(99 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on electrical stimulation and hardware modifications.
Yes.
The device is used for pain management to provide therapeutic relief for chronic, intractable pain.
No
The system is described as providing therapeutic relief for chronic, intractable pain, which is a treatment function, not a diagnostic one. While a trial period is mentioned to determine efficacy, this is for treatment planning, not for diagnosing a condition.
No
The device description clearly states the system incorporates a miniature implanted neurostimulator and an externally worn Therapy Disc device, which are hardware components. The submission is for adding different lead options to this existing hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this system is a neurostimulation system used for pain management by applying electrical current to peripheral nerves. It is an implanted device that directly interacts with the body.
- Intended Use: The intended use is for managing chronic pain, not for diagnosing or monitoring a condition through analysis of bodily samples.
The device description and intended use clearly place this device in 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 than 30 days) to determine efficacy before recommendation for a permanent (long term) device.
Product codes
GZF
Device Description
This submission will add 4 stimulation contact options to the predicate Nalu Neurostimulation System (also referred to as the "Nalu PNS System"). The Nalu PNS System is used for peripheral nerve stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The Nalu PNS System incorporates a miniature implanted neurostimulator, 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 PNS System may be implanted following a successful trial period using the Nalu PNS trial system.
The leads that were cleared with the Nalu PNS System featured 8 stimulation contacts. This submission will provide an optional use of leads with 4 stimulation contacts.
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 a single pre-attached lead (available in two lengths) and a "ported" system where a single lead (available in two effective lengths) may be attached, via connector ports. 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 are implantable and are designed to deliver electrical pulses to the peripheral nerve via an array of four cylindrical electrodes at the distal end. Leads may be integrated with or connected to the IPG. The leads use polyurethane insulation with Pt/Ir electrodes. The leads are secured in place with tines designed into the lead body. A 4 contact Lead Extension is also available which connects to the proximal end of the lead to extend the lead subcutaneously.
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)
Nonclinical Performance Testing: Nalu Medical performed a range of testing to gather data supporting the safety and performance of the 4 Contact PNS 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, 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.
Summary of Nonclinical Performance Testing: Verification testing of the 4 Contact PNS System included electrical and mechanical 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.
Clinical Performance Data: Nalu Medical determined that bench and non-clinical testing are sufficient to demonstrate that the 4 Contact PNS System is as safe and effective as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Nalu Neurostimulation System for Peripheral Nerve Stimulation (K183579)
Reference Device(s)
StimQ Peripheral Nerve Stimulator (PNS) System (K152178), StimQ Peripheral Nerve Stimulator (PNS) System (K171366), Medtronic Mattrix 3271/3272 (K934065), Medtronic Xtrel 3425 (K883780)
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
September 6, 2019
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Nalu Medical, Inc. Michele Chin-Purcell VP Regulatory Affairs and Quality Assurance 2320 Faraday Ave. Suite 100 Carlsbad, California 92008
Re: K191435
Trade/Device Name: IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4 Regulation Number: 21 CFR 882.5870 Regulation Name: Implanted Peripheral Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: GZF Dated: August 5, 2019 Received: August 7, 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/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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,
Robert Kang, PharmD Acting Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191435
Device Name Nalu Neurostimulation System for PNS
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) |
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3
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
Date Prepared
August 30, 2019
Device Identification
Trade/Proprietary Name: Nalu Neurostimulation System, 4 Contact PNS System 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
Legally Marketed Predicate Device(s)
Nalu Neurostimulation System for Peripheral Nerve Stimulation (K183579)
For areas where slight differences occur between the Nalu Neurostimulation system and the primary predicate (K183579), 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 below:
Predicate history of the proposed primary predicate
| Device | 510(k) | Predicate(s) used for clearance |
|---|---|---|
| StimQ Peripheral Nerve | ||
| Stimulator (PNS) System | ||
| (Reference Devices) | K152178 | Stimwave Freedom SCS (K150517) |
| Medtronic Mattrix 3271/3272 (K934065) | ||
| Medtronic Xtrel, 3425 (K883780) | ||
| StimQ Peripheral Nerve | ||
| Stimulator (PNS) System | ||
| (Reference Devices) | K171366 | K152178 |
| Nalu Neurostimulation System | ||
| for PNS | K183579 | K171366 |
4
| Device | 510(k) | Predicate(s) used for clearance |
|---|---|---|
| (Primary Predicate) |
The 510(k) history of the StimQ PNS System includes design changes over time. The original Medtronic devices are part of the predicate history of the StimO PNS System and are also used as reference devices in this document.
Device Description
This submission will add 4 stimulation contact options to the predicate Nalu Neurostimulation System (also referred to as the "Nalu PNS System"). The Nalu PNS System is used for peripheral nerve stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The Nalu PNS System incorporates a miniature implanted neurostimulator, 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 PNS System may be implanted following a successful trial period using the Nalu PNS trial system.
The leads that were cleared with the Nalu PNS System featured 8 stimulation contacts. This submission will provide an optional use of leads with 4 stimulation contacts.
| 1. | 4 Contact
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 a single pre-
attached lead (available in two lengths) and a "ported" system where
a single lead (available in two effective lengths) may be attached,
via connector ports. 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. | 4 Contact
Leads/Lead
Extension | Leads are implantable and are designed to deliver electrical pulses to
the peripheral nerve via an array of four cylindrical electrodes at the
distal end. Leads may be integrated with or connected to the IPG.
The leads use polyurethane insulation with Pt/Ir electrodes. The
leads are secured in place with tines designed into the lead body. A
4 contact Lead Extension is also available which connects to the
proximal end of the lead to extend the lead subcutaneously. |
The 4 Contact PNS System include the following subject devices in this submission:
5
Indications for Use Statement
"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 4 Contact PNS System are identical to the predicate Nalu Neurostimulation System. The intended use is unchanged from the predicate.
Substantial Equivalence Discussion
The following tables compare the 4 Contact PNS 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.
6
| | 4 Contact PNS
System
(Subject
Device) | Nalu
Neurostimulati
on System
(Primary
Predicate) | StimQ
PNS
System
(Referen
ce
Device) | StimQ
PNS
System
(Referen
ce
Device) | Medtroni
c Mattrix
3271/327
2
(Referenc
e Device) | Medtroni
c Xtrel
3425
(Referenc
e Device) | Analysis of
Technologi
cal
Differences
from
Primary
Predicate |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| 510(k) | K191435 | K183579 | K171366 | K152178 | K934065 | K883780 | NA |
| Product
Code and
class | GZF, Class II | Same | Same | Same | GZF and
GZB | GZB | Same |
| Regulation
number | 21 CFR
§882.5870 | Same | Same | Same | Same,
plus 21
CFR
882.5880 | Same | Same |
| Classificatio
n name | Stimulator,
Peripheral
Nerve,
Implanted
(pain relief) | Same | Same | Same | Same
plus
Stimulato
r, Spinal
Cord,
Implante
d (Pain
Relief) | Same | Same |
| Intended
Use | Stimulation of
peripheral
nerves for
chronic,
intractable
pain | Same | Same | Same | Same,
plus
Stimulati
on of
spinal
cord for
chronic,
intractabl
e pain | Same | 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
multidisciplina | Same | 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
intended to treat | 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
intended to treat | Indicated as an aide in
the management of
chronic, intractable
pain of the trunk or
limbs | Indicated as an aide in
the management of
chronic, intractable
pain of the trunk or
limbs | Same |
| | 4 Contact PNS
System
(Subject
Device) | Nalu
Neurostimulati
on System
(Primary
Predicate) | StimQ
PNS
System
(Referen
ce
Device) | StimQ
PNS
System
(Referen
ce
Device) | Medtroni
c Mattrix
3271/327
2
(Referenc
e Device) | Medtroni
c Xtrel
3425
(Referenc
e Device) | Analysis of
Technologi
cal
Differences
from
Primary
Predicate |
| | ry 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
recommendati
on for a
permanent
(long term)
device. | | 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. | | | | |
| Prescription
Use? | Yes | Same | Same | Same | Same | Same | Same |
| Implant site | Peripheral
nerves,
excluding
craniofacial
region | Same | Same | Same | Same | Same | Same |
| Environmen
tal Use | Hospital,
Home | Same | Same | Same | Same | Same | Same |
| Intended
Clinician | Orthopedic,
Neurosurgeon
Anesthesiologi
st | 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 |
| | 4 Contact PNS
System
(Subject
Device) | Nalu
Neurostimulati
on System
(Primary
Predicate) | StimQ
PNS
System
(Referen
ce
Device) | StimQ
PNS
System
(Referen
ce
Device) | Medtroni
c Mattrix
3271/327
2
(Referenc
e Device) | Medtroni
c Xtrel
3425
(Referenc
e Device) | Analysis of
Technologi
cal
Differences
from
Primary
Predicate |
| Software
Level of
Concern | Moderate | Same | Same | Same | Unreport
ed | Unreport
ed | Same |
| Sterilization | Ethylene
Oxide | Same | Same | Same | Same | Same | Same |
Table: Substantial Equivalence Table – General and Implanted Components
7
8
| | 4 Contact
PNS
System
(Subject
Device) | Nalu
Neurostimulatio
n System
(K183579)
(Primary
Predicate) | StimQ PNS
System
(K171366)
(Referenc
e
Predicate) | StimQ PNS
System
(K152178)
(Referenc
e Device) | Medtroni
c Mattrix
3271/327
2
(K934065)
(Referenc
e Device) | Medtroni
c Xtrel
3425
(K883780)
(Referenc
e Device) | Analysis of
Technologic
al
Differences
from
Primary
Predicate |
|------------------------------------|---------------------------------------------------|----------------------------------------------------------------------------|------------------------------------------------------------------|------------------------------------------------------------|-------------------------------------------------------------------------------|--------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Electrode
Material | Platinum-
iridium
90:10 | Same | Same | Same | Same | Same | Same |
| Insulation
Body
Material | Pellethan
e 2363-
55D | Same | Same | Same | Same | Same | Same |
| Cable
features | Coiled
Wires | Multilumen tube | Multilume
n tube | Multilume
n tube | Coiled
Wires | Coiled
Wires | Differences
do not affect
safety and
effectiveness
of intended
use |
| Lead
length | 25 cm, 40
cm | 40 cm, 60 cm | 44 cm | 45 cm | 30 to 110
cm | 30 to 110
cm | Differences
do not affect
safety and
effectiveness
of intended
use |
| Diameter | 1.30 mm | 1.30 mm | 1.35 mm | 1.35 mm | 1.3 mm | 1.3 mm | Same |
| Electrode
Array
length | 21 mm | 52 mm | 24 mm
(FRE-4)
52 mm
(FRE-8) | 24 mm | 24 mm | 24 mm | Differences
do not affect
safety and
effectiveness
of intended
use |
| No. of
Electrodes
, per lead | 4 | 8 | 4 (FRE-4)
8 (FRE-8) | 4 | Same | Same | Differences
do not affect
safety and
effectiveness
of intended
use |
9
| | 4 Contact
PNS
System
(Subject
Device) | Nalu
Neurostimulatio
n System
(K183579)
(Primary
Predicate) | StimQ PNS
System
(K171366)
(Referenc
e
Predicate) | StimQ PNS
System
(K152178)
(Referenc
e Device) | Medtroni
c Mattrix
3271/327
2
(K934065)
(Referenc
e Device) | Medtroni
c Xtrel
3425
(K883780)
(Referenc
e Device) | Analysis of
Technologic
al
Differences
from
Primary
Predicate |
|-----------------------------------|---------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|--------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Individual
Electrode
length | 3.0 mm | Same | Same | Same | Same | Same | Same |
| Electrode
spacing | 3.0 mm | 4.0 mm | 4.0 mm | 4.0 mm | 4.0 mm | 4.0 mm | Differences
do not affect
safety and
effectiveness
of intended
use |
| Electrode
surface
area | 12.25 mm² | 12.25 mm² | 12.72 mm² | 12.72 mm² | 12.25 mm² | 12.25 mm² | Same |
| Lead
extension | Lead
extension
available | Lead extension
available | NA | NA | Lead
extension
available | Lead
extension
available | Differences
do not affect
safety and
effectiveness
of intended
use |
| Lead
Anchor | Integrate
d Lead
Tines | Separate molded
silicone anchor
with Ti locking
mechanism | Integrated
Lead Tines
Separate
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 | Differences
do not affect
safety and
effectiveness
of intended
use |
10
Table: Substantial Equivalence Table - Therapy
| | 4 Contact PNS System
(Subject Device) | Nalu
Neurostimulation
System
(K183579)
(Predicate) | Analysis of
Technological
Differences |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|---------------------------------------------|
| Pulse Frequency | 2 Hz to 1500 Hz | Same | Same |
| Pulse Width | 12 µs to 1000 µs | Same | Same |
| Current/Voltage Regulated | Current | Same | Same |
| Output Voltage (300
Ohms) | 0 to 3.1 V | Same | Same |
| Output Voltage (500
Ohms) | 0 to 5.1 V | Same | Same |
| Output Voltage (800
Ohms) | 0 to 8.2 V | Same | Same |
| Output Current (300
Ohms) | 0 to 10.2 mA | Same | Same |
| Output Current (500
Ohms) | 0 to 10.2 mA | Same | Same |
| Output Current (800
Ohms) | 0 to 10.2 mA | Same | Same |
| Waveform | Charge balanced (delayed) biphasic
asymmetrical | Same | Same |
| Pulse Shape | Decaying Exponential | Same | Same |
| Maximum phase charge
(300 Ohms) | 10.2 µC/pulse | Same | Same |
| Maximum phase charge
(500 Ohms) | 10.2 µC/pulse | Same | Same |
| Maximum phase charge
(800 Ohms) | 10.2 µC/pulse | Same | Same |
| Maximum charge density
(300 Ohm) | 83.3 µC/cm² | Same | Same |
| Maximum charge density
(500 Ohm) | 83.3 µC/cm² | Same | Same |
| Maximum charge density
(800 Ohm) | 83.3 µC/cm² | Same | Same |
| Maximum current density
(300 Ohm) | 83.3 mA/cm² | Same | Same |
| Maximum current density
(500 Ohm) | 83.3 mA/cm² | Same | Same |
| Maximum current density
(800 Ohm) | 83.3 mA/cm² | Same | Same |
| Net Charge | 0 µC | Same | Same |
| Average Phase Power (300
Ohms) | 0.031 W/phase | Same | Same |
| Average Phase Power (500
Ohms) | 0.052 W/phase | Same | Same |
| Average Phase Power (800
Ohms) | 0.083 W/phase | Same | Same |
| Average Phase Power
density (300 Ohms) | 0.25 W/cm²/phase | Same | Same |
| Average Phase Power
density (500 Ohms) | 0.51 W/cm²/phase | Same | Same |
| | 4 Contact PNS System
(Subject Device) | Nalu
Neurostimulation
System
(K183579)
(Predicate) | Analysis of
Technological
Differences |
| Average Phase Power
density (800 Ohms) | 0.55 W/cm²/phase | Same | Same |
| Pulse Delivery Mode | Continuous | Same | Same |
| Current Path options | Bipolar | Same | Same |
| Software level of Concern | Moderate | Same | Same |
| Program Cycle | Cycle through programs | Same | Same |
| Pulse Pattern | Fine tuning of pulse patterns
(On/Off; If On, spans from 12 µs to
1000 µs) | Same | Same |
| Dosage Time | Allows for stimulation to be applied
in periodic doses (On/Off; If On,
spans from 1 ms to 25 ms) | Same | Same |
| Transmit Frequency | 40.68 MHz | Same | Same |
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All of the physical and therapeutic attributes for the 4 Contact PNS System are the same as the parameters in the predicate devices. There are no significant differences in these characteristics that would raise different questions of safety or effectiveness.
The main difference between the subject device and the primary predicate is the number and spacing of electrical contacts, integrated tines, and a coiled lead design. This reduced number of contacts reduces the stimulation area, allowing the physician to target a smaller affected area, if needed. The integrated tines eliminate the need for a separate anchor making the system more convenient to be placed in peripheral location. All of the physical attributes for the 4 Contact PNS System are within the parameters seen in the predicate and reference devices, or the differences are minor and do not affect the safe and effective use of the devices.
Nonclinical Performance Testing
Nalu Medical performed a range of testing to gather data supporting the safety and performance of the 4 Contact PNS 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, 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.
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Applicable Standards and Guidance Documents
The testing for the 4 Contact PNS 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 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 | |
| EN ISO 14971:2012 | Medical devices -- Application of risk management to medical devices |
| ISO 14971:2007 | |
| 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 |
Table: Standards and Guidance Documents
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.
The same biocompatibility reports that supported the Nalu Neurostimulation System also support the 4 Contact PNS System in this submission. The materials and processes involved in producing the 4 Contact PNS System were already assessed in the previous test reports. No additional testing was necessary.
Animal Testing
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Additional animal testing was not necessary to support the addition of the 4 Contact PNS System to this system.
Summary of Nonclinical Performance Testing
Verification testing of the 4 Contact PNS System included electrical and mechanical 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.
Clinical Performance Data
Nalu Medical determined that bench and non-clinical testing are sufficient to demonstrate that the 4 Contact PNS System is as safe and effective as the predicate device.
Conclusions
The bench and non-clinical data support the safety of the device, and the verification and validation demonstrated that the 4 Contact PNS System performs as intended in the specified use conditions. The results do not raise different questions of safety and effectiveness.