Intended for use for lesioning of neural tissue and for pain management. It is indicated for use in the peripheral nervous system. The APEX 6 is to be used with LCCS electrodes and cannulae and Conmed Thermogard Dispersive Electrodes.

Device Description

The RF Innovations APEX 6 is a desktop RF lesioning generator which is used for the lesioning of neural tissue. The APEX 6 is a multi-lesioning, 6 channel portable generator that can provide continuous or pulsed RF output at 460 kHz, and monopolar or dual electrode modes. The device includes sensory and motor stimulation functions to fine tune electrode placement for procedures. Based on performance testing the device is designed to connect to LCCS FDA cleared lesioning probes which are inserted into patients for lesioning of neural tissue during medical procedures. Device features include a touch screen monitor incorporating microprocessor and graphics display for user interface as well as self-diagnostics, calibration checks, and recordkeeping functions.

AI/ML Overview

This document is a 510(k) summary for the APEX 6 Lesioning Generator. It outlines the device's characteristics, its intended use, and how it compares to a predicate device (NeuroTherm NT 2000 RF Lesioning Generator) to establish substantial equivalence.

Here's an analysis of the acceptance criteria and the supporting study, based on the provided text:

Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (Implied)	Reported Device Performance
Lesion Size (comparison to predicate device)	Affected area differences between `APEX 6` and predicate device should be minimal (implied: insignificant for clinical equivalence).	"All affected area differences were less than 1 mm." The study confirms "the Apex 6 and the predicate device are substantially equivalent in regards to affected tissue size."
Comparison of Treatment Times (comparison to predicate device)	Time to ramp up to set temperature and treatment times for `APEX 6` should be substantially equivalent to the predicate device under worst-case conditions.	"Results demonstrated that the APEX 6 was substantially equivalent in terms of treatment times compared to the predicate device."
Design Validation Review	All documented device requirements (Requirement Specification, Traceability Matrix, Software Specifications, Validation Plans, Instructions for Use) must be met.	"The finished unit design review verified that all documented device requirements were met."
Every Unit Functional Test	Each manufactured unit must pass a full functional test regimen (Voltage checks, Program and Impedance Testing, Software testing, Main GUI, Final testing: Impedance/Temperature measurement, Electrical safety testing) prior to shipment.	"Each unit must pass all tests prior to shipment."
Safety (Bench Testing)	Compliance with ANSI/AAMI 60601-1, CAN/CSA-C22.2 No. 60601-1, ANSI/AAMI 60601-2-2, and CAN/CSA-C22.2 No. 60601-2-2.	"Tested to ANSI/AAMI 60601-1:2005 + C1:2009 + A2:2010 + A1:2012, CAN/CSA-C22.2 & 60601-1:2014 AND ANSI/AAMI 60601-2-2:2017, CAN/CSA-C22.2 No. 60601-2-2:2019." The document states compliance implicitly by reporting "Tested to...".
Electromagnetic Compatibility (EMC) (Bench Testing)	Compliance with IEC 60601-1-2 / EN 60601-1-2.	"EMC was tested in accordance with IEC 60601-1-2:2014/ EN 60601-1-2:2015/IEC 60601-2-2." The document states compliance implicitly by reporting "Tested in accordance with...".
Software Performance (Validation to FDA Moderate Level of Concern)	Software performs as expected per validation to FDA guidance for Moderate Level of Concern.	"Software testing supports that the APEX 6 performs as expected. Validation was performed to the FDA Moderate Level of Concern per the FDA software guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

Study Details:

The provided document describes bench testing to demonstrate the substantial equivalence of the APEX 6 to its predicate device, primarily focusing on physical performance characteristics and safety standards. There is no clinical study (human-in-the-loop or standalone AI performance) described for this device, as it is a medical device generator and not an AI/Software as a Medical Device (SaMD).

Here's an breakdown of the specific points requested, based on the provided text:

A table of acceptance criteria and the reported device performance: (See table above)
Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify exact sample sizes for the "Lesion size" or "Comparison of treatment times" tests. It refers to "minimal, typical, and maximum energy delivery" for lesion size and "worse case conditions" for treatment times, implying a set of controlled experimental conditions rather than a large clinical "test set" in the common AI/SaMD sense. For "Every unit functional test," the sample size is "Every unit manufactured."
- Data Provenance: The tests are described as "Bench testing," indicating they were performed in a laboratory or controlled environment. There is no information regarding country of origin or whether it's retrospective or prospective, as it's not a clinical data study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable to the type of testing described. The "ground truth" for a device like a radiofrequency lesion generator is based on physical measurements (e.g., lesion dimensions, electrical parameters, time) and established engineering/safety standards. It's not about expert interpretation of medical images or clinical outcomes that would require human expert consensus for ground truth.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This is not applicable. Adjudication methods are typically used in clinical studies where multiple human readers interpret data, and significant disagreements require a tie-breaking mechanism or consensus. The tests described are bench tests with objective physical measurements.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC study was not done. This type of study is relevant for AI/SaMD devices where the AI assists human readers in diagnostic or screening tasks. The APEX 6 is a physical medical device generator, not an AI software.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- While the APEX 6 itself performs functions autonomously (e.g., generating RF energy), the "standalone" concept usually applies to AI algorithms whose performance is evaluated independently of human input. No such "algorithm-only" performance study is described here, as the device's function is the generation and control of RF energy, which is evaluated through bench tests against physical parameters and predicate device performance. Software functions were validated, but this is different from a standalone AI performance study.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the bench tests was based on physical measurements (e.g., linear dimensions in millimeters, time in seconds, electrical parameters like impedance, voltage, current, power) and compliance with established international and national standards (e.g., IEC 60601 series, ANSI/AAMI, CAN/CSA).
- For "Lesion size" and "Comparison of treatment times," the "ground truth" was derived from the performance of the legally marketed predicate device, used as a benchmark for substantial equivalence.
The sample size for the training set:
- This information is not applicable. The device is not an AI/machine learning model that requires a "training set" in the sense of data used to train a statistical or learning algorithm. Its design and validation rely on engineering principles, product specifications, and comparisons to predicate devices.
How the ground truth for the training set was established:
- This information is not applicable, as there is no training set for an AI/ML model for this device.

Summary

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March 15, 2023

RF Innovations, Inc % Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct Naples, Florida 34114

Re: K220122

Trade/Device Name: Apex 6 Regulation Number: 21 CFR 882.4400 Regulation Name: Radiofrequency Lesion Generator Regulatory Class: Class II Product Code: GXD Dated: April 27, 2022 Received: April 28, 2022

Dear Daniel Kamm:

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

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Digitally signed am D. bv Adam D. Pierce -S Pierce -Spate: 2023.03.15 13:24:54 -04'00'

Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K220122

Device Name APEX 6

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary K220122

Date Prepared: March 10, 2023

SUBMITTED BY:	RF Innovations, IncMiddleton, MA 01940
CONTACT:	William Rittman, Director.RF Innovations, Inc
	Middleton, MA 01949
	781-640-1212
DEVICE NAME:	APEX 6 Lesioning Generator
Regulation Number:	21 CFR 882.4400
Regulation Name:	Radiofrequency Lesion Generator
Regulatory Class:	II
Product Code:	GXD
PREDICATE DEVICE:	K111576
DEVICE NAME:	NeuroTherm NT 2000 RF Lesioning Generator
Regulation Number:	21 CFR 882.4400
Regulation Name:	Radiofrequency Lesion Generator
Regulatory Class:	II
Product Code:	GXD
Reference Devices:	Compatible electrodes:
510(k) number:	K191293
Trade/Device Name:	LCCS RF Cannula
Regulation Number:	21 CFR 882.4725
Regulation Name:	Radiofrequency Lesion Probe
Regulatory Class:	Class II
Product Code:	GXI
510(k) number:	K152642
Trade/Device Name:	LCCS Radiofrequency (RF) Electrode
Regulation Number:	21 CFR 882.4725
Regulation Name:	Radiofrequency Lesion Probe
Regulatory Class:	Class II
Product Code:	GXI
Compatible Dispersive Grounding Pad:
510(k) number:	K140658
510(k) number:	K140658
Trade/Device Name:	Thermogard & Thermogard Plus ABC dispersive electrodes
Regulation Number:	21CFR878.4400
Regulation Name:	Electrosurgical cutting and coagulation device and accessories

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Regulatory Class:	Class I
Product Code:	GEI

DEVICE DESCRIPTION:

INDICATIONS FOR USE: Intended for use for lesioning of neural tissue and for pain management. It is indicated for use in the peripheral nervous system. The APEX 6 is to be used with LCCS electrodes and cannulae and Conmed Thermogard Dispersive Electrodes.

	NeuroThermNT 2000Generator K111576	RF InnovationsAPEX 6Generator K220122	Discussion
Indicationfor Use	The NT 2000 is intended for use forlesioning of neural tissue. The NT2000 is indicated for use in theperipheral nervous system. The NT2000 is to be used only, with FDAcleared NeuroTherm RF probes andSmith & Nephew SPINECATH andACUTHERM catheters, catheters.	Intended for use for lesioning of neuraltissue and for pain management. It isindicated for use in the peripheralnervous system. The APEX 6 is to beused with LCCS electrodes andcannulae and Conmed ThermogardDispersive Electrodes.	SIMILAR
Appearance	Image: NeuroTherm NT 2000 Generator	Image: RF Innovations APEX 6 Generator	SIMILAR
Touchscreendimensions	12" diagonal LCD	15" diagonal LCD	SIMILAR
Number ofChannels	4	6	Same maxpowerdelivered
RF OutputFrequency	460 kHz	460 kHz	SAME
Maximumoutputpower (100ohm load)	50 watts	50 watts	SAME
Energydeliveryduring multichannel RFtreatment	Independent sequential energy delivery	Independent sequential energy delivery	SAME
Powerdeliverymodes	Continuous and pulsed	Continuous and pulsed	SAME
Powersupply	AC Line	AC Line	SAME
Autoshutdownfor powerexceedingsafe levels	Yes	Yes	SAME
Electricalsafety/EMC	IEC 60601 compliant	Tested to ANSI/AAMI 60601-1:2005 +C1:2009 + A2:2010 + A1:2012, CAN/CSA-C22.2 & 60601-1:2014 AND ANSI/AAMI60601-2-2:2017, CAN/CSA-C22.2 No.60601-2-2:2019. AND IEC 60601-1-2:2014/EN 60601-1-2:2015	Equivalent
RF energy delivery modes:
Continuousthermal	YES	YES	SAME
Stimulation-sensory andmotor	YES	YES	SAME
Pulsed RF	YES	YES	SAME
RF energy delivery channel types
Monopolar	YES	YES	SAME
Bipolar*	Yesaka "dual"	Yesaka "dual"	SAME

SUBSTANTIAL EQUIVALENCE COMPARISON AND DISCUSSION

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current between two monopolar electrodes

Any differences between the APEX 6 and the predicate 4-channel devices do not raise new issues of safety or effectiveness. The APEX 6 uses the same amount of energy output across 6 channels and delivers this energy sequentially as opposed to continuously. Therefore, the APEX 6 is substantially equivalent to the predicate device based upon the Indication for Use, technology, functional modes, hardware and software components, and performance.

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PERFORMANCE TESTING

Bench - Bench testing supports that the APEX 6 performs as expected. Safety was tested in accordance with Standard for Medical electrical equipment - Part 1: General requirements for basic safety and essential performance ANSI/AAMI 60601-1:2005 + Cl:2009 + A2:2010 + Al:2012, CAN/CSA-C22.2 No. 60601-1:2014 and the Standard for Medical Electrical Equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories ANSI/AAMI 60601-2-2:2017, CAN/CSA-C22.2 No. 60601-2-2:2019. EMC was tested in accordance with IEC 60601-1-2:2014/ EN 60601-1-2:2015/IEC 60601-2-2.

Test	Test Method Summary	Results
Lesion size	Purpose was to document the maximumlinear dimensions in all three planes aswell as the volume for the affected tissueregion and compare them to thepredicate device for minimal, typical, andmaximum energy delivery	Analysis: All affected area differences were lessthan 1 mm. Minor errors can introduced by:• Measuring small diameters with fuzzy borderscan increase the measurement error.• For volume, a 10% error in the lineardimensions will result in a 33% error in volume.Therefore this study confirms that the Apex 6and the predicate device are substantiallyequivalent in regards to affected tissue size.
Comparisonof treatmenttimesbetweenNeuroThermNT 2000and Apex 6	The purpose of this protocol is tomeasure and compare the time to rampup to set temperature of the Apex 6 andthe predicate device under worse caseconditions to evaluate the efficiency ofenergy delivery and measure treatmenttimes.	Results demonstrated that the APEX 6 wassubstantially equivalent in terms of treatmenttimes compared to the predicate device.
DesignValidationReview	A documented review of deviceacceptance criteria was performed toconfirm compliance with the followingplans:• Requirement Specification• Requirements, Design and VerificationTraceability Matrix• Embedded Software RequirementSpecification• GUI Software RequirementSpecification• Embedded Software Validation Plan• GUI Software Validation Plan• Instructions for Use	The finished unit design review verified that alldocumented device requirements were met.
Every unitfunctionaltest	Every unit manufactured is subjected to afull functional test regimen and the resultsare recorded in the Device HistoryRecord:Voltage checksProgram and Impedance TestingSoftware testingMain GUI	Each unit must pass all tests prior to shipment.
Test	Test Method Summary	Results
	Final testing: Impedance/TemperaturemeasurementElectrical safety testing

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Software - Software testing supports that the APEX 6 performs as expected. Validation was performed to the FDA Moderate Level of Concern per the FDA software guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

CLINICAL TESTING Not required.

CONCLUSION

The APEX 6 is similar to or the same as the predicate device as follows:

. Technology
Intended use/Indication for Use
Technical specifications, or ranges of technical specifications
. Functional modes compared to 4-channel devices

The fundamental technological characteristics of the APEX 6 are substantially equivalent to the predicate device based upon the Indication for Use, technology, functional modes, hardware components, and performance. Therefore, the APEX 6 is substantially equivalent to the predicate device.

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).