(140 days)
The Nalu Neurostimulation 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 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 spinal cord stimulation to provide therapeutic relief for chronic, intractable pain of the trunk and/or limbs including unilateral or bilateral pain. The Nalu Neurostimulation system incorporates a miniature implanted neurostimulator, powered by an externally worn device. Similar to the predicate Stimwave system, the Nalu Neurostimulation therapy utilizes pulsed electrical current to create an energy field that acts on nerves in the spinal cord 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 is comprised of 5 elements: Nalu Implantable Pulse Generator, Leads, Surgical and Trial Tools, Externally worn Therapy Discs, and Programmer, Remote.
This document is a 510(k) premarket notification for the Nalu Neurostimulation System, indicating that clinical performance data was not required for substantial equivalence. Therefore, there is no study described in this document that proves the device meets specific acceptance criteria based on human clinical data.
The acceptance criteria described in the document relate to non-clinical performance testing (bench testing, biocompatibility, and animal testing) to demonstrate safety and effectiveness relative to a predicate device.
Here's an breakdown of the information requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance
Since no clinical acceptance criteria or performance metrics were provided in the document due to the nature of a 510(k) without clinical studies, I will summarize the general approach to substantial equivalence and the scope of non-clinical testing.
General Acceptance Criteria (Implied for 510(k) clearance): The Nalu Neurostimulation System is substantially equivalent to the predicate device (Stimwave Freedom SCS System K170141) in terms of:
- Intended Use
- Technological Characteristics
- Principles of Operation
Reported Device Performance (Non-Clinical):
| Acceptance Criteria Category | Reported Device Performance | Justification/Outcome |
|---|---|---|
| Substantial Equivalence (Overall) | Nalu Neurostimulation System vs. Stimwave Freedom SCS System (K170141) | No significant differences in physical and therapeutic attributes that would raise new questions of safety or effectiveness. Differences exist but do not alter intended therapeutic use or affect safety/effectiveness. |
| Biocompatibility | Compliance with ISO 10993-1:2009 | Components categorized by contact type (Implant, Externally Communicating, Surface) and duration, and subjected to testing including cytotoxicity, sensitization, irritation/intracutaneous reactivity, systematic toxicity, implant studies, and chemical characterization. Biocompatibility was demonstrated. |
| Animal Study | Evaluation in porcine model over 90 days | Six Nalu Neurostimulation IPGs and Lead systems implanted. Evaluated surgical usability, RF communication/stimulation, implanted device stability, and tissue response. All devices performed as expected with no device- or procedure-related complications or premature deaths. Preliminary validation of safety and use. |
| Electrical, Mechanical, Software Performance | Verification Testing | Device met target specifications over a range of operating and storage conditions. |
| Usability/Human Factors | Validation and Usability Testing | Device demonstrated to meet user needs as reflected in the functional specification. |
| Sterilization | Ethylene Oxide sterilization validation | Performed to ISO 11135-1:2014 standards. |
| Software Life Cycle Processes | Compliance with IEC 62304:2015 | Processes followed for medical device software. (Software Level of Concern: Moderate) |
| Risk Management | Compliance with EN ISO 14971:2012, ISO 14971:2007 | Application of risk management to medical devices. |
| Packaging | Compliance with ISO 11607-1:2006/Amd 1:2014 and -2:2006/Amd 1:2014 | Packaging for terminally sterilized medical devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set (Non-Clinical):
- Animal Study: Six Nalu Neurostimulation IPGs and Lead systems were used in a porcine model. This was a prospective animal study. The specific country of origin for the animal study is not mentioned.
- Bench Testing: The document does not specify exact sample sizes for each bench test (electrical, mechanical, software), but it implies sufficient testing was conducted to meet relevant international standards and guidance documents. This is typically prospective testing conducted in a laboratory setting.
- Biocompatibility Testing: The number of samples for biocompatibility testing is not specified but would follow established protocols for ISO 10993. This is typically prospective testing.
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 for clinical studies. For the non-clinical tests described:
- Animal Study: The study was conducted by researchers/veterinary staff, but the "ground truth" was established by direct observation and measurement of device performance, tissue response, and lack of complications in the porcine model. No external experts for ground truth establishment were specifically mentioned in this context.
- Bench/Biocompatibility/Software Testing: Ground truth is established by engineering specifications, validated test methods, and compliance with recognized standards. Expertise would come from internal design and quality engineers, and potentially third-party testing laboratories, but not in the "expert medical consensus" sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for clinical studies. For the non-clinical tests described, adjudication methods like 2+1 or 3+1 are not used. Results are based on objective measurements and compliance with predefined specifications and standards.
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 MRMC comparative effectiveness study was done. The document explicitly 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." This is a premarket notification (510(k)) that established substantial equivalence based on non-clinical data, not clinical performance or AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The Nalu Neurostimulation System is an implantable medical device for pain relief, not an AI or imaging diagnostic tool. Therefore, standalone algorithm performance is not relevant to this submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Non-Clinical Ground Truth:
- Bench Testing: Engineering specifications, validated test methods, and compliance with national and international standards (e.g., ISO 14708, IEC 60601 series, ISO 11135, CISPR 11).
- Biocompatibility Testing: Standards-based evaluation (ISO 10993-1) of material interactions with biological systems.
- Animal Study: Direct observation of surgical usability, RF communication, device stability, and histopathological tissue response in the porcine model, as interpreted by veterinary and scientific experts.
8. The sample size for the training set
- Not applicable. This device is hardware for neurostimulation, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As stated above, this device does not use an AI/ML algorithm with a training set.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
March 22, 2019
Nalu Medical, Inc Michele Chin-Purcell Vice President RA/QA 1525 Faraday Ave. Suite 180 Carlsbad, California 92008
Re: K183047
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 Dated: February 17, 2019 Received: February 21, 2019
Dear Michele Chin-Purcell:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's 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 medical devices and radiation-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) K183047
Device Name Nalu Neurostimulation System
Indications for Use (Describe)
The Nalu Neurostimulation 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 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 92009 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 20, 2019
5.3. Device Identification
Trade/Proprietary Name: Nalu Neurostimulation System Common/Usual Name: Spinal Cord Stimulator Product Code: GZB Regulation number: 21 CFR 882.5880: Stimulator, spinal-cord, implanted (Pain Relief) Class: Class II Device Classification Panel: Neurology
5.4. Legally Marketed Predicate Device(s)
Freedom SCS System (K170141) by Stimwave Technologies, Inc. Hereafter, also referred to as the Stimwave Freedom SCS System.
In addition, references are made to other 510(k) devices that were used as part of the predicate history to the primary predicate in this submission. This history of the predicates is summarized in Table 5-1:
| Device | 510(k) | Predicate(s) used for clearance |
|---|---|---|
| Stimwave Freedom SCS System | K141399 | Medtronic Mattrix 3271/3272 (K934065)Medtronic Xtrel, 3425 (K883780)ANS Renew (K000852) |
| Stimwave Freedom SCS System | K150517 | K141399 |
| Stimwave Freedom SCS System | K160600 | K150517 |
| Stimwave Freedom SCS System | K162161 | K160600 |
Table 5-1: Predicate history of the proposed primary predicate
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| Stimwave Freedom SCS System(Primary Predicate) | K170141 | K162161 |
|---|---|---|
| ---------------------------------------------------- | --------- | --------- |
The 510(k) history of the Stimwave device includes design changes over time. The original Medtronic and ANS devices are part of the predicate history of the Stimwave device and are also used as reference devices in this document.
5.5. Device Description
The Nalu Neurostimulation system (also referred to as the "Nalu System") is used for spinal cord stimulation to provide therapeutic relief for chronic, intractable pain of the trunk and/or limbs including unilateral or bilateral pain. The Nalu Neurostimulation system incorporates a miniature implanted neurostimulator, powered by an externally worn device. Similar to the predicate Stimwave system, the Nalu Neurostimulation therapy utilizes pulsed electrical current to create an energy field that acts on nerves in the spinal cord 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 is comprised of 5 elements:
| 1. | NaluImplantablePulseGenerator | The implantable pulse generator (IPG) provides electricalstimulation pulses that are transmitted through the leads, throughthe dura, to the desired spinal cord site. The IPG is available in twodifferent 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 availablein single or dual lead configurations. The hermetic IPG housingincludes a ceramic enclosure and a feedthrough connected internallyto a printed 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 pulsesto the spinal cord in the epidural space via an array of eightcylindrical electrodes at the distal end. Leads may be integratedwith or connected to the IPG. Both Trial and Permanent Implantleads are available for use. The leads use polyurethane insulationwith Pt/Ir electrodes. The leads may be secured in place with theNalu Lead Anchor. | |
| 3. | Surgical andTrial Tools | Implantation of the Nalu IPG and lead components for Spinal CordStimulation (SCS) is performed via standard SCS surgicaltechniques. Epidural space is accessed via epidural needleplacement with the loss of resistance technique, followed by leadplacement through an introducer. The leads are anchored and the |
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| IPG is placed in a subcutaneous pocket. Patient contacting materials include medical grade stainless steel, thermoplastic elastomers, ABS, silicone, and Urethane. | |
|---|---|
| 4. 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 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 worn against the skin or over clothing. |
| 5. Programmer, Remote | 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 issued to provide the patient with a convenient secondary option to control their system in addition to the 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 physician-defined therapy options. turning stimulation on and off. and managing alerts. |
5.6. Indications for Use Statement
"The 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."
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
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predicate. Both the subject and predicate devices have the same intended use for the stimulation of the spinal cord 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, 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
| NaluNeurostimulationSystem(Subject Device) | StimwaveFreedom-8 SCSsystem(PrimaryPredicate) | StimwaveFreedom SCSsystem(ReferenceDevice) | Medtronic Mattrix3271/3272(ReferenceDevice) | Medtronic Xtrel3425(ReferenceDevice) | ANS Renew(ReferenceDevice) | Analysis ofTechnologicalDifferences fromPrimary Predicate | |
|---|---|---|---|---|---|---|---|
| 510(k) | TBD | K170141 | K141399 | K934065 | K883780 | K000852 | NA |
| Product Code andclass | GZB, Class II | Same | Same | Same | Same | Same | |
| Regulation number | 21 CFR 882.5880 | Same | Same | Same | Same | Same | |
| Classification name | Implanted spinalcord stimulator forpain relief. | Same | Same | Same | Same | Same | |
| Intended Use | Stimulation ofspinal cord forchronic, intractablepain | Same | Same | Same | Same | Same | |
| Indications for Use | The NaluNeurostimulationSystem is indicatedas the solemitigating agent,or as an adjunct toother modes oftherapy used in amultidisciplinaryapproach forchronic, intractablepain of the trunkand/or limbs, | The Freedom Spinal Cord Stimulator(SCS) System is intended as the solemitigating agent, or as an adjunct toother modes of therapy used in amultidisciplinary approach for chronic,intractable pain of the trunk and/orlower limbs, including unilateral orbilateral pain.The Freedom-8A Trial Lead Kit is onlyused in conjunction with the Freedom-8A Stimulator Receiver Kit, and theFreedom-4A Trial Lead Kit is used foreither the Receiver Kit Freedom-4AStimulator or the Receiver Kit Freedom- | Indicated as an aide in the managementof chronic, intractable pain of the trunkor limbs | Indicated for thetreatment ofchronic pain oftrunk and limbs,either as thesole mitigatingagent, or as anadjunct to othermodes oftherapy used inamultidisciplinaryapproach. | Differences do notaffect safety andeffectiveness ofintended use | ||
| NaluNeurostimulationSystem(Subject Device) | StimwaveFreedom-8 SCSsystem(PrimaryPredicate) | StimwaveFreedom SCSsystem(ReferenceDevice) | Medtronic Mattrix3271/3272(ReferenceDevice) | Medtronic Xtrel3425(ReferenceDevice) | ANS Renew(ReferenceDevice) | Analysis ofTechnologicalDifferences fromPrimary Predicate | |
| including unilateralor bilateral pain.The trial devicesare solely used fortrial stimulation(no longer than 30days) to determineefficacy beforerecommendationfor a permanent(long term) device. | 8A Stimulator. The trial devices are solelyused for trial stimulation (no longer than30 days) to determine efficacy beforerecommendation for a permanent (longterm) device. | ||||||
| Prescription Use? | Yes | Same | Same | Same | Same | Same | Same |
| Anatomical site | Epidural space | Same | Same | Same | Same | Same | Same |
| Environmental Use | Hospital, Home | Same | Same | Same | Same | Same | Same |
| Intended Clinician | 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 ofenergy to producestimulation atstimulatorelectrodes. | Same | Same | Same | Same | Same | Same |
| NaluNeurostimulationSystem(Subject Device) | StimwaveFreedom-8 SCSsystem(PrimaryPredicate) | StimwaveFreedom SCSsystem(ReferenceDevice) | Medtronic Mattrix3271/3272(ReferenceDevice) | Medtronic Xtrel3425(ReferenceDevice) | ANS Renew(ReferenceDevice) | Analysis ofTechnologicalDifferences fromPrimary Predicate | |
| Software Level ofConcern | Moderate | Moderate | Moderate | Unreported | Unreported | Moderate | Same |
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| Nalu NeurostimulationSystem(Subject Device) | Stimwave Freedom SCSsystem(K170141)(Primary Predicate) | Stimwave FreedomSCS system(K141399)(Reference Device) | MedtronicMattrix3271/3272(K934065)(ReferenceDevice) | MedtronicXtrel 3425(K883780)(ReferenceDevice) | ANS Renew(K000852) | 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 | Details unavailable | Details unavailable | Differences donot affect safetyand effectivenessof intended use |
| Housingmaterial | Silicone and Pellethane2363-55D | Pellethane 2363-55D | Pellethane 2363-55D | Details unavailable. | Details unavailable. | Details unavailable. | Differences donot affect safetyand effectivenessof intended use |
| Implantlocation | Lead: Epidural spaceIPG: Subcutaneous, midback | Epidural space andSubcutaneous, mid back | 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,hardwired | Same |
| Nalu NeurostimulationSystem(Subject Device) | Stimwave Freedom SCSsystem(K170141)(Primary Predicate) | Stimwave FreedomSCS system(K141399)(Reference Device) | MedtronicMattrix3271/3272(K934065)(ReferenceDevice) | MedtronicXtrel 3425(K883780)(ReferenceDevice) | ANS Renew(K000852) | Analysis ofTechnologicalDifferences fromPrimaryPredicate | |
| withconnector | |||||||
| 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 |
| 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 |
| Nalu NeurostimulationSystem(Subject Device) | Stimwave Freedom SCSsystem(K170141)(Primary Predicate) | Stimwave FreedomSCS system(K141399)(Reference Device) | MedtronicMattrix3271/3272(K934065)(ReferenceDevice) | MedtronicXtrel 3425(K883780)(ReferenceDevice) | ANS Renew(K000852) | Analysis ofTechnologicalDifferences fromPrimaryPredicate | |
| 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 |
| 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
| Comparator | NaluNeurostimulationSystem(Subject Device) | Stimwave FreedomSCS system(K170141)(Primary Predicate) | Stimwave FreedomSCS system(K141399)(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 Hz | 5 to 1500 Hz | 2 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 | 49 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) | Stimwave FreedomSCS system(K170141)(Primary Predicate) | Stimwave FreedomSCS system(K141399)(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) | Stimwave FreedomSCS system(K170141)(Primary Predicate) | Stimwave FreedomSCS system(K141399)(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 | 78.6 mA/cm² | 78.6 mA/cm² | 120.8 mA/cm² | 87.5 mA/cm² | 92.3 mA/cm² | Differences do notaffect safety andeffectiveness ofintended use |
| Net Charge | 0 µC | 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) | Stimwave FreedomSCS system(K170141)(Primary Predicate) | Stimwave FreedomSCS system(K141399)(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 | 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) | Stimwave FreedomSCS system(K170141)(Primary Predicate) | Stimwave FreedomSCS system(K141399)(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 |
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| Nalu Neurostimulation System(Subject Device) | Stimwave Freedom SCS system(K170141)(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● | WAA worn in a BeltAntenna positioned over deviceusing an elastic belt | 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 | 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 may beworn directly on the skin.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 |
| BatteryCharging | Electrically isolated cradlecharger | A battery and wire assembly forcharging and for power delivery | Differences do not affectsafety and effectivenessof intended use |
| Nalu Neurostimulation System(Subject Device) | Stimwave Freedom SCS system(K170141)(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 |
Table 5-4: Substantial Equivalence Table – External components
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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 new 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 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 WAA. 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
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Control Application cannot alter the state of the Therapy Disc or Trial Therapy Disc from the state configured by the Clinician Programmer.
Nonclinical Performance Testing 5.8.
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 implantablemedical devices - Part 1: General requirementsfor safety, marking and for information to beprovided by the manufacturer |
| ISO 14708-3:2017 | Implants for surgery -- Active implantable medicaldevices -- Part 3: Implantable neurostimulators |
| IEC 60601-1:2005: A2012 | Medical electrical equipment - Part 1: Generalrequirements for basic safety and essentialperformance |
| IEC 60601-1-11:2015 | Medical electrical equipment - Part 1-11: Generalrequirements for basic safety and essentialperformance - Collateral Standard: Requirementsfor medical electrical equipment and medicalelectrical systems used in the home healthcareenvironment |
| IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essentialperformance - Collateral Standard:Electromagnetic disturbances - Requirements andtests |
Table 5-6: Standards and Guidance Documents
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| Standard Number | Title |
|---|---|
| IEC 60601-1-6:2010 +A1:2013 | Medical electrical equipment - Part 1-6: Generalrequirements for basic safety and essentialperformance – Collateral Standard: Usability |
| IEC 62366-1:2015 | Medical Devices - Part 1: Application of usabilityengineering to medical devices |
| ISO 10993-1:2009 | Biological evaluation of medical devices - Part 1:Evaluation and testing within a risk managementprocess |
| IEC 62304:2015 | Medical device software - Software life cycleprocesses |
| EN ISO 14971:2012 | Medical devices -- Application of risk managementto medical devices |
| ISO 14971:2007 | |
| ISO 11607-1:2006/Amd 1:2014 and -2:2006/Amd1:2014 | Packaging for terminally sterilized medical devices-- Part 1: Requirements for materials, sterilebarrier systems and packaging systems, Part 2:Validation requirements for forming, sealing andassembly processes |
| ISO 11135-1:2014 | Sterilization of health-care products -- Ethyleneoxide -- Requirements for the development,validation and routine control of a sterilizationprocess for medical devices |
| CISPR 11 | Industrial, scientific and medical equipment -Radio-frequency disturbance characteristics -Limits and methods of measurement |
| FDA Guidance: Applying Human Factors and Usability Engineering to Medical Devices issued February |
5.8.2 Biocompatibility testing
3, 2016
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:
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- Implant Device, in Tissue, permanent contact duration (>30 days): Nalu IPG, Leads, Lead Anchor, Lead Extension
- 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 and belt
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 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 new questions of safety and effectiveness.
§ 882.5880 Implanted spinal cord stimulator for pain relief.
(a)
Identification. An implanted spinal cord stimulator for pain relief is a device that is used to stimulate electrically a patient's spinal cord to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed on the patient's spinal cord and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.(b)
Classification. Class II (performance standards).