The Racz Neurostat RF Generator is intended for lesioning of neural tissue. It is indicated for use in the peripheral nervous system. It is to be used with Epimed RF probes and cannula.

Device Description

The Racz Neruostat RF Generator is a touchscreen controlled Radio Frequency (RF) Generator used to lesion neural tissue for pain management. It has 4 outputs for delivering RF from a single source into the patient, it includes functions for nerve stimulation (Sensory and Motor), Continuous Thermal RF Lesioning, Pulsed RF Lesioning and Pulsed Dose RF Lesioning. The RF Energy is transmitted via each individual probe and a Neutral Electrode when in monopolar mode; or between probes when running in bipolar mode. The device will monitor the patient's impedance, probe temperature, along with the voltage and current of the RF Energy during a procedure.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them, structured according to your requested information.

Based on the provided FDA 510(k) summary for the Racz Neurostat RF Generator (K232632), the information focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with specific acceptance criteria that would typically be seen for a novel AI/software-based medical device.

The Racz Neurostat RF Generator is a radiofrequency lesion generator, a hardware device, and not an AI or software algorithm in the traditional sense that generates diagnostic output or assists human readers in interpretation. Therefore, many of the typical questions for AI/software performance studies (like sample size for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not directly applicable or explicitly detailed in this type of submission.

The "acceptance criteria" discussed in this document are primarily related to safety, electrical performance, and functional equivalence to a predicate device, rather than diagnostic accuracy or clinical effectiveness in the way an AI algorithm would be evaluated.

Acceptance Criteria and Device Performance (as inferred from the 510(k) summary)

The "acceptance criteria" for a hardware device like this are generally satisfied by demonstrating compliance with recognized standards and functional equivalence to a legally marketed predicate device.

Acceptance Criteria (Inferred)	Reported Device Performance
I. Safety & Electrical Performance:
1. Compliance with Electrical Safety Standards (IEC 60601-1)	Meets: IEC 60601-1 Compliant. Testing was performed.
2. Compliance with EMC Standards (IEC 60601-1-2)	Meets: IEC 60601-1-2 Compliant. Testing was performed.
3. Compliance with Particular Requirements (IEC 60601-2-2)	Meets: IEC 60601-2-2 Compliant. Testing was performed.
4. Excess Power Safety Feature functionality	Meets: Yes (Equivalent to predicate)
5. Excess Temperature Safety Feature functionality	Meets: Yes (Equivalent to predicate)
II. Functional Equivalence to Predicate Device:
1. Identical Indications for Use	Meets: "The predicate and subject device have identical indications for use."
2. Equivalent Power Output (Max W, per channel)	Meets: Max power output 98W split into 50W max per channel (Equivalent to predicate's 50W into 100 Ohms, as output per channel is the same).
3. Continuous RF Frequency	Meets: 460 kHz (Equivalent to predicate).
4. Stimulation - Sensory and Motor functionality	Meets: Yes (Equivalent to predicate).
5. Energy Delivered during multi-channel RF treatment	Meets: Continuous independent simultaneous energy delivery (Equivalent to predicate).
6. Continuous Thermal functionality	Meets: Yes (Equivalent to predicate).
7. Pulsed RF functionality	Meets: Yes (Equivalent to predicate).
8. Monopolar mode channels	Meets: 4 (Equivalent to predicate).
9. Bipolar mode functionality	Meets: Yes (Equivalent to predicate, aka "dual").
10. Hardware Performance (function as intended over lifetime)	Meets: "Testing was performed to demonstrate the hardware will function as intended through the expected lifetime of the device." (Equivalent to predicate's "Bench testing").
11. Comparative Lesion Testing Performance	Meets: "Comparative lesion testing was performed to support substantial equivalence to the predicate device." (This implies the lesions produced are comparable in desired characteristics to those produced by the predicate, though specific metrics are not provided).
12. Software Verification and Validation	Meets: "Software verification and validation testing was performed to ensure the generator met all relevant requirements." (Equivalent to predicate's "Software verification and validation testing"). This generally covers functionality, reliability, and security of the embedded software.
13. Usability	Meets: "Testing was performed to verify and validate the usability of the generator." This indicates that the device's user interface and operational aspects meet usability requirements (e.g., ease of use, error prevention) and are acceptable. Improvements like a larger screen and lighter weight also contribute to usability but are not explicitly quantified against a specific acceptance criterion here.

Detailed Study Information (Based on provided text):

As the device is a hardware RF generator with embedded software for control, the "study" is more akin to engineering testing and validation rather than a clinical trial assessing diagnostic performance.

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not applicable/not specified in the context of an FDA 510(k) for a hardware device like this. The "test set" for this device refers to the specific physical units or simulated environments on which engineering and performance tests were conducted. These are not datasets of patient images or clinical data.
Data Provenance: Not applicable. The "data" being generated and tested are electrical signals, temperature readings, and physical lesion formation, not patient-derived medical data. The tests are likely performed in a lab setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable for this type of device. "Ground truth" for this device would be established by engineering specifications, physical laws, and recognized medical device standards (e.g., a specific power output measured by calibrated equipment, or a lesion size measured by a pathologist/engineer during comparative testing). There's no subjective expert interpretation required in the same way as for image-based diagnostics.

4. Adjudication method for the test set:

Not applicable. The "adjudication" for this type of device involves comparing measured performance against engineering specifications and predicate performance, not resolving discrepancies between expert readings.

5. 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 systems that aid human interpretation (e.g., radiologists reading images). This device is a therapeutic generator, not a diagnostic aid.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The device inherently operates as a "standalone" therapeutic device, meaning its core function (generating RF energy) does not require "human-in-the-loop" interpretation for its primary output. However, it is human-controlled to perform procedures. Performance testing was done on the device itself (hardware and embedded software), as detailed in the "Performance Testing" section.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this device's performance would be established through a combination of:
- Engineering specifications: (e.g., accurate power output, temperature control).
- Measurement against calibrated standards: using specialized test equipment.
- Physical demonstration: (e.g., the ability to generate a lesion of a certain size/shape in a controlled medium during "Comparative Lesion Testing").
- Compliance with recognized standards: (e.g., IEC 60601 series).
- Functional equivalence to predicate: demonstrating it performs the same functions as the already cleared predicate device.

8. The sample size for the training set:

Not applicable. This device does not use machine learning in a way that requires a "training set" for an AI model.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for an AI model.

Summary

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May 24, 2024

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Epimed International % Robert Packard President, Medical Device Academy 141 Sal Landrio Drive. Crossroads Business Park Johnstown, NY 12095

Re: K232632

Trade/Device Name: Racz Neurostat RF Generator Regulation Number: 21 CFR 882.4400 Regulation Name: Radiofrequency Lesion Generator Regulatory Class: Class II Product Code: GXD Dated: April 26, 2024 Received: April 26, 2024

Dear Robert Packard:

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" (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).

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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 medical devices and radiation-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 Date: 2024.05.24 Pierce -S 17:13:00 -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

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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) K232632

Device Name Racz Neurstat RF Generator

Indications for Use (Describe)

The Racz Neurostat RF Generator is intended for lesioning of neural tissue. It is indicated for use in the peripheral nervous system. It is to be used with Epimed RF probes and cannula.

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) SUMMARY

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

SUBMITTER 1. Epimed International 141 Sal Landrio Dr. Crossroads Business Park Johnstown, NY 12095 Tel: +1.518.725.0209 ext. 1300

Contact Person:	Robert Packard
Date Prepared:	May 24, 2024

II. DEVICE
Name of Device:	Racz Neurostat RF Generator
Classification Name:	Radiofrequency lesion generator
Regulation:	21 CFR §882.4400
Regulatory Class:	Class II
Product Classification Code:	GXD

PREDICATE DEVICE III.

Predicate Manufacturer:	NeuroTherm, Inc.
Predicate Trade Name:	NT 2000 Lesioning Generator
Predicate 510(k):	K111576

No reference devices were used in this submission.

DEVICE DESCRIPTION IV.

V. INDICATIONS FOR USE

The Racz Neurostat RF Generator is intended for lesioning of neural tissue. It is indicated for use in the peripheral nervous system. It is to be used with Epimed RF probes and cannula.

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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVCE

The following characteristics were compared between the subject device and the predicate device in order to demonstrate substantial equivalence:

Indications for Use The predicate and subject device have identical indications for use. ● Both are intended for lesioning of neural tissue and for use in the peripheral nervous svstem.
Materials The predicate and subject device are made of equivalent materials. The . patient contact materials of the subject device are found in the probe, which has already been 510(k) cleared.
Design - The predicate and subject device have equivalent designs. Both devices supply continuous RF energy to the tissue causing the tissues surrounding the electrode to reach ablative temperatures.
Energy Source The predicate and subject devices both connect to mains power. Both are ● capable of delivering continuous RF energy at 460 kHz.
. Performance Testing - The predicate and subject device were tested against the applicable EMC and Electrical Safety IEC 60601 standards. The devices both underwent hardware performance testing to demonstrate that the hardware will function as intended through the expected lifetime of the device. Comparative lesion testing was performed to demonstrate performance equivalence compared against the predicate device. Software verification and validation testing were performed to ensure the generator met all relevant requirements. The subject device also conducted a usability test to validate the usability of the generator.

	Racz Neurostat RF Generator	NeuroTherm NT 2000 Lesioning Generator – K111576	Comments on SE
Indications for Use	The Racz Neurostat RFGenerator is intended forlesioning of neural tissue.It is indicated for use in theperipheral nervous system.It is to be used with EpimedRF probes and cannula.	Intended for use forlesioning of neural tissue.Indicated for use in theperipheral nervous system.To be used only with FDAcleared NeuroTherm RFprobes.To be used only with FDAcleared Smith & NephewSPINECATH andACUTHERM catheters.	Equivalentindications for use.
Power Output	Max power output 98W splitinto 50W max per channel	Max power output 50Winto 100 Ohms	Equivalent. Outputper channel is thesame
RF Board Design	Single board for all 4channels using multiplexing	1 board for each channel

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Continuous RFFrequency	460 kHz	460 kHz	Equivalent
Stimulation - Sensoryand Motor	Yes	Yes	Equivalent
Energy Deliveredduring multi channelRF treatment	Continuous independentsimultaneous energy delivery	Continuous independentsimultaneous energy delivery	Equivalent
Continuous Thermal	Yes	Yes	Equivalent
Pulsed RF	Yes	Yes	Equivalent
Monopolar	4	4	Equivalent
Bipolar	Yes	Yes aka "dual"	Equivalent
Printer	No	Yes	Not a necessary oruseful function toachieve intended use.
Wireless Mouse	No	No	Equivalent
Touch Screen	Yes	Full operation	Equivalent
Excess Power SafetyFeature	Yes	Yes	Equivalent
Excess TemperatureSafety Feature	Yes	Yes	Equivalent
Footprint	279 x 368 x 203 mm (w x h x d)	370 x 320 x 430 mm (w x h x d)	Smaller system iseasier to move.
Weight	12 lbs (6 kg)	11.4 kg	Lighter systemimproves usability.
TouchscreenDimensions	15.4" Diagonal	14" Diagonal	Larger screenincreases usability ofthe interface.
Electrical Safety/EMC	IEC 60601 Compliant	IEC 60601 Compliant	Equivalent

Testing Comparison

EMC and ElectricalSafety Product Testing	IEC 60601-1IEC 60601-1-2IEC 60601-2-2	IEC 60601	Equivalent
Hardware PerformanceTesting	Testing was performed todemonstrate the hardwarewill function as intendedthrough the expected lifetimeof the device.	Bench testing.	Equivalent
Comparative LesionTesting	Comparative lesion testingwas performed to supportsubstantial equivalence to thepredicate device.	Not referenced in 510(k)summary.	N/A
Software Verificationand Validation	Software verification andvalidation testing wasperformed to ensure thegenerator met all relevantrequirements.	Software verification andvalidation testing.	Equivalent

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Usability	Testing was performed toverify and validate theusability of the generator.	Not referenced in 510(k)summary.	N/A
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VIII. CONCLUSIONS

The Racz Neurostat RF Generator is similar or the same as the predicate as follows:

Technology ●
. Intended use/Indications for use
Technical Specifications, or ranges of technical specifications ●
Functional modes .

The testing demonstrates that the subject device performs as well as the predicate device and complies with all of the applicable electrical safety and ECM tests. Therefore, it is concluded that the subject device 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).