The NeuroOne OneRF Radiofrequency Ablation System is indicated for creation of radiofrequency lesions in nervous tissue for functional neurosurgical procedures.

Device Description

The OneRF™ Ablation System components consist of the:

Radiofrequency (RF) Generator and Accessories
Generator Interface Cable (GIC), Cart and Foot Pedal (optional)
sEEG-RF Probe (with Universal Cable Assembly) and Ablation Accessories
Temperature Accessory, Spacer Tubes, Stylet and RF Connector Box

The OneRF™ Ablation System uses radiofrequency ablation to create lesion (s) in an area of nervous tissue that the neurosurgeon has identified for ablation. This is accomplished by diagnostically locating the area to ablate using the implanted Stereoelectroencephalography (sEEG). Once the area of ablation is located, the generator and ablation accessories are taken to the patient with implanted sEEG(s). The sEEG(s) now function as an sEEG-RF Probe for RF ablation.

To perform the ablation the Temperature Accessory (TA) is inserted into the sEEG-RF Probe to the predetermined electrode contact location using the specified spacer tube. A stylet may be used to ensure the lumen is patent prior to inserting the TA. The universal cable assembly remains attached to the sEEG-RF Probe while its cables are disconnected from the diagnostic head box. One (monopolar) or two (bipolar) cables from the universal cable assembly are inserted into the radiofrequency connector box (RFCB) depending on the contact area(s) to be ablated. The TA is also connected to the RFCB is attached to the Generator Interface Cable which is attached to the Generator. Temperature and time are used to create lesion (s).

AI/ML Overview

The provided text describes the NeuroOne OneRF Ablation System, a radiofrequency lesion generator and probe indicated for creating radiofrequency lesions in nervous tissue for functional neurosurgical procedures.

Here's an analysis of the acceptance criteria and study proving the device meets them, based solely on the provided text:

Important Note: The provided text is a summary from an FDA 510(k) premarket notification. It describes the device, its intended use, comparison to predicate devices, and a high-level summary of performance testing. It does not contain detailed pass/fail acceptance criteria values for most tests or granular study design information (e.g., specific sample sizes for particular experiments, expert qualifications, or detailed ground truth methodologies beyond "lesion size was determined"). The information here is inferred from the "Results and Conclusions" section, which consistently states "Pass" or "Met applicable requirements."

1. Table of Acceptance Criteria and Reported Device Performance

Given the lack of specific quantitative acceptance criteria in the provided text, the table below will list the tests performed and their reported outcomes, implying that the device met the (unstated) acceptance criteria for each.

Acceptance Criteria (Implied)	Reported Device Performance
Lesion Size: Lesion sizes determined based on time and temperature should be comparable to the predicate.	Pass - Lesion sizes were determined based on time and temperature. Lesion size is comparable to predicate.
Dimensional Verification & RFCB Cable Durability: Dimensional characteristics and compatibility between components must be demonstrated; flexural durability of RFCB cables must be met.	Pass - The test results indicate that the sEEG-RF Probe / Temperature Accessory / Stylet / Spacer Tube and Radio Frequency Connector Box designs meet the dimensional and cable durability requirements.
Mechanical Performance: Specifications related to the mechanical interaction between the sEEG-RF Probe and Accessories must be verified.	Pass - The test results indicate that the sEEG-RF Probe / Temperature Accessory / Stylet / Spacer Tube and Radio Frequency Connector Box designs meet the mechanical performance requirements.
Mechanical Integrity: Mechanical durability of the sEEG-RF Probe Accessories must be demonstrated.	Pass - The test results indicate that the sEEG-RF Probe Accessories (Temperature Accessory and Radio Frequency Connector Box) designs meet the mechanical integrity requirements.
Ablation System Performance: Specifications related to energy delivery and temperature accuracy, including durability after use, must be met.	Pass - The test results indicate that the sEEG-RF Probe / Temperature Accessory / Stylet / Spacer Tube and Radio Frequency Connector Box designs meet the system performance requirements.
Generator System Performance: Specifications related to the Generator and UI Software must be met.	Pass - The test results indicate that the Generator and UI Software designs meet the system performance requirements.
Electrical Safety: Product must meet applicable requirements of Electromagnetic Compatibility and Electrical Safety standards (e.g., IEC 60601-1, -2, -6 and IEC 60601-2-2).	Pass - Met applicable requirements.
Temperature Accessory Kit and RFCB Package Integrity: Packaged device and labeling must withstand packaging, shelf life, and distribution testing (e.g., ISO 11607-1, ISTA 3A, ASTM D4169, ASTM F1980-16, ASTM 2096, ASTM F88) without loss of function, sterility, or legibility.	Pass - The test results indicate that the sEEG-RF Probe Accessories (Temperature Accessory / Stylet / Spacer Tube and Radio Frequency Connector Box) packaging designs meet the integrity requirements (i.e., seal strength, bubble leak, label inspection, and no damage that impacts device sterility).
Sterilization: Sterilization process must be validated to demonstrate a minimum SAL of 10-6 for the product using Ethylene Oxide per ISO 11135.	Pass - All criteria passed and the sterilization cycle was validated.
Usability - Summative Validation: Device must be found safe and effective for intended users, uses, and use environments, in accordance with FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices."	Pass – The NeuroOne OneRF™ Ablation System has been found to be safe and effective for the intended users, uses, and use environments.
Software: Software must address applicable requirements in accordance with FDA Guidance "Content of Premarket Submissions for Software Contained in Medical Devices" and IEC 62304.	Software analysis addressed applicable requirements.
Cybersecurity: Cybersecurity analysis must address applicable requirements in accordance with FDA guidance documents.	Cybersecurity analysis addressed applicable requirements.
Biocompatibility: Components with prolonged (>24 hours to 30 days) contact with tissue/bone and limited (<24 hours) contact with intact skin must pass biocompatibility tests.	Passed – Reference (K211367/K222404). (Note: Sterile components that have no direct or indirect patient contact did not require testing).

Details of the Study Proving Device Meets Acceptance Criteria:

Given the nature of the device (radiofrequency ablation system) and the provided 510(k) summary, the "study" primarily refers to a series of non-clinical performance tests rather than a typical clinical trial involving medical imaging data analysis.

Sample sizes used for the test set and the data provenance:
- Test Set (Non-Clinical Performance Tests): The document does not specify exact sample sizes for each non-clinical test (e.g., number of probes tested for durability, number of lesions created for size testing). It generally refers to these as "testing" or "activities."
- Data Provenance: Not explicitly stated, however, the tests are laboratory-based ("ex-vivo tissue" mentioned for lesion size testing) rather than human or geographical. All studies are described as "design verification and validation activities."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. For engineering performance tests (e.g., electrical safety, mechanical integrity, sterilization), "ground truth" is typically established by objective measurement against engineering specifications rather than expert consensus. For "Lesion Size Testing," the document states "Lesion sizes were determined based on time and temperature," implying measured outcomes rather than expert visual assessment establishing "ground truth."
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not mentioned. For engineering performance tests, outcomes are typically definitive (pass/fail against a specification) and do not usually involve adjudication in the way that clinical imaging studies might.
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. This type of study (MRMC for AI-assisted human readers) is not applicable to a radiofrequency ablation system as described. The device is a direct treatment tool, not an AI diagnostic aid that assists human readers in interpreting medical images.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device functions as a system with a human operator (neurosurgeon) in control ("Operator controlled; RF delivered from RF generator to compatible sEEG - RF probes to create lesions in nervous tissue"). Performance tests were conducted on the system, including the generator, probes, and software, to ensure it operates according to specifications. While software verification was done, the "standalone" performance in the context of an AI-only diagnostic algorithm is not relevant here.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For Lesion Size Testing: "Lesion sizes were determined based on time and temperature." This suggests direct physical measurement or calculation based on set parameters and observed outcomes, likely in ex-vivo tissue as mentioned in the table.
- For other engineering tests: The "ground truth" is adherence to established engineering specifications, international standards (e.g., IEC, ISO, ASTM), and design requirements. This is verified through direct measurement, functional testing, and environmental challenges.
The sample size for the training set:
- Not applicable. This device is not an AI/machine learning algorithm that requires a training set in the conventional sense for diagnostic image analysis. Its software facilitates control and monitoring of the ablation process. Software verification was conducted in accordance with relevant FDA guidance and IEC 62304.
How the ground truth for the training set was established:
- Not applicable, as there is no "training set" in the context of an AI algorithm learning from data. The software within the device is deterministic and performs control functions based on predefined algorithms and parameters. Ground truth for software verification typically involves demonstrating that the software meets its specified functional and non-functional requirements through testing against those requirements.

Summary

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December 6, 2023

NeuroOne Medical Technologies Corp. % John Doucet, Ph.D. Vice President, Regulatory Affairs - Neuromodulation and Evolving Technologies MCRA, LLC 803 7th Street, NW, 3rd Floor Washington, District of Columbia 20001

Re: K231675

Trade/Device Name: OneRF Ablation System Regulation Number: 21 CFR 882.4400 Regulation Name: Radiofrequency Lesion Generator Regulatory Class: Class II Product Code: GXD, GXI Dated: November 6, 2023 Received: November 6, 2023

Dear Dr. John Doucet:

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. Digitally signed by Adam D. Adam D. Pierce -S Pierce -S Date: 2023.12.06 15:41:45 -05'00' Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological

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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)

K231675

Device Name

NeuroOne OneRF Radiofrequency Ablation System

Indications for Use (Describe)

The NeuroOne OneRF Radiofrequency Ablation System is indicated for creation of radiofrequency lesions in nervous tissue for functional neurosurgical procedures.

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) Summarv K231675

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

510(k) Number:	K231675
Date Prepared:	December 6, 2023
Applicant:	NeuroOne Medical Technologies Corp.7599 Anagram DriveEden Prairie, MN 55344Phone: (952) 426-1383E-mail: debk@nmtc1.com
Contact Person:	Debra KridnerRegulatory Affairs Consultant7599 Anagram DriveEden Prairie, MN 55344

SUBJECT DEVICE

Trade/Device Name:	OneRF TM Ablation System
Device Regulation Number:	21 CFR§882.440021 CFR§882.4725
Device/Regulation Name:	Radiofrequency Lesion Generator, Radiofrequency Lesion Probe
Product Code:	GXDGXI
Device Class/RegulationClassification:	Class II

DEVICE DESCRIPTION (For the Device Subject to this 510(k) Premarket Notification)

OneRF™ Ablation System

The OneRF™ Ablation System components consist of the:

Radiofrequency (RF) Generator and Accessories 1.
Generator Interface Cable (GIC), Cart and Foot Pedal (optional) a.
1. sEEG-RF Probe (with Universal Cable Assembly) and Ablation Accessories
- a. Temperature Accessory, Spacer Tubes, Stylet and RF Connector Box

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PREDICATE DEVICE

NeuroOne has chosen a Radiofrequency Lesion Generator as our primary predicate device; specifically, the Cosman G4 Radiofrequency Generator that received marketing authorization after FDA review of K082051 and was cleared under 21 CFR 882.4400 (product code GXD). This RF Generator was chosen as the primary predicate because it has the same intended use, namely lesioning nervous tissue for neurosurgical procedures and similar technological characteristics as the subject device generator.

A second predicate device Radiofrequency Lesion Probe was chosen as RF lesions can only be created with a RF Generator and RF Probe. This device is the Diros OWL RF Probe which received marketing authorization after FDA review of K010202 and was cleared under 21 CFR 882.4725 (product code GXI). To create an RF Ablation System this RF Probe was chosen as an additional predicate because it has the same intended use as NeuroOne's sEEG-RF Probe: namely, to be connected to an RF Generator for lesioning nervous tissue for neurosurgical procedures and similar technological characteristics as the subject device probe.

The predicate devices were chosen as the Intended Use is the same. The Indications for Use, Fundamental Scientific Technology, and Principles of Operation are either the same or if different did not raise new questions of safety and/or effectiveness when compared to the subject device.

INDICATIONS FOR USE

The NeuroOne OneRF Radiofrequency Ablation System is indicated for creation of radiofrequency lessions in nervous tissue for functional neurosurgical procedures.

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COMPARISON OF SUBJECT DEVICE (SYSTEM) TO PRIMARY PREDICATE DEVICE (RF GENERATOR) and PREDICATE (RF PROBE)

Device Classification Comparison - Generator
	Subject Device	Primary PredicateDeviceK082051	ComparisonSame/Different
Trade/Device Name:	NeuroOne OneRFTMAblation SystemGenerator	Cosman RFGenerator	NA
Device RegulationNumber	21 CFR§882.4400	21 CFR§882.4400	Same
Device / RegulationName	Radiofrequency lesiongenerator	Radiofrequency lesiongenerator	Same
Device RegulationIdentification	A radiofrequency lesiongenerator is a deviceused to produce lesionsin the nervous system orother tissue by the directapplication ofradiofrequency currentsto selected sites.	A radiofrequency lesiongenerator is a deviceused to produce lesionsin the nervous system orother tissue by the directapplication ofradiofrequency currentsto selected sites.	Same
Product Codes	GXD	GXD	Same
Device Class / RegulationClassification	Class II	Class II	Same

DEVICE CLASSIFICATION COMPARISON - RF GENERATOR AND RF PROBE

Device Classification Comparison - Probe
	SubjectDevice	Predicate DeviceK010202	ComparisonSame/Different
Trade/Device Name:	NeuroOne OneRFTMAblation System sEEG-RF Probe	Diros RF Probe	NA
Device RegulationNumber	21 CFR§882.4725	21 CFR§882.4725	Same
Device / RegulationName:	Radiofrequency lesionprobe	Radiofrequency lesionprobe	Same
Device RegulationIdentification	A radiofrequency lesionprobe is a deviceconnected to aradiofrequency (RF)lesion generator todeliver the RF energy tothe site within thenervous system where alesion is desired.	A radiofrequency lesionprobe is a deviceconnected to aradiofrequency (RF)lesion generator to deliverthe RF energy to the sitewithin the nervous systemwhere a lesion is desired.	Same
Product Codes	GXI	GXI	Same
Device Class / RegulationClassification	Class II	Class II	Same

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INTENDED USE/INDICATIONS FOR USE COMPARISON TABLE – RF GENERATOR/RF PROBE (ABLATION SYSTEM)

Intended Use/Indications for Use Comparison RF Generator and RF Probe (Ablation System)
	Subject Device(RF Ablation System)K231675	Primary PredicateRF Generator K082051 andPredicate RF ProbeK010202	ComparisonSame/Different
IntendedUse	RF Ablation System consists ofa generator and probe used forlesioning nervous tissue forneurosurgical procedures.	RF Ablation System consists ofa generator and probe used forlesioning nervous tissue forneurosurgical procedures.	Same
Indicationsfor Use	The NeuroOne OneRFTMRadiofrequency AblationSystem is indicated for creationof radiofrequency lesions innervous tissue for functionalneurosurgical procedures.	RF GeneratorThe Cosman G4 RadiofrequencyGenerator is indicated for use inprocedurestocreateradiofrequency lesions for thetreatment of pain, or for lesioningnerve tissue for functionalneurosurgical procedures.TheCosmanG4Radiofrequency Generator isused with separately approvedCosmanRadiofrequencyProbesRF Probe1. Lesioning nerve tissue forfunctional neurosurgicalprocedures such asthalamotomies, pallidotomies,tractomies, and myelotomies;or2. radiofrequency heat lesionprocedures for the relief of pain	DifferentRemoved referenceto relief/treatmentof pain.The subject deviceindications for usedoes not separatelydefine a specificprobe or generatoras they are definedas part of theNeuroOne system.

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Technological and Performance Characteristics Comparison – RF Generator
	Subject Device	Primary PredicateDevice K082051	ComparisonSame/Different
Device name	NeuroOne OneRF™Generator	Cosman RFGenerator	N/A
RF Output Frequency	465.1 kHz	480 kHz	Different
Maximum output power(Hardware)	50 watts	50 watts	Same
Maximum output power(Software)	2 watts	50 watts	Different
Power delivery modes	Continuous and pulsed	Continuous and pulsed	Same
AC Power Compatibility	AC Line 100-240V	AC Line 100-240V	Same
Lesion Creation	Yes	Yes	Same
Temperature Monitoring	Yes	Yes	Same
Temperature Range (°C)	20 to 90	0 to 110	Different
Temperature Shut Off (°C)	90	>100	Different
Auto shutdown fortemperature exceedingsafe levels	Yes	Yes	Same
Electrical safety/EMCcompliant	IEC 60601-1 andIEC 60601-1-2 compliant	IEC 60601-1 andIEC 60601-1-2 compliant	Same
RF energy deliverymodes:	● Manual control● Temperature control	● Manual control● Temperature control	Same
RF energy deliverychannel types	MonopolarBipolar	MonopolarBipolar	Same
User TouchscreenInterface	Yes	Yes	Same
USB Port updatingsoftware anddownloading logs	Yes	Yes	Same

TECHNOLOGICAL AND PERFORMANCE CHARACTERISTICS COMPARISON

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Technological and Performance Characteristics Comparison - RF Probe
	Subject Device	Predicate DeviceK010202	ComparisonSame/Different
Device name	NeuroOne OneRF™sEEG-RF Probe	Diros RF Probe(Tasker IntracranialLesion Electrode)	N/A
RF ProbeConfiguration	Single open lumen probe(closed at tip)	Single closed lumenprobe	Same
TemperatureMeasurementCapabilities	Yes	Yes	Same
Location ofTemperature Sensor	On TemperatureAccessory (inserted intolumen of probe)	Embedded in probe tip	Different
Patient- ContactMaterials	Polyimide - electrodePlatinum - contact	Stainless steelInsulation - (medicalgrade, abrasionresistant)	Different
Compatibility with RFGenerator	Yes, NeuroOne RFGenerator (usingadapters)	Yes, Diros and CosmanRF Generators (usinglegally marketedadapters)	Same
Key Dimensions:
Electrode ActiveLength	2 mm	2 mm	Same
Diameter	0.8 mm	0.8 mm	Same
Number of Contacts	4 - 15 on each probeenabled for Ablation	1 on each probe	Different
Creation of Lesions inNervous Tissue	Yes	Yes	Same
Comparative LesionSize Testing in Ex-vivo Tissue	Yes	Yes	Same

System Characteristics
System Characteristic	Identification
User	Neurosurgeons familiar with RF lesion techniques
Anatomical Site ofUse	Nervous tissue
Access Method	Intracranial
EnergyType	Radiofrequency
Procedure Type	Ablation
Principle of Operation	Operator controlled; RF delivered from RF generator to compatible sEEG - RF probes to create lesions in nervous tissue
Mechanism ofAction	Cellular necrosis through thermal coagulation
System FeedbackMechanism	Temperature controlled
Ability to MakeMultiple Lesions	Yes

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SUMMARY OF PERFORMANCE TESTING AND STANDARDS

The following performance data were provided in support of the substantial equivalence determination for the subject NeuroOne OneRF™ Ablation System. Performance testing of the subject device (system) was conducted to demonstrate that the device (system) meets its performance specifications. Results of design verification and validation activities did not raise any new or different questions of safety or effectiveness. The risk management process was used throughout the non-clinical verification activities in accordance with ISO 14971. The following tests/analysis were conducted.

Non-Clinical Performance Tests
Test	Overview Summary	Results and Conclusions
Lesion Size Testing	This testing was performed toprovide a measurement of the size(width and length) of the lesion foreach active electrode contact:temperature, time, configuration(monopolar, bipolar), mode(temperature control, manual).	Lesion sizes were determined based on timeand temperature. Lesion size is comparableto predicate.
DimensionalVerification andRFCB CableDurability	This testing was performed toevaluate the dimensionalcharacteristics and to demonstratecompatibility between components.In addition, the flexural durability ofthe RFCB cables was tested.	Pass - The test results indicate that thesEEG-RF Probe / Temperature Accessory /Stylet / Spacer Tube and Radio FrequencyConnector Box designs meet thedimensional and cable durabilityrequirements.
MechanicalPerformance	This testing was performed to verifyspecifications related to themechanical interaction between thesEEG-RF Probe and Accessories	Pass - The test results indicate that thesEEG-RF Probe / Temperature Accessory /Stylet / Spacer Tube and Radio FrequencyConnector Box designs meet the mechanicalperformance requirements
Mechanical Integrity	This testing was performed toevaluate the mechanical durabilityof the sEEG-RF ProbeAccessories.	Pass - The test results indicate that thesEEG-RF Probe Accessories (TemperatureAccessory and Radio Frequency ConnectorBox) designs meet the mechanical integrityrequirements
Ablation SystemPerformance	The purpose of this testing is toevaluate specifications related toenergy delivery and temperatureaccuracy of the OneRF AblationSystem including durability afteruse.	Pass - The test results indicate that thesEEG-RF Probe / Temperature Accessory /Stylet / Spacer Tube and Radio FrequencyConnector Box designs meet the systemperformance requirements.
Generator System	This testing was performed to verifyspecifications related to theGenerator and UI Software.	Pass - The test results indicate that theGenerator and UI Software designs meet thesystem performance requirements.
Electrical Safety	Product shall meet the applicablerequirements of ElectromagneticCompatibility and Electrical Safetystandards - IEC 60601-1, -2, -6 andIEC 60601-2-2	Pass - Met applicable requirements
TemperatureAccessory Kit andRFCB PackageIntegrity	The packaged device and labelingshall withstand the conditions ofpackaging, shelf life, and distributiontesting to ISO 11607-1, ISTA 3A,ASTM D4169, ASTM F1980-16,ASTM 2096, ASTM F88without lossof function, sterility, or legibility.	Pass - The test results indicate that thesEEG-RF Probe Accessories (TemperatureAccessory / Stylet / Spacer Tube and RadioFrequency Connector Box) packagingdesigns meet the integrity requirements (i.e.,seal strength, bubble leak, label inspection,and no damage that impacts device sterility).
Sterilization	The sterilization process shall bevalidated to demonstrate aminimum of SAL of $10^{-6}$ for theproduct using Ethylene Oxide perISO 11135	Pass - All criteria passed and the sterilizationcycle was validated.
Usability -SummativeValidation•	This testing was performed inaccordance with FDA guidance,"Applying Human Factors andUsability Engineering to MedicalDevices", February 3, 2016	Pass – The NeuroOne OneRF™ AblationSystem has been found to be safe andeffective for the intended users, uses, anduse environments.
Software	Software was presented inaccordance with FDA Guidance"Content of Premarket Submissionsfor Software Contained in MedicalDevices "issued on: May 11, 2005).In addition, IEC 62304 wasfollowed, as applicable	Software analysis addressed applicablerequirements
Cybersecurity	Cybersecurity analysis wasperformed on the OneRF™Ablation System in accordancewith "Content of PremarketSubmissions for Management ofCybersecurity in Medical Devices"- Final Guidance October 2, 2014and "Cybersecurity in MedicalDevices: Quality SystemConsiderations and Content ofPremarket Submissions DraftGuidance for Industry and Foodand Drug Administration Staff" -Draft Guidance April 7, 2022.	Cybersecurity analysis addressed applicablerequirements

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Biocompatibility
Biocompatibility Overview	Conclusions
Components tested: sEEG Electrode (sEEG-RF Probe), Anchor Bolt,Cap with prolonged (>24 hours to 30 days) contact with tissue/bone.Components tested: Strain Relief, Lock Band, Stylet Assembly,Electrode Tail, and Electrode Connector with limited (<24 hours)contact with intact skin.	Passed – Reference(K211367/K222404)
OneRF Ablation System Sterile Components: TemperatureAccessory/Spacer Tubes/Stylet and Radio Frequency Connector Box	No testing - there is No direct orindirect patient contact

BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE

The subject device and predicate devices have the same Intended Use, Device Regulation Number/Name/Identification and Product Codes. The differences in the Indications for Use and Fundamental Scientific Technology between the subject device, OneRF™ Ablation System (RF Generator and RF Probe) and the predicate RF Generator (Cosman) and RF Probe (Diros) do not raise new questions regarding safety and effectiveness when compared. Conclusions drawn from the nonclinical testing demonstrate the device is as safe, as effective, and performs as well as the legally marketed device predicates, per 21 CFR 807.92(b)(3). The OneRF™ Ablation System is substantially equivalent to the 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).