· Coagulation and ablation of tissue in bone during surgical procedures including palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard therapy.

Device Description

The OsteoCool V-3 RF Ablation System delivers controlled radiofrequency (RF) enerqy in a bipolar manner with a cooling mechanism to facilitate RF lesions in target tissue. The OsteoCool Radiofrequency (RF) Generator operates together with the OsteoCool RF Ablation Probe to deliver the RF energy 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 enerqy 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 document describes the OsteoCool V-3 RF Ablation System and its substantial equivalence to predicate devices, particularly focusing on its indications for use. The submission is not for a new device but for a modification to the indications for use of an already cleared device (K152057). Therefore, the performance testing focuses on demonstrating that this modification does not introduce new safety or effectiveness concerns.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with quantitative targets for the device's performance in terms of diagnostic accuracy or clinical outcomes. Instead, it demonstrates "substantial equivalence" to predicate devices, meaning it performs similarly with no new safety or effectiveness concerns. The performance testing primarily addresses the physical and functional characteristics of the device and its safety.

However, based on the comparative effectiveness and performance testing, we can infer some "acceptance" in the context of substantial equivalence:

Acceptance Criteria (Inferred from Substantial Equivalence and Testing)	Reported Device Performance (OsteoCool V-3 RF Ablation System)
Mechanical Requirements: Compliance with standards	Compliant: Verified to meet IEC 60601-1: 2005, IEC 60601-2-2: 2009, and Baylis self-enforced requirements.
Electrical Requirements: Compliance with standards	Compliant: Verified to meet current electrical standard requirements.
Electromagnetic Compatibility (EMC): Compliance with standards	Compliant: Verified to meet IEC 60601-1-2 standard requirements.
Biocompatibility: Absence of adverse biological reactions	Compliant: Verified in accordance with current ISO 10993-1 requirements for patient-contacting components.
Thermocouple Temperature Accuracy: Accurate temperature measurements	Accurate: Verification testing demonstrated accurate temperature measurements per specified test requirements.
Usability: Meeting usability requirements	Compliant: Testing performed to verify and validate usability requirements.
Software Verification & Validation: Meeting software requirements	Compliant: Applicable software V&V completed based on a Major Level of Concern classification using FDA's "Guidance for the content of premarket submissions for software contained in Medical Devices" (May-2005).
Ablation Performance: Substantial equivalence in lesion dimensions	Substantially Equivalent: Direct comparative bench-top validation testing demonstrated that lesion dimensions achieved by the subject device (OsteoCool V-3 RF Ablation System) were substantially equivalent to those obtained with the predicate device (Uniblate Electrosurgical Device K080451) under the same test setup and conditions. (Tested in a soft tissue model consisting of fresh bovine liver placed in a shell of bovine bone).
Pyrogenicity: Non-pyrogenic	Non-pyrogenic: OsteoCool RF Ablation Kit and OsteoCool Thermocouple Monitor Kit are supplied non-pyrogenic and meet current FDA and USP pyrogen limit specifications, with LAL testing conducted on every lot to verify.
Clinical Efficacy (Pain Palliation for Bone Metastasis): Evidence from literature	Supported: An updated scientific literature review (2007-present) of RFA for metastatic bone tumors for pain palliation, combined with the literature review from the predicate Uniblate device (K080451), supports the established clinical use of RFA in patients with bone metastases for pain palliation. The literature review did not include exclusion criteria, suggesting a broad review.

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

Mechanical, Electrical, EMC, Biocompatibility, Thermocouple Accuracy, Usability, Software: The document states that "system components were subjected to the following verification and validation tests, as applicable." It does not specify the exact sample sizes for each of these engineering and safety tests (e.g., number of devices or components tested). The tests are typically performed on a statistically relevant sample size during product development and regulatory submission.
Ablation Performance (Comparative Bench-top): The document mentions that for each test, "temperature response curves showing temperature and power over time were generated from procedural data obtained from each respective RF generator." It then states, "Following lesion formation, the tissue samples were cross-sectioned and lesion dimensions directly measured." The exact number of "tests" or "tissue samples" is not specified, but it implies multiple comparative tests ("For each test," "lesion dimensions achieved by the subject device... compared to those obtained with the predicate device under the same test setup and conditions").
Data Provenance:
- Bench-top testing: Prospective in-vitro testing conducted by the manufacturer with fresh bovine liver and bovine bone.
- Clinical Efficacy (Literature Review): Retrospective analysis of published clinical articles (scientific literature review) from 2007 to present, focusing on RFA for metastatic bone tumors. This combines with a prior literature review for the K080451 predicate. The country of origin of the data might be global, depending on the scope of the literature search, but is not specified.

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

Bench-top Testing: No "experts" were used to establish ground truth in the sense of clinical diagnoses. The ground truth for lesion dimensions was direct measurement from cross-sectioned tissue samples in a lab environment.
Clinical Efficacy (Literature Review): The "ground truth" here is derived from the aggregated findings of published clinical studies, which is considered a form of outcome data or expert consensus within the scientific community. The individual studies would have had their own ground truth determination methods (e.g., pain assessment scales, imaging, clinical follow-up), but the document does not detail this for the literature review itself. No specific number or qualification of experts are mentioned for establishing the "ground truth" of the literature review itself, rather it's leveraging existing published clinical evidence.

4. Adjudication Method for the Test Set

Bench-top Testing: Adjudication is not applicable in the sense of expert review of data. Lesion dimensions were directly measured.
Clinical Efficacy (Literature Review): Not explicitly stated. Literature reviews typically involve a systematic process for inclusion/exclusion and synthesis of findings based on predetermined criteria, but a formal adjudication method by a specific panel of experts is not described for this regulatory submission. The document only mentions that articles not meeting "predetermined exclusion criteria were included."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC comparative effectiveness study was not conducted. The submission is for a modification to an existing device's indications for use, and it primarily relies on demonstrating substantial equivalence through engineering, biocompatibility, and bench-top performance tests, complemented by a literature review for clinical efficacy.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The OsteoCool V-3 RF Ablation System is a medical device for performing RF ablation; it is not an AI algorithm for diagnosis or image analysis. Therefore, the concept of "standalone (algorithm only)" performance is not applicable to this device. It is an operator-controlled device where the physician is always "in the loop." Its software ensures proper device function, not autonomous decision-making or diagnostic output.

7. The Type of Ground Truth Used

Bench-top Testing: Direct physical measurement of lesion dimensions in ex-vivo tissue (fresh bovine liver in bovine bone).
Clinical Efficacy (Literature Review): Published clinical outcomes data from peer-reviewed scientific literature, largely related to pain palliation and the established use of RFA.

8. The Sample Size for the Training Set

The concept of a "training set" is typically associated with machine learning algorithms. Since the OsteoCool V-3 RF Ablation System is a physical medical device and not an AI algorithm, there is no "training set" in this context. The device's design and operating parameters are developed through engineering principles, bench testing, and potentially pre-clinical studies, rather than machine learning training data.

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

As there is no "training set" for an AI algorithm in this submission, this question is not applicable. The device's functionality and performance are established through traditional engineering verification and validation methods and comparison to predicate devices, not through a "training set" with established ground truth.

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

January 31, 2017

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

Re: K161949

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: January 23, 2017 Received: January 24, 2017

Dear Meghal 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 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (QS) 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, Jennifer R. Stevenson -S

For 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) K161949

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: 14-Jul-2016

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 Devices

Table 7.1: Predicate Devices

Predicate Device	Manufacturer	510(k)
OsteoCool V-3 RF AblationSystem (Primary)	Baylis Medical Company Inc.	K152057(Primary)
Uniblate ElectrosurgicalDevice	AngioDynamics, Inc.	K080451

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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.
Coaqulation and ablation of tissue in bone during surgical procedures including palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard therapy.

Device Description

The current 510(k) submission is only for a modification to the indications for use of the cleared OsteoCool V-3 RF Ablation System (K152057). The subject device is identical in all other aspects to the cleared OsteoCool V-3 RF Ablation System (K152057).

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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Footswitch. The OsteoCool RF Generator and Peristaltic Pump are mounted on the OsteoCool Cart during use.

Comparison to Predicate Devices

The intended use of the subject device is substantially equivalent to those of the predicate devices. The indications for use of the subject device represents a modification to the primary predicate OsteoCool V-3 RF Ablation System (K152057) indications for use to enable use in all bones, including the vertebral body. The indications for use of the subject device is a subset of the predicate Uniblate Electrosurgical Device (K080451).

Except for the indications for use, the subject device is identical in all aspects to the primary predicate OsteoCool V-3 RF Ablation System (K152057). This includes the fundamental scientific technology, principles of operation and mechanism of action, and design and technological aspects (Table 7.2). The proposed modification to the indications for use does not impact any of these device characteristics.

The subject OsteoCool V-3 RF Ablation System and predicate Uniblate Electrosurgical Device (K080451) share the same fundamental scientific technology, including principles of operation and mechanism of action. They are substantially equivalent with respect to design and technological characteristics. The predicate Uniblate Electrosurgical device delivers RF energy in a monopolar configuration, with a retractable insulating sheath to expose a variable active electrode length. The subject OsteoCool RF Ablation Probe delivers RF energy in a bipolar manner, which eliminates the need for a grounding pad. The subject device includes different available electrodes of fixed active electrode lengths. The Uniblate predicate device provides local fluid delivery to the ablation site through an infusion channel, while the subject device integrates an internal cooling mechanism by internally circulating water through the electrode/probe during RF delivery. In addition, the compatible RF generator used with the Uniblate and OsteoCool probes differ primarily with respect to output power and default ablation temperature. Table 7.2 provides a detailed comparison of the predicate Uniblate and subject OsteoCool devices. Existing differences do not raise any new types of questions of safety and effectiveness.

The results of verification and validation testing provide reasonable assurance of the substantial equivalence of the subject OsteoCool V-3 RF Ablation System to the predicate devices.

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	PREDICATE DEVICES		SUBJECT DEVICE	Identical/SubstantiallyEquivalent(SE)
	OsteoCool V-3 RFAblation System(K152057)(Primary Predicate)	UniblateElectrosurgicalDevice(K080451)	OsteoCool V-3 RFAblation System
Class	II	II	II	YES/YES
Product Code	GEI, 878.4400	GEI, 878.4400	GEI, 878.4400	YES/YES
Indications for Use	The OsteoCool V-3RF Ablation Systemis intended forpalliative treatmentin spinal proceduresby ablation ofmetastaticmalignant lesions ina vertebral body.	The AngioDynamicsUniblateElectrosurgicalDevice is intended forcoagulation andablation of tissueduring percutaneous,laparoscopic, andintraoperativesurgical proceduressuch as partial orcomplete ablation ofnon-resectable liverlesions, osteoidosteoma, andpalliation of painassociated withmetastatic lesionsinvolving bone inpatients who havefailed or are notcandidates forstandard therapy.	The OsteoCool V-3 RFAblation System isintended for:Palliativetreatment inspinal proceduresby ablation ofmetastaticmalignant lesionsin a vertebralbody.Coagulation andablation of tissuein bone duringsurgicalproceduresincluding palliationof pain associatedwith metastaticlesions involvingbone in patientswho have failed orare not candidatesfor standardtherapy.	NO/YES
User	Physicians familiarwith RF lesiontechniques	Physicians familiarwith RF lesiontechniques	Physicians familiarwith RF lesiontechniques	YES/YES
Anatomical site ofuse	Bone (Vertebralbody)	Bone, Soft tissue	Bone	NO/YES
Access method	Percutaneous	Percutaneous,laparoscopic,intraoperative	Percutaneous	NO/YES
Energy type	RadiofrequencyEnergy	RadiofrequencyEnergy	RadiofrequencyEnergy	YES/YES
Principle ofoperation	Operator controlled;RF delivered fromcompatible RFgenerator	Operator controlled;RF delivered fromcompatible RFgenerator	Operator controlled;RF delivered fromcompatible RFgenerator	YES/YES
		PREDICATE DEVICES		SUBJECT DEVICE	Identical/SubstantiallyEquivalent(SE)
		OsteoCool V-3 RFAblation System(K152057)(Primary Predicate)	UniblateElectrosurgicalDevice(K080451)	OsteoCool V-3 RFAblation System
	Mechanism ofaction	Cellular necrosisthrough thermalcoagulation	Cellular necrosisthrough thermalcoagulation	Cellular necrosisthrough thermalcoagulation	YES/YES
	Rate oftemperature risein sample tissues	Controlled by RFgenerator energyoutput mechanism	Controlled by RFgenerator energyoutput mechanism	Controlled by RFgenerator energyoutput mechanism	YES/YES
	Feedbackmechanism	Temperature-controlled	Temperature-controlled	Temperature-controlled	YES/YES
	Operating mode	Bipolar RF energy	Monopolar RF energy	Bipolar RF energy	NO/YES
	Active electrodelengths	0.7, 1.0, 2.0 cm	1.0 to 3.0 cm(adjustable)	0.7, 1.0, 2.0 cm	NO/YES
	Location ofthermocouple onprobe/electrode	0.5-1.0 mm fromthe probe distal tip	6-7 mm from theprobe distal tip	0.5-1.0 mm from theprobe distal tip	NO/YES
	Active electrodematerial	Stainless steel	Stainless steel	Stainless steel	YES/YES
	Electrodeinsulation material	Polyimide	Polyimide	Polyimide	YES/YES
	Electrode/probelength(s)	16 cm	10, 15, 25 cm	16 cm	NO/YES
	Electrodediameter	17 Gauge	17 Gauge	17 Gauge	YES/YES
	Sterilization(Electrode)	EO, Single use	EO, Single use	EO, Single use	YES/YES
	Compatible RFgenerator	OsteoCoolRadiofrequency (RF)Generator	RITA MedicalSystems 1500XGenerator	OsteoCoolRadiofrequency (RF)Generator	NO/YES
	OutputPower	40 W	250 W	40 W	NO/YES
Generator Parameters	MaximumVoltage	130 $V_{RMS}$	135 $V_{RMS}$	130 $V_{RMS}$	NO/YES
	OutputFrequency	465 kHz ± 3%	460 kHz ±5%	465 kHz ± 3%	NO/YES
	MaximumCurrent	1.0 $A_{RMS}$	6.0 $A_{RMS}$	1.0 $A_{RMS}$	NO/YES
	DefaultAblationTemperature	70 °C	103 °C	70 °C	NO/YES
	Other systemcomponents	Thermocouplemonitor andintroducer,peristaltic pump andtube kit, connectorhub, footswitch	Peristaltic pump andinfusion tubing,connector cable,grounding pad,footswitch	Thermocouple monitorand introducer,peristaltic pump andtube kit, connectorhub, footswitch	NO/YES

Table 7.2: Comparison of Subject and Predicate Devices

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Performance Testing

Performance testing has been completed to demonstrate substantial equivalence of the subject OsteoCool V-3 RF Ablation System to the predicate devices. The system components were subjected to the following verification and validation tests, as applicable:

Mechanical testing

Mechanical verification testing was conducted for the subject 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 subject OsteoCool V-3 RF Ablation System to ensure compliance with current electrical standard requirements.

Electromaqnetic compatibility

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

Biocompatibility

Biocompatibility verification was performed for patient-contacting components of the OsteoCool V-3 RF Ablation System in accordance with current ISO 10993-1 requirements.

Thermocouple temperature accuracy

Verification testing demonstrated that the relevant components of the subject 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 subject OsteoCool V-3 RF Ablation System.

Software

The applicable software verification and validation was completed for the OsteoCool Radiofrequency Generator and Osteocool Peristaltic Pump based on a Major Level of Concern classification for the devices. 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 devices.

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Comparative bench-top validation testing

Direct comparative bench top validation testing was completed to demonstrate the substantially equivalent ablation performance of the subject device and predicate Uniblate Electrosurqical Device (K080451). The soft tissue model consisted of fresh bovine liver placed in shell of bovine bone. For each test, temperature response curves showing temperature and power over time were generated from procedural data obtained from each respective RF generator. Following lesion formation, the tissue samples were cross-sectioned and lesion dimensions directly measured. The results demonstrated that the lesion dimensions achieved by the subject device are substantially equivalent to those obtained with the predicate device under the same test setup and conditions.

Clinical

An updated scientific literature review of the current scientific literature describing radiofrequency ablation (RFA) of metastatic bone tumors for pain palliation was completed. The literature search was performed for published clinical articles from 2007 to present. All scientific literature describing the use of RFA systems for ablation of metastatic bone tumors for pain palliation within this period that did not meet the predetermined exclusion criteria were included in the literature review. Based on the established criteria and assessment of the peer-reviewed literature, in conjunction with the literature review submitted in the predicate Uniblate device 510(k) K080451, the literature review results support the established use of RFA in patients with bone metastases for pain palliation.

Pyrogen testing

The OsteoCool RF Ablation Kit and OsteoCool Thermocouple Monitor Kit are supplied non-pyrogenic. LAL testing using the Kinetic Chromogenic method will be conducted on every lot to verify that devices are non-pyrogenic. The devices meet current FDA and USP pyrogen limit specifications.

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

Conclusions

The intended use of the subject OsteoCool V-3 RF Ablation System is substantially equivalent to the predicate devices. The subject and predicate devices share the same fundamental scientific technology, including principles of operation and mechanism of action. Differences in design and technological characteristics between the subject device and predicate Uniblate Electrosurgical Device (K080451) do not raise any new types of questions of safety and effectiveness. The results of verification and validation testing support the substantial equivalence of the subject OsteoCool V-3 RF Ablation System to the predicate devices.

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.