OsteoCool V-3 RF Ablation System

K161949 · Baylis Medical Company, Inc. · GEI · Jan 31, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K161949
• Device Name: OsteoCool V-3 RF Ablation System
• Applicant: Baylis Medical Company, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jan 31, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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. · 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 Story

System delivers bipolar radiofrequency (RF) energy to bone tissue to induce cellular necrosis via thermal coagulation. Components include RF generator, ablation probe, thermocouple monitor, peristaltic pump, connector hub, footswitch, and cart. During percutaneous procedures, physician inserts probe into target bone; internal water circulation through probe provides cooling. Thermocouple monitor enables real-time temperature tracking near ablation zone. Generator controls RF energy delivery and pump speed. System is used in clinical settings by physicians familiar with RF lesion techniques. Output provides localized thermal ablation to treat metastatic bone lesions, aiming to palliate pain. Bipolar configuration eliminates need for grounding pad.

Clinical Evidence

No clinical trials performed. Evidence based on updated scientific literature review (2007–2016) regarding RFA for metastatic bone tumor pain palliation and comparative bench-top validation testing using bovine liver/bone models. Bench testing demonstrated lesion dimensions substantially equivalent to predicate.

Technological Characteristics

Bipolar RF energy delivery; 465 kHz frequency; 40W max power. Stainless steel electrodes; polyimide insulation. Internal water cooling via peristaltic pump. 17-gauge probe diameter. Temperature-controlled feedback via thermocouple. EO sterilized, single-use components. Complies with IEC 60601-1, IEC 60601-2-2, IEC 60601-1-2, and ISO 10993-1.

Indications for Use

Indicated for palliative treatment of metastatic malignant lesions in vertebral bodies and coagulation/ablation of bone tissue for pain palliation in patients with metastatic bone lesions who failed or are not candidates for standard 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

• OsteoCool V-3 RF Ablation System (K152057)
• Uniblate Electrosurgical Device (K080451)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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.

· 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.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| <div> <span> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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: [phone]
- D. Company Facsimile: [phone]
- 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 Ablation<br>System (Primary) | Baylis Medical Company Inc. | K152057<br>(Primary) |
| Uniblate Electrosurgical<br>Device | 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
- 2. OsteoCool RF Ablation Kit:
- i. OsteoCool RF Ablation Probe
- ii. OsteoCool Tube Kit
- 3. OsteoCool Thermocouple Kit:
- i. Osteocool Thermocouple Monitor
- ii. Osteocool Thermocouple Monitor Introducer
- 4. Osteocool Peristaltic Pump & OsteoCool Pump Cable
- 5. OsteoCool Connector Hub
- 6. OsteoCool Footswitch
- 7. OsteoCool Cart

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

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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/<br>Substantially<br>Equivalent<br>(SE) | |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|---------------------------------------------------|
| | OsteoCool V-3 RF<br>Ablation System<br>(K152057)<br>(Primary Predicate) | Uniblate<br>Electrosurgical<br>Device<br>(K080451) | OsteoCool V-3 RF<br>Ablation 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-3<br>RF Ablation System<br>is intended for<br>palliative treatment<br>in spinal procedures<br>by ablation of<br>metastatic<br>malignant lesions in<br>a vertebral body. | The AngioDynamics<br>Uniblate<br>Electrosurgical<br>Device is intended for<br>coagulation and<br>ablation of tissue<br>during percutaneous,<br>laparoscopic, and<br>intraoperative<br>surgical procedures<br>such as partial or<br>complete ablation of<br>non-resectable liver<br>lesions, osteoid<br>osteoma, and<br>palliation of pain<br>associated with<br>metastatic lesions<br>involving bone in<br>patients who have<br>failed or are not<br>candidates for<br>standard therapy. | The OsteoCool V-3 RF<br>Ablation System is<br>intended for:<br>Palliative<br>treatment in<br>spinal procedures<br>by ablation of<br>metastatic<br>malignant lesions<br>in a vertebral<br>body.Coagulation and<br>ablation of tissue<br>in bone during<br>surgical<br>procedures<br>including palliation<br>of pain associated<br>with metastatic<br>lesions involving<br>bone in patients<br>who have failed or<br>are not candidates<br>for standard<br>therapy. | NO/YES | |
| User | Physicians familiar<br>with RF lesion<br>techniques | Physicians familiar<br>with RF lesion<br>techniques | Physicians familiar<br>with RF lesion<br>techniques | YES/YES | |
| Anatomical site of<br>use | Bone (Vertebral<br>body) | Bone, Soft tissue | Bone | NO/YES | |
| Access method | Percutaneous | Percutaneous,<br>laparoscopic,<br>intraoperative | Percutaneous | NO/YES | |
| Energy type | Radiofrequency<br>Energy | Radiofrequency<br>Energy | Radiofrequency<br>Energy | YES/YES | |
| Principle of<br>operation | Operator controlled;<br>RF delivered from<br>compatible RF<br>generator | Operator controlled;<br>RF delivered from<br>compatible RF<br>generator | Operator controlled;<br>RF delivered from<br>compatible RF<br>generator | YES/YES | |
| | | PREDICATE DEVICES | | SUBJECT DEVICE | Identical/<br>Substantially<br>Equivalent<br>(SE) |
| | | OsteoCool V-3 RF<br>Ablation System<br>(K152057)<br>(Primary Predicate) | Uniblate<br>Electrosurgical<br>Device<br>(K080451) | OsteoCool V-3 RF<br>Ablation System | |
| | Mechanism of<br>action | Cellular necrosis<br>through thermal<br>coagulation | Cellular necrosis<br>through thermal<br>coagulation | Cellular necrosis<br>through thermal<br>coagulation | YES/YES |
| | Rate of<br>temperature rise<br>in sample tissues | Controlled by RF<br>generator energy<br>output mechanism | Controlled by RF<br>generator energy<br>output mechanism | Controlled by RF<br>generator energy<br>output mechanism | YES/YES |
| | Feedback<br>mechanism | Temperature-<br>controlled | Temperature-<br>controlled | Temperature-<br>controlled | YES/YES |
| | Operating mode | Bipolar RF energy | Monopolar RF energy | Bipolar RF energy | NO/YES |
| | Active electrode<br>lengths | 0.7, 1.0, 2.0 cm | 1.0 to 3.0 cm<br>(adjustable) | 0.7, 1.0, 2.0 cm | NO/YES |
| | Location of<br>thermocouple on<br>probe/electrode | 0.5-1.0 mm from<br>the probe distal tip | 6-7 mm from the<br>probe distal tip | 0.5-1.0 mm from the<br>probe distal tip | NO/YES |
| | Active electrode<br>material | Stainless steel | Stainless steel | Stainless steel | YES/YES |
| | Electrode<br>insulation material | Polyimide | Polyimide | Polyimide | YES/YES |
| | Electrode/probe<br>length(s) | 16 cm | 10, 15, 25 cm | 16 cm | NO/YES |
| | Electrode<br>diameter | 17 Gauge | 17 Gauge | 17 Gauge | YES/YES |
| | Sterilization<br>(Electrode) | EO, Single use | EO, Single use | EO, Single use | YES/YES |
| | Compatible RF<br>generator | OsteoCool<br>Radiofrequency (RF)<br>Generator | RITA Medical<br>Systems 1500X<br>Generator | OsteoCool<br>Radiofrequency (RF)<br>Generator | NO/YES |
| | Output<br>Power | 40 W | 250 W | 40 W | NO/YES |
| Generator Parameters | Maximum<br>Voltage | 130 $V_{RMS}$ | 135 $V_{RMS}$ | 130 $V_{RMS}$ | NO/YES |
| | Output<br>Frequency | 465 kHz ± 3% | 460 kHz ±5% | 465 kHz ± 3% | NO/YES |
| | Maximum<br>Current | 1.0 $A_{RMS}$ | 6.0 $A_{RMS}$ | 1.0 $A_{RMS}$ | NO/YES |
| | Default<br>Ablation<br>Temperature | 70 °C | 103 °C | 70 °C | NO/YES |
| | Other system<br>components | Thermocouple<br>monitor and<br>introducer,<br>peristaltic pump and<br>tube kit, connector<br>hub, footswitch | Peristaltic pump and<br>infusion tubing,<br>connector cable,<br>grounding pad,<br>footswitch | Thermocouple monitor<br>and introducer,<br>peristaltic pump and<br>tube kit, connector<br>hub, 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.