(111 days)
No
The summary describes a neurostimulation system that delivers electrical pulses for pain management. There is no mention of AI or ML in the intended use, device description, or performance studies. The changes mentioned relate to software specifications for increased therapy options, not AI/ML capabilities.
Yes
The device is indicated for pain management and provides therapeutic relief for chronic pain, utilizing electrical stimulation to inhibit pain signals.
No
Explanation: The device is a neurostimulation system indicated for pain management and provides therapeutic relief by inhibiting pain signals. While trial stimulation is mentioned to determine efficacy, its primary function is not to diagnose a condition but rather to provide therapy for an already diagnosed condition.
No
The device description explicitly details hardware components including an implantable pulse generator (IPG), leads, and a Therapy Disc, indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The Nalu Neurostimulation System is an implantable medical device that delivers electrical stimulation directly to nerves (spinal cord or peripheral nerves) to manage pain. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it is for "chronic, intractable pain of the trunk and/or limbs" and "pain management in adults who have severe intractable chronic pain of peripheral nerve origin." This is a therapeutic intervention, not a diagnostic test performed on a sample.
- Device Description: The description details components like an implantable pulse generator, leads, and therapy discs, all of which are part of an implanted system for delivering electrical stimulation.
Therefore, the Nalu Neurostimulation System falls under the category of an active implantable medical device used for therapy, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
For Spinal Cord Stimulation
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.
For Peripheral Nerve Stimulation
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 day) to determine efficacy before recommendation for a permanent (long term) device.
Product codes
GZB, GZF
Device Description
The Nalu Neurostimulation System has been cleared by the FDA for spinal cord stimulation, and peripheral nerve stimulation (K201618), to provide therapeutic relief for chronic, intractable pain of the trunk and/or limbs including unilateral, bilateral nerve pain. The Nalu Neurostimulation therapy utilizes pulsed electrical current to create an energy field that acts on nerves in the spinal cord or peripheral nerve to inhibit the transmission of pain signals to the brain. The Nalu System is implanted only following a successful trial period using the Nalu Neurostimulation trial system.
The Nalu Neurostimulation System consists of several components. The implantable pulse generator (IPG) provides electrical stimulation pulses that are transmitted through the leads, to the desired location, either on the spinal cord or peripheral nerve site. The leads are implantable and designed to deliver electrical pulses to the nerves via an array of four or eight cylindrical electrodes at the distal end. The Trial Therapy Disc or the Therapy Disc houses the battery and electronics for RF power and controls the IPG for therapy delivery via the remote programmer. Implantation of the Nalu IPG and lead components for spinal cord stimulation (SCS) or peripheral nerve stimulation (PNS) is performed via standard surgical tools and techniques, as described in (K201618).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal cord
Peripheral nerve
Indicated Patient Age Range
Adults
Intended User / Care Setting
Physician, Layperson
Hospital, 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)
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 evaluated and tested. The system is designed and tested to ensure that it meets all applicable standards and guidance documents. The subject device of this 510(k) has the same technological and performance criteria which have not changed from the predicate device. The proposed changes on the software specifications to increase therapy options are within the limits that have been previously cleared in predicate and reference devices. Validation and performance testing demonstrate that the device meets the performance criteria as reflected in the functional specifications. All of the required testing and results from the predicate device (K201618) remain applicable to the subject device of this 510(k) except for the updated software and firmware verification testing to support the proposed changes that are included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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March 25, 2021
Nalu Medical, Inc. Pauline Lieu Principle Regulatory Affairs Associate 2320 Faraday Ave. Suite 100 Carlsbad, California 92008
Re: K203547
Trade/Device Name: Nalu Neurostimulation System Regulation Number: 21 CFR 882.5880 Regulation Name: Implanted spinal cord stimulator for pain relief Regulatory Class: Class II Product Code: GZB, GZF Dated: December 4, 2020 Received: December 4, 2020
Dear Pauline Lieu:
(NOTE: Reprocessed SUD device types require a separate attachment of the list of all models cleared in the submission. A corrected SE letter will be required if the attachment is omitted.)
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
1
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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,
Jitendra Virani Acting Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203547
Device Name Nalu Neurostimulation System
Indications for Use (Describe) For Spinal Cord Stimulation
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.
For Peripheral Nerve Stimulation
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 day) 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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3
510(k) Summary
K203547
1. Submission Sponsor
Nalu Medical, Incorporated 2320 Faraday Ave., Suite 100 Carlsbad, CA 92008 Phone: (858) 442-6370 Fax: (760) 448-2377 Contact Pauline Lieu, Ph.D. Principle Regulatory Affairs Associate
Date Prepared: March 23吋, 2021
2. Device Names and Classification
| Primary Product Code | |
|---|---|
| Proprietary Name | Nalu Neurostimulation System |
| Common Names | Stimulator, Spinal-Cord Implanted (Pain Relief); |
| Class | II |
| Classification Regulation | 21 CFR 882.5880; Stimulator, Implanted Spinal-cord (Pain |
| Relief) | |
| Product Code | GZB |
| Review Panel | Division of Neurological and Physical Medicine Devices |
| Secondary Product Code | |
|---|---|
| Proprietary Name | Nalu Neurostimulation System |
| Common Names | Stimulator, Peripheral Nerve, Implanted (Pain Relief); |
| Class | II |
| Classification Regulation | 21 CFR 882.5870 Stimulator, Peripheral Nerve Stimulator |
| (Pain Relief) | |
| Product Code | GZF |
| Review Panel | Division of Neurological and Physical Medicine Devices |
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3. Predicate and Reference Devices:
Predicate Device: Nalu Neurostimulation System (K201618)
Reference Devices: Medtronic Xtrel Model 3425 (K883780 and K982902)
4. Device Description
The Nalu Neurostimulation System has been cleared by the FDA for spinal cord stimulation, and peripheral nerve stimulation (K201618), to provide therapeutic relief for chronic, intractable pain of the trunk and/or limbs including unilateral, bilateral nerve pain. The Nalu Neurostimulation therapy utilizes pulsed electrical current to create an energy field that acts on nerves in the spinal cord or peripheral nerve to inhibit the transmission of pain signals to the brain. The Nalu System is implanted only following a successful trial period using the Nalu Neurostimulation trial system.
The Nalu Neurostimulation System consists of several components. The implantable pulse generator (IPG) provides electrical stimulation pulses that are transmitted through the leads, to the desired location, either on the spinal cord or peripheral nerve site. The leads are implantable and designed to deliver electrical pulses to the nerves via an array of four or eight cylindrical electrodes at the distal end. The Trial Therapy Disc or the Therapy Disc houses the battery and electronics for RF power and controls the IPG for therapy delivery via the remote programmer. Implantation of the Nalu IPG and lead components for spinal cord stimulation (SCS) or peripheral nerve stimulation (PNS) is performed via standard surgical tools and techniques, as described in (K201618).
5. Indications for Use
Spinal Cord Stimulation (SCS)
This system is indicated as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain.
The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.
Peripheral Nerve Stimulation (PNS)
5
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.
6. Comparison with the Predicate and Reference Device:
The following tables illustrate the substantial equivalence between the subject, predicate, and reference devices.
| | Nalu
Neurostimulation
System
(Subject Device) | Nalu
Neurostimulation
System
(Predicate
Device, K201618) | Medtronic Xtrel
Model 3425
(Reference
Device, K883780
and K982902) | Analysis of
Technological
Differences from
Predicate |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K203547 | K201618 (SCS and
PNS) | K883780 (SCS)
K982902 (PNS) | NA |
| Product Code and
class | GZB and GZF,
Class II | GZB and GZF,
Class II | GZB and GZF, Class
II | Same |
| Regulation
number | 21 CFR 882.5880
(GZB)
21 CFR 882.5870
(GZF) | 21 CFR 882.5880
(GZB)
21 CFR 882.5870
(GZF) | 21 CFR 882.5880
(GZB)
21 CFR 882.5870
(GZF) | Same |
| Classification
name | Implanted spinal
cord stimulator
for pain relief.
(GZB)
Implanted
peripheral nerve
stimulator for
pain relief (GZF) | Same | Same | Same |
| Intended Use | Stimulation of
spinal cord for
chronic,
intractable pain
(GZB)
Stimulation of
peripheral nerves
for chronic | Same | Same | Same |
| | Nalu
Neurostimulation
System
(Subject Device) | Nalu
Neurostimulation
System
(Predicate
Device, K201618) | Medtronic Xtrel
Model 3425
(Reference
Device, K883780
and K982902) | Analysis of
Technological
Differences from
Predicate |
| | intractable pain
(GZF) | | | |
| Indications for
Use | SCS:
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.
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.
Both SCS and
PNS:
The trial devices
are solely used
for trial
stimulation (no
longer than 30
days) to | Same | The X-trel
Transmitter is part
of a system for
Spinal Cord
Stimulation or
Peripheral nerve
Stimulation. The
system is
indicated in the
management of
chronic,
intractable pain of
the trunk or limbs | Same |
| | Nalu
Neurostimulation
System
(Subject Device) | Nalu
Neurostimulation
System
(Predicate
Device, K201618) | Medtronic Xtrel
Model 3425
(Reference
Device, K883780
and K982902) | Analysis of
Technological
Differences from
Predicate |
| | determine
efficacy before
recommendation
for a permanent
(long term)
device. | | | |
| Prescription Use? | Yes | Same | Same | Same |
| Implant site, leads | Epidural space
(SCS) or
peripheral nerve
areas (PNS) | Same | Same | Same |
| Environmental
Use | Hospital, Home | Same | Same | Same |
| Intended Clinician | Orthopedic,
Neurosurgeon,
Anesthesiologist | Same | Same | Same |
| Intended User | Physician,
Layperson | Same | Same | Same |
| Mode of Action | Radio Frequency
(RF) wireless
transmission of
energy to
produce
stimulation at
stimulator
electrodes. | Same | Same | Same |
| Software Level of
Concern | Moderate | Moderate | Unreported | Same |
| Comparator | Nalu
Neurostimulation
System
(Subject Device) | Nalu
Neurostimulation
System
(Predicate Device,
K201618) | Medtronic Xtrel
Model 3425
(Reference Device,
K883780 and
K982902) | Analysis of
Technological
Differences from
Predicate |
| Pulse
Frequency | 2 Hz to 1500 Hz | 2 Hz to 1500 Hz | 5 to 1400 Hz | Same as predicate |
| Pulse Width | 12 to 2000 µs | 12 to 1000 µs | 50 to 1000 µs | Available
programmable pulse
width will be capped
to maintain Maximum
Phase Charge and
Maximum Charge
Density within limits
of Medtronic Xtrel
reference device limit.
No impact to safety
and effectiveness. |
| Current/Volta
ge Regulated | Current | Same | Voltage | Same as predicate |
| Output
Voltage (300
Ohms) | 0 to 3.1 V | 0 to 3.1 V | 0 to 5.4 V | Same as predicate |
| Output
Voltage (500
Ohms) | 0 to 5.1 V | 0 to 5.1 V | 0 to 7.1 V | Same as predicate |
| Output
Voltage (800
Ohms) | 0 to 8.2 V | 0 to 8.2 V | 0 to 8.4 V | Same as predicate |
| Output
Current (300
Ohms) | 0 to 10.2 mA | 0 to 10.2 mA | 0 to 18.0 mA | Same as predicate |
| Output
Current (500
Ohms) | 0 to 10.2 mA | 0 to 10.2 mA | 0 to 14.2 mA | Same as predicate |
| Output
Current (800
Ohms) | 0 to 10.2 mA | 0 to 10.2 mA | 0 to 10.5 mA | Same as predicate |
| Comparator | Nalu
Neurostimulation
System
(Subject Device) | Nalu
Neurostimulation
System
(Predicate Device,
K201618) | Medtronic Xtrel
Model 3425
(Reference Device,
K883780 and
K982902) | Analysis of
Technological
Differences from
Predicate |
| Waveform | charge balanced
(delayed) biphasic
asymmetrical | Same | Same | Same as predicate |
| Pulse Shape | Decaying
Exponential | Same | Same | Same as predicate |
| Maximum
phase charge
(300 Ohms) | 18.0 µC/pulse | 10.2 µC/pulse | 18.0 µC/pulse | Same as Medtronic
Xtrel reference device |
| Maximum
phase charge
(500 Ohms) | 18.0 µC/pulse | 10.2 µC/pulse | 14.2 µC/pulse | Same as Medtronic
Xtrel reference device
at 300 Ohms.
Maximum Phase
Charge constant in
current controlled
system and enforced
below maximum
reference device value
(at 300 Ohms). No
impact to safety and
effectiveness. |
| Maximum
phase charge
(800 Ohms) | 18.0 µC/pulse | 10.2 µC/pulse | 10.5 µC/pulse | Same as Medtronic
Xtrel reference device
at 300 Ohms.
Maximum Phase
Charge constant in
current controlled
system and enforced
below maximum
reference device value
(at 300 Ohms). No
impact to safety and
effectiveness. |
| Maximum
charge density
(300 Ohm) | 146.94 µC/cm² | 83.3 µC/cm² | 150.0 µC/cm² | Within maximum limit
as set by Medtronic
Xtrel reference device. |
| Comparator | Nalu
Neurostimulation
System
(Subject Device) | Nalu
Neurostimulation
System
(Predicate Device,
K201618) | Medtronic Xtrel
Model 3425
(Reference Device,
K883780 and
K982902) | Analysis of
Technological
Differences from
Predicate |
| Maximum
charge density
(500 Ohm) | 146.94 µC/cm² | 83.3 µC/cm² | 118.3 µC/cm² | Same as Medtronic
Xtrel reference device
at 300 Ohms.
Maximum Phase
Charge constant in
current controlled
system and enforced
below maximum
reference device value
(at 300 Ohms). No
impact to safety and
effectiveness. |
| Maximum
charge density
(800 Ohm) | 146.94 µC/cm² | 83.3 µC/cm² | 87.5 µC/cm² | Same as Medtronic
Xtrel reference device
at 300 Ohms.
Maximum Phase
Charge constant in
current controlled
system and enforced
below maximum
reference device value
(at 300 Ohms). No
impact to safety and
effectiveness. |
| Maximum
current
density (300
Ohm) | 83.3 mA/cm² | 83.3 mA/cm² | 150.0 mA/cm² | Same as predicate |
| Maximum
current
density (500
Ohm) | 83.3 mA/cm² | 83.3 mA/cm² | 118.3 mA/cm2 | Same as predicate |
| Maximum
current
density (800
Ohm) | 83.3 mA/cm² | 83.3 mA/cm² | 87.5 mA/cm² | Same as predicate |
| Net Charge | 0 μC | Same | Same | Same as predicate |
| Average Phase
Power (300
Ohms) | 0.031 W/phase | 0.031 W/phase | 0.068 W/phase | Same as predicate |
| Comparator | Nalu
Neurostimulation
System
(Subject Device) | Nalu
Neurostimulation
System
(Predicate Device,
K201618) | Medtronic Xtrel
Model 3425
(Reference Device,
K883780 and
K982902) | Analysis of
Technological
Differences from
Predicate |
| Average Phase
Power (500
Ohms) | 0.052 W/phase | 0.052 W/phase | 0.074 W/phase | Same as predicate |
| Average Phase
Power (800
Ohms) | 0.083 W/phase | 0.083 W/phase | 0.066 W/phase | Same as predicate. |
| Average Phase
Power density
(300 Ohms) | 0.25 $W/cm^2$ /phase | 0.25 $W/cm^2$ /phase | 0.57 $W/cm^2$ /phase | Same as predicate. |
| Average Phase
Power density
(500 Ohms) | 0.51 $W/cm^2$ /phase | 0.51 $W/cm^2$ /phase | 0.62 $W/cm^2$ /phase | Same as predicate. |
| Average Phase
Power density
(800 Ohms) | 0.55 $W/cm^2$ /phase | 0.55 $W/cm^2$ /phase | 0.55 $W/cm^2$ /phase | Same as predicate. |
| Pulse Delivery
Mode | Continuous | Same | Same | Same as predicate. |
| Current Path
options | Bipolar | Same | Same | Same as predicate. |
| Program Cycle | Cycle through
programs | Same | Details unavailable | Same as predicate. |
| Pulse Pattern | Fine tuning of
pulse patterns
(On/Off; If On,
spans from 12 $\mu$ s
to 1000 $\mu$ s) | Same | Details unavailable | 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 25 ms) | Same (Cycle
ON/OFF) | This parameter has no
impact on safety and
effectiveness
considerations.
Increasing the range
allows the clinician to
offer more flexibility
to accommodate
patient preferences |
| Comparator | Nalu
Neurostimulation
System
(Subject Device) | Nalu
Neurostimulation
System
(Predicate Device,
K201618) | Medtronic Xtrel
Model 3425
(Reference Device,
K883780 and
K982902) | Analysis of
Technological
Differences from
Predicate |
| Daily Therapy
Time | Limits the number
of hours in a day
that stimulation
may be used
(Seconds to hours) | Same | Details unavailable | Same as predicate. |
| Transmit
Frequency | 40.68 MHz | 40.68 MHz | 1.6 MHz | Same as predicate |
Table 6.1. Primary Predicate and Reference Device Summary
6
7
The Implanted Pulse Generator, Leads, all surgical implant accessories and all external accessories are unchanged from the predicate Nalu Neurostimulation System. The only difference between the subject devices and the predicate devices is the change in the software. The Nalu Neurostimulation System uses the same software for both SCS and PNS. A table below details the impact of those changes in comparison with the predicate and reference devices.
8
Table 6.2. Predicate and Reference Device comparison with the Nalu Neurostimulation therapy delivery
9
10
11
12
7. Technological Characteristics
All of the physical and therapeutic attributes for the proposed Nalu Neurostimulation System and the predicate and reference devices share the same technological characteristics and have no differences that would impact safety or effectiveness.
8. Summary of Performance Testing
Nalu Medical performed a range of testing to gather data supporting the safety and performance of the Nalu Neurostimulation System prior to use. Nalu follows the Design Controls section of 21 CFR 820.30, ISO 14971, and ISO 13485:2016. These procedures ensure that all designs are appropriately evaluated and tested. The system is designed and tested to ensure that it meets all applicable standards and guidance documents. The subject device of this 510(k) has the same technological and performance criteria which have not changed from the predicate device. The proposed changes on the software specifications to increase therapy options are within the limits that have been previously cleared in predicate and reference devices. Validation and performance testing demonstrate that the device meets the performance criteria as reflected in the functional specifications. All of the required testing and results from the predicate device (K201618) remain applicable to the subject device of this 510(k) except for the updated software and firmware verification testing to support the proposed changes that are included in this submission.
13
9. Conclusions
The subject device of this 510(k) is substantially equivalent to the predicate since it has identical intended use and the change in software and differences in technological characteristics do not raise new questions of safety and effectiveness.