(268 days)
No
The summary does not mention AI, ML, deep learning, neural networks, or any related terms. The device description focuses on electrical stimulation and system components, and the performance studies are standard verification and validation tests, not AI/ML model performance evaluations.
Yes.
The device is indicated for pain management and acts as a "sole mitigating agent, or as an adjunct to other modes of therapy" for chronic, intractable pain, which directly describes a therapeutic function.
No
Explanation: The device is indicated for pain management and acts as a mitigating agent for chronic pain, meaning it treats or manages pain rather than diagnosing a condition. Its primary function is to deliver electrical stimulation for therapeutic purposes.
No
The device description explicitly lists implantable components (IPG, leads, surgical and trial tools) and external hardware components (Therapy Disc, Adhesive Clip, Wearable Garment, Therapy Disc Charger, Trial Therapy Disc, Electrode Interface Cable). While software is a component of the system and the subject of this specific submission, the overall medical device system includes significant hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for pain management by stimulating nerves (spinal cord or peripheral nerves). This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a neurostimulation system with implantable and external components designed to deliver electrical pulses to nerves. This is consistent with a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's condition based on in vitro testing.
In summary, the Nalu Neurostimulation System is a therapeutic device used to manage pain through nerve stimulation, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
GZB, GZF
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 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal Cord, Peripheral Nerves (excluding craniofacial region)
Indicated Patient Age Range
Adults
Intended User / Care Setting
Intended Clinician: Orthopedic, Neurosurgeon, Anesthesiologist
Intended User: Physician, Layperson
Environmental Use: Hospital Use, Home
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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.
1
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
2
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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4
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).
7
| | Nalu Neurostimulation System for SCS & PNS
K233801 (Proposed Device) | Nalu Neurostimulation System for SCS & PNS
K221376 (Predicate Device) | Comparison |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|
| Product Code
and
Classification | GZB, Class II
GZF, Class II | GZB, Class II
GZF, Class II | Same as predicate. |
| Regulation | SCS:
21 CFR §882.5880
PNS:
21 CFR §882.5870 | SCS:
21 CFR §882.5880
PNS:
21 CFR §882.5870 | Same as predicate. |
| Classification
Name | SCS:
Implanted spinal cord stimulator for pain
relief
PNS:
Implanted peripheral nerve stimulator for
pain relief | SCS:
Implanted spinal cord stimulator for pain
relief
PNS:
Implanted peripheral nerve stimulator for
pain relief | Same as predicate. |
| Intended Use | SCS:
Stimulation of the spinal cord for treatment
of chronic, intractable pain
PNS:
Stimulation of peripheral nerves for
chronic, intractable pain | SCS:
Stimulation of the spinal cord for
treatment of chronic, intractable pain
PNS:
Stimulation of peripheral nerves for
chronic, intractable pain | Same as predicate. |
| Indications for
Use | SCS:
This system is indicated as the sole
mitigating agent, or as an adjunct to other
modes of therapy used in a
multidisciplinary approach for chronic,
intractable pain of the trunk and/or limbs,
including unilateral or bilateral pain.
The trial devices are solely used for trial
stimulation (no longer than 30 days) to
determine efficacy before
recommendation for a permanent (long
term) device.
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. | SCS:
This system is indicated as the sole
mitigating agent, or as an adjunct to other
modes of therapy used in a
multidisciplinary approach for chronic,
intractable pain of the trunk and/or limbs,
including unilateral or bilateral pain.
The trial devices are solely used for trial
stimulation (no longer than 30 days) to
determine efficacy before
recommendation for a permanent (long
term) device.
PNS:
This system is indicated for pain
management in adults who have severe
intractable chronic pain of peripheral
nerve origin, as the sole mitigating agent,
or as an adjunct to other modes of
therapy used in a multidisciplinary
approach. The system is not intended to
treat pain in the craniofacial region.
The trial devices are solely used for trial
stimulation (no longer than 30 days) to
determine efficacy before
recommendation for a permanent (long
term) device. | Same as predicate. |
| Prescription
Use | Yes | Yes | Same as predicate. |
| Implant Site | SCS:
Lead: Epidural space
IPG: Subcutaneous, mid back
PNS: | SCS:
Lead: Epidural space
IPG: Subcutaneous, mid back
PNS: | Same as predicate. |
8
| 310(k) Summary K233801 | |||
|---|---|---|---|
| Peripheral nerves, excluding craniofacial | |||
| region. | Peripheral nerves, excluding craniofacial | ||
| region. | Peripheral nerves, excluding craniofacial region. | ||
| Environmental | |||
| Use | Hospital Use, Home | Hospital Use, Home | Same as predicate. |
| Intended | |||
| Clinician | Orthopedic, Neurosurgeon, | ||
| Anesthesiologist | Orthopedic, Neurosurgeon, | ||
| Anesthesiologist | Same as predicate. | ||
| Intended User | Physician, Layperson | Physician, Layperson | Same as predicate. |
| Mode of Action | Radiofrequency (RF) wireless | ||
| transmission of energy to produce | |||
| stimulation at stimulator electrodes. | Radiofrequency (RF) wireless | ||
| transmission of energy to produce | |||
| stimulation at stimulator electrodes. | Same as predicate. | ||
| Labeling | SCS: | ||
| MR Conditional Labeling for Head and | |||
| Extremities. | |||
| Full Body MR Conditional Labeling for | |||
| Full Body. | |||
| PNS: | |||
| MR Conditional Labeling for Head and | |||
| Extremities. | Not publicly available | SCS: | |
| Same as reference | |||
| device K202274. | |||
| PNS: | |||
| Same as reference | |||
| device K183579. | |||
| External Device | |||
| Names | Therapy Disc (second generation), Base | ||
| Station Charger and Trial Therapy Disc | Therapy Disc and Trial Therapy Disc | Therapy Disc and | |
| Therapy Disc Charger | |||
| (Base Station) have | |||
| updated design. Trial | |||
| Therapy Disc remains | |||
| unchanged. | |||
| Electronics | Updated folded printed circuit board | ||
| (PCB) design that generates RF power | |||
| with embedded waveform parameter | |||
| settings that can be changed as needed by | |||
| the user | A printed circuit board (PCB) that | ||
| generates RF power with embedded | |||
| waveform parameter settings and buttons | |||
| for changing parameter settings as | |||
| needed by the user | Functional output of | ||
| TD2 electronics | |||
| remains unchanged. | |||
| PCB changes were | |||
| evaluated through | |||
| usability and EMC | |||
| testing to confirm | |||
| there are no different | |||
| questions of safety or | |||
| effectiveness. | |||
| User Interface | Integrated indicators allow the user to | ||
| monitor device status. Therapy Disc can | |||
| be controlled through flip gesture. The | |||
| Remote Control allows the user to | |||
| stop/start stimulation, increase or decrease | |||
| therapy levels, and select from configured | |||
| therapy profiles. | Integrated controls and indicators that | ||
| allow the user to turn the device on/off, | |||
| increase or decrease therapy levels, select | |||
| from configured therapy profiles and | |||
| monitor device status. | Gesture controls on | ||
| Therapy Disc replace | |||
| buttons. Changes | |||
| were evaluated | |||
| through usability | |||
| testing to confirm | |||
| there are no different | |||
| questions of safety or | |||
| effectiveness. | |||
| Antenna | |||
| (Therapy Disc | |||
| Only) | Integrated antenna supporting 40.68 MHz | ||
| power and data transfer | Integrated antenna supporting 40.68 | ||
| MHz power and data transfer. | Same as predicate. | ||
| Wearable | |||
| Garments and | |||
| Adhesive Clips | |||
| (Therapy Disc | |||
| Only) | Therapy Disc is positioned over Nalu IPG | ||
| via two options: | |||
| • Adhesive clip (hydrocolloid adhesive) | |||
| • Elastic Belt/Cuff | |||
| Wearable accessories design has been | |||
| updated to accommodate smaller footprint | |||
| TD2 device | Therapy Disc is positioned over Nalu | ||
| IPG via two options: | |||
| • Adhesive clip (hydrocolloid adhesive) | |||
| • Elastic Belt/Cuff | New adhesive clip | ||
| using same materials. | |||
| Updated Elastic | |||
| Belt/Cuff. Changes | |||
| were evaluated | |||
| through usability | |||
| testing to confirm | |||
| there are no different | |||
| questions of safety or | |||
| effectiveness. | |||
| Size/Weight | Disc: ~1.3 cm thick, ~6.2 cm diameter | Disc: ~1.5 cm thick, 7.5 cm diameter | Similar. The |
| size/weight |
9
| Externally
Contacting
Materials | Biocompatible PC ABS housing.
Occasional contact to fingers (e.g., taking
disc in and out of adhesive clip or
wearable garment. Textile material of
belt/cuff may be worn over clothing.
Hydrocolloid adhesive applied to skin. | Biocompatible PC ABS housing.
Occasional contact to fingers (e.g., button
use). Textile material of belt/cuff may be
worn over clothing. Hydrocolloid
adhesive applied to skin. | modifications do not
raise different
questions of safety or
effectiveness.
Dimensional
verification confirms
that the device meets
its specifications.
Similar as predicate.
Biocompatible PC
ABS housing
materials for the
bottom housing have
not changed. The
patient contacting
materials of the TD2
top housing are
similar to the top
housing of the
predicate device, the
differences in the top
housing materials do
not raise different
questions of safety or
effectiveness. The
biological evaluation
of these materials
poses a very low
biocompatibility risk
because they have a
long history of safe
use in legally
marketed medical
devices that contact
intact skin. |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Battery
Charging
Configuration | Electrically isolated cradle charger
compatible with Therapy Disc devices.
Software installed on a compatible
Android tablet. | Electrically isolated cradle charger
compatible with Therapy Disc devices.
Software installed on a compatible
Android tablet. | Same as predicate. |
| Purpose | Allows healthcare provider to set desired
therapy levels and device settings across
Therapy Disc, Trial Therapy Disc, and
Patient Remote-Control devices | Allows healthcare provider to set desired
therapy levels and device settings across
Therapy Disc, Trial Therapy Disc, and
Patient Remote-Control devices. | Same as predicate. |
| Communication | Secure Bluetooth to Therapy Disc, Trial
Therapy Disc, Patient Remote Control and
Clinician Programmer.
Clinician Programmer and Base Station
Charger (BSC) also upload/download
encrypted data using a secure connection
to a Nalu cloud service via a Wi-Fi access
point. | Secure Bluetooth to Therapy Disc, Trial
Therapy Disc, Patient Remote Control
and Clinician Programmer.
Device usage information is stored
offline on the Therapy Disc and can be
transferred to the Clinician Programmer
via BLE connection | Same methods of
communication.
Changes were
evaluated through
usability and Software
testing to confirm
there are no different
questions of safety or
effectiveness. |
| Patient Remote
Control | Software app installed on compatible
mobile device (Android/iOS) providing
wireless selection among preconfigured
options and status readout for paired
Therapy Disc devices | Software app installed on compatible
mobile device (Android/iOS) providing
wireless selection among preconfigured
options and status readout for paired
Therapy Disc devices. | Same as predicate. |
10
| 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 of
Technological
Differences
from 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/
Voltage
Regulated | 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) biphasic
asymmetrical | charge balanced (delayed) biphasic
asymmetrical | Same as
predicate |
| Pulse Shape | Decaying Exponential | Decaying Exponential | Same as predicate |
11
| Maximum phase
charge (300
| Ohms) | 18.0 µC/pulse | 18.0 µC/pulse | Same as predicate |
|---|---|---|---|
| Maximum phase | |||
| charge (500 | |||
| Ohms) | 18.0 µC/pulse | 18.0 µC/pulse | Same as predicate |
| Maximum | |||
| phase charge | |||
| (800 Ohms) | 18.0 µC/pulse | 18.0 µC/pulse | Same as predicate |
| Maximum | |||
| charge density | |||
| (300 | |||
| Ohm) | 146.94 µC/cm2 | 146.94 µC/cm2 | Same as predicate |
| Maximum | |||
| charge density | |||
| (500 Ohm) | 146.94 µC/cm2 | 146.94 µC/cm2 | Same as predicate |
| Maximum | |||
| charge density | |||
| (800 Ohm) | 146.94 µC/cm2 | 146.94 µC/cm2 | Same as |
| predicate | |||
| Maximum | |||
| current | |||
| density (300 | |||
| Ohm) | 83.3 mA/cm2 | 83.3 mA/cm2 | Same as predicate |
| Maximum | |||
| current | |||
| density (500 | |||
| Ohm) | 83.3 mA/cm2 | 83.3 mA/cm2 | Same as predicate |
| Maximum | |||
| current | |||
| density (800 | |||
| Ohm) | 83.3 mA/cm2 | 83.3 mA/cm2 | Same as predicate |
| Net Charge | 0 µC | 0 µC | Same as predicate |
| Average Phase | |||
| Power (300 | |||
| Ohms) | 0.031 W/phase | 0.031 W/phase | Same as predicate |
| Average Phase | 0.052 W/phase | 0.052 W/phase | Same as predicate |
12
| Power (500
| Ohms) | |||
|---|---|---|---|
| Average Phase | |||
| Power (800 | |||
| Ohms) | 0.083 W/phase | 0.083 W/phase | Same as predicate. |
| Average Phase | |||
| Power density | |||
| (300 Ohms) | 0.25 W/cm²/phase | 0.25 W/cm²/phase | Same as |
| predicate. | |||
| Average Phase | |||
| Power density | |||
| (500 Ohms) | 0.51 W/cm²/phase | 0.51 W/cm²/phase | Same as predicate. |
| Average Phase | |||
| Power density | |||
| (800 Ohms) | 0.55 W/cm²/phase | 0.55 W/cm²/phase | Same as predicate. |
| Pulse Delivery | |||
| Mode | Continuous | Continuous | Same as predicate. |
| Current Path | |||
| options | 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 to | |||
| 1000 μs) | Same as predicate. | ||
| Dosage Time | Allows for stimulation to be applied in | ||
| periodic doses (On/Off; If On, spans | |||
| from 1 ms to 1000 ms, If Off, spans | |||
| from 1 ms to 2000 ms) | Allows for stimulation to be | ||
| applied in periodic doses (On/Off; | |||
| If On, spans from 1 ms to 1000 | |||
| ms, If Off, spans from 1 ms to | |||
| 2000 ms) | Same as predicate | ||
| Daily Therapy | |||
| Time | Limits the number of hours in a day that | ||
| stimulation may be used | |||
| (Seconds to hours) | Limits the number of hours in a day | ||
| that stimulation may be used | |||
| (Seconds to hours) | Same as predicate. | ||
| Transmit | |||
| Frequency | 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
13
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.