(128 days)
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.
The Abbott IonicRF™ Generator is a desktop radiofrequency (RF) lesioning generator, which is intended for lesioning of neural tissue in the peripheral nervous system as an aid in the management of pain.
The generator is portable and can be placed on a level surface using the countertop stand or mounted to a compatible roll stand using the optional pole mount.
The IonicRF™ Generator is a multi-lesioning, 4 channel portable generator that can provide continuous or pulsed RF output at 460 KHz, monopolar or dual electrode modes, and a Simplicity™ mode for large lesion creation. The generator includes sensory and motor stimulation functions to fine-tune electrode placement before procedures are performed. The generator is also designed to be compatible with all existing Abbott electrodes and cannulas.
Device features include a touch screen monitor incorporating microprocessor and graphics display for user interface, and recordkeeping functions. The user interface controls all functions of the generator. The generator incudes a dial on the front for control of stimulation level during stimulation and motor testing. The IonicRF™ Generator can be set on a flat surface or mounted on a pole with the accessory pole mount bracket.
The IonicRF™ Generator can be used with previously cleared Abbott RF Electrodes (K011387, K111576), and Cannula/Introducers (K042375, K000073) used with the predicate device.
The IonicRF™ Generator is a device intended for radiofrequency lesioning of neural tissue as an aid in pain management. The provided document does not contain acceptance criteria or study details in the typical sense of a clinical performance study for an AI/ML medical device. Instead, it demonstrates substantial equivalence to a predicate device (NeuroTherm NT2000 Lesioning Generator (K111576)) through non-clinical testing.
Here's the breakdown of the information available in relation to your request:
1. A table of acceptance criteria and the reported device performance
The document provides a comparison of technological characteristics between the IonicRF™ Generator and its predicate device, and a summary of non-clinical testing. These serve as the performance evaluation for substantial equivalence.
| Acceptance Criteria (Parameter) | Reported Device Performance (IonicRF™ Generator) | Predicate Performance (NeuroTherm™ NT2000 Generator) | Equivalency Discussion / Results |
|---|---|---|---|
| Product Code | GXD | GXD | Equivalent to predicate |
| Indication for Use | The IonicRF™ Generator, in combination with approved compatible electrodes and cannulae, is indicated as an aid in the management of pain in the nervous system. Examples include, facet denervation, trigeminal rhizotomy, and related functional neurosurgical procedures. | The NT2000 is intended for use for lesioning of neural tissue. The NT2000 is indicated for use in the peripheral nervous system. The NT2000 is to be used only with FDA cleared NeuroTherm RF probes and Smith & Nephew SPINCATH and ACUTHERM catheters | The verbiage is different, but the differences do not raise new issues of safety and effectiveness since the IonicRF™ Generator is used in the same manner as the predicate for the same procedures using the same accessories. Neural tissue lesioning is used by physicians to aid in the management of pain. |
| Modes of Operation | Pulsed and continuous lesioning. Sensory and motor stimulation. | Pulsed and continuous lesioning. Sensory and motor stimulation. | Equivalent to predicate |
| Generator Dimensions | 35.3 cm H x 32.8 cm W x 28.6 cm D | 32.0 cm H x 37.0 cm W x 43.0 cm D | The IonicRF™ Generator is similar in height and width to the predicate. The proposed generator is thinner and weighs 10 lbs less than the predicate. |
| Maximum Weight | 7.3 kg (16.0 lb) | 12 kg (26.4 lb) | Proposed generator is thinner and weighs 10 lbs less than the predicate. |
| Display | 30.5 cm (12") diagonal, 1024x768 pixels, Capacitive Touch Screen | 12" 1366x768 Touch Screen | The IonicRF has the same size touch screen |
| Number of electrode 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 power management. In addition, 700mA is the limit specified in IEC 60601-2-2. |
| Measuring Frequency | 460 kHz ± 3% | 460 kHz ± 3% | Equivalent to predicate |
| Able to Mount on a Roll Stand | Yes | No | Added feature of the IonicRF™ Generator |
| Uses all of Abbott's Cannulas and Electrodes | Yes | Yes | Equivalent to predicate |
| Printer Connection | No | Yes | Removed feature not frequently used. |
| USB for Flash Drive | Yes (2) | Yes (1) | Similar, IonicRF™ Generator has 2. |
| Ability to Store User Profiles and Treatment Profiles | Yes | Yes | Equivalent to predicate |
| Ability to be Upgraded | Yes | Yes | Equivalent to predicate |
| Ability to Generate Treatment Reports | Yes | Yes | Equivalent to predicate |
| Probe Recognition | Yes | Yes | Equivalent to predicate |
| EMC and Electrical Product Safety Testing | The IonicRF™ Generator met all relevant requirements confirming compliance with IEC 60601-1 and IEC 60601-1-2. | N/A (implied compliance for predicate, not explicitly stated as an acceptance criterion for the predicate in this document) | Met all relevant requirements. |
| Hardware Performance Testing | The hardware testing met all performance requirements. | N/A | Met all performance requirements. |
| Comparative Lesion Testing | The generator met all performance requirements and supports the substantial equivalence to the predicate device. | N/A (implied comparable lesion creation to predicate) | Met all performance requirements and supports substantial equivalence. |
| Software Verification and Validation | Testing demonstrated the IonicRF™ Generator met all software requirements. | N/A (implied predicate has validated software) | Met all software requirements. |
| Usability | The generator met all usability requirements. Results support the substantial equivalence to the predicate device. | N/A (implied predicate has established usability) | Met all usability requirements. Results support substantial equivalence. |
| Biocompatibility | Established that the IonicRF™ Generator is biocompatible based on materials of construction. | N/A | Biocompatible. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes a medical device (radiofrequency generator), not an AI/ML software. Therefore, there isn't a "test set" in the context of image data or patient data for an algorithm. The "testing" refers to non-clinical verification and validation activities of the hardware and software. No specific sample sizes for these tests (e.g., number of devices tested, number of lesion creations) or data provenance (as it pertains to human-derived data) are detailed in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. As this is a hardware device undergoing non-clinical testing for substantial equivalence, there is no "ground truth" establishment by medical experts in the way an AI/ML diagnostic algorithm would require.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no test set of patient cases requiring adjudication by experts.
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
Not applicable. This device is a radiofrequency generator, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a radiofrequency generator, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical testing, the "ground truth" is defined by the technical specifications, performance requirements, and established standards (e.g., IEC 60601-1, IEC 60601-1-2). For instance, for comparative lesion testing, the "ground truth" would be the expected characteristics of a lesion created by a radiofrequency generator, likely determined through validated experimental methods and comparison to the predicate.
8. The sample size for the training set
Not applicable. This device is a radiofrequency generator, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for an AI/ML algorithm.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) |
| ManufacturerName &Address | Abbott Medical5050 Nathan Lane NorthPlymouth, Minnesota, 55442USA |
| Contact Person | Jim ChapmanManager, Regulatory Affairs972-526-4624jim.chapman@abbott.com |
| Device Information | |
| Trade Name | IonicRF™ Generator |
| CommonName | Radiofrequency lesion generator |
| Class | II |
| ClassificationName | 882.4400 Generator, Lesion, Radiofrequency |
| Product Code | GXD |
| PredicateDevice | NeuroTherm NT2000 Lesioning Generator (K111576) |
| DeviceDescription | The Abbott IonicRF™ Generator is a desktop radiofrequency (RF) lesioning generator, whichis intended for lesioning of neural tissue in the peripheral nervous system as an aid in themanagement of pain.The generator is portable and can be placed on a level surface using the countertop stand ormounted to a compatible roll stand using the optional pole mount.The IonicRF™ Generator is a multi-lesioning, 4 channel portable generator that can providecontinuous or pulsed RF output at 460 KHz, monopolar or dual electrode modes, and aSimplicity™ mode for large lesion creation. The generator includes sensory and motorstimulation functions to fine-tune electrode placement before procedures are performed. Thegenerator is also designed to be compatible with all existing Abbott electrodes and cannulas.Device features include a touch screen monitor incorporating microprocessor and graphicsdisplay for user interface, and recordkeeping functions. The user interface controls allfunctions of the generator. The generator incudes a dial on the front for control of stimulationlevel during stimulation and motor testing. The IonicRF™ Generator can be set on a flatsurface or mounted on a pole with the accessory pole mount bracket.The IonicRF™ Generator can be used with previously cleared Abbott RF Electrodes(K011387, K111576), and Cannula/Introducers (K042375, K000073) used with the predicatedevice. |
| Indicationsfor Use | The IonicRF™ Generator, in combination with approved compatible electrodes and cannulae,is indicated as an aid in the management of pain in the nervous system. Examples include,facet denervation, trigeminal rhizotomy, and related functional neurosurgical procedures. |
| 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 managementof 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 DeviceAbbott MedicallonicRF™ Generator | Primary PredicateAbbott Medical (NeuroTherm™)NT2000 Generator | EquivalencyDiscussion |
|---|---|---|---|
| 510(k) | TBD | K111576 | Not Applicable |
| Product Code | GXD | GXD | Equivalent to predicate |
| Indication for Use | The lonicRF™ Generator, incombination with approvedcompatible electrodes andcannulae, is indicated as an aid inthe management of pain in thenervous system. Examplesinclude, facet denervation,trigeminal rhizotomy, and relatedfunctional neurosurgicalprocedures. | The NT2000 is intended for usefor lesioning of neural tissue. TheNT2000 is indicated for use in theperipheral nervous system.The NT2000 is to be used onlywith FDA cleared NeuroTherm RFprobes and Smith & NephewSPINCATH and ACUTHERMcatheters | The verbiage is different, but thedifferences do not raisenew issues of safety andeffectiveness since the lonicRFGenerator is used in the samemanner as the predicate for the sameprocedures using the sameaccessories. Neural tissue lesioningis used by physicians to aid in themanagement of pain |
| Modes ofOperation | Pulsed and continuous lesioning.Sensory and motor stimulation. | Pulsed and continuous lesioning.Sensory and motor stimulation. | Equivalent to predicate |
| GeneratorDimensions | 35.3 cm H x 32.8 cmW x 28.6 cm D | 32.0 cm H x 37.0 cmW x 43.0 cm D | The lonicRF™ Generator is similar inheight and width to the predicate. The |
| Maximum Weight | 7.3 kg (16.0 lb) | 12 kg (26.4 lb) | proposed generator is thinner andweighs 10 lbs less than the predicate |
| Display | 30.5 cm (12") diagonal, 1024x768pixels, Capacitive Touch Screen | 12" 1366x768 Touch Screen | The lonicRF has the same size touchscreen |
| Number ofelectrodeConnections | 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 thepower management. In addition,700mA is the limit specified in IEC60601-2-2 |
| MeasuringFrequency | 460 kHz ± 3% | 460 kHz ± 3% | Equivalent to predicate |
| Able to Mounton a Roll Stand | Yes | No | Added feature of the lonicRFGenerator |
| Uses all ofAbbott's Cannulasand Electrodes | Yes | Yes | Equivalent to predicate |
| Printer Connection | No | Yes | Removed feature not frequently used |
| USB forFlash Drive | Yes (2) | Yes (1) | Similar, IonicRF™ Generator has 2 |
| Ability to StoreUser Profiles andTreatment Profiles | Yes | Yes | |
| Ability to beUpgraded | Yes | Yes | Equivalent to predicate |
| Ability to GenerateTreatment 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 ElectricalProduct SafetyTesting | The IonicRF Generator togetherwith approved accessories weretested in accordance with IEC60601-1 and IEC 60601-1-2. | The IonicRF™ Generator metall relevant requirementsconfirming compliance withIEC 61601-1 andIEC 60601-1-2. |
| HardwarePerformanceTesting | Testing was performed todemonstrate the hardware willfunction as intended through theexpected lifetime of the device. | The hardware testing met allperformance requirements. |
| ComparativeLesion Testing | Comparative lesion testing wasperformed to support substantialequivalence of the IonicRF™Generator to the predicate. | The generator met allperformance requirementsand supports the substantialequivalence to the predicatedevice. |
| SoftwareVerification andValidation | Software verification andvalidation testing was performedto ensure the generator met allrelevant requirements. | Testing demonstrated theIonicRF™ Generator met allsoftware requirements. |
| Usability | Testing was performed to verifyand validate the usability of theIonicRF™ Generator. | The generator met allusability requirements.Results support thesubstantial equivalence to thepredicate 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.
§ 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).