(90 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on hardware components and standard stimulation techniques.
Yes
The device delivers electrical stimulation pulses to the spinal cord to alleviate chronic intractable pain, which is a therapeutic intervention.
No
The device is a neurostimulation system used to deliver electrical pulses to the spinal cord for pain management, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly lists multiple hardware components including an implantable pulse generator (IPG), leads, a lead anchor, and therapy discs, indicating it is a hardware-based system with software control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for Spinal Cord Stimulation to treat chronic, intractable pain. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device components (IPG, leads, therapy disc) are designed for implantation and delivery of electrical stimulation directly to the spinal cord. This is a physical intervention, not a method for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or processes related to collecting, analyzing, or interpreting biological samples (like blood, urine, tissue, etc.) to diagnose a condition or disease.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly operates in vivo (within the body) for therapeutic purposes.
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 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.
Product codes
GZB
Device Description
The Nalu Neurostimulation system has been cleared by the FDA (K183047) for spinal cord stimulation to provide therapeutic relief for chronic, intractable pain of the trunk and/or limbs including unilateral or bilateral pain. The Nalu Neurostimulation therapy utilizes pulsed electrical current to create an energy field that acts on nerves in the spinal cord 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 is consisted of five components. The implantable pulse generator (IPG) provides electrical stimulation pulses that are transmitted through the leads, through the dura, to the desired location of the spinal cord site. The leads are implantable and designed to deliver electrical pulses to the spinal cord in the epidural space via an array of eight cylindrical electrodes at the distal end. The leads may be secured in place with the Nalu Lead Anchor. 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) is performed via standard SCS surgical tools and techniques, as described in (K183047).
The Nalu Neurostimulation System has been previously cleared by the FDA (K183047) with the magnetic resonance imaging (MRI) Conditional Labeling for the leads, anchor and implantable pulse generator which can be scanned safely with the local RF coils, including head, foot/ankle, knee, or wrist, as stated in the instructions for use. In this submission, Nalu performed MRI testing on the standard horizontal MR bore system to support the safety of the RF body coil. Nalu proposes an update to the MR Conditional Labeling with the full body scan as indicated in the proposed labeling update.
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
Indicated Patient Age Range
Not Found
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. 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. Bench testing includes design verification and validation, sterilization validation, and biocompatibility testing. Human factors and usability testing were performed on the device. 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. Therefore, test results from the predicate device (K183047) except for the updated Magnetic Resonance testing remain applicable to the subject device of this 510(k).
The testing for the labeling changes proposed for the Nalu Neurostimulation System includes the following test standards and guidance:
- ISO/TS 10974: Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
- ISO 14708: Implant for surgery – Active implantable medical devices – Part 1 and Part 3, General requirements and Implantable neurostimulator
- ASTM F2052-15: Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
- ASTM F2213-17: Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
- ASTM F2129-2013: Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
Nalu Medical determined that bench and non-clinical testing are sufficient to demonstrate that the Nalu Neurostimulation System is safe and effective as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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 shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 9, 2020
Nalu Medical, Inc. Pauline Lieu, Ph.D. Regulatory Affairs Consultant 2320 Faraday Ave. Suite 100 Carlsbad, California 92009
Re: K202274
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 Dated: August 10, 2020 Received: August 11, 2020
Dear Dr. 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 probibitions 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 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
1
801); medical device reporting (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 (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,
Pamela D. 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) K202274
Device Name
Nalu Neurostimulation System for SCS
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 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.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
K202274
1. 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: Aug. 10th, 2020
2. 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 |
3. Predicate Device:
Nalu Neurostimulation System for Spinal Cord Stimulation (K183047)
4. Device Description
The Nalu Neurostimulation system has been cleared by the FDA (K183047) for spinal cord stimulation to provide therapeutic relief for chronic, intractable pain of the trunk and/or
4
limbs including unilateral or bilateral pain. The Nalu Neurostimulation therapy utilizes pulsed electrical current to create an energy field that acts on nerves in the spinal cord 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 is consisted of five components. The implantable pulse generator (IPG) provides electrical stimulation pulses that are transmitted through the leads, through the dura, to the desired location of the spinal cord site. The leads are implantable and designed to deliver electrical pulses to the spinal cord in the epidural space via an array of eight cylindrical electrodes at the distal end. The leads may be secured in place with the Nalu Lead Anchor. 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) is performed via standard SCS surgical tools and techniques, as described in (K183047).
The Nalu Neurostimulation System has been previously cleared by the FDA (K183047) with the magnetic resonance imaging (MRI) Conditional Labeling for the leads, anchor and implantable pulse generator which can be scanned safely with the local RF coils, including head, foot/ankle, knee, or wrist, as stated in the instructions for use. In this submission, Nalu performed MRI testing on the standard horizontal MR bore system to support the safety of the RF body coil. Nalu proposes an update to the MR Conditional Labeling with the full body scan as indicated in the proposed labeling update.
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.
5
6. 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
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 |
| Implant
Neurostimulat
or | 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
| Same |
| Externally
Contacting
Materials | Clip adhesives applied to
skin
Biocompatible PC ABS
housing | Clip adhesives applied to
skin
Biocompatible PC ABS
housing | Same |
Table 1. Nalu Neurostimulation System for Spinal Cord Stimulation (SCS)
6
7
| Textile material of belt | Textile material of belt | ||
|---|---|---|---|
| Labeling | MR Conditional Labeling | ||
| for Head and Extremities | MR Conditional Labeling | ||
| for Head and Extremities | Same | ||
| Full Body | |||
| Do not use RF transmit | |||
| body coil | Full body | ||
| MR Conditional Labeling | |||
| for Full Body | Different but | ||
| does not raise | |||
| different | |||
| questions of | |||
| safety and | |||
| effectiveness |
7. Technological Characteristics
All of the physical and therapeutic attributes for the proposed Nalu Neurostimulation System and the predicate device (K183047) share the same technological characteristics and has no differences that would impact safety or effectiveness.
8. 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 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. Bench testing includes design verification and validation, sterilization validation, and biocompatibility testing. Human factors and usability testing were performed on the device. 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. Therefore, test results from the predicate device (K183047) except for the updated Magnetic Resonance testing remain applicable to the subject device of this 510(k).
Table 2. Applicable Standards and Guidance Documents
The testing for the labeling changes proposed for the Nalu Neurostimulation System includes the following test standards and guidance:
| Standard Number | Title |
|---|---|
| ISO/TS 10974 | Assessment of the safety of magnetic resonance imaging for |
| patients with an active implantable medical device | |
| ISO 14708 | Implant for surgery – Active implantable medical devices – Part |
| 1 and Part 3, General requirements and Implantable | |
| neurostimulator |
8
| ASTM F2052-15 | Standard Test Method for Measurement of Magnetically
Induced Displacement Force on Medical Devices in the
Magnetic Resonance Environment |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| ASTM F2213-17 | Standard Test Method for Measurement of Magnetically
Induced Torque on Medical Devices in the Magnetic Resonance
Environment |
| ASTM F2129-2013 | Standard Test Method for Evaluation of MR Image Artifacts
from Passive Implants |
9. Clinical performance data
Nalu Medical determined that bench and non-clinical testing are sufficient to demonstrate that the Nalu Neurostimulation System is safe and effective as the predicate device.
10. Conclusions
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. Nalu performed testing to support the full body MR scan and the proposed changes in the instructions for use to ensure the safety and effectiveness of the device.