Freedom Peripheral Nerve Stimulator (PNS) System

K233162 · Curonix · GZF · Jun 20, 2024 · Neurology

Device Facts

• Record ID: K233162
• Device Name: Freedom Peripheral Nerve Stimulator (PNS) System
• Applicant: Curonix
• Product Code: GZF · Neurology
• Decision Date: Jun 20, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5870
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Freedom 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 Freedom Trial Lead Kit is only to be used in conjunction with the Freedom Neurostimulator Kit. The trial devices are solely used for a trial stimulation period (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.

Device Story

Freedom PNS System provides neurostimulation for chronic, intractable pain. System components: two-component implantable neurostimulator (electrode array and receiver), external transmitter assembly, and WaveCrest software. Principle: HF-EMC (915 MHz) wireless power/data transmission from external transmitter to implanted receiver; receiver converts energy to pulsed electrical current at electrode array to inhibit pain signal transmission. Implanted by neurosurgeons, orthopedic surgeons, or pain physicians. Clinician uses WaveCrest iPad app to program stimulation parameters (pulse shape, rate, width, amplitude). Patient wears transmitter assembly in elastic sleeve to receive therapy. Output: programmable electrical stimulation. Benefits: non-opioid pain management; minimally invasive implantation.

Clinical Evidence

Multi-center randomized clinical trial (n=60) evaluated craniofacial application. 56/58 patients achieved >50% pain relief during 7-day confirmation. Randomized 28 (Active) vs 28 (Deactivated) control. Primary effectiveness endpoint met: active group showed superior pain relief at 3 months. Primary safety endpoint met: 0% serious adverse events (SAE) at 3 months (threshold <30%).

Technological Characteristics

HF-EMC neurostimulation (915 MHz). Implantable components: Polyurethane 2363-55D casing, platinum-iridium (90:10) electrodes, PEEK-coated copper receiver. Dimensions: 1.35mm diameter, 45cm length. Pulse parameters: 5-1500 Hz, 50-500 µs, 0-13.5 mA. Bipolar current-regulated, charge-balanced biphasic asymmetrical waveform. Sterilization: Ethylene Oxide. Connectivity: Bluetooth (transmitter status). Software: WaveCrest iPad app for programming.

Indications for Use

Indicated for adults with severe intractable chronic pain of peripheral nerve origin, including craniofacial applications. Used as sole therapy or adjunct in multidisciplinary approach. Trial period limited to 30 days.

Regulatory Classification

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.

Predicate Devices

• StimQ Peripheral Nerve Stimulator System (K171366)

Submission Summary (Full Text)

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June 20, 2024

Curonix % Danielle Besal Principal Consultant MRC Global, LLC 9085 E. Mineral Circle, Suite 110 Centennial, Colorado 80112

Re: K233162

Trade/Device Name: Freedom Peripheral Nerve Stimulator (PNS) System Regulation Number: 21 CFR 882.5870 Regulation Name: Implanted Peripheral Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: GZF Dated: May 17, 2024 Received: May 17, 2024

Dear Danielle Besal:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Amber T. Ballard -S

Amber Ballard, PhD Assistant Director DHT5B: Division of Neuromodulation and Rehabilitation Devices

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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) K233162

#### Device Name

Freedom Peripheral Nerve Stimulator (PNS) System

#### Indications for Use (Describe)

The Freedom 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 therany used in a multidisciplinary approach. The Freedom Trial Lead Kit is only to be used in conjunction with the Freedom Neurostimulator Kit. The trial devices are solely used for a trial stimulation period (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) |
|----------------------------------------------------------------------------------|
| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
| <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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## 510(k) Summary Freedom Peripheral Nerve Stimulator (PNS) System K233162 June 20, 2024

| Company: | Curonix<br>1310 Park Central Blvd S.<br>Pompano Beach FL 33064 |
|--------------------|--------------------------------------------------------------------------------------------------------|
| Primary Contact: | Danielle Besal<br>Principal Consultant MRC Global<br>901.827.8670<br>[e-mail] |
| Company Contact: | Hailey Rooney<br>Vice President, Quality and Regulatory<br>800.965.5134<br>[e-mail] |
| Trade Name: | Freedom Peripheral Nerve Stimulator (PNS) System |
| Common Name: | Implanted peripheral nerve stimulator |
| Classification: | Class II |
| Regulation Number: | 21 CFR 882.5870 Implanted peripheral nerve stimulator for pain relief |
| Product Code: | GZF |
| Predicate Devices: | K171366 StimQ Peripheral Nerve Stimulator System |

## Device Description:

The Freedom PNS System uses HF-EMC (High Frequency Electromagnetic Coupling) neurostimulation technology to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The Freedom PNS System is comprised of a two-component implantable neurostimulator, an externallyworn transmitter, and WaveCrest software used to set patient-specific stimulation programs. The system's mechanism of action relies on programmable pulsed electrical current to create an energy field that acts on the targeted peripheral nerve to inhibit the transmission of pain signals to the brain. The two-component neurostimulator, comprised of an electrode array and a separate receiver, are surgically connected and anchored within two separate incisions, including creation of a subcutaneous pocket. The stimulation program is adjusted as needed to provide pain relief for the patient. The purpose of this submission is to modify the indications for use for the existing system (K171366) to include craniofacial applications.

The Freedom PNS System is a single-use, prescription-only system, to be implanted by an appropriate clinician, such as a neurosurgeon, interventional pain physicial surgeon or orthopedic surgeon. The system components are described in Table 1.

| Component | Description |
|------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Neurostimulator –<br>Permanent Implant<br>(two components) | The Neurostimulator consists of two permanently implanted components that are<br>connected during the surgical procedure, a 4- or 8-Electrode Array and a separate<br>Receiver. The Electrode Array is placed next to the target peripheral nerve<br>through the first incision. Through a second incision, the Receiver is then<br>connected to the electrode array and anchored within a subcutaneous pocket. |
| Component | Description |
| Electrode Array<br>(First Implanted Component) | The Electrode Array is comprised of a polyurethane casing, flexible circuit board, ASIC chip, and 4 or 8 electrodes (platinum iridium alloy, 90:10 w%). The Electrode Array contains a port designed to connect with the separate Receiver component. |
| Receiver<br>(Second Implanted Component) | The Receiver is an HF-EMC conductor that receives wireless power and data signals from the External Transmitter Assembly. The Receiver device consists of a PEEK-coated copper core that is precisely tuned to the HF-EMC frequency. The Receiver connects to the Electrode Array connection port to form the Neurostimulator. |
| Neurostimulator – Trial<br>Implant | Trial Neurostimulators (Leads) are available for trial stimulation (no longer than 30 days) to determine efficacy for an individual patient before recommendation for a permanent (long-term) device. Following the trial period, the Trial Lead must be explanted. If determined that permanent implantation would be appropriate for the patient, the surgeon then implants the permanent Neurostimulator(s). |
| Transmitter Assembly | The Transmitter Assembly utilizes HF-EMC to provide power and data to the implanted Receiver and transmits stimulation parameter settings embedded on the carrier frequency, which includes the waveform pulse shape, pulse rate, pulse width, and amplitude. A single Transmitter Assembly may power multiple implanted Neurostimulators. The Transmitter Assembly consists of a Transmitter and an Antenna:<br>The Transmitter houses the following components:<br>Microwave field stimulator (MFS) - A printed circuit board (PCB) that generates 915 MHz RF power with embedded waveform parameter settings and circuitry to enable changing parameter settings as needed by the user. Switch membrane (Buttons) - Elastomeric silicon rubber pad that corresponds to switches on the MFS that allows the user to turn the device on/off or increase or decrease power amplitude as well as interpret device power status (On, Off, Charging, Transmitting, and Bluetooth® Connection). Battery assembly – a rechargeable battery and wire assembly for MFS power delivery. Transmitting (Tx) Antenna – An antenna and cable assembly that is attached to the Transmitter Assembly and used to transmit energy to the implanted Receiver. |
| Accessories | Steering Stylet – A stainless steel stylet with a polypropylene handle that is inserted into the open central lumen of the Electrode Array to provide rigidity during implantation; available in curved and straight configurations. Guidewire – A stainless steel, rigid, solid core guidewire that may be used to create a hollow pathway for the Electrode Array through the tissue. Introducer Assembly – a 15-gauge stainless steel dilator and yellow Hytrel introducer assembly that acts as a conduit for passage of the electrode array next to the targeted peripheral nerve. Charging Accessory – An off-the-shelf battery charger that uses a power adapter and USB cable to recharge the lithium-ion battery of the Transmitter Assembly. Wearable Accessories – A wearable, elastic neoprene sleeve worn to house the Transmitter Assembly; available in vertical/horizontal configurations in various sizes and torso configuration in various sizes, with potential extender available. configuration is available to hold the antenna in place when using the subject system for craniofacial applications. Transmitter Cover Accessory – A removable cover that snaps onto the Transmitter Assembly providing to reduce the likelihood inadvertent pressing of the Transmitter buttons. |
| Component | Description |
| WaveCrest Software | An iPad application, WaveCrest™, is used by trained company representatives to program the Transmitter Assembly. |

#### Table 1. System Components

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## Indications for Use:

The Freedom 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 Freedom Trial Lead Kit is only to be used in conjunction with the Freedom Neurostimulator Kit. The trial devices are solely used for a trial stimulation period (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.

## Substantial Equivalence:

The Freedom PNS System is substantially equivalent to the predicate device (K171366). The subject and predicate devices are similar in intended use, materials, and technological characteristics. The difference in the subject device's indication for use versus the predicate is supported by clinical data demonstrating the safety and effectiveness of the subject system in craniofacial applications. A detailed comparison is provided in Table 2.

| Device Type | SUBJECT DEVICE | PREDICATE DEVICE | Substantial<br>Equivalence<br>Discussion |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Freedom PNS System | StimQ PNS System | |
| 510(k) Clearance | TBD | K171366 | |
| Prescription Use/OTC | Rx Only | Rx Only | Identical |
| Product Code | GZF | GZF | Identical |
| Indications for Use | The Freedom Peripheral Nerve<br>Stimulator (PNS) System is<br>indicated for pain management in<br>adults who have severe intractable<br>chronic pain of peripheral nerve<br>origin, as the sole mitigating agent,<br>or as an adjunct to other modes of<br>therapy used in a multidisciplinary<br>approach. The Freedom Trial Lead<br>Kit is only to be used in<br>conjunction with the Freedom<br>Neurostimulator Kit. The trial<br>devices are solely used for a trial<br>stimulation period (no longer than<br>30 days) to determine efficacy<br>before recommendation for a<br>permanent (long term) device. | The StimQ Peripheral Nerve<br>Stimulator (PNS) System is<br>indicated for pain management in<br>adults who have severe intractable<br>chronic pain of peripheral nerve<br>origin, as the sole mitigating agent,<br>or as an adjunct to other modes of<br>therapy used in a multidisciplinary<br>approach. The StimQ PNS System<br>is not intended to treat pain in the<br>craniofacial region. The StimQ Trial<br>Lead Kit is only used in conjunction<br>with the StimQ Stimulator Receiver<br>Kit. The trial devices are solely<br>used for trial stimulation (no<br>longer than 30 days) to determine<br>efficacy before recommendation<br>for a permanent (long term)<br>device. | Substantially equivalent. A<br>clinical study of the<br>subject device implanted<br>in the craniofacial region<br>showed the trial met its<br>primary effectiveness,<br>primary safety, and<br>secondary endpoints;<br>thus, demonstrating its<br>acceptability for use<br>treating peripheral nerves<br>in the craniofacial region. |
| Mode of Action | RF wireless transmission of energy<br>to produce stimulation at<br>Neurostimulator electrodes.<br>Transmitter Assembly sends a<br>pulsed RF signal on a carrier<br>frequency of 915MHz to the<br>Receiver. | RF wireless transmission of energy<br>to produce stimulation at<br>Stimulator electrodes. SWAG<br>sends a pulsed RF signal on a<br>carrier<br>frequency of 915MHz to the<br>Stimulator. | Identical |
| Environment of Use | Hospital, Home | Hospital, Home | Identical |
| Intended Clinician | Orthopedic, Neurosurgeon, Pain<br>Physician, Anesthesiologist,<br>Craniofacial Surgeon | Orthopedic, Neurosurgeon,<br>Anesthesiologist | Additional intended<br>clinician population per<br>expanded indication for<br>use. |
| Name | Freedom PNS System | StimQ PNS System | Substantial<br>Equivalence<br>Discussion |
| 510(k) Clearance | TBD | K171366 | |
| Intended User | Layperson | Layperson | Identical |
| Stimulator Body Material | Polyurethane 2363-55D | Polyurethane 2363-55D | Identical |
| Electrode Material | Platinum-iridium 90:10 | Platinum-iridium 90:10 | Identical |
| Cable Features | Multi-lumen Tube | Multi-lumen Tube | Identical |
| Stimulator Length | 45 centimeters | 45 centimeters | Identical |
| Diameter | 1.35 millimeters | 1.35 millimeters | Identical |
| Electrode Array Length | 24 millimeters<br>52 millimeters | 24 millimeters<br>52 millimeters | Identical |
| No. of Electrodes | 4 or 8 | 4 or 8 | Identical |
| Electrode Length | 3.0 millimeters | 3.0 millimeters | Identical |
| Electrode Spacing | 4.0 millimeters | 4.0 millimeters | Identical |
| Electrode Surface Area | 12.72 mm² | 12.72 mm² | Identical |
| Method of Introduction | Percutaneous | Percutaneous | Identical |
| Tissue Contact | Yes | Yes | Identical |
| Sterilization | Ethylene Oxide (EO) | Ethylene Oxide (EO) | Identical |
| Labeling | Labeled as Sterile, Single Use,<br>Prescription Device | Labeled as Sterile, Single Use,<br>Prescription Device | Identical |
| Package | Backer card and two sterile<br>pouches | Backer card and two sterile<br>pouches | Identical |
| Pulse Frequency | 5 to 1500 Hertz | 5 to 1500 Hertz | Identical |
| Pulse Width | 50 to 500 microseconds | 50 to 500 microseconds | Identical |
| Current/Voltage Regulated | Current | Current | Identical |
| Output Voltage (300 Ω) | 0 to 4.1 V | 0 to 4.1 V | Identical |
| Output Voltage (500 Ω) | 0 to 6.4 V | 0 to 6.4 V | Identical |…