OSTEOCOOL (TM) RF ABLATION SYSTEM

K111523 · Baylis Medical Co., Inc. · GEI · Mar 13, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K111523
• Device Name: OSTEOCOOL (TM) RF ABLATION SYSTEM
• Applicant: Baylis Medical Co., Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Mar 13, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

System delivers bipolar radiofrequency (RF) energy to ablate metastatic malignant lesions in vertebral bodies. Components include RF probe, introducer, tube kit, pain management pump unit, and generator. Probe inserted percutaneously via introducer to target site; internal water cooling circulates through probe during energy delivery to manage tissue temperature. Thermocouple in probe monitors tissue temperature for feedback control. Operated by physicians familiar with RF lesion techniques in clinical settings. Output is thermal coagulation causing cellular necrosis; intended to provide palliative pain relief for patients failing standard therapy.

Clinical Evidence

No clinical trial data provided. Evidence consists of bench testing (biocompatibility, mechanical stress, electrical safety, thermocouple accuracy, lesion reproducibility), in-vivo animal studies validating safety/efficacy in bone tumor ablation, and human cadaver testing demonstrating successful RF energy delivery in osteoporotic vertebrae.

Technological Characteristics

Bipolar RF ablation system. Components: RF probe, introducer, pump unit, generator. Features internal water-cooling mechanism and integrated thermocouple for temperature-controlled feedback. Electrical safety: high-frequency leakage and dielectric strength testing. Mechanical: pull, impulse, and pressurization testing. Sterile, single-use probe.

Indications for Use

Indicated for palliative treatment of metastatic malignant lesions in a vertebral body in patients who have failed or are not candidates for standard pain therapy.

Regulatory Classification

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.

Predicate Devices

• RITA® System (K040989)
• Ablation Generator System, and Ablation Instrument (K091310)

Submission Summary (Full Text)

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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: [phone]; ext 252
- D. Company Facsimile: [phone]
- 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 RF<br>Ablation System | RITA® System | RITA Medical<br>Systems Inc. | K040989 |
| | Ablation Generator System, and<br>Ablation Instrument | DFine Inc. | K091310 |

### Intended Use

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.

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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
- 2. Pain Management Pump Unit & Pump Connector Cable
- 3. Baylis Pain Management Generator-TD
- 4. 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 [phone] or [phone] 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:

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.

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

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Appendix A-Page 1