Nalu Lead Blank (50cm)

K190960 · Boston Scientific Neuromodulation · GZB · Jul 11, 2019 · Neurology

Device Facts

• Record ID: K190960
• Device Name: Nalu Lead Blank (50cm)
• Applicant: Boston Scientific Neuromodulation
• Product Code: GZB · Neurology
• Decision Date: Jul 11, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5880
• Device Class: Class 2

Intended 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 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.

Device Story

Nalu Lead Blank is an optional, non-implantable surgical accessory for the Nalu Neurostimulation System; used by surgeons (orthopedic, neurosurgeon, anesthesiologist) during lead implantation. Device is a 50cm flexible stainless steel coiled wire; functions as a guide to create a pathway in the epidural space for Nalu system leads. Used during surgical procedures (≤24 hours). Enhances surgical experience by facilitating lead placement. Does not incorporate electronics or stimulation capabilities; purely mechanical surgical tool.

Clinical Evidence

Bench testing only. Includes design verification, validation, sterilization validation (ISO 11135-1), and biocompatibility testing (ISO 10993-1) for limited duration (≤24 hours) tissue/bone contact. Usability evaluated in a surgical validation cadaver lab. No clinical data required.

Technological Characteristics

Material: Stainless steel. Form factor: 50cm flexible coiled wire, 1.30mm diameter. Sterilization: Ethylene Oxide. Standards: ISO 10993-1 (biocompatibility), ISO 11070 (introducers/guidewires), ISO 11135-1 (sterilization), ISO 11607 (packaging), IEC 62366-1 (usability). Non-electronic, mechanical surgical tool.

Indications for Use

Indicated for adult patients with chronic, intractable pain of the trunk and/or limbs (unilateral or bilateral) as a sole mitigating agent or adjunct therapy. Trial devices are for stimulation up to 30 days to determine efficacy.

Regulatory Classification

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.

Predicate Devices

• Nalu Neurostimulation System (K183047)

Reference Devices

• Stimwave Freedom 8 SCS System (K170141)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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: [phone] Fax: [phone] 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.

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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<br>clearance |
|----------------------------------------------------|---------|------------------------------------|
| Stimwave Freedom 8 SCS System | K170141 | K162161 |
| Nalu Neurostimulator System<br>(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:

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| | Nalu Lead Blank<br>(Subject Device) | Nalu<br>Neurostimulation<br>System<br>(Primary Predicate) | Stimwave Freedom<br>8 SCS system<br>(K170141)<br>(Reference Device) | Analysis of<br>Technological<br>Differences from<br>Primary<br>Predicate |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| 510(k) | K190960 | K183047 | K170141 | NA |
| Product Code and<br>class | GZB, Class II | Same | Same | Same |
| Regulation number | 21 CFR 882.5880 | Same | Same | Same |
| Classification name | Implanted spinal<br>cord stimulator for<br>pain relief. | Same | Same | Same |
| Intended Use | Stimulation of spinal<br>cord for chronic,<br>intractable pain | Same | Same | Same |
| Indications for Use | This system is<br>indicated as the sole<br>mitigating agent, or<br>as an adjunct to<br>other modes of<br>therapy used in a<br>multidisciplinary<br>approach for<br>chronic, intractable<br>pain of the trunk<br>and/or limbs,<br>including unilateral<br>or bilateral pain.<br>The trial devices are<br>solely used for trial<br>stimulation (no<br>longer than 30 days)<br>to determine<br>efficacy before<br>recommendation for<br>a permanent (long<br>term) device.<br>The Nalu Lead Blank<br>is an optional<br>accessory intended<br>to be used as a<br>surgical aide to<br>insert the Nalu<br>Neurostimulation<br>System Leads. | This system is<br>indicated as the sole<br>mitigating agent, or<br>as an adjunct to<br>other modes of<br>therapy used in a<br>multidisciplinary<br>approach for<br>chronic, intractable<br>pain of the trunk<br>and/or limbs,<br>including unilateral<br>or bilateral pain.<br>The trial devices are<br>solely used for trial<br>stimulation (no<br>longer than 30 days)<br>to determine<br>efficacy before<br>recommendation<br>for a permanent<br>(long term) device. | The Freedom Spinal<br>Cord Stimulator<br>(SCS) System is<br>intended as the sole<br>mitigating agent, or<br>as an adjunct to<br>other modes of<br>therapy used in a<br>multidisciplinary<br>approach for<br>chronic, intractable<br>pain of the trunk<br>and/or lower limbs,<br>including unilateral<br>or bilateral pain.<br>The trial devices are<br>solely used for trial<br>stimulation (no<br>longer than 30 days)<br>to determine<br>efficacy before<br>recommendation<br>for a permanent<br>(long term) device. | Same |
| Prescription Use? | Yes | Same | Same | Same |
| Anatomical site | Epidural space | Same | Same | Same |
| | Nalu Lead Blank<br>(Subject Device) | Nalu<br>Neurostimulation<br>System<br>(Primary Predicate) | Stimwave Freedom<br>8 SCS system<br>(K170141)<br>(Reference Device) | Analysis of<br>Technological<br>Differences from<br>Primary<br>Predicate |
| Environmental Use | Hospital, Home | Same | Same | Same |
| Intended Clinician | Orthopedic,<br>Neurosurgeon,<br>Anesthesiologist | Same | Same | Same |
| Intended User | Physician, Layperson | Same | Same | Same |

# Table 5-2: Substantial Equivalence Table – Primary predicate and Reference Device Summary

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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<br>(Subject Device) | Lead within Nalu<br>Neurostimulation<br>System<br>(K183047)<br>(Primary Predicate) | Guide wire within<br>the Stimwave<br>Freedom 8 SCS<br>system<br>(K170141)<br>(Reference Device) | Analysis of<br>Technological<br>Differences from<br>Primary Predicate |
|--------------------|------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Function | Create a pathway in<br>the epidural space<br>for the lead to<br>follow | The stimulating<br>portion of the<br>neurostimulator<br>that is inserted into<br>the epidural space<br>and creates a<br>pathway through its<br>insertion. | Create a pathway in<br>the epidural space<br>for the lead to<br>follow | Optional device<br>meant to enhance<br>the surgical<br>experience<br>compared to the<br>primary predicate.<br>Same as reference<br>device. |
| Construction | Flexible coiled wire | Flexible multilumen<br>extrusion consisting<br>of 8 (1x19) lead<br>wires and 8 contacts | Flexible coiled wire | Optional device<br>meant to enhance<br>the surgical<br>experience<br>compared to the<br>primary predicate.<br>Same as reference<br>device |
| Material | Stainless steel | Multilumen<br>extrusion made of<br>55D Pellethane; lead<br>wires made of<br>35NLT-DFT-28%AG<br>(ETFE<br>COATED); and<br>contacts made of<br>(90/10) PT/IR | Stainless steel | Optional device<br>meant to enhance<br>the surgical<br>experience<br>compared to the<br>primary predicate.<br>Same as reference<br>device |
| Duration of<br>Use | Surgical procedure | Duration of long-<br>term implant (>30<br>days) | Surgical procedure | Optional device<br>meant to enhance<br>the surgical |

Table 5-3: Predicate and Reference Device comparison with the Nalu Lead Blank

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| | Nalu Lead Blank<br>(Subject Device) | Lead within Nalu<br>Neurostimulation<br>System<br>(K183047)<br>(Primary Predicate) | Guide wire within<br>the Stimwave<br>Freedom 8 SCS<br>system<br>(K170141)<br>(Reference Device) | Analysis of<br>Technological<br>Differences from<br>Primary Predicate |
|-----------------------|-------------------------------------|------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| | Implant tool, limited<br>(≤24 hrs) | Implant tool, limited<br>(≤24 hrs) | | experience<br>compared to the<br>primary predicate.<br>Same as reference<br>device |
| Length | 50 cm | 40 cm, 60 cm | Unpublished | Differences do not<br>affect safety and<br>effectiveness of<br>intended use |
| Diameter | 1.30 mm | 1.30 mm | Unpublished | Differences do not<br>affect safety and<br>effectiveness of<br>intended use |
| Packaging | Tyvek and Mylar<br>pouch | Tyvek and Mylar<br>pouch | Unpublished | Same |
| Sterilization<br>Type | Ethylene Oxide | Same sterilization<br>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:

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| Standard Number | Title |
|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 10993-1:2009 | Biological evaluation of medical devices - Part 1: Evaluation<br>and testing within a risk management process |
| ISO 11070:2014 | Sterile single-use intravascular introducers, dilators and<br>guidewires |
| ISO 11135-1:2014 | Sterilization of health-care products -- Ethylene oxide --<br>Requirements for the development, validation and routine<br>control of a sterilization process for medical devices |
| ISO 11607-1:2006/Amd<br>1:2014 and -2:2006/Amd<br>1:2014 | Packaging for terminally sterilized medical devices -- Part 1:<br>Requirements for materials, sterile barrier systems and<br>packaging systems, Part 2: Validation requirements for<br>forming, sealing and assembly processes |
| EN ISO 14971:2012 | Medical devices -- Application of risk management to<br>medical devices |
| ISO 14971:2007 | |
| IEC 62366-1:2015 | Medical Devices – Part 1: Application of usability<br>engineering to medical devices |
| FDA Guidance: Applying Human Factors and Usability Engineering to Medical Devices<br>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.

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- 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.