Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a radiofrequency ablation system with a generator, probes, pump, and monitoring components. There is no mention of AI, ML, or any features that would typically involve learning algorithms or data-driven decision making beyond standard device control. The modifications are described as aesthetic and for user convenience, not related to advanced computational capabilities.

Therapeutic

Yes
The device is intended for "palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body," which is a therapeutic purpose.

Diagnostic

No

The device is an RF ablation system intended for palliative treatment of metastatic malignant lesions, which is a therapeutic function, not a diagnostic one. While it includes temperature monitoring, this is for controlling the therapeutic procedure, not for diagnosing a condition.

SaMD (Software as a Medical Device)

No

The device description explicitly lists multiple hardware components including a generator, probes, pump, and cart, indicating it is a hardware-based system with associated software.

IVD (In Vitro Diagnostic)

Based on the provided information, the OsteoCool® V-3 RF Ablation System is not an IVD (In Vitro Diagnostic) 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 a patient's body, not a test performed on a sample taken from the body.
Device Description: The device components are designed to deliver radiofrequency energy and cooling directly to the target tissue within the vertebral body. This is consistent with a therapeutic device.
Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (like blood, urine, tissue biopsies, etc.) to provide diagnostic information.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The OsteoCool V-3 RF Ablation System's function is to treat a condition within the body, not to diagnose it.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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.

Product codes

GEI

Device Description

The OsteoCool V-3 RF Ablation System includes the following components:

1. OsteoCool Radiofrequency Generator
1. OsteoCool RF Ablation Kit:
- i. OsteoCool RF Ablation Probe
- ii. OsteoCool Tube Kit
1. OsteoCool Thermocouple Kit:
- i. Osteocool Thermocouple Monitor
- ii. Osteocool Thermocouple Monitor Introducer
1. Osteocool Peristaltic Pump & OsteoCool Pump Cable
1. OsteoCool Connector Hub
1. OsteoCool Footswitch
1. 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.

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

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:
Ex-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 imagery
Comparison of ablation volumes with predicate

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)

K142480

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

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

1

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

2

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)
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: 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
System	Baylis Medical Company Inc.	K142480

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.

Device Description

The OsteoCool V-3 RF Ablation System includes the following components:

1. OsteoCool Radiofrequency Generator
1. OsteoCool RF Ablation Kit:
- i. OsteoCool RF Ablation Probe
- ii. OsteoCool Tube Kit
1. OsteoCool Thermocouple Kit:
- i. Osteocool Thermocouple Monitor
- ii. Osteocool Thermocouple Monitor Introducer
1. Osteocool Peristaltic Pump & OsteoCool Pump Cable
1. OsteoCool Connector Hub
1. OsteoCool Footswitch
1. 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.

5

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
ABLATION SYSTEM
(predicate) | OSTEOCOOL V-3 RF
ABLATION SYSTEM
(proposed) | Identical
/ SE |
|------------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|-------------------|
| Manufacturer | Baylis Medical
Company Inc. | Baylis Medical
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
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 | Radiofrequency Energy | YES/YES |
| 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 |
| Feedback mechanism | Temperature-
controlled | Temperature-
controlled | YES/YES |

Table 7.2: Comparison of Proposed and Predicate Devices

6

| | System components | -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 | -OsteoCool RF Ablation
Kit (Probe and Tube Kit)
-OsteoCool
Radiofrequency
Generator
-OsteoCool
Thermocouple Kit
(Thermocouple
Monitor, Thermocouple
Monitor Introducer)
-OsteoCool Peristaltic
Pump & Pump Cable
-OsteoCool Connector
Hub
-OsteoCool Footswitch
-OsteoCool Cart | NO/YES |
|----------------------------------|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| | Generator | | | |
| | Name | Pain Management
Generator – TD | OsteoCool
Radiofrequency
Generator | N/A |
| in bone | Maximum power
output for RF ablation | 25W | 25W | YES/YES |
| | Frequency/
Waveforms/
Modulation | 460kHz Sinusoidal | 465 kHz Sinusoidal | NO/YES |
| | | 'Track Burn' Mode | 'Retract' Mode | |
| | Target
temperature | N/A-Power setting is
used | 95 °C | |
| | Cooling | No | No | |
| Needle tract ablation parameters | Additional
patient
connections
required | No | No | NO/YES |
| | Same ablation
probe used | Yes | Yes | |
| | On-screen
temperature
display | Yes | Yes | |
| | User controlled | Yes | Yes | |
| | On-screen error
messaging | Yes | Yes | |
| Display parameters | | Real time
temperature,
impedance, and power | Real time
temperature,
impedance, and power | YES/YES |
| | Probe recognition
through EEPROM chip | No | Yes | NO/YES |
| | Touchscreen | No | Yes | NO/YES |
| Used with OsteoCool
Cart | | No | Yes | NO/YES |

7

| Used with optional

Footswitch		Yes	Yes	YES/YES
Environment		Supplied non-sterile;
non-sterilizable	Supplied non-sterile;
non-sterilizable	YES/YES
Kit components		OsteoCool Probe,
Introducer, Tube Kit	OsteoCool Probe, Tube
Kit	NO/YES
Ablation probe	configuration	Bipolar	Bipolar	YES/YES
Ablation
probe
dimension	Shaft
diameter	17 Gauge	17 Gauge
	RF active
electrode
lengths	10 or 20mm	7, 10, or 20mm	NO/YES

Ablation
probe
materials	Shaft,
thermocouple	304 Stainless steel	304 Stainless steel
	Insulation	Polyethylene
terephthalate (PET)	Polyimide	NO/YES
	Radiopaque
band	Platinum/10% Iridium	Platinum/10% Iridium
	EEPROM in connector	No	Yes	NO/YES
	Tube kit clip (for
pump attachment)	NO	Yes	NO/YES
Tube kit
dimensions	Tubing
length	140"	140"	YES/YES
	Burette
capacity	70 mL	70 mL
Tube kit
materials	Tubing	Tygon	Tygon
	Burette,
female luer
cap, luer
locks	Polycarbonate	Polycarbonate	NO/YES
	Clip (for
pump
attachment)	N/A	Polycarbonate
	Reinforceme
nt crimp for
tubing	N/A	Stainless steel
Packaging		PETG thermoform tray
sealed with coated
Tyvek® lid	PETG thermoform tray
sealed with coated
Tyvek® lid	YES/YES
Sterilization		Ethylene oxide	Ethylene oxide	YES/YES
Sterility Assurance
Level		10-6	10-6	YES/YES
Environment		Provided sterile; Single
use	Provided sterile; Single
use	YES/YES
		OsteoCool Thermocouple Monitor
Number of system
thermocouples		Two	Two	YES/YES

8

| Temperature display | | OsteoCool
Thermocouple Monitor
Box | OsteoCool RF
Generator | NO/YES |
|---------------------------------------|-------------------|----------------------------------------------------------|----------------------------------------------------------|---------|
| Dimen-
sions | Shaft
diameter | 18 Gauge | 28 Gauge | NO/YES |
| | Usable
length | 160 mm | 200 mm | NO/YES |
| Packaging | | PETG thermoform tray
sealed with coated
Tyvek® lid | PETG thermoform tray
sealed with coated
Tyvek® lid | YES/YES |
| Sterilization | | Ethylene oxide | Ethylene oxide | YES/YES |
| Sterility Assurance
Level | | 10-6 | 10-6 | YES/YES |
| Environment | | Provided sterile; Single
use | Provided sterile; Single
use | YES/YES |
| OsteoCool Pump Unit & Pump Cable | | | | |
| Number of pump
heads | | Two | Two | YES/YES |
| Control of pump speed
by generator | | Yes | Yes | YES/YES |
| Used with Tube Kit(s) | | Yes | Yes | YES/YES |
| Safety switch | | Yes | Yes | YES/YES |
| Used with OsteoCool
Cart | | No | Yes | NO/YES |
| Environment | | Supplied non-sterile;
non-sterilizable | Supplied non-sterile;
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.

9

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

10

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.