(268 days)
No reference devices were used in this submission.
No
The summary describes a standard RF generator for pain management with monitoring capabilities, but there is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is described as "lesioning of neural tissue" for "pain management," which is a therapeutic intervention.
No
The device is described as an RF Generator used to lesion neural tissue for pain management. This indicates a therapeutic function rather than a diagnostic one. While it monitors patient impedance, probe temperature, voltage, and current, these are parameters for controlling the lesioning process, not for diagnosing a condition.
No
The device description explicitly states it is a "Radio Frequency (RF) Generator" and mentions hardware components like outputs, probes, cannula, and a neutral electrode, along with hardware performance testing.
Based on the provided information, the Racz Neurostat RF Generator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is "lesioning of neural tissue" in the "peripheral nervous system" for "pain management." This involves a direct intervention on the patient's body.
- Device Description: The device delivers radio frequency energy to the patient via probes and a neutral electrode to create lesions. It monitors physiological parameters like impedance and temperature during the procedure.
- Lack of In Vitro Activity: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information about a physiological state, health, or disease. This device does not perform any such analysis on specimens.
The Racz Neurostat RF Generator is a therapeutic device used for a medical procedure performed directly on the patient.
N/A
Intended Use / 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.
Product codes
GXD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral nervous system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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).
1
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
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
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.
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.
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.
5
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 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. | Intended for use for
lesioning of neural tissue.
Indicated for use in the
peripheral nervous system.
To be used only with FDA
cleared NeuroTherm RF
probes.
To be used only with FDA
cleared Smith & Nephew
SPINECATH and
ACUTHERM catheters. | Equivalent
indications for use. |
| Power Output | Max power output 98W split
into 50W max per channel | Max power output 50W
into 100 Ohms | Equivalent. Output
per channel is the
same |
| RF Board Design | Single board for all 4
channels using multiplexing | 1 board for each channel | |
6
| Continuous RF
| Frequency | 460 kHz | 460 kHz | Equivalent |
|---|---|---|---|
| Stimulation - Sensory | |||
| and Motor | Yes | Yes | Equivalent |
| Energy Delivered | |||
| during multi channel | |||
| RF treatment | Continuous independent | ||
| simultaneous energy delivery | Continuous independent | ||
| simultaneous 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 or |
| useful function to | |||
| achieve intended use. | |||
| Wireless Mouse | No | No | Equivalent |
| Touch Screen | Yes | Full operation | Equivalent |
| Excess Power Safety | |||
| Feature | Yes | Yes | Equivalent |
| Excess Temperature | |||
| Safety 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 is |
| easier to move. | |||
| Weight | 12 lbs (6 kg) | 11.4 kg | Lighter system |
| improves usability. | |||
| Touchscreen | |||
| Dimensions | 15.4" Diagonal | 14" Diagonal | Larger screen |
| increases usability of | |||
| the interface. | |||
| Electrical Safety/EMC | IEC 60601 Compliant | IEC 60601 Compliant | Equivalent |
Testing Comparison
| EMC and Electrical
Safety Product Testing | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-2 | IEC 60601 | Equivalent |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|------------|
| Hardware Performance
Testing | Testing was performed to
demonstrate the hardware
will function as intended
through the expected lifetime
of the device. | Bench testing. | Equivalent |
| Comparative Lesion
Testing | Comparative lesion testing
was performed to support
substantial equivalence to the
predicate device. | Not referenced in 510(k)
summary. | N/A |
| Software Verification
and Validation | Software verification and
validation testing was
performed to ensure the
generator met all relevant
requirements. | Software verification and
validation testing. | Equivalent |
7
| Usability | Testing was performed to
verify and validate the
usability of the generator. | Not referenced in 510(k)
summary. | N/A |
| ----------- | ------------------------------------------------------------------------------------ | -------------------------------------- | ----- |
|---|
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.