(98 days)
No
The document describes a neurostimulation system that delivers electrical pulses based on clinician-defined levels and patient preferences, controlled by a microcontroller and software. There is no mention of AI or ML being used for therapy control, data analysis, or any other function.
Yes
The device's intended use and description explicitly state it provides "pain management" and "therapeutic relief for chronic, intractable pain" by inhibiting pain signals.
No
Explanation: The device is indicated for pain management and provides therapeutic relief by delivering electrical pulses to peripheral nerves. It is not described as being used to diagnose a medical condition.
No
The device description clearly outlines multiple hardware components including an implantable pulse generator, leads, surgical tools, and externally worn therapy discs. While software is mentioned as part of the system (Clinician Programmer and Remote Control applications), the device as a whole is not software-only.
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 about a person's health. This testing is performed outside of the body (in vitro).
- Device Function: The Nalu Neurostimulation System is an implantable medical device that directly stimulates peripheral nerves within the body to manage pain. It does not analyze biological samples.
- Intended Use: The intended use clearly states it's for "pain management in adults who have severe intractable chronic pain of peripheral nerve origin." This is a therapeutic application, not a diagnostic one based on in vitro testing.
- Device Description: The description details implanted components (IPG, leads) and external components (Therapy Discs, Programmer, Remote Control) that work together to deliver electrical stimulation to the body, not to analyze samples from the body.
Therefore, the Nalu Neurostimulation System falls under the category of an implantable therapeutic device, not an In Vitro Diagnostic device.
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 thank 30 days) to determine efficacy before recommendation for a permanent (long term) device.
Product codes
GZF
Device Description
The Nalu Neurostimulation System (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 Neurostimulation system incorporates a miniature implanted neurostimulator, powered by an externally worn Therapy Disc device. Similar to the predicate StimQ, 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 Neurostimulation System is comprised of 5 elements:
- Nalu Implantable Pulse Generator: The implantable pulse generator (IPG) 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.
- 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.
- 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.
- Externally worn Therapy Discs: Two types of Therapy Disc are available. One is to be used during the trial phase (Trial Therapy Disc), and one is to be used after permanent IPG implantation (Therapy Disc). 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.
- 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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Nalu Medical determined that bench and non-clinical testing are sufficient to demonstrate that the Nalu Neurostimulation System is as safe and effective as the predicate device. Note that the predicate device did not need clinical evidence to obtain a determination of substantial equivalence.
Verification testing of the Nalu Neurostimulation System included electrical, mechanical and software tests to show that the device met its target specifications over a range of operating and storage conditions. Validation, performance, and usability testing demonstrated that the device met user needs as reflected in the functional specification.
Animal Testing:
In the animal study, six (6) Nalu Neurostimulation IPGs and Lead systems were implanted in a porcine model and evaluated over a period of 90 days. The purpose of the study included: evaluating the surgical usability of the Nalu components, demonstrating the RF communication and ensuing stimulation, observing implanted device stability, and observing tissue response in a live model over the implant time.
All devices performed as expected without incident and together provided pre-clinical validation of the safety and clinical use of the Nalu Neurostimulation System in a live model. There were no device- or procedure-related complications or premature deaths in this study. Data was collected at 30, 60 and 90 day intervals.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K152178, K934065, K883780, K000852
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 two logos. The logo on the left is the Department of Health & Human Services - USA logo, which features a stylized human figure. The logo on the right is the FDA U.S. Food & Drug Administration logo, with the FDA acronym in a blue square and the full name of the administration written in blue text.
March 29, 2019
Nalu Medical, Inc Michele Chin-Purcell, Ph.D. Vice President Regulatory Affairs and Quality Assurance 2320 Faraday Ave.. Suite 100 Carlsbad, CA 92008
Re: K183579
Trade/Device Name: Nalu Neurostimulation System for Peripheral Nerve Stimulation Regulation Number: 21 CFR 882.5870 Regulation Name: Implanted Peripheral Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: GZF Dated: February 26, 2019 Received: February 27, 2019
Dear Michele Chin-Purcell:
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/cdr/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal 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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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-S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K183579
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 thank 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
5.1. Submission Sponsor
Nalu Medical, Incorporated 2320 Faraday Ave., Suite 100 Carlsbad, CA 92008 Phone: (760) 448-2360 Fax: (760) 448-2377 Contact: Michele Chin-Purcell, Vice President of Regulatory Affairs and Quality Assurance
5.2. Date Prepared
March 22, 2019
5.3. Device Identification
Trade/Proprietary Name: Nalu Neurostimulation System for Peripheral Nerve Stimulation Common/Usual Name: Peripheral Nerve Stimulator Product Code: GZF Regulation number: 21 CFR 882.5870: Stimulator, peripheral nerve, implanted (Pain Relief) Class: Class II Device Classification Panel: Neurology
5.4. Legally Marketed Predicate Device(s)
StimQ Peripheral Nerve Stimulator (PNS) System (K171366) by StimQ LLC Hereafter, also referred to as the StimQ PNS System or StimQ
For areas where slight differences occur between the Nalu Neurostimulation system and the primary predicate (K171366), substantial equivalence to other reference devices in this same product code is demonstrated. These reference devices were used as part of the predicate history to the primary predicate in this submission. The history of the predicates is summarized in Table 5-1:
| Device | 510(k) | Predicate(s) used for clearance |
|---|---|---|
| StimQ Peripheral Nerve | ||
| Stimulator (PNS) System | K152178 | Stimwave Freedom SCS (K150517) |
| Medtronic Mattrix 3271/3272 (K934065) | ||
| Medtronic Xtrel, 3425 (K883780) | ||
| ANS Renew (K000852) | ||
| StimQ Peripheral Nerve | ||
| Stimulator (PNS) System | ||
| (Primary Predicate) | K171366 | K152178 |
4
The 510(k) history of the StimQ system includes design changes over time. The original Medtronic and ANS devices are part of the predicate history of the StimQ device and are also used as references devices in this 510(k).
5.5. Device Description
The Nalu Neurostimulation System (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 Neurostimulation system incorporates a miniature implanted neurostimulator, powered by an externally worn Therapy Disc device. Similar to the predicate StimQ, 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 Neurostimulation System is comprised of 5 elements:
| 1. | Nalu
Implantable
Pulse
Generator | The implantable pulse generator (IPG) 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 | Two types of Therapy Disc are available. One is to be used during
the trial phase (Trial Therapy Disc), and one is to be used after
permanent IPG implantation (Therapy Disc). Both devices are worn
by the patient using one of the Nalu-provided options The Therapy |
5
| Therapy
Discs | 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. |
Indications for Use Statement 5.6.
"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. "
The Indications for Use statement for the Nalu Neurostimulation System is not identical to the predicate device; however, the differences do not alter the intended therapeutic use of the device nor do they affect the safety and effectiveness of the device relative to the predicate. Both the subject and predicate devices have the same intended use for the stimulation of peripheral nerves for treatment of chronic, intractable pain.
5.7. Substantial Equivalence Discussion
The following tables compare the Nalu Neurostimulation System to the predicate device with respect to intended use, technological characteristics and principles of operation,
6
providing more detailed information regarding the basis for the determination of substantial equivalence.
7
Table 5-2: Substantial Equivalence Table – General and Implanted Components
| | Nalu Neurostimulation System
(Subject Device) | StimQ PNS
System
(Primary
Predicate) | StimQ PNS
System
(Reference
Device) | Medtronic
Mattrix
3271/3272
(Reference
Device) | Medtronic
Xtrel 3425
(Reference
Device) | ANS Renew
(Reference Device) | Analysis of
Technological
Differences from
Primary Predicate |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|---------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| 510(k) | K183579 | K171366 | K152178 | K934065 | K883780 | K000852 | NA |
| Product Code
and class | GZF, Class II | Same | Same | GZF and GZB | GZB | GZF and GZB | Same |
| Regulation
number | 21 CFR §882.5870 | Same | Same | Same, plus 21
CFR 882.5880 | Same | Same, plus 21 CFR
§882.5880 | Same |
| Classification
name | Stimulator, Peripheral Nerve,
Implanted (pain relief) | Same | Same | Same plus
Stimulator,
Spinal Cord,
Implanted (Pain
Relief) | Same | Same plus
Stimulator, Spinal
Cord, Implanted
(Pain Relief) | Same |
| Intended Use | Stimulation of peripheral nerves
for chronic, intractable pain | Same | Same | Same, plus
Stimulation of
spinal cord for
chronic,
intractable pain | Same | Same, plus
Stimulation of spinal
cord for 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 StimQ Peripheral Nerve
Stimulator (PNS) 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
StimQ PNS System is not | | Indicated as an aide in the
management of chronic,
intractable pain of the trunk or
limbs | | Indicated for the
treatment of chronic
pain of trunk and
limbs, either as the
sole mitigating
agent, or as an
adjunct to other
modes of therapy
used in a | Differences do not
affect safety and
effectiveness of
intended use |
| | Nalu Neurostimulation System
(Subject Device) | StimQ PNS
System
(Primary
Predicate) | StimQ PNS
System
(Reference
Device) | Medtronic
Mattrix
3271/3272
(Reference
Device) | Medtronic
Xtrel 3425
(Reference
Device) | ANS Renew
(Reference Device) | Analysis of
Technological
Differences from
Primary Predicate |
| | The trial devices are solely used
for trial stimulation (no longer
than 30 days) to determine
efficacy before recommendation
for a permanent (long term)
device. for a permanent (long
term) device. | intended to treat pain in the
craniofacial region.
The StimQ Trial Lead Kit is only
used in conjunction with the
StimQ Stimulator Receiver Kit.
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. | | | | multidisciplinary
approach. | |
| Prescription
Use? | Yes | Same | Same | Same | Same | Same | Same |
| Implant site | Peripheral nerves, excluding
craniofacial region | Same | Same | Same | Same | Same | Same |
| Environmental
Use | Hospital, Home | Same | Same | Same | Same | Same | Same |
| Intended
Clinician | Orthopedic, Neurosurgeon,
Anesthesiologist | Same | Same | Same | Same | Same | Same |
| Intended User | Physician, Layperson | Same | Same | Same | Same | Same | Same |
| Mode of Action | Radio Frequency (RF) wireless
transmission of energy to
produce stimulation at stimulator
electrodes. | Same | Same | Same | Same | Same | Same |
| Software Level
of Concern | Moderate | Moderate | Moderate | Unreported | Unreported | Moderate | Same |
| | Nalu Neurostimulation
System
(Subject Device) | StimQ PNS System
(K171366)
(Primary Predicate) | StimQ PNS System
(K152178)
(Reference
Device) | Medtronic
Mattrix
3271/3272
(K934065)
(Reference
Device) | Medtronic
Xtrel 3425
(K883780)
(Reference
Device) | ANS Renew
(K000852)
(Reference
Device) | Analysis of
Technological
Differences from
Primary
Predicate |
| IPG | | | | | | | |
| Dimensions | Lead = 1.30 mm diameter
IPG = 28 x 11 x 4.9 mm | Integrated with lead body,
1.35 mm diameter | Integrated with
lead body, 1.35
mm diameter | Details unavailable. See Section 12.2.1 below | | | Differences do
not affect safety
and effectiveness
of intended use |
| Housing
material | Silicone and Pellethane
2363-55D | Pellethane 2363-55D | Pellethane 2363-
55D | Details unavailable. See Section 12.2.1 below | | | Differences do
not affect safety
and effectiveness
of intended use |
| Implant site | Peripheral nerves,
excluding craniofacial
region | Same | Same | Same | Same | Same | Same |
| Electrical
components | Embedded receiver,
flexible circuit board | Same | Same | Sealed
electronic
circuits | Sealed
electronic
circuits | Sealed
electronic
circuits | Same |
| Power Delivery | Coupled receiver radio
frequency transmission | Same | Same | Same | Same | Coupled
receiver,
hardwired
with
connector | Same |
| Lead | | | | | | | |
| Electrode
Material | Platinum-iridium 90:10 | Same | Same | Same | Same | Same | Same |
| Insulation Body
Material | Pellethane 2363-55D | Same | Same | Same | Same | Same | Same |
| Cable features | Multilumen tube | Same | Same | Coiled Wires | Coiled Wires | Braided Wire | Same |
| | Nalu Neurostimulation
System
(Subject Device) | StimQ PNS System
(K171366)
(Primary Predicate) | StimQ PNS System
(K152178)
(Reference
Device) | Medtronic
Mattrix
3271/3272
(K934065)
(Reference
Device) | Medtronic
Xtrel 3425
(K883780)
(Reference
Device) | ANS Renew
(K000852)
(Reference
Device) | Analysis of
Technological
Differences from
Primary
Predicate |
| Lead length | 40 cm, 60 cm | 44 cm | 45 cm | 30 to 110 cm | 30 to 110 cm | 30 and 60 cm | Differences do
not affect safety
and effectiveness
of intended use |
| Diameter | 1.30 mm | 1.35 mm | 1.35 mm | 1.3 mm | 1.3 mm | 1.37 mm | Differences do
not affect safety
and effectiveness
of intended use |
| Electrode Array
length | 52 mm | 24 mm (FRE-4)
52 mm (FRE-8) | 24 mm | 24 mm | 24 mm | 24 mm | Differences do
not affect safety
and effectiveness
of intended use |
| No. of
Electrodes, per
lead | 8 | 4 (FRE-4)
8 (FRE-8) | 4 | Same | Same | 4 or 8 | Differences do
not affect safety
and effectiveness
of intended use |
| Individual
Electrode
length | 3.0 mm | Same | Same | Same | Same | Same | Same |
| Electrode
spacing | 4.0 mm | Same | Same | Same | Same | Same | Same |
| Electrode
surface area | 12.25 mm² | 12.72 mm² | 12.72 mm² | 12.25 mm² | 12.25 mm² | ~13 mm² | Differences do
not affect safety
and effectiveness
of intended use |
| Lead extension | Lead extension available | NA | NA | Lead extension
available | Lead extension
available | Lead
extension
available | Differences do
not affect safety
and effectiveness
of intended use |
| | Nalu Neurostimulation
System
(Subject Device) | StimQ PNS System
(K171366)
(Primary Predicate) | StimQ PNS System
(K152178)
(Reference
Device) | Medtronic
Mattrix
3271/3272
(K934065)
(Reference
Device) | Medtronic
Xtrel 3425
(K883780)
(Reference
Device) | ANS Renew
(K000852)
(Reference
Device) | Analysis of
Technological
Differences from
Primary
Predicate |
| Lead Anchor | Molded silicone anchor
with Ti locking mechanism | Suture Sleeve Cap,
Pellethane 55-D, placed
over proximal end of
stimulator | Suture Sleeve Cap,
Pellethane 55-D,
placed over
proximal end of
stimulator | Molded silicone
anchor | Molded
silicone anchor | Molded
silicone
anchor | Differences do
not affect safety
and effectiveness
of intended use |
| Configurations | Integrated and with Ports | Integrated | Integrated | With Ports | With Ports | With Ports | Differences do
not affect safety
and effectiveness
of intended use |
| Sterilization | Ethylene Oxide | Same | Same | Same | Same | Same | Same |
8
9
10
11
Table 5-3: Substantial Equivalence Table – Therapy
12
| Comparator | Nalu
Neurostimulation
System
(Subject Device) | StimQ PNS System
(K171366)
(Primary Predicate) | StimQ PNS System
(K152178)
(Reference Device) | Medtronic Mattrix
3271/3272
(K934065)
(Reference Device) | Medtronic
Xtrel 3425
(K883780)
(Reference
Device) | ANS Renew
(K000852)
(Reference
Device) | Analysis of
Technological
Differences from
Primary Predicate |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|-----------------------------------------------------|-------------------------------------------------------------------|---------------------------------------------------------------|-------------------------------------------------|-----------------------------------------------------------------------------|
| Pulse Frequency | 2 Hz to 1500 Hz1 | 5 to 1500 Hz | 5 Hz to 1500 Hz | 5 to 240 Hz | 5 to 1400 Hz | 10 to 1500 Hz | Differences do not
affect safety and
effectiveness of
intended use |
| Pulse Width | 12 to 1000 µs | 50 to 500 µs | 50 to 500 µs | 50 to 500 µs | 50 to 1000 µs | 50 to 500 µs | Differences do not
affect safety and
effectiveness of
intended use |
| Current/Voltage
Regulated | Current | Current | Current | Voltage | Voltage | Current | Same |
| Output Voltage
(300 Ohms) | 0 to 3.1 V | 0 to 4.1 V | 0 to 6.3 V | 0 to 7 V | 0 to 5.4 V | 0 to 5.7 V | Differences do not
affect safety and
effectiveness of
intended use |
| Output Voltage
(500 Ohms) | 0 to 5.1 V | 0 to 6.4 V | 0 to 7.2 V | 0 to 10.8 V | 0 to 7.1 V | 0 to 7.6 V | Differences do not
affect safety and
effectiveness of
intended use |
| Output Voltage
(800 Ohms) | 0 to 8.2 V | 0 to 7.5 V | 0 to 8.0 V | 0 to 11.6 V | 0 to 8.4 V | 0 to 9.6 V | Differences do not
affect safety and
effectiveness of
intended use |
| Output Current
(300 Ohms) | 0 to 10.2 mA | 0 to 13.5 mA | 0 to 21 mA | 0 to 23.3 mA | 0 to 18.0 mA | 0 to 19.0 mA | Differences do not
affect safety and
effectiveness of
intended use |
| Comparator | Nalu
Neurostimulation
System
(Subject Device) | StimQ PNS System
(K171366)
(Primary Predicate) | StimQ PNS System
(K152178)
(Reference Device) | Medtronic Mattrix
3271/3272
(K934065)
(Reference Device) | Medtronic
Xtrel 3425
(K883780)
(Reference
Device) | ANS Renew
(K000852)
(Reference
Device) | Analysis of
Technological
Differences from
Primary Predicate |
| Output Current
(500 Ohms) | 0 to 10.2 mA | 0 to 12.8 mA | 0 to 15 mA | 0 to 21.6 mA | 0 to 14.2 mA | 0 to 15.2 mA | Differences do not
affect safety and
effectiveness of
intended use |
| Output Current
(800 Ohms) | 0 to 10.2 mA | 0 to 9.4 mA | 0 to 10 mA | 0 to 14.5 mA | 0 to 10.5 mA | 0 to 12.0 mA | Differences do not
affect safety and
effectiveness of
intended use |
| Waveform | charge balanced
(delayed) biphasic
asymmetrical | Same | Same | Same | Same | Same | Same |
| Pulse Shape | Decaying
Exponential | Decaying
Exponential | Decaying
Exponential | Decaying
Exponential | Decaying
Exponential | Decaying
Exponential | Same |
| Maximum phase
charge (300 Ohms) | 10.2 µC/pulse | 6.8 µC/pulse | 10.5 µC/pulse | 11.7 µC/pulse | 18.0 µC/pulse | 9.5 µC/pulse | Differences do not
affect safety and
effectiveness of
intended use |
| Maximum phase
charge (500 Ohms) | 10.2 µC/pulse | 6.4 µC/pulse | 7.2 µC/pulse | 10.8 µC/pulse | 14.2 µC/pulse | 7.6 µC/pulse | Differences do not
affect safety and
effectiveness of
intended use |
| Maximum phase
charge (800 Ohms) | 10.2 µC/pulse | 4.7 µC/pulse | 5.0 µC/pulse | 7.3 µC/pulse | 10.5 µC/pulse | 6.0 µC/pulse | Differences do not
affect safety and
effectiveness of
intended use |
| Maximum charge
density (300 Ohm) | 83.3 µC/cm² | 53.1 µC/cm² | 82.5 µC/cm² | 97.2 µC/cm² | 150.0 µC/cm² | 73.1 µC/cm² | Differences do not
affect safety and
effectiveness of
intended use |
| Comparator | Nalu
Neurostimulation
System
(Subject Device) | StimQ PNS System
(K171366)
(Primary Predicate) | StimQ PNS System
(K152178)
(Reference Device) | Medtronic Mattrix
3271/3272
(K934065)
(Reference Device) | Medtronic
Xtrel 3425
(K883780)
(Reference
Device) | ANS Renew
(K000852)
(Reference
Device) | Analysis of
Technological
Differences from
Primary Predicate |
| Maximum charge
density (500 Ohm) | 83.3 µC/cm² | 50.3 µC/cm² | 56.6 µC/cm² | 90.0 µC/cm² | 118.3 µC/cm² | 58.5 µC/cm² | Differences do not
affect safety and
effectiveness of
intended use |
| Maximum charge
density (800 Ohm) | 83.3 µC/cm² | 36.9 µC/cm² | 39.3 µC/cm² | 60.4 µC/cm² | 87.5 µC/cm² | 46.2 µC/cm² | Differences do not
affect safety and
effectiveness of
intended use |
| Maximum current
density (300 Ohm) | 83.3 mA/cm² | 106.1 mA/cm² | 165.1 mA/cm² | 194.4 mA/cm² | 150.0
mA/cm² | 146.2 mA/cm² | Differences do not
affect safety and
effectiveness of
intended use |
| Maximum current
density (500 Ohm) | 83.3 mA/cm² | 100.6 mA/cm² | 113.2 mA/cm² | 180.0 mA/cm² | 118.3
mA/cm² | 116.9 mA/cm² | Differences do not
affect safety and
effectiveness of
intended use |
| Maximum current
density (800 Ohm) | 83.3 mA/cm² | 73.9 mA/cm² | 73.9 mA/cm² | 120.8 mA/cm² | 87.5 mA/cm² | 92.3 mA/cm² | Differences do not
affect safety and
effectiveness of
intended use |
| Net Charge | 0 uC | Same | Same | Same | Same | Same | Same |
| Average Phase
Power (300 Ohms) | 0.031 W/phase | 0.053 W/phase | 0.060 W/phase | 0.132 W/phase | 0.068
W/phase | 0.070 W/phase | Differences do not
affect safety and
effectiveness of
intended use |
| Average Phase
Power (500 Ohms) | 0.052 W/phase | 0.073 W/phase | 0.076 W/phase | 0.166 W/phase | 0.074
W/phase | 0.090 W/phase | Differences do not
affect safety and
effectiveness of
intended use |
| Average Phase
Power (800 Ohms) | 0.083 W/phase | 0.062 W/phase | 0.060 W/phase | 0.131 W/phase | 0.066
W/phase | 0.100 W/phase | Differences do not
affect safety and
effectiveness of
intended use |
| Comparator | Nalu
Neurostimulation
System
(Subject Device) | StimQ PNS System
(K171366)
(Primary Predicate) | StimQ PNS System
(K152178)
(Reference Device) | Medtronic Mattrix
3271/3272
(K934065)
(Reference Device) | Medtronic
Xtrel 3425
(K883780)
(Reference
Device) | ANS Renew
(K000852)
(Reference
Device) | Analysis of
Technological
Differences from
Primary Predicate |
| Average Phase
Power density (300
Ohms) | 0.25 W/cm²/phase | 0.42 W/cm²/phase | 0.48 W/cm²/phase | 1.10 W/cm²/phase | 0.57
W/cm²/phase | 0.54
W/cm²/phase | Differences do not
affect safety and
effectiveness of
intended use |
| Average Phase
Power density (500
Ohms) | 0.51 W/cm²/phase | 0.58 W/cm²/phase | 0.59 W/cm²/phase | 1.38 W/cm²/phase | 0.62
W/cm²/phase | 0.69
W/cm²/phase | Differences do not
affect safety and
effectiveness of
intended use |
| Average Phase
Power density (800
Ohms) | 0.55 W/cm²/phase | 0.48 W/cm²/phase | 0.60 W/cm²/phase | 1.09 W/cm²/phase | 0.55
W/cm²/phase | 0.77
W/cm²/phase | Differences do not
affect safety and
effectiveness of
intended use |
| Pulse Delivery
Mode | Continuous | Same | Same | Same | Same | Same | Same |
| Current Path
options | Bipolar | Bipolar | Bipolar | Bipolar | Bipolar | Bipolar | Same |
| Program Cycle | Cycle through
programs | Same | Details unavailable | Details unavailable | Details
unavailable | Details
unavailable | Same |
| Pulse Pattern | Fine tuning of pulse
patterns
(On/Off; If On, spans
from 12 μs to 1000
μs) | Same (over span of
1 sec) | Details unavailable | Details unavailable | Details
unavailable | Details
unavailable | Same |
| Dosage Time | Allows for
stimulation to be
applied in periodic
doses (On/Off; If
On, spans from 1 ms
to 25 ms) | Same (over span of
several minutes,
hours, and up to
one day) | Details unavailable | Same (Cycle
ON/OFF) | Same (Cycle
ON/OFF) | Details
unavailable | Differences do not
affect safety and
effectiveness of
intended use |
| Comparator | Nalu
Neurostimulation
System
(Subject Device) | StimQ PNS System
(K171366)
(Primary Predicate) | StimQ PNS System
(K152178)
(Reference Device) | Medtronic Mattrix
3271/3272
(K934065)
(Reference Device) | Medtronic
Xtrel 3425
(K883780)
(Reference
Device) | ANS Renew
(K000852)
(Reference
Device) | Analysis of
Technological
Differences from
Primary Predicate |
| Daily Therapy Time | Limits the number of
hours in a day that
stimulation may be
used
(Seconds to hours) | Same (hours) | Details unavailable | Details unavailable | Details
unavailable | Details
unavailable | Differences do not
affect safety and
effectiveness of
intended use |
| Transmit
Frequency | 40.68 MHz | 915 MHz | 915 MHz | 2 MHz | 1.6 MHz | 2 MHz | Differences do not
affect safety and
effectiveness of
intended use |
1 Pulse Frequency range from 2 Hz to 1500 Hz available in the Stimwave Freedom SCS System (K141399), which was part of the Primary Predicate StimQ PNS System K171366.
13
14
15
16
17
| | Nalu Neurostimulation System
(Subject Device) | StimQ Peripheral Nerve
Stimulator (PNS) System
(K171366)
(Predicate) | Analysis of Technological
Differences |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Externally worn devices | | | |
| Name | Therapy Disc and Trial Therapy
Disc | Wearable Antenna Assembly
(WAA) | NA |
| 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 |
| 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 |
| Antenna
(Therapy Disc
only) | Integrated antenna supporting
40.68 MHz power and data
transfer. | Transmitting (Tx) Antenna
Assembly, 915 MHz – An
antenna and coaxial cable
assembly that is attached to the
WAA that is used to transmit
microwave energy to the
implanted Stimulator. | Differences do not affect
safety and effectiveness
of intended use |
| Wearing
(Therapy Disc
only) | Therapy Disc is positioned over
Nalu IPG via two options:
• Adhesive clip (hydrocolloid
adhesive)
• Elastic Belt/Cuff | SWAG Accessory Kit
Antenna positioned over device
with wearable unit to fit
different extremities | Differences do not affect
safety and effectiveness
of intended use |
| Size/Weight | Disc: ~1.5 cm thick, 7.5 cm
diameter
Weight: ~0.08 kg | 7.6 cm x 5 cm x 2 cm
0.5 kg
(Estimates based on available
information) | Differences do not affect
safety and effectiveness
of intended use |
| 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. | Silicone and Aluminum (not to
be worn on body).
Occasional contact to fingers
(e.g. button use).
Textile material of belt may be
worn directly on the skin.
No adhesive option reported. | Differences do not affect
safety and effectiveness
of intended use |
| Table 5-4: Substantial Equivalence Table - External components | |
|---|---|
| ---------------------------------------------------------------- | -- |
18
| | Nalu Neurostimulation System
(Subject Device) | StimQ Peripheral Nerve
Stimulator (PNS) System
(K171366)
(Predicate) | Analysis of Technological
Differences |
|---------------------|--------------------------------------------------|-------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Battery
Charging | Electrically isolated cradle
charger | A battery and wire assembly for
charging and for power delivery | Differences do not affect
safety and effectiveness
of intended use |
Table 5-5: Substantial Equivalence Table – Clinician Programmer and Remote Control
| | Nalu Neurostimulation System
(Subject Device) | StimQ Peripheral Nerve
Stimulator (PNS) System
(K171366)
(Predicate) | Analysis of
Technological
Differences |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Clinician Programmer | | | |
| Configuration | Software installed on a
compatible Android tablet. | Software installed on an iPad | Differences do not
affect safety and
effectiveness of
intended use |
| 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 | Same |
| Communication | Secure Bluetooth to Therapy Disc,
Trial Therapy Disc, and Patient
Remote Control. | Bluetooth | Differences do not
affect safety and
effectiveness of
intended use |
| 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. | NA | Differences do not
affect safety and
effectiveness of
intended use |
All of the physical and therapeutic attributes for the Nalu Neurostimulation System are within or equivalent to the parameters seen in the predicate and reference devices. There are no significant differences in these characteristics that would raise different questions of safety or effectiveness.
The Nalu Neurostimulation System includes a few features that are different from the predicate as listed below:
- . Differences in surgical tools and components above are a reflection of the subtly different insertion techniques between Nalu and the various predicate devices.
- . The Nalu Neurostimulation System comes with an adhesive wearable option that is not provided with the primary predicate but is provided with referenced
19
predicate devices such as the Medtronic XTREL, K883780. The approach allows for reliable positioning of the external transmitter module over the Nalu IPG device.
- . The Nalu Neurostimulation programming system's Therapy Discs provide the same physical controls as the predicate's SWAG. An added feature to the Nalu Neurostimulation System is the option of a mobile app replicating these same controls through a smartphone interface. No clinical programming functions are available through the Patient Remote Control Application. The Patient Remote Control Application cannot alter the state of the Therapy Disc or Trial Therapy Disc from the state configured by the Clinician Programmer.
ર .8. 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 planned, defined, evaluated, transferred to production, and ongoing changes are reviewed for impact on safety and effectiveness and 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 also performed on the device. Validation and performance testing demonstrate that the device meets user needs as reflected in the functional specification.
5.8.1 Applicable Standards and Guidance Documents
The testing for the Nalu Neurostimulation System includes the following test standards and guidance:
| Standard Number | Title |
|---|---|
| ISO 14708-1:2014 | Implants for surgery — Active implantable medical devices — Part 1: |
| General requirements for safety, marking and for information to be | |
| provided by the manufacturer | |
| ISO 14708-3:2017 | Implants for surgery — Active implantable medical devices — Part 3: |
| Implantable neurostimulators | |
| IEC 60601-1:2005: A2012 | Medical electrical equipment — Part 1: General requirements for basic |
| safety and essential performance | |
| IEC 60601-1-11:2015 | Medical electrical equipment — Part 1-11: General requirements for basic |
| safety and essential performance — Collateral Standard: Requirements for | |
| medical electrical equipment and medical electrical systems used in the | |
| home healthcare environment |
Table 5-6: Standards and Guidance Documents
20
| Standard Number | Title |
|---|---|
| IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for basic |
| safety and essential performance - Collateral Standard: Electromagnetic | |
| disturbances - Requirements and tests | |
| IEC 60601-1-6:2010 | |
| +A1:2013 | Medical electrical equipment - Part 1-6: General requirements for basic |
| safety and essential performance - Collateral Standard: Usability | |
| IEC 62366-1:2015 | Medical Devices - Part 1: Application of usability engineering to medical |
| devices | |
| ISO 10993-1:2009 | Biological evaluation of medical devices - Part 1: Evaluation and testing |
| within a risk management process | |
| IEC 62304:2015 | Medical device software - Software life cycle processes |
| EN ISO 14971:2012 | Medical devices - Application of risk management to medical devices |
| ISO 14971:2007 | Medical devices - Application of risk management to medical devices |
| ISO 11607-1:2006/Amd | |
| 1:2014 and -2:2006/Amd | |
| 1:2014 | Packaging for terminally sterilized medical devices - Part 1: Requirements |
| for materials, sterile barrier systems and packaging systems, Part 2: | |
| Validation requirements for forming, sealing and assembly processes | |
| ISO 11135-1:2014 | Sterilization of health-care products - Ethylene oxide - Requirements for |
| the development, validation and routine control of a sterilization process | |
| for medical devices | |
| CISPR 11 | Industrial, scientific and medical equipment - Radio-frequency disturbance |
| characteristics - Limits and methods of measurement | |
| FDA Guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices | |
| issued October 2, 2014 | |
| FDA Guidance: Applying Human Factors and Usability Engineering to Medical Devices issued February | |
| 3, 2016 |
5.8.2 Biocompatibility testing
The biocompatibility testing followed the International Standard ISO 10993-1: 2009 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process," as well as Guidance for Industry and Food and Drug Administration Staff Document entitled "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process," issued on: June 16, 2016.
Biocompatibility testing was based upon the categorization of the different bodycontacting components and duration of the Nalu Neurostimulation system. The categories are based upon the following classifications, per the FDA guidance:
- Implant Device, in Tissue, permanent contact duration (>30 days): Nalu IPG, Leads, ● Lead Anchor, Lead Extension
21
- . Externally Communicating Device, in Tissue, limited contract duration (≤24 hours): Needles, Sheaths and other surgical tools
- Surface Device, intact skin contact, permanent duration (>30 days): Therapy Discs, ● Adhesive clip
Testing included: cytotoxicity, sensitization, irritation or intracutaneous reactivity, systematic toxicity, implant studies, and chemical characterization. Biocompatibility was demonstrated.
5.8.3 Animal Testing
In the animal study, six (6) Nalu Neurostimulation IPGs and Lead systems were implanted in a porcine model and evaluated over a period of 90 days. The purpose of the study included: evaluating the surgical usability of the Nalu components, demonstrating the RF communication and ensuing stimulation, observing implanted device stability, and observing tissue response in a live model over the implant time.
All devices performed as expected without incident and together provided pre-clinical validation of the safety and clinical use of the Nalu Neurostimulation System in a live model. There were no device- or procedure-related complications or premature deaths in this study. Data was collected at 30, 60 and 90 day intervals.
5.8.4 Summary of Nonclinical Performance Testing
Verification testing of the Nalu Neurostimulation System included electrical, mechanical and software tests to show that the device met its target specifications over a range of operating and storage conditions. Validation, performance, and usability testing demonstrated that the device met user needs as reflected in the functional specification.
5.9. Clinical Performance Data
Nalu Medical determined that bench and non-clinical testing are sufficient to demonstrate that the Nalu Neurostimulation System is as safe and effective as the predicate device. Note that the predicate device did not need clinical evidence to obtain a determination of substantial equivalence.
5.10. Conclusions
The bench and non-clinical data support the safety of the device and the hardware and the software verification and validation demonstrated that the Nalu Neurostimulation System performs as intended in the specified use conditions and the results of which do not raise different questions of safety and effectiveness.