The OsteoCool™ RF Ablation System is intended for palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body in patients who have failed or are not candidates for standard pain therapy.

Device Description

The OsteoCool™ RF Ablation System includes the following components:

OsteoCool™ RF Ablation Kit consisting of:
a. OsteoCool™ Probe
b. OsteoCool™ Introducer
c. Tube Kit
Pain Management Pump Unit & Pump Connector Cable
Baylis Pain Management Generator-TD
DuoCool™ Connector Cable
The OsteoCool™ 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 operates together with the OsteoCool™ Probe to deliver the RF energy. The Pump Connector Cable connects the Pump Unit to the Baylis Pain Management Generator-TD, which powers and controls the pump speed for delivery of cooling fluid during the procedure. The DuoCool™ Connector Cable connects the OsteoCool™ Probe to the Baylis Pain Management Generator-TD to transmit RF current and thermocouple signals to and from the electrodes of the probe.
The OsteoCool™ Probe is a single-use device that is inserted through the OsteoCool™ Introducer to the target site. The introducer is used for skin penetration and facilitates the navigation and accurate placement of the probe at the target site. The Tube Kit is used with the Pump Unit to circulate water internally to cool the probe while it delivers RF energy. The OsteoCool™ Probe includes a thermocouple to monitor and control the tissue temperature throughout the procedure.

AI/ML Overview

The provided document (K111523) is a 510(k) summary for the OsteoCool™ RF Ablation System, which details its intended use, device description, and substantial equivalence to predicate devices, primarily through performance testing. However, it does not include information on acceptance criteria for device performance, nor does it describe a study specifically designed to prove the device meets such criteria in terms of accuracy or clinical effectiveness with quantitative metrics.

Instead, the document details various engineering and preclinical tests conducted to demonstrate the device's safety and functionality in order to establish substantial equivalence to previously cleared devices.

Given the information provided, here's a breakdown of what can and cannot be answered regarding acceptance criteria and performance studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria (e.g., specific accuracy thresholds, lesion size targets, or pain reduction percentages) that the device must meet to
be considered effective for its intended use (palliative treatment of metastatic lesions). Instead, it lists types of tests performed to ensure fundamental device functionality and safety.

Therefore, a table of acceptance criteria and reported device performance as typically understood for clinical efficacy cannot be generated from this document. The "performance" reported pertains to the device passing engineering and preclinical tests.

Acceptance Criteria (Implied / Qualitative)	Reported Device Performance (as per document)
Biocompatibility: Meet ISO 10993 requirements	Passed: Cytotoxicity, Sensitization, Irritation or Intracutaneous Reactivity, Systemic Toxicity (Acute) (Pg 3)
Mechanical Strength (OsteoCool™ Probe): Withstand specified forces	Passed: 40N or 15N steady pull test, 0.64J impulse test, Pressurization of 200psi, Cord Anchorage test over 100 or 200 cycles (Pg 3)
Mechanical Strength (OsteoCool™ Introducer): Withstand specified force	Passed: 200N of force without failure (Pg 3)
Mechanical Strength (DuoCool™ Connector Cable): Withstand specified forces	Passed: 40N or 15N steady pull test, 0.64J impulse test, Cord Anchorage test over 5000 cycles (Pg 3)
Electrical Safety: Meet high frequency leakage, dielectric strength	Passed: High frequency leakage current, High frequency dielectric strength (1.2 times rated voltage at 460 kHz), Mains frequency dielectric strength (1000V greater than rated voltage at 60 Hz) (Pg 3)
Thermocouple Accuracy: Establish accuracy of measurements	Tested: Accuracy of thermocouple measurements was established (no specific metrics provided, but implies satisfactory performance) (Pg 3)
Lesion Formation (Bench): Reproducible lesions of consistent size/shape	Examined: Ability to form reproducible lesions of consistent size and shape (no specific metrics provided, but implies satisfactory performance) (Pg 3)
Safety & Efficacy (Animal): Ablate bone tumors in vivo	Validated: Safety and efficacy in ablating bone tumors, including those in the vertebral body, validated in animal studies (no specific metrics provided, but implies satisfactory performance) (Pg 4)
Deliver RF Energy (Cadaver): Successfully deliver RF energy	Demonstrated: Ability to successfully deliver RF energy in osteoporotic human cadaver vertebrae (no specific metrics provided, but implies satisfactory performance) (Pg 4)
Additional Validation (Probe): Rough handling, visualization, connectivity	Performed: Rough Handling, Visualization, Connectivity (no specific metrics provided, but implies satisfactory performance) (Pg 4)

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

The document details engineering tests, bench tests, and preclinical studies, but not a "test set" in the context of a clinical study or a dataset for AI algorithm evaluation.

Test Set Sample Size: Not applicable in the context of a clinical test set from human participants for performance evaluation against acceptance criteria. The "test sets" would refer to the samples used in the engineering and animal studies, which are not specified in terms of number. For instance, "animal studies" or "human cadaver testing" are mentioned, but the number of animals or cadavers is not provided.
Data Provenance:
- Biocompatibility: Standardized tests typically using in-vitro or small animal models.
- Mechanical/Electrical/Thermocouple/Bench Testing: Likely laboratory-based, in-vitro testing.
- In-vivo Animal Testing: Animal studies (species and number not specified). This would be prospective.
- Human Cadaver Testing: Human cadaver studies (number not specified).

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

This information is not provided in the document. The document describes various validation tests, but not a process involving expert ground truth for a clinical test set.

4. Adjudication Method for the Test Set

This information is not provided in the document. No adjudication method is mentioned as there is no "test set" in the context of human data requiring expert review and consensus.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or mentioned in this 510(k) summary. The device is not an AI diagnostic tool that assists human readers; it is a physical device for RF ablation.

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

Not applicable. The device is not an AI algorithm. It's an RF ablation system used by a physician. The term "standalone performance" typically refers to the performance of an AI algorithm independent of human input.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically applied to performance evaluation of AI or diagnostic devices (e.g., pathology, clinical outcomes, expert consensus) is not explicitly mentioned in the context of determining the effectiveness of the RF ablation system's intended use (palliative treatment for metastatic lesions).

The "ground truth" in this context would be implied by the various performance tests:

Biocompatibility: Conformance to ISO standards.
Mechanical/Electrical: Engineering specifications and standards.
Thermocouple: Known temperature standards.
Bench Testing (Lesion Formation): Physical measurement of lesions.
In-vivo Animal Testing: Observation of lesion formation and likely histological examination or imaging to confirm ablation efficacy in animal models.
Human Cadaver Testing: Physical demonstration of RF energy delivery.

8. The Sample Size for the Training Set

Not applicable. The OsteoCool™ RF Ablation System is a hardware medical device, not an AI algorithm that requires a training set.

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

Not applicable. (See point 8).

In summary, the 510(k) document primarily focuses on demonstrating substantial equivalence through a series of engineering, bench, and preclinical (animal, cadaver) tests to establish safety and fundamental functionality, rather than presenting a clinical study with quantitative acceptance criteria for efficacy in human patients or AI performance metrics.

Summary

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OsteoCool™ RF Ablation System

K111523
Pg 1 of 4
MAR
Baylis Medical Company Inc.

MAR 1 3 2012

6. 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; ext 252
D. Company Facsimile: (905) 602-5671
E. Contact Person: Meghal Khakhar
F. Summary Prepared on: March 7, 2011

Device Identification

A. Device Trade Name: OsteoCool™ RF Ablation System
B. Device Common Name: Electrosurgical cutting and coagulation device and accessories
C. Classification Name: Electrosurgical cutting and coagulation device and accessories, 21CFR 878.4400
D. Device Class: Class II
E. Device Code: GEI

Identification of Predicate Devices

Predicate Devices: OsteoCool™ RF Ablation System

Proposed Device	Predicate Device	Manufacturer	510(k) No.
OsteoCool TM RFAblation System	RITA® System	RITA MedicalSystems Inc.	K040989
	Ablation Generator System, andAblation Instrument	DFine Inc.	K091310

Intended Use

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Device Description

The OsteoCool™ RF Ablation System includes the following components:

1. OsteoCool™ RF Ablation Kit consisting of:
- a. OsteoCool™ Probe
- b. OsteoCool™ Introducer
- c. Tube Kit
1. Pain Management Pump Unit & Pump Connector Cable
1. Baylis Pain Management Generator-TD
1. DuoCool™ Connector Cable

The OsteoCool™ 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 operates together with the OsteoCool™ Probe to deliver the RF energy. The Pump Connector Cable connects the Pump Unit to the Baylis Pain Management Generator-TD, which powers and controls the pump speed for delivery of cooling fluid during the procedure. The DuoCool™ Connector Cable connects the OsteoCool™ Probe to the Baylis Pain Management Generator-TD to transmit RF current and thermocouple signals to and from the electrodes of the probe.

The OsteoCool™ Probe is a single-use device that is inserted through the OsteoCool™ Introducer to the target site. The introducer is used for skin penetration and facilitates the navigation and accurate placement of the probe at the target site. The Tube Kit is used with the Pump Unit to circulate water internally to cool the probe while it delivers RF energy. The OsteoCool™ Probe includes a thermocouple to monitor and control the tissue temperature throughout the procedure.

Substantial Equivalence

The OsteoCool™ RF Ablation System is determined to be substantially equivalent to the predicate devices with respect to intended use, technological characteristics, and principles of operation.

The OsteoCool™ RF Ablation System and predicate devices share the following technological aspects:

. Principle of operation: Radiofrequency energy
. Mechanism of action: Cellular necrosis through thermal coagulation
Feedback mechanism: Temperature-controlled .
. Environment: Sterile
User: Physicians familiar with RF lesion techniques .
Anatomical site of use: Bone .

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The proposed device is determined to be substantially equivalent to the predicate devices based on the results of performance tests listed below:

i] Biocompatibility Testing

The OsteoCool™ Probe and Introducer meet the requirements of the following biocompatibility tests:

. Cytotoxicity
Sensitization .
Irritation or Intracutaneous Reactivity .
Systemic Toxicity (Acute) .

ii) Mechanical Testing

The OsteoCool™ Probe can withstand the following mechanical stresses without failure:

A 40N or 15N steady pull test (as required by the joint) .
. A 0.64J impulse test
. Pressurization of 200psi
Cord Anchorage test over 100 or 200 cycles (as required by joint) .

The OsteoCool™ Introducer can withstand the following mechanical stress without failure:

. 200N of force without failure.
The DuoCool™ Connector Cable can withstand the following mechanical stresses without failure:
. A 40N or 15N steady pull test (as required by the joint)
. A 0.64J impulse test
Cord Anchorage test over 5000 cycles .

Electrical Testing iii)

The OsteoCool™ Probe and DuoCool™ Connector Cable were subjected to and passed the requirements of the following electrical tests:

High frequency leakage current .
High frequency dielectric strength at 1.2 times rated voltage (160Vms) at 460 kHz .
Mains frequency dielectric strength of 1000V greater than rated voltage (160 . Vrms) at 60 Hz

Thermocouple Testing iv)

The OsteoCool™ Probe was tested to establish the accuracy of the thermocouple measurements.

Bench Testing v)
Bench testing was conducted to examine the ability of the OsteoCool™ Probe to form reproducible lesions of consistent size and shape.

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In-vivo Animal Testing vi)

The safety and efficacy of the OsteoCool™ RF Ablation System in ablating bone tumors, including those in the vertebral body has been validated in animal studies.

vii) Human Cadaver Testing
Testing was conducted to demonstrate the OsteoCool™ RF Ablation System's ability to successfully deliver RF energy in osteoporotic human cadaver vertebrae.

viii) Other Validation Testing

The following additional validation tests were performed on the OsteoCool™ Probe:

Rough Handling .
Visualization .
Connectivity .

The OsteoCool™ RF Ablation System is determined to be substantially equivalent to the predicate devices based on the performance tests described above. The technological differences between the proposed and predicate devices do not raise any new concerns of safety or effectiveness.

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Public Health Service

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

MAR 1 3 2012

Baylis Medical Co., Inc. % Ms. Meghal Khakhar 2645 Matheson Blvd. E Mississauga, Ontario Canada L4W 5S4

Re: K111523

Trade/Device Name: OsteoCool™ 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: March 7, 2012 Received: March 8, 2012

Dear Ms. 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 I 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

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Page 2 - Ms. Meghal Khakhar

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 Or ic Fart 607), aboning (21 CFR 803); good manufacturing practice requirements as set de rice relation adverse overles) (2) 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 n you assite bpcs.fida.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 1 807.97). 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 Tou may of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark A. Milken

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K111523
Pg 1 of 1

Indications for Use

510(k) Number (if known):

Device Name: OsteoCoo!™ RF Ablation System

Indications for Use:

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)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign Off)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K111523

Page 1 of 1

Appendix A-Page 1

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.