(174 days)
The Polaris RF Ablation System is intended for the creation of radiofrequency lesions in nervous tissue.
The Polaris RF Ablation System includes the following components:
- Polaris Radiofrequency Generator and Desk Stand
- Polaris Pump, Pump Cable and Desk Stand
- Polaris Standard Connector Hub / Polaris Cooled Connector Hub
- Polaris Footswitch
- Polaris Cooled RF Probe Kit:
i. Polaris Cooled RF Ablation Probe
ii. Polaris Tube Kit
iii. Polaris Introducer - Polaris Single-Use RF Probe
- Polaris Reusable RF Probe
- Polaris RF Cannula
The Polaris RF Ablation System is intended for the creation of radiofrequency lesions in nervous tissue. The system is designed to deliver controlled RF energy from the Polaris RF Generator to target tissues via the Polaris RF Probes for standard RF procedures or Polaris Cooled RF Probes for cooled RF procedures. RF energy is applied based on the configured RF generator settings to create the desired lesions in the target tissue. The generator also delivers low frequency stimulation pulses during procedures.
During standard RF procedures, the Polaris RF Probe is used with a compatible Polaris RF Cannula to enable RF energy delivery via the active electrode to the target tissues. During cooled RF procedures with Polaris Cooled RF Probes, the system integrates a cooling mechanism by internally circulating water through the probes using the Polaris Pump Unit. This cooling results in minimal charring of the surrounding tissue and also prevents tissue from adhering to the electrodes. This allows for larger and more consistent ablation volumes to be achieved.
The document you provided is a 510(k) summary for a medical device, the Polaris RF Ablation System. It details the device's substantial equivalence to predicate devices, rather than establishing primary effectiveness through clinical trials with defined acceptance criteria for diagnostic output.
Therefore, the information requested for AI/ML device studies such as sample sizes for test/training sets, ground truth establishment, expert qualifications, and MRMC studies, is not present in this document, as it focuses on demonstrating product safety and performance against established standards and predicate devices.
However, I can extract the information relevant to performance testing based on the provided tables.
1. Table of Acceptance Criteria and Reported Device Performance
The document lists various performance tests conducted on different components of the Polaris RF Ablation System. The general acceptance criterion for all tests is "All samples passed the acceptance criteria," with the reported performance consistently stating that the device or its components met all relevant requirements and confirmed compliance with applicable standards.
| Test Category | Component | Test Method Summary | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|---|
| Mechanical | Polaris Re-Usable RF Probe | Temperature Test, Pull Test, Cleaning and Sterilization Reuse Test, Mechanical Reuse Test, Mechanical Test (Flexion), Continuity Test, Functional Test | Compliance with IEC 60601-2-2:2009 | All samples passed the acceptance criteria. Results confirmed compliance of the device with IEC 60601-2-2:2009 and support substantial equivalence. |
| Electrical | Polaris Re-Usable RF Probe | Comparison with Polaris Standard Single-Use Probe for electrical stresses | Compliance with IEC 60601-1:2005+A1:2012 and IEC 60601-2-2:2009 | The device was verified to meet the requirements of IEC 60601-1:2005+A1:2012 and IEC 60601-2-2:2009. Results support substantial equivalence. |
| Biocompatibility | Polaris Re-Usable RF Probe | Comparisons to similar legally marketed devices per ISO 10993-1 and FDA guidance. | Compliance with current ISO 10993-1 requirements | Results confirmed compliance of the device with the current ISO 10993-1 requirements and support substantial equivalence. |
| Packaging | Polaris Re-Usable RF Probe | Ship testing for integrity through shipping and handling. | Packaging met relevant requirements. | All packaging met relevant requirements. Results support substantial equivalence. |
| Cleaning and Sterilization | Reusable components | Validation of reprocessing methods to achieve SAL of 10-6. | Compliance with AAMI TIR12, AAMI TIR30, ANSI/AAMI ST81, and FDA guidance. | The device was verified to meet the requirements of AAMI TIR12, AAMI TIR30 and ANSI/AAMI ST81 requirements and the FDA guidance. Results support substantial equivalence. |
| Mechanical | Polaris Single-Use RF Probe | Temperature Test, Pull Test, Durability Test, Mechanical Test (Flexion), Continuity Test, Functional Test | Compliance with IEC 60601-2-2:2009 | All samples passed the acceptance criteria. Results confirmed compliance of the device with IEC 60601-2-2:2009 and support substantial equivalence. |
| Electrical | Polaris Single-Use RF Probe | High Frequency Leakage Current Test, High Frequency Dielectric Strength Test, Mains Frequency Dielectric Strength Test (for cable, handle, connector) | Compliance with IEC 60601-1:2005+A1:2012 and IEC 60601-2-2:2009 | All samples passed the acceptance criteria. Results confirmed compliance of the device with IEC 60601-1:2005+A1:2012 and IEC 60601-2-2:2009 and support substantial equivalence. |
| Biocompatibility | Polaris Single-Use RF Probe | Comparisons to similar legally marketed devices per ISO 10993-1 and FDA guidance. | Compliance with current ISO 10993-1 requirements | Results confirmed compliance of the device with the current ISO 10993-1 requirements and support substantial equivalence. |
| Packaging | Polaris Single-Use RF Probe | Ship testing for integrity; Seal strength and sterile barrier validated per ANSI/AAMI/ISO 11607-1 and 11607-2 over shelf life. | Packaging met relevant requirements; Compliance with ANSI/AAMI/ISO 11607-1 and 11607-2. | The device packaging met relevant requirements. Results confirmed compliance of device packaging with ANSI/AAMI/ISO 11607-1 and 11607-2 and support substantial equivalence. |
| Mechanical | Polaris RF Cannula | Positive Pressure Liquid Leakage Test, Sub-atmospheric Pressure Air Leakage Test, Resistance to Separation Test, Stress Cracking Test, Hub Strength Test | Compliance with ISO 80369-7:2016, ISO 594-1:1986, and ISO 7864:2016. | All samples passed the acceptance criteria. Results confirmed the device met with the mechanical requirements of ISO 80369-7:2016, ISO 594-1:1986 and ISO 7864:2016 and support substantial equivalence. |
| Electrical | Polaris RF Cannula | High Frequency Leakage Current Test, High Frequency Dielectric Strength Test, Mains Frequency Dielectric Strength Test | Compliance with IEC 60601-1:2005+A1:2012 and IEC 60601-2-2:2009 | All samples passed the acceptance criteria. Results confirmed compliance of the device with IEC 60601-1:2005+A1:2012 and IEC 60601-2-2:2009 and support substantial equivalence. |
| Biocompatibility | Polaris RF Cannula | Biological testing and comparisons per ISO 10993-1 and FDA guidance. | Compliance with current ISO 10993-1 requirements | Results confirmed compliance of the device with the current ISO 10993-1 requirements and support substantial equivalence. |
| Packaging | Polaris RF Cannula | Ship testing for integrity; Seal strength and sterile barrier validated per ANSI/AAMI/ISO 11607-1 and 11607-2 over shelf life. | Packaging met relevant requirements; Compliance with ANSI/AAMI/ISO 11607-1 and 11607-2. | The device packaging met relevant requirements. Results confirmed compliance of device packaging with ANSI/AAMI/ISO 11607-1 and 11607-2 and support substantial equivalence. |
| Mechanical | Polaris Cooled RF Probe Kit (Probe & Introducer) | Leak/Pressure Test, Pull Test, Temperature Test, Tip Compression Test, Mechanical Test (Flexion), Continuity Test, Functional Test (for probe); Resistance to Separation tests (for introducer) | Compliance with IEC 60601-2-2:2009 for probe; Relevant mechanical stresses without failure for introducer. | All samples passed the acceptance criteria. Results confirmed compliance of the device with IEC 60601-2-2:2009 (probe) and support substantial equivalence. |
| Electrical | Polaris Cooled RF Probe Kit (Probe) | High Frequency Leakage Current Test, High Frequency Dielectric Strength Test, Mains Frequency Dielectric Strength Test (for cable, shaft, handle, connector) | Compliance with IEC 60601-1:2005+A1:2012 and IEC 60601-2-2:2009 | All samples passed the acceptance criteria. Results confirmed compliance of the device with IEC 60601-1:2005+A1:2012 and IEC 60601-2-2:2009 and support substantial equivalence. |
| Biocompatibility | Polaris Cooled RF Probe and Polaris Introducer | Biological testing and comparisons per ISO 10993-1 and FDA guidance. | Compliance with current ISO 10993-1 requirements | Results confirmed compliance of the devices with the current ISO 10993-1 requirements and support substantial equivalence. |
| Packaging | Polaris Cooled RF Probe Kit | Ship testing for integrity; Seal strength and sterile barrier validated per ANSI/AAMI/ISO 11607-1 and 11607-2 over shelf life. | Packaging met relevant requirements; Compliance with ANSI/AAMI/ISO 11607-1 and 11607-2. | The subject device packaging met relevant requirements. Results confirmed compliance of device packaging with ANSI/AAMI/ISO 11607-1 and 11607-2 and support substantial equivalence. |
| Verification | Polaris Radiofrequency Generator | Electrical testing of hardware components (RF board, User Interface Board, Multiplexer board) | Device met all relevant requirements. | The subject device met all relevant requirements. Results support substantial equivalence. |
| Packaging | Polaris Radiofrequency Generator | Ship testing for integrity. | Packaging met relevant requirements. | All packaging met relevant requirements. Results support substantial equivalence. |
| Verification | Polaris Pump Unit | Assessment of inspection, configuration, installation, operation, environment, and service life. | Device met all relevant requirements. | The subject device met all relevant requirements. Results support substantial equivalence. |
| Packaging | Polaris Pump Unit | Ship testing for integrity. | Packaging met relevant requirements. | All packaging met relevant requirements. Results support substantial equivalence. |
| Verification | Polaris Connector Hub | Cable Pull Test, Cable Impulse Test, Device Identification. | Compliance with Baylis self-enforced requirements. | The subject device met all relevant requirements. Results confirmed compliance of the device with Baylis self-enforced requirements and support substantial equivalence. |
| Packaging | Polaris Connector Hub | Ship testing for integrity. | Packaging met relevant requirements; Compliance with Baylis self-enforced requirements. | All packaging met relevant requirements. Results confirmed compliance of device packaging with Baylis self-enforced requirements and support substantial equivalence. |
| Packaging | Polaris Footswitch | Ship testing for integrity. | Packaging met relevant requirements. | All packaging met relevant requirements. Results support substantial equivalence. |
| Electrical Product Safety | Polaris RF Ablation System | Compliance with IEC 60601-1:2005+A1:2012 (including national deviations) and IEC 60601-2-2:2009. | Device met all relevant requirements; Compliance with specified IEC standards. | The subject device met all relevant requirements. Results confirmed compliance of the device with IEC 60601-1:2005+A1:2012 and IEC 60601-2-2:2009 and support substantial equivalence. |
| Electromagnetic Compatibility | Polaris RF Ablation System | Compliance with IEC 60601-1-2:2014. | Device met all relevant requirements; Compliance with IEC 60601-1-2:2014. | The subject device met all relevant requirements. Results confirmed compliance of the device with IEC 60601-1-2:2014 and support substantial equivalence. |
| Benchtop Lesion Validation | Polaris RF Ablation System | Comparative lesion validation testing using a soft tissue model (single and multi-probe scenarios). | Device met all relevant requirements; Substantially equivalent ablation performance to predicate. | The subject device met all relevant requirements. Results support substantial equivalence. |
| Usability | Polaris RF Ablation System | Verification and validation of usability requirements including normal use, worst-case scenario, and primary operating functions. | Device met all relevant requirements. | The device met all relevant requirements. Results support substantial equivalence. |
| Software | Polaris RF Ablation System | Software V&V per FDA Guidance for Software Contained in Medical Devices. | Device met all relevant requirements. | The device met all relevant requirements. Results support substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes (e.g., number of units tested) for most of the performance tests. It mentions "All samples passed" for many tests, indicating that multiple units were likely tested for each category. No information on data provenance (country of origin, retrospective/prospective) is provided, as these are technical performance tests on the device itself, not clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This is a technical performance and substantial equivalence submission for a medical device, not an AI/ML diagnostic or prognostic device that requires expert-established ground truth for a test set. The "ground truth" here is compliance with engineering standards and predicate device performance.
4. Adjudication Method for the Test Set
Not applicable. As this is not an AI/ML diagnostic output, there is no adjudication method in the context of expert review. Test results are compared against predefined technical standards and requirements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No. This document does not pertain to an AI/ML device that assists human readers, so an MRMC study is not relevant here.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
No. The Polaris RF Ablation System is a physical medical device, not an algorithm, so a standalone algorithm performance study is not applicable.
7. The Type of Ground Truth Used
The "ground truth" in this context refers to established engineering and medical device standards (e.g., IEC 60601 series, ISO 10993 series, ANSI/AAMI ISO 11607) and the performance characteristics of the legally marketed predicate devices. For mechanical and electrical tests, it's compliance with these standards. For lesion validation, it's the demonstration of "substantially equivalent ablation performance" compared to the predicate in a soft tissue model.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device, so there is no training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI/ML model, this question is not relevant.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Baylis Medical Company Inc. May Tsai Team Leader, Regulatory Affairs 2775 Matheson Blvd. East Mississauga, L4W 4P7 Canada
January 2, 2019
Re: K181864
Trade/Device Name: Polaris RF Ablation System Regulation Number: 21 CFR 882.4400 Regulation Name: Radiofrequency Lesion Generator Regulatory Class: Class II Product Code: GXD, GXI Dated: November 30, 2018 Received: December 3, 2018
Dear May Tsai:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
$$\textbf{John Marker-S}_{\textbf{Date:2019.01.02}\textbf{16:14:56}}^{\textbf{Digitalby signed by John}}$$
For Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K181864
Device Name Polaris RF Ablation System
Indications for Use (Describe)
The Polaris RF Ablation System is intended for the creation of radiofrequency lesions in nervous tissue.
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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7. 510(k) Summary
7.1 Submitter Information
- A. Company Name: Baylis Medical Company Inc.
- B. Company Address: 2775 Matheson Blvd. East Mississauga, Ontario L4W 4P7 Canada
- C. Company Phone: (905) 602-4875
- D. Company Facsimile: (905) 602-5671
- E. Contact Person: May Tsai, Requlatory & Scientific Affairs Team Leader
- F. Summary Prepared on: 11-Jul-2018
7.2 Device Identification
- A. Device Trade Name:
- . Polaris RF Ablation System
- B. Device Common Name:
- Radiofrequency lesion generator ●
- . Radiofrequency lesion probe
- C. Classification Name:
- CFR 882.4400 Radiofrequency lesion generator ●
- CFR 882.4725 Radiofrequency lesion probe .
- D. Product Code:
- . GXD, GXI
- E. Device Class: Class II
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7.3 Identification of Predicate Device
Table 7.1: Predicate Devices
| Predicate Device | Manufacturer | 510(k) |
|---|---|---|
| Baylis Pain Management Generator-TD | K072478 | |
| Baylis TransDiscal System | K062937 | |
| Baylis Pain Management Cooled Probe | Halyard Health* | K053082 |
| Baylis Pain Management Probe andConnector Cable | K002389 | |
| BMC RF Cannula | K972846 |
*Note: Originally submitted by Baylis Medical Company Inc. as the manufacturer, but product line has since been acquired by Halyard Health.
7.4 Indications for Use
The Polaris RF Ablation System is intended for the creation of radiofrequency lesions in nervous tissue.
7.5 Device Description
The Polaris RF Ablation System includes the following components:
-
- Polaris Radiofrequency Generator and Desk Stand
-
- Polaris Pump, Pump Cable and Desk Stand
-
- Polaris Standard Connector Hub / Polaris Cooled Connector Hub
-
- Polaris Footswitch
-
- Polaris Cooled RF Probe Kit:
- i. Polaris Cooled RF Ablation Probe
- ii. Polaris Tube Kit
- iii. Polaris Introducer
-
- Polaris Single-Use RF Probe
-
- Polaris Reusable RF Probe
-
- Polaris RF Cannula
The Polaris RF Ablation System is intended for the creation of radiofrequency lesions in nervous tissue. The system is designed to deliver controlled RF energy from the Polaris RF Generator to target tissues via the Polaris RF Probes for standard RF procedures or Polaris Cooled RF Probes for cooled RF
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procedures. RF energy is applied based on the configured RF generator settings to create the desired lesions in the target tissue. The generator also delivers low frequency stimulation pulses during procedures.
During standard RF procedures, the Polaris RF Probe is used with a compatible Polaris RF Cannula to enable RF energy delivery via the active electrode to the target tissues. During cooled RF procedures with Polaris Cooled RF Probes, the system integrates a cooling mechanism by internally circulating water through the probes using the Polaris Pump Unit. This cooling results in minimal charring of the surrounding tissue and also prevents tissue from adhering to the electrodes. This allows for larger and more consistent ablation volumes to be achieved.
7.6 Comparison to Predicate Device
The intended use of the subject Polaris RF Ablation System is the same as the predicate devices. The indication for use of the Polaris RF Ablation System is the same, or a subset of, the indications for use of the predicate devices. The subject and predicate devices share the same fundamental scientific technology, including principles of operation and mechanism of action (Tables 7.2 and 7.3). Differences in design and technological characteristics between the proposed and predicate devices do not raise any new types of safety and effectiveness questions. Verification and validation test results provide reasonable assurance of the substantial equivalence of the Polaris RF Ablation System compared to the predicate system.
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Table 7.2: Comparison of Subject and Predicate Devices – Overall System
| PREDICATE DEVICES | SUBJECTDEVICE | Identical /SubstantiallyEquivalent(SE) | |||||
|---|---|---|---|---|---|---|---|
| Device Name | Baylis PainManagementGenerator-TD | TransDiscal (TD)System | BMC RFCannula | BMC PM Probeand ConnectorCable | Baylis PMCooled Probe | Polaris RFAblation System | N/A |
| 510(k) # | K072478 | K062937 | K972846 | K002389 | K053082 | K181864 | N/A |
| Manufacturer | Halyard Health* | Baylis MedicalCompany Inc. | N/A | ||||
| Class | II | II | II | II | II | II | YES/YES |
| Product Code,Regulation | GEI, 882.4400GXD, 882.4400 | GXI, 882.4725 | GXI, 882.4725 | GXI, 882.4725 | GXI, 882.4725 | GXD, 882.4400GXI, 882.4725 | YES/YES |
| Indications forUse | Baylis PainManagementGenerator - TD;Model PMG-115-TD (ForDomestic Use)and Model PMG-230-TD (ForInternationalUse) is indicatedfor use to createlesions duringneurologicallesionprocedures, andfor thecoagulation anddecompressionof disc materialto treatsymptomaticpatients with | The Baylis TDsystem, used incombination withthe Baylis PMGenerator, isindicated for thecreation of RFheat lesions innervous tissueincluding thatwhich is situatedin theintervertebraldisc material. | The BMC RFCannula isintended foruse in RF heatlesionprocedures forrelief of pain | To create RFlesions innervous tissue. | The Baylis PMCooled Probewill be used inconjunctionwith a RFGenerator tocreate RFlesions innervous tissue. | The Polaris RFAblation Systemis intended forthe creation ofRF lesions innervous tissue. | NO/YES |
| PREDICATE DEVICES | SUBJECTDEVICE | Identical /SubstantiallyEquivalent(SE) | |||||
| containedherniated discs.The Baylis PMG-TD is to be usedwith separatelyapproved probessuch as BaylisTransDiscalProbe, OratecSpinecath andBaylis PainManagementProbes. | |||||||
| RelevantSystemComponents | RF Generator | Peristaltic Pump,Connector CableTube KitIntroducerY-ConnectingCable | RF Cannula | Standard RFProbes (non-cooled) | Cooled RFProbe | RF Generatorand Desk StandPeristaltic Pumpand Desk Stand,Pump ConnectorCableConnector HubRF CannulaStandard RFProbes (non-cooled)Cooled RF Probekit (Cooled RFProbe, Tube Kit,Introducer) | NO/YES |
Traditional 510(k)
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| PREDICATE DEVICES | SUBJECTDEVICE | Identical /SubstantiallyEquivalent(SE) | |
|---|---|---|---|
| User | Physicians familiar with RF lesion techniques | Physiciansfamiliar with RFlesiontechniques | YES/YES |
| AnatomicalSite of Use | Nervous tissue | Nervous tissue | YES/YES |
| Access Method | Percutaneous | Percutaneous | YES/YES |
| EnergyType | Radiofrequency | Radiofrequency | YES/YES |
| Principle ofOperation | Operator controlled; RF delivered from RF generator to compatible RF probes | Operatorcontrolled; RFdelivered fromRF generator tocompatible RFprobes | YES/YES |
| Mechanism ofAction | Cellular necrosis through thermal coagulation | Cellular necrosisthrough thermalcoagulation | YES/YES |
| SystemFeedbackMechanism | Temperature controlled | Temperaturecontrolled | YES/YES |
| Ability to MakeMultipleLesions | Yes | Yes | YES/YES |
| PREDICATE DEVICE | SUBJECT DEVICE | Identical/SE | |
| RF GENERATOR | |||
| Device Name | Baylis Pain ManagementGenerator-TD | Polaris RadiofrequencyGenerator | N/A |
| 510(k) # | K072478 | K181864 | N/A |
| Available Generator Modes | Standard RF Mode• Stimulation(Sensory/Motor)• Pulsed RF (SingleRF, Multi-RF,Bipolar RF)• RF lesion (SingleRF, Multi-RF,Bipolar RF) | Standard RF Mode• Stimulation(Sensory/Motor)• Pulsed RF (SingleRF, Multi-RF,Bipolar RF)• RF lesion (SingleRF, Multi-RF,Bipolar RF) | YES/YES |
| Cooled RF Mode• Stimulation(Sensory/Motor)• RF lesion (SingleRF, Multi-RF,Bipolar RF) | Cooled RF Mode• Stimulation(Sensory/Motor)• RF lesion (SingleRF, Multi-RF,Bipolar RF) | ||
| Maximum Power Output | 50 Watts | 50 Watts | YES/YES |
| Operating FrequencyWaveform | 461 kHz Sinusoidal | 465 kHz Sinusoidal | NO/YES |
| Temperature MonitoringThermocouple (RF modes) | Yes | Yes | YES/YES |
| Display Parameters | Real time temperature,impedance, power andvoltage (pulsed RFmode) | Real time temperature,impedance, power andvoltage (pulsed RFmode) | YES/YES |
| Safety Features | • Automatic shut-off for:o Out-of-rangeimpedance andtemperatureo Over power,voltage, current | • Automatic shut-off for:o Out-of-rangeimpedance andtemperatureo Over power,voltage, current | YES/YES |
| • Output of errors,including:o Fault indicator,fault code displayand descriptiono Audible alarm | • Output of errors,including :o Alert icon, faultcode display anddescriptiono Audible alarm | ||
| Touchscreen | No | Yes | NO/YES |
| Used with Desk Stand | No | Yes | NO/YES |
| Used with OptionalFootswitch | Yes | Yes | YES/YES |
| Environment | Supplied non-sterile;Non-sterilisable | Supplied non-sterile;Non-sterilisable | YES/YES |
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Table 7.3: Comparison of Subject and Predicate Devices – Relevant Components
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| PREDICATE DEVICE | SUBJECT DEVICE | Identical/SE | ||
|---|---|---|---|---|
| COOLED RF PROBE | ||||
| Device Name | PM Cooled Probe | Polaris Cooled RFAblation Probe | N/A | |
| 510(k) # | K053082 | K181864 | N/A | |
| Probe Configuration | Monopolar | Monopolar | YES/YES | |
| Tissue TemperatureMeasurement | Includes Thermocouple for | Yes | Yes | YES/YES |
| Location of Thermocouple | Exposed at probe distaltip | Embedded within probedistal tip | NO/YES | |
| Patient-Contact | Shaft,Thermocouple | Stainless steel | Stainless steel | YES/YES |
| Materials | Insulation | Polyimide | Polyimide | |
| Key Non- | Handle | Acetal | ABS | NO/YES |
| patient | Cable | Silicone | Silicone | |
| ContactMaterials | Tubing | Polyvinyl chloride | Polyvinyl chloride | |
| Luer lock | Polycarbonate | Polycarbonate | ||
| KeyDimensions | ShaftDiameter | 18 Gauge | 18 Gauge | NO/YES |
| Active TipLengths | 2, 4, 5.5, 6 mm | 4, 5.5 mm | ||
| CompatibleIntroducerLengths | 50, 75, 100, 150 mm | 50, 100, 150 mm | ||
| Cable | 48" (length);3.80 mm (OD) | 48" (length);3.80 mm (OD) | ||
| Tubing | 48" (length);3.18 mm (OD) | 48" (length);3.18 mm (OD) | ||
| Environment | Provided sterile;Single use | Provided sterile;Single use | YES/YES | |
| Sterilization Method:Sterility Assurance Level(SAL) | Ethylene oxide;10-6 | Ethylene oxide;10-6 | YES/YES | |
| TUBE KIT | ||||
| Device Name | TransDiscal Tube Kit | Polaris Tube Kit | N/A | |
| 510(k) # | K062937 | K181864 | N/A | |
| Key non-patientContactMaterials | TubingBurette,Female LuerCap, LuerLocks | TygonPolycarbonate | TygonPolycarbonate | NO/YES |
| Crimp | N/A | Stainless steel | ||
| Key | Tubing Length | 140" | 140" | YES/YES |
| Dimensions | BuretteCapacity | 70 mL | 70 mL | |
| Environment | Provided sterile;Single use | Provided sterile;Single use | YES/YES | |
| Sterilization Method;(SAL) | Sterility Assurance Level | Ethylene oxide;10-6 | Ethylene oxide;10-6 | YES/YES |
| PREDICATE DEVICE | SUBJECT DEVICE | Identical/SE | ||
| INTRODUCER | ||||
| Device Name | TransDiscal Introducer | Polaris Introducer | N/A | |
| 510(k) # | K062937 | K181864 | N/A | |
| Comprises Cannula and Stylet | Yes | Yes | YES/YES | |
| Depth Markers | Yes | Yes | YES/YES | |
| Patient-contactMaterials | ShaftIntroducer, Stylet | Stainless steel | Stainless steel | NO/YES |
| Insulation | Polyimide | Polyimide | ||
| Hub | Unknown | Copolyester | ||
| KeyDimensions | Shaft OuterDiameter | 17 Gauge | 17 Gauge | NO/YES |
| UsableLength(s) | 50, 75, 100, 150 mm | 50, 100, 150mm | ||
| Environment | Provided sterile;Single use | Provided sterile;Single use | YES/YES | |
| Sterilization Method;Sterility Assurance Level(SAL) | Ethylene oxide;10-6 | Ethylene oxide;10-6 | YES/YES | |
| SINGLE-USE RF PROBE | ||||
| Device Name | Pain Management Probe | Polaris Single-Use RFProbe | N/A | |
| 510(k) # | K002389 | K181864 | N/A | |
| Configuration | Monopolar | Monopolar | YES/YES | |
| Used with CompatibleCannula | Yes | Yes | YES/YES | |
| Thermocouple for TissueTemperature Measurement | Yes | Yes | YES/YES | |
| Patient-contactMaterials | Shaft, Stylet | Stainless steel | Stainless steel | YES/YES |
| KeyDimensions | ShaftDiameter | 24, 28, 31 Ga | 28 Ga | NO/YES |
| CompatibleCannulaLength(s) | 50, 54, 60, 100, 145,200 mm | 50, 100, and 150 mm | ||
| Environment | Provided non-sterile;Re-sterilisable (steam) | Provided sterile;Single use | NO/YES | |
| Sterilization Method;Sterility Assurance Level(SAL) | N/A | Ethylene oxide;10-6 | NO/YES | |
| REUSABLE RF PROBE | ||||
| Device Name | Pain Management Probe | Polaris Reusable RFProbe | N/A | |
| 510(k) # | K002389 | K181864 | N/A | |
| Configuration | Monopolar | Monopolar | YES/YES | |
| Used with Cannula | Yes | Yes | YES/YES | |
| Thermocouple for TissueTemperature Measurement | Yes | Yes | YES/YES | |
| PREDICATE DEVICE | SUBJECT DEVICE | Identical/SE | ||
| Patient-contactMaterials | Shaft, Stylet | Stainless steel or nitinol | Stainless steel or nitinol | YES/YES |
| KeyDimensions | ShaftDiameter | 24, 28, 31 Ga | 28 Ga | NO/YES |
| CompatibleCannulaLength(s) | 50, 54, 60, 100, 145,200 mm | 50, 100, and 150 mm | NO/YES | |
| Environment | Provided non-sterile;Re-sterilisable (steam) | Provided non-sterile;Re-sterilisable (steam) | YES/YES | |
| RF CANNULA | ||||
| Device Name | BMC RF Cannula | Polaris RF Cannula | N/A | |
| 510(k) # | K972846 | K181864 | N/A | |
| Patient-contactMaterials | Shaft, Stylet | Stainless steel | Stainless steel | YES/YES |
| ShaftInsulation | Polyethyleneterephthalate | Polyethyleneterephthalate | YES/YES | |
| Hub | Copolyester | Copolyester | YES/YES | |
| KeyDimensions | ShaftDiameter | 16, 18, 20, 21, 22 Ga | 16, 18, 20, 22 Ga | NO/YES |
| UsableLength | 50, 54, 60, 100, 145,200 mm | 50, 100, 150 mm | NO/YES | |
| Bare ActiveTip | 2, 4, 5, 10, 15 mm | 5, 10 mm | NO/YES | |
| Tip Configurations | Straight sharpStraight bluntCurved sharpCurved blunt | Straight sharpCurved sharpCurved blunt | NO/YES | |
| Environment | Provided sterile;Single use | Provided sterile;Single use | YES/YES | |
| Sterilization Method;Sterility Assurance Level(SAL) | Ethylene oxide;10-6 | Ethylene oxide;10-6 | YES/YES | |
| PUMP UNIT | ||||
| Device Name | TransDiscal Pump Unit | Polaris Pump Unit | N/A | |
| 510(k) # | K062937 | K181864 | N/A | |
| Number of Pump Heads | Two | Two | YES/YES | |
| Pump Controlled byGenerator | Yes | Yes | YES/YES | |
| Used with Tube Kit(s) | Yes | Yes | YES/YES | |
| Safety Switch | Yes | Yes | YES/YES | |
| Used with Desk Stand | No | Yes | NO/YES | |
| Environment | Supplied non-sterile;Non-sterilisable | Supplied non-sterile;Non-sterilisable | YES/YES | |
| CONNECTOR HUB | ||||
| Device Name | TransDiscal Y-Connecting Cable | Polaris Connector Hub | N/A | |
| 510(k) # | K062937 | K181864 | N/A | |
| Number of ProbeConnections Possible | Two | Four | NO/YES | |
| PREDICATE DEVICE | SUBJECT DEVICE | Identical/SE | ||
| Connector | Probe | 5-pin female | 7-pin female | NO/YES |
| Generator | 19-pin male | 33-pin HG4 male | NO/YES | |
| Key Cable Materials | Silicone, Thermoplastic elastomer | Thermoplastic elastomer, injection molded plastic | NO/YES | |
| Cable Length | 9 feet | 8 feet | NO/YES | |
| Environment | Supplied non-sterile; Non-sterilisable | Supplied non-sterile; Non-sterilisable | YES/YES |
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7.7 Performance Testing
Performance testing was completed to demonstrate substantial equivalence of the Polaris RF Ablation System and relevant system components to the identified predicate devices in Table 7.1. The system components were subjected to the verification and validation testing listed in Table 7.4.
Table 7.4: Performance Testing of Subject Device
| Tests | Test Method Summary | Results | ||
|---|---|---|---|---|
| Mechanical | Polaris Re-Usable RF Probe | |||
| Mechanical | The following tests were conductedto verify whether the subject devicewas capable of withstanding therelevant mechanical stresses withoutfailure:• Temperature Test• Pull Test• Cleaning and SterilizationReuse Test• Mechanical Reuse Test• Mechanical Test (Flexion)• Continuity Test• Functional Test | All samples passed theacceptance criteria. Resultsconfirmed compliance of thedevice with IEC 60601-2-2:2009 and supportsubstantial equivalence withthe predicate device. | ||
| Electrical | Electrical verification was conductedthrough comparison with the PolarisStandard Single-Use Probe to verifywhether the device was capable ofwithstanding the relevant electricalstresses without failure. | The device was verified tomeet the requirements of IEC60601-1:2005+A1:2012 andIEC 60601-2-2:2009. Resultssupport substantialequivalence with the predicatedevice. |
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| Tests | Test Method Summary | Results |
|---|---|---|
| Biocompatibility | Biocompatibility of the subject devicewas demonstrated throughcomparisons to similar legallymarketed devices as per current ISO10993-1 requirements and the FDAguidance, "Use of InternationalStandard ISO 10993-1, "Biologicalevaluation of medical devices - Part1: Evaluation and testing within arisk management process". | Results confirmed complianceof the device with the currentISO 10993-1 requirementsand support substantialequivalence with the predicatedevice. |
| Packaging | Ship testing was performed to ensurethe integrity of the subject devicepackaging through the rigors ofshipping and handling. | All packaging met relevantrequirements. Results supportsubstantial equivalence withthe predicate device. |
| Cleaning and Sterilization | The recommended reprocessingmethods provided in the Instructionsfor use were validated to ensure therecommended parameters andmethod could achieve a SterilityAssurance Level of 10-6. | The device was verified tomeet the requirements ofAAMI TIR12, AAMI TIR30 andANSI/AAMI ST81requirements and the FDAguidance, "ReprocessingMedical Devices in Health CareSettings: Validation Methodsand Labeling". Results supportsubstantial equivalence withthe predicate device. |
| Mechanical | Polaris Single-Use RF ProbeThe following tests were conductedto verify whether the subject devicewas capable of withstanding therelevant mechanical stresses withoutfailure:● Temperature Test● Pull Test● Durability Test● Mechanical Test (Flexion)● Continuity Test● Functional Test | All samples passed theacceptance criteria. Resultsconfirmed compliance of thedevice with IEC 60601-2-2:2009 and supportsubstantial equivalence withthe predicate device. |
| Tests | Test Method Summary | Results |
| Electrical | The following tests were conductedto verify whether the subject devicewas capable of withstanding therelevant electrical stresses withoutfailure:High Frequency LeakageCurrent Test - Cable High Frequency DielectricStrength Test – Cable High Frequency DielectricStrength Test - Handle Mains Frequency DielectricStrength Test - Cable Mains Frequency DielectricStrength Test - Handle Mains Frequency DielectricStrength Test – Connector | All samples passed theacceptance criteria. Resultsconfirmed compliance of thedevice with IEC 60601-1:2005+A1:2012 and IEC60601-2-2:2009 and supportsubstantial equivalence withthe predicate device. |
| Biocompatibility | Biocompatibility of the subject devicewas demonstrated throughcomparisons to similar legallymarketed devices as per current ISO10993-1 requirements and the FDAguidance, "Use of InternationalStandard ISO 10993-1, "Biologicalevaluation of medical devices - Part1: Evaluation and testing within arisk management process". | Results confirmed complianceof the device with the currentISO 10993-1 requirementsand support substantialequivalence with the predicatedevice. |
| Packaging | Ship testing was performed to ensurethe integrity of the subject devicepackaging through the rigors ofshipping and handling. The sealstrength and sterile barrier integritywas validated per ANSI/AAMI/ISO11607-1 and 11607-2 over the shelflife of the device. | The device packaging metrelevant requirements. Resultsconfirmed compliance ofdevice packaging withANSI/AAMI/ISO 11607-1 and11607-2 and supportsubstantial equivalence withthe predicate device. |
| Tests | Test Method Summary | Results |
| Polaris RF Cannula | ||
| Mechanical | The following tests were conductedto verify whether the subject devicewas capable of withstanding therelevant mechanical stresses withoutfailure:Positive Pressure LiquidLeakage Test Sub-atmospheric Pressure AirLeakage Test Resistance to Separation Test Stress Cracking Test Hub Strength Test | All samples passed theacceptance criteria. Resultsconfirmed the device met withthe mechanical requirementsof ISO 80369-7:2016, ISO594-1:1986 and ISO7864:2016 and supportsubstantial equivalence withthe predicate device. |
| Electrical | The following tests were conductedto verify whether the subject devicewas capable of withstanding therelevant electrical stresses withoutfailure:High Frequency LeakageCurrent Test High Frequency DielectricStrength Test Mains Frequency DielectricStrength Test | All samples passed theacceptance criteria. Resultsconfirmed compliance of thedevice with IEC 60601-1:2005+A1:2012 and IEC60601-2-2:2009 and supportsubstantial equivalence withthe predicate device. |
| Biocompatibility | Biocompatibility of the subject devicewas demonstrated through biologicaltesting as per current ISO 10993-1requirements and the FDA guidance,"Use of International Standard ISO10993-1, "Biological evaluation ofmedical devices - Part 1: Evaluationand testing within a riskmanagement process". | Results confirmed complianceof the device with the currentISO 10993-1 requirementsand support substantialequivalence with the predicatedevice. |
| Packaging | Ship testing was performed to ensurethe integrity of the subject devicepackaging through the rigors ofshipping and handling. The sealstrength and sterile barrier integritywas validated per ANSI/AAMI/ISO11607-1 and 11607-2 over the shelflife of the device. | The device packaging metrelevant requirements. Resultsconfirmed compliance ofdevice packaging withANSI/AAMI/ISO 11607-1 and11607-2 and supportsubstantial equivalence withthe predicate device. |
| Tests | Test Method Summary | Results |
| Polaris Cooled RF Probe Kit | ||
| Mechanical | The following tests were conducted to verify whether the Polaris Cooled RF Probe was capable of withstanding the relevant mechanical stresses without failure:Leak/Pressure Test Pull Test Temperature Test Tip Compression Test Mechanical Test (Flexion) Continuity Test Functional Test | All samples passed the acceptance criteria. Results confirmed compliance of the device with IEC 60601-2-2:2009 and support substantial equivalence with the predicate device. |
| The following tests were conducted to verify whether the Polaris Introducer was capable of withstanding the relevant mechanical stresses without failure:Resistance to Separation from Unscrewing Test Resistance to Separation Test | All samples passed the acceptance criteria. Results support substantial equivalence with the predicate device. | |
| Electrical | The following tests were conducted to verify whether the Polaris Cooled RF Probe was capable of withstanding the relevant electrical stresses without failure:High Frequency Leakage Current Test - Cable High Frequency Leakage Current Test - Shaft High Frequency Dielectric Strength Test – Cable High Frequency Dielectric Strength Test - Handle/Shaft Mains Frequency Dielectric Strength Test – Cable Mains Frequency Dielectric Strength Test - Handle/Shaft Mains Frequency Dielectric Strength Test Connector | All samples passed the acceptance criteria. Results confirmed compliance of the device with IEC 60601-1:2005+A1:2012 and IEC 60601-2-2:2009 and support substantial equivalence with the predicate device. |
| Tests | Test Method Summary | Results |
| Biocompatibility | Biocompatibility of the Polaris CooledRF Probe and Polaris Introducer wasdemonstrated through biologicaltesting and comparisons to similarlegally marketed devices as percurrent ISO 10993-1 requirementsand the FDA guidance, "Use ofInternational Standard ISO 10993-1,"Biological evaluation of medicaldevices - Part 1: Evaluation andtesting within a risk managementprocess". | Results confirmed complianceof the devices with the currentISO 10993-1 requirementsand support substantialequivalence with the predicatedevices. |
| Packaging | Ship testing was performed to ensurethe integrity of the subject devicepackaging through the rigors ofshipping and handling. The sealstrength and sterile barrier integritywas validated per ANSI/AAMI/ISO11607-1 and 11607-2 over the shelflife of the device. | The subject device packagingmet relevant requirements.Results confirmed complianceof device packaging withANSI/AAMI/ISO 11607-1 and11607-2 and supportsubstantial equivalence withthe predicate device. |
| Verification | Polaris Radiofrequency GeneratorTesting was conducted to verify thefunction of the subject device,including electrical testing of thefollowing hardware components:• RF board• User Interface Board• Multiplexer board | The subject device met allrelevant requirements. Resultssupport substantialequivalence with the predicatedevice. |
| Packaging | Ship testing was performed to ensurethe integrity of the subject devicepackaging through the rigors ofshipping and handling. | All packaging met relevantrequirements. Results supportsubstantial equivalence withthe predicate device. |
| Tests | Test Method Summary | Results |
| Polaris Pump Unit | ||
| Verification | Testing was conducted to verify specified design requirements of the subject device, including hardware. Performance was assessed in test cases covering the following aspects:● Inspection● Configuration and Installation● Operation● Environment and Service Life | The subject device met all relevant requirements. Results support substantial equivalence with the predicate device. |
| Packaging | Ship testing was performed to ensure the integrity of the subject device packaging through the rigors of shipping and handling. | All packaging met relevant requirements. Results support substantial equivalence with the predicate device. |
| Polaris Connector Hub | ||
| Verification | Testing was conducted to verify specified design requirements of the subject device, including hardware. Performance was assessed through various test cases, including:● Cable Pull Test● Cable Impulse Test● Device Identification | The subject device met all relevant requirements. Results confirmed compliance of the device with Baylis self-enforced requirements and support substantial equivalence with the predicate device. |
| Packaging | Ship testing was performed to ensure the integrity of the device packaging through the rigors of shipping and handling. | All packaging met relevant requirements. Results confirmed compliance of device packaging with Baylis self-enforced requirements and support substantial equivalence with the predicate device. |
| Polaris Footswitch | ||
| Packaging | Ship testing was performed to ensure the integrity of the subject device packaging through the rigors of shipping and handling. | All packaging met relevant requirements. Results support substantial equivalence with the predicate device. |
| Tests | Test Method Summary | Results |
| Polaris RF Ablation System | ||
| Electrical ProductSafety | The Polaris RF Generator, togetherwith relevant accessories anddetachable parts, was tested todemonstrate compliance with theapplicable requirements of IEC60601-1:2005+A1:2012 (includingnational deviations as per ANSI AAMIES 60601-1:2005(R) 2012 +A1:2012) and IEC 60601-2-2: 2009. | The subject device met allrelevant requirements. Resultsconfirmed compliance of thedevice withIEC 60601-1:2005+A1:2012and IEC 60601-2-2:2009 andsupport substantialequivalence with the predicatedevice. |
| ElectromagneticCompatibility | The Polaris RF Generator, togetherwith applicable system components,was tested to demonstratecompliance with the applicablerequirements of IEC 60601-1-2:2014. | The subject device met allrelevant requirements. Resultsconfirmed compliance of thedevice withIEC 60601-1-2:2014 andsupport substantialequivalence with the predicatedevice. |
| Benchtop LesionValidation | Comparative lesion validation testingwas performed using a soft tissuemodel to demonstrate thesubstantially equivalent ablationperformance of the subject andpredicate systems. Testing wasperformed for both single and multi-probe scenarios. | The subject device met allrelevant requirements. Resultssupport substantialequivalence with the predicatedevice. |
| Usability | Testing was performed to verify andvalidate the usability requirements ofthe subject Polaris RF AblationSystem. Elements captured includednormal use cases, a foreseeableworst-case use scenario, andtestable requirements for primaryoperating functions. | The device met all relevantrequirements. Results supportsubstantial equivalence withthe predicate device. |
| Tests | Test Method Summary | Results |
| Software | Software verification and validationwas completed for the subjectdevice. FDA's current "Guidance forthe Content of PremarketSubmissions for Software Containedin Medical Devices" was used todetermine the Level of Concern forthe software in the subject Polaris RFAblation System. | The device met all relevantrequirements. Results supportsubstantial equivalence withthe predicate device. |
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All test requirements were met as specified by applicable standards and the test protocols. Results demonstrate that the Polaris RF Ablation System functions as intended and is as safe and effective as the predicate device.
7.8 Conclusions
The intended use of the subject Polaris RF Ablation System is the same as the predicate devices. The indications for use of the Polaris RF Ablation System is the same, or a subset of, the indications for use of the predicate devices. The fundamental scientific technology of the Polaris RF Ablation System, including principles of operation and mechanism of action, is the same as the predicate devices. Differences in design and technological characteristics between the subject and predicate devices do not raise any new types of questions of safety and effectiveness. Verification and validation test results support the substantial equivalence of the Polaris RF Ablation System to the predicate system.
§ 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).