Relievant Medsystems RF Generator

K171143 · Relievant Medsystems · GXD · Aug 18, 2017 · Neurology

Device Facts

• Record ID: K171143
• Device Name: Relievant Medsystems RF Generator
• Applicant: Relievant Medsystems
• Product Code: GXD · Neurology
• Decision Date: Aug 18, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Relievant RFG is intended to be used with RF probes FDA cleared as part of the Relievant INTRACEPT Intraosseous Nerve Ablation System for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least 6 months duration that has not responded to at least six months of conservative care, and is also accompanied by either Type 1 or Type 2 Modic changes on an MRI.

Device Story

Relievant RFG is a microcontrolled, AC-powered, bipolar radiofrequency (RF) generator. It delivers RF energy to targeted sites for thermal coagulation of basivertebral nerves. Used in conjunction with Relievant INTRACEPT RF probes. Device monitors power, temperature, and impedance at the treatment site to control energy delivery. Ablation settings are embedded in the generator, ensuring consistent thermal parameters (85°C for 15 minutes). Used by clinicians in a medical setting. Output provides controlled thermal necrosis to alleviate chronic low back pain. Benefits include standardized, automated energy delivery for nerve ablation procedures.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including electrical safety (IEC 60601-1, IEC 60601-2-2), EMC (IEC 60601-1-2), temperature accuracy, and mechanical testing. Software and usability validation performed per FDA guidance.

Technological Characteristics

Microcontrolled, bipolar RF generator. Energy source: AC power. Output frequency: 475 kHz. Max power: 20 W. Feedback: Temperature and impedance monitoring. Embedded ablation settings: 85°C, 1°C/sec ramp, 15-minute duration. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 62304, IEC 62366.

Indications for Use

Indicated for patients with chronic low back pain (≥6 months) unresponsive to ≥6 months of conservative care, with Type 1 or Type 2 Modic changes on MRI, requiring basivertebral nerve ablation at L3-S1 levels.

Regulatory Classification

Identification

A radiofrequency lesion generator is a device used to produce lesions in the nervous system or other tissue by the direct application of radiofrequency currents to selected sites.

Predicate Devices

• Stockert NEURO N50 Generator (K070336)

Reference Devices

• Relievant INTRACEPT Intraosseous Nerve Ablation System (K153272)

Submission Summary (Full Text)

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Public Health Service

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 18, 2017

Relievant Medsystems Laurie Hook Clinical/Regulatory Consultant 2688 Middlefield Road. Suite A Redwood City, California 94063

Re: K171143

Trade/Device Name: Relievant Medsystems RF Generator Regulation Number: 21 CFR 882.4400 Regulation Name: Radiofrequency Lesion Generator Regulatory Class: Class II Product Code: GXD Dated: July 18, 2017 Received: July 20, 2017

Dear Laurie Hook:

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Michael J. Hoffmann -S

for

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K171143

Device Name Relievant Medsystems RF Generator (RFG)

#### Indications for Use (Describe)

The Relievant RFG is intended to be used with RF probes FDA cleared as part of the Relievant INTRACEPT Intraosseous Nerve Ablation System for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least 6 months duration that has not responded to at least six months of conservative care, and is also accompanied by either Type 1 or Type 2 Modic changes on an MRI.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| <div> <span> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 510(k) SUMMARY

## Applicant's Name and Address:

Relievant Medsystems, Inc. 2688 Middlefield Road, Suite A Redwood City, CA 94063

| Contact Person: | Laurie Hook |
|------------------------|----------------------------------------------------------------------|
| Telephone: | 650/368-1000 |
| Facsimile: | 650/298-9205 |
| Date Prepared: | July 18, 2017 |
| Device Name: | |
| Device Generic Name: | RF Generator |
| Device Trade Name: | Relievant Medsystems RF Generator™ (Relievant RFG) |
| Device Classification: | II |
| Classification Name: | Radiofrequency lesion generator<br>21 CFR 882.4400, Product Code GXD |
| Predicate Devices: | |

Stockert NEURO N50 Generator: K070336 (primary) Relievant INTRACEPT Intraosseous Nerve Ablation System: K153272 (reference)

#### Device Description:

The Relievant RFG is a universal AC powered, microcontrolled, bipolar RF generator intended to deliver RF energy to a targeted site. During RF energy delivery, power is continuously monitored and controlled, based on temperature and impedance measurements at the treatment site, to ensure proper operation. RF probes FDA cleared as part of the Relievant INTRACEPT Intraosseous Nerve Ablation System are used with the Relievant RFG.

#### Indications for Use

The Relievant RFG is intended to be used with RF probes FDA cleared as part of the Relievant INTRACEPT Intraosseous Nerve Ablation System for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least 6 months duration that has not responded to at least six months of conservative care, and is also accompanied by either Type 1 or Type 2 Modic changes on an MRI.

#### Substantial Equivalence

The Relievant RFG and the Stockert NEURO N50 RFG are microcontrolled, bipolar RF energy generators intended to delivery RF energy to a targeted site for thermal coagulation. The RFGs include the same indication, have the same intended use, have a similar overall design, and similar operational characteristics. The ablation settings for the Relievant RFG are embedded within the RFG. These embedded settings are a subset of the manually set ablation settings for the primary

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predicate device and are the same as the manually set ablation settings for the reference predicate. Differences between the devices do not raise different questions of safety and effectiveness for the subject device. A comparison of the subject to the predicate devices is provided in the table below.

| | PREDICATE | PREDICATE:<br>Reference | SUBJECT | |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Category | Stockert NEURO N50<br>Radiofrequency<br>Lesion Generator | Relievant<br>INTRACEPT<br>Intraosseous Nerve<br>Ablation System | Relievant RF<br>Generator | COMPARISON |
| 510(k) | K070336 | K153272 | K171143 | -- |
| Class | II | II | II | Equivalent |
| Product<br>Code/Classification | GXD, 882.4400 | GXI, 882.4725 | GXD, 882.4400 | Equivalent |
| Characteristics: | | | | |
| Indications For Use | The Stockert NEURO<br>N50 RFG is for general<br>high frequency<br>applications:<br>1. Radiofrequency heat<br>lesion procedures for<br>the relief of pain, or<br><br>2. Lesioning nerve<br>tissue for functional<br>neurosurgical<br>procedures; or | The Relievant<br>INTRACEPT<br>Intraosseous Nerve<br>Ablation System is<br>intended to be used<br>in conjunction with<br>radiofrequency (RF)<br>generators for the<br>ablation of<br>basivertebral nerves<br>of the L3 through<br>S1 vertebrae for the<br>relief of chronic low<br>back pain of at least<br>6 months duration<br>that has not<br>responded to at least<br>six months of<br>conservative care,<br>and is also<br>accompanied by<br>either Type 1 or<br>Type 2 Modic<br>changes on an MRI. | The Relievant<br>RFG is intended<br>to be used with<br>RF probes FDA<br>cleared as part of<br>the Relievant<br>INTRACEPT<br>Intraosseous<br>Nerve Ablation<br>System for the<br>ablation of<br>basivertebral<br>nerves of the L3<br>through S1<br>vertebrae for the<br>relief of chronic<br>low back pain of<br>at least 6 months<br>duration that has<br>not responded to<br>at least six<br>months of<br>conservative<br>care, and is also<br>accompanied by<br>either Type 1 or<br>Type 2 Modic<br>changes on an<br>MRI. | Equivalent |
| | PREDICATE | PREDICATE:<br>Reference | SUBJECT | |
| Category | Stockert NEURO N50<br>Radiofrequency<br>Lesion Generator | Relievant<br>INTRACEPT<br>Intraosseous Nerve<br>Ablation System | Relievant RF<br>Generator | COMPARISON |
| | 3. Stimulation<br>procedures like<br>provoking stimulation,<br>localized stimulation,<br>blocking stimulation or<br>intraoperative test<br>stimulation. | -- | -- | -- |
| Anatomical Site | Bone and soft tissue | Bone and soft tissue | Bone and soft<br>tissue | Equivalent |
| Energy type | Radiofrequency energy | Radiofrequency<br>energy | Radiofrequency<br>energy | Equivalent |
| Mechanism of<br>action | Cellular necrosis<br>through thermal<br>coagulation | Cellular necrosis<br>through thermal<br>coagulation | Cellular necrosis<br>through thermal<br>coagulation | Equivalent |
| Operating Mode | Monopolar<br>Bipolar RF energy<br>Neuro-stimulation | Bipolar RF energy | Bipolar RF energy | Equivalent |
| Output Power | 50 W | Not applicable* | 20 W | Different |
| Output Frequency | 475kHz | Not applicable* | 475kHz | Equivalent |
| Feedback<br>Mechanism | Power Controlled<br>Temperature<br>Controlled | Not applicable* | Temperature<br>Controlled | Equivalent |
| Ablation Settings: | User Set, manual | User Set, manual | Embedded | Equivalent |
| Temperature | 42°C - 100.0°C | 85° C | 85° C | Equivalent |
| Temperature Ramp | 0 - 50°C /seconds | 1°/seconds | 1°/seconds | Equivalent |
| RF Duration | <1 to 16 minutes | 15 minutes | 15 minutes | Equivalent |

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*The INTRACEPT Intraosseous Nerve Ablation System is intended to be used with RF generators; however, a RF generator was not included with the INTRACEPT System cleared.

## Non-Clinical Performance Testing

Testing of the Relievant RFG demonstrated that the device met specifications and performance requirements, and supports demonstration of equivalence to the predicate device. Performance testing of the subject device was provided in support of the substantial equivalence determination as follows.

| Test | Test Method Summary | Results |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| Electrical | IEC 60601-1-1 Medical electrical equipment<br>Part 1: General requirements for basic safety<br>and essential performance and IEC 60601-2-2<br>Medical electrical equipment-Part 2-2:<br>Particular requirements for the basic safety and<br>essential performance of high frequency surgical<br>equipment and high frequency surgical<br>accessories | Pass. Complies with the standards. |
| Electromagnetic<br>Compatibility (EMC) | IEC 60601-1-2 Medical electric equipment-Part<br>1-2: General requirements of safety-Collateral<br>Standard: Electromagnetic compatibility-<br>Requirements and Tests | Pass. Complies with the standard. |
| Temperature Accuracy | Verify output temperature 25°C-100°C+1.9°C | Pass |

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| Test | Test Method Summary | Results |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| RF Output Power | IEC 60601-1-2 Medical electric equipment-Part<br>1-2: General requirements of safety-Collateral<br>Standard: Electromagnetic compatibility-<br>Requirements and Tests | Pass. Complies with the standard. |
| Mechanical Testing | IEC 60601-1-1 Medical electrical equipment<br>Part 1: General requirements for basic safety<br>and essential performance, IEC 60601-2-2<br>Medical electrical equipment-Part 2-2:<br>Particular requirements for the basic safety and<br>essential performance of high frequency surgical<br>equipment and high frequency surgical<br>accessories, as well as Relievant specified<br>requirements. | Pass. Complies with the standards<br>and Relievant requirements. |
| Software | FDA's May 2005 “Guidance for the<br>Content of Premarket Submissions for<br>Software Contained in Medical Devices"<br>for devices designated as a Major Level of<br>Concern | Pass. Met FDA's Guidance<br>requirements for software<br>development documentation and<br>testing. |
| Other | Programmable Electrical Medical System<br>(PEMS) IEC 62304 Medical Device Software<br>– Software Life-Cycle Processes | Pass. Complies with the standard. |
| Interface: Usability | FDA Guidance Document: Applying Human<br>Factors and Usability Engineering to Medical<br>Devices, IEC 60601-6 Medical Electrical<br>Equipment – Part 1-6: General Requirements<br>for basic safety and essential performance –<br>Collateral Standard: Usability and IEC 62366<br>Medical Devices – Part 1: Application of<br>usability engineering to medical devices | Pass. Complies with the standards. |

### Clinical Performance Testing

Substantial equivalence is not dependent upon clinical data and no clinical testing was performed.

#### Conclusions

Based upon device comparison and non-clinical performance testing, the Relievant RFG is substantially equivalent to the legally marketed predicate devices and any differences in design or technologic characteristics do not raise different questions of safety or effectiveness. All test requirements were met and results support the substantial equivalence of the subject and predicate devices.