The OsteoCool® V-3 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-3 RF Ablation System includes the following components:

OsteoCool Radiofrequency Generator
OsteoCool RF Ablation Kit:
i. OsteoCool RF Ablation Probe
ii. OsteoCool Tube Kit
OsteoCool Thermocouple Kit:
i. Osteocool Thermocouple Monitor
ii. Osteocool Thermocouple Monitor Introducer
Osteocool Peristaltic Pump & OsteoCool Pump Cable
OsteoCool Connector Hub
OsteoCool Footswitch
OsteoCool Cart

The OsteoCool V-3 RF Ablation System represents an upgrade to the predicate OsteoCool V-2 RF Ablation System (K142480). Modifications have been made to the predicate generator and pump unit for aesthetic changes and to provide increased user flexibility and convenience. Minor changes have also been made to other system components for increased user flexibility and convenience and to optimize existing features.

The OsteoCool V-3 RF Ablation System delivers controlled radiofrequency (RF) energy in a bipolar manner with a cooling mechanism to facilitate RF lesions in the vertebral body. The OsteoCool Radiofrequency (RF) Generator operates together with the OsteoCool RF Ablation Probe to deliver the RF enerqy to the target ablation site(s). The OsteoCool Tube Kit is used with the Osteocool Peristaltic Pump to circulate water internally through the OsteoCool RF Ablation Probe(s) during RF energy delivery. The OsteoCool Pump Cable connects the Osteocool Peristaltic Pump to the OsteoCool RF Generator, which controls the pump speed. The OsteoCool Connector Hub connects the OsteoCool RF Ablation Probe(s) and Osteocool Thermocouple Monitor(s) to the OsteoCool RF Generator. The Osteocool Thermocouple Monitor is used with the OsteoCool Thermocouple Monitor Introducer and enables temperature monitoring around the thermal ablation zones during procedures. The OsteoCool RF Generator can be used with the optional OsteoCool Footswitch. The OsteoCool RF Generator and Peristaltic Pump are mounted on the OsteoCool Cart during use.

AI/ML Overview

The provided text describes the OsteoCool V-3 RF Ablation System and its substantial equivalence to its predicate device, the OsteoCool V-2 RF Ablation System. This is a 510(k) summary, which focuses on demonstrating equivalence to a legally marketed device rather than proving absolute safety and effectiveness from scratch. Therefore, the "acceptance criteria" and "device performance" are primarily framed around meeting established standards and demonstrating similar or improved performance compared to the predicate device.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a quantitative table for a clinical study comparing the device against a benchmark. Instead, the acceptance criteria are implicitly defined by compliance with various industry standards and demonstration of comparable performance to the predicate device through verification and validation testing. The "reported device performance" refers to the successful outcomes of these tests.

Acceptance Criteria (Implied by Compliance Needs)	Reported Device Performance (as stated in the document)
Compliance with mechanical safety standards (e.g., IEC 60601-1, -2-2)	Mechanical verification testing conducted; compliance with IEC 60601-1: 2005, IEC 60601-2-2: 2009, and Baylis self-enforced requirements ensured.
Compliance with electrical safety standards	Electrical verification testing conducted; compliance with current electrical standard requirements ensured for relevant components.
Compliance with electromagnetic compatibility (EMC) standards	EMC testing completed; results demonstrated compliance of the proposed system to current IEC 60601-1-2 standard requirements.
Biocompatibility in accordance with ISO 10993-1 and FDA guidelines	Biocompatibility verification performed in accordance with requirements of ISO 10993-1 and FDA's modified ISO guidelines in accordance with FDA's blue book memorandum #G95-1 on biocompatibility.
Accuracy of thermocouple temperature measurements	Verification testing demonstrated that relevant components achieve accurate temperature measurements as per specified test requirements.
Usability requirements met	Testing performed to verify and validate the usability requirements.
Software level of concern addressed per FDA guidance	FDA's "Guidance for the content of premarket submissions for software contained in Medical Devices" (May-2005) used to determine the Level of Concern for the software. (Implicitly, the software was deemed acceptable for its intended use.)
Comparable ablation probe response curves to predicate device	Ex-vivo Bovine Liver Testing: Ablation probe response curves demonstrated and compared.
Comparable lesion sizes to predicate device	Ex-vivo Bovine Liver Testing: Comparison of lesion sizes demonstrated.
Acceptable thermal profile and lesion boundaries	Ex-vivo Bovine Liver Testing: Thermal profile and lesion boundaries demonstrated.
Comparable ablation volume in human cadaver vertebrae to predicate device	Human Cadaver Vertebrae Testing: Ablation volume and thermal imaging demonstrated; comparison of ablation volumes with predicate device performed.
Overall substantial equivalence to predicate device	All test requirements were met as specified by applicable standards and test protocols. Differences in design and technological characteristics between the proposed and predicate devices do not raise any new types of questions of safety and effectiveness. 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.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify exact sample sizes for the "test set" in terms of number of cases or patients. The studies described are primarily bench-top validation testing and ex-vivo/human cadaver testing.

Ex-vivo Bovine Liver Testing: No sample size (number of livers or tests) is provided.
Human Cadaver Vertebrae Testing: No sample size (number of cadavers or vertebrae) is provided.
The provenance of the data is from laboratory testing (bench-top, ex-vivo bovine liver, human cadaver vertebrae), not clinical data from specific countries or retrospective/prospective patient studies.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

The document does not mention the use of experts to establish "ground truth" for the test set in the context of diagnostic performance or clinical outcomes. The studies described are engineering and preclinical performance evaluations (e.g., measuring lesion size, temperature accuracy). For these types of tests, the "ground truth" would be objective measurements obtained through calibrated instruments and established protocols, rather than expert consensus on medical findings.

4. Adjudication Method for the Test Set

Given that the studies are bench-top and ex-vivo performance evaluations focusing on objective measurements (e.g., lesion size, temperature), an "adjudication method" in the sense of resolving discrepancies in expert opinion (like 2+1 or 3+1 for medical image interpretation) is not applicable or described. The results would be based on direct physical measurements and observations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No. The document describes a 510(k) submission for a radiofrequency ablation system, not an AI-powered diagnostic or assistive tool for human readers/clinicians, nor does it involve a MRMC study. Therefore, this question is not applicable to the provided context.

6. If a Standalone (i.e. Algorithm Only Without Human-in-the-Loop Performance) Was Done

No. This device is an RF ablation system, which is a therapeutic medical device used by clinicians. It does not operate as a standalone algorithm without human intervention. The software component mentioned is for device control and data display, not for autonomous diagnostic or therapeutic decisions.

7. The Type of Ground Truth Used

The "ground truth" for the performance testing described here is based on objective physical measurements and verified standards compliance.

For mechanical, electrical, EMC, and biocompatibility, the ground truth is defined by the requirements of the relevant international and self-imposed standards (e.g., IEC 60601, ISO 10993) and the successful demonstration of meeting those requirements.
For thermocouple temperature accuracy, the ground truth is established by calibrated temperature references.
For ex-vivo and cadaver testing, the ground truth related to ablation probe response, lesion sizes, thermal profiles, and ablation volumes would be derived from direct measurements using imaging (e.g., thermal imaging, gross pathology sectioning) and measuring instruments.

8. The Sample Size for the Training Set

The document does not describe any "training set" in the context of machine learning or AI. The tests performed are engineering and preclinical performance evaluations rather than the development or validation of an algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established

As there is no mention of an AI model or a "training set," this question is not applicable.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 24, 2015 Baylis Medical Company Inc. Meghal Khakhar Director, Regulatory & Scientific Affairs/ Project Leader Regulatory Affairs 2645 Matheson Blvd. East Mississauga, L4W 5S4 CA

Re: K152057

Trade/Device Name: Osteocool V-3 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: November 2, 2015 Received: November 3, 2015

Dear Meghal Khakhar:

This letter corrects our substantial equivalent letter of November 24, 2015.

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 with all the Act's requirements, including, but not limited to: registration and listing (21 CFR

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated 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" (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 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 yours,

Joshua C. Nipper -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director For 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) K152057

Device Name OsteoCool® V-3 RF Ablation System

Indications for Use (Describe)

The OsteoCool® V-3 RF Ablation System is intended for palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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7. 510(k) Summary

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: 23-Jul-2015

Device Identification

A. Device Trade Name: OsteoCool® V-3 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

Table 7.1: Predicate Device

Predicate Device	Manufacturer	510(k)
OsteoCool V-2 RF AblationSystem	Baylis Medical Company Inc.	K142480

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Indications for Use

The OsteoCool® V-3 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-3 RF Ablation System includes the following components:

1. OsteoCool Radiofrequency Generator
1. OsteoCool RF Ablation Kit:
- i. OsteoCool RF Ablation Probe
- ii. OsteoCool Tube Kit
1. OsteoCool Thermocouple Kit:
- i. Osteocool Thermocouple Monitor
- ii. Osteocool Thermocouple Monitor Introducer
1. Osteocool Peristaltic Pump & OsteoCool Pump Cable
1. OsteoCool Connector Hub
1. OsteoCool Footswitch
1. OsteoCool Cart

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Comparison to Predicate Device

The indications for use of the OsteoCool V-3 RF Ablation System are identical to that of the predicate OsteoCool V-2 RF Ablation System (K142480). The proposed and predicate devices also share the same fundamental scientific technology, including principles of operation and mechanism of action (Table 7.2). Differences in design and technological characteristics between the proposed and predicate devices do not raise any new types of questions of safety and effectiveness. The results of verification and validation testing provide reasonable assurance of substantial equivalence of the OsteoCool V-3 RF Ablation System with the predicate device.

	OSTEOCOOL V-2 RFABLATION SYSTEM(predicate)	OSTEOCOOL V-3 RFABLATION SYSTEM(proposed)	Identical/ SE
Manufacturer	Baylis MedicalCompany Inc.	Baylis MedicalCompany Inc.	YES/YES
510(K) #	K1422480	K152057	N/A
Class	II	II	YES/YES
Product Code	GEI, 878.4400	GEI, 878.4400	YES/YES
Indications for Use	For palliativetreatment in spinalprocedures by ablationof metastaticmalignant lesions in avertebral body	For palliativetreatment in spinalprocedures by ablationof metastaticmalignant lesions in avertebral body	YES/YES
User	Physicians familiarwith RF lesiontechniques	Physicians familiarwith RF lesiontechniques	YES/YES
Anatomical site of use	Bone	Bone	YES/YES
Access method	Percutaneous	Percutaneous	YES/YES
Energy Type	Radiofrequency Energy	Radiofrequency Energy	YES/YES
Principle of Operation	Operator controlled;RF delivered fromcompatible generatorvia connector cable	Operator controlled;RF delivered fromcompatible generatorvia connector cable	YES/YES
Mechanism of action	Cellular necrosisthrough thermalcoagulation	Cellular necrosisthrough thermalcoagulation	YES/YES
Feedback mechanism	Temperature-controlled	Temperature-controlled	YES/YES

Table 7.2: Comparison of Proposed and Predicate Devices

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	System components	-OsteoCool RF AblationKit (Probe, Introducer, and Tube Kit)-Baylis PainManagementGenerator-TD-DuoCool Y-ConnectorCable with TC-Pain ManagementPump Unit & PumpConnector Cable-ThermocoupleMonitor-ThermocoupleMonitor Box	-OsteoCool RF AblationKit (Probe and Tube Kit)-OsteoCoolRadiofrequencyGenerator-OsteoCoolThermocouple Kit(ThermocoupleMonitor, ThermocoupleMonitor Introducer)-OsteoCool PeristalticPump & Pump Cable-OsteoCool ConnectorHub-OsteoCool Footswitch-OsteoCool Cart	NO/YES
	Generator
	Name	Pain ManagementGenerator – TD	OsteoCoolRadiofrequencyGenerator	N/A
in bone	Maximum poweroutput for RF ablation	25W	25W	YES/YES
	Frequency/Waveforms/Modulation	460kHz Sinusoidal	465 kHz Sinusoidal	NO/YES
		'Track Burn' Mode	'Retract' Mode
	Targettemperature	N/A-Power setting isused	95 °C
	Cooling	No	No
Needle tract ablation parameters	Additionalpatientconnectionsrequired	No	No	NO/YES
	Same ablationprobe used	Yes	Yes
	On-screentemperaturedisplay	Yes	Yes
	User controlled	Yes	Yes
	On-screen errormessaging	Yes	Yes
Display parameters		Real timetemperature,impedance, and power	Real timetemperature,impedance, and power	YES/YES
	Probe recognitionthrough EEPROM chip	No	Yes	NO/YES
	Touchscreen	No	Yes	NO/YES
Used with OsteoCoolCart		No	Yes	NO/YES

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Used with optionalFootswitch		Yes	Yes	YES/YES
Environment		Supplied non-sterile;non-sterilizable	Supplied non-sterile;non-sterilizable	YES/YES
Kit components		OsteoCool Probe,Introducer, Tube Kit	OsteoCool Probe, TubeKit	NO/YES
Ablation probe	configuration	Bipolar	Bipolar	YES/YES
Ablationprobedimension	Shaftdiameter	17 Gauge	17 Gauge
	RF activeelectrodelengths	10 or 20mm	7, 10, or 20mm	NO/YES

Ablationprobematerials	Shaft,thermocouple	304 Stainless steel	304 Stainless steel
	Insulation	Polyethyleneterephthalate (PET)	Polyimide	NO/YES
	Radiopaqueband	Platinum/10% Iridium	Platinum/10% Iridium
	EEPROM in connector	No	Yes	NO/YES
	Tube kit clip (forpump attachment)	NO	Yes	NO/YES
Tube kitdimensions	Tubinglength	140"	140"	YES/YES
	Burettecapacity	70 mL	70 mL
Tube kitmaterials	Tubing	Tygon	Tygon
	Burette,female luercap, luerlocks	Polycarbonate	Polycarbonate	NO/YES
	Clip (forpumpattachment)	N/A	Polycarbonate
	Reinforcement crimp fortubing	N/A	Stainless steel
Packaging		PETG thermoform traysealed with coatedTyvek® lid	PETG thermoform traysealed with coatedTyvek® lid	YES/YES
Sterilization		Ethylene oxide	Ethylene oxide	YES/YES
Sterility AssuranceLevel		10-6	10-6	YES/YES
Environment		Provided sterile; Singleuse	Provided sterile; Singleuse	YES/YES
		OsteoCool Thermocouple Monitor
Number of systemthermocouples		Two	Two	YES/YES

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Temperature display		OsteoCoolThermocouple MonitorBox	OsteoCool RFGenerator	NO/YES
Dimen-sions	Shaftdiameter	18 Gauge	28 Gauge	NO/YES
	Usablelength	160 mm	200 mm	NO/YES
Packaging		PETG thermoform traysealed with coatedTyvek® lid	PETG thermoform traysealed with coatedTyvek® lid	YES/YES
Sterilization		Ethylene oxide	Ethylene oxide	YES/YES
Sterility AssuranceLevel		10-6	10-6	YES/YES
Environment		Provided sterile; Singleuse	Provided sterile; Singleuse	YES/YES
OsteoCool Pump Unit & Pump Cable
Number of pumpheads		Two	Two	YES/YES
Control of pump speedby generator		Yes	Yes	YES/YES
Used with Tube Kit(s)		Yes	Yes	YES/YES
Safety switch		Yes	Yes	YES/YES
Used with OsteoCoolCart		No	Yes	NO/YES
Environment		Supplied non-sterile;non-sterilizable	Supplied non-sterile;non-sterilizable	YES/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

Performance testing was completed to demonstrate substantial equivalence of the OsteoCool V-3 RF Ablation System to the predicate OsteoCool V-2 RF Ablation System (K142480). The system components were subjected to the following verification and validation tests, as applicable:

Mechanical testing

Mechanical verification testing was conducted for the proposed OsteoCool V-3 RF Ablation System to ensure compliance with mechanical requirements of IEC 60601-1: 2005, IEC 60601-2-2: 2009, and Baylis self-enforced requirements.

Electrical testing

Electrical verification testing was conducted for the relevant components of the proposed OsteoCool V-3 RF Ablation System to ensure compliance with current electrical standard requirements.

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Electromagnetic compatibility

Electromagnetic compatibility (EMC) testing has been completed for the applicable components of the proposed OsteoCool V-3 RF Ablation System. The results demonstrated compliance of the proposed system to current IEC 60601-1-2 standard requirements.

Biocompatibility

Biocompatibility verification was performed in accordance with requirements of ISO 10993-1 and FDA's modified ISO quidelines in accordance with FDA's blue book memorandum #G95-1 on biocompatibility

Thermocouple temperature accuracy

Verification testing demonstrated that the relevant components of the proposed OsteoCool V-3 RF Ablation system achieves accurate temperature measurements as per specified test requirements.

Usability

Testing was performed to verify and validate the usability requirements of the proposed OsteoCool V-3 RF Ablation System.

Software

FDA's "Guidance for the content of premarket submissions for software contained in Medical Devices" (May-2005) was used to determine the Level of Concern for the software in the OsteoCool V-3 RF Ablation System.

Bench-top validation testing

Ev-vivo Bovine Liver Testing:

Testing was conducted to demonstrate:

Ablation probe response curves .
Comparison of lesion sizes .
Thermal profile and lesion boundaries .

Human Cadaver Vertebrae Testing:

Testing was conducted to demonstrate:

. Ablation volume
. Thermal imaqinq
Comparison of ablation volumes with predicate ●

All test requirements were met as specified by applicable standards and the test protocols.

Conclusions

The OsteoCool V-3 RF Ablation System and the predicate OsteoCool V-2 RF Ablation System share the same indications for use and fundamental

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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 types of questions of safety and effectiveness. The results of verification and validation testing support substantial equivalence of the OsteoCool V-3 RF Ablation System with its 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.