(90 days)
No
The document describes a neurostimulation system and a surgical accessory, focusing on hardware and basic functionality. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the Nalu Neurostimulation System is "indicated as the sole mitigating agent or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or limbs." This indicates its purpose is to provide therapeutic relief.
No
Explanation: The device, the Nalu Lead Blank, is an accessory used as a surgical tool to insert leads for neurostimulation. It is not designed to diagnose any condition, but rather to aid in a therapeutic procedure.
No
The device description explicitly states it incorporates a miniature implanted neurostimulator and an externally worn device, which are hardware components. The Lead Blank is also described as a non-implantable surgical tool.
Based on the provided information, the Nalu Neurostimulation System and its accessory, the Nalu Lead Blank, are not In Vitro Diagnostic (IVD) devices.
Here's why:
- Intended Use: The intended use is for the treatment of chronic pain through neurostimulation, specifically spinal cord stimulation. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a neurostimulation system and a surgical tool used during implantation. These are physical devices used for treatment and surgical procedures, not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status, disease, or condition based on sample analysis.
- Using reagents or assays.
In summary, the Nalu Neurostimulation System and its accessory are medical devices used for therapeutic purposes (pain management) and surgical assistance, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Nalu Neurostimulation System is indicated as the sole mitigating agent or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain.
The trial devices are solely used for trial stimulation (no longer thank 30 days) to determine efficacy before recommendation for a permanent (long term) device.
The Nalu Lead Blank is an optional accessory intended to be used as a surgical aide to insert the Nalu Neurostimulation System Leads.
Product codes
GZB
Device Description
The Nalu Lead Blank is an optional accessory to the Nalu Neurostimulation System (also referred to as the "Nalu System"), which is used for spinal cord stimulation to provide therapeutic relief for chronic, intractable pain of the trunk and/or limbs including unilateral or bilateral pain. The Nalu Neurostimulation System incorporates a miniature implanted neurostimulator, powered by an externally worn device. The Nalu Lead Blank is an optional non-implantable surgical tool used during implant of the Nalu Neurostimulation System leads. The Nalu Lead Blank may be used to create a path for the lead in the epidural space.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Epidural space
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Intended Clinician: Orthopedic, Neurosurgeon, Anesthesiologist
Intended User: Physician, Layperson
Environmental Use: Hospital, Home
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Nalu Medical determined that bench and non-clinical testing are sufficient to demonstrate that the Nalu Lead Blank is as safe and effective as the predicate and reference device.
Verification testing of the Nalu Lead Blank included 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.
Human factors and usability testing was also performed on the device. Validation and performance testing demonstrate that the device acceptably meets user needs as reflected in the product requirements.
Biocompatibility testing was based upon the categorization of the bodycontacting component and duration of the Nalu Lead Blank. The category was based upon the following classification, per the FDA guidance: implant tool for tissue/bone contact for a limited duration (≤ 24 hours). Testing included: cytotoxicity, sensitization, intracutaneous reactivity, and systematic toxicity. Biocompatibility was demonstrated.
Animal Testing was not a necessary part of the verification and validation testing for the Nalu Lead Blank. Instead, usability of the Nalu Lead Blank was evaluated in a Surgical Validation cadaver lab.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5880 Implanted spinal cord stimulator for pain relief.
(a)
Identification. An implanted spinal cord stimulator for pain relief is a device that is used to stimulate electrically a patient's spinal cord to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed on the patient's spinal cord and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 11, 2019
Nalu Medical, Inc. Sunny Gill Senior Quality Assurance and Regulatory Affairs Specialist 2320 Faraday Avenue, Suite 100 Carlsbad, California 92008
Re: K190960
Trade/Device Name: Nalu Lead Blank (50cm) Regulation Number: 21 CFR 882.5880 Regulation Name: Implanted Spinal Cord Stimulator For Pain Relief Regulatory Class: Class II Product Code: GZB Dated: April 11, 2019 Received: April 12, 2019
Dear Sunny Gill:
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,
Pamela Scott Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190960
Device Name Nalu Lead Blank
Indications for Use (Describe)
The Nalu Neurostimulation System is indicated as the sole mitigating agent or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain.
The trial devices are solely used for trial stimulation (no longer thank 30 days) to determine efficacy before recommendation for a permanent (long term) device.
The Nalu Lead Blank is an optional accessory intended to be used as a surgical aide to insert the Nalu Neurostimulation System Leads.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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5.1. Submission Sponsor
Nalu Medical, Incorporated 2320 Faraday Ave., Suite 100 Carlsbad, CA 92008 Phone: (760) 448-2360 Fax: (760) 448-2377 Contact: Sunny Gill, Senior Quality Assurance and Regulatory Affairs Specialist
5.2. Date Prepared
July 11, 2019
Device Identification 5.3.
Trade/Proprietary Name: Nalu Lead Blank Common/Usual Name: Lead Blank Product Code: GZB Regulation number: 21 CFR 882.5880: Stimulator, spinal-cord, implanted (Pain Relief) Class: Class II Device Classification Panel: Neurology
5.4. Legally Marketed Predicate Device(s)
Nalu Neurostimulation System (K183047) by Nalu Medical, Inc.
5.5. Device Description
The Nalu Lead Blank is an optional accessory to the Nalu Neurostimulation System (also referred to as the "Nalu System"), which is used for spinal cord stimulation to provide therapeutic relief for chronic, intractable pain of the trunk and/or limbs including unilateral or bilateral pain. The Nalu Neurostimulation System incorporates a miniature implanted neurostimulator, powered by an externally worn device. The Nalu Lead Blank is an optional non-implantable surgical tool used during implant of the Nalu Neurostimulation System leads. The Nalu Lead Blank may be used to create a path for the lead in the epidural space.
5.6. Indications for Use Statement
The Nalu Neurostimulation System is indicated as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain.
4
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 Nalu Lead Blank is an optional accessory intended to be used as a surgical aide to insert the Nalu Neurostimulation System Leads.
The Indications for Use statement for the Nalu Lead Blank is identical to the predicate device. Both the subject and predicate devices have the same intended use, which is for the stimulation of the spinal cord for treatment of chronic, intractable pain.
5.7. Substantial Equivalence Discussion
The primary predicate for this submission is the Nalu Neurostimulation System that was most recently cleared in K183047. The Nalu System is intended for adult patients and contains a lead that has the same intended use as the lead blank. The Nalu Lead Blank is an optional non-implantable surgical tool used during implant of the Nalu Neurostimulation System leads. The Nalu Lead Blank is used to create a path for the lead in the epidural space. With this submission, there is no change to the Nalu neurostimulator, leads, external components, or therapy.
For areas where slight differences occur between the Nalu Lead Blank and the primary predicate (K183047), substantial equivalence to a reference device in this same product code is demonstrated. The Stimwave Freedom 8 SCS System cleared in K170141 is used as the reference device since the design of the lead blank and its sole purpose is more aligned with the guide wire used as part of the Stimwave Freedom 8 SCS System. This reference device was 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 |
|----------------------------------------------------|---------|------------------------------------|
| Stimwave Freedom 8 SCS System | K170141 | K162161 |
| Nalu Neurostimulator System
(Primary Predicate) | K183047 | K170141 |
Table 5-1: Predicate history of the proposed primary predicate
The following table compares the Nalu Lead Blank to the predicate device and the reference 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. Summary information on the Nalu device, predicate device and reference device are provided in Table 5-2 below:
5
| | Nalu Lead Blank
(Subject Device) | Nalu
Neurostimulation
System
(Primary Predicate) | Stimwave Freedom
8 SCS system
(K170141)
(Reference Device) | Analysis of
Technological
Differences from
Primary
Predicate |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| 510(k) | K190960 | K183047 | K170141 | NA |
| Product Code and
class | GZB, Class II | Same | Same | Same |
| Regulation number | 21 CFR 882.5880 | Same | Same | Same |
| Classification name | Implanted spinal
cord stimulator for
pain relief. | Same | Same | Same |
| Intended Use | Stimulation of spinal
cord for chronic,
intractable pain | Same | Same | Same |
| Indications for Use | This system is
indicated as the sole
mitigating agent, or
as an adjunct to
other modes of
therapy used in a
multidisciplinary
approach for
chronic, intractable
pain of the trunk
and/or limbs,
including unilateral
or bilateral pain.
The trial devices are
solely used for trial
stimulation (no
longer than 30 days)
to determine
efficacy before
recommendation for
a permanent (long
term) device.
The Nalu Lead Blank
is an optional
accessory intended
to be used as a
surgical aide to
insert the Nalu
Neurostimulation
System Leads. | This system is
indicated as the sole
mitigating agent, or
as an adjunct to
other modes of
therapy used in a
multidisciplinary
approach for
chronic, intractable
pain of the trunk
and/or limbs,
including unilateral
or bilateral pain.
The trial devices are
solely used for trial
stimulation (no
longer than 30 days)
to determine
efficacy before
recommendation
for a permanent
(long term) device. | The Freedom Spinal
Cord Stimulator
(SCS) System is
intended as the sole
mitigating agent, or
as an adjunct to
other modes of
therapy used in a
multidisciplinary
approach for
chronic, intractable
pain of the trunk
and/or lower limbs,
including unilateral
or bilateral pain.
The trial devices are
solely used for trial
stimulation (no
longer than 30 days)
to determine
efficacy before
recommendation
for a permanent
(long term) device. | Same |
| Prescription Use? | Yes | Same | Same | Same |
| Anatomical site | Epidural space | Same | Same | Same |
| | Nalu Lead Blank
(Subject Device) | Nalu
Neurostimulation
System
(Primary Predicate) | Stimwave Freedom
8 SCS system
(K170141)
(Reference Device) | Analysis of
Technological
Differences from
Primary
Predicate |
| Environmental Use | Hospital, Home | Same | Same | Same |
| Intended Clinician | Orthopedic,
Neurosurgeon,
Anesthesiologist | Same | Same | Same |
| Intended User | Physician, Layperson | Same | Same | Same |
Table 5-2: Substantial Equivalence Table – Primary predicate and Reference Device Summary
6
Physical characteristics of the implantable components of the Nalu Lead Blank, the lead within the Nalu Neurostimulation System (primary predicate) and the guide wire within the Stimwave reference device are compared in Table 5-3 below.
| | Nalu Lead Blank
(Subject Device) | Lead within Nalu
Neurostimulation
System
(K183047)
(Primary Predicate) | Guide wire within
the Stimwave
Freedom 8 SCS
system
(K170141)
(Reference Device) | Analysis of
Technological
Differences from
Primary Predicate |
|--------------------|------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Function | Create a pathway in
the epidural space
for the lead to
follow | The stimulating
portion of the
neurostimulator
that is inserted into
the epidural space
and creates a
pathway through its
insertion. | Create a pathway in
the epidural space
for the lead to
follow | Optional device
meant to enhance
the surgical
experience
compared to the
primary predicate.
Same as reference
device. |
| Construction | Flexible coiled wire | Flexible multilumen
extrusion consisting
of 8 (1x19) lead
wires and 8 contacts | Flexible coiled wire | Optional device
meant to enhance
the surgical
experience
compared to the
primary predicate.
Same as reference
device |
| Material | Stainless steel | Multilumen
extrusion made of
55D Pellethane; lead
wires made of
35NLT-DFT-28%AG
(ETFE
COATED); and
contacts made of
(90/10) PT/IR | Stainless steel | Optional device
meant to enhance
the surgical
experience
compared to the
primary predicate.
Same as reference
device |
| Duration of
Use | Surgical procedure | Duration of long-
term implant (>30
days) | Surgical procedure | Optional device
meant to enhance
the surgical |
Table 5-3: Predicate and Reference Device comparison with the Nalu Lead Blank
7
| | Nalu Lead Blank
(Subject Device) | Lead within Nalu
Neurostimulation
System
(K183047)
(Primary Predicate) | Guide wire within
the Stimwave
Freedom 8 SCS
system
(K170141)
(Reference Device) | Analysis of
Technological
Differences from
Primary Predicate |
|-----------------------|-------------------------------------|------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| | Implant tool, limited
(≤24 hrs) | Implant tool, limited
(≤24 hrs) | | experience
compared to the
primary predicate.
Same as reference
device |
| Length | 50 cm | 40 cm, 60 cm | Unpublished | Differences do not
affect safety and
effectiveness of
intended use |
| Diameter | 1.30 mm | 1.30 mm | Unpublished | Differences do not
affect safety and
effectiveness of
intended use |
| Packaging | Tyvek and Mylar
pouch | Tyvek and Mylar
pouch | Unpublished | Same |
| Sterilization
Type | Ethylene Oxide | Same sterilization
site and cycle | Ethylene Oxide | Same |
All of the physical and therapeutic attributes for the Nalu Lead Blank 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 new questions of safety or effectiveness. The information above supports the conclusion that the Nalu Lead Blank has the same intended use as the predicate and reference devices.
5.8. Nonclinical Performance Testing
Nalu Medical performed a range of testing to gather data supporting the safety and performance of the Nalu Lead Blank for its intended use. Nalu followed the Design Controls section of 21 CFR 820.30, ISO 14971:2007, and ISO 13485:2016. These procedures ensured that all designs were appropriately planned, defined, evaluated, transferred to production, and ongoing changes are reviewed for impact on safety and effectiveness and appropriately evaluated and tested. The Nalu Lead Blank 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 was also performed on the device. Validation and performance testing demonstrate that the device acceptably meets user needs as reflected in the product requirements.
- 5.8.1 Applicable Standards and Guidance Documents
The testing for the Nalu Lead Blank includes the following test standards and guidance:
8
| Standard Number | Title |
|---|---|
| ISO 10993-1:2009 | Biological evaluation of medical devices - Part 1: Evaluation |
| and testing within a risk management process | |
| ISO 11070:2014 | Sterile single-use intravascular introducers, dilators and |
| guidewires | |
| 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 | |
| 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 | |
| EN ISO 14971:2012 | Medical devices -- Application of risk management to |
| medical devices | |
| ISO 14971:2007 | |
| IEC 62366-1:2015 | Medical Devices – Part 1: Application of usability |
| engineering to medical devices | |
| FDA Guidance: Applying Human Factors and Usability Engineering to Medical Devices | |
| issued February 3, 2016 |
Table 5-4: Standards and Guidance Documents
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 bodycontacting component and duration of the Nalu Lead Blank. The category was based upon the following classification, per the FDA guidance:
- . implant tool for tissue/bone contact for a limited duration (≤ 24 hours)
Testing included: cytotoxicity, sensitization, intracutaneous reactivity, and systematic toxicity. Biocompatibility was demonstrated.
5.8.3 Animal Testing
Animal Testing was not a necessary part of the verification and validation testing for the Nalu Lead Blank. Instead, usability of the Nalu Lead Blank was evaluated in a Surgical Validation cadaver lab.
9
- 5.8.4 Summary of Nonclinical Performance Testing
Verification testing of the Nalu Lead Blank included 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.
5.9. Clinical Performance Data
Nalu Medical determined that bench and non-clinical testing are sufficient to demonstrate that the Nalu Lead Blank is as safe and effective as the predicate and reference device.
5.10. Conclusions
The bench and non-clinical data support the safety of the device. The verification and validation demonstrated that the Nalu Lead Blank, which is part of the Nalu Neurostimulation System, performs as intended in the specified use conditions. The results do not raise new questions of safety and effectiveness.