(163 days)
COOLIEF* Radiofrequency Generator (CRG) System is indicated for use to create lesions during neurological lesion procedures and for the coagulation and decompression of disc material to treat symptomatic patients with contained herniated discs. The CRG is to be used with only Avanos RF Probes and accessories, such as Avanos TransDiscal Probes, COOLIEF*/Standard RF Pain Management Probes, Cannulas, Introducers, and Fluid Delivery Introducers. Use of CRG System is limited to the indications cleared under these Avanos devices and accessories.
The COOLIEF* Radiofrequency Generator (CRG) System uses controlled radiofrequency energy to generate heat that is used to create lesions in neurological tissues or to coagulate and decompress disc material to treat symptomatic patients with contained herniated discs. The following components of the predicate Pain Management Generator-TD (K072478), which must be used together, have been modified and are the subject of this 510(k): a) COOLIEF* Radiofrequency Generator (CRG), b) COOLIEF* Quad Pump Unit (QPU), and c) COOLIEF* Therapy Cables.
The provided text describes the 510(k) premarket notification for the COOLIEF* Radiofrequency Generator (CRG) System. It lists general and technological characteristics of the device and compares them to a predicate device, along with non-clinical performance data.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative manner (e.g., minimum accuracy percentages). Instead, it lists various performance tests conducted and their successful completion, implying that "Pass" is the acceptance criterion for each test.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| COOLIEF* RF Generator Hardware Performance | Pass |
| Quad Pump Unit Flow-Rate Verification | Pass |
| Therapy Cable Mechanical Testing | Pass |
| Software Verification and Validation | Pass |
| Temperature Control - Benchtop and Perfused Tissue | Pass |
| Bench-Top Lesion Validation | Pass |
| Transportation and Handling (Packaging) | Pass |
| IEC 60601-1 (Medical Electrical Equipment – General Requirements for basic safety and essential performance 2012, Edition 3.1, Class 1) | Pass |
| IEC 60601-1-2: 2014 (Medical Electrical Equipment - General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests) | Pass |
| IEC 60601-2-2: 2009 (Fifth Ed.) Medical electrical equipment Part 2-2: Particular requirements for basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories | Pass |
| IEC 62366-1:2015 (Part 1: Application of Usability Engineering to Medical Devices) | Pass |
| IEC 62304:2006 A1:2015 (Medical device software – software life cycle processes) | Pass |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily discusses non-clinical testing (performance testing). For these tests, specific sample sizes are not explicitly stated. For example, "Therapy Cable Mechanical Testing" implies that multiple cables were tested, but the number is not provided. Similarly, for "Bench-Top Lesion Validation," the number of lesions or trials is not detailed.
No clinical data was used for this submission, therefore, none of the typical provenance information (country of origin, retrospective/prospective) applies.
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)
This section is not applicable as the submission relies on non-clinical performance data and engineering verification tests. The "ground truth" for these tests would be established by the expected technical specifications and standards (e.g., a flow rate of >18mL/min, successful completion of a software test protocol). It doesn't involve subjective expert review in the way medical image analysis or diagnostic decision-making would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable as the submission focuses on non-clinical performance testing and engineering verification. Adjudication methods are typically used in clinical studies or studies involving expert interpretation where there might be disagreements on ground truth.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted and is not applicable to this submission. The device is a radiofrequency generator, not an AI-powered diagnostic or assistive tool for human readers. No AI assistance or human reader performance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a hardware system (radiofrequency generator, pump, cables) and is not an algorithm or AI product capable of standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the non-clinical performance tests is based on engineering specifications, established standards (e.g., IEC 60601 series), and expected functional performance. For instance, for "Quad Pump Unit Flow-Rate Verification," the ground truth is whether the measured flow rate meets the specified >18mL/min. For "Software Verification and Validation," the ground truth is compliance with the software requirements and absence of critical bugs. There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for this type of submission.
8. The sample size for the training set
This section is not applicable. The submission describes a medical device (radiofrequency generator system), not a machine learning or AI model that requires a training set.
9. How the ground truth for the training set was established
This section is not applicable as there is no training set for this device.
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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 the FDA logo, which 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.
February 21, 2020
Avanos Medical, Inc. Thomas Kozma, Ph.D. Director, Regulatory Affairs 5405 Windward Parkway Alpharetta, Georgia 30004
Re: K192491
Trade/Device Name: COOLIEF* Radiofrequency Generator (CRG) System Regulation Number: 21 CFR 882.4400 Regulation Name: Radiofrequency Lesion Generator Regulatory Class: Class II Product Code: GXD Dated: January 20, 2020 Received: January 22, 2020
Dear Dr. Thomas Kozma:
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 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,
Xiaolin Zheng, Ph.D., M.S. 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) K192491
Device Name
COOLIEF* Radiofrequency Generator (CRG) System
Indications for Use (Describe)
COOLIEF* Radiofrequency Generator (CRG) System is indicated for use to create lesions during neurological lesion procedures and for the coagulation and decompression of disc material to treat symptomatic patients with contained herniated discs. The CRG is to be used with only Avanos RF Probes and accessories, such as Avanos TransDiscal Probes, COOLIEF*/Standard RF Pain Management Probes, Cannulas, Introducers, and Fluid Delivery Introducers. Use of CRG System is limited to the indications cleared under these Avanos devices and accessories.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | X |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY
MANUFACTURER/SPONSOR NAME, ADDRESS, TELEPHONE, CONTACT INFORMATION
| Date Summary Prepared | February 18, 2020 |
|---|---|
| 510(k) Manufacturer/ SponsorAddress | Avanos Medical, Inc.5405 Windward ParkwayAlpharetta, GA 30004 |
| Contact Person | Thomas Kozma, PhDDirector, Regulatory AffairsPhone: (470) 448-5681 |
CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME
| Trade Name | COOLIEF* Radiofrequency Generator (CRG) System |
|---|---|
| Common Name | Lesion Radiofrequency Generator |
| Classification Name | Generator, Lesion, Radiofrequency |
| Regulation Number | 21 CFR § 882.4400 |
| Product Code | GXD |
| Device Classification | II |
PREDICATE DEVICES
| Manufacturer Name | Predicate Device Trade Name | 510(k)Number |
|---|---|---|
| Baylis Medical Company(Currently Owned by AvanosMedical, Inc.) | Baylis Pain Management Generator – TD | K072478 |
DEVICE DESCRIPTION
The COOLIEF* Radiofrequency Generator (CRG) System uses controlled radiofrequency energy to generate heat that is used to create lesions in neurological tissues or to coagulate and decompress disc material to treat symptomatic patients with contained herniated discs. The following components of the predicate Pain Management Generator-TD (K072478), which must be used together, have been modified and are the subject of this 510(k): a) COOLIEF* Radiofrequency Generator (CRG), b) COOLIEF* Quad Pump Unit (QPU), and c) COOLIEF* Therapy Cables.
- a) COOLIEF* Radiofrequency Generator (CRG):
CRG is an 80-watt Radio-Frequency (RF) Generator with four independent RF channels, allowing all RF channels to be activated individually or altogether. The system is controlled via a touchscreen interface display that includes user controls, alarm messages, and on-screen selection of lesioning modalities. Like the predicate Pain Management Generator device (K072478), the CRG can operate in six treatment modes that include: Standard RF, Bipolar RF, Cooled RF, TransDiscal Monopolar RF, and TransDiscal Bipolar RF. The CRG can only be used with the other subject devices components of the COOLIEF* Radiofrequency Generator System (i.e the QPU and Therapy Cables).
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-
b) COOLIEF* Quad Pump Unit (QPU):
COOLIEF* QPU pump heads circulate fluid within a closed-loop system, using Avanos-marketed COOLIEF* fluid tubing kits, to cool the tip region of the COOLIEF* RF Probes. The QPU has four peristaltic pump heads that rotate to drive the fluid flow. The COOLIEF* QPU is controlled by the CRG and can be used with only components of the COOLIEF* Radiofrequency Generator System. -
c) COOLIEF* Therapy Cables:
COOLIEF* Therapy Cables are provided in the following three configurations for use with only the CRG: -
- COOLIEF* Multi-RF Therapy Cable is used for Standard, Pulsed, or Biopolar RF treatment modes. The cable is re-usable and not intended to be in the sterile field.
-
- COOLIEF* Multi-Cooled RF Therapy Cable is used for Cooled RF treatment mode. The cable is re-usable and not intended to be in the sterile field.
-
- COOLIEF* TransDiscal* Y-Connector Therapy Cable is used for the TransDiscal Monopolar or TransDiscal Bipolar RF treatment modes. The cable is re-usable and not intended to be in the sterile field.
Each configuration of the COOLIEF* cable is compatible with only the CRG.
The subject device components of the COOLIEF* Radiofrequency Generator System can be used with the following additional COOLIEF* components that have been previously cleared: RF Probe Electrodes (i.e., Standard, TransDiscal, or Cooled) (K002389, K031951, and K163461), Cannula/Introducers (K972846, K031951, and K163236), Fluid Tubing Kit (K031951), and Split Grounding Pad (K140658).
INDICATIONS FOR USE
COOLIEF* Radiofrequency Generator (CRG) System is indicated for use to create lesions during neurological lesion procedures and for the coagulation and decompression of disc material to treat symptomatic patients with contained herniated discs. The CRG is to be used with only Avanos RF Probes and accessories, such as Avanos TransDiscal Probes, COOLIEF*/Standard RF Pain Management Probes, Cannulas, Introducers, and Fluid Delivery Introducers. Use of CRG System is limited to the indications cleared under these Avanos devices and accessories.
COMPARISON OF SUBJECT DEVICE TO PREDICATE DEVICE
Like the predicate devices, the Generator, Quad Pump, and Therapy Cable are used outside of the sterile field and are reusable. The COOLIEF* Radiofrequency Generator (CRG) System is used in a clinical setting, such as an outpatient surgery center or operating room in a hospital by licensed healthcare professionals with access to fluoroscopic or ultrasound imaging. The following table compares the general and technological characteristics of the subject CRG System and predicate device (i.e., Baylis Pain Management Generator - TD (K072478) that must be used together to achieve intended use).
| COOLIEF* Radiofrequency Generator (CRG) | |||
|---|---|---|---|
| Subject Device - CRG | Predicate Device - PMG | Comment | |
| Device Name(510(k)) | COOLIEF* RadiofrequencyGenerator (CRG) System (RFGenerator, Peristaltic Pump,and Therapy Cables) (K192491) | Baylis Pain ManagementGenerator-TD (RF Generator)(K072478) | RF Generator, Peristaltic Pump,and Therapy Cables must be usedtogether to achieve intended use. |
| Regulation | 21 CFR § 882.4400 | 21 CFR § 882.4400 | Same as Predicate Device |
| Product Code | GXD - RF Lesion Generator | GXD - RF Lesion Generator | Same as Predicate Device |
| COOLIEF* Radiofrequency Generator (CRG) | |||
| Subject Device - CRG | Predicate Device - PMG | Comment | |
| Indications forUse | COOLIEF* RadiofrequencyGenerator (CRG) System isindicated for use to create lesionsduring neurological lesionprocedures and for thecoagulation and decompression ofdisc material to treat symptomaticpatients with contained herniateddiscs. The CRG is to be used withonly Avanos RF Probes andaccessories, such as AvanosTransDiscal Probes,COOLIEF*/Standard RF PainManagement Probes, Cannulas,Introducers, and Fluid DeliveryIntroducers. Use of CRG System islimited to the indications clearedunder these Avanos devices andaccessories. | Baylis Pain ManagementGenerator is indicated for use tocreate lesions during neurologicallesion procedures, and for thecoagulation and decompression ofdisc material to treat symptomaticpatient with contained herniateddiscs. The Baylis PMG-TD is to beused with separately approvedprobes such as Baylis TransDiscalProbe, Oratec Spinecath™ andBaylis Pain Management Probes. | Same as Predicate Device, exceptfor:Updated branding from Baylis toAvanos COOLIEF and specified useto only Avanos probes andaccessories, and indicationslimited to these Avanos probesand Accessories. This brandingchange has no impact onperformance or safety. |
| PrescriptiveStatus | Rx Only | Rx Only | Same as Predicate Device |
| Environment ofUse | Clinical setting with licensedprofessional | Clinical setting with licensedprofessional | Same as Predicate Device |
| AC PowerCompatibility | 100-120V, 220-240V | 100-120V, 220-240V | Same as Predicate Device |
| Energy Delivery | Radiofrequency at 460kHz +/- 1%,Quasi-sinusoidal | Radiofrequency at 460kHz +/- 1%,Quasi-sinusoidal | Same as Predicate Device |
| Generator MaxPower | 80 Watts | 50 Watts | Equivalent to Predicate DeviceSubject device has greater maxpower capacity, but max powerper probe is equivalent at 50 W(see row below); therefore, nonegative impact on performanceor safety. |
| Max Power(Current) perProbe | 50 Watts (900mA) | 50 Watts (900mA) | Same as Predicate Device |
| StimulationFrequency | Sensory = 50 HzMotor = 2Hz | Sensory = 50 HzMotor = 2Hz | Same as Predicate Device |
| StimulationPulse Width | 0.1, 0.2, 0.5, and 1.0 msec | 0.1, 0.2, 0.5, and 1.0 msec | Same as Predicate Device |
| StimulationVoltage | Voltage Mode: 0 to 10V | Voltage Mode: 0 to 10V | Same as Predicate Device |
| Multiple Lesions | Yes | Yes | Same as Predicate Device |
| ProbeConnections | 1 to 4 | 1 to 4 | Same as Predicate Device |
| AccessoryCompatibility | Compatible with Avanos-marketedRF Probes, Cannula/Introducers,Fluid Tubing Kits, and SplitGrounding Pad. | Compatible with Avanos-marketedRF Probes, Cannula/Introducers,Fluid Tubing Kits, and SplitGrounding Pad. | Same as Predicate Device(All COOLIEF* system componentsare used together to achieve theintended use. The subject CRG,QPU, and Therapy Cables are notcompatible/interchangeable withthe predicate PMG, PPU, orTherapy Cables.) |
| Type of Control | Automatic | Manual, Automatic, PneumaticFoot Switch | Equivalent to PredicateSubject device no longer includesManual or Foot Switch Controls,which were rarely used, optionalfeatures. |
| OverallTemperature | 30°C - 95°C | 30°C - 95°C | Same as Predicate Device |
| COOLIEF* Radiofrequency Generator (CRG) | |||
| Subject Device - CRG | Predicate Device - PMG | Comment | |
| Lesioning Times | 10 sec to 30 min | 10 sec to 30 min | Same as Predicate Device |
| Pulse RF Time | 10 to 900 seconds | 10 to 900 seconds | Same as Predicate Device |
| Type of UserInterface | Capacitive touch screen graphicaluser interface and rotary dial | Manual soft keys and rotary dial | Equivalent to Predicate DeviceSubject device includes touchscreen display |
| System SafetyFeatures | Automatic Shut-Off includes:• Out-of-range impedance andtemperature• Over power, voltage, currentOutput of errors:• Fault indicator, fault codedisplay and descriptionAudible alarm | Automatic Shut-Off includes:• Out-of-range impedance andtemperature• Over power, voltage, currentOutput of errors:• Fault indicator, fault codedisplay and descriptionAudible alarm | Same as Predicate Device |
| Contact QualityMonitoring | Yes | No | Subject Device circuitry andassociated alarms were added tocomply with IEC 60601-2-2. |
| Printer Output | No | No | Same as Predicate Device |
| WiFi Capability | No | No | Same as Predicate Device |
| InternetConnectivity | No | No | Same as Predicate Device |
| Sterility | Supplied non-sterile; Non-sterilizable | Supplied non-sterile; Non-sterilizable | Same as Predicate Device |
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| COOLIEF* Quad Pump Unit (QPU) | |||
|---|---|---|---|
| Subject DeviceCOOLIEF* RadiofrequencyGenerator System | Predicate Peristaltic Pump | Comment | |
| Device Name(510(k)) | COOLIEF* Quad Pump Unit,QPU (K192491) | Baylis Peristaltic Pump Unit, PPU(K072478) | Same as Predicate Device |
| Pump Flow Rate | >18mL/min | >18mL/min | Same as Predicate Device |
| Pump PowerRequirement | 24VDC from RF Generator,1000mA max | 24VDC from RF Generator,1000mA max | Same as Predicate Device |
| Sterility | Supplied non-sterile; Non-sterilizable | Supplied non-sterile; Non-sterilizable | Same as Predicate Device |
| COOLIEF* Therapy Cables | |||
|---|---|---|---|
| Subject Devices – MRF, MCRF, and TDP2 | Predicate Devices – MRF, MCRF, and TDP2 (K072478) | Comment | |
| Device Name(510(k)) | Avanos Accessory Therapy Cables:COOLIEF* Multi-RF Therapy Cable, MRF COOLIEF* Multi-Cooled Therapy Cable, MCRF COOLIEF* TransDiscal* Y-Connector Cable, TDP2 | Baylis Accessory Therapy Cables:COOLIEF* Multi-RF Therapy Cable, MRF COOLIEF* Multi-Cooled Therapy Cable, MCRF COOLIEF* TransDiscal* Y-Connector Cable, TDP2 | |
| Cable Length | 8 Ft | 8 Ft | Same as Predicate Device |
| ProbeConnections -Distal End | Pinned and keyed to be compatiblewith Avanos-marketed probes | Pinned and keyed to be compatiblewith Avanos-marketed probes | Same as Predicate Device |
| Number ofProbeConnections | Two (TDP2)Four (MRF & MCRF) | Two (TDP2)Four (MRF & MCRF) | Same as Predicate Device |
| Key CableMaterials | Internal Materials:Copper/NickelExternal Materials:Silicone & Thermoplastic elastomer | Internal Materials:Copper/NickelExternal Materials:Silicone & Thermoplastic elastomer | Same as Predicate Device |
| Sterility | Supplied non-sterile; Non-sterilizable | Supplied non-sterile; Non-sterilizable | Same as Predicate Device |
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Summary of Non-Clinical Testing (Performance Testing)
Non-Clinical Performance Data
The following performance data were provided in support of the substantial equivalence determination for the subject COOLIEF* Radiofrequency Generator (CRG) System. Performance testing of the subject device was conducted to demonstrate that the modified device continued to meet performance specifications. Results of design verification activities did not raise any new or different issues of safety or effectiveness. The risk management process was used throughout the non-clinical verification activities in accordance with ISO 14971. The following verification tests were conducted.
| Bench Testing Performed | Result |
|---|---|
| COOLIEF* RF Generator Hardware Performance | Pass |
| Quad Pump Unit Flow-Rate Verification | Pass |
| Therapy Cable Mechanical Testing | Pass |
| Software Verification and Validation | Pass |
| Temperature Control - Benchtop and Perfused Tissue | Pass |
| Bench-Top Lesion Validation | Pass |
| Transportation and Handling (Packaging) | Pass |
| IEC 60601-1 (Medical Electrical Equipment – General Requirementsfor basic safety and essential performance 2012, Edition 3.1, Class 1. | Pass |
| IEC 60601-1-2: 2014 (Medical Electrical Equipment - General requirements for basic safety andessential performance – Collateral standard: Electromagnetic compatibility – Requirements andtests. | Pass |
| IEC 60601-2-2: 2009 (Fifth Ed.)Medical electrical equipment Part 2-2: Particular requirements for basic safety and essentialperformance of high frequency surgical equipment and high frequency surgical accessories | Pass |
| IEC 62366-1:2015 (Part 1: Application of Usability Engineering to Medical Devices.) | Pass |
| IEC 62304:2006 A1:2015 (Medical device software – software life cycle processes) | Pass |
Clinical Performance Data
Clinical data was not applicable to these subject devices.
Conclusion
The differences between the subject COOLIEF* Radiofrequency Generator (CRG) System and predicate device Baylis Pain Management Generator-TD (K072478)) do not raise any new or different questions of safety or effectiveness. The subject COOLIEF* Radiofrequency Generator System is substantially equivalent to the predicate devices with respect to the indications for use, technology, material composition, which are not patient contacting, and performance.
§ 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).