OsteoCool™ 2.0 RF Ablation System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. February 28, 2024 Medtronic Sofamor Danek USA Inc. Denise Gaston Sr. Regulatory Affairs Specialist 1800 Pvramid Place Memphis, Tennessee 38132 Re: K233830 Trade/Device Name: OsteoCool™ 2.0 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 30, 2023 Received: December 1, 2023 Dear Denise Gaston: 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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" {1}------------------------------------------------ (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). > Sincerely, Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2024.02.28 > 14-05'00' Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices {2}------------------------------------------------ Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use Submission Number (if known) K233830 Device Name OsteoCool™ 2.0 RF Ablation System Indications for Use (Describe) · Palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body. · Coagulation and ablation of tissue during surgical procedures such as palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard therapy. · Ablation of benign bone tumors such as osteoid osteoma. 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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. {4}------------------------------------------------ ## 510(k) Summary Medtronic Sofamor Danek USA, Inc. ### February 27, 2024 | Submitter | Medtronic Sofamor Danek USA, Inc.<br>1800 Pyramid Place<br>Memphis, Tennessee 38132<br>Telephone: (901) 498-2697 | |-----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact | Jeff Sprague<br>Sr. Prin. Regulatory Affairs Lead<br>Direct Telephone: 901-498-2697<br>Email: jeffrey.a.sprague@medtronic.com<br>Or<br>Denise Gaston<br>Sr. Regulatory Affairs Specialist<br>Direct Telephone: 416-576-8749<br>Email: denise.gaston@medtronic.com | | Date Prepared | February 27, 2024 | | Common Name | OsteoCool™ 2.0 RF Ablation System | | Regulatory Class | Class II | | Regulation Number | 21 CFR 878.4400 | | Regulation Name and Device<br>Product Classification Code | Electrosurgical cutting and coagulation device and accessories<br>GEI | | Predicate Devices | OsteoCool™ RF Ablation System<br>K182497 (S.E. 12/17/2018) – primary predicate | | Description of Device | The predicate devices have not been subject to a design related recall.<br>The current 510(k) submission is for a line extension to the cleared<br>OsteoCool™ RF Ablation System (K182497 S.E. 12/17/2018).<br>The subject OsteoCool™ 2.0 RF Ablation System includes<br>the following hardware components:<br>1. OsteoCool™ 2.0 Radiofrequency Generator<br>2. OsteoCool™ 2.0 Peristaltic Pump & Pump Cable<br>3. OsteoCool™ 2.0 Connector Hub<br>4. OsteoCool™ 2.0 Cart<br>The OsteoCool™ 2.0 RF Ablation System line extension includes the<br>following commercially available sterile disposables that remain<br>unchanged from the OsteoCool™ RF Ablation System K182497 (S.E.<br>12/17/2018): | | Description of Device | 5. OsteoCool™ RF Ablation Probe with Tube Kit<br>6. OsteoCool™ Independent Thermocouple with Introducer Kit: | | | The OsteoCool™ 2.0 RF Ablation System delivers controlled<br>radiofrequency (RF) energy in a bipolar manner with a cooling<br>mechanism to facilitate RF lesions in target tissue. The OsteoCool™ 2.0<br>Radiofrequency (RF) Generator operates together with the OsteoCool™<br>RF Ablation Probe to deliver the RF energy to the target ablation site(s).<br>The OsteoCool™ Tube Kit is used with the OsteoCool™ 2.0 Peristaltic<br>Pump to circulate water internally through the OsteoCool™ RF Ablation<br>Probe(s) during RF energy delivery. The OsteoCool™ 2.0 Pump Cable<br>connects the OsteoCool™ 2.0 Peristaltic Pump to the OsteoCool™ 2.0<br>RF Generator, which controls the pump flowrate.<br>The OsteoCool™ 2.0 Connector Hub connects the OsteoCool RF<br>Ablation Probe(s) and OsteoCool™ Thermocouple (s) to the<br>OsteoCool™ 2.0 RF Generator. The OsteoCool™ Thermocouple<br>Monitor is used with the OsteoCool™ Thermocouple Introducer and<br>enables temperature monitoring around the thermal ablation zones<br>during procedures. | | Indications for Use: | The OsteoCool™ 2.0 RF Ablation System is indicated for:<br>• Palliative treatment in spinal procedures by ablation of metastatic<br>malignant lesions in a vertebral body.<br>• Coagulation and ablation of tissue in bone during surgical procedures<br>including palliation of pain associated with metastatic lesions involving<br>bone in patients who have failed or are not candidates for standard<br>therapy.<br>• Ablation of benign bone tumors such as osteoid osteoma. | | Comparison of Technological<br>Characteristics with the<br>Predicate Device | The intended use of the subject device is substantially equivalent to those<br>of the predicate device. This includes the fundamental scientific<br>technology, principles of operation and mechanism of action, and design | {5}------------------------------------------------ {6}------------------------------------------------ | and technological aspects. | |----------------------------| |----------------------------| | Comparison Table of Subject and Predicate Devices: | | | |----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | <i>OsteoCool</i> TM 2.0<br>RF Ablation System | <i>OsteoCool</i> RF Ablation System | | | SUBJECT DEVICE | PREDICATE DEVICE | | 510(k) Clearance<br>Regulation Number | TBD<br>21 CFR 878.4400 | K182497 (S.E. 12/17/2018)<br>21 CFR 878.4400 | | Product Code | GEI | GEI | | Product Class | Class II | Class II | | Indication for Use | The <i>OsteoCool</i> TM 2.0 RF Ablation System is intended for:<br>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.Ablation of benign bone tumors such as osteoid osteoma. | The <i>OsteoCool</i> TM RF Ablation System is intended for:<br>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.Ablation of benign bone tumors such as osteoid osteoma. | | User | Physicians trained in the use of <i>OsteoCool</i> RF ablation system | Physicians trained in the use of <i>OsteoCool</i> RF ablation system | | Anatomical Site of Use | Bone | Bone | | Method of Access | Percutaneous | Percutaneous | | TECHNICAL DETAILS - System | | | |----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | FEATURE | <i>OsteoCoolTM 2.0</i><br>RF Ablation System<br><br>SUBJECT DEVICE | <i>OsteoCool RF Ablation System</i><br><br>PREDICATE DEVICE | | Energy Type | Radiofrequency | Radiofrequency | | Principle of Operation | Radiofrequency energy delivered by operator from generator | Radiofrequency energy delivered by operator from generator | | Mechanism of Action | Thermal coagulation necrosis | Thermal coagulation necrosis | | Energy Delivery Control Mechanism | Temperature controlled | Temperature controlled | | Probe Active Tip Size | 7mm, 10mm, 15mm, 20mm | 7mm, 10mm, 15mm, 20mm | | Probe Outer Diameter | 17Gauge | 17Gauge | | Probe length | 16 cm | 16 cm | | Probe Electrodes<br>Material | Stainless Steel | Stainless Steel | | Probe Dielectric<br>Materials | Polyimide | Polyimide | | Electrode Sterilization | EtO, single use | EtO, single use | | Compatible RF<br>Generator | OsteoCool 2.0 | OsteoCool | | Number of independent<br>thermocouples | 4 | 2 | | Number of probes | 4 | 2 | | Generator Power Output<br>Channels | 4 | 2 | | Generator Maximum<br>Output Power | 80 Watts total20 W/channel | 40 Watts total20 W/channel | | Generator Maximum<br>Voltage | 224 VRMS | 130 VRMS | | Generator Maximum<br>Current | 1.2 ARMS | 1.0 ARMS | | Generator Output<br>Frequency | 465.1 kHz | 465.1 kHz | | Default Ablation<br>Temperature | 70C (Gradual) | 70C | | | 75C (Accelerated) | N/A | | Cooling medium | Sterile water | Sterile water | | System<br>components | Pump OC02-100<br>Hub OC04-100<br>Single Probe Kit 7 mm -OCP107<br>Single Probe Kit 10 mm -OCP110<br>Single Probe Kit 15 mm -OCP115<br>Single Probe Kit 20 mm -OCP120<br>Dual Probe Kit 7 mm x2 -OCP207<br>Dual Probe Kit 10 mm x2 -OCP210<br>Dual Probe Kit 15 mm x2 -OCP215<br>Dual Probe Kit 20 mm x2 -OCP220<br>RF Pump - OC02<br>ITC 28G - OCN001 | Pump OC02<br>Hub OC04<br>Single Probe Kit 7 mm -OCP107<br>Single Probe Kit 10 mm -OCP110<br>Single Probe Kit 15 mm - OCP115<br>Single Probe Kit 20 mm -OCP120<br>Dual Probe Kit 7 mm x2 -OCP207<br>Dual Probe Kit 10 mm x2 -OCP210<br>Dual Probe Kit 15 mm x2 -OCP215<br>Dual Probe Kit 20 mm x2 -OCP220<br>RF Pump - OC02<br>ITC 28G - OCN001 | {7}------------------------------------------------ {8}------------------------------------------------ | Performance Data | Bench top testing was performed to demonstrate substantial equivalence of<br>the OsteoCool™ 2.0 RF Ablation System to the predicate device. The<br>system components were subjected to the following verification and<br>validation tests, as applicable: mechanical, electrical, biocompatibility,<br>data integrity, temperature accuracy, cleaning, connectivity, and usability.<br>Bench-top validation testing was performed for the OsteoCool™ 2.0 RF<br>Ablation System using ex-vivo tissue and product usage in cadaveric bone<br>as per the guidance. Lesion size (length and width) was measured during<br>ex-vivo testing at the 50 degree C isotherm. Color change due to blood<br>coagulation at elevated temperatures between thermally affected tissue and<br>raw tissue was evaluated. | |------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Conclusion | The subject and predicate devices share the same fundamental scientific<br>technology, including principles of operation and mechanism of action.<br>The subject OsteoCool™ 2.0 RF Ablation System has been shown<br>through technological comparison and comparison testing to be<br>substantially equivalent to the identified predicate system for the<br>requested indications for use. |