(267 days)
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.
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 provided text describes the acceptance criteria and the study conducted for the Freedom Peripheral Nerve Stimulator (PNS) System (K233162) to support the expansion of its indications for use to include craniofacial applications.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Primary Effectiveness Endpoint | A statistically significant proportion of patients in the active treatment group demonstrate significant pain relief (at least 50% reduction) at 3 months compared to baseline, and this is superior to the deactivated control device. | The study showed that "continued treatment with the subject device is superior to the deactivated control device in the proportion of patients with significant (at least 50%) pain relief at 3 months compared to baseline and, thus, the primary effectiveness endpoint was met." |
| Primary Safety Endpoint | The proportion of patients with serious adverse events by 3 months is less than 30%. | The treatment with the subject device was shown to be safe, "passing the safety hypothesis test by demonstrating the proportion of patients with serious adverse events by 3 months was less than 30%." Specifically, "None of the 60 subjects who had implanted devices (Treatment or Control groups) had serious adverse events." |
| Secondary Endpoints | Not explicitly stated in the provided text, but mentioned as having been met. | "The study met its primary effectiveness, primary safety, and secondary endpoints." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 60 patients were implanted with the Freedom® PNS system. Of these, 58 completed the 7-day confirmation visit. 56 of these 58 responders were randomized to either the Active (Treatment group) or Deactivated (Control group).
- Treatment/Active group: 28 patients
- Control/Deactivated group: 28 patients
- Data Provenance: The study was a "multi-center randomized clinical trial." The country of origin is not specified in the provided text, but "clinical data" and "multi-center randomized clinical trial" imply prospective data collection in a clinical setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The study described is a clinical trial assessing the effectiveness of a pain management device. The "ground truth" for effectiveness in this context is self-reported pain relief from the patients themselves, and safety is determined by the occurrence of serious adverse events. Therefore, there's no mention of a traditional expert panel establishing "ground truth" in the same way it would be for, say, image interpretation. The efficacy is based on patient outcomes as measured against the specified endpoints.
4. Adjudication Method for the Test Set
Not applicable in the context of this clinical trial for device effectiveness and safety endpoints. The assessment of pain relief and adverse events would typically follow pre-defined clinical protocols and criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This study is a randomized controlled trial comparing the device's effectiveness (active stimulation) against a control (deactivated device) in patients.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The Freedom PNS System is a physical implanted medical device that requires human implantation and patient interaction (wearing an external transmitter) to function. Its "performance" is assessed through clinical outcomes in patients, not as a standalone algorithm.
7. The Type of Ground Truth Used
The ground truth for effectiveness was established by patient-reported pain relief (at least 50% reduction compared to baseline). The ground truth for safety was established by the occurrence of serious adverse events.
8. The Sample Size for the Training Set
Not applicable. This is a clinical trial for device approval/expanded indication, not an AI/ML algorithm development where data sets are typically split into training and test sets in that manner. The described study is the clinical evidence used to support the device's efficacy and safety for its intended use.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there isn't a "training set" in the context of an AI/ML algorithm. The clinical data from the trial serves as the evidence for the device's performance.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| 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: | Curonix1310 Park Central Blvd S.Pompano Beach FL 33064 |
|---|---|
| Primary Contact: | Danielle BesalPrincipal Consultant MRC Global901.827.8670Danielle.Besal@askmrcglobal.com |
| Company Contact: | Hailey RooneyVice President, Quality and Regulatory800.965.5134Hailey.Rooney@curonix.com |
| 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 –Permanent Implant(two components) | The Neurostimulator consists of two permanently implanted components that areconnected during the surgical procedure, a 4- or 8-Electrode Array and a separateReceiver. The Electrode Array is placed next to the target peripheral nervethrough the first incision. Through a second incision, the Receiver is thenconnected to the electrode array and anchored within a subcutaneous pocket. |
| Component | Description |
| Electrode Array(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(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 – TrialImplant | 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:The Transmitter houses the following components: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 | SubstantialEquivalenceDiscussion |
|---|---|---|---|
| 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 NerveStimulator (PNS) System isindicated for pain management inadults who have severe intractablechronic pain of peripheral nerveorigin, as the sole mitigating agent,or as an adjunct to other modes oftherapy used in a multidisciplinaryapproach. The Freedom Trial LeadKit is only to be used inconjunction with the FreedomNeurostimulator Kit. The trialdevices are solely used for a trialstimulation period (no longer than30 days) to determine efficacybefore recommendation for apermanent (long term) device. | The StimQ Peripheral NerveStimulator (PNS) System isindicated for pain management inadults who have severe intractablechronic pain of peripheral nerveorigin, as the sole mitigating agent,or as an adjunct to other modes oftherapy used in a multidisciplinaryapproach. The StimQ PNS Systemis not intended to treat pain in thecraniofacial region. The StimQ TrialLead Kit is only used in conjunctionwith the StimQ Stimulator ReceiverKit. The trial devices are solelyused for trial stimulation (nolonger than 30 days) to determineefficacy before recommendationfor a permanent (long term)device. | Substantially equivalent. Aclinical study of thesubject device implantedin the craniofacial regionshowed the trial met itsprimary effectiveness,primary safety, andsecondary endpoints;thus, demonstrating itsacceptability for usetreating peripheral nervesin the craniofacial region. |
| Mode of Action | RF wireless transmission of energyto produce stimulation atNeurostimulator electrodes.Transmitter Assembly sends apulsed RF signal on a carrierfrequency of 915MHz to theReceiver. | RF wireless transmission of energyto produce stimulation atStimulator electrodes. SWAGsends a pulsed RF signal on acarrierfrequency of 915MHz to theStimulator. | Identical |
| Environment of Use | Hospital, Home | Hospital, Home | Identical |
| Intended Clinician | Orthopedic, Neurosurgeon, PainPhysician, Anesthesiologist,Craniofacial Surgeon | Orthopedic, Neurosurgeon,Anesthesiologist | Additional intendedclinician population perexpanded indication foruse. |
| Name | Freedom PNS System | StimQ PNS System | SubstantialEquivalenceDiscussion |
| 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 millimeters52 millimeters | 24 millimeters52 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,Prescription Device | Labeled as Sterile, Single Use,Prescription Device | Identical |
| Package | Backer card and two sterilepouches | Backer card and two sterilepouches | 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 |
| Output Voltage (800 Ω) | 0 to 7.5 V | 0 to 7.5 V | Identical |
| Output Current (300 Ω) | 0 to 13.5 mA | 0 to 13.5 mA | Identical |
| Output Current (500 Ω) | 0 to 12.8 mA | 0 to 12.8 mA | Identical |
| Output Current (800 Ω) | 0 to 9.4 mA | 0 to 9.4 mA | Identical |
| Waveform | Charge Balanced (delayed)Biphasic asymmetrical | Charge Balanced (delayed)Biphasic asymmetrical | Identical |
| Polarity | Programmable (Anode, Cathode,or Off) | Programmable (Anode, Cathode,or Off) | Identical |
| Pulse Shape | Decaying Exponential | Decaying Exponential | Identical |
| Avg. Current Density (300 Ω) | 105.0 mA/cm² | 105.0 mA/cm² | Identical |
| Avg. Current Density (500 Ω) | 95.1 mA/cm² | 95.1 mA/cm² | Identical |
| Avg. Current Density (800 Ω) | 69.0 mA/cm² | 69.0 mA/cm² | Identical |
| Max. Phase Charge* (300 Ω) | 6.8 µC/pulse | 6.8 µC/pulse | Identical |
| Max. Phase Charge* (500 Ω) | 6.4 µC/pulse | 6.4 µC/pulse | Identical |
| Max. Phase Charge* (800 Ω) | 4.7 µC/pulse | 4.7 µC/pulse | Identical |
| Max. Charge Density* (300 Ω) | 53.1 µC/cm² | 53.1 µC/cm² | Identical |
| Max. Charge Density* (500 Ω) | 50.3 µC/cm² | 50.3 µC/cm² | Identical |
| Max. Charge Density* (800 Ω) | 36.9 µC/cm² | 36.9 µC/cm² | Identical |
| Max. Current Density* (300 Ω) | 106.1 mA/cm² | 106.1 mA/cm² | Identical |
| Max. Current Density* (500 Ω) | 100.6 mA/cm² | 100.6 mA/cm² | Identical |
| Max. Current Density* (800 Ω) | 73.9 mA/cm² | 73.9 mA/cm² | Identical |
| Net Charge | 0 µC | 0 µC | Identical |
| Avg. Phase Power (300 Ω) | 0.053 W/phase | 0.053 W/phase | Identical |
| Avg. Phase Power (500 Ω) | 0.073 W/phase | 0.073 W/phase | Identical |
| Avg. Phase Power (800 Ω) | 0.062 W/phase | 0.062 W/phase | Identical |
| Avg. Phase Power Density (300 Ω) | 0.42 W/cm²/phase | 0.42 W/cm²/phase | Identical |
| Avg. Phase Power Density (500 Ω) | 0.58 W/cm²/phase | 0.58 W/cm²/phase | Identical |
| Avg. Phase Power Density (800 Ω) | 0.48 W/cm²/phase | 0.48 W/cm²/phase | Identical |
| Pulse Delivery Mode | Continuous | Continuous | Identical |
| ON/OFF Times | No Cycling | No Cycling | Identical |
| Current Path Options | Bipolar | Bipolar | Identical |
| Device Type | SUBJECT DEVICE | PREDICATE DEVICE | Substantial |
| Name | Freedom PNS System | StimQ PNS System | Equivalence |
| 510(k) Clearance | TBD | K171366 | Discussion |
| Power Delivery | External Transmitter Assemblydelivers power to implantedReceiver | Embedded receiver and coupledreceiver in lumen of Stimulatorbody | Identical |
| Transmit Frequency | 915 MHz | 915 MHz | Identical |
| Single-Use | Yes | Yes | Identical |
| Shelf Life | 2 years | 2 years | Identical |
| Complies with ISO 10993-1 | Yes | Yes | Identical |
| Safety Testing Passed | Yes, no new safety testing wasrequired | Yes | Identical |
| MR Conditional | Yes, FR4A/STQ4 MR Conditional | Yes, FR4A/STQ4 MR Conditional | Identical |
| Accessories | Receiver (Spare), IntroducerAssembly, Needle, Stylet(s),Wearables | Receiver/RF Stylet, Stylet,Introducer Assembly,Guidewire | Identical |
| Charger | USB Charger | USB Charger | Identical |
| Transmitter assembly | Transmitter and Antenna | Aluminum transmitter andseparate, connected Antenna | Identical |
| iPad Application | WaveCrest™ | WaveCrest™ | Substantially equivalent;minor software changesversus predicate. No newquestions of safety oreffectiveness wereintroduced and thechanges have beenverified and validated. |
Table 2. Substantial Equivalence Comparison
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Non-Clinical Performance Testing:
No modifications were made to the components of K171366 (Freedom-8A/4A Stimulators, Receiver, Transmitter Assembly, WaveCrest software, Battery Charger, Sterilization, Kitting Options) in support of the device safety and performance of this submission. The Freedom PNS System testing is leveraged from prior cleared premarket notifications where components were tested to verify that the performance meets the system design requirements as well as all applicable voluntary standards. The Freedom PNS System complies with all design requirements and applicable voluntary standards.
Clinical Performance Testing:
A multi-center randomized clinical trial was conducted on the subject system and demonstrated the subject system met both its primary safety and effectiveness endpoints. Sixty patients were implanted with the Freedom® PNS system in the craniofacial region using an identical minimally invasive surgical technique. At time of surgery, all 60 patients received an External Transmitter for a period of 7 days to confirm the effectiveness of device. During the 7-day activated permanent therapy confirmation period visit, therapy effectiveness was confirmed (at least 50% pain relief) in 56 of the 58 patients that completed the confirmation visit. Those 56 responding patients were randomized during the 7-day confirmation period visit to either an Active (Treatment group) or Deactivated group). Twenty-eight patients were randomized to the Treatment/Active group and kept their External Transmitter. Twenty-eight patients were randomized to the Control/Deactivated group and their External Transmitters were taken away. Subjects then began the therapy to which they were randomized for evaluation of the primary endpoints at 3 months.
Results showed the continued treatment with the subject device is superior to the deactivated control device in the proportion of patients with significant (at least 50%) pain relief at 3 months compared to baseline and, thus, the primary effectiveness endpoint was met. The primary safety endpoint for the study was also met as treatment with the subject device was shown to be safe, passing the safety hypothesis test by demonstrating the proportion of patients with serious adverse events by 3 months
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was less than 30%. None of the 60 subjects who had implanted devices (Treatment or Control groups) had serious adverse events.
The results from the clinical study demonstrated that the subject system provided superior pain relief compared to the control deactivated device for stimulation of craniofacial peripheral nerves and demonstrated the system is safe when used with peripheral nerves in the craniofacial region.
Conclusion:
The clinical study results are adequate to support the expansion of the indications for use and, thus, the Freedom PNS System is considered substantially equivalent to the predicate StimQ PNS System (K171366).
§ 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).