(98 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 thank 30 days) to determine efficacy before recommendation for a permanent (long term) device.
The Nalu Neurostimulation System (also referred to as the "Nalu System") is used for peripheral nerve stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The Nalu Neurostimulation system incorporates a miniature implanted neurostimulator, powered by an externally worn Therapy Disc device. Similar to the predicate StimQ, 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 System may be implanted following a successful trial period using the Nalu Neurostimulation trial system.
The Nalu Neurostimulation System is comprised of 5 elements:
- Nalu Implantable Pulse Generator: The implantable pulse generator (IPG) provides electrical stimulation pulses that are transmitted through the leads to the desired peripheral nerve. The IPG is available in two different implant architectures: an “integrated" system with pre-attached leads and a "ported" system where leads may be attached, via connector ports. In addition, both of these versions are available in single or dual lead configurations. The hermetic IPG housing includes a ceramic enclosure and a feedthrough connected internally to a printed circuit board assembly. Wires leaving the IPG are encapsulated in polyurethane and a silicone over mold forms the final biocompatible surface of the IPG for direct patient tissue contact.
- Leads: Leads are implantable and are designed to deliver electrical pulses to the peripheral nerve via an array of eight cylindrical electrodes at the distal end. Leads may be integrated with or connected to the IPG. Both Trial and Permanent Implant leads are available for use. The leads use polyurethane insulation with Pt/Ir electrodes. The leads may be secured in place with the Nalu Lead Anchor.
- Surgical and Trial Tools: Implantation of the Nalu IPG and lead components for Peripheral Nerve Stimulation (PNS) is performed via standard PNS surgical techniques. The desired implant location is accessed via needle placement, followed by lead placement through an introducer. The leads are anchored and the IPG is placed in a subcutaneous pocket. Patient contacting materials include medical grade stainless steel, thermoplastic elastomers, ABS, silicone, and Urethane.
- Externally worn Therapy Discs: Two types of Therapy Disc are available. One is to be used during the trial phase (Trial Therapy Disc), and one is to be used after permanent IPG implantation (Therapy Disc). Both devices are worn by the patient using one of the Nalu-provided options The Therapy Discs house a rechargeable lithium ion battery, and electronics including a microcontroller running software for therapy control, patient interaction and communication with Nalu's Clinician Programmer and Remote Control devices. The Therapy Disc used to power and command the implant does so wirelessly using Radio Frequency (RF) and is held in place by an adhesive clip applied to the skin or a belt/cuff worn over clothing.
- Clinician Programmer and Remote Control: A Clinician Programmer Application is provided to configure the Trial Therapy Disc and Therapy Disc devices during surgery and programming. A Patient Remote Control Application is available to provide the patient with a convenient secondary option to control their system in addition to built-in controls on the Therapy Disc. The Clinician Programming Application runs on an Android tablet and communicates over a secure Bluetooth Low Energy link with the Trial Therapy Disc and Therapy Disc devices. The programmer is responsible for configuring the devices to deliver therapy according to clinician defined levels and patient preferences, and for managing patient and session records. The Patient Remote Control Application runs on iOS and Android platforms and offers basic control of the Trial Therapy Disc and Therapy Disc through a secure Bluetooth Low Energy link. The controls include selecting between clinician-defined therapy options (programs), turning stimulation on and off, and managing alerts.
The provided text is a 510(k) premarket notification for the Nalu Neurostimulation System for Peripheral Nerve Stimulation. It describes the device, its intended use, and a comparison to predicate devices to demonstrate substantial equivalence. However, it explicitly states that no clinical performance data was deemed necessary for this submission.
Therefore, I cannot provide a table of acceptance criteria and reported device performance from a clinical study, nor details about sample sizes, expert ground truth establishment, adjudication, MRMC studies, or standalone algorithm performance, as these were not part of the documented submission process for this device.
The section "5.9. Clinical Performance Data" clearly 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. Note that the predicate device did not need clinical evidence to obtain a determination of substantial equivalence."
Based on the provided document, the device's acceptance was based on non-clinical performance (bench testing, animal studies, and compliance with standards).
Here's a breakdown of what can be extracted from the document regarding the device's safety and effectiveness without clinical data:
1. A table of acceptance criteria and the reported device performance:
As no clinical study was performed for this submission, there are no "acceptance criteria" related to a clinical performance study with human subjects, nor "reported device performance" in terms of clinical outcomes. The device's performance was evaluated through non-clinical testing to demonstrate substantial equivalence to predicate devices.
Table: Performance Evaluation based on Non-Clinical Testing and Substantial Equivalence
| Acceptance Criteria Category (based on Non-Clinical Testing) | Reported Device Performance (Nalu Neurostimulation System) |
|---|---|
| Functional and Electrical Performance | Verified to meet target specifications over a range of operating and storage conditions through electrical testing. |
| Mechanical Performance | Verified to meet target specifications over a range of operating and storage conditions through mechanical testing. |
| Software Verification & Validation | Demonstrated to perform as intended in the specified use conditions. |
| Biocompatibility | Demonstrated to be biocompatible based on testing (cytotoxicity, sensitization, irritation/intracutaneous reactivity, systemic toxicity, implant studies, chemical characterization) according to ISO 10993-1:2009 and FDA guidance. This included testing for implant devices (IPG, Leads, Anchor, Extension: permanent contact), externally communicating devices (Needles, Sheaths, surgical tools: limited contact), and surface devices (Therapy Discs, adhesive clip: permanent intact skin contact). |
| Sterilization Validation | Validated using Ethylene Oxide (ISO 11135-1:2014). |
| Human Factors & Usability | Testing performed on the device to ensure it met user needs as reflected in the functional specification, adhering to IEC 60601-1-6:2010+A1:2013 and IEC 62366-1:2015, and FDA guidance. |
| Animal Study Findings (Pre-clinical Validation) | Six (6) Nalu Neurostimulation IPGs and Lead systems implanted in a porcine model for 90 days. All devices performed as expected without incident. No device- or procedure-related complications or premature deaths. Data collected at 30, 60, and 90-day intervals. This study covered surgical usability, RF communication and stimulation, implanted device stability, and tissue response. |
| Compliance with Standards | Compliance demonstrated with relevant standards (e.g., ISO 14708-1:2014, ISO 14708-3:2017, IEC 60601-1:2005:A2012, IEC 60601-1-11:2015, IEC 60601-1-2:2014, IEC 62304:2015, ISO 14971:2012/2007, ISO 11607-1/2:2006, CISPR 11, and FDA guidance on Cybersecurity). |
| Substantial Equivalence to Predicate | All physical and therapeutic attributes are within or equivalent to the parameters of the StimQ Peripheral Nerve Stimulator (PNS) System (K171366) and other reference devices (Medtronic Mattrix, Medtronic Xtrel, ANS Renew). Differences in lead length, diameter, electrode array length, number of electrodes, electrode surface area, lead extension, anchor, configurations, software platforms, and transmit frequency were deemed not to affect safety and effectiveness of the intended use, based on engineering analysis and comparison to a range of previously cleared devices. |
2. Sample size used for the test set and the data provenance:
- Test Set (Non-clinical):
- Animal Study: 6 Nalu Neurostimulation IPGs and Lead systems were implanted. Data provenance is a pre-clinical study conducted by Nalu Medical (presumably in the USA, as it's an FDA submission for a US company). It's a prospective study.
- Bench Testing: Quantities of devices or components used for electrical, mechanical, biocompatibility, sterilization, and human factors testing are not specified in numerical terms within this document. The provenance is internal testing by Nalu Medical.
- Training Set (Not applicable for this submission method): No training set data is referenced, as this is a 510(k) based on substantial equivalence to predicates, not a de novo clearance requiring clinical studies or algorithmic training data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable for clinical ground truth. For the animal study, the "ground truth" was the observed performance of the device in a living model and tissue response, assessed by the study investigators. The qualifications of these experts are not detailed in the document.
- For engineering and performance testing, the ground truth is established by the design specifications, validated test methods, and industry standards, implemented and evaluated by qualified engineers and testers.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable for clinical studies. For the non-clinical and animal studies, methods like peer review of study protocols, data analysis, and report generation would be in place, but a "2+1" or "3+1" adjudication method typically refers to radiologist consensus in image-based AI studies, which is not relevant here.
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:
- No, an MRMC comparative effectiveness study was not done. This type of study would be relevant for AI-powered diagnostic devices, which is not the case for this neurostimulation system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a neurostimulation system, not an AI algorithm for diagnosis or interpretation. Its software controls the device's function, and its performance is evaluated in the context of device operation, not as a standalone diagnostic tool. The software was subject to verification and validation tests as per IEC 62304.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the animal study: The ground truth was based on direct observation of device performance, surgical usability, stability, tissue response, and lack of complications in the porcine model.
- For bench testing: Ground truth was based on established engineering specifications, validated test methods, and compliance with national and international standards.
8. The sample size for the training set:
- Not applicable. This submission is based on substantial equivalence and non-clinical data, not on an algorithm trained with a specific dataset.
9. How the ground truth for the training set was established:
- Not applicable. (See point 8).
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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo, which features a stylized human figure. The logo on the right is the FDA U.S. Food & Drug Administration logo, with the FDA acronym in a blue square and the full name of the administration written in blue text.
March 29, 2019
Nalu Medical, Inc Michele Chin-Purcell, Ph.D. Vice President Regulatory Affairs and Quality Assurance 2320 Faraday Ave.. Suite 100 Carlsbad, CA 92008
Re: K183579
Trade/Device Name: Nalu Neurostimulation System for Peripheral Nerve Stimulation Regulation Number: 21 CFR 882.5870 Regulation Name: Implanted Peripheral Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: GZF Dated: February 26, 2019 Received: February 27, 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/cdr/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Pamela D. Scott-S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K183579
Device Name
Nalu Neurostimulation System for Peripheral Nerve Stimulation
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 thank 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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5.1. 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
5.2. Date Prepared
March 22, 2019
5.3. Device Identification
Trade/Proprietary Name: Nalu Neurostimulation System for Peripheral Nerve Stimulation 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
5.4. Legally Marketed Predicate Device(s)
StimQ Peripheral Nerve Stimulator (PNS) System (K171366) by StimQ LLC Hereafter, also referred to as the StimQ PNS System or StimQ
For areas where slight differences occur between the Nalu Neurostimulation system and the primary predicate (K171366), 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 5-1:
| Device | 510(k) | Predicate(s) used for clearance |
|---|---|---|
| StimQ Peripheral NerveStimulator (PNS) System | K152178 | Stimwave Freedom SCS (K150517)Medtronic Mattrix 3271/3272 (K934065)Medtronic Xtrel, 3425 (K883780)ANS Renew (K000852) |
| StimQ Peripheral NerveStimulator (PNS) System(Primary Predicate) | K171366 | K152178 |
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The 510(k) history of the StimQ system includes design changes over time. The original Medtronic and ANS devices are part of the predicate history of the StimQ device and are also used as references devices in this 510(k).
5.5. Device Description
The Nalu Neurostimulation System (also referred to as the "Nalu System") is used for peripheral nerve stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The Nalu Neurostimulation system incorporates a miniature implanted neurostimulator, powered by an externally worn Therapy Disc device. Similar to the predicate StimQ, 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 System may be implanted following a successful trial period using the Nalu Neurostimulation trial system.
The Nalu Neurostimulation System is comprised of 5 elements:
| 1. | NaluImplantablePulseGenerator | 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 pre-attached leadsand a "ported" system where leads may be attached, via connectorports. In addition, both of these versions are available in single ordual lead configurations. The hermetic IPG housing includes aceramic enclosure and a feedthrough connected internally to aprinted circuit board assembly. Wires leaving the IPG areencapsulated in polyurethane and a silicone over mold forms thefinal biocompatible surface of the IPG for direct patient tissuecontact. |
|---|---|---|
| 2. | Leads | Leads are implantable and are designed to deliver electrical pulses tothe peripheral nerve via an array of eight cylindrical electrodes at thedistal end. Leads may be integrated with or connected to the IPG.Both Trial and Permanent Implant leads are available for use. Theleads use polyurethane insulation with Pt/Ir electrodes. The leadsmay be secured in place with the Nalu Lead Anchor. |
| 3. | Surgical andTrial Tools | Implantation of the Nalu IPG and lead components for PeripheralNerve Stimulation (PNS) is performed via standard PNS surgicaltechniques. The desired implant location is accessed via needleplacement, followed by lead placement through an introducer. Theleads are anchored and the IPG is placed in a subcutaneous pocket.Patient contacting materials include medical grade stainless steel,thermoplastic elastomers, ABS, silicone, and Urethane. |
| 4. | Externallyworn | Two types of Therapy Disc are available. One is to be used duringthe trial phase (Trial Therapy Disc), and one is to be used afterpermanent IPG implantation (Therapy Disc). Both devices are wornby the patient using one of the Nalu-provided options The Therapy |
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| TherapyDiscs | Discs house a rechargeable lithium ion battery, and electronicsincluding a microcontroller running software for therapy control,patient interaction and communication with Nalu's ClinicianProgrammer and Remote Control devices. The Therapy Disc used topower and command the implant does so wirelessly using RadioFrequency (RF) and is held in place by an adhesive clip applied tothe skin or a belt/cuff worn over clothing. |
|---|---|
| 5. ClinicianProgrammerand RemoteControl | A Clinician Programmer Application is provided to configure theTrial Therapy Disc and Therapy Disc devices during surgery andprogramming. A Patient Remote Control Application is available toprovide the patient with a convenient secondary option to controltheir system in addition to built-in controls on the Therapy Disc.The Clinician Programming Application runs on an Android tabletand communicates over a secure Bluetooth Low Energy link withthe Trial Therapy Disc and Therapy Disc devices. The programmeris responsible for configuring the devices to deliver therapyaccording to clinician defined levels and patient preferences, and formanaging patient and session records.The Patient Remote Control Application runs on iOS and Androidplatforms and offers basic control of the Trial Therapy Disc andTherapy Disc through a secure Bluetooth Low Energy link. Thecontrols include selecting between clinician-defined therapy options(programs), turning stimulation on and off, and managing alerts. |
Indications for Use Statement 5.6.
"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 Nalu Neurostimulation System is not identical to the predicate device; however, the differences do not alter the intended therapeutic use of the device nor do they affect the safety and effectiveness of the device relative to the predicate. Both the subject and predicate devices have the same intended use for the stimulation of peripheral nerves for treatment of chronic, intractable pain.
5.7. Substantial Equivalence Discussion
The following tables compare the Nalu Neurostimulation System to the predicate device with respect to intended use, technological characteristics and principles of operation,
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providing more detailed information regarding the basis for the determination of substantial equivalence.
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Table 5-2: Substantial Equivalence Table – General and Implanted Components
| Nalu Neurostimulation System(Subject Device) | StimQ PNSSystem(PrimaryPredicate) | StimQ PNSSystem(ReferenceDevice) | MedtronicMattrix3271/3272(ReferenceDevice) | MedtronicXtrel 3425(ReferenceDevice) | ANS Renew(Reference Device) | Analysis ofTechnologicalDifferences fromPrimary Predicate | |
|---|---|---|---|---|---|---|---|
| 510(k) | K183579 | K171366 | K152178 | K934065 | K883780 | K000852 | NA |
| Product Codeand class | GZF, Class II | Same | Same | GZF and GZB | GZB | GZF and GZB | Same |
| Regulationnumber | 21 CFR §882.5870 | Same | Same | Same, plus 21CFR 882.5880 | Same | Same, plus 21 CFR§882.5880 | Same |
| Classificationname | Stimulator, Peripheral Nerve,Implanted (pain relief) | Same | Same | Same plusStimulator,Spinal Cord,Implanted (PainRelief) | Same | Same plusStimulator, SpinalCord, Implanted(Pain Relief) | Same |
| Intended Use | Stimulation of peripheral nervesfor chronic, intractable pain | Same | Same | Same, plusStimulation ofspinal cord forchronic,intractable pain | Same | Same, plusStimulation of spinalcord for chronic,intractable pain | Same |
| Indications forUse | This system is indicated for painmanagement in adults who havesevere intractable chronic pain ofperipheral nerve origin, as thesole mitigating agent, or as anadjunct to other modes oftherapy used in amultidisciplinary approach. Thesystem is not intended to treatpain in the craniofacial region. | The StimQ Peripheral NerveStimulator (PNS) System isindicated for pain managementin adults who have severeintractable chronic pain ofperipheral nerve origin, as thesole mitigating agent, or as anadjunct to other modes oftherapy used in amultidisciplinary approach. TheStimQ PNS System is not | Indicated as an aide in themanagement of chronic,intractable pain of the trunk orlimbs | Indicated for thetreatment of chronicpain of trunk andlimbs, either as thesole mitigatingagent, or as anadjunct to othermodes of therapyused in a | Differences do notaffect safety andeffectiveness ofintended use | ||
| Nalu Neurostimulation System(Subject Device) | StimQ PNSSystem(PrimaryPredicate) | StimQ PNSSystem(ReferenceDevice) | MedtronicMattrix3271/3272(ReferenceDevice) | MedtronicXtrel 3425(ReferenceDevice) | ANS Renew(Reference Device) | Analysis ofTechnologicalDifferences fromPrimary Predicate | |
| The trial devices are solely usedfor trial stimulation (no longerthan 30 days) to determineefficacy before recommendationfor a permanent (long term)device. for a permanent (longterm) device. | intended to treat pain in thecraniofacial region.The StimQ Trial Lead Kit is onlyused in conjunction with theStimQ Stimulator Receiver Kit.The trial devices are solely usedfor trial stimulation (no longerthan 30 days) to determineefficacy beforerecommendation for apermanent (long term) device. | multidisciplinaryapproach. | |||||
| PrescriptionUse? | Yes | Same | Same | Same | Same | Same | Same |
| Implant site | Peripheral nerves, excludingcraniofacial region | Same | Same | Same | Same | Same | Same |
| EnvironmentalUse | Hospital, Home | Same | Same | Same | Same | Same | Same |
| IntendedClinician | Orthopedic, Neurosurgeon,Anesthesiologist | Same | Same | Same | Same | Same | Same |
| Intended User | Physician, Layperson | Same | Same | Same | Same | Same | Same |
| Mode of Action | Radio Frequency (RF) wirelesstransmission of energy toproduce stimulation at stimulatorelectrodes. | Same | Same | Same | Same | Same | Same |
| Software Levelof Concern | Moderate | Moderate | Moderate | Unreported | Unreported | Moderate | Same |
| Nalu NeurostimulationSystem(Subject Device) | StimQ PNS System(K171366)(Primary Predicate) | StimQ PNS System(K152178)(ReferenceDevice) | MedtronicMattrix3271/3272(K934065)(ReferenceDevice) | MedtronicXtrel 3425(K883780)(ReferenceDevice) | ANS Renew(K000852)(ReferenceDevice) | Analysis ofTechnologicalDifferences fromPrimaryPredicate | |
| IPG | |||||||
| Dimensions | Lead = 1.30 mm diameterIPG = 28 x 11 x 4.9 mm | Integrated with lead body,1.35 mm diameter | Integrated withlead body, 1.35mm diameter | Details unavailable. See Section 12.2.1 below | Differences donot affect safetyand effectivenessof intended use | ||
| Housingmaterial | Silicone and Pellethane2363-55D | Pellethane 2363-55D | Pellethane 2363-55D | Details unavailable. See Section 12.2.1 below | Differences donot affect safetyand effectivenessof intended use | ||
| Implant site | Peripheral nerves,excluding craniofacialregion | Same | Same | Same | Same | Same | Same |
| Electricalcomponents | Embedded receiver,flexible circuit board | Same | Same | Sealedelectroniccircuits | Sealedelectroniccircuits | Sealedelectroniccircuits | Same |
| Power Delivery | Coupled receiver radiofrequency transmission | Same | Same | Same | Same | Coupledreceiver,hardwiredwithconnector | Same |
| Lead | |||||||
| ElectrodeMaterial | Platinum-iridium 90:10 | Same | Same | Same | Same | Same | Same |
| Insulation BodyMaterial | Pellethane 2363-55D | Same | Same | Same | Same | Same | Same |
| Cable features | Multilumen tube | Same | Same | Coiled Wires | Coiled Wires | Braided Wire | Same |
| Nalu NeurostimulationSystem(Subject Device) | StimQ PNS System(K171366)(Primary Predicate) | StimQ PNS System(K152178)(ReferenceDevice) | MedtronicMattrix3271/3272(K934065)(ReferenceDevice) | MedtronicXtrel 3425(K883780)(ReferenceDevice) | ANS Renew(K000852)(ReferenceDevice) | Analysis ofTechnologicalDifferences fromPrimaryPredicate | |
| Lead length | 40 cm, 60 cm | 44 cm | 45 cm | 30 to 110 cm | 30 to 110 cm | 30 and 60 cm | Differences donot affect safetyand effectivenessof intended use |
| Diameter | 1.30 mm | 1.35 mm | 1.35 mm | 1.3 mm | 1.3 mm | 1.37 mm | Differences donot affect safetyand effectivenessof intended use |
| Electrode Arraylength | 52 mm | 24 mm (FRE-4)52 mm (FRE-8) | 24 mm | 24 mm | 24 mm | 24 mm | Differences donot affect safetyand effectivenessof intended use |
| No. ofElectrodes, perlead | 8 | 4 (FRE-4)8 (FRE-8) | 4 | Same | Same | 4 or 8 | Differences donot affect safetyand effectivenessof intended use |
| IndividualElectrodelength | 3.0 mm | Same | Same | Same | Same | Same | Same |
| Electrodespacing | 4.0 mm | Same | Same | Same | Same | Same | Same |
| Electrodesurface area | 12.25 mm² | 12.72 mm² | 12.72 mm² | 12.25 mm² | 12.25 mm² | ~13 mm² | Differences donot affect safetyand effectivenessof intended use |
| Lead extension | Lead extension available | NA | NA | Lead extensionavailable | Lead extensionavailable | Leadextensionavailable | Differences donot affect safetyand effectivenessof intended use |
| Nalu NeurostimulationSystem(Subject Device) | StimQ PNS System(K171366)(Primary Predicate) | StimQ PNS System(K152178)(ReferenceDevice) | MedtronicMattrix3271/3272(K934065)(ReferenceDevice) | MedtronicXtrel 3425(K883780)(ReferenceDevice) | ANS Renew(K000852)(ReferenceDevice) | Analysis ofTechnologicalDifferences fromPrimaryPredicate | |
| Lead Anchor | Molded silicone anchorwith Ti locking mechanism | Suture Sleeve Cap,Pellethane 55-D, placedover proximal end ofstimulator | Suture Sleeve Cap,Pellethane 55-D,placed overproximal end ofstimulator | Molded siliconeanchor | Moldedsilicone anchor | Moldedsiliconeanchor | Differences donot affect safetyand effectivenessof intended use |
| Configurations | Integrated and with Ports | Integrated | Integrated | With Ports | With Ports | With Ports | Differences donot affect safetyand effectivenessof intended use |
| Sterilization | Ethylene Oxide | Same | Same | Same | Same | Same | Same |
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Table 5-3: Substantial Equivalence Table – Therapy
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| Comparator | NaluNeurostimulationSystem(Subject Device) | StimQ PNS System(K171366)(Primary Predicate) | StimQ PNS System(K152178)(Reference Device) | Medtronic Mattrix3271/3272(K934065)(Reference Device) | MedtronicXtrel 3425(K883780)(ReferenceDevice) | ANS Renew(K000852)(ReferenceDevice) | Analysis ofTechnologicalDifferences fromPrimary Predicate |
|---|---|---|---|---|---|---|---|
| Pulse Frequency | 2 Hz to 1500 Hz1 | 5 to 1500 Hz | 5 Hz to 1500 Hz | 5 to 240 Hz | 5 to 1400 Hz | 10 to 1500 Hz | Differences do notaffect safety andeffectiveness ofintended use |
| Pulse Width | 12 to 1000 µs | 50 to 500 µs | 50 to 500 µs | 50 to 500 µs | 50 to 1000 µs | 50 to 500 µs | Differences do notaffect safety andeffectiveness ofintended use |
| Current/VoltageRegulated | Current | Current | Current | Voltage | Voltage | Current | Same |
| Output Voltage(300 Ohms) | 0 to 3.1 V | 0 to 4.1 V | 0 to 6.3 V | 0 to 7 V | 0 to 5.4 V | 0 to 5.7 V | Differences do notaffect safety andeffectiveness ofintended use |
| Output Voltage(500 Ohms) | 0 to 5.1 V | 0 to 6.4 V | 0 to 7.2 V | 0 to 10.8 V | 0 to 7.1 V | 0 to 7.6 V | Differences do notaffect safety andeffectiveness ofintended use |
| Output Voltage(800 Ohms) | 0 to 8.2 V | 0 to 7.5 V | 0 to 8.0 V | 0 to 11.6 V | 0 to 8.4 V | 0 to 9.6 V | Differences do notaffect safety andeffectiveness ofintended use |
| Output Current(300 Ohms) | 0 to 10.2 mA | 0 to 13.5 mA | 0 to 21 mA | 0 to 23.3 mA | 0 to 18.0 mA | 0 to 19.0 mA | Differences do notaffect safety andeffectiveness ofintended use |
| Comparator | NaluNeurostimulationSystem(Subject Device) | StimQ PNS System(K171366)(Primary Predicate) | StimQ PNS System(K152178)(Reference Device) | Medtronic Mattrix3271/3272(K934065)(Reference Device) | MedtronicXtrel 3425(K883780)(ReferenceDevice) | ANS Renew(K000852)(ReferenceDevice) | Analysis ofTechnologicalDifferences fromPrimary Predicate |
| Output Current(500 Ohms) | 0 to 10.2 mA | 0 to 12.8 mA | 0 to 15 mA | 0 to 21.6 mA | 0 to 14.2 mA | 0 to 15.2 mA | Differences do notaffect safety andeffectiveness ofintended use |
| Output Current(800 Ohms) | 0 to 10.2 mA | 0 to 9.4 mA | 0 to 10 mA | 0 to 14.5 mA | 0 to 10.5 mA | 0 to 12.0 mA | Differences do notaffect safety andeffectiveness ofintended use |
| Waveform | charge balanced(delayed) biphasicasymmetrical | Same | Same | Same | Same | Same | Same |
| Pulse Shape | DecayingExponential | DecayingExponential | DecayingExponential | DecayingExponential | DecayingExponential | DecayingExponential | Same |
| Maximum phasecharge (300 Ohms) | 10.2 µC/pulse | 6.8 µC/pulse | 10.5 µC/pulse | 11.7 µC/pulse | 18.0 µC/pulse | 9.5 µC/pulse | Differences do notaffect safety andeffectiveness ofintended use |
| Maximum phasecharge (500 Ohms) | 10.2 µC/pulse | 6.4 µC/pulse | 7.2 µC/pulse | 10.8 µC/pulse | 14.2 µC/pulse | 7.6 µC/pulse | Differences do notaffect safety andeffectiveness ofintended use |
| Maximum phasecharge (800 Ohms) | 10.2 µC/pulse | 4.7 µC/pulse | 5.0 µC/pulse | 7.3 µC/pulse | 10.5 µC/pulse | 6.0 µC/pulse | Differences do notaffect safety andeffectiveness ofintended use |
| Maximum chargedensity (300 Ohm) | 83.3 µC/cm² | 53.1 µC/cm² | 82.5 µC/cm² | 97.2 µC/cm² | 150.0 µC/cm² | 73.1 µC/cm² | Differences do notaffect safety andeffectiveness ofintended use |
| Comparator | NaluNeurostimulationSystem(Subject Device) | StimQ PNS System(K171366)(Primary Predicate) | StimQ PNS System(K152178)(Reference Device) | Medtronic Mattrix3271/3272(K934065)(Reference Device) | MedtronicXtrel 3425(K883780)(ReferenceDevice) | ANS Renew(K000852)(ReferenceDevice) | Analysis ofTechnologicalDifferences fromPrimary Predicate |
| Maximum chargedensity (500 Ohm) | 83.3 µC/cm² | 50.3 µC/cm² | 56.6 µC/cm² | 90.0 µC/cm² | 118.3 µC/cm² | 58.5 µC/cm² | Differences do notaffect safety andeffectiveness ofintended use |
| Maximum chargedensity (800 Ohm) | 83.3 µC/cm² | 36.9 µC/cm² | 39.3 µC/cm² | 60.4 µC/cm² | 87.5 µC/cm² | 46.2 µC/cm² | Differences do notaffect safety andeffectiveness ofintended use |
| Maximum currentdensity (300 Ohm) | 83.3 mA/cm² | 106.1 mA/cm² | 165.1 mA/cm² | 194.4 mA/cm² | 150.0mA/cm² | 146.2 mA/cm² | Differences do notaffect safety andeffectiveness ofintended use |
| Maximum currentdensity (500 Ohm) | 83.3 mA/cm² | 100.6 mA/cm² | 113.2 mA/cm² | 180.0 mA/cm² | 118.3mA/cm² | 116.9 mA/cm² | Differences do notaffect safety andeffectiveness ofintended use |
| Maximum currentdensity (800 Ohm) | 83.3 mA/cm² | 73.9 mA/cm² | 73.9 mA/cm² | 120.8 mA/cm² | 87.5 mA/cm² | 92.3 mA/cm² | Differences do notaffect safety andeffectiveness ofintended use |
| Net Charge | 0 uC | Same | Same | Same | Same | Same | Same |
| Average PhasePower (300 Ohms) | 0.031 W/phase | 0.053 W/phase | 0.060 W/phase | 0.132 W/phase | 0.068W/phase | 0.070 W/phase | Differences do notaffect safety andeffectiveness ofintended use |
| Average PhasePower (500 Ohms) | 0.052 W/phase | 0.073 W/phase | 0.076 W/phase | 0.166 W/phase | 0.074W/phase | 0.090 W/phase | Differences do notaffect safety andeffectiveness ofintended use |
| Average PhasePower (800 Ohms) | 0.083 W/phase | 0.062 W/phase | 0.060 W/phase | 0.131 W/phase | 0.066W/phase | 0.100 W/phase | Differences do notaffect safety andeffectiveness ofintended use |
| Comparator | NaluNeurostimulationSystem(Subject Device) | StimQ PNS System(K171366)(Primary Predicate) | StimQ PNS System(K152178)(Reference Device) | Medtronic Mattrix3271/3272(K934065)(Reference Device) | MedtronicXtrel 3425(K883780)(ReferenceDevice) | ANS Renew(K000852)(ReferenceDevice) | Analysis ofTechnologicalDifferences fromPrimary Predicate |
| Average PhasePower density (300Ohms) | 0.25 W/cm²/phase | 0.42 W/cm²/phase | 0.48 W/cm²/phase | 1.10 W/cm²/phase | 0.57W/cm²/phase | 0.54W/cm²/phase | Differences do notaffect safety andeffectiveness ofintended use |
| Average PhasePower density (500Ohms) | 0.51 W/cm²/phase | 0.58 W/cm²/phase | 0.59 W/cm²/phase | 1.38 W/cm²/phase | 0.62W/cm²/phase | 0.69W/cm²/phase | Differences do notaffect safety andeffectiveness ofintended use |
| Average PhasePower density (800Ohms) | 0.55 W/cm²/phase | 0.48 W/cm²/phase | 0.60 W/cm²/phase | 1.09 W/cm²/phase | 0.55W/cm²/phase | 0.77W/cm²/phase | Differences do notaffect safety andeffectiveness ofintended use |
| Pulse DeliveryMode | Continuous | Same | Same | Same | Same | Same | Same |
| Current Pathoptions | Bipolar | Bipolar | Bipolar | Bipolar | Bipolar | Bipolar | Same |
| Program Cycle | Cycle throughprograms | Same | Details unavailable | Details unavailable | Detailsunavailable | Detailsunavailable | Same |
| Pulse Pattern | Fine tuning of pulsepatterns(On/Off; If On, spansfrom 12 μs to 1000μs) | Same (over span of1 sec) | Details unavailable | Details unavailable | Detailsunavailable | Detailsunavailable | Same |
| Dosage Time | Allows forstimulation to beapplied in periodicdoses (On/Off; IfOn, spans from 1 msto 25 ms) | Same (over span ofseveral minutes,hours, and up toone day) | Details unavailable | Same (CycleON/OFF) | Same (CycleON/OFF) | Detailsunavailable | Differences do notaffect safety andeffectiveness ofintended use |
| Comparator | NaluNeurostimulationSystem(Subject Device) | StimQ PNS System(K171366)(Primary Predicate) | StimQ PNS System(K152178)(Reference Device) | Medtronic Mattrix3271/3272(K934065)(Reference Device) | MedtronicXtrel 3425(K883780)(ReferenceDevice) | ANS Renew(K000852)(ReferenceDevice) | Analysis ofTechnologicalDifferences fromPrimary Predicate |
| Daily Therapy Time | Limits the number ofhours in a day thatstimulation may beused(Seconds to hours) | Same (hours) | Details unavailable | Details unavailable | Detailsunavailable | Detailsunavailable | Differences do notaffect safety andeffectiveness ofintended use |
| TransmitFrequency | 40.68 MHz | 915 MHz | 915 MHz | 2 MHz | 1.6 MHz | 2 MHz | Differences do notaffect safety andeffectiveness ofintended use |
1 Pulse Frequency range from 2 Hz to 1500 Hz available in the Stimwave Freedom SCS System (K141399), which was part of the Primary Predicate StimQ PNS System K171366.
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| Nalu Neurostimulation System(Subject Device) | StimQ Peripheral NerveStimulator (PNS) System(K171366)(Predicate) | Analysis of TechnologicalDifferences | |
|---|---|---|---|
| Externally worn devices | |||
| Name | Therapy Disc and Trial TherapyDisc | Wearable Antenna Assembly(WAA) | NA |
| Electronics | A printed circuit board (PCB)that generates RF power withembedded waveform parametersettings and buttons forchanging parameter settings asneeded by the user | A printed circuit board (PCB)that generates RF power withembedded waveform parametersettings and buttons forchanging parameter settings asneeded by the user | Same |
| Userinterface | Integrated controls andindicators that allows the userto turn the device on/off,increase or decrease therapylevels, select from configuredtherapy profiles and monitordevice status | Integrated controls andindicators that allows the userto turn the device on/off,increase or decrease therapylevels, select from configuredtherapy profiles and monitordevice status | Same |
| Antenna(Therapy Disconly) | Integrated antenna supporting40.68 MHz power and datatransfer. | Transmitting (Tx) AntennaAssembly, 915 MHz – Anantenna and coaxial cableassembly that is attached to theWAA that is used to transmitmicrowave energy to theimplanted Stimulator. | Differences do not affectsafety and effectivenessof intended use |
| Wearing(Therapy Disconly) | Therapy Disc is positioned overNalu IPG via two options:• Adhesive clip (hydrocolloidadhesive)• Elastic Belt/Cuff | SWAG Accessory KitAntenna positioned over devicewith wearable unit to fitdifferent extremities | Differences do not affectsafety and effectivenessof intended use |
| Size/Weight | Disc: ~1.5 cm thick, 7.5 cmdiameterWeight: ~0.08 kg | 7.6 cm x 5 cm x 2 cm0.5 kg(Estimates based on availableinformation) | Differences do not affectsafety and effectivenessof intended use |
| ExternallycontactingMaterials | Biocompatible PC ABS housing.Occasional contact to fingers(e.g., button use).Textile material of belt/cuff maybe worn over clothing.Hydrocolloid adhesive applied toskin. | Silicone and Aluminum (not tobe worn on body).Occasional contact to fingers(e.g. button use).Textile material of belt may beworn directly on the skin.No adhesive option reported. | Differences do not affectsafety and effectivenessof intended use |
| Table 5-4: Substantial Equivalence Table - External components | |
|---|---|
| ---------------------------------------------------------------- | -- |
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| Nalu Neurostimulation System(Subject Device) | StimQ Peripheral NerveStimulator (PNS) System(K171366)(Predicate) | Analysis of TechnologicalDifferences | |
|---|---|---|---|
| BatteryCharging | Electrically isolated cradlecharger | A battery and wire assembly forcharging and for power delivery | Differences do not affectsafety and effectivenessof intended use |
Table 5-5: Substantial Equivalence Table – Clinician Programmer and Remote Control
| Nalu Neurostimulation System(Subject Device) | StimQ Peripheral NerveStimulator (PNS) System(K171366)(Predicate) | Analysis ofTechnologicalDifferences | |
|---|---|---|---|
| Clinician Programmer | |||
| Configuration | Software installed on acompatible Android tablet. | Software installed on an iPad | Differences do notaffect safety andeffectiveness ofintended use |
| Purpose | Allows healthcare provider to setdesired therapy levels and devicesettings across Therapy Disc, TrialTherapy Disc, and Patient RemoteControl devices. | Allows healthcare provider to setdesired therapy levels and devicesettings | Same |
| Communication | Secure Bluetooth to Therapy Disc,Trial Therapy Disc, and PatientRemote Control. | Bluetooth | Differences do notaffect safety andeffectiveness ofintended use |
| Patient Remote Control | |||
| Patient RemoteControl | Software app installed oncompatible mobile device(Android/iOS) providing wirelessselection among preconfiguredoptions and status readout forpaired Therapy Disc and TrialTherapy Disc devices. | NA | Differences do notaffect safety andeffectiveness ofintended use |
All of the physical and therapeutic attributes for the Nalu Neurostimulation System are within or equivalent to the parameters seen in the predicate and reference devices. There are no significant differences in these characteristics that would raise different questions of safety or effectiveness.
The Nalu Neurostimulation System includes a few features that are different from the predicate as listed below:
- . Differences in surgical tools and components above are a reflection of the subtly different insertion techniques between Nalu and the various predicate devices.
- . The Nalu Neurostimulation System comes with an adhesive wearable option that is not provided with the primary predicate but is provided with referenced
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predicate devices such as the Medtronic XTREL, K883780. The approach allows for reliable positioning of the external transmitter module over the Nalu IPG device.
- . The Nalu Neurostimulation programming system's Therapy Discs provide the same physical controls as the predicate's SWAG. An added feature to the Nalu Neurostimulation System is the option of a mobile app replicating these same controls through a smartphone interface. No clinical programming functions are available through the Patient Remote Control Application. The Patient Remote Control Application cannot alter the state of the Therapy Disc or Trial Therapy Disc from the state configured by the Clinician Programmer.
ર .8. 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 procedures ensure that all designs are appropriately planned, defined, evaluated, 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.
5.8.1 Applicable Standards and Guidance Documents
The testing for the Nalu Neurostimulation 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 60601-1:2005: A2012 | Medical electrical equipment — Part 1: General requirements for basicsafety and essential performance |
| IEC 60601-1-11:2015 | Medical electrical equipment — Part 1-11: General requirements for basicsafety and essential performance — Collateral Standard: Requirements formedical electrical equipment and medical electrical systems used in thehome healthcare environment |
Table 5-6: Standards and Guidance Documents
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| Standard Number | Title |
|---|---|
| IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for basicsafety and essential performance - Collateral Standard: Electromagneticdisturbances - Requirements and tests |
| IEC 60601-1-6:2010+A1:2013 | Medical electrical equipment - Part 1-6: General requirements for basicsafety and essential performance - Collateral Standard: Usability |
| 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 |
| IEC 62304:2015 | Medical device software - Software life cycle processes |
| EN ISO 14971:2012 | Medical devices - Application of risk management to medical devices |
| ISO 14971:2007 | Medical devices - Application of risk management to medical devices |
| 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 |
| FDA Guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devicesissued October 2, 2014 | |
| FDA Guidance: Applying Human Factors and Usability Engineering to Medical Devices issued February3, 2016 |
5.8.2 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.
Biocompatibility testing was based upon the categorization of the different bodycontacting components and duration of the Nalu Neurostimulation system. The categories are based upon the following classifications, per the FDA guidance:
- Implant Device, in Tissue, permanent contact duration (>30 days): Nalu IPG, Leads, ● Lead Anchor, Lead Extension
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- . Externally Communicating Device, in Tissue, limited contract duration (≤24 hours): Needles, Sheaths and other surgical tools
- Surface Device, intact skin contact, permanent duration (>30 days): Therapy Discs, ● Adhesive clip
Testing included: cytotoxicity, sensitization, irritation or intracutaneous reactivity, systematic toxicity, implant studies, and chemical characterization. Biocompatibility was demonstrated.
5.8.3 Animal Testing
In the animal study, six (6) Nalu Neurostimulation IPGs and Lead systems were implanted in a porcine model and evaluated over a period of 90 days. The purpose of the study included: evaluating the surgical usability of the Nalu components, demonstrating the RF communication and ensuing stimulation, observing implanted device stability, and observing tissue response in a live model over the implant time.
All devices performed as expected without incident and together provided pre-clinical validation of the safety and clinical use of the Nalu Neurostimulation System in a live model. There were no device- or procedure-related complications or premature deaths in this study. Data was collected at 30, 60 and 90 day intervals.
5.8.4 Summary of Nonclinical Performance Testing
Verification testing of the Nalu Neurostimulation System included electrical, mechanical and software 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.
5.9. 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.
5.10. Conclusions
The bench and non-clinical data support the safety of the device and the hardware and the software verification and validation demonstrated that the Nalu Neurostimulation System performs as intended in the specified use conditions and the results of which 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).