The OsteoCool® V-2 RF Ablation System is intended for palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body.

Device Description

The OsteoCool V-2 RF Ablation System represents an upgrade to the cleared OsteoCool RF Ablation System (K111523) for the addition of a secondary system thermocouple to enable temperature monitoring around thermal ablation zones.

The OsteoCool V-2 RF Ablation System includes the following components:

1. OsteoCool RF Ablation Kit (OsteoCool Probe, OsteoCool Introducer, and Tube Kit)
1. Pain Management Pump Unit & Pump Connector Cable
1. Baylis Pain Management Generator-TD
1. DuoCool™ Y-Connector Cable With TC
1. Thermocouple Monitor
1. Thermocouple Monitor Box

The OsteoCool V-2 RF Ablation System is designed to deliver controlled radiofrequency (RF) energy in a bipolar manner with a cooling mechanism. The Baylis Pain Management Generator-TD (PMG-TD) operates together with the OsteoCool Probe to deliver the RF energy to the target ablation site. The OsteoCool Introducer provides a path for the OsteoCool Probe to its target site. The Tube Kit is used with the Pain Management Pump Unit to circulate water internally through the OsteoCool Probe during RF energy delivery. The Pump Connector Cable connects the Pain Management Pump Unit to the PMG-TD, which powers and controls the pump speed. The DuoCool Y-Connector Cable With TC connects the OsteoCool Probe and Thermocouple Monitor to the PMG-TD. The Thermocouple Monitor Box is battery operated and connects to a port on the PMG-TD to display the temperature detected by the Thermocouple Monitor.

AI/ML Overview

This document, a 510(k) Summary for the OsteoCool® V-2 RF Ablation System (K142480), focuses on establishing substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria for a new device's performance against clinical endpoints. Therefore, it does not contain the specific information requested in many of your points, such as detailed acceptance criteria, sample sizes for test sets, expert-driven ground truth, or MRMC studies.

However, I can extract information related to performance testing that was conducted to support the substantial equivalence claim.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in a quantitative, pass/fail format for clinical performance. Instead, it relies on demonstrating that the OsteoCool® V-2 RF Ablation System performs comparably to the predicate device and meets safety and effectiveness requirements through various tests.

The comparison table provided focuses on design and technological characteristics. The performance data section describes the types of tests conducted rather than specific acceptance criteria for clinical outcomes.

Here's a table summarizing the areas of performance testing and the general intent, as acceptance criteria are not explicitly defined in the provided document:

Performance Area	General Intent (Implied Acceptance Criteria)	Reported Device Performance
Mechanical Testing	Device components (e.g., probe, introducer) should withstand typical forces encountered during use without failure that would compromise safety or effectiveness.	Pull test: Performed to assess mechanical integrity. Specific results are not provided but are stated to support safe and effective use and substantial equivalence. Impulse test: Performed to assess mechanical integrity. Specific results are not provided but are stated to support safe and effective use and substantial equivalence.
Electrical Testing	The Thermocouple Monitor must meet relevant electrical safety standards (IEC 60601-1:2005 and IEC 60601-2-2:2009) at baseline and after simulated aging to ensure continued safe and accurate operation.	Electrical verification: Conducted to ensure the OsteoCool Thermocouple Monitor (OST) meets the electrical requirements of IEC 60601-1:2005 and IEC 60601-2-2:2009 after 0 and 4 years of aging. Specific results are not provided but are stated to support safe and effective use and substantial equivalence.
Temperature Testing	The device should accurately measure and report temperature.	Temperature accuracy testing: Conducted. Specific results are not provided but are stated to support safe and effective use and substantial equivalence.
Bench Top Validation
Ex-vivo Bovine Liver	Ablation parameters (probe and thermocouple response) should be consistent with expected device function. Lesion sizes and thermal profiles should be comparable to what is understood for RF ablation and potentially to the predicate device's expected performance.	Ablation probe response curves: Tested. Specific results are not provided but are stated to support safe and effective use and substantial equivalence. Thermocouple monitor response curves: Tested. Specific results are not provided but are stated to support safe and effective use and substantial equivalence. Comparison of lesion sizes: Tested. Specific results are not provided but are stated to support safe and effective use and substantial equivalence. Thermal profile and lesion boundaries: Tested. Specific results are not provided but are stated to support safe and effective use and substantial equivalence.
Human Cadaver Vertebrae	Ablation volumes and thermal characteristics in human vertebral tissue should be consistent with the intended therapeutic effect and comparable to the predicate device, demonstrating effective palliative treatment of metastatic lesions in vertebral bodies.	Ablation volume: Tested. Specific results are not provided but are stated to support safe and effective use and substantial equivalence. Thermal imaging: Tested. Specific results are not provided but are stated to support safe and effective use and substantial equivalence. Comparison of ablation volumes with predicate: Tested. Specific results are not provided but are stated to support safe and effective use and substantial equivalence.
Overall Scientific Basis	Differences in design/technological characteristics between the proposed and predicate devices should not raise new concerns of safety and effectiveness. The device should be safe and effective for its stated indications for use, and demonstrate substantial equivalence to the predicate.	The document concludes that "The results of verification and validation testing support the safe and effective use of the proposed device for its intended use and its substantial equivalence determination to the predicate device." And "Differences in design and technological characteristics between the proposed and predicate devices do not raise any new concerns of safety and effectiveness."

For the remaining points, the provided 510(k) summary does not contain the detailed information typically found in a clinical study report. This document focuses on demonstrating substantial equivalence through a comparison of technological characteristics and
non-clinical performance data, rather than a clinical trial with human subjects and specific endpoints for AI performance.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified for any of the performance tests. The testing described (Ex-vivo Bovine Liver, Human Cadaver Vertebrae) did not involve human subjects as a "test set" in the clinical sense.
Data Provenance: Not specified for the benchtop tests. Ex-vivo bovine liver and human cadaver vertebrae are mentioned, indicating lab-based, non-clinical data. This type of data would be considered "prospective" in the sense that the experiments were set up and performed to generate the data for this submission, rather than re-analyzing existing data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. The ground truth for the performance tests (e.g., lesion sizes, thermal profiles, electrical measurements) would be established by direct measurement from the conducted experiments, not by expert consensus on clinical cases.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There was no clinical test set requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This document does not mention any MRMC study or AI assistance. The device is a physical ablation system, not a diagnostic imaging AI tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The device is a physical electrosurgical system. There is no "algorithm only" performance for this type of medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance tests conducted would be:

Measurements taken directly during mechanical and electrical testing.
Physical measurements of lesion size and thermal profiles from ex-vivo bovine liver and human cadaver vertebrae experiments.

8. The sample size for the training set

Not applicable. This device is an RF ablation system, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable for the same reason as point 8.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W O66-G609 Silver Spring, MD 20993-0002

June 16, 2015

Baylis Medical Company Incorporated Meghal Khakhar Director, Regulatory & Scientific Affairs 2645 Matheson Boulevard East Mississauga, Ontario L4W 5S4 Canada

Re: K142480

Trade/Device Name: OsteoCool® V-2 RF Ablation System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: May 7, 2015 Received: May 8, 2015

Dear Khakhar:

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. 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

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with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Binita S. Ashar -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K142480

Device Name: OsteoCool® V-2 RF Ablation System

Indications for Use:

The OsteoCool® V-2 RF Ablation System is intended for palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body.

AND/OR Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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7. 510(k) Summary

Submitter Information

A. Company Name: Baylis Medical Company Inc.
B. Company Address: 2645 Matheson Blvd. East Mississauga, Ontario L4W 5S4 Canada
C. Company Phone: (905) 602-4875
D. Company Facsimile: (905) 602-5671
E. Contact Person: Meqhal Khakhar, Director of Requlatory & Scientific Affairs
F. Summary Prepared on: 09-Jun-2015

Device Identification

A. Device Trade Name: OsteoCool® V-2 RF Ablation System
B. Device Common Name: Electrosurgical cutting and coagulation device and accessories
C. Classification Name: CFR 878.4400 Electrosurgical cutting and coagulation device and accessories
D. Product Code: GEI
E. Device Class: Class II

I dentification of Predicate Device

Predicate Device

Predicate Device	Manufacturer	510(k)
Ablation Generator System,and Ablation Instrument	DFine Inc.	K091310

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Reference Device

Reference Device	Manufacturer	510(k)
OsteoCool RF Ablation System	Baylis Medical Company Inc.	K111523

Indications for Use

The OsteoCool® V-2 RF Ablation System is intended for palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body.

Device Description

The OsteoCool V-2 RF Ablation System includes the following components:

1. OsteoCool RF Ablation Kit (OsteoCool Probe, OsteoCool Introducer, and Tube Kit)
1. Pain Management Pump Unit & Pump Connector Cable
1. Baylis Pain Management Generator-TD
1. DuoCool™ Y-Connector Cable With TC
1. Thermocouple Monitor
1. Thermocouple Monitor Box

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Comparison to Predicate Device

The OsteoCool V-2 RF Ablation System and predicate system by DFine Inc. share the same intended use and fundamental scientific technology, including principles of operation and mechanism of action. Differences in design and technological characteristics between the proposed and predicate devices do not raise any new concerns of safety and effectiveness.

A comparison of the intended use/indications for use and technological characteristics is provided in the table below.

Note: This document uses the term "substantial equivalence" as defined in 21 CFR 807.87 and not as defined in Title 35 of the U.S. Code. Any statement made in conjunction with this submission regarding substantial equivalence to any other product only relates to whether the product can be lawfully marketed without pre-market approval or reclassification and is not to be interpreted as an admission or used as evidence in patent infringement litigation. As the Commissioner of the FDA has indicated, determination of substantial equivalence under the Federal Food, Drug, and Cosmetic Act relates to the fact that the product can be lawfully marketed without premarket approval or reclassification. The determination is not intended to have any bearing whatsoever on the resolution of patent infringement suits." 42 Fed. Reg. 42.520 et seg. (1977).

	ABLATION GENERATORSYSTEM, AND ABLATIONINSTRUMENT(K091310)	OSTEOCOOL V-2 RFABLATION SYSTEM(Proposed)	Identical/SubstantiallyEquivalent
Manufacturer	DFine Inc.	Baylis Medical CompanyInc.	N/A
510(k) #	K091310	K142480	N/A
Class	II	II	YES/YES
Product Code	GEI, 878.4400	GEI, 878.4400	YES/YES
Indications for Use	For palliative treatment inspinal procedures byablation of metastaticmalignant lesions in avertebral body.	For palliative treatmentin spinal procedures byablation of metastaticmalignant lesions in avertebral body.	YES/YES
User	Physicians familiar with RFlesion techniques	Physicians familiar withRF lesion techniques	YES/YES
Anatomical site of use	Bone	Bone	YES/YES
Access method	Percutaneous	Percutaneous	YES/YES
Energy type	Radiofrequency Energy(RF)	Radiofrequency Energy(RF)	YES/YES

Comparison of Proposed and Predicate Device

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	ABLATION GENERATOR SYSTEM, AND ABLATION INSTRUMENT (K091310)	OSTEOCOOL V-2 RF ABLATION SYSTEM (Proposed)	Identical/ Substantially Equivalent
Principle of Operation	Operator controlled; RF delivered from compatible generator via connector cable	Operator controlled; RF delivered from compatible generator via connector cable	YES/YES
Mechanism of action	Cellular necrosis through thermal coagulation	Cellular necrosis through thermal coagulation	YES/YES
Maximum power output for RF ablation in bone	25W	25W	YES/YES
Ablation probe configuration	Bipolar	Bipolar	YES/YES
Ablation probe dimensions	Shaft length= 16.5 cmMax OD= 3.0 mmRF active electrode length= up to 10 mm(Active electrode dimension refers to output portion of electrode.)	Shaft length= 21.5 cmActive tip OD= 1.5 mmRF active electrode length= up to 10 mm(Active electrode dimension refers to output portion of electrode.)	NO/YES
Number of system thermocouples	Two	Two	YES/YES
Location of distal thermocouple	5 or 10 mm from insulation tip depending on model	5 or 10 mm from centre of active tip depending on model	YES/YES
Location of proximal thermocouple	10 or 15 mm from insulation tip depending on model	Can be placed at 10 or 15 mm from centre of active tip depending on model	NO/YES

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	ABLATION GENERATORSYSTEM, AND ABLATION ABLATION SYSTEMINSTRUMENT(K091310)	OSTEOCOOL V-2 RF(Proposed)	Identical/SubstantiallyEquivalent
Expected ablation zonepropagation	As per DFine Inc. systemIFU:-50°C on the probe at the5mm TC represents anablation zone ofapproximately 10mm long	-When proximal TC isplaced at 5mm from thecentre of the active tip,this represents anablation zone ofapproximately 10mmlong	YES/YES
	-50°C on the probe at the10mm TC represents anablation zone ofapproximately 20mm long	-When proximal TC isplaced at 10mm fromthe centre of the activetip, this represents anablation zone ofapproximately 20 mmlong
	-50°C on the probe at the15mm TC represents anablation zone ofapproximately 30mm long	-When proximal TC isplaced at 15mm fromthe centre of the activetip, this represents anablation zone ofapproximately 30mmlong
Frequency/Waveforms/Modulation	480kHz Sinusoidal	460kHz Sinusoidal	NO/YES
Rate of temperature risein sample tissues	Controlled by RF generatorenergy output mechanism	Controlled by RFgenerator energy outputmechanism	NO/YES
Conductive fluid used andflow rate	N/A-no conductive fluid ispassed to patient	N/A-no conductive fluidis passed to patient(Internally cooled)	YES/YES
Feedback mechanism	Temperature-controlled	Temperature-controlled	YES/YES

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	ABLATION GENERATORSYSTEM, AND ABLATIONINSTRUMENT(K091310)	OSTEOCOOL V-2 RFABLATION SYSTEM(Proposed)	Identical/SubstantiallyEquivalent
System components	-Ablation Instrument(including thermocouples)-Ablation RF Generator-AE Cable (for connectionof generator to ablationinstrument)	-OsteoCool RF AblationKit (Probe, Introducer,and Tube Kit)-Baylis PainManagement Generator-TD-DuoCool Y-ConnectorCable With TC-Pain Management PumpUnit & Pump ConnectorCable-Thermocouple Monitor-Thermocouple MonitorBox	NO/YES

The results of verification and validation testing support the safe and effective use of the proposed device for its intended use and its substantial equivalence determination to the predicate device.

Performance Testing

The following performance data were provided in support of the substantial equivalence determination:

Mechanical testing

Pull test Impulse test

Electrical testing:

Electrical verification was conducted to ensure that the OsteoCool Thermocouple Monitor (OST) meets the electrical requirements of IEC 60601-1:2005 and IEC 60601-2-2:2009 after 0 and 4 years of aging.

Temperature Testing:

Temperature accuracy testing

Bench Top Validation Testing:

Ex-vivo Bovine Liver Testing:

Testing was conducted to demonstrate:

Ablation probe response curves .
Thermocouple monitor response curves ●
Comparison of lesion sizes .

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Thermal profile and lesion boundaries .
Human Cadaver Vertebrae Testing: Testing was conducted to demonstrate:
ablation volume ●
thermal imaging .
. comparison of ablation volumes with predicate

Conclusions

The OsteoCool V-2 RF Ablation System and the predicate device by DFine Inc. share the same intended use and fundamental scientific technology, including principles of operation and mechanism of action. Differences in design and technological characteristics between the proposed and predicate devices do not raise any new concerns of safety and effectiveness. The results of verification and validation support the safety and effectiveness of the proposed device for its intended use and its substantial equivalence determination to the predicate device.

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.