(200 days)
Not Found
No
The device description focuses on the hardware components and their functions (RF energy delivery, cooling, temperature monitoring) and does not mention any AI or ML capabilities. The performance studies also do not indicate the use of AI/ML.
Yes
The device is intended for "palliative treatment" and "coagulation and ablation of tissue in bone" for metastatic malignant lesions, which are therapeutic interventions.
No
Explanation: The device description and intended use clearly state that the OsteoCool® V-3 RF Ablation System is used for "palliative treatment in spinal procedures by ablation of metastatic malignant lesions" and "coagulation and ablation of tissue in bone". This indicates a therapeutic function (treatment by destroying tissue) rather than a diagnostic one (identifying a condition or disease).
No
The device description explicitly lists multiple hardware components (RF Generator, RF Ablation Probe, Tube Kit, Peristaltic Pump, Pump Cable, Connector Hub, Thermocouple Monitor, Thermocouple Monitor Introducer, Footswitch, Cart) that are integral to the device's function. While software is mentioned in the performance studies, the device is clearly a hardware-based system with software control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a therapeutic procedure performed in vivo (within the body) to ablate metastatic lesions in bone and soft tissue. IVDs are used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The device components (generator, probes, pump, etc.) are designed for delivering energy directly to tissue within the body.
- Anatomical Site: The specified anatomical sites are within the human body (vertebral body, bone, soft tissue).
- Performance Studies: The performance studies described focus on the device's physical and electrical performance, biocompatibility, and clinical literature review related to the therapeutic application. There is no mention of testing involving human specimens or diagnostic accuracy.
Therefore, the OsteoCool® V-3 RF Ablation System is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
GEI
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:
- OsteoCool Radiofrequency Generator
- OsteoCool RF Ablation Kit:
i. OsteoCool RF Ablation Probe
ii. OsteoCool Tube Kit - OsteoCool Thermocouple Kit:
i. Osteocool Thermocouple Monitor
ii. Osteocool Thermocouple Monitor Introducer - Osteocool Peristaltic Pump & OsteoCool Pump Cable
- OsteoCool Connector Hub
- OsteoCool Footswitch
- 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 Footswitch. The OsteoCool RF Generator and Peristaltic Pump are mounted on the OsteoCool Cart during use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
- Electromagnetic 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.
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads facing to the right. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.
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
1
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 (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, 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
2
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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: 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 | ||
| System (Primary) | Baylis Medical Company Inc. | K152057 |
| (Primary) | ||
| Uniblate Electrosurgical | ||
| Device | AngioDynamics, Inc. | K080451 |
4
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:
-
- OsteoCool Radiofrequency Generator
-
- OsteoCool RF Ablation Kit:
- i. OsteoCool RF Ablation Probe
- ii. OsteoCool Tube Kit
-
- OsteoCool Thermocouple Kit:
- i. Osteocool Thermocouple Monitor
- ii. Osteocool Thermocouple Monitor Introducer
-
- Osteocool Peristaltic Pump & OsteoCool Pump Cable
-
- OsteoCool Connector Hub
-
- OsteoCool Footswitch
-
- 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
5
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.
6
| | PREDICATE DEVICES | | SUBJECT DEVICE | Identical/
Substantially
Equivalent
(SE) | |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|---------------------------------------------------|
| | OsteoCool V-3 RF
Ablation System
(K152057)
(Primary Predicate) | Uniblate
Electrosurgical
Device
(K080451) | OsteoCool V-3 RF
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
RF Ablation System
is intended for
palliative treatment
in spinal procedures
by ablation of
metastatic
malignant lesions in
a vertebral body. | The AngioDynamics
Uniblate
Electrosurgical
Device is intended for
coagulation and
ablation of tissue
during percutaneous,
laparoscopic, and
intraoperative
surgical procedures
such as partial or
complete ablation of
non-resectable liver
lesions, osteoid
osteoma, and
palliation of pain
associated with
metastatic lesions
involving bone in
patients who have
failed or are not
candidates for
standard therapy. | 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. | NO/YES | |
| User | Physicians familiar
with RF lesion
techniques | Physicians familiar
with RF lesion
techniques | Physicians familiar
with RF lesion
techniques | YES/YES | |
| Anatomical site of
use | Bone (Vertebral
body) | Bone, Soft tissue | Bone | NO/YES | |
| Access method | Percutaneous | Percutaneous,
laparoscopic,
intraoperative | Percutaneous | NO/YES | |
| Energy type | Radiofrequency
Energy | Radiofrequency
Energy | Radiofrequency
Energy | YES/YES | |
| Principle of
operation | Operator controlled;
RF delivered from
compatible RF
generator | Operator controlled;
RF delivered from
compatible RF
generator | Operator controlled;
RF delivered from
compatible RF
generator | YES/YES | |
| | | PREDICATE DEVICES | | SUBJECT DEVICE | Identical/
Substantially
Equivalent
(SE) |
| | | OsteoCool V-3 RF
Ablation System
(K152057)
(Primary Predicate) | Uniblate
Electrosurgical
Device
(K080451) | OsteoCool V-3 RF
Ablation System | |
| | Mechanism of
action | Cellular necrosis
through thermal
coagulation | Cellular necrosis
through thermal
coagulation | Cellular necrosis
through thermal
coagulation | YES/YES |
| | Rate of
temperature rise
in sample tissues | Controlled by RF
generator energy
output mechanism | Controlled by RF
generator energy
output mechanism | Controlled by RF
generator energy
output mechanism | YES/YES |
| | Feedback
mechanism | Temperature-
controlled | Temperature-
controlled | Temperature-
controlled | YES/YES |
| | Operating mode | Bipolar RF energy | Monopolar RF energy | Bipolar RF energy | NO/YES |
| | Active electrode
lengths | 0.7, 1.0, 2.0 cm | 1.0 to 3.0 cm
(adjustable) | 0.7, 1.0, 2.0 cm | NO/YES |
| | Location of
thermocouple on
probe/electrode | 0.5-1.0 mm from
the probe distal tip | 6-7 mm from the
probe distal tip | 0.5-1.0 mm from the
probe distal tip | NO/YES |
| | Active electrode
material | Stainless steel | Stainless steel | Stainless steel | YES/YES |
| | Electrode
insulation material | Polyimide | Polyimide | Polyimide | YES/YES |
| | Electrode/probe
length(s) | 16 cm | 10, 15, 25 cm | 16 cm | NO/YES |
| | Electrode
diameter | 17 Gauge | 17 Gauge | 17 Gauge | YES/YES |
| | Sterilization
(Electrode) | EO, Single use | EO, Single use | EO, Single use | YES/YES |
| | Compatible RF
generator | OsteoCool
Radiofrequency (RF)
Generator | RITA Medical
Systems 1500X
Generator | OsteoCool
Radiofrequency (RF)
Generator | NO/YES |
| | Output
Power | 40 W | 250 W | 40 W | NO/YES |
| Generator Parameters | Maximum
Voltage | 130 $V_{RMS}$ | 135 $V_{RMS}$ | 130 $V_{RMS}$ | NO/YES |
| | Output
Frequency | 465 kHz ± 3% | 460 kHz ±5% | 465 kHz ± 3% | NO/YES |
| | Maximum
Current | 1.0 $A_{RMS}$ | 6.0 $A_{RMS}$ | 1.0 $A_{RMS}$ | NO/YES |
| | Default
Ablation
Temperature | 70 °C | 103 °C | 70 °C | NO/YES |
| | Other system
components | Thermocouple
monitor and
introducer,
peristaltic pump and
tube kit, connector
hub, footswitch | Peristaltic pump and
infusion tubing,
connector cable,
grounding pad,
footswitch | Thermocouple monitor
and introducer,
peristaltic pump and
tube kit, connector
hub, footswitch | NO/YES |
Table 7.2: Comparison of Subject and Predicate Devices
7
8
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.
9
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.