(268 days)
SCS:
This system is indicated as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or limbs, including unilateral pain. The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.
PNS:
This system is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The Nalu Neurostimulation System for PNS is not intended to treat pain in the craniofacial region. The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.
The Nalu Neurostimulation System (referred to as the "Nalu System") incorporates a miniature implantable pulse generator (IPG), powered by an externally worn Therapy Disc device. The Nalu System therapy utilizes pulsed electrical current to create an energy field that acts on peripheral nerves or central 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. This device is intended to be used in the spinal column as well as the peripheral nerves in arm, leg, pelvic and other areas, as is typical of other devices and treatments for the same intended use.
The Nalu System is intended for stimulation of the spinal cord or peripheral nerves for patients experiencing chronic, intractable pain. This system is indicated for pain management in adults who have severe intractable chronic pain, as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The system is not intended to treat pain in the craniofacial region. The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.
The Nalu System is comprised of the following components:
• Implantables (there are no proposed changes to these components as previously provided in K221376):
o Implantable pulse generator (IPG; available either as an integrated lead unit or with separately connected lead(s)) – provides electrical stimulation pulses that are transmitted through the leads, to the desired location, either on the spinal cord or peripheral nerve site(s).
o Leads – implantable and designed to deliver electrical pulses to the nerves via an array of four (4) or eight (8) cylindrical electrodes at the distal end.
o Surgical and Trial Tools – includes anchors, spoonbill needs, stylets, tearaway introducers, pocket tunneler, torque wrench, IPG insertion tool, straw tunneler; tools to support implantation of lead and IPG.
- Externals, Non-Sterile:
o Externally worn controllers (for use with the permanent implant) and accessories – includes the Therapy Disc, Adhesive Clip, Wearable Garment, Therapy Disc Charger; houses the battery and electronics for RF power and controls the IPG for therapy delivery via the remote programmer (subject of this submission).
o Externally worn stimulator (for use with the trial lead) and accessories – includes the Trial Therapy Disc; sends signals to the percutaneous leads during the trial period by way of the Electrode Interface Cable (EIC).
• Software (subject of this submission):
o Clinician Programmer, Patient Remote Control – used to configure the system parameters; also manages patient records, Therapy Discs and remote controls for patients with the Nalu System; runs on Android and iOS platforms and can be optionally used to control and manage Therapy Discs over a secure Bluetooth® Low Energy connection.
The provided text is a 510(k) premarket notification for the Nalu Neurostimulation System. It details modifications made to an existing device, primarily to its external components and software, and argues for substantial equivalence to a previously cleared predicate device (K221376).
Crucially, this document does not describe a study to prove a device meets acceptance criteria related to efficacy or performance comparable to what would be found in a multi-reader, multi-case (MRMC) study or a standalone algorithm performance evaluation for an AI/ML medical device.
Instead, the "acceptance criteria" and "proof" provided are focused on engineering verification and validation to demonstrate that the modifications to the existing device do not raise new questions of safety or effectiveness, thus maintaining substantial equivalence to its predicate. The device itself is a neurostimulation system for pain relief, not an AI/ML diagnostic tool.
Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, effect size of human reader improvement, standalone performance, type of ground truth, training set sample size, ground truth for training set) are not applicable to this submission, as it is not for an AI/ML algorithm requiring such performance evaluations.
However, I can extract information relevant to the engineering acceptance criteria and the validation activities performed for the modified device components.
Here's a breakdown of the information that can be extracted from the provided text, and an explanation of why other requested information is not present:
Acceptance Criteria and Device Performance (Engineering/Safety Context)
The document frames its "acceptance criteria" as demonstrating that the modified device's technological characteristics are effectively the same or do not raise different questions of safety and effectiveness compared to the predicate device. The performance is then shown through various engineering and validation tests.
| Acceptance Criterion (Implicit) | Reported Device Performance/Proof (Validation Activity) |
|---|---|
| Functional Equivalence: The modified external components (Therapy Disc, Base Station, software) maintain the same fundamental function as the predicate device's external components, particularly regarding therapy delivery parameters and communication. | Software testing: In accordance with IEC 62304 Edition 1.1 2015-06, FDA guidance documents (Content of Premarket Submissions for Device Software Functions, General Principles of Software Validation).Electronics evaluation: "Functional output of TD2 electronics remains unchanged." PCB changes were evaluated through usability and EMC testing. |
| Safety - Electromagnetic Compatibility (EMC): The modified device, especially the updated electronics, continues to meet EMC standards. | EMC testing: In accordance with 60601-1 Edition 3.2 2020-08, 60601-1-2 Edition 4.0 2014-02, 60601-1-2 Edition 4.1 2020-09. |
| Safety - Biocompatibility: New/modified patient-contacting materials (e.g., in the Therapy Disc housing, adhesive clip) are biocompatible and do not pose new risks. | Biocompatibility testing: In accordance with ISO 10993-1:2018. New adhesive clip using same materials. Patient contacting materials of TD2 top housing are similar to predicate, and differences pose "very low biocompatibility risk because they have a long history of safe use." |
| User Interface/Usability: Changes to the user interface (e.g., gesture controls on Therapy Disc) do not negatively impact usability or introduce new risks. | Formative & Summative Usability Testing: In accordance with 62366-1 Edition 1.1 2020-06. |
| Physical Specifications/Integrity: The smaller Therapy Disc size and updated accessories maintain physical integrity and fit for purpose. | Dimensional verification: Confirms "that the device meets its specifications." |
| Packaging Integrity: The packaging adequately protects the device during transport. | Packaging Validation: In accordance with ISTA 3A 2018. |
| Risk Management: All modifications have been evaluated under a robust risk management system to ensure no new hazards or risks are introduced. (Implicit, as a foundational requirement for medical devices). | The testing was "developed in accordance with Nalu Medical, Inc. (Nalu)'s Quality System, including Design Control and Risk Management, per ISO 14971: 2019-12. Design Controls apply to all medical devices manufactured by Nalu in accordance with ISO 13485:2016." |
Study Details (Context of Engineering Validation, Not AI Performance)
-
Sample size used for the test set and the data provenance: Not applicable in the context of clinical results from a test set as would be used for an AI/ML diagnostic device. The "test set" here refers to physical units of the modified device and its software undergoing various engineering and software validation tests. Data provenance is not described in terms of patient data.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/ML performance (e.g., expert consensus on medical images) is not relevant for this engineering and software validation. The "ground truth" for these tests are largely defined by engineering specifications, regulatory standards, and functional requirements.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are used in studies involving human interpretation or performance, typically for diagnostic accuracy.
-
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. The document explicitly states: "No clinical testing was performed."
- This device is a neurostimulation system, not a diagnostic imaging AI/ML device that assists human readers.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable in the context of an AI/ML algorithm. The "software testing" mentioned evaluates the software's functional correctness against its specifications, not its standalone diagnostic or interpretive performance.
-
The type of ground truth used (expert concensus, pathology, outcomes data, etc.): Not applicable for an AI/ML context. For the engineering and software validation, the "ground truth" is adherence to established engineering specifications, industry standards (e.g., ISO, IEC), and regulatory guidance.
-
The sample size for the training set: Not applicable. This submission is for hardware and software modifications to a neurostimulation device, not for an AI/ML model that requires a training set.
-
How the ground truth for the training set was established: Not applicable, as there is no AI/ML training set in this context.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with intertwined snakes and wings. To the right of the symbol is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue, with "FDA" in a larger font size than the rest of the text.
August 23, 2024
Nalu Medical Inc. Chelsea Gutierrez Vice President, Regulatory/Quality 2320 Faraday Ave., Suite 100 Carlsbad, California 92008
Re: K233801
Trade/Device Name: Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation Regulation Number: 21 CFR 882.5880 Regulation Name: Implanted Spinal Cord Stimulator For Pain Relief Regulatory Class: Class II Product Code: GZB, GZF Dated: August 16, 2024 Received: August 16, 2024
Dear Chelsea Gutierrez:
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products: and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Lauren E. Woodard -S
for Amber Ballard, PhD Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices
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OHT5: Office of Neuromodulation and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
510(k) Number (if known) K233801
Device Name
Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation
Indications for Use (Describe)
SCS:
This system is indicated as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or limbs, including unilateral pain. The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.
PNS:
This system is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The Nalu Neurostimulation System for PNS is not intended to treat pain in the craniofacial region. The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Submission Sponsor
Nalu Medical, Inc. 2320 Faraday Avenue, Suite 100 Carlsbad, CA 92008 Phone: (760) 448-2360 Fax: (760) 448-2377 Contact: Chelsea Gutierrez, Vice President of Regulatory Affairs and Quality Assurance
Date Prepared: August 22, 2024
Device Names and Classification
510(k) Number: K233801
| Primary Product Code | |
|---|---|
| Trade/Proprietary Name | Nalu Neurostimulation System |
| Common/Usual Name | Stimulator, Spinal-Cord, Implanted (Pain Relief) |
| Classification Regulation | 21 CFR 882.5880; Implanted spinal cord stimulator for pain relief |
| Product Code | GZB |
| Class | Class II |
| Review Panel | Neurology |
| Secondary Product Code | |
| Trade/Proprietary Name | Nalu Neurostimulation System |
| Common/Usual Name | Stimulator, Peripheral Nerve, Implanted (Pain Relief) |
| Classification Regulation | 21 CFR 882.5870; Implanted peripheral nerve stimulator for pain relief |
| Product Code | GZF |
| Class | Class II |
| Review Panel | Neurology |
Predicate/Reference Devices
- Predicate Device: Nalu Neurostimulation System (for SCS & PNS) (K221376)
- Reference Device: Nalu Neurostimulation System for SCS (K202274)
- . Reference Device: Nalu Neurostimulation System for Peripheral Nerve Stimulation ( K183579)
Device Description
The Nalu Neurostimulation System (referred to as the "Nalu System") incorporates a miniature implantable pulse generator (IPG), powered by an externally worn Therapy Disc device. The Nalu System therapy utilizes pulsed electrical current to create an energy field that acts on
{5}------------------------------------------------
peripheral nerves or central 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. This device is intended to be used in the spinal column as well as the peripheral nerves in arm, leg, pelvic and other areas, as is typical of other devices and treatments for the same intended use.
The Nalu System is intended for stimulation of the spinal cord or peripheral nerves for patients experiencing chronic, intractable pain. This system is indicated for pain management in adults who have severe intractable chronic pain, as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The system is not intended to treat pain in the craniofacial region. The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.
The Nalu System is comprised of the following components:
• Implantables (there are no proposed changes to these components as previously provided in K221376):
o Implantable pulse generator (IPG; available either as an integrated lead unit or with separately connected lead(s)) – provides electrical stimulation pulses that are transmitted through the leads, to the desired location, either on the spinal cord or peripheral nerve site(s).
o Leads – implantable and designed to deliver electrical pulses to the nerves via an array of four (4) or eight (8) cylindrical electrodes at the distal end.
o Surgical and Trial Tools – includes anchors, spoonbill needs, stylets, tearaway introducers, pocket tunneler, torque wrench, IPG insertion tool, straw tunneler; tools to support implantation of lead and IPG.
- Externals, Non-Sterile:
o Externally worn controllers (for use with the permanent implant) and accessories – includes the Therapy Disc, Adhesive Clip, Wearable Garment, Therapy Disc Charger; houses the battery and electronics for RF power and controls the IPG for therapy delivery via the remote programmer (subject of this submission).
o Externally worn stimulator (for use with the trial lead) and accessories – includes the Trial Therapy Disc; sends signals to the percutaneous leads during the trial period by way of the Electrode Interface Cable (EIC).
• Software (subject of this submission):
o Clinician Programmer, Patient Remote Control – used to configure the system parameters; also manages patient records, Therapy Discs and remote controls for patients with the Nalu System; runs on Android and iOS platforms and can be optionally used to control and manage Therapy Discs over a secure Bluetooth® Low Energy connection.
Technological characteristics of the device under review (non-sterile externals including the Therapy Disc and Therapy Disc Charger and the associated software updates) are identical to
{6}------------------------------------------------
that of the predicate device previously cleared under K221376, with the exception of minor electronics updates, updates to the user interfaces (which now include the use of gesture controls for BLE bond renegotiation), reduction of the size of the Therapy Disc (including updates to the wearable accessories to accommodate the new Therapy Disc size) and lastly, minor patient-contacting material updates. None of these technological differences in the device under review affect safety or efficacy of the Nalu System as they have been fully evaluated for equivalence through design Verification and Validation.
Indications for Use
ટર:
This system is indicated as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain.
The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.
PNS:
This system is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The Nalu Neurostimulation System for PNS 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.
Substantial Equivalence Comparison
This Traditional 510(k) premarket notification is for the proposed device, the Nalu Neurostimulation System (inclusive of both the SCS and PNS indications), which is a modification of the cleared Nalu Neurostimulation System (K221376). Nalu is proposing design modifications to the externally worn controller (i.e., Therapy Disc and Base Station), as well as software application updates (i.e., Clinician Programmer and Remote Control). The modifications outlined in this 510(k) do not raise different questions of safety or effectiveness as demonstrated by the completed testing provided within this submission. Based on the similarities between the cleared and modified devices, the proposed Nalu System is substantially equivalent to the cleared Nalu Neurostimulation System (K221376). Provided in Table 1 is a comparison of the cleared and modified devices which includes a rationale for substantial equivalence.
Of note, the implanted components, surgical tools, and therapy settings remain unchanged. The modifications made to the Nalu System described herein only impact the external control device referred to as the Therapy Disc and the Therapy Disc Base Station (charger) as well as the Clinician Programmer and Remote-Control Application Software.
Please also note that the second-generation Therapy Disc, Base Station Charger and accessories as well as the updated PC and RC software applications are to be used in both FDA cleared indications for use, Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS).
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| Nalu Neurostimulation System for SCS & PNSK233801 (Proposed Device) | Nalu Neurostimulation System for SCS & PNSK221376 (Predicate Device) | Comparison | |
|---|---|---|---|
| Product CodeandClassification | GZB, Class IIGZF, Class II | GZB, Class IIGZF, Class II | Same as predicate. |
| Regulation | SCS:21 CFR §882.5880PNS:21 CFR §882.5870 | SCS:21 CFR §882.5880PNS:21 CFR §882.5870 | Same as predicate. |
| ClassificationName | SCS:Implanted spinal cord stimulator for painreliefPNS:Implanted peripheral nerve stimulator forpain relief | SCS:Implanted spinal cord stimulator for painreliefPNS:Implanted peripheral nerve stimulator forpain relief | Same as predicate. |
| Intended Use | SCS:Stimulation of the spinal cord for treatmentof chronic, intractable painPNS:Stimulation of peripheral nerves forchronic, intractable pain | SCS:Stimulation of the spinal cord fortreatment of chronic, intractable painPNS:Stimulation of peripheral nerves forchronic, intractable pain | Same as predicate. |
| Indications forUse | SCS:This system is indicated as the solemitigating agent, or as an adjunct to othermodes of therapy used in amultidisciplinary approach for chronic,intractable pain of the trunk and/or limbs,including unilateral or bilateral pain.The trial devices are solely used for trialstimulation (no longer than 30 days) todetermine efficacy beforerecommendation for a permanent (longterm) device.PNS:This system is indicated for painmanagement in adults who have severeintractable chronic pain of peripheral nerveorigin, as the sole mitigating agent, or asan adjunct to other modes of therapy usedin a multidisciplinary approach. The NaluNeurostimulation System for PNS is notintended to treat pain in the craniofacialregion.The trial devices are solely used for trialstimulation (no longer than 30 days) todetermine efficacy beforerecommendation for a permanent (longterm) device. | SCS:This system is indicated as the solemitigating agent, or as an adjunct to othermodes of therapy used in amultidisciplinary approach for chronic,intractable pain of the trunk and/or limbs,including unilateral or bilateral pain.The trial devices are solely used for trialstimulation (no longer than 30 days) todetermine efficacy beforerecommendation for a permanent (longterm) device.PNS:This system is indicated for painmanagement in adults who have severeintractable chronic pain of peripheralnerve origin, as the sole mitigating agent,or as an adjunct to other modes oftherapy used in a multidisciplinaryapproach. The system is not intended totreat pain in the craniofacial region.The trial devices are solely used for trialstimulation (no longer than 30 days) todetermine efficacy beforerecommendation for a permanent (longterm) device. | Same as predicate. |
| PrescriptionUse | Yes | Yes | Same as predicate. |
| Implant Site | SCS:Lead: Epidural spaceIPG: Subcutaneous, mid backPNS: | SCS:Lead: Epidural spaceIPG: Subcutaneous, mid backPNS: | Same as predicate. |
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| 310(k) Summary K233801 | |||
|---|---|---|---|
| Peripheral nerves, excluding craniofacialregion. | Peripheral nerves, excluding craniofacialregion. | Peripheral nerves, excluding craniofacial region. | |
| EnvironmentalUse | Hospital Use, Home | Hospital Use, Home | Same as predicate. |
| IntendedClinician | Orthopedic, Neurosurgeon,Anesthesiologist | Orthopedic, Neurosurgeon,Anesthesiologist | Same as predicate. |
| Intended User | Physician, Layperson | Physician, Layperson | Same as predicate. |
| Mode of Action | Radiofrequency (RF) wirelesstransmission of energy to producestimulation at stimulator electrodes. | Radiofrequency (RF) wirelesstransmission of energy to producestimulation at stimulator electrodes. | Same as predicate. |
| Labeling | SCS:MR Conditional Labeling for Head andExtremities.Full Body MR Conditional Labeling forFull Body.PNS:MR Conditional Labeling for Head andExtremities. | Not publicly available | SCS:Same as referencedevice K202274.PNS:Same as referencedevice K183579. |
| External DeviceNames | Therapy Disc (second generation), BaseStation Charger and Trial Therapy Disc | Therapy Disc and Trial Therapy Disc | Therapy Disc andTherapy Disc Charger(Base Station) haveupdated design. TrialTherapy Disc remainsunchanged. |
| Electronics | Updated folded printed circuit board(PCB) design that generates RF powerwith embedded waveform parametersettings that can be changed as needed bythe user | A printed circuit board (PCB) thatgenerates RF power with embeddedwaveform parameter settings and buttonsfor changing parameter settings asneeded by the user | Functional output ofTD2 electronicsremains unchanged.PCB changes wereevaluated throughusability and EMCtesting to confirmthere are no differentquestions of safety oreffectiveness. |
| User Interface | Integrated indicators allow the user tomonitor device status. Therapy Disc canbe controlled through flip gesture. TheRemote Control allows the user tostop/start stimulation, increase or decreasetherapy levels, and select from configuredtherapy profiles. | Integrated controls and indicators thatallow the user to turn the device on/off,increase or decrease therapy levels, selectfrom configured therapy profiles andmonitor device status. | Gesture controls onTherapy Disc replacebuttons. Changeswere evaluatedthrough usabilitytesting to confirmthere are no differentquestions of safety oreffectiveness. |
| Antenna(Therapy DiscOnly) | Integrated antenna supporting 40.68 MHzpower and data transfer | Integrated antenna supporting 40.68MHz power and data transfer. | Same as predicate. |
| WearableGarments andAdhesive Clips(Therapy DiscOnly) | Therapy Disc is positioned over Nalu IPGvia two options:• Adhesive clip (hydrocolloid adhesive)• Elastic Belt/CuffWearable accessories design has beenupdated to accommodate smaller footprintTD2 device | Therapy Disc is positioned over NaluIPG via two options:• Adhesive clip (hydrocolloid adhesive)• Elastic Belt/Cuff | New adhesive clipusing same materials.Updated ElasticBelt/Cuff. Changeswere evaluatedthrough usabilitytesting to confirmthere are no differentquestions of safety oreffectiveness. |
| Size/Weight | Disc: ~1.3 cm thick, ~6.2 cm diameter | Disc: ~1.5 cm thick, 7.5 cm diameter | Similar. Thesize/weight |
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| ExternallyContactingMaterials | Biocompatible PC ABS housing.Occasional contact to fingers (e.g., takingdisc in and out of adhesive clip orwearable garment. Textile material ofbelt/cuff may be worn over clothing.Hydrocolloid adhesive applied to skin. | Biocompatible PC ABS housing.Occasional contact to fingers (e.g., buttonuse). Textile material of belt/cuff may beworn over clothing. Hydrocolloidadhesive applied to skin. | modifications do notraise differentquestions of safety oreffectiveness.Dimensionalverification confirmsthat the device meetsits specifications.Similar as predicate.Biocompatible PCABS housingmaterials for thebottom housing havenot changed. Thepatient contactingmaterials of the TD2top housing aresimilar to the tophousing of thepredicate device, thedifferences in the tophousing materials donot raise differentquestions of safety oreffectiveness. Thebiological evaluationof these materialsposes a very lowbiocompatibility riskbecause they have along history of safeuse in legallymarketed medicaldevices that contactintact skin. |
|---|---|---|---|
| BatteryChargingConfiguration | Electrically isolated cradle chargercompatible with Therapy Disc devices.Software installed on a compatibleAndroid tablet. | Electrically isolated cradle chargercompatible with Therapy Disc devices.Software installed on a compatibleAndroid tablet. | Same as predicate. |
| Purpose | Allows healthcare provider to set desiredtherapy levels and device settings acrossTherapy Disc, Trial Therapy Disc, andPatient Remote-Control devices | Allows healthcare provider to set desiredtherapy levels and device settings acrossTherapy Disc, Trial Therapy Disc, andPatient Remote-Control devices. | Same as predicate. |
| Communication | Secure Bluetooth to Therapy Disc, TrialTherapy Disc, Patient Remote Control andClinician Programmer.Clinician Programmer and Base StationCharger (BSC) also upload/downloadencrypted data using a secure connectionto a Nalu cloud service via a Wi-Fi accesspoint. | Secure Bluetooth to Therapy Disc, TrialTherapy Disc, Patient Remote Controland Clinician Programmer.Device usage information is storedoffline on the Therapy Disc and can betransferred to the Clinician Programmervia BLE connection | Same methods ofcommunication.Changes wereevaluated throughusability and Softwaretesting to confirmthere are no differentquestions of safety oreffectiveness. |
| Patient RemoteControl | Software app installed on compatiblemobile device (Android/iOS) providingwireless selection among preconfiguredoptions and status readout for pairedTherapy Disc devices | Software app installed on compatiblemobile device (Android/iOS) providingwireless selection among preconfiguredoptions and status readout for pairedTherapy Disc devices. | Same as predicate. |
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| Table 2: Predicate and Subject Device Comparison with the Nalu Neurostimulation therapy delivery (SCS and PNS) | ||
|---|---|---|
| Comparator | Nalu Neurostimulation System(Subject Device, K233801) | Nalu Neurostimulation System(Predicate Device, K221376) | Analysis ofTechnologicalDifferencesfrom Predicate |
|---|---|---|---|
| Pulse Frequency | 2 Hz to 1500 Hz | 2 Hz to 1500 Hz | Same as predicate |
| Pulse Width | 12 to 2000 μs | 12 to 2000 μs | Same as predicate |
| Current/VoltageRegulated | Current | Current | Same as predicate |
| Output Voltage(300 Ohms) | 0 to 3.1 V | 0 to 3.1 V | Same as predicate |
| Output Voltage(500 Ohms) | 0 to 5.1 V | 0 to 5.1 V | Same as predicate |
| Output Voltage(800 Ohms) | 0 to 8.2 V | 0 to 8.2 V | Same as predicate |
| Output Current(300 Ohms) | 0 to 10.2 mA | 0 to 10.2 mA | Same as predicate |
| Output Current(500 Ohms) | 0 to 10.2 mA | 0 to 10.2 mA | Same as predicate |
| Output Current(800 Ohms) | 0 to 10.2 mA | 0 to 10.2 mA | Same as predicate |
| Waveform | charge balanced (delayed) biphasicasymmetrical | charge balanced (delayed) biphasicasymmetrical | Same aspredicate |
| Pulse Shape | Decaying Exponential | Decaying Exponential | Same as predicate |
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| Maximum phasecharge (300Ohms) | 18.0 µC/pulse | 18.0 µC/pulse | Same as predicate |
|---|---|---|---|
| Maximum phasecharge (500Ohms) | 18.0 µC/pulse | 18.0 µC/pulse | Same as predicate |
| Maximumphase charge(800 Ohms) | 18.0 µC/pulse | 18.0 µC/pulse | Same as predicate |
| Maximumcharge density(300Ohm) | 146.94 µC/cm2 | 146.94 µC/cm2 | Same as predicate |
| Maximumcharge density(500 Ohm) | 146.94 µC/cm2 | 146.94 µC/cm2 | Same as predicate |
| Maximumcharge density(800 Ohm) | 146.94 µC/cm2 | 146.94 µC/cm2 | Same aspredicate |
| Maximumcurrentdensity (300Ohm) | 83.3 mA/cm2 | 83.3 mA/cm2 | Same as predicate |
| Maximumcurrentdensity (500Ohm) | 83.3 mA/cm2 | 83.3 mA/cm2 | Same as predicate |
| Maximumcurrentdensity (800Ohm) | 83.3 mA/cm2 | 83.3 mA/cm2 | Same as predicate |
| Net Charge | 0 µC | 0 µC | Same as predicate |
| Average PhasePower (300Ohms) | 0.031 W/phase | 0.031 W/phase | Same as predicate |
| Average Phase | 0.052 W/phase | 0.052 W/phase | Same as predicate |
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| Power (500Ohms) | |||
|---|---|---|---|
| Average PhasePower (800Ohms) | 0.083 W/phase | 0.083 W/phase | Same as predicate. |
| Average PhasePower density(300 Ohms) | 0.25 W/cm²/phase | 0.25 W/cm²/phase | Same aspredicate. |
| Average PhasePower density(500 Ohms) | 0.51 W/cm²/phase | 0.51 W/cm²/phase | Same as predicate. |
| Average PhasePower density(800 Ohms) | 0.55 W/cm²/phase | 0.55 W/cm²/phase | Same as predicate. |
| Pulse DeliveryMode | Continuous | Continuous | Same as predicate. |
| Current Pathoptions | Bipolar | Bipolar | Same as predicate. |
| Program Cycle | Cycle through programs | Cycle through programs | Same as predicate. |
| Pulse Pattern | Fine tuning of pulse patterns(On/Off; If On, spans from 12 μs to 1000 μs) | Fine tuning of pulse patterns(On/Off; If On, spans from 12 μs to1000 μs) | Same as predicate. |
| Dosage Time | Allows for stimulation to be applied inperiodic doses (On/Off; If On, spansfrom 1 ms to 1000 ms, If Off, spansfrom 1 ms to 2000 ms) | Allows for stimulation to beapplied in periodic doses (On/Off;If On, spans from 1 ms to 1000ms, If Off, spans from 1 ms to2000 ms) | Same as predicate |
| Daily TherapyTime | Limits the number of hours in a day thatstimulation may be used(Seconds to hours) | Limits the number of hours in a daythat stimulation may be used(Seconds to hours) | Same as predicate. |
| TransmitFrequency | 40.68 MHz | 40.68 MHz | Same as predicate |
Technological Comparison
The Nalu Neurostimulation System has the same intended use and Indications for Use as the predicate device (K221376). Of note, the implanted components, surgical tools, and therapy settings remain unchanged. The modifications made to the Nalu Neurostimulation System described herein only impact the external control device referred to as the Therapy Disc and the Therapy Disc Base Station (charger) as well as the Clinician Programmer and Remote
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Control Application software. The differences between the Nalu Neurostimulation System and the predicate device (K221376) do not raise any different questions of safety or effectiveness as confirmed through non-clinical testing.
Non-Clinical and/or Clinical Test Summary & Conclusions
The testing performed for the Nalu Neurostimulation System was developed in accordance with Nalu Medical, Inc. (Nalu)'s Quality System, including Design Control and Risk Management, per ISO 14971: 2019-12. Design Controls apply to all medical devices manufactured by Nalu in accordance with ISO 13485:2016 Medical devices - Quality management systems -Requirements for regulatory purposes, 21 CFR Part 820.
The testing performed consisted of the following:
• Verification and Validation Testing for second-generation Therapy Disc (TD2) System, including the following:
- . EMC testing in accordance with 60601-1 Edition 3.2 2020-08, 60601-1-2 Edition 4.0 2014-02, 60601-1-2 Edition 4.1 2020-09, 60601-1-6 Edition 3.2 2020-07, 60601-1-11 Edition 2.1 2020-07
- Packaging Validation in accordance with ISTA 3A 2018
- Biocompatibility testing in accordance with ISO 10993-1:2018
- Software testing in accordance with IEC 62304 Edition 1.1 2015-06, Content of Premarket Submissions for Device Software Functions, Guidance for Industry and Food and Drug Administration Staff published on June 14, 2023, and General Principles of Software Validation, Guidance for Industry and FDA Staff published on January 11, 2002.
- . Formative & Summative Usability Testing for TD2 System, in accordance with 62366-1 Edition 1.1 2020-06
No clinical testing was performed.
Testing demonstrated that the Nalu Neurostimulation System has been verified to perform in accordance with its product specifications, in support of its intended use.
§ 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).