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 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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Relievant Medsystems RF Generator:

The provided document describes the Relievant Medsystems RF Generator (RFG), a radiofrequency lesion generator. The acceptance criteria and testing detailed are primarily non-clinical performance tests aimed at demonstrating the device's substantial equivalence to a predicate device, rather than clinical efficacy.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria / Standard	Reported Device Performance (Results)
Electrical Safety	IEC 60601-1-1 (General requirements for basic safety and essential performance) AND IEC 60601-2-2 (Particular requirements for high-frequency surgical equipment)	Pass. Complies with the standards.
Electromagnetic Compatibility (EMC)	IEC 60601-1-2 (Electromagnetic compatibility – Requirements and Tests)	Pass. Complies with the standard.
Temperature Accuracy	Verify output temperature 25°C-100°C ± 1.9°C	Pass
RF Output Power	IEC 60601-1-2 (Electromagnetic compatibility – Requirements and Tests)	Pass. Complies with the standard.
Mechanical Testing	IEC 60601-1-1, IEC 60601-2-2, and Relievant specified requirements	Pass. Complies with the standards and Relievant requirements.
Software	FDA's May 2005 “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Major Level of Concern)	Pass. Met FDA's Guidance requirements for software development documentation and testing.
Programmable Electrical Medical System (PEMS)	IEC 62304 Medical Device Software – Software Life-Cycle Processes	Pass. Complies with the standard.
Interface: Usability	FDA Guidance Document: "Applying Human Factors and Usability Engineering to Medical Devices", IEC 60601-1-6 (Usability), and IEC 62366-1 (Application of usability engineering)	Pass. Complies with the standards.

2. Sample Size Used for the Test Set and Data Provenance

The provided document describes non-clinical performance testing, primarily bench testing and software validation. Therefore, there are:

No "test set" in the traditional sense of patient data.
No human "sample size" for these performance tests.
The data provenance is laboratory testing of the device itself against established medical device standards and internal company requirements.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Since the testing described is non-clinical (electrical, mechanical, software, etc.), the "ground truth" is established by adherence to recognized medical device standards and internal specifications. This means:

No external human experts were used to establish a "ground truth" for a patient-based test set.
The "ground truth" is derived from engineering specifications and regulatory standards. Presumably, internal engineers and quality personnel with relevant expertise in these standards conducted and verified the testing.

4. Adjudication Method for the Test Set

Given that the performance testing is non-clinical and based on objective measurements against standards:

There was no adjudication method (like 2+1 or 3+1 consensus) as this is typically applied to subjective human interpretation of patient data or images.
The results are either a "Pass" or "Fail" based on whether the device meets the defined quantifiable specifications of the standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No MRMC comparative effectiveness study was done.
The device described is an RF Generator, a piece of medical hardware. It does not involve AI or human-in-the-loop performance improvement with AI assistance.
The document explicitly states: "Substantial equivalence is not dependent upon clinical data and no clinical testing was performed."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No standalone (algorithm-only) performance was done.
As noted above, this device is hardware (an RF generator) and does not involve an algorithm for diagnostic or interpretative purposes.

7. The Type of Ground Truth Used

For the non-clinical performance testing, the "ground truth" used was:

Engineering Specifications and Recognized Medical Device Standards: These include IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-2, IEC 62304, IEC 60601-1-6, IEC 62366-1, and FDA guidance documents for software and human factors.
Relievant Specified Requirements: Internal requirements set by the manufacturer for mechanical testing.

8. The Sample Size for the Training Set

Not applicable. This document describes non-clinical performance testing of a hardware device (RF Generator). There is no "training set" in the context of machine learning or AI that would produce diagnostic results.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set mentioned or implied for this medical device, there is no ground truth established for it.

Summary

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Public Health Service

Image /page/0/Picture/2 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, arranged in a way that they resemble a bird in flight. The profiles are black, and they are set against a white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

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

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 generator21 CFR 882.4400, Product Code GXD
Predicate Devices:

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

Device Description:

Indications for Use

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:Reference	SUBJECT
Category	Stockert NEURO N50RadiofrequencyLesion Generator	RelievantINTRACEPTIntraosseous NerveAblation System	Relievant RFGenerator	COMPARISON
510(k)	K070336	K153272	K171143	--
Class	II	II	II	Equivalent
ProductCode/Classification	GXD, 882.4400	GXI, 882.4725	GXD, 882.4400	Equivalent
Characteristics:
Indications For Use	The Stockert NEURON50 RFG is for generalhigh frequencyapplications:1. Radiofrequency heatlesion procedures forthe relief of pain, or2. Lesioning nervetissue for functionalneurosurgicalprocedures; or	The RelievantINTRACEPTIntraosseous NerveAblation System isintended to be usedin conjunction withradiofrequency (RF)generators for theablation ofbasivertebral nervesof the L3 throughS1 vertebrae for therelief of chronic lowback pain of at least6 months durationthat has notresponded to at leastsix months ofconservative care,and is alsoaccompanied byeither Type 1 orType 2 Modicchanges on an MRI.	The RelievantRFG is intendedto be used withRF probes FDAcleared as part ofthe RelievantINTRACEPTIntraosseousNerve AblationSystem for theablation ofbasivertebralnerves of the L3through S1vertebrae for therelief of chroniclow back pain ofat least 6 monthsduration that hasnot responded toat least sixmonths ofconservativecare, and is alsoaccompanied byeither Type 1 orType 2 Modicchanges on anMRI.	Equivalent
	PREDICATE	PREDICATE:Reference	SUBJECT
Category	Stockert NEURO N50RadiofrequencyLesion Generator	RelievantINTRACEPTIntraosseous NerveAblation System	Relievant RFGenerator	COMPARISON
	3. Stimulationprocedures likeprovoking stimulation,localized stimulation,blocking stimulation orintraoperative teststimulation.	--	--	--
Anatomical Site	Bone and soft tissue	Bone and soft tissue	Bone and softtissue	Equivalent
Energy type	Radiofrequency energy	Radiofrequencyenergy	Radiofrequencyenergy	Equivalent
Mechanism ofaction	Cellular necrosisthrough thermalcoagulation	Cellular necrosisthrough thermalcoagulation	Cellular necrosisthrough thermalcoagulation	Equivalent
Operating Mode	MonopolarBipolar RF energyNeuro-stimulation	Bipolar RF energy	Bipolar RF energy	Equivalent
Output Power	50 W	Not applicable*	20 W	Different
Output Frequency	475kHz	Not applicable*	475kHz	Equivalent
FeedbackMechanism	Power ControlledTemperatureControlled	Not applicable*	TemperatureControlled	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 equipmentPart 1: General requirements for basic safetyand essential performance and IEC 60601-2-2Medical electrical equipment-Part 2-2:Particular requirements for the basic safety andessential performance of high frequency surgicalequipment and high frequency surgicalaccessories	Pass. Complies with the standards.
ElectromagneticCompatibility (EMC)	IEC 60601-1-2 Medical electric equipment-Part1-2: General requirements of safety-CollateralStandard: Electromagnetic compatibility-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-Part1-2: General requirements of safety-CollateralStandard: Electromagnetic compatibility-Requirements and Tests	Pass. Complies with the standard.
Mechanical Testing	IEC 60601-1-1 Medical electrical equipmentPart 1: General requirements for basic safetyand essential performance, IEC 60601-2-2Medical electrical equipment-Part 2-2:Particular requirements for the basic safety andessential performance of high frequency surgicalequipment and high frequency surgicalaccessories, as well as Relievant specifiedrequirements.	Pass. Complies with the standardsand Relievant requirements.
Software	FDA's May 2005 “Guidance for theContent of Premarket Submissions forSoftware Contained in Medical Devices"for devices designated as a Major Level ofConcern	Pass. Met FDA's Guidancerequirements for softwaredevelopment documentation andtesting.
Other	Programmable Electrical Medical System(PEMS) IEC 62304 Medical Device Software– Software Life-Cycle Processes	Pass. Complies with the standard.
Interface: Usability	FDA Guidance Document: Applying HumanFactors and Usability Engineering to MedicalDevices, IEC 60601-6 Medical ElectricalEquipment – Part 1-6: General Requirementsfor basic safety and essential performance –Collateral Standard: Usability and IEC 62366Medical Devices – Part 1: Application ofusability 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.

Regulation Number and Section

§ 882.4400 Radiofrequency lesion generator.

(a)
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.(b)
Classification. Class II (performance standards).