(30 days)
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 capabilities.
Yes
The device is indicated for pain management and therapeutic relief for chronic, intractable pain, which directly aligns with the definition of a therapeutic device.
No
The device is indicated for pain management and provides therapeutic relief by inhibiting pain signals. While trial devices are mentioned for determining efficacy, the primary purpose of the system is therapeutic stimulation, not diagnosis.
No
The device description explicitly lists multiple hardware components including an implantable pulse generator (IPG), leads, and a Therapy Disc, which are integral to the device's function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are 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) to manage pain. It does not analyze biological samples.
- Intended Use: The intended use is for pain management through direct nerve stimulation, not for diagnostic testing of biological specimens.
Therefore, the Nalu Neurostimulation system falls under the category of an active implantable medical device, not an In Vitro Diagnostic device.
N/A
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 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)
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
GZB, GZF
Device Description
The Nalu Neurostimulation system has been cleared by the FDA for spinal cord stimulation (SCS; K183047) and peripheral nerve stimulation (PNS; K183579, and K191435) 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 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 (K183047, K183579, and K191435).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
trunk and/or limbs, spinal cord, peripheral nerve site
Indicated Patient Age Range
Adults
Intended User / Care Setting
Physician, Layperson
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. The system is designed and tested to ensure that it meets all applicable standards and guidance documents. Validation and performance testing demonstrate that the device meets user needs as reflected in the functional specification. The subject device of this 510(k) has the same technological and performance criteria which have not changed from the predicate device. All relevant testing for the proposed labeling changes were submitted and cleared in the previous submissions (K183047, K183579, and K191435). Therefore, test results from the predicate device remain applicable to the subject device of this 510(k).
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 15, 2020
Nalu Medical, Inc % Pauline Lieu Regulatory Affairs Consultant 2320 Faraday Ave., Suite 100 Carlsbad, California 92008
Re: K201618
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: June 12, 2020 Received: June 15, 2020
Dear Pauline Lieu:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
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 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.
For
Pamela Scott Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201618
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 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)
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)
| ☑ 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
K201618
Submission Sponsor
Nalu Medical, Incorporated 2320 Faraday Ave., Suite 100 Carlsbad, CA 92009 Phone: (760) 448-2360 Fax: (760) 448-2377 Contact Pauline Lieu, Regulatory Affairs
Date Prepared: June 12, 2020
Device Names and Classification
| Predicate Device | |
|---|---|
| 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 |
| Reference Device | |
|---|---|
| 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 |
4
Predicate Device
Nalu Neurostimulation System for Spinal Cord Stimulation (K183047)
Reference Devices: Nalu Neurostimulation System for Peripheral Nerve Stimulation (K183579 and K191435)
Device Description
The Nalu Neurostimulation system has been cleared by the FDA for spinal cord stimulation (SCS; K183047) and peripheral nerve stimulation (PNS; K183579, and K191435) 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 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 (K183047, K183579, and K191435).
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)
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
Comparison with the Predicate Device
| Device | Nalu Neurostimulation
System (Predicate
Device: K183047) | Nalu Neurostimulation
System (Subject Device) | Analysis of
Technological
Differences |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| Trade Name | Nalu Neurostimulation
System | Nalu Neurostimulation
System | Same |
| Manufacturer | Nalu Medical, Inc. | Nalu Medical, Inc. | Same |
| Intended Use | The Nalu
Neurostimulation system
is intended for the
stimulation of the spinal
cord for treatment of
chronic, intractable pain. | The Nalu
Neurostimulation system
is intended for the
stimulation of the spinal
cord for treatment of
chronic, intractable pain. | Same |
| Indications for
Use | 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. | 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. | Same |
| 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 |
| Intended User | Physician, Layperson | Physician, Layperson | Same |
| Principle of
Operation | Stimulation of the spinal
cord to provide
therapeutic relief for | Stimulation of the spinal
cord to provide
therapeutic relief for | Same |
| | chronic, intractable pain
of the trunk and/or limbs
including unilateral or
bilateral pain | chronic, intractable pain
of the trunk and/or limbs
including unilateral or
bilateral pain | |
| 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 |
| Implant
Neurostimulator | Nalu IPG 27.7 mm x 9.3
mm x 4.2 mm | Nalu IPG 27.7 mm x 9.3
mm x 4.2 mm | Same |
| Lead | 40 cm, 60 cm; Platinum-
iridium 90:10;
Multilumen tube | 40 cm, 60 cm; Platinum-
iridium 90:10; Multilumen
tube | Same |
| Externally worn
devices | Trial Therapy Disc and
Therapy Disc | Trial Therapy Disc and
Therapy Disc | Same |
| Electronics | A printed circuit board
(PCB) that generates RF
power with embedded
waveform parameter
settings and buttons for
changing parameter
settings | A printed circuit board
(PCB) that generates RF
power with embedded
waveform parameter
settings and buttons for
changing parameter
settings | Same |
| Clinician
Programmer | Software to communicate
to Trial Therapy or
Therapy Disc | Software to communicate
to Trial Therapy or
Therapy Disc | Same |
| Patient Remote
Control | Software to pair with
Trial Therapy or Therapy
Disc | Software to pair with Trial
Therapy or Therapy Disc | Same |
| Human Factors | Integrated controls and
indicators that allows the
user to turn the device
on/off, increase or
decrease therapy levels,
select from configured
therapy profiles and
monitor device status | Integrated controls and
indicators that allows the
user to turn the device
on/off, increase or
decrease therapy levels,
select from configured
therapy profiles and
monitor device status | Same |
| Externally
Contacting
Materials | Hydrocolloid adhesive
applied to skin | Hydrocolloid adhesive
applied to skin | Same |
| | Biocompatible PC ABS
housing | Biocompatible PC ABS
housing | |
| | Textile material of belt | Textile material of belt | |
| Labeling | Implantable Pulse
Generator:
The service life of the
Implantable Pulse
Generator is 10 | Implantable Pulse
Generator:
The service life of the
Implantable Pulse
Generator is 18 | New |
Nalu Neurostimulation System for Spinal Cord Stimulation (SCS)
6
7
| Therapy Disc: Single use | Therapy Disc: Re-usable | |||
|---|---|---|---|---|
| -- | -------------------------- | ------------------------- | -- | -- |
Nalu Neurostimulation System for Peripheral Nerve Stimulation
| Device | Nalu Neurostimulation
System (Reference
Devices: K183579,
K191435) | Nalu Neurostimulation
System (Subject Device) | Analysis of
Technological
Differences |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| Trade Name | Nalu Neurostimulation
System | Nalu Neurostimulation
System | Same |
| Manufacturer | Nalu Medical, Inc. | Nalu Medical, Inc. | Same |
| Intended Use | The Nalu
Neurostimulation system
is intended for the
stimulation of the
peripheral nerve for
treatment of chronic,
intractable pain. | The Nalu
Neurostimulation 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 |
| Clinical
application | Treatment of chronic
peripheral nerve pain | Treatment of chronic
peripheral nerve pain | Same |
| Prescription Use | Yes | Yes | Same |
| Intended User | Physician, Layperson | Physician, Layperson | Same |
| Device | Nalu Neurostimulation
System (Reference
Devices: K183579,
K191435) | Nalu Neurostimulation
System (Subject Device) | Analysis of
Technological
Differences |
| 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 |
| Implant
Neurostimulator | Nalu IPG 27.7 mm x 9.3
mm x 4.2 mm | Nalu IPG 27.7 mm x 9.3
mm x 4.2 mm | Same |
| Lead | 40 cm, 60 cm; Platinum-
iridium 90:10;
Multilumen tube | 40 cm, 60 cm; Platinum-
iridium 90:10;
Multilumen tube | Same |
| | 25 cm, 40 cm Platinum-
iridium 90:10, Coiled
wires | 25 cm, 40 cm Platinum-
iridium 90:10, Coiled
wires | |
| Externally worn
devices | Trial Therapy Disc and
Therapy Disc | Trial Therapy Disc and
Therapy Disc | Same |
| Electronics | A printed circuit board
(PCB) that generates RF
power with embedded
waveform parameter
settings and buttons for
changing parameter
settings | A printed circuit board
(PCB) that generates RF
power with embedded
waveform parameter
settings and buttons for
changing parameter
settings | Same |
| Clinician
Programmer | Software to communicate
to Trial Therapy or
Therapy Disc | Software to
communicate to Trial
Therapy or Therapy Disc | Same |
| Patient Remote
Control | Software to pair with
Trial Therapy or Therapy
Disc | Software to pair with
Trial Therapy or Therapy
Disc | Same |
| Human Factors | Integrated controls and
indicators that allows the
user to turn the device
on/off, increase or
decrease therapy levels,
select from configured
therapy profiles and
monitor device status | Integrated controls and
indicators that allows the
user to turn the device
on/off, increase or
decrease therapy levels,
select from configured
therapy profiles and
monitor device status | Same |
| Externally
Contacting
Materials | Hydrocolloid adhesive
applied to skin | Hydrocolloid adhesive
applied to skin | Same |
| Device | Nalu Neurostimulation
System (Reference
Devices: K183579,
K191435) | Nalu Neurostimulation
System (Subject Device) | Analysis of
Technological
Differences |
| | Biocompatible PC ABS
housing | Biocompatible PC ABS
housing | |
| | Textile material of belt | Textile material of belt | |
| Labeling | Implantable Pulse
Generator:
The service life of the
Implantable Pulse
Generator is 10 years. | Implantable Pulse
Generator:
The service life of the
Implantable Pulse
Generator is 18 years | New |
| | Therapy Disc: Single use | Therapy Disc: Re-usable | |
8
9
Technological Characteristics
All of the physical and therapeutic attributes for the proposed Nalu Neurostimulation System and the predicate devices share the same technological characteristics and have no differences that would impact safety or effectiveness.
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. The system is designed and tested to ensure that it meets all applicable standards and guidance documents. Validation and performance testing demonstrate that the device meets user needs as reflected in the functional specification. The subject device of this 510(k) has the same technological and performance criteria which have not changed from the predicate device. All relevant testing for the proposed labeling changes were submitted and cleared in the previous submissions (K183047, K183579, and K191435). Therefore, test results from the predicate device remain applicable to the subject device of this 510(k).
Conclusion
The subject device of this 510(k) is substantially equivalent to the predicate devices as they are identical with regard to indications for use, performance and the technological characteristics. Risk analysis of the proposed changes did not raise any questions of safety and effectiveness.