Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on electrical stimulation and hardware components without mentioning any AI/ML functionalities.

Therapeutic

Yes
The device delivers electrical stimulation to nerves to inhibit pain signals, which is a form of therapy for chronic pain.

Diagnostic

No

The device is described as providing therapeutic relief for chronic, intractable pain by inhibiting pain signals. While the trial period determines efficacy, its primary purpose is treatment, not diagnosis of a condition.

SaMD (Software as a Medical Device)

No

The device description explicitly lists multiple hardware components including an implantable pulse generator (IPG), leads, and a Therapy Disc, indicating it is not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

IVDs analyze samples from the human body. The description clearly states that the Nalu Neurostimulation System is an implantable device that delivers electrical stimulation directly to nerves (spinal cord or peripheral). It does not involve the analysis of blood, urine, tissue, or any other biological sample.
The intended use is pain management. The system is used to treat chronic pain by modulating nerve signals, not to diagnose a condition or provide information about a patient's health status based on sample analysis.
The device description focuses on electrical stimulation and implantation. The components described (IPG, leads, Therapy Disc) are all related to delivering electrical therapy, not to collecting or analyzing biological samples.

Therefore, the Nalu Neurostimulation System falls under the category of an active implantable medical device used for therapeutic purposes, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 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)

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.

Product codes (comma separated list FDA assigned to the subject device)

GZB, GZF

Device Description

The Nalu Neurostimulation System has been cleared by the FDA for spinal cord stimulation (SCS; K203547) and peripheral nerve stimulation (PNS; K203547) 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 five (5) 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 (4) or eight (8) 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 (K203547).

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

Intended Clinician: Orthopedic, Neurosurgeon, Anesthesiologist
Intended User: Physician, Layperson
Environmental Use: 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 determined that bench and non-clinical testing are sufficient to demonstrate that the Nalu Neurostimulation system is as safe and effective as the predicate device. The proposed changes on the Clinician Programmer 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 devices (K203547) remain applicable to the subject device of this 510(k) except for the updated software and firmware validation testing to support the proposed changes that are included in this submission.

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.

K203547

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.

Not Found

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

Regulation Number and Section

§ 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).

Summary

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services-USA seal. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

June 10, 2022

Nalu Medical, Inc. Chelsea Gutierrez VP Regulatory and Quality 2320 Faraday Avenue, Suite 100 Carlsbad, California 92008

Re: K221376

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: May 12, 2022 Received: May 12, 2022

Dear Chelsea Gutierrez:

We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

1

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-reporting-

combination-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 medical devices and radiation-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,

Amber Ballard, PhD 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) K221376

Device Name Nalu Neurostimulation System

Indications for Use (Describe)

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 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)

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.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

☑ Research that is Part 21 CFR 58 Subject to Bioresearch Monitoring Program
☐ One Time Contracted (to Part 21 CFR 58) Study

Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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1. Submission Sponsor

Nalu Medical, Incorporated 2320 Faraday Ave., Suite 100 Carlsbad, CA 92008 Phone: (714) 401-0608 Fax: (760) 448-2377 Contact: Chelsea Gutierrez Vice President of Regulatory Affairs and Quality Assurance

2. Date Prepared: June 10, 2022

3. 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; Implanted spinal cord stimulator for pain relief
Product Code	GZB
Review Panel	Division of Neurology

Secondary Product Code
Proprietary Name	Nalu Neurostimulation System
Common Names	Stimulator, Peripheral Nerve, Implanted (Pain Relief)
Class	II
Classification Regulation	21 CFR 882.5870; Implanted peripheral nerve stimulator for pain relief
Product Code	GZF
Review Panel	Division of Neurology

4. Predicate Device(s)

Nalu Neurostimulation System, K203547

For software differences between the Nalu Neuromodulation System and the predicate(s) (K203547), substantial equivalence to the predicate device is demonstrated.

5. Device Description

The Nalu Neurostimulation System has been cleared by the FDA for spinal cord stimulation (SCS; K203547) and peripheral nerve stimulation (PNS; K203547) 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

4

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 five (5) 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 (4) or eight (8) 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 (K203547).

6. 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 Stimulator (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.

5

7. Comparison with the Predicate Device

Table 1: Nalu Neuromodulation System for Spinal Cord Stimulation (SCS)
------------------------------------------------------------------------	--	--	--

| Device | Nalu
Neuromodulation System (Subject Device, K221376) | Nalu
Neuromodulation System (Predicate Device, K203547) | Analysis of Technological Differences |
|---------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K221376 | K203547 | N/A |
| Product Code and Class | 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) | Same |
| Classification Name | Implanted spinal cord stimulator for pain relief. (GZB)
Implanted peripheral nerve stimulator for pain relief. (GZF) | Implanted spinal cord stimulator for pain relief. (GZB)
Implanted peripheral nerve stimulator for pain relief. (GZF) | Same |
| Trade Name | Nalu
Neuromodulation System | Nalu
Neurostimulation System | Same |
| Manufacturer | Nalu Medical, Inc. | Nalu Medical, Inc. | Same |
| Intended Use | The Nalu
Neuromodulation system is intended for the stimulation of the spinal cord for treatment of chronic, intractable pain (GZB).
Stimulation of peripheral nerves for chronic, intractable pain (GZF). | The Nalu
Neuromodulation system is intended for the stimulation of the spinal cord for treatment of chronic, intractable pain (GZB).
Stimulation of peripheral nerves for chronic, intractable pain (GZF). | Same |
| Indications for Use | For Spinal Cord Stimulation-
This system is indicated as the | For Spinal Cord Stimulation-
This system is indicated as the | Same |
| Device | Nalu
Neuromodulation
System (Subject
Device, K221376) | Nalu
Neuromodulation
System (Predicate
Device, K203547) | Analysis of
Technological
Differences |
| | 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 | 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 | |
| Device | Nalu
Neuromodulation
System (Subject
Device, K221376) | Nalu
Neuromodulation
System (Predicate
Device, K203547) | Analysis of
Technological
Differences |
| | stimulation (no
longer than 30 day)
to determine
efficacy before
recommendation
for a permanent
(long term) device. | stimulation (no
longer than 30 day)
to determine
efficacy before
recommendation
for a permanent
(long term) device. | |
| Clinical application | Treatment of
chronic, intractable
pain of the trunk
and/or limbs,
including unilateral
or bilateral pain. | Treatment of
chronic, intractable
pain of the trunk
and/or limbs,
including unilateral
or bilateral pain. | Same |
| Prescription Use | Yes | Yes | Same |
| Environmental Use | Hospital, Home | Hospital, Home | Same |
| Intended Clinician | Orthopedic,
Neurosurgeon,
Anesthesiologist | Orthopedic,
Neurosurgeon,
Anesthesiologist | Same |
| Intended User | Physician,
Layperson | Physician,
Layperson | Same |
| Implant site, leads | Epidural space (SCS)
or peripheral nerve
areas (PNS) | Epidural space (SCS)
or peripheral nerve
areas (PNS) | Same |
| Principle of
Operation | Stimulation of the
spinal cord to
provide therapeutic
relief for chronic,
intractable pain of
the trunk and/or
limbs including
unilateral or
bilateral pain. | Stimulation of the
spinal cord to
provide therapeutic
relief for chronic,
intractable pain of
the trunk and/or
limbs including
unilateral or
bilateral pain. | Same |
| Mode of Action | RF wireless
transmission of
energy to deliver
stimulation at
stimulator
electrodes. | RF wireless
transmission of
energy to deliver
stimulation at
stimulator
electrodes. | Same |
| Software Level of
Concern | Moderate | Moderate | Same |
| Clinician
Programmer | Software to
communicate to | Not publicly
available | The differences
do not impact the
safety and |
| Device | Nalu
Neuromodulation
System (Subject
Device, K221376) | Nalu
Neuromodulation
System (Predicate
Device, K203547) | Analysis of
Technological
Differences |
| | Trial Therapy or
Therapy Disc

Manual control of
current for selected
electrodes and
optional model
based allocation. | | effectiveness of
the device. The
safety parameters
(charge per phase,
charge density
and current
density) remain
unchanged. The
updated software
allows the
clinician to
optionally use a
mode to set the
current values on
up to 4 electrodes
based on a model.
The safety limits
continue to be
applied as before.
The new method
is an option that
may allow
programming to
go faster when
causing the
current steering
stimulation mode.
As with all
programming in
neurostimulation
the patient
remains in the
feedback loop and
determines the
effectiveness of
the therapy. |
| Patient Remote
Control | Software to pair
with Trial Therapy
or Therapy Disc

Firmware update to
reflect changes on
the Clinician
Programmer and
Remote Control | Not publicly
available | - |
| Labelling
Clinician
Programmer User
Guide/Remote
Control User Guide | Labeling updated to
support Clinical
Programmer
Current Steering
options. | Not publicly
available | The differences to
labeling do not
impact the safety
and effectiveness
of the device. |

6

7

8

9

Table 2: Nalu Neuromodulation System for Peripheral Nerve Stimulation

| Device | Nalu
Neuromodulation
System (Subject
Device, K221376) | Nalu
Neuromodulation
System (Predicate
Device, K203547) | Analysis of
Technological
Differences |
|--------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K221376 | K203547 | N/A |
| Product Code and
Class | 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) | Same |
| Classification
Name | Implanted spinal
cord stimulator for
pain relief. (GZB) | Implanted spinal
cord stimulator for
pain relief. (GZB) | Same |
| Device | Nalu
Neuromodulation
System (Subject
Device, K221376) | Nalu
Neuromodulation
System (Predicate
Device, K203547) | Analysis of
Technological
Differences |
| | Implanted
peripheral nerve
stimulator for pain
relief. (GZF) | Implanted
peripheral nerve
stimulator for pain
relief. (GZF) | |
| Trade Name | Nalu
Neuromodulation
System | Nalu
Neurostimulation
System | Same |
| Manufacturer | Nalu Medical, Inc. | Nalu Medical, Inc. | Same |
| Intended Use | The Nalu
Neuromodulation
system is intended
for the stimulation
of the peripheral
nerve for treatment
of chronic,
intractable pain. | The Nalu
Neuromodulation
system is intended
for the stimulation
of the peripheral
nerve for treatment
of chronic,
intractable pain. | Same |
| Indications for Use | 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. | 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 |
| Device | Nalu
Neuromodulation
System (Subject
Device, K221376) | Nalu
Neuromodulation
System (Predicate
Device, K203547) | Analysis of
Technological
Differences |
| Clinical application | Treatment of
chronic peripheral
nerve pain. | Treatment of
chronic peripheral
nerve pain. | Same |
| Prescription Use | Yes | Yes | Same |
| Environmental Use | Hospital, Home | Hospital, Home | Same |
| Intended Clinician | Orthopedic,
Neurosurgeon,
Anesthesiologist | Orthopedic,
Neurosurgeon,
Anesthesiologist | Same |
| Implant site, leads | Epidural space (SCS)
or peripheral nerve
areas (PNS) | Epidural space (SCS)
or peripheral nerve
areas (PNS) | Same |
| Intended User | Physician,
Layperson | Physician,
Layperson | Same |
| Principle of
Operation | Stimulation of the
peripheral nerve to
provide therapeutic
relief for chronic,
pain. | Stimulation of the
peripheral nerve to
provide therapeutic
relief for chronic,
pain. | Same |
| Mode of Action | RF wireless
transmission of
energy to deliver
stimulation at
stimulator
electrodes. | RF wireless
transmission of
energy to deliver
stimulation at
stimulator
electrodes. | Same |
| Software Level of
Concern | Moderate | Moderate | Same |
| Clinician
Programmer | Software to
communicate to
Trial Therapy or
Therapy Disc

Manual control of
current for selected
electrodes and
optional model
based allocation. | Not publicly
available | The differences
do not impact the
safety and
effectiveness of
the device. The
safety parameters
(charge per
phase, charge
density and
current density)
remain
unchanged. The
updated software
allows the
clinician to
optionally use a
mode to set the |
| Device | Nalu
Neuromodulation
System (Subject
Device, K221376) | Nalu
Neuromodulation
System (Predicate
Device, K203547) | Analysis of
Technological
Differences |
| | | | current values on
up to 4 electrodes
based on a model.
The safety limits
continue to be
applied as before.
The new method
is an option that
may allow
programming to
go faster when
causing the
current steering
stimulation mode.
As with all
programming in
neurostimulation
the patient
remains in the
feedback loop and
determines the
effectiveness of
the therapy. |
| Patient Remote
Control | Software to pair
with Trial Therapy
or Therapy Disc

10

11

12

13

Table 3 Predicate and Subject Device comparison with the Nalu Neurostimulation therapy delivery (SCS and PNS)

| Comparator | Nalu
Neurostimulation
System
(Subject Device,
K221376) | Nalu
Neurostimulation
System
(Predicate Device,
K203547) | 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/Volta ge
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 |

14

| 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

15

| Comparator | Nalu
Neurostimulation
System
(Subject Device, K221376) | Nalu
Neurostimulation
System
(Predicate Device, K203547) | Analysis of
Technological
Differences
from
Predicate |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| Waveform | charge balanced
(delayed) biphasic
asymmetrical | charge balanced
(delayed) biphasic
asymmetrical | Same as predicate |
| Pulse Shape | Decaying
Exponential | Decaying
Exponential | Same as predicate |
| 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
Ohms) | 146.94 µC/cm² | 146.94 µC/cm² | Same as predicate |
| Comparator | Nalu
Neurostimulation
System
(Subject Device, K221376) | Nalu
Neurostimulation
System
(Predicate Device, K201618) | Analysis of
Technological
Differences from
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 |
| Comparator | Nalu
Neurostimulation
System
(Subject Device,
K221376) | Nalu
Neurostimulation
System
(Predicate Device,
K201618) | Analysis of
Technological
Differences
from
Predicate |
| Average Phase
Power (500
Ohms) | 0.052 W/phase | 0.052 W/phase | Same as predicate |
| 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 |
| Comparator | Nalu
Neurostimulation
System
(Subject Device, K221376) | Nalu
Neurostimulation
System
(Predicate Device, K203547) | 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) | 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 |

16

17

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8. Technological Characteristics

All of the physical and therapeutic attributes for the proposed Nalu Neuromodulation System and the predicate device share the same technological characteristics and have no differences that would impact safety and effectiveness.

9. Summary of Nonclinical Performance Testing

Nalu Medical performed a range of testing to gather data supporting the safety and performance of the Nalu Neurostimulation System prior to use. Nalu follows the Design Controls section of 21 CFR 820.30, ISO 14971, and ISO 13485:2016. These standards 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 similar technological and performance criteria to the predicate device(s). The proposed changes on the Clinician Programmer 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 devices (K203547) remain applicable to the subject device of this 510(k) except for the updated software and firmware validation testing to support the proposed changes that are included in this submission.

Table 4: Standards and Guidance Documents

Standard Number	Title
EN ISO 14971:2012	Medical devices -- Application of risk management to medical devices

19

Standard Number	Title
ISO 14708-1:2014	Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
ISO 14708-3:2017	Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators
IEC 60601-1:2005: A2012	Medical electrical equipment — Part 1: General requirements for basic safety and essential performance
IEC 60601-1-11:2015	Medical electrical equipment — Part 1-11: General requirements for basic safety and essential performance — Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
IEC 60601-1-2:2014	Medical electrical equipment — Part 1-2: General requirements for basic safety and essential performance — Collateral Standard: Electromagnetic disturbances — Requirements and tests
BS EN 62311-2008	Assessment of electronic and electrical equipment related to human exposure restrictions for electromagnetic fields
ANSI IEEE C63.27	American National Standard for Evaluation of Wireless Coexistence
	FDA Guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices issued October 2, 2014
	FDA Guidance: Applying Human Factors and Usability Engineering to Medical Devices issued February 3, 2016
	Refuse to Accept Policy for 510(k)s dated September 13, 2019
	"eCopy Program for Medical Device Submissions" dated April 27, 2020
	"Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Premarket Submissions for Medical Devices" (September 14, 2018)
	"Deciding When to Submit a 510(k) for a Software Change to an Existing Device dated Oct 25th 2017
	The Special 510(k) Program: Guidance for Industry and Food and Drug Administration Staff
	Providing Regulatory Submissions for Medical Devices in Electronic Format – Submissions under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry and Food and Drug Administration Staff

10. Clinical Performance Data

Nalu Medical determined that bench and non-clinical testing are sufficient to demonstrate that the Nalu Neurostimulation system is as safe and effective as the predicate device. Note that the predicate device did not need clinical evidence to obtain a determination of substantial equivalence.

11. Conclusions

The subject device of this 510(k) is substantially equivalent to the predicate device as they are identical with regard to indications for use, performance and the technological

20

characteristics. Risk analysis of the proposed changes did not raise any different questions of safety and effectiveness.