Who is the manufacturer of Polaris RF Ablation System?

Baylis Medical Company, Inc. filed the 510(k) submission for Polaris RF Ablation System (K181864).

What is the FDA product code for Polaris RF Ablation System?

GXD. It is classified under 21 CFR 882.4400 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for Polaris RF Ablation System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Polaris RF Ablation System?

Baylis Pain Management Generator-TD (K072478); Baylis TransDiscal System (K062937); Baylis Pain Management Cooled Probe (K053082); Baylis Pain Management Probe and Connector Cable (K002389); BMC RF Cannula (K972846).

Who can help prepare an FDA 510(k) submission like Polaris RF Ablation System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Polaris RF Ablation System

K181864 · Baylis Medical Company, Inc. · GXD · Jan 2, 2019 · Neurology

Device Facts

Record ID	K181864
Device Name	Polaris RF Ablation System
Applicant	Baylis Medical Company, Inc.
Product Code	GXD · Neurology
Decision Date	Jan 2, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.4400
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Polaris RF Ablation System is intended for the creation of radiofrequency lesions in nervous tissue.

Device Story

The Polaris RF Ablation System is a radiofrequency (RF) lesion generator used by physicians to create thermal lesions in nervous tissue for pain management. The system delivers controlled RF energy from a generator to target tissues via various RF probes (standard or cooled). For cooled procedures, a pump unit circulates water through the probe to minimize tissue charring and adhesion, allowing for larger, more consistent ablation volumes. The system also delivers low-frequency stimulation pulses for nerve localization. The generator features a touchscreen interface, real-time monitoring of temperature, impedance, power, and voltage, and automatic safety shut-offs for out-of-range parameters. The device is used in a clinical setting by physicians familiar with RF lesion techniques. The output (lesions) is used to treat patients by inducing cellular necrosis through thermal coagulation.

Clinical Evidence

Bench testing only. No clinical data. Performance was validated through mechanical stress testing (IEC 60601-2-2), electrical safety testing (IEC 60601-1), biocompatibility (ISO 10993-1), packaging integrity (ISO 11607), and comparative benchtop lesion validation in a soft tissue model to confirm ablation performance against predicates.

Technological Characteristics

System includes RF generator, peristaltic pump, connector hub, footswitch, and various RF probes/cannulae. Materials include stainless steel, polyimide, ABS, silicone, PVC, polycarbonate, and copolyester. Energy source: RF generator (465 kHz sinusoidal). Connectivity: Standalone system with touchscreen interface. Sterilization: Ethylene oxide (probes/cannulae) or steam (reusable probes). Software: Embedded firmware for generator control and monitoring.

Indications for Use

Indicated for the creation of radiofrequency lesions in nervous tissue.

Regulatory Classification

Identification

A radiofrequency lesion generator is a device used to produce lesions in the nervous system or other tissue by the direct application of radiofrequency currents to selected sites.

Predicate Devices

Baylis Pain Management Generator-TD (K072478)
Baylis TransDiscal System (K062937)
Baylis Pain Management Cooled Probe (K053082)
Baylis Pain Management Probe and Connector Cable (K002389)
BMC RF Cannula (K972846)

Related Devices

K192491 — Coolief Radiofrequency Generator (CRG) System · Avanos Medical, Inc. · Feb 21, 2020
K050084 — COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEMINAL ELECTRODE KIT; COSMAN TIC TRIGEMINAL ELECTRODE KIT; · Cosman Medical, Inc. · Mar 17, 2005
K071482 — STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000 · Synergetics, Inc. · Dec 20, 2007
K982489 — RFG-3C PLUS · Radionics, Inc. · Oct 5, 1998
K052878 — NT-1000 · Neuro Therm, Inc. · Jan 23, 2006

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {2}------------------------------------------------ # 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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 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 {4}------------------------------------------------ #### 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 and Connector 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: - 1. Polaris Radiofrequency Generator and Desk Stand - 2. Polaris Pump, Pump Cable and Desk Stand - 3. Polaris Standard Connector Hub / Polaris Cooled Connector Hub - 4. Polaris Footswitch - 5. Polaris Cooled RF Probe Kit: - i. Polaris Cooled RF Ablation Probe - ii. Polaris Tube Kit - iii. Polaris Introducer - 6. Polaris Single-Use RF Probe - 7. Polaris Reusable RF Probe - 8. 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 {5}------------------------------------------------ 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. {6}------------------------------------------------ # Table 7.2: Comparison of Subject and Predicate Devices – Overall System | | PREDICATE DEVICES | | | | | SUBJECT DEVICE | Identical / Substantially Equivalent (SE) | |----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------| | Device Name | Baylis Pain Management Generator-TD | TransDiscal (TD) System | BMC RF Cannula | BMC PM Probe and Connector Cable | Baylis PM Cooled Probe | Polaris RF Ablation System | N/A | | 510(k) # | K072478 | K062937 | K972846 | K002389 | K053082 | K181864 | N/A | | Manufacturer | Halyard Health* | | | | | Baylis Medical Company Inc. | N/A | | Class | II | II | II | II | II | II | YES/YES | | Product Code, Regulation | GEI, 882.4400 GXD, 882.4400 | GXI, 882.4725 | GXI, 882.4725 | GXI, 882.4725 | GXI, 882.4725 | GXD, 882.4400 GXI, 882.4725 | YES/YES | | Indications for Use | Baylis Pain Management Generator - TD; Model PMG-115- TD (For Domestic Use) and Model PMG- 230-TD (For International Use) 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 | The Baylis TD system, used in combination with the Baylis PM Generator, is indicated for the creation of RF heat lesions in nervous tissue including that which is situated in the intervertebral disc material. | The BMC RF Cannula is intended for use in RF heat lesion procedures for relief of pain | To create RF lesions in nervous tissue. | The Baylis PM Cooled Probe will be used in conjunction with a RF Generator to create RF lesions in nervous tissue. | The Polaris RF Ablation System is intended for the creation of RF lesions in nervous tissue. | NO/YES | | | PREDICATE DEVICES | | | | SUBJECT DEVICE | Identical / Substantially Equivalent (SE) | | | | contained herniated discs. The Baylis PMG- TD is to be used with separately approved probes such as Baylis TransDiscal Probe, Oratec Spinecath and Baylis Pain Management Probes. | | | | | | | | Relevant System Components | RF Generator | Peristaltic Pump, Connector Cable Tube Kit Introducer Y-Connecting Cable | RF Cannula | Standard RF Probes (non- cooled) | Cooled RF Probe | RF Generator and Desk Stand Peristaltic Pump and Desk Stand, Pump Connector Cable Connector Hub RF Cannula Standard RF Probes (non- cooled) Cooled RF Probe kit (Cooled RF Probe, Tube Kit, Introducer) | NO/YES | Traditional 510(k) {7}------------------------------------------------ {8}------------------------------------------------ | | PREDICATE DEVICES | SUBJECT DEVICE | Identical / Substantially Equivalent (SE) | |---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------| | User | Physicians familiar with RF lesion techniques | Physicians familiar with RF lesion techniques | YES/YES | | Anatomical Site of Use | Nervous tissue | Nervous tissue | YES/YES | | Access Method | Percutaneous | Percutaneous | YES/YES | | Energy Type | Radiofrequency | Radiofrequency | YES/YES | | Principle of Operation | Operator controlled; RF delivered from RF generator to compatible RF probes | Operator controlled; RF delivered from RF generator to compatible RF probes | YES/YES | | Mechanism of Action | Cellular necrosis through thermal coagulation | Cellular necrosis through thermal coagulation | YES/YES | | System Feedback Mechanism | Temperature controlled | Temperature controlled | YES/YES | | Ability to Make Multiple Lesions | Yes | Yes | YES/YES | | | PREDICATE DEVICE | SUBJECT DEVICE | Identical/ SE | | | RF GENERATOR | | | | Device Name | Baylis Pain Management Generator-TD | Polaris Radiofrequency Generator | N/A | | 510(k) # | K072478 | K181864 | N/A | | Available Generator Modes | Standard RF Mode • Stimulation (Sensory/Motor) • Pulsed RF (Single RF, Multi-RF, Bipolar RF) • RF lesion (Single RF, Multi-RF, Bipolar RF) | Standard RF Mode • Stimulation (Sensory/Motor) • Pulsed RF (Single RF, Multi-RF, Bipolar RF) • RF lesion (Single RF, Multi-RF, Bipolar RF) | YES/YES | | | Cooled RF Mode • Stimulation (Sensory/Motor) • RF lesion (Single RF, Multi-RF, Bipolar RF) | Cooled RF Mode • Stimulation (Sensory/Motor) • RF lesion (Single RF, Multi-RF, Bipolar RF) | | | Maximum Power Output | 50 Watts | 50 Watts | YES/YES | | Operating Frequency Waveform | 461 kHz Sinusoidal | 465 kHz Sinusoidal | NO/YES | | Temperature Monitoring Thermocouple (RF modes) | Yes | Yes | YES/YES | | Display Parameters | Real time temperature, impedance, power and voltage (pulsed RF mode) | Real time temperature, impedance, power and voltage (pulsed RF mode) | YES/YES | | Safety Features | • Automatic shut-off for: o Out-of-range impedance and temperature o Over power, voltage, current | • Automatic shut-off for: o Out-of-range impedance and temperature o Over power, voltage, current | YES/YES | | | • Output of errors, including: o Fault indicator, fault code display and description o Audible alarm | • Output of errors, including : o Alert icon, fault code display and description o Audible alarm | | | Touchscreen | No | Yes | NO/YES | | Used with Desk Stand | No | Yes | NO/YES | | Used with Optional Footswitch | Yes | Yes | YES/YES | | Environment | Supplied non-sterile; Non-sterilisable | Supplied non-sterile; Non-sterilisable | YES/YES | {9}------------------------------------------------ ## Table 7.3: Comparison of Subject and Predicate Devices – Relevant Components {10}------------------------------------------------ | | | PREDICATE DEVICE | SUBJECT DEVICE | Identical/SE | |-------------------------------------------------------------|---------------------------------------------------------|------------------------------------------------------------------|---------------------------------------------------|------------------| | | | COOLED RF PROBE | | | | Device Name | | PM Cooled Probe | Polaris Cooled RF Ablation Probe | N/A | | 510(k) # | | K053082 | K181864 | N/A | | Probe Configuration | | Monopolar | Monopolar | YES/YES | | Tissue Temperature Measurement | Includes Thermocouple for | Yes | Yes | YES/YES | | | Location of Thermocouple | Exposed at probe distal tip | Embedded within probe distal 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 | | | Contact Materials | Tubing | Polyvinyl chloride | Polyvinyl chloride | | | | Luer lock | Polycarbonate | Polycarbonate | | | Key Dimensions | Shaft Diameter | 18 Gauge | 18 Gauge | NO/YES | | | Active Tip Lengths | 2, 4, 5.5, 6 mm | 4, 5.5 mm | | | | Compatible Introducer Lengths | 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- patient Contact Materials | Tubing Burette, Female Luer Cap, Luer Locks | Tygon Polycarbonate | Tygon Polycarbonate | NO/YES | | | Crimp | N/A | Stainless steel | | | Key | Tubing Length | 140" | 140" | YES/YES | | Dimensions | Burette Capacity | 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- contact Materials | Shaft Introducer, Stylet | Stainless steel | Stainless steel | NO/YES | | | Insulation | Polyimide | Polyimide | | | | Hub | Unknown | Copolyester | | | Key Dimensions | Shaft Outer Diameter | 17 Gauge | 17 Gauge | NO/YES | | | Usable Length(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 RF Probe | N/A | | 510(k) # | | K002389 | K181864 | N/A | | Configuration | | Monopolar | Monopolar | YES/YES | | Used with Compatible Cannula | | Yes | Yes | YES/YES | | Thermocouple for Tissue Temperature Measurement | | Yes | Yes | YES/YES | | Patient- contact Materials | Shaft, Stylet | Stainless steel | Stainless steel | YES/YES | | Key Dimensions | Shaft Diameter | 24, 28, 31 Ga | 28 Ga | NO/YES | | | Compatible Cannula Length(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 RF Probe | N/A | | 510(k) # | | K002389 | K181864 | N/A | | Configuration | | Monopolar | Monopolar | YES/YES | | Used with Cannula | | Yes | Yes | YES/YES | | Thermocouple for Tissue Temperature Measurement | | Yes | Yes | YES/YES | | | | PREDICATE DEVICE | SUBJECT DEVICE | Identical/ SE | | Patient- contact Materials | Shaft, Stylet | Stainless steel or nitinol | Stainless steel or nitinol | YES/YES | | Key Dimensions | Shaft Diameter | 24, 28, 31 Ga | 28 Ga | NO/YES | | | Compatible Cannula Length(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- contact Materials | Shaft, Stylet | Stainless steel | Stainless steel | YES/YES | | | Shaft Insulation | Polyethylene terephthalate | Polyethylene terephthalate | YES/YES | | | Hub | Copolyester | Copolyester | YES/YES | | Key Dimensions | Shaft Diameter | 16, 18, 20, 21, 22 Ga | 16, 18, 20, 22 Ga | NO/YES | | | Usable Length | 50, 54, 60, 100, 145, 200 mm | 50, 100, 150 mm | NO/YES | | | Bare Active Tip | 2, 4, 5, 10, 15 mm | 5, 10 mm | NO/YES | | Tip Configurations | | Straight sharp Straight blunt Curved sharp Curved blunt | Straight sharp Curved sharp Curved 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 by Generator | | 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 Probe Connections 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 | {11}------------------------------------------------ {12}------------------------------------------------ {13}------------------------------------------------ #### 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 conducted to verify whether the subject device was capable of withstanding the relevant mechanical stresses without failure: • Temperature Test • Pull Test • Cleaning and Sterilization Reuse Test • Mechanical Reuse 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. | | | | Electrical | Electrical verification was conducted through comparison with the Polaris Standard Single-Use Probe to verify whether the device was capable of withstanding the relevant electrical stresses without failure. | 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 with the predicate device. | | | {14}------------------------------------------------ | Tests | Test Method Summary | Results | |----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Biocompatibility | Biocompatibility of the subject device was demonstrated through comparisons to similar legally marketed devices as per current ISO 10993-1 requirements and the FDA guidance, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". | Results confirmed compliance of the device with the current ISO 10993-1 requirements and 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. | | Cleaning and Sterilization | The recommended reprocessing methods provided in the Instructions for use were validated to ensure the recommended parameters and method could achieve a Sterility Assurance Level of 10-6. | The device was verified to meet the requirements of AAMI TIR12, AAMI TIR30 and ANSI/AAMI ST81 requirements and the FDA guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling". Results support substantial equivalence with the predicate device. | | Mechanical | Polaris Single-Use RF Probe The following tests were conducted to verify whether the subject device was capable of withstanding the relevant mechanical stresses without failure: ● Temperature Test ● Pull Test ● Durability 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. | | Tests | Test Method Summary | Results | | Electrical | The following tests were conducted to verify whether the subject device was capable of withstanding the relevant electrical stresses without failure: High Frequency Leakage Current Test - Cable High Frequency Dielectric Strength Test – Cable High Frequency Dielectric Strength Test - Handle Mains Frequency Dielectric Strength Test - Cable Mains Frequency Dielectric Strength Test - Handle 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. | | Biocompatibility | Biocompatibility of the subject device was demonstrated through comparisons to similar legally marketed devices as per current ISO 10993-1 requirements and the FDA guidance, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". | Results confirmed compliance of the device with the current ISO 10993-1 requirements and 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. The seal strength and sterile barrier integrity was validated per ANSI/AAMI/ISO 11607-1 and 11607-2 over the shelf life of the device. | 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 with the predicate device. | | Tests | Test Method Summary | Results | | | Polaris RF Cannula | | | Mechanical | The following tests were conducted to verify whether the subject device was capable of withstanding the relevant mechanical stresses without failure: Positive Pressure Liquid Leakage Test Sub-atmospheric Pressure Air Leakage Test Resistance to Separation Test Stress Cracking Test Hub Strength Test | 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 with the predicate device. | | Electrical | The following tests were conducted to verify whether the subject device was capable of withstanding the relevant electrical stresses without failure: High Frequency Leakage Current Test High Frequency Dielectric Strength Test Mains Frequency Dielectric Strength Test | 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. | | Biocompatibility | Biocompatibility of the subject device was demonstrated through biological testing as per current ISO 10993-1 requirements and the FDA guidance, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". | Results confirmed compliance of the device with the current ISO 10993-1 requirements and 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. The seal strength and sterile barrier integrity was validated per ANSI/AAMI/ISO 11607-1 and 11607-2 over the shelf life of the device. | 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 with the 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…