Predicate Devices

K072478, K062937, K053082, K002389, K972846

Reference Devices

Unknown

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the hardware components and the physical process of delivering RF energy and cooling, with no mention of AI or ML for analysis, decision-making, or control.

Therapeutic

Yes.
The device is intended for the creation of radiofrequency lesions in nervous tissue, which is a therapeutic intervention aimed at treating medical conditions.

Diagnostic

No
The device's intended use is for the creation of radiofrequency lesions in nervous tissue, which is a therapeutic intervention, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description explicitly lists multiple hardware components including a generator, pump, probes, cannula, and footswitch. While software is mentioned in the performance studies, the device is clearly a system with significant hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, the Polaris RF Ablation System is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use is "for the creation of radiofrequency lesions in nervous tissue." This describes a therapeutic procedure performed directly on a patient's body, not a test performed on a sample taken from the body.
Device Description: The components listed are all designed for delivering energy and managing the procedure within the body (generator, probes, pump, etc.). There are no components mentioned for analyzing biological samples.
Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.) or the use of reagents, which are hallmarks of IVD devices.
Anatomical Site: The target is "Nervous tissue," indicating a direct interaction with the patient's anatomy.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Polaris RF Ablation System is a therapeutic device used to treat conditions by creating lesions in nervous tissue.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes

GXD, GXI

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 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Nervous tissue

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Physicians familiar with RF lesion techniques

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Polaris Re-Usable RF Probe

Mechanical Testing:
- Test Method Summary: Performed Temperature Test, Pull Test, Cleaning and Sterilization Reuse Test, Mechanical Reuse Test, Mechanical Test (Flexion), Continuity Test, Functional Test.
- Results: All samples passed acceptance criteria, confirming compliance with IEC 60601-2-2:2009 and supporting substantial equivalence.
Electrical Testing:
- Test Method Summary: Electrical verification by comparison with Polaris Standard Single-Use Probe to assess electrical stress resistance.
- Results: Verified to meet requirements of IEC 60601-1:2005+A1:2012 and IEC 60601-2-2:2009, supporting substantial equivalence.

Biocompatibility

Test Method Summary: Demonstrated through comparisons to similar legally marketed devices per ISO 10993-1 and FDA guidance.
Results: Confirmed compliance with ISO 10993-1 requirements and supported substantial equivalence.

Packaging

Test Method Summary: Ship testing performed to ensure integrity through shipping and handling.
Results: All packaging met relevant requirements, supporting substantial equivalence.

Cleaning and Sterilization

Test Method Summary: Validated recommended reprocessing methods in Instructions for Use to achieve a Sterility Assurance Level of 10-6.
Results: Verified to meet AAMI TIR12, AAMI TIR30, ANSI/AAMI ST81 requirements and FDA guidance, supporting substantial equivalence.

Polaris Single-Use RF Probe

Mechanical Testing:
- Test Method Summary: Performed Temperature Test, Pull Test, Durability Test, Mechanical Test (Flexion), Continuity Test, Functional Test.
- Results: All samples passed acceptance criteria, confirming compliance with IEC 60601-2-2:2009 and supporting substantial equivalence.
Electrical Testing:
- Test Method Summary: Performed 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.
- Results: All samples passed acceptance criteria, confirming compliance with IEC 60601-1:2005+A1:2012 and IEC 60601-2-2:2009, supporting substantial equivalence.

Biocompatibility

Test Method Summary: Demonstrated through comparisons to similar legally marketed devices per ISO 10993-1 and FDA guidance.
Results: Confirmed compliance with ISO 10993-1 requirements and supported substantial equivalence.

Packaging

Test Method Summary: Ship testing performed to ensure integrity through shipping and handling. Seal strength and sterile barrier integrity validated per ANSI/AAMI/ISO 11607-1 and 11607-2 over shelf life.
Results: Met relevant requirements, confirming compliance with ANSI/AAMI/ISO 11607-1 and 11607-2, supporting substantial equivalence.

Polaris RF Cannula

Mechanical Testing:
- Test Method Summary: Performed Positive Pressure Liquid Leakage Test, Sub-atmospheric Pressure Air Leakage Test, Resistance to Separation Test, Stress Cracking Test, Hub Strength Test.
- Results: All samples passed acceptance criteria, confirming compliance with ISO 80369-7:2016, ISO 594-1:1986, and ISO 7864:2016, supporting substantial equivalence.
Electrical Testing:
- Test Method Summary: Performed High Frequency Leakage Current Test, High Frequency Dielectric Strength Test, Mains Frequency Dielectric Strength Test.
- Results: All samples passed acceptance criteria, confirming compliance with IEC 60601-1:2005+A1:2012 and IEC 60601-2-2:2009, supporting substantial equivalence.

Biocompatibility

Test Method Summary: Demonstrated through biological testing per ISO 10993-1 and FDA guidance.
Results: Confirmed compliance with ISO 10993-1 requirements and supported substantial equivalence.

Packaging

Test Method Summary: Ship testing performed to ensure integrity through shipping and handling. Seal strength and sterile barrier integrity validated per ANSI/AAMI/ISO 11607-1 and 11607-2 over shelf life.
Results: Met relevant requirements, confirming compliance with ANSI/AAMI/ISO 11607-1 and 11607-2, supporting substantial equivalence.

Polaris Cooled RF Probe Kit

Mechanical Testing (Polaris Cooled RF Probe):
- Test Method Summary: Performed Leak/Pressure Test, Pull Test, Temperature Test, Tip Compression Test, Mechanical Test (Flexion), Continuity Test, Functional Test.
- Results: All samples passed acceptance criteria, confirming compliance with IEC 60601-2-2:2009 and supporting substantial equivalence.
Mechanical Testing (Polaris Introducer):
- Test Method Summary: Performed Resistance to Separation from Unscrewing Test, Resistance to Separation Test.
- Results: All samples passed acceptance criteria, supporting substantial equivalence.
Electrical Testing (Polaris Cooled RF Probe):
- Test Method Summary: Performed 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.
- Results: All samples passed acceptance criteria, confirming compliance with IEC 60601-1:2005+A1:2012 and IEC 60601-2-2:2009, supporting substantial equivalence.

Biocompatibility

Test Method Summary: Demonstrated through biological testing and comparisons to similar legally marketed devices per ISO 10993-1 and FDA guidance.
Results: Confirmed compliance with ISO 10993-1 requirements and supported substantial equivalence.

Packaging

Test Method Summary: Ship testing performed to ensure integrity through shipping and handling. Seal strength and sterile barrier integrity validated per ANSI/AAMI/ISO 11607-1 and 11607-2 over shelf life.
Results: Met relevant requirements, confirming compliance with ANSI/AAMI/ISO 11607-1 and 11607-2, supporting substantial equivalence.

Polaris Radiofrequency Generator

Verification:
- Test Method Summary: Tested function, including electrical testing of RF board, User Interface Board, and Multiplexer board.
- Results: Met all relevant requirements, supporting substantial equivalence.

Packaging

Test Method Summary: Ship testing performed to ensure integrity through shipping and handling.
Results: All packaging met relevant requirements, supporting substantial equivalence.

Polaris Pump Unit

Verification:
- Test Method Summary: Tested specified design requirements, including hardware. Performance assessed for inspection, configuration and Installation, operation, environment, and service life.
- Results: Met all relevant requirements, supporting substantial equivalence.

Packaging

Test Method Summary: Ship testing performed to ensure integrity through shipping and handling.
Results: All packaging met relevant requirements, supporting substantial equivalence.

Polaris Connector Hub

Verification:
- Test Method Summary: Tested specified design requirements, including hardware. Performance assessed through Cable Pull Test, Cable Impulse Test, Device Identification.
- Results: Met all relevant requirements, confirmed compliance with Baylis self-enforced requirements and supported substantial equivalence.

Packaging

Test Method Summary: Ship testing performed to ensure integrity through shipping and handling.
Results: All packaging met relevant requirements, confirmed compliance of device packaging with Baylis self-enforced requirements and supported substantial equivalence.

Polaris Footswitch

Packaging:
- Test Method Summary: Ship testing performed to ensure integrity through shipping and handling.
- Results: All packaging met relevant requirements, supporting substantial equivalence.

Polaris RF Ablation System

Electrical Product Safety:
- Test Method Summary: Tested Polaris RF Generator with accessories and detachable parts for compliance with IEC 60601-1:2005+A1:2012 (including ANSI AAMI ES 60601-1:2005(R) 2012 + A1:2012) and IEC 60601-2-2:2009.
- Results: Met all relevant requirements, confirming compliance and supporting substantial equivalence.
Electromagnetic Compatibility:
- Test Method Summary: Tested Polaris RF Generator with system components for compliance with IEC 60601-1-2:2014.
- Results: Met all relevant requirements, confirming compliance and supporting substantial equivalence.
Benchtop Lesion Validation:
- Test Method Summary: Comparative lesion validation testing in a soft tissue model to demonstrate ablation performance. Performed for single and multi-probe scenarios.
- Results: Met all relevant requirements, supporting substantial equivalence.
Usability:
- Test Method Summary: Verified and validated usability requirements. Included normal use cases, foreseeable worst-case use scenario, and testable requirements for primary operating functions.
- Results: Met all relevant requirements, supporting substantial equivalence.
Software:
- Test Method Summary: Software verification and validation completed. FDA's guidance for software in medical devices used to determine Level of Concern.
- Results: Met all relevant requirements, supporting substantial equivalence.

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K072478, K062937, K053082, K002389, K972846

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

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)

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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
1. Polaris Pump, Pump Cable and Desk Stand
1. Polaris Standard Connector Hub / Polaris Cooled Connector Hub
1. Polaris Footswitch
1. Polaris Cooled RF Probe Kit:
- i. Polaris Cooled RF Ablation Probe
- ii. Polaris Tube Kit
- iii. Polaris Introducer
1. Polaris Single-Use RF Probe
1. Polaris Reusable RF Probe
1. 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

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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 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 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 Cooled
RF Probe and Polaris Introducer was
demonstrated through biological
testing and 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 devices with the current
ISO 10993-1 requirements
and support substantial
equivalence with the predicate
devices.
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 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 with
the predicate device.
Verification	Polaris Radiofrequency Generator
Testing was conducted to verify the
function of the subject device,
including electrical testing of the
following hardware components:
• RF board
• User Interface Board
• Multiplexer board	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.
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 Product
Safety	The Polaris RF Generator, together
with relevant accessories and
detachable parts, was tested to
demonstrate compliance with the
applicable requirements of IEC
60601-1:2005+A1:2012 (including
national deviations as per ANSI AAMI
ES 60601-1:2005(R) 2012 +
A1:2012) and IEC 60601-2-2: 2009.	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 with the predicate
device.
Electromagnetic
Compatibility	The Polaris RF Generator, together
with applicable system components,
was tested to demonstrate
compliance with the applicable
requirements of 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 with the predicate
device.
Benchtop Lesion
Validation	Comparative lesion validation testing
was performed using a soft tissue
model to demonstrate the
substantially equivalent ablation
performance of the subject and
predicate systems. Testing was
performed for both single and multi-
probe scenarios.	The subject device met all
relevant requirements. Results
support substantial
equivalence with the predicate
device.
Usability	Testing was performed to verify and
validate the usability requirements of
the subject Polaris RF Ablation
System. Elements captured included
normal use cases, a foreseeable
worst-case use scenario, and
testable requirements for primary
operating functions.	The device met all relevant
requirements. Results support
substantial equivalence with
the predicate device.
Tests	Test Method Summary	Results
Software	Software verification and validation
was completed for the subject
device. FDA's current "Guidance for
the Content of Premarket
Submissions for Software Contained
in Medical Devices" was used to
determine the Level of Concern for
the software in the subject Polaris RF
Ablation System.	The device met all relevant
requirements. Results support
substantial equivalence with
the predicate device.

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19

20

21

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.