(421 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard RF lesioning technology with microprocessor control for user interface and basic functions.
Yes
The device's intended use is for "lesioning of neural tissue and for pain management," which are therapeutic interventions.
No
This device is described as an RF lesioning generator intended for lesioning neural tissue and pain management, which is a therapeutic function, not diagnostic. While it has "sensory and motor stimulation functions to fine tune electrode placement," this is for optimizing a therapeutic procedure, not for diagnosing a condition.
No
The device description explicitly states it is a "desktop RF lesioning generator" and mentions hardware components like a touch screen monitor, microprocessor, and graphics display. It also connects to physical electrodes and cannulae.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for lesioning of neural tissue and for pain management" and is used in the "peripheral nervous system." This describes a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a "desktop RF lesioning generator" that "connects to LCCS FDA cleared lesioning probes which are inserted into patients for lesioning of neural tissue during medical procedures." This confirms it's an active medical device used for treatment within the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body) to provide diagnostic information. The device's function is to deliver energy for therapeutic purposes.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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.
Product codes
GXD
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.
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
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.
Lesion size: Purpose was to document the maximum linear dimensions in all three planes as well as the volume for the affected tissue region and compare them to the predicate device for minimal, typical, and maximum energy delivery. Results: All affected area differences were less than 1 mm. Minor errors can introduced by: Measuring small diameters with fuzzy borders can increase the measurement error. For volume, a 10% error in the linear dimensions will result in a 33% error in volume. Therefore this study confirms that the Apex 6 and the predicate device are substantially equivalent in regards to affected tissue size.
Comparison of treatment times between NeuroTherm NT 2000 and Apex 6: The purpose of this protocol is to measure and compare the time to ramp up to set temperature of the Apex 6 and the predicate device under worse case conditions to evaluate the efficiency of energy delivery and measure treatment times. Results: demonstrated that the APEX 6 was substantially equivalent in terms of treatment times compared to the predicate device.
Design Validation Review: A documented review of device acceptance criteria was performed to confirm compliance with the following plans: Requirement Specification, Requirements, Design and Verification Traceability Matrix, Embedded Software Requirement Specification, GUI Software Requirement Specification, Embedded Software Validation Plan, GUI Software Validation Plan, Instructions for Use. Results: The finished unit design review verified that all documented device requirements were met.
Every unit functional test: Every unit manufactured is subjected to a full functional test regimen and the results are recorded in the Device History Record: Voltage checks, Program and Impedance Testing, Software testing, Main GUI. Results: Each unit must pass all tests prior to shipment.
Software Validation: 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
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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
1
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
2
Indications for Use
510(k) Number (if known) K220122
Device Name APEX 6
Indications for Use (Describe)
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.
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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3
510(k) Summary K220122
Date Prepared: March 10, 2023
| SUBMITTED BY: | RF Innovations, Inc
Middleton, 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 |
4
| Regulatory Class: | Class I |
|---|---|
| Product Code: | GEI |
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.
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.
| | NeuroTherm
NT 2000
Generator K111576 | RF Innovations
APEX 6
Generator K220122 | Discussion |
|---------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| Indication
for Use | The NT 2000 is intended for use for
lesioning of neural tissue. The NT
2000 is indicated for use in the
peripheral nervous system. The NT
2000 is to be used only, with FDA
cleared NeuroTherm RF probes and
Smith & Nephew SPINECATH and
ACUTHERM catheters, catheters. | 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. | SIMILAR |
| Appearance | Image: NeuroTherm NT 2000 Generator | Image: RF Innovations APEX 6 Generator | SIMILAR |
| Touchscreen
dimensions | 12" diagonal LCD | 15" diagonal LCD | SIMILAR |
| Number of
Channels | 4 | 6 | Same max
power
delivered |
| RF Output
Frequency | 460 kHz | 460 kHz | SAME |
| Maximum
output
power (100
ohm load) | 50 watts | 50 watts | SAME |
| Energy
delivery
during multi
channel RF
treatment | Independent sequential energy delivery | Independent sequential energy delivery | SAME |
| Power
delivery
modes | Continuous and pulsed | Continuous and pulsed | SAME |
| Power
supply | AC Line | AC Line | SAME |
| Auto
shutdown
for power
exceeding
safe levels | Yes | Yes | SAME |
| Electrical
safety/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/AAMI
60601-2-2:2017, 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: | | | |
| Continuous
thermal | YES | YES | SAME |
| Stimulation-
sensory and
motor | YES | YES | SAME |
| Pulsed RF | YES | YES | SAME |
| RF energy delivery channel types | | | |
| Monopolar | YES | YES | SAME |
| Bipolar* | Yes
aka "dual" | Yes
aka "dual" | SAME |
SUBSTANTIAL EQUIVALENCE COMPARISON AND DISCUSSION
5
- 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.
6
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 maximum | |
| linear dimensions in all three planes as | ||
| well as the volume for the affected tissue | ||
| region and compare them to the | ||
| predicate device for minimal, typical, and | ||
| maximum energy delivery | Analysis: All affected area differences were less | |
| than 1 mm. Minor errors can introduced by: | ||
| • Measuring small diameters with fuzzy borders | ||
| can increase the measurement error. | ||
| • For volume, a 10% error in the linear | ||
| dimensions will result in a 33% error in volume. | ||
| Therefore this study confirms that the Apex 6 | ||
| and the predicate device are substantially | ||
| equivalent in regards to affected tissue size. | ||
| Comparison | ||
| of treatment | ||
| times | ||
| between | ||
| NeuroTherm | ||
| NT 2000 | ||
| and Apex 6 | The purpose of this protocol is to | |
| measure and compare the time to ramp | ||
| up to set temperature of the Apex 6 and | ||
| the predicate device under worse case | ||
| conditions to evaluate the efficiency of | ||
| energy delivery and measure treatment | ||
| times. | Results demonstrated that the APEX 6 was | |
| substantially equivalent in terms of treatment | ||
| times compared to the predicate device. | ||
| Design | ||
| Validation | ||
| Review | A documented review of device | |
| acceptance criteria was performed to | ||
| confirm compliance with the following | ||
| plans: | ||
| • Requirement Specification | ||
| • Requirements, Design and Verification | ||
| Traceability Matrix | ||
| • Embedded Software Requirement | ||
| Specification | ||
| • GUI Software Requirement | ||
| Specification | ||
| • Embedded Software Validation Plan | ||
| • GUI Software Validation Plan | ||
| • Instructions for Use | The finished unit design review verified that all | |
| documented device requirements were met. | ||
| Every unit | ||
| functional | ||
| test | Every unit manufactured is subjected to a | |
| full functional test regimen and the results | ||
| are recorded in the Device History | ||
| Record: | ||
| Voltage checks | ||
| Program and Impedance Testing | ||
| Software testing | ||
| Main GUI | Each unit must pass all tests prior to shipment. | |
| Test | Test Method Summary | Results |
| Final testing: Impedance/Temperature | ||
| measurement | ||
| Electrical safety testing |
7
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.