(285 days)
No
The summary describes a radiofrequency ablation system with temperature monitoring, but there is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is intended for the "palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body," which is a therapeutic intervention.
No
The device is intended for palliative treatment by ablation of metastatic malignant lesions, which is a therapeutic function, not a diagnostic one. While it monitors temperature, this is for therapeutic control, not for diagnosing a condition.
No
The device description explicitly lists multiple hardware components, including probes, generators, pumps, and cables, which are integral to its function.
Based on the provided information, the OsteoCool® V-2 RF Ablation System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body." This describes a therapeutic procedure performed directly on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a system that delivers radiofrequency energy and cooling to ablate tissue. This is a therapeutic intervention, not a diagnostic test.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (like blood, urine, tissue samples, etc.) to diagnose a condition or monitor a patient's health status.
In Vitro Diagnostic devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The OsteoCool V-2 RF Ablation System is a therapeutic device used for treatment.
N/A
Intended Use / Indications for Use
The OsteoCool® V-2 RF Ablation System is intended for palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body.
Product codes
GEI
Device Description
The OsteoCool V-2 RF Ablation System represents an upgrade to the cleared OsteoCool RF Ablation System (K111523) for the addition of a secondary system thermocouple to enable temperature monitoring around thermal ablation zones.
The OsteoCool V-2 RF Ablation System includes the following components:
-
- OsteoCool RF Ablation Kit (OsteoCool Probe, OsteoCool Introducer, and Tube Kit)
-
- Pain Management Pump Unit & Pump Connector Cable
-
- Baylis Pain Management Generator-TD
-
- DuoCool™ Y-Connector Cable With TC
-
- Thermocouple Monitor
-
- Thermocouple Monitor Box
The OsteoCool V-2 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 (PMG-TD) operates together with the OsteoCool Probe to deliver the RF energy to the target ablation site. The OsteoCool Introducer provides a path for the OsteoCool Probe to its target site. The Tube Kit is used with the Pain Management Pump Unit to circulate water internally through the OsteoCool Probe during RF energy delivery. The Pump Connector Cable connects the Pain Management Pump Unit to the PMG-TD, which powers and controls the pump speed. The DuoCool Y-Connector Cable With TC connects the OsteoCool Probe and Thermocouple Monitor to the PMG-TD. The Thermocouple Monitor Box is battery operated and connects to a port on the PMG-TD to display the temperature detected by the Thermocouple Monitor.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Vertebral body, Bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians familiar with RF lesion techniques
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The following performance data were provided in support of the substantial equivalence determination:
Mechanical testing: Pull test Impulse test
Electrical testing: Electrical verification was conducted to ensure that the OsteoCool Thermocouple Monitor (OST) meets the electrical requirements of IEC 60601-1:2005 and IEC 60601-2-2:2009 after 0 and 4 years of aging.
Temperature Testing: Temperature accuracy testing
Bench Top Validation Testing:
Ex-vivo Bovine Liver Testing: Testing was conducted to demonstrate:
- Ablation probe response curves
- Thermocouple monitor response curves
- Comparison of lesion sizes
- Thermal profile and lesion boundaries
Human Cadaver Vertebrae Testing: Testing was conducted to demonstrate:
- ablation volume
- thermal imaging
- comparison of ablation volumes with predicate
Key Results: The results of verification and validation support the safety and effectiveness of the proposed device for its intended use and its substantial equivalence determination to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked one behind the other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W O66-G609 Silver Spring, MD 20993-0002
June 16, 2015
Baylis Medical Company Incorporated Meghal Khakhar Director, Regulatory & Scientific Affairs 2645 Matheson Boulevard East Mississauga, Ontario L4W 5S4 Canada
Re: K142480
Trade/Device Name: OsteoCool® V-2 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: May 7, 2015 Received: May 8, 2015
Dear 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
1
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 of medical device-related 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" (21CFR 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 vours.
Binita S. Ashar -S
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
2
Indications for Use
510(k) Number (if known): K142480
Device Name: OsteoCool® V-2 RF Ablation System
Indications for Use:
The OsteoCool® V-2 RF Ablation System is intended for palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body.
AND/OR 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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of __ 1
3
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: 09-Jun-2015
Device Identification
- A. Device Trade Name: OsteoCool® V-2 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
Predicate Device
| Predicate Device | Manufacturer | 510(k) |
|---|---|---|
| Ablation Generator System, | ||
| and Ablation Instrument | DFine Inc. | K091310 |
4
Reference Device
| Reference Device | Manufacturer | 510(k) |
|---|---|---|
| OsteoCool RF Ablation System | Baylis Medical Company Inc. | K111523 |
Indications for Use
The OsteoCool® V-2 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-2 RF Ablation System represents an upgrade to the cleared OsteoCool RF Ablation System (K111523) for the addition of a secondary system thermocouple to enable temperature monitoring around thermal ablation zones.
The OsteoCool V-2 RF Ablation System includes the following components:
-
- OsteoCool RF Ablation Kit (OsteoCool Probe, OsteoCool Introducer, and Tube Kit)
-
- Pain Management Pump Unit & Pump Connector Cable
-
- Baylis Pain Management Generator-TD
-
- DuoCool™ Y-Connector Cable With TC
-
- Thermocouple Monitor
-
- Thermocouple Monitor Box
The OsteoCool V-2 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 (PMG-TD) operates together with the OsteoCool Probe to deliver the RF energy to the target ablation site. The OsteoCool Introducer provides a path for the OsteoCool Probe to its target site. The Tube Kit is used with the Pain Management Pump Unit to circulate water internally through the OsteoCool Probe during RF energy delivery. The Pump Connector Cable connects the Pain Management Pump Unit to the PMG-TD, which powers and controls the pump speed. The DuoCool Y-Connector Cable With TC connects the OsteoCool Probe and Thermocouple Monitor to the PMG-TD. The Thermocouple Monitor Box is battery operated and connects to a port on the PMG-TD to display the temperature detected by the Thermocouple Monitor.
5
Comparison to Predicate Device
The OsteoCool V-2 RF Ablation System and predicate system by DFine Inc. share the same intended use and fundamental 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 concerns of safety and effectiveness.
A comparison of the intended use/indications for use and technological characteristics is provided in the table below.
Note: This document uses the term "substantial equivalence" as defined in 21 CFR 807.87 and not as defined in Title 35 of the U.S. Code. Any statement made in conjunction with this submission regarding substantial equivalence to any other product only relates to whether the product can be lawfully marketed without pre-market approval or reclassification and is not to be interpreted as an admission or used as evidence in patent infringement litigation. As the Commissioner of the FDA has indicated, determination of substantial equivalence under the Federal Food, Drug, and Cosmetic Act relates to the fact that the product can be lawfully marketed without premarket approval or reclassification. The determination is not intended to have any bearing whatsoever on the resolution of patent infringement suits." 42 Fed. Reg. 42.520 et seg. (1977).
| | ABLATION GENERATOR
SYSTEM, AND ABLATION
INSTRUMENT
(K091310) | OSTEOCOOL V-2 RF
ABLATION SYSTEM
(Proposed) | Identical/
Substantially
Equivalent |
|------------------------|----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|
| Manufacturer | DFine Inc. | Baylis Medical Company
Inc. | N/A |
| 510(k) # | K091310 | K142480 | N/A |
| Class | II | II | YES/YES |
| Product Code | GEI, 878.4400 | GEI, 878.4400 | YES/YES |
| Indications for Use | For palliative treatment in
spinal procedures by
ablation of metastatic
malignant lesions in a
vertebral body. | For palliative treatment
in spinal procedures by
ablation of metastatic
malignant lesions in a
vertebral body. | YES/YES |
| User | Physicians familiar with RF
lesion techniques | Physicians familiar with
RF lesion techniques | YES/YES |
| Anatomical site of use | Bone | Bone | YES/YES |
| Access method | Percutaneous | Percutaneous | YES/YES |
| Energy type | Radiofrequency Energy
(RF) | Radiofrequency Energy
(RF) | YES/YES |
Comparison of Proposed and Predicate Device
6
| ABLATION GENERATOR SYSTEM, AND ABLATION INSTRUMENT (K091310) | OSTEOCOOL V-2 RF ABLATION SYSTEM (Proposed) | Identical/ Substantially Equivalent | |
|---|---|---|---|
| Principle of Operation | Operator controlled; RF delivered from compatible generator via connector cable | Operator controlled; RF delivered from compatible generator via connector cable | YES/YES |
| Mechanism of action | Cellular necrosis through thermal coagulation | Cellular necrosis through thermal coagulation | YES/YES |
| Maximum power output for RF ablation in bone | 25W | 25W | YES/YES |
| Ablation probe configuration | Bipolar | Bipolar | YES/YES |
| Ablation probe dimensions | Shaft length= 16.5 cm | ||
| Max OD= 3.0 mm | |||
| RF active electrode length= up to 10 mm | |||
| (Active electrode dimension refers to output portion of electrode.) | Shaft length= 21.5 cm | ||
| Active tip OD= 1.5 mm | |||
| RF active electrode length= up to 10 mm | |||
| (Active electrode dimension refers to output portion of electrode.) | NO/YES | ||
| Number of system thermocouples | Two | Two | YES/YES |
| Location of distal thermocouple | 5 or 10 mm from insulation tip depending on model | 5 or 10 mm from centre of active tip depending on model | YES/YES |
| Location of proximal thermocouple | 10 or 15 mm from insulation tip depending on model | Can be placed at 10 or 15 mm from centre of active tip depending on model | NO/YES |
7
| | ABLATION GENERATOR
SYSTEM, AND ABLATION ABLATION SYSTEM
INSTRUMENT
(K091310) | OSTEOCOOL V-2 RF
(Proposed) | Identical/
Substantially
Equivalent |
|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|
| Expected ablation zone
propagation | As per DFine Inc. system
IFU:
-50°C on the probe at the
5mm TC represents an
ablation zone of
approximately 10mm long | -When proximal TC is
placed at 5mm from the
centre of the active tip,
this represents an
ablation zone of
approximately 10mm
long | YES/YES |
| | -50°C on the probe at the
10mm TC represents an
ablation zone of
approximately 20mm long | -When proximal TC is
placed at 10mm from
the centre of the active
tip, this represents an
ablation zone of
approximately 20 mm
long | |
| | -50°C on the probe at the
15mm TC represents an
ablation zone of
approximately 30mm long | -When proximal TC is
placed at 15mm from
the centre of the active
tip, this represents an
ablation zone of
approximately 30mm
long | |
| Frequency/Waveforms/Mo
dulation | 480kHz Sinusoidal | 460kHz Sinusoidal | NO/YES |
| Rate of temperature rise
in sample tissues | Controlled by RF generator
energy output mechanism | Controlled by RF
generator energy output
mechanism | NO/YES |
| Conductive fluid used and
flow rate | N/A-no conductive fluid is
passed to patient | N/A-no conductive fluid
is passed to patient
(Internally cooled) | YES/YES |
| Feedback mechanism | Temperature-controlled | Temperature-controlled | YES/YES |
8
| | ABLATION GENERATOR
SYSTEM, AND ABLATION
INSTRUMENT
(K091310) | OSTEOCOOL V-2 RF
ABLATION SYSTEM
(Proposed) | Identical/
Substantially
Equivalent |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|
| System components | -Ablation Instrument
(including thermocouples)
-Ablation RF Generator
-AE Cable (for connection
of generator to ablation
instrument) | -OsteoCool RF Ablation
Kit (Probe, Introducer,
and Tube Kit)
-Baylis Pain
Management Generator-
TD
-DuoCool Y-Connector
Cable With TC
-Pain Management Pump
Unit & Pump Connector
Cable
-Thermocouple Monitor
-Thermocouple Monitor
Box | NO/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
The following performance data were provided in support of the substantial equivalence determination:
Mechanical testing
Pull test Impulse test
Electrical testing:
Electrical verification was conducted to ensure that the OsteoCool Thermocouple Monitor (OST) meets the electrical requirements of IEC 60601-1:2005 and IEC 60601-2-2:2009 after 0 and 4 years of aging.
Temperature Testing:
Temperature accuracy testing
Bench Top Validation Testing:
Ex-vivo Bovine Liver Testing:
Testing was conducted to demonstrate:
- Ablation probe response curves .
- Thermocouple monitor response curves ●
- Comparison of lesion sizes .
9
-
Thermal profile and lesion boundaries .
Human Cadaver Vertebrae Testing: Testing was conducted to demonstrate: -
ablation volume ●
-
thermal imaging .
-
. comparison of ablation volumes with predicate
Conclusions
The OsteoCool V-2 RF Ablation System and the predicate device by DFine Inc. share the same intended use and fundamental 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 concerns of safety and effectiveness. The results of verification and validation support the safety and effectiveness of the proposed device for its intended use and its substantial equivalence determination to the predicate device.