IonicRF Generator

K201610 · ABBOTT MEDICAL · GXD · Oct 21, 2020 · Neurology

Device Facts

• Record ID: K201610
• Device Name: IonicRF Generator
• Applicant: ABBOTT MEDICAL
• Product Code: GXD · Neurology
• Decision Date: Oct 21, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The IonicRF™ Generator, in combination with approved compatible electrodes and cannulae, is intended for lesioning of neural tissue in the nervous system as an aid in the management of pain.

Device Story

Desktop radiofrequency (RF) lesioning generator; 4-channel; portable. Inputs: user-selected parameters via capacitive touch screen and front-panel dial. Operation: provides continuous or pulsed RF output at 460 kHz; supports monopolar or dual electrode modes; includes Simplicity™ mode for large lesion creation. Features sensory and motor stimulation for electrode placement verification. Used in clinical settings by physicians. Output: RF energy delivered to neural tissue via compatible electrodes/cannulae; visual display of stimulation/lesioning data; treatment reports. Benefits: aids in pain management through targeted neural tissue lesioning. Device includes recordkeeping, user/treatment profile storage, and USB connectivity for data management.

Clinical Evidence

No clinical data. Substantial equivalence established via non-clinical bench testing, including EMC/electrical safety (IEC 60601-1, IEC 60601-1-2), hardware performance, comparative lesion testing, software verification/validation, and usability testing.

Technological Characteristics

Desktop RF generator; 4-channel; 460 kHz ± 3% output frequency; 50W max power; 700 mA max current. 12" capacitive touch screen interface. Connectivity: 2 USB ports. Mounting: countertop or roll stand. Biocompatible materials. Software-controlled stimulation and lesioning parameters. Compliant with IEC 60601-1 and IEC 60601-1-2.

Indications for Use

Indicated for pain management in the nervous system, including facet denervation, trigeminal rhizotomy, and related functional neurosurgical procedures.

Regulatory Classification

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.

Predicate Devices

• NeuroTherm NT2000 Lesioning Generator (K111576)

Submission Summary (Full Text)

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Image /page/0/Picture/0 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.

October 21, 2020

Jim Chapman Manager, Regulatory Affairs 5050 Nathan Lane Plymouth, Minnesota 55442

Re: K201610

Trade/Device Name: IonicRF™ Generator Regulation Number: 21 CFR 882.4400 Regulation Name: Radiofrequency Lesion Generator Regulatory Class: Class II Product Code: GXD Dated: September 16, 2020 Received: September 21, 2020

Dear Jim Chapman:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 (QS) 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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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

Enclosure

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# Indications for Use

510(k) Number (if known) K201610

Device Name IonicRF™ Generator

Indications for Use (Describe)

The lonicRF™ Generator, in combination with approved compatible electrodes and cannulae, is an aid in the management of pain in the nervous system. Examples include, facet denervation, trigeminal rhizotomy, and related functional neurosurgical procedures.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|---------------------------------------------|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |

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| 510(k) Number: | K201610 |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Type: | Traditional 510(k) |
| Manufacturer<br>Name &<br>Address | Abbott Medical<br>5050 Nathan Lane North<br>Plymouth, Minnesota, 55442<br>USA |
| Contact Person | Jim Chapman<br>Manager, Regulatory Affairs<br>972-526-4624<br>[e-mail] |
| Device Information | |
| Trade Name | IonicRF™ Generator |
| Common<br>Name | Radiofrequency lesion generator |
| Class | II |
| Classification<br>Name | 882.4400 Generator, Lesion, Radiofrequency |
| Product Code | GXD |
| Predicate<br>Device | NeuroTherm NT2000 Lesioning Generator (K111576) |
| Device<br>Description | The Abbott IonicRF™ Generator is a desktop radiofrequency (RF) lesioning generator, which<br>is intended for lesioning of neural tissue in the peripheral nervous system as an aid in the<br>management of pain.<br><br>The generator is portable and can be placed on a level surface using the countertop stand or<br>mounted to a compatible roll stand using the optional pole mount.<br><br>The IonicRF™ Generator is a multi-lesioning, 4 channel portable generator that can provide<br>continuous or pulsed RF output at 460 KHz, monopolar or dual electrode modes, and a<br>Simplicity™ mode for large lesion creation. The generator includes sensory and motor<br>stimulation functions to fine-tune electrode placement before procedures are performed. The<br>generator is also designed to be compatible with all existing Abbott electrodes and cannulas.<br><br>Device features include a touch screen monitor incorporating microprocessor and graphics<br>display for user interface, and recordkeeping functions. The user interface controls all<br>functions of the generator. The generator incudes a dial on the front for control of stimulation<br>level during stimulation and motor testing. The IonicRF™ Generator can be set on a flat<br>surface or mounted on a pole with the accessory pole mount bracket.<br><br>The IonicRF™ Generator can be used with previously cleared Abbott RF Electrodes<br>(K011387, K111576), and Cannula/Introducers (K042375, K000073) used with the predicate<br>device. |
| Indications<br>for Use | The IonicRF™ Generator, in combination with approved compatible electrodes and cannulae,<br>is indicated as an aid in the management of pain in the nervous system. Examples include,<br>facet denervation, trigeminal rhizotomy, and related functional neurosurgical procedures. |
| Intended Use | The IonicRF™ Generator, in combination with approved compatible electrodes and cannulae,<br>is intended for lesioning of neural tissue in the nervous system as an aid in the management<br>of pain. |

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## Comparison of Technological Characteristics with the Predicate Device

The predicate device is the Abbott NeuroTherm™ NT2000 generator. The intended use of the lonicRF™ Generator and the predicate device is the same. Both are indicated for the lesioning of neural tissue.

Based on comparison of intended use and technical characteristics, the lonicRF™ Generator is similar to the legally marketed predicates. Hardware and software verification and validation demonstrated the lonicRF Generator meets performance specifications. Any differences between the lonicRF™ Generator and predicate devices do not raise new types of questions of safety and effectiveness. Therefore, the lonicRF™ Generator is substantially equivalent to the predicate device.

### Substantial Equivalence Table

| Parameter | Subject Device<br>Abbott Medical<br>lonicRF™ Generator | Primary Predicate<br>Abbott Medical (NeuroTherm™)<br>NT2000 Generator | Equivalency<br>Discussion |
|-------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | TBD | K111576 | Not Applicable |
| Product Code | GXD | GXD | Equivalent to predicate |
| Indication for Use | The lonicRF™ Generator, in<br>combination with approved<br>compatible electrodes and<br>cannulae, is indicated as an aid in<br>the management of pain in the<br>nervous system. Examples<br>include, facet denervation,<br>trigeminal rhizotomy, and related<br>functional neurosurgical<br>procedures. | The NT2000 is intended for use<br>for lesioning of neural tissue. The<br>NT2000 is indicated for use in the<br>peripheral nervous system.<br>The NT2000 is to be used only<br>with FDA cleared NeuroTherm RF<br>probes and Smith & Nephew<br>SPINCATH and ACUTHERM<br>catheters | The verbiage is different, but the<br>differences do not raise<br>new issues of safety and<br>effectiveness since the lonicRF<br>Generator is used in the same<br>manner as the predicate for the same<br>procedures using the same<br>accessories. Neural tissue lesioning<br>is used by physicians to aid in the<br>management of pain |
| Modes of<br>Operation | Pulsed and continuous lesioning.<br>Sensory and motor stimulation. | Pulsed and continuous lesioning.<br>Sensory and motor stimulation. | Equivalent to predicate |
| Generator<br>Dimensions | 35.3 cm H x 32.8 cm<br>W x 28.6 cm D | 32.0 cm H x 37.0 cm<br>W x 43.0 cm D | The lonicRF™ Generator is similar in<br>height and width to the predicate. The |
| Maximum Weight | 7.3 kg (16.0 lb) | 12 kg (26.4 lb) | proposed generator is thinner and<br>weighs 10 lbs less than the predicate |
| Display | 30.5 cm (12") diagonal, 1024x768<br>pixels, Capacitive Touch Screen | 12" 1366x768 Touch Screen | The lonicRF has the same size touch<br>screen |
| Number of<br>electrode<br>Connections | 4 | 4 | Equivalent to predicate |
| Monopolar/Bipolar | Both | Both | Equivalent to predicate |
| Output Energy | 50 watts | 50 watts | Equivalent to predicate |
| Maximum Current | 700 mA | 625 mA | Similar. This is a function of the<br>power management. In addition,<br>700mA is the limit specified in IEC<br>60601-2-2 |
| Measuring<br>Frequency | 460 kHz ± 3% | 460 kHz ± 3% | Equivalent to predicate |
| Able to Mount<br>on a Roll Stand | Yes | No | Added feature of the lonicRF<br>Generator |
| Uses all of<br>Abbott's Cannulas<br>and Electrodes | Yes | Yes | Equivalent to predicate |
| Printer Connection | No | Yes | Removed feature not frequently used |
| USB for<br>Flash Drive | Yes (2) | Yes (1) | Similar, IonicRF™ Generator has 2 |
| Ability to Store<br>User Profiles and<br>Treatment Profiles | Yes | Yes | |
| Ability to be<br>Upgraded | Yes | Yes | Equivalent to predicate |
| Ability to Generate<br>Treatment Reports | Yes | Yes | |
| Probe Recognition | Yes | Yes | |

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# Non-Clinical Testing Summary

Non-clinical testing included assessment of the physical properties of the IonicRF™ Generator to ensure the lonicRF™ Generator met all of the performance requirements and specifications. The test results demonstrated the suitability of the lonicRF™ Generator for its intended use and supported the substantial equivalence to the predicate device. Risk management in accordance with ISO 14971 was used throughout the non-clinical verification activities. Testing included the following:

| Test | Test Summary | Results |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| EMC and Electrical<br>Product Safety<br>Testing | The IonicRF Generator together<br>with approved accessories were<br>tested in accordance with IEC<br>60601-1 and IEC 60601-1-2. | The IonicRF™ Generator met<br>all relevant requirements<br>confirming compliance with<br>IEC 61601-1 and<br>IEC 60601-1-2. |
| Hardware<br>Performance<br>Testing | Testing was performed to<br>demonstrate the hardware will<br>function as intended through the<br>expected lifetime of the device. | The hardware testing met all<br>performance requirements. |
| Comparative<br>Lesion Testing | Comparative lesion testing was<br>performed to support substantial<br>equivalence of the IonicRF™<br>Generator to the predicate. | The generator met all<br>performance requirements<br>and supports the substantial<br>equivalence to the predicate<br>device. |
| Software<br>Verification and<br>Validation | Software verification and<br>validation testing was performed<br>to ensure the generator met all<br>relevant requirements. | Testing demonstrated the<br>IonicRF™ Generator met all<br>software requirements. |
| Usability | Testing was performed to verify<br>and validate the usability of the<br>IonicRF™ Generator. | The generator met all<br>usability requirements.<br>Results support the<br>substantial equivalence to the<br>predicate device. |

A biocompatibility assessment of the device was performed and established, based on the materials of construction that the lonicRF™ Generator is biocompatible.

- Clinical Testing Based on substantial equivalence to the predicate device and results of testing, clinical studies were not required to establish substantial equivalence of the lonicRF™ Generator.
- Based on comparison of intended use and technical characteristics, the lonicRF™ Statement of Equivalence Generator is similar to the legally marketed predicate. Hardware and software verification and validation demonstrated the lonicRF™ Generator met all performance specifications. Any differences between the lonicRF™ Generator and the predicate device do not raise new types of questions of safety and effectiveness. Therefore, the lonicRF™ Generator is substantially equivalent to the predicate device.