(376 days)
No
The summary does not mention AI, ML, or related terms, and the device description focuses on electrical stimulation and hardware components.
Yes
The device is indicated for "pain management" and provides "therapeutic relief for chronic, intractable pain," directly stating its use for therapy.
No
The device is indicated for pain management and provides therapeutic relief by inhibiting pain signals. It is not used to diagnose a condition or disease.
No
The device description explicitly lists multiple hardware components including an implantable pulse generator, leads, surgical and trial tools, and an externally worn Therapy Disc device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for pain management by stimulating peripheral nerves. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a neurostimulation system that is implanted and delivers electrical current to nerves. This is a physical treatment, not a method for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on sample analysis.
The device is clearly a therapeutic device used for pain management through electrical stimulation of nerves.
N/A
Intended Use / 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.
Product codes
GZF
Device Description
The Nalu Neurostimulation System for Peripheral Nerve Stimulation (also referred to as the "Nalu System") is used for peripheral nerve stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The Nalu System incorporates a miniature implantable pulse generator, powered by an externally worn Therapy Disc device. The Nalu Neurostimulation therapy utilizes pulsed electrical current to create an energy field that acts on the peripheral nerves to inhibit the transmission of pain signals to the brain. The Nalu System may be implanted following a successful trial period using the Nalu Neurostimulation trial system. The Nalu System is comprised of 5 elements:
- Nalu Implantable Pulse Generator (IPG)
- Leads
- Surgical and Trial Tools
- Externally worn Therapy Disc
- Clinician Programmer and Remote Control
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peripheral nerves, excluding craniofacial region
Indicated Patient Age Range
Adults
Intended User / Care Setting
Intended Clinician: Orthopedic, Neurosurgeon, Anesthesiologist
Intended User: Physician, Layperson
Environmental Use: Hospital, 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
Nalu Medical performed a range of testing to gather data supporting the safety and performance of the Nalu 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 Nalu System is designed and tested to ensure that it meets all applicable standards and guidance documents. Bench testing includes design verification and validation, sterilization, 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 (K183579) 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 System includes the following test standards:
- 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 F2119-2013: 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 System is equivalently safe and effective as the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5870 Implanted peripheral nerve stimulator for pain relief.
(a)
Identification. An implanted peripheral nerve stimulator for pain relief is a device that is used to stimulate electrically a peripheral nerve in a patient to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed around a peripheral nerve 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 logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
August 21, 2024
Nalu Medical, Inc. Chelsea Gutierrez Vice President, Quality Assurance and Regulatory Affairs 2320 Faraday Ave. Suite 100 Carlsbad, California 92008
Re: K232415
Trade/Device Name: Nalu Neurostimulation Kit (Integrated 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 cm: Single 8/Dual 8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 cm Kit, 40cm/60cm/ 60cm Trial/ Extension Lead Kits, Patient Kits and Miscellaneous Replacement Kits Regulation Number: 21 CFR 882.5870 Regulation Name: Implanted Peripheral Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: GZF Dated: April 24, 2024 Received: April 24, 2024
Dear Chelsea Gutierrez:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Lauren E. Woodard -S
for Amber Ballard, PhD Assistant Director DHT5B: Division of Neuromodulation and
2
Enclosure
3
Indications for Use
510(k) Number (if known) K232415
Device Name
Nalu Neurostimulation System for Peripheral Nerve Stimulation
Indications for Use (Describe)
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Submission Sponsor
Nalu Medical, Inc. 2320 Faraday Avenue, Suite 100 Carlsbad, CA 92008 Phone: (760) 448-2360 Fax: (760) 448-2377 Contact: Chelsea Gutierrez, Vice President of Regulatory Affairs and Quality Assurance
Date Prepared: May 15, 2024
Device Names and Classification
| Device Identification | ||||
|---|---|---|---|---|
| 510(k) Number | K232415 | |||
| Trade/Proprietary Name | Nalu Neurostimulation System for Peripheral Nerve Stimulation | |||
| Common/Usual Name | Peripheral Nerve Stimulator | |||
| Product Code | GZF; Stimulator, peripheral nerve, implanted (Pain Relief) | |||
| Regulation Number | 21 CFR§882.5870; Implanted peripheral nerve stimulator for pain relief | |||
| Class | Class II | |||
| Neurology | Neurology |
Predicate/Reference Devices
- Predicate Device: Nalu Neurostimulation System for Peripheral Nerve Stimulation (K183579)
- . Reference Device: Nalu Neurostimulation System, 4 Contact PNS System (K191435)
- Reference Device: Nalu Neurostimulation System for Spinal Cord Stimulation (K202274)
Device Description
The Nalu Neurostimulation System for Peripheral Nerve Stimulation (also referred to as the "Nalu System") is used for peripheral nerve stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The Nalu System incorporates a miniature implantable pulse generator, powered by an externally worn Therapy Disc device. The Nalu Neurostimulation therapy utilizes pulsed electrical current to create an energy field that acts on the peripheral nerves to inhibit the transmission of pain signals to the brain. The Nalu System may be implanted following a successful trial period using the Nalu Neurostimulation trial system. The Nalu System is comprised of 5 elements:
5
| 1. | Nalu Implantable
Pulse Generator | The implantable pulse generator (IPG), also referred to as the Implantable
Neurostimulator (INS), provides electrical stimulation pulses that are transmitted
through the leads to the desired peripheral nerve. The IPG is available in two different
implant architectures: an "integrated" system with pre-attached leads and a "ported"
system where leads may be attached, via connector ports. In addition, both of these
versions are available in single or dual lead configurations. The hermetic IPG housing
includes a ceramic enclosure and a feedthrough connected internally to a printed
circuit board assembly. Wires leaving the IPG are encapsulated in polyurethane and a
silicone over mold forms the final biocompatible surface of the IPG for direct patient
tissue contact. |
|----|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Leads | Leads are implantable and are designed to deliver electrical pulses to the peripheral
nerve via an array of eight cylindrical electrodes at the distal end. Leads may be
integrated with or connected to the IPG. Both Trial and Permanent Implant leads are
available for use. The leads use polyurethane insulation with Pt/Ir electrodes. The leads
may be secured in place with the Nalu Lead Anchor. |
| 3. | Surgical and Trial
Tools | Implantation of the Nalu IPG and lead components for Peripheral Nerve Stimulation
(PNS) is performed via standard PNS surgical techniques. The desired implant location
is accessed via needle placement, followed by lead placement through an introducer.
The leads are anchored and the IPG is placed in a subcutaneous pocket. Patient
contacting materials include medical grade stainless steel, thermoplastic elastomers,
ABS, silicone, and Urethane. |
| 4. | Externally worn
Therapy Disc | Two types of Therapy Disc are available, which are also referred to as the External Trial
Stimulator (ETS) and the External Transmitter Module (ETM). One is to be used during
the trial phase (Trial Therapy Disc or ETS), and one is to be used after permanent IPG
implantation (Therapy Disc or ETM). Both devices are worn by the patient using one of
the Nalu-provided options. The Therapy Discs house a rechargeable lithium-ion
battery, and electronics including a microcontroller running software for therapy
control, patient interaction and communication with Nalu's Clinician Programmer and
Remote Control devices. The Therapy Disc used to power and command the implant
does so wirelessly using Radio Frequency (RF) and is held in place by an adhesive clip
applied to the skin or a belt/cuff worn over clothing. |
| 5. | Clinician
Programmer and
Remote Control | A Clinician Programmer Application is provided to configure the Trial Therapy Disc and
Therapy Disc devices during surgery and programming. A Patient Remote Control
Application is available to provide the patient with a convenient secondary option to
control their system in addition to built-in controls on the Therapy Disc. The Clinician
Programming Application runs on an Android tablet and communicates over a secure
Bluetooth Low Energy link with the Trial Therapy Disc and Therapy Disc devices. The
programmer is responsible for configuring the devices to deliver therapy according to
clinician defined levels and patient preferences, and for managing patient and session
records. The Patient Remote Control Application runs on iOS and Android platforms
and offers basic control of the Trial Therapy Disc and Therapy Disc through a secure
Bluetooth Low Energy link. The controls include selecting between clinician-defined
therapy options (programs), turning stimulation on and off, and managing alerts. |
The Nalu System has been previously cleared (K183579) by the FDA 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
6
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.
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.
Substantial Equivalence Comparison
The Indications for Use for the predicate device and subject device are identical. Any differences in the specifications or performance between the devices do not raise any different questions of safety or effectiveness, as demonstrated by performance testing. Thus, the subject device is substantially equivalent to the predicate device.
Testing results included in this submission support the full body MR Conditional Labeling proposed in the instructions for use. There are no other significant differences from the predicate device in these characteristics that would raise different questions of safety or effectiveness.
The following tables compare the Nalu System to the predicate device with respect to intended use, technological characteristics, and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence. Please refer to Table 1 for Substantial Equivalence Table – General and Implanted Components, Table 2 for Substantial Equivalence Table – External Components and Table 3 for Substantial Equivalence Table - Clinician Programmer and Remote Control.
7
| Table 1: Substantial Equivalence Table - General and Implanted Components | |||
|---|---|---|---|
| --------------------------------------------------------------------------- | -- | -- | -- |
| Device | Nalu Neurostimulation System for Peripheral
Nerve Stimulation (Subject Device) | Nalu Neurostimulation System for Peripheral
Nerve Stimulation
(Predicate Device) | Analysis of
Technological
Differences |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K232415 | K183579 | Different. |
| Product Code and
Class | GZF, Class II | GZF, Class II | Same as
predicate. |
| Regulation Number | 21 CFR §882.5870 | 21 CFR §882.5870 | Same as
predicate. |
| Classification Name | Implanted peripheral nerve stimulator for pain
relief. | Implanted peripheral nerve stimulator for pain
relief. | Same as
predicate. |
| Intended Use | Stimulation of peripheral nerves for chronic,
intractable pain | Stimulation of peripheral nerves for chronic,
intractable pain | Same as
predicate. |
| 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 as
predicate. |
| Prescription Use | Yes | Yes | Same as
predicate. |
| Implant Site | Peripheral nerves, excluding craniofacial region | Peripheral nerves, excluding craniofacial region | Same as
predicate. |
| Environmental Use | Hospital, Home | Hospital, Home | Same as
predicate. |
| Intended Clinician | Orthopedic, Neurosurgeon, Anesthesiologist | Orthopedic, Neurosurgeon, Anesthesiologist | Same as
predicate. |
| Intended User | Physician, Layperson | Physician, Layperson | Same as
predicate. |
| Mode of Action | Radiofrequency (RF) wireless transmission of
energy to produce stimulation at stimulator
electrodes. | Radiofrequency (RF) wireless transmission of
energy to produce stimulation at stimulator
electrodes. | Same as
predicate. |
| Labeling | MR Conditional Labeling for Head and Extremities
Full Body
MR Conditional Labeling for Full Body | MR Conditional Labeling for Head and Extremities
Full Body
Do not use RF transmit body coil | Different than
predicate.
Testing included in
this submission
demonstrates the
safety and
compatibility of the |
8
Substantial Equivalence Table - General and Implanted Components Nalu Neurostimulation System for Peripheral Analysis of Nalu Neurostimulation System for Peripheral Nerve Stimulation Device Technological Nerve Stimulation (Subject Device) Differences (Predicate Device) Nalu System for PNS in the Magnetic Resonance (MR) Environment for full body. IPG Dimensions Lead = 1.30 mm diameter Lead = 1.30 mm diameter Same as predicate. IPG = 28 x 11 x 4.9 mm IPG = 28 x 11 x 4.9 mm Housing Material Silicone and Pellethane 2363-55D Silicone and Pellethane 2363-55D Same as predicate. Implant Site Peripheral nerves, excluding craniofacial region Peripheral nerves, excluding craniofacial region Same as predicate. Same as Electrical Embedded receiver, flexible circuit board Embedded receiver, flexible circuit board Components predicate. Power Delivery Coupled receiver radio frequency transmission Coupled receiver radio frequency transmission Same as predicate. Lead Same as Electrode Material Platinum-iridium 90:10 Platinum-iridium 90:10 predicate. Insulation Body Pellethane 2363-55D Pellethane 2363-55D Same as Material predicate. Cable Features Multilumen tube Multilumen tube Same as predicate. Lead Length 40 cm, 60 cm 40 cm, 60 cm Same as predicate. Diameter 1.30 mm 1.30 mm Same as predicate. Electrode Array 52 mm 52 mm Same as Length predicate. No. of Electrodes 8 8 Same as (per lead) predicate. Individual Electrode 3.0 mm 3.0 mm Same as Length predicate. Electrode Spacing 4.0 mm 4.0 mm Same as predicate. 12.25 mm² Electrode Surface 12.25 mm² Same as Area predicate.
Table 1: Substantial Equivalence Table - General and Implanted Components
9
| Substantial Equivalence Table - General and Implanted Components | |||
|---|---|---|---|
| Device | Nalu Neurostimulation System for Peripheral | ||
| Nerve Stimulation (Subject Device) | Nalu Neurostimulation System for Peripheral | ||
| Nerve Stimulation | |||
| (Predicate Device) | Analysis of | ||
| Technological | |||
| Differences | |||
| Lead Extension | Lead extension available | Lead extension available | Same as |
| predicate. | |||
| Lead Anchor | Molded silicone anchor with Ti locking mechanism | Molded silicone anchor with Ti locking mechanism | Same as |
| predicate. | |||
| Configurations | Integrated and with Ports | Integrated and with Ports | Same as |
| predicate. | |||
| Sterilization | Ethylene Oxide | Ethylene Oxide | Same as |
| predicate. |
Table 2: Substantial Equivalence Table – External Components
| Substantial Equivalence Table - External Components | |||
|---|---|---|---|
| Device | Nalu Neurostimulation System (Subject Device) | Nalu Neurostimulation System for PNS | |
| (Predicate Device) | Analysis of | ||
| Technological | |||
| Differences | |||
| Name | Therapy Disc and Trial Therapy Disc | Therapy Disc and Trial Therapy Disc | Same as |
| predicate. | |||
| Electronics | A printed circuit board (PCB) that generates RF | ||
| power with embedded waveform parameter | |||
| settings and buttons for changing parameter | |||
| settings as needed by the user | A printed circuit board (PCB) that generates RF | ||
| power with embedded waveform parameter | |||
| settings and buttons for changing parameter | |||
| settings as needed by the user | Same as | ||
| predicate. | |||
| User Interface | 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 as | ||
| predicate. | |||
| Antenna | |||
| (Therapy Disc only) | Integrated antenna supporting 40.68 MHz power | ||
| and data transfer. | Integrated antenna supporting 40.68 MHz power | ||
| and data transfer. | Same as | ||
| predicate. | |||
| Wearing | |||
| (Therapy Disc only) | Therapy Disc is positioned over Nalu IPG via two | ||
| options: | |||
| • Adhesive clip (hydrocolloid adhesive) | |||
| • Elastic Belt/Cuff | Therapy Disc is positioned over Nalu IPG via two | ||
| options: | |||
| • Adhesive clip (hydrocolloid adhesive) | |||
| • Elastic Belt/Cuff | Same as | ||
| predicate. | |||
| Size/Weight | Disc: ~1. 5 cm thick, 7. 5 cm diameter | ||
| Weight: ~0.08 kg | Disc: ~1. 5 cm thick, 7. 5 cm diameter | ||
| Weight: ~0.08 kg | Same as | ||
| predicate. | |||
| Externally | |||
| contacting | |||
| Materials | Biocompatible PC ABS housing. | ||
| Occasional contact to fingers (e.g., button use). | |||
| Textile material of belt/cuff may be worn over | |||
| clothing. | |||
| Hydrocolloid adhesive applied to skin. | Biocompatible PC ABS housing. | ||
| Occasional contact to fingers (e.g., button use). | |||
| Textile material of belt/cuff may be worn over | |||
| clothing. | |||
| Hydrocolloid adhesive applied to skin. | Same as | ||
| predicate. |
10
Table 2: Substantial Equivalence Table – External Components
| Substantial Equivalence Table - External Components | |||
|---|---|---|---|
| Device | Nalu Neurostimulation System (Subject Device) | Nalu Neurostimulation System for PNS | |
| (Predicate Device) | Analysis of | ||
| Technological | |||
| Differences | |||
| Battery Charging | Electrically isolated cradle charger | Electrically isolated cradle charger | Same as |
| predicate. |
11
Table 3: Substantial Equivalence Table – Clinician Programmer and Remote Control
| Substantial Equivalence Table - Clinician Programmer and Remote Control | |||
|---|---|---|---|
| Device | Nalu Neurostimulation System (Subject Device) | Nalu Neurostimulation System for PNS | |
| (Predicate Device) | Analysis of | ||
| Technological | |||
| Differences | |||
| Clinician Programmer | |||
| Configuration | Software installed on a compatible Android tablet. | Software installed on a compatible Android tablet. | Same as |
| predicate. | |||
| Purpose | Allows healthcare provider to set desired therapy | ||
| levels and device settings across Therapy Disc, | |||
| Trial Therapy Disc, and Patient Remote Control | |||
| devices. | Allows healthcare provider to set desired therapy | ||
| levels and device settings across Therapy Disc, Trial | |||
| Therapy Disc, and Patient Remote Control devices. | Same as | ||
| predicate. | |||
| Communication | Secure Bluetooth to Therapy Disc, Trial Therapy | ||
| Disc, and Patient Remote Control. | Secure Bluetooth to Therapy Disc, Trial Therapy | ||
| Disc, and Patient Remote Control. | Same as | ||
| predicate. | |||
| Patient Remote Control | |||
| Patient Remote | |||
| Control | Software app installed on compatible mobile | ||
| device (Android/iOS) providing wireless selection | |||
| among preconfigured options and status readout | |||
| for paired Therapy Disc and Trial Therapy Disc | |||
| devices. | Software app installed on compatible mobile device | ||
| (Android/iOS) providing wireless selection among | |||
| preconfigured options and status readout for | |||
| paired Therapy Disc and Trial Therapy Disc devices. | Same as | ||
| predicate. |
Table 4: Substantial Equivalence Table – Therapy
| Substantial Equivalence Table - Therapy | |||
|---|---|---|---|
| Device | Nalu Neurostimulation System (Subject Device) | Nalu Neurostimulation System for PNS | |
| (Predicate Device) | Analysis of | ||
| Technological | |||
| Differences | |||
| Pulse Frequency | 2 Hz to 1500 Hz | 2 Hz to 1500 Hz | Same as |
| predicate. | |||
| Pulse Width | 12 to 2000 $μ$ s | 12 to 1000 $μ$ s | No impact to |
| therapy. | |||
| Programming | |||
| changes were | |||
| made as part of | |||
| the software | |||
| update (cleared | |||
| under K203547). | |||
| Current/Voltage | |||
| Regulated | Current | Current | Same as |
| predicate. | |||
| Output Voltage | |||
| (300 Ohms) | 0 to 3.1 V | 0 to 3.1 V | Same as |
| predicate. | |||
| Output Voltage | |||
| (500 Ohms) | 0 to 5.1 V | 0 to 5.1 V | Same as |
| predicate. | |||
| Substantial Equivalence Table - Therapy | |||
| Device | Nalu Neurostimulation System (Subject Device) | Nalu Neurostimulation System for PNS | |
| (Predicate Device) | Analysis of | ||
| Technological | |||
| Differences | |||
| Output Voltage | |||
| (800 Ohms) | 0 to 8.2 V | 0 to 8.2 V | Same as |
| predicate. | |||
| Output Current | |||
| (300 Ohms) | 0 to 10.2 mA | 0 to 10.2 mA | Same as |
| predicate. | |||
| Output Current | |||
| (500 Ohms) | 0 to 10.2 mA | 0 to 10.2 mA | Same as |
| predicate. | |||
| Output Current | |||
| (800 Ohms) | 0 to 10.2 mA | 0 to 10.2 mA | Same as |
| predicate. | |||
| Waveform | charge balanced (delayed) biphasic asymmetrical | charge balanced (delayed) biphasic asymmetrical | Same as |
| predicate. | |||
| Pulse Shape | Decaying Exponential | Decaying Exponential | Same as |
| predicate. | |||
| Maximum phase | |||
| charge (300 Ohms) | 10.2 µC/pulse | 10.2 µC/pulse | Same as |
| predicate. | |||
| Maximum phase | |||
| charge (500 Ohms) | 10.2 µC/pulse | 10.2 µC/pulse | Same as |
| predicate. | |||
| Maximum phase | |||
| charge (800 Ohms) | 10.2 µC/pulse | 10.2 µC/pulse | Same as |
| predicate. | |||
| Maximum charge | |||
| density (300 Ohm) | 83.3 µC/cm² | 83.3 µC/cm² | Same as |
| predicate. | |||
| Maximum charge | |||
| density (500 Ohm) | 83.3 µC/cm² | 83.3 µC/cm² | Same as |
| predicate. | |||
| Maximum charge | |||
| density (800 Ohm) | 83.3 µC/cm² | 83.3 µC/cm² | Same as |
| predicate. | |||
| Maximum current | |||
| density (300 Ohm) | 83.3 mA/cm² | 83.3 mA/cm² | Same as |
| predicate. | |||
| Maximum current | |||
| density (500 Ohm) | 83.3 mA/cm² | 83.3 mA/cm² | Same as |
| predicate. | |||
| Maximum current | |||
| density (800 Ohm) | 83.3 mA/cm² | 83.3 mA/cm² | Same as |
| predicate. | |||
| Net Charge | 0 µC | 0 µC | Same as |
| predicate. | |||
| Average Phase | |||
| Power (300 Ohms) | 0.031 W/phase | 0.031 W/phase | Same as |
| predicate. | |||
| Average Phase | |||
| 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 | 0.25 W/cm²/phase | 0.25 W/cm²/phase | Same as |
| Substantial Equivalence Table - Therapy | |||
| Device | Nalu Neurostimulation System (Subject Device) | Nalu Neurostimulation System for PNS | |
| (Predicate Device) | Analysis of | ||
| Technological | |||
| Differences | |||
| Power density (300 | |||
| Ohms) | 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 | |||
| (advanced | |||
| programming) | 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 | |||
| (advanced | |||
| programming) | Allows for stimulation to be applied in periodic | ||
| doses (On/Off; If On, spans from 1 ms to 25 ms) | Allows for stimulation to be applied in periodic | ||
| doses (On/Off; If On, spans from 1 ms to 25 ms) | Same as | ||
| predicate. | |||
| Daily Therapy Time | Limits the number of hours in a day that | ||
| stimulation may be used (Seconds to hours) | Limits the number of hours in a day that stimulation | ||
| may be used (Seconds to hours) | Same as | ||
| predicate. | |||
| Transmit Frequency | 40.68 MHz | 40.68 MHz | Same as |
| predicate. |
12
13
14
Technological Characteristics
The subject device and the predicate device (K183579) share the same technological characteristics with regard to physical and therapeutic attributes. There are no differences that would impact safety or effectiveness.
Summary of Non-Clinical Performance Testing
Nalu Medical performed a range of testing to gather data supporting the safety and performance of the Nalu 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 Nalu System is designed and tested to ensure that it meets all applicable standards and guidance documents. Bench testing includes design verification and validation, sterilization, 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 (K183579) 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 System includes the following test standards.
| 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 | |
| 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 F2119-2013 | Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants |
Table 5. Applicable Standards
Clinical Performance Data
Nalu Medical determined that bench and non-clinical testing are sufficient to demonstrate that the Nalu System is equivalently safe and effective as the predicate device.
Conclusion
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 characteristics. Nalu performed testing to support the full body MR scan and the proposed changes in the instructions for use were made to ensure the safety and effectiveness of the device.