(128 days)
No
The document describes a standard radiofrequency generator with microprocessor control for user interface and recordkeeping, but there is no mention of AI or ML capabilities in the device description, intended use, or performance studies.
Yes.
The device is used to manage pain in the nervous system, including specific procedures like facet denervation and trigeminal rhizotomy, which directly addresses a health condition.
No
The device is described as a radiofrequency (RF) lesioning generator intended for lesioning neural tissue to manage pain. It has sensory and motor stimulation functions to fine-tune electrode placement before procedures, but its primary function is therapeutic (lesioning), not diagnosing disease or conditions.
No
The device description clearly states it is a "desktop radiofrequency (RF) lesioning generator" and describes physical components like a touch screen monitor, dial, and options for mounting, indicating it is a hardware device with integrated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "an aid in the management of pain in the nervous system" through procedures like facet denervation and trigeminal rhizotomy. This involves directly treating a patient's condition.
- Device Description: The device is a "radiofrequency (RF) lesioning generator" used for "lesioning of neural tissue." This is a therapeutic intervention performed on the patient's body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
The device is a therapeutic device used for pain management through a physical intervention on the nervous system.
N/A
Intended Use / Indications for Use
The IonicRF™ 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.
Product codes (comma separated list FDA assigned to the subject device)
GXD
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nervous system, neural tissue, 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)
Non-clinical testing included assessment of the physical properties of the IonicRF™ Generator to ensure the IonicRF™ Generator met all of the performance requirements and specifications. The test results demonstrated the suitability of the IonicRF™ 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:
- EMC and Electrical Product Safety Testing: The IonicRF Generator together with approved accessories were tested in accordance with IEC 60601-1 and IEC 60601-1-2. Results: The IonicRF™ Generator met all relevant requirements confirming compliance with IEC 61601-1 and IEC 60601-1-2.
- Hardware Performance Testing: Testing was performed to demonstrate the hardware will function as intended through the expected lifetime of the device. Results: The hardware testing met all performance requirements.
- Comparative Lesion Testing: Comparative lesion testing was performed to support substantial equivalence of the IonicRF™ Generator to the predicate. Results: The generator met all performance requirements and supports the substantial equivalence to the predicate device.
- Software Verification and Validation: Software verification and validation testing was performed to ensure the generator met all relevant requirements. Results: Testing demonstrated the IonicRF™ Generator met all software requirements.
- Usability: Testing was performed to verify and validate the usability of the IonicRF™ Generator. Results: The generator met all usability requirements. Results support the substantial equivalence to the predicate device.
A biocompatibility assessment of the device was performed and established, based on the materials of construction that the IonicRF™ 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 IonicRF™ Generator.
- Based on comparison of intended use and technical characteristics, the IonicRF™ Statement of Equivalence Generator is similar to the legally marketed predicate. Hardware and software verification and validation demonstrated the IonicRF™ Generator met all performance specifications. Any differences between the IonicRF™ Generator and the predicate device do not raise new types of questions of safety and effectiveness. Therefore, the IonicRF™ Generator is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
NeuroTherm NT2000 Lesioning Generator (K111576)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K011387, K111576, K042375, K000073
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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
1
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
2
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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3
| 510(k) Number: | K201610 |
|---|---|
| 510(k) Type: | Traditional 510(k) |
| Manufacturer | |
| Name & | |
| Address | Abbott Medical |
| 5050 Nathan Lane North | |
| Plymouth, Minnesota, 55442 | |
| USA | |
| Contact Person | Jim Chapman |
| Manager, Regulatory Affairs | |
| 972-526-4624 | |
| jim.chapman@abbott.com | |
| Device Information | |
| Trade Name | IonicRF™ Generator |
| Common | |
| Name | Radiofrequency lesion generator |
| Class | II |
| Classification | |
| Name | 882.4400 Generator, Lesion, Radiofrequency |
| Product Code | GXD |
| Predicate | |
| Device | NeuroTherm NT2000 Lesioning Generator (K111576) |
| Device | |
| Description | 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. |
| Indications
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. |
| 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. |
4
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
Abbott Medical
lonicRF™ Generator | Primary Predicate
Abbott Medical (NeuroTherm™)
NT2000 Generator | Equivalency
Discussion |
|-------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | TBD | K111576 | Not Applicable |
| Product Code | GXD | GXD | Equivalent to predicate |
| Indication for Use | The lonicRF™ 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 lonicRF
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 lonicRF™ Generator is similar in
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
weighs 10 lbs less than the predicate |
| Display | 30.5 cm (12") diagonal, 1024x768
pixels, Capacitive Touch Screen | 12" 1366x768 Touch Screen | The lonicRF 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 lonicRF
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 | |
| Ability to be
Upgraded | Yes | Yes | Equivalent to predicate |
| Ability to Generate
Treatment Reports | Yes | Yes | |
| Probe Recognition | Yes | Yes | |
5
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 | ||
| Product Safety | ||
| Testing | The IonicRF Generator together | |
| with approved accessories were | ||
| tested in accordance with IEC | ||
| 60601-1 and IEC 60601-1-2. | The IonicRF™ Generator met | |
| all relevant requirements | ||
| confirming compliance with | ||
| IEC 61601-1 and | ||
| IEC 60601-1-2. | ||
| Hardware | ||
| Performance | ||
| Testing | Testing was performed to | |
| demonstrate the hardware will | ||
| function as intended through the | ||
| expected lifetime of the device. | The hardware testing met all | |
| performance requirements. | ||
| Comparative | ||
| Lesion Testing | Comparative lesion testing was | |
| performed to support substantial | ||
| equivalence of the IonicRF™ | ||
| Generator to the predicate. | The generator met all | |
| performance requirements | ||
| and supports the substantial | ||
| equivalence to the predicate | ||
| device. | ||
| Software | ||
| Verification and | ||
| Validation | Software verification and | |
| validation testing was performed | ||
| to ensure the generator met all | ||
| relevant requirements. | Testing demonstrated the | |
| IonicRF™ Generator met all | ||
| software requirements. | ||
| Usability | Testing was performed to verify | |
| and validate the usability of the | ||
| IonicRF™ Generator. | The generator met all | |
| usability requirements. | ||
| Results support the | ||
| substantial equivalence to the | ||
| 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.