OsteoCool V-3 RF Ablation System
Device Facts
| Record ID | K152057 |
|---|---|
| Device Name | OsteoCool V-3 RF Ablation System |
| Applicant | Baylis Medical Company, Inc. |
| Product Code | GEI · General, Plastic Surgery |
| Decision Date | Nov 24, 2015 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4400 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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 Story
The OsteoCool V-3 RF Ablation System is a bipolar radiofrequency (RF) ablation device used for palliative treatment of metastatic malignant lesions in vertebral bodies. The system comprises an RF generator, ablation probes, a peristaltic pump for internal probe cooling, a thermocouple monitor, connector hub, footswitch, and cart. During percutaneous spinal procedures, a physician inserts the probe into the target lesion; the generator delivers controlled RF energy while the pump circulates water through the probe to manage thermal ablation zones. Thermocouples monitor tissue temperature in real-time to ensure controlled cellular necrosis through thermal coagulation. The system provides real-time feedback on temperature, impedance, and power to the physician via the generator interface. This device is an upgrade to the predicate OsteoCool V-2 system, featuring an integrated touchscreen, probe recognition via EEPROM, and improved user ergonomics. The device is intended for use by physicians familiar with RF lesion techniques in a clinical setting.
Clinical Evidence
Bench testing only. No clinical data. Validation included mechanical, electrical, EMC, and biocompatibility testing per ISO 10993-1. Performance validation included ex-vivo bovine liver testing (ablation probe response curves, lesion size comparison, thermal profiles) and human cadaver vertebrae testing (ablation volume, thermal imaging, comparison to predicate).
Technological Characteristics
Bipolar RF ablation system; 465 kHz sinusoidal waveform; 25W max power output. Components: 304 stainless steel probe shafts, polyimide insulation, platinum/10% iridium radiopaque bands. Cooling: Internal water circulation via peristaltic pump. Connectivity: EEPROM chip for probe recognition. Interface: Touchscreen generator. Sterilization: Ethylene oxide (10^-6 SAL). Standards: IEC 60601-1, IEC 60601-2-2, IEC 60601-1-2.
Indications for Use
Indicated for palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body.
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-2 RF Ablation System (K142480)
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
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) | |
|---------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</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: (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 Ablation<br>System | 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
- 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 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.
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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 RF<br>ABLATION SYSTEM<br>(predicate) | OSTEOCOOL V-3 RF<br>ABLATION SYSTEM<br>(proposed) | Identical<br>/ SE |
|------------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|-------------------|
| Manufacturer | Baylis Medical<br>Company Inc. | Baylis Medical<br>Company 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 palliative<br>treatment in spinal<br>procedures by ablation<br>of metastatic<br>malignant lesions in a<br>vertebral body | For palliative<br>treatment in spinal<br>procedures by ablation<br>of metastatic<br>malignant lesions in a<br>vertebral body | YES/YES |
| User | Physicians familiar<br>with RF lesion<br>techniques | Physicians familiar<br>with RF lesion<br>techniques | 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;<br>RF delivered from<br>compatible generator<br>via connector cable | Operator controlled;<br>RF delivered from<br>compatible generator<br>via connector cable | YES/YES |
| Mechanism of action | Cellular necrosis<br>through thermal<br>coagulation | Cellular necrosis<br>through thermal<br>coagulation | YES/YES |
| Feedback mechanism | Temperature-<br>controlled | Temperature-<br>controlled | YES/YES |
#### Table 7.2: Comparison of Proposed and Predicate Devices
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| | System components | -OsteoCool RF Ablation<br>Kit (Probe, Introducer, and Tube Kit)<br>-Baylis Pain<br>Management<br>Generator-TD<br>-DuoCool Y-Connector<br>Cable with TC<br>-Pain Management<br>Pump Unit & Pump<br>Connector Cable<br>-Thermocouple<br>Monitor<br>-Thermocouple<br>Monitor Box | -OsteoCool RF Ablation<br>Kit (Probe and Tube Kit)<br>-OsteoCool<br>Radiofrequency<br>Generator<br>-OsteoCool<br>Thermocouple Kit<br>(Thermocouple<br>Monitor, Thermocouple<br>Monitor Introducer)<br>-OsteoCool Peristaltic<br>Pump & Pump Cable<br>-OsteoCool Connector<br>Hub<br>-OsteoCool Footswitch<br>-OsteoCool Cart | NO/YES |
|----------------------------------|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| | Generator | | | |
| | Name | Pain Management<br>Generator – TD | OsteoCool<br>Radiofrequency<br>Generator | N/A |
| in bone | Maximum power<br>output for RF ablation | 25W | 25W | YES/YES |
| | Frequency/<br>Waveforms/<br>Modulation | 460kHz Sinusoidal | 465 kHz Sinusoidal | NO/YES |
| | | 'Track Burn' Mode | 'Retract' Mode | |
| | Target<br>temperature | N/A-Power setting is<br>used | 95 °C | |
| | Cooling | No | No | |
| Needle tract ablation parameters | Additional<br>patient<br>connections<br>required | No | No | NO/YES |
| | Same ablation<br>probe used | Yes | Yes | |
| | On-screen<br>temperature<br>display | Yes | Yes | |
| | User controlled | Yes | Yes | |
| | On-screen error<br>messaging | Yes | Yes | |
| Display parameters | | Real time<br>temperature,<br>impedance, and power | Real time<br>temperature,<br>impedance, and power | YES/YES |
| | Probe recognition<br>through EEPROM chip | No | Yes | NO/YES |
| | Touchscreen | No | Yes | NO/YES |
| Used with OsteoCool<br>Cart | | No | Yes | NO/YES |
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| Used with optional<br>Footswitch | | Yes | Yes | YES/YES |
|-----------------------------------|-----------------------------------------------|----------------------------------------------------------|----------------------------------------------------------|---------|
| Environment | | Supplied non-sterile;<br>non-sterilizable | Supplied non-sterile;<br>non-sterilizable | YES/YES |
| Kit components | | OsteoCool Probe,<br>Introducer, Tube Kit | OsteoCool Probe, Tube<br>Kit | NO/YES |
| Ablation probe | configuration | Bipolar | Bipolar | YES/YES |
| Ablation<br>probe<br>dimension | Shaft<br>diameter | 17 Gauge | 17 Gauge | |
| | RF active<br>electrode<br>lengths | 10 or 20mm | 7, 10, or 20mm | NO/YES |
| | | | | |
| Ablation<br>probe<br>materials | Shaft,<br>thermocouple | 304 Stainless steel | 304 Stainless steel | |
| | Insulation | Polyethylene<br>terephthalate (PET) | Polyimide | NO/YES |
| | Radiopaque<br>band | Platinum/10% Iridium | Platinum/10% Iridium | |
| | EEPROM in connector | No | Yes | NO/YES |
| | Tube kit clip (for<br>pump attachment) | NO | Yes | NO/YES |
| Tube kit<br>dimensions | Tubing<br>length | 140" | 140" | YES/YES |
| | Burette<br>capacity | 70 mL | 70 mL | |
| Tube kit<br>materials | Tubing | Tygon | Tygon | |
| | Burette,<br>female luer<br>cap, luer<br>locks | Polycarbonate | Polycarbonate | NO/YES |
| | Clip (for<br>pump<br>attachment) | N/A | Polycarbonate | |
| | Reinforceme<br>nt crimp for<br>tubing | N/A | Stainless steel | |
| Packaging | | PETG thermoform tray<br>sealed with coated<br>Tyvek® lid | PETG thermoform tray<br>sealed with coated<br>Tyvek® lid | YES/YES |
| Sterilization | | Ethylene oxide | Ethylene oxide | YES/YES |
| Sterility Assurance<br>Level | | 10-6 | 10-6 | YES/YES |
| Environment | | Provided sterile; Single<br>use | Provided sterile; Single<br>use | YES/YES |
| | | OsteoCool Thermocouple Monitor | | |
| Number of system<br>thermocouples | | Two | Two | YES/YES |
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| Temperature display | | OsteoCool<br>Thermocouple Monitor<br>Box | OsteoCool RF<br>Generator | NO/YES |
|---------------------------------------|-------------------|----------------------------------------------------------|----------------------------------------------------------|---------|
| Dimen-<br>sions | Shaft<br>diameter | 18 Gauge | 28 Gauge | NO/YES |
| | Usable<br>length | 160 mm | 200 mm | NO/YES |
| Packaging | | PETG thermoform tray<br>sealed with coated<br>Tyvek® lid | PETG thermoform tray<br>sealed with coated<br>Tyvek® lid | YES/YES |
| Sterilization | | Ethylene oxide | Ethylene oxide | YES/YES |
| Sterility Assurance<br>Level | | 10-6 | 10-6 | YES/YES |
| Environment | | Provided sterile; Single<br>use | Provided sterile; Single<br>use | YES/YES |
| OsteoCool Pump Unit & Pump Cable | | | | |
| Number of pump<br>heads | | Two | Two | YES/YES |
| Control of pump speed<br>by generator | | Yes | Yes | YES/YES |
| Used with Tube Kit(s) | | Yes | Yes | YES/YES |
| Safety switch | | Yes | Yes | YES/YES |
| Used with OsteoCool<br>Cart | | No | Yes | NO/YES |
| Environment | | Supplied non-sterile;<br>non-sterilizable | Supplied non-sterile;<br>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.
