prepared: June 10, 2022
3. 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; Implanted spinal cord stimulator for pain relief |
| Product Code | GZB |
| Review Panel | Division of Neurology |
| Secondary Product Code | |
|---|---|
| Proprietary Name | Nalu Neurostimulation System |
| Common Names | Stimulator, Peripheral Nerve, Implanted (Pain Relief) |
| Class | II |
| Classification Regulation | 21 CFR 882.5870; Implanted peripheral nerve stimulator for pain relief |
| Product Code | GZF |
| Review Panel | Division of Neurology |
4. Predicate Device(s)
Nalu Neurostimulation System, K203547
For software differences between the Nalu Neuromodulation System and the predicate(s) (K203547), substantial equivalence to the predicate device is demonstrated.
5. Device Description
The Nalu Neurostimulation System has been cleared by the FDA for spinal cord stimulation (SCS; K203547) and peripheral nerve stimulation (PNS; K203547) 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
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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 five (5) 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 (4) or eight (8) 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 (K203547).
6. 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 Stimulator (PNS)
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.
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7. Comparison with the Predicate Device
| Table 1: Nalu Neuromodulation System for Spinal Cord Stimulation (SCS) | |||
|---|---|---|---|
| ------------------------------------------------------------------------ | -- | -- | -- |
| Device | NaluNeuromodulation System (Subject Device, K221376) | NaluNeuromodulation System (Predicate Device, K203547) | Analysis of Technological Differences |
|---|---|---|---|
| 510(k) | K221376 | K203547 | N/A |
| Product Code and Class | GZB and GZF, Class II | GZB and GZF, Class II | Same |
| Regulation Number | 21 CFR 882.5880 (GZB)21 CFR 882.5870 (GZF) | 21 CFR 882.5880 (GZB)21 CFR 882.5870 (GZF) | Same |
| Classification Name | Implanted spinal cord stimulator for pain relief. (GZB)Implanted peripheral nerve stimulator for pain relief. (GZF) | Implanted spinal cord stimulator for pain relief. (GZB)Implanted peripheral nerve stimulator for pain relief. (GZF) | Same |
| Trade Name | NaluNeuromodulation System | NaluNeurostimulation System | Same |
| Manufacturer | Nalu Medical, Inc. | Nalu Medical, Inc. | Same |
| Intended Use | The NaluNeuromodulation system is intended for the stimulation of the spinal cord for treatment of chronic, intractable pain (GZB).Stimulation of peripheral nerves for chronic, intractable pain (GZF). | The NaluNeuromodulation system is intended for the stimulation of the spinal cord for treatment of chronic, intractable pain (GZB).Stimulation of peripheral nerves for chronic, intractable pain (GZF). | Same |
| Indications for Use | For Spinal Cord Stimulation-This system is indicated as the | For Spinal Cord Stimulation-This system is indicated as the | Same |
| Device | NaluNeuromodulationSystem (SubjectDevice, K221376) | NaluNeuromodulationSystem (PredicateDevice, K203547) | Analysis ofTechnologicalDifferences |
| sole mitigatingagent, or as anadjunct to othermodes of therapyused in amultidisciplinaryapproach forchronic, intractablepain of the trunkand/or limbs,including unilateralor bilateral pain.The trial devices aresolely used for trialstimulation (nolonger than 30days) to determineefficacy beforerecommendationfor a permanent(long- term) device.For PeripheralNerve Stimulation-This system isindicated for painmanagement inadults who havesevere intractablechronic pain ofperipheral nerveorigin, as the solemitigating agent, oras an adjunct toother modes oftherapy used in amultidisciplinaryapproach. Thesystem is notintended to treatpain in thecraniofacial region.The trial devices are | sole mitigatingagent, or as anadjunct to othermodes of therapyused in amultidisciplinaryapproach forchronic, intractablepain of the trunkand/or limbs,including unilateralor bilateral pain.The trial devices aresolely used for trialstimulation (nolonger than 30days) to determineefficacy beforerecommendationfor a permanent(long- term) device.For PeripheralNerve Stimulation-This system isindicated for painmanagement inadults who havesevere intractablechronic pain ofperipheral nerveorigin, as the solemitigating agent, oras an adjunct toother modes oftherapy used in amultidisciplinaryapproach. Thesystem is notintended to treatpain in thecraniofacial region.The trial devices are | ||
| Device | NaluNeuromodulationSystem (SubjectDevice, K221376) | NaluNeuromodulationSystem (PredicateDevice, K203547) | Analysis ofTechnologicalDifferences |
| stimulation (nolonger than 30 day)to determineefficacy beforerecommendationfor a permanent(long term) device. | stimulation (nolonger than 30 day)to determineefficacy beforerecommendationfor a permanent(long term) device. | ||
| Clinical application | Treatment ofchronic, intractablepain of the trunkand/or limbs,including unilateralor bilateral pain. | Treatment ofchronic, intractablepain of the trunkand/or limbs,including unilateralor bilateral pain. | Same |
| Prescription Use | Yes | Yes | Same |
| Environmental Use | Hospital, Home | Hospital, Home | Same |
| Intended Clinician | Orthopedic,Neurosurgeon,Anesthesiologist | Orthopedic,Neurosurgeon,Anesthesiologist | Same |
| Intended User | Physician,Layperson | Physician,Layperson | Same |
| Implant site, leads | Epidural space (SCS)or peripheral nerveareas (PNS) | Epidural space (SCS)or peripheral nerveareas (PNS) | Same |
| Principle ofOperation | Stimulation of thespinal cord toprovide therapeuticrelief for chronic,intractable pain ofthe trunk and/orlimbs includingunilateral orbilateral pain. | Stimulation of thespinal cord toprovide therapeuticrelief for chronic,intractable pain ofthe trunk and/orlimbs includingunilateral orbilateral pain. | Same |
| Mode of Action | RF wirelesstransmission ofenergy to deliverstimulation atstimulatorelectrodes. | RF wirelesstransmission ofenergy to deliverstimulation atstimulatorelectrodes. | Same |
| Software Level ofConcern | Moderate | Moderate | Same |
| ClinicianProgrammer | Software tocommunicate to | Not publiclyavailable | The differencesdo not impact thesafety and |
| Device | NaluNeuromodulationSystem (SubjectDevice, K221376) | NaluNeuromodulationSystem (PredicateDevice, K203547) | Analysis ofTechnologicalDifferences |
| Trial Therapy orTherapy DiscManual control ofcurrent for selectedelectrodes andoptional modelbased allocation. | effectiveness ofthe device. Thesafety parameters(charge per phase,charge densityand currentdensity) remainunchanged. Theupdated softwareallows theclinician tooptionally use amode to set thecurrent values onup to 4 electrodesbased on a model.The safety limitscontinue to beapplied as before.The new methodis an option thatmay allowprogramming togo faster whencausing thecurrent steeringstimulation mode.As with allprogramming inneurostimulationthe patientremains in thefeedback loop anddetermines theeffectiveness ofthe therapy. | ||
| Patient RemoteControl | Software to pairwith Trial Therapyor Therapy DiscSW update toreflect changes onthe ClinicianProgrammer and | Not publiclyavailable | - |
| Device | NaluNeuromodulationSystem (SubjectDevice, K221376) | NaluNeuromodulationSystem (PredicateDevice, K203547) | Analysis ofTechnologicalDifferences |
| Externally worndevices | Remote ControlTrial Therapy Discand Therapy DiscFirmware update toreflect changes onthe ClinicianProgrammer andRemote Control | Not publiclyavailable | - |
| LabellingClinicianProgrammer UserGuide/RemoteControl User Guide | Labeling updated tosupport ClinicalProgrammerCurrent Steeringoptions. | Not publiclyavailable | The differences tolabeling do notimpact the safetyand effectivenessof the device. |
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Table 2: Nalu Neuromodulation System for Peripheral Nerve Stimulation
| Device | NaluNeuromodulationSystem (SubjectDevice, K221376) | NaluNeuromodulationSystem (PredicateDevice, K203547) | Analysis ofTechnologicalDifferences |
|---|---|---|---|
| 510(k) | K221376 | K203547 | N/A |
| Product Code andClass | GZB and GZF, ClassII | 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) | Same |
| ClassificationName | Implanted spinalcord stimulator forpain relief. (GZB) | Implanted spinalcord stimulator forpain relief. (GZB) | Same |
| Device | NaluNeuromodulationSystem (SubjectDevice, K221376) | NaluNeuromodulationSystem (PredicateDevice, K203547) | Analysis ofTechnologicalDifferences |
| Implantedperipheral nervestimulator for painrelief. (GZF) | Implantedperipheral nervestimulator for painrelief. (GZF) | ||
| Trade Name | NaluNeuromodulationSystem | NaluNeurostimulationSystem | Same |
| Manufacturer | Nalu Medical, Inc. | Nalu Medical, Inc. | Same |
| Intended Use | The NaluNeuromodulationsystem is intendedfor the stimulationof the peripheralnerve for treatmentof chronic,intractable pain. | The NaluNeuromodulationsystem is intendedfor the stimulationof the peripheralnerve for treatmentof chronic,intractable pain. | Same |
| Indications for Use | This system isindicated for painmanagement inadults who havesevere intractablechronic pain ofperipheral nerveorigin, as the solemitigating agent, oras an adjunct toother modes oftherapy used in amultidisciplinaryapproach. Thesystem is notintended to treatpain in thecraniofacial region.The trial devices aresolely used for trialstimulation (nolonger than 30days) to determineefficacy beforerecommendationfor a permanent(long-term) device. | This system isindicated for painmanagement inadults who havesevere intractablechronic pain ofperipheral nerveorigin, as the solemitigating agent, oras an adjunct toother modes oftherapy used in amultidisciplinaryapproach. Thesystem is notintended to treatpain in thecraniofacial region.The trial devices aresolely used for trialstimulation (nolonger than 30days) to determineefficacy beforerecommendationfor a permanent(long-term) device. | Same |
| Device | NaluNeuromodulationSystem (SubjectDevice, K221376) | NaluNeuromodulationSystem (PredicateDevice, K203547) | Analysis ofTechnologicalDifferences |
| Clinical application | Treatment ofchronic peripheralnerve pain. | Treatment ofchronic peripheralnerve pain. | Same |
| Prescription Use | Yes | Yes | Same |
| Environmental Use | Hospital, Home | Hospital, Home | Same |
| Intended Clinician | Orthopedic,Neurosurgeon,Anesthesiologist | Orthopedic,Neurosurgeon,Anesthesiologist | Same |
| Implant site, leads | Epidural space (SCS)or peripheral nerveareas (PNS) | Epidural space (SCS)or peripheral nerveareas (PNS) | Same |
| Intended User | Physician,Layperson | Physician,Layperson | Same |
| Principle ofOperation | Stimulation of theperipheral nerve toprovide therapeuticrelief for chronic,pain. | Stimulation of theperipheral nerve toprovide therapeuticrelief for chronic,pain. | Same |
| Mode of Action | RF wirelesstransmission ofenergy to deliverstimulation atstimulatorelectrodes. | RF wirelesstransmission ofenergy to deliverstimulation atstimulatorelectrodes. | Same |
| Software Level ofConcern | Moderate | Moderate | Same |
| ClinicianProgrammer | Software tocommunicate toTrial Therapy orTherapy DiscManual control ofcurrent for selectedelectrodes andoptional modelbased allocation. | Not publiclyavailable | The differencesdo not impact thesafety andeffectiveness ofthe device. Thesafety parameters(charge perphase, chargedensity andcurrent density)remainunchanged. Theupdated softwareallows theclinician tooptionally use amode to set the |
| Device | NaluNeuromodulationSystem (SubjectDevice, K221376) | NaluNeuromodulationSystem (PredicateDevice, K203547) | Analysis ofTechnologicalDifferences |
| current values onup to 4 electrodesbased on a model.The safety limitscontinue to beapplied as before.The new methodis an option thatmay allowprogramming togo faster whencausing thecurrent steeringstimulation mode.As with allprogramming inneurostimulationthe patientremains in thefeedback loop anddetermines theeffectiveness ofthe therapy. | |||
| Patient RemoteControl | Software to pairwith Trial Therapyor Therapy DiscSW update toreflect changes onthe ClinicianProgrammer andRemote Control | Not publiclyavailable | - |
| Externally worndevices | Trial Therapy Discand Therapy DiscFirmware update toreflect changes onthe ClinicianProgrammer andRemote Control | Not publiclyavailable | - |
| Labelling | Labeling updated tosupport Clinical | Not publiclyavailable | The differences tolabeling do not |
| Device | NaluNeuromodulation System (SubjectDevice, K221376) | NaluNeuromodulation System (PredicateDevice, K203547) | Analysis ofTechnologicalDifferences |
| ClinicianProgrammer UserGuide/RemoteControl User Guide | Current Steeringoptions. | and effectivenessof the device. |
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Table 3 Predicate and Subject Device comparison with the Nalu Neurostimulation therapy delivery (SCS and PNS)
| Comparator | NaluNeurostimulationSystem(Subject Device,K221376) | NaluNeurostimulationSystem(Predicate Device,K203547) | Analysis ofTechnologicalDifferencesfromPredicate |
|---|---|---|---|
| Pulse Frequency | 2 Hz to 1500 Hz | 2 Hz to 1500 Hz | Same as predicate |
| Pulse Width | 12 to 2000 µs | 12 to 2000 µs | Same as predicate |
| Current/Volta geRegulated | Current | Current | Same as predicate |
| Output Voltage(300 Ohms) | 0 to 3.1 V | 0 to 3.1 V | Same as predicate |
| Output Voltage(500 Ohms) | 0 to 5.1 V | 0 to 5.1 V | Same as predicate |
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| Output Voltage(800 Ohms) | 0 to 8.2 V | 0 to 8.2 V | Same as predicate |
|---|---|---|---|
| Output Current(300 Ohms) | 0 to 10.2 mA | 0 to 10.2 mA | Same as predicate |
| Output Current(500 Ohms) | 0 to 10.2 mA | 0 to 10.2 mA | Same as predicate |
| Output Current(800 Ohms) | 0 to 10.2 mA | 0 to 10.2 mA | Same as predicate |
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| Comparator | NaluNeurostimulationSystem(Subject Device, K221376) | NaluNeurostimulationSystem(Predicate Device, K203547) | Analysis ofTechnologicalDifferencesfromPredicate |
|---|---|---|---|
| Waveform | charge balanced(delayed) biphasicasymmetrical | charge balanced(delayed) biphasicasymmetrical | Same as predicate |
| Pulse Shape | DecayingExponential | DecayingExponential | Same as predicate |
| Maximum phasecharge (300Ohms) | 18.0 µC/pulse | 18.0 µC/pulse | Same as predicate |
| Maximum phasecharge (500Ohms) | 18.0 µC/pulse | 18.0 µC/pulse | Same as predicate |
| Maximum phasecharge (800Ohms) | 18.0 µC/pulse | 18.0 µC/pulse | Same as predicate |
| Maximum chargedensity (300Ohms) | 146.94 µC/cm² | 146.94 µC/cm² | Same as predicate |
| Comparator | NaluNeurostimulationSystem(Subject Device, K221376) | NaluNeurostimulationSystem(Predicate Device, K201618) | Analysis ofTechnologicalDifferences fromPredicate |
| Maximum chargedensity (500Ohm) | 146.94 µC/cm2 | 146.94 µC/cm2 | Same as predicate |
| Maximum chargedensity (800Ohm) | 146.94 µC/cm2 | 146.94 µC/cm2 | Same as predicate |
| Maximumcurrent density(300 Ohm) | 83.3 mA/cm2 | 83.3 mA/cm2 | Same as predicate |
| Maximumcurrent density(500 Ohm) | 83.3 mA/cm2 | 83.3 mA/cm2 | Same as predicate |
| Maximumcurrent density(800 Ohm) | 83.3 mA/cm2 | 83.3 mA/cm2 | Same as predicate |
| Net Charge | 0 µC | 0 µC | Same as predicate |
| Average PhasePower (300Ohms) | 0.031 W/phase | 0.031 W/phase | Same as predicate |
| Comparator | NaluNeurostimulationSystem(Subject Device,K221376) | NaluNeurostimulationSystem(Predicate Device,K201618) | Analysis ofTechnologicalDifferencesfromPredicate |
| Average PhasePower (500Ohms) | 0.052 W/phase | 0.052 W/phase | Same as predicate |
| Average PhasePower (800Ohms) | 0.083 W/phase | 0.083 W/phase | Same as predicate. |
| Average PhasePower density(300 Ohms) | 0.25 W/cm²/phase | 0.25 W/cm²/phase | Same as predicate. |
| Average PhasePower density(500 Ohms) | 0.51 W/cm²/phase | 0.51 W/cm²/phase | Same as predicate. |
| Average PhasePower density(800 Ohms) | 0.55 W/cm²/phase | 0.55 W/cm²/phase | Same as predicate. |
| Pulse DeliveryMode | Continuous | Continuous | Same as predicate. |
| Current Pathoptions | Bipolar | Bipolar | Same as predicate. |
| Program Cycle | Cycle throughprograms | Cycle throughprograms | Same as predicate. |
| Pulse Pattern | Fine tuning ofpulse patterns(On/Off; If On,spans from 12 µs to1000 µs) | Fine tuning ofpulse patterns(On/Off; If On, spansfrom 12 µs to 1000µs) | 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 1000 ms, IfOff, spans from 1ms to 2000 ms) | Same as predicate |
| Comparator | NaluNeurostimulationSystem(Subject Device, K221376) | NaluNeurostimulationSystem(Predicate Device, K203547) | Analysis ofTechnologicalDifferencesfromPredicate |
| Daily Therapy Time | Limits the numberof hours in a daythat stimulationmay be used(Seconds to hours) | Limits the numberof hours in a daythat stimulationmay be used(Seconds to hours) | Same as predicate. |
| Transmit Frequency | 40.68 MHz | 40.68 MHz | Same as predicate |
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8. Technological Characteristics
All of the physical and therapeutic attributes for the proposed Nalu Neuromodulation System and the predicate device share the same technological characteristics and have no differences that would impact safety and effectiveness.
9. Summary of Nonclinical 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 standards 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 similar technological and performance criteria to the predicate device(s). The proposed changes on the Clinician Programmer 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 devices (K203547) remain applicable to the subject device of this 510(k) except for the updated software and firmware validation testing to support the proposed changes that are included in this submission.
Table 4: Standards and Guidance Documents
| Standard Number | Title |
|---|---|
| EN ISO 14971:2012 | Medical devices -- Application of risk management to medical devices |
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| 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 be provided by the manufacturer |
| ISO 14708-3:2017 | Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators |
| IEC 60601-1:2005: A2012 | Medical electrical equipment — Part 1: General requirements for basic safety and essential performance |
| IEC 60601-1-11:2015 | Medical electrical equipment — Part 1-11: General requirements for basic safety and essential performance — Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment |
| IEC 60601-1-2:2014 | Medical electrical equipment — Part 1-2: General requirements for basic safety and essential performance — Collateral Standard: Electromagnetic disturbances — Requirements and tests |
| BS EN 62311-2008 | Assessment of electronic and electrical equipment related to human exposure restrictions for electromagnetic fields |
| ANSI IEEE C63.27 | American National Standard for Evaluation of Wireless Coexistence |
| FDA Guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices issued October 2, 2014 | |
| FDA Guidance: Applying Human Factors and Usability Engineering to Medical Devices issued February 3, 2016 | |
| Refuse to Accept Policy for 510(k)s dated September 13, 2019 | |
| "eCopy Program for Medical Device Submissions" dated April 27, 2020 | |
| "Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Premarket Submissions for Medical Devices" (September 14, 2018) | |
| "Deciding When to Submit a 510(k) for a Software Change to an Existing Device dated Oct 25th 2017 | |
| The Special 510(k) Program: Guidance for Industry and Food and Drug Administration Staff | |
| Providing Regulatory Submissions for Medical Devices in Electronic Format – Submissions under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry and Food and Drug Administration Staff |
10. Clinical Performance Data
Nalu Medical determined that bench and non-clinical testing are sufficient to demonstrate that the Nalu Neurostimulation system is as safe and effective as the predicate device. Note that the predicate device did not need clinical evidence to obtain a determination of substantial equivalence.
11. Conclusions
The subject device of this 510(k) is substantially equivalent to the predicate device as they are identical with regard to indications for use, performance and the technological
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characteristics. Risk analysis of the proposed changes did not raise any different 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).