IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation System Mobile Cart (IB-CART); IntelliBlate Ximitry Probe Assembly, 13G x 15cm (IB-XPA-1315); IntelliBlate Ximitry Probe Assembly, 13G x 20cm (IB-XPA-1320); IntelliBlate Ximitry Probe Assembly, 13G x 27cm (IB-XPA-1327)

Q: Who is the manufacturer of IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation System Mobile Cart (IB-CART); IntelliBlate Ximitry Probe Assembly, 13G x 15cm (IB-XPA-1315); IntelliBlate Ximitry Probe Assembly, 13G x 20cm (IB-XPA-1320); IntelliBlate Ximitry Probe Assembly, 13G x 27cm (IB-XPA-1327)?

Varian Medical Systems, Inc. filed the 510(k) submission for IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation System Mobile Cart (IB-CART); IntelliBlate Ximitry Probe Assembly, 13G x 15cm (IB-XPA-1315); IntelliBlate Ximitry Probe Assembly, 13G x 20cm (IB-XPA-1320); IntelliBlate Ximitry Probe Assembly, 13G x 27cm (IB-XPA-1327) (K240480).

Q: What is the FDA product code for IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation System Mobile Cart (IB-CART); IntelliBlate Ximitry Probe Assembly, 13G x 15cm (IB-XPA-1315); IntelliBlate Ximitry Probe Assembly, 13G x 20cm (IB-XPA-1320); IntelliBlate Ximitry Probe Assembly, 13G x 27cm (IB-XPA-1327)?

NEY. It is classified under 21 CFR 878.4400 as a Class 2 device in the General, Plastic Surgery panel.

Q: What is the regulatory pathway for IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation System Mobile Cart (IB-CART); IntelliBlate Ximitry Probe Assembly, 13G x 15cm (IB-XPA-1315); IntelliBlate Ximitry Probe Assembly, 13G x 20cm (IB-XPA-1320); IntelliBlate Ximitry Probe Assembly, 13G x 27cm (IB-XPA-1327)?

510(k) clearance (submission type: Traditional).

Q: Who can help prepare an FDA 510(k) submission like IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation System Mobile Cart (IB-CART); IntelliBlate Ximitry Probe Assembly, 13G x 15cm (IB-XPA-1315); IntelliBlate Ximitry Probe Assembly, 13G x 20cm (IB-XPA-1320); IntelliBlate Ximitry Probe Assembly, 13G x 27cm (IB-XPA-1327)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K240480 · Varian Medical Systems, Inc. · NEY · Jul 19, 2024 · General, Plastic Surgery

Device Facts

Record ID	K240480
Device Name	IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation System Mobile Cart (IB-CART); IntelliBlate Ximitry Probe Assembly, 13G x 15cm (IB-XPA-1315); IntelliBlate Ximitry Probe Assembly, 13G x 20cm (IB-XPA-1320); IntelliBlate Ximitry Probe Assembly, 13G x 27cm (IB-XPA-1327)
Applicant	Varian Medical Systems, Inc.
Product Code	NEY · General, Plastic Surgery
Decision Date	Jul 19, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The IntelliBlate Microwave Ablation System is intended for coagulation (ablation) of soft tissue. The IntelliBlate Microwave Ablation System is not intended for use in cardiac procedures. The IntelliBlate Ximitry Probe Assembly, used with the IntelliBlate Microwave Ablation System is intended for coagulation (ablation) of soft tissue. The IntelliBlate Ximitry Probe Assembly is not intended for use in cardiac procedures.

Device Story

Microwave ablation system for soft tissue coagulation; utilizes 2.45 GHz microwave energy to induce cellular death via coagulation necrosis. System comprises tabletop console with integrated peristaltic pump for coolant delivery and sterile, single-use disposable Ximitry Probe Assemblies. Operated by clinicians in facility settings. Console features graphical user interface (GUI) and touchscreen for monitoring and control; supports two independent ablation channels. Probe assembly integrates power cable and coolant tubing (supply/return) into single bundle; includes ceramic trocar tip and multiple thermocouples for temperature monitoring. System provides ablation, track ablation, and needle lock modes. Output power up to 170W (single) or 2x 150W (double). Safety features include automatic shutdown upon temperature limit or high reflected power. Output affects clinical decision-making by enabling targeted tissue necrosis; benefits patients by providing minimally invasive soft tissue ablation.

Clinical Evidence

No clinical data. Evidence consists of non-clinical bench testing (functional, ablation performance in ex-vivo porcine liver/kidney/muscle, reliability, electrical safety, EMC), GLP animal studies (porcine soft tissue), and systematic literature review of predicate device performance (1,628 patients, 2,438 tumors).

Technological Characteristics

2.45 GHz microwave generator; tabletop console; peristaltic pump cooling; sterile ETO-sterilized single-use probes (fiberglass shaft, ceramic trocar tip). Connectivity: USB. Standards: IEC 60601-1, 60601-1-6, 60601-2-6, 60601-1-2. Biocompatibility: ISO 10993-1. Packaging: ISO 11607-1/2.

Indications for Use

Indicated for coagulation (ablation) of soft tissue. Not for use in cardiac procedures.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

Emprint Ablation System with Thermosphere Technology (K200796)
Neuwave Certus 140 2.45 GHz Ablation System and Accessories (K100744)

Related Devices

K113237 — CERTUS 140 2.45GHZ ABLATION SYSTEM · Neuwave Medical, Inc. · Jan 4, 2012
K233140 — Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact) · Hygea Medical Technology Co., Ltd. · Jan 31, 2024
K122217 — CERTUS 140 2.45GHZ ABLATION SYSTEM · Neuwave Medical, Inc. · Dec 19, 2012
K173756 — Certus 140 2.45GHz Ablation System · Neuwave Medical, Inc. · Oct 24, 2018
K160936 — Certus 140 2.45GHz Ablation System · Neuwave Medical, Inc. · May 4, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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 acronym with the full name of the agency on the right. The symbol on the left is the Department of Health & Human Services logo. The FDA acronym is in a blue square, and the full name of the agency, "U.S. Food & Drug Administration," is in blue text to the right of the square. July 19, 2024 Varian Medical Systems, Inc. Lynn Allman Sr. Director Regulatory Affairs 3100 Hansen Way Palo Alto, California 94304 # Re: K240480 Trade/Device Name: IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation System Mobile Cart (IB-CART); IntelliBlate Ximitry Probe Assembly, 13G x 15cm (IB-XPA-1315); IntelliBlate Ximitry Probe Assembly, 13G x 20cm (IB-XPA-1320); IntelliBlate Ximitry Probe Assembly, 13G x 27cm (IB-XPA-1327) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: NEY Dated: June 17, 2024 Received: June 18, 2024 Dear Lynn Allman: 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. {1}------------------------------------------------ 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" (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 QS 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 Colin K. Colin K. Chen -S Date: 2024.07.19 Chen -S 13:35:14 -04'00' Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices for {2}------------------------------------------------ OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K240480 Device Name IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation System Mobile Cart (IB-CART); IntelliBlate Ximitry Probe Assembly, 13G x 15cm (1B-XPA-1315); IntelliBlate Ximitry Probe Assembly, 13G x 20cm (1B-XPA-1320); IntelliBlate Ximitry Probe Assembly, 13G x 27cm (IB-XPA-1327). Indications for Use (Describe) IntelliBlate Microwave Ablation System: The IntelliBlate Microwave Ablation System is intended for coagulation (ablation) of soft tissue. The IntelliBlate Microwave Ablation System is not intended for use in cardiac procedures. IntelliBlate Ximitry Probe Assembly: The IntelliBlate Ximitry Probe Assembly, used with the IntelliBlate Microwave Ablation System is intended for coagulation (ablation) of soft tissue. The IntelliBlate Ximitry Probe Assembly is not intended for use in cardiac procedures. Type of Use (Select one or both, as applicable)X 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." {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows three blue circles in a row. The circles are evenly spaced and are all the same size. The background is white. The circles are a bright, vibrant blue. Varian Medical Systems, Inc 3100 Hansen Way Palo Alto, CA 94304-1038 Telephone: 1.650.493.4000 Toll Free: 800.544.4636 www.varian.com # PREMARKET NOTIFICATION K240480 510(k) Summary IntelliBlate Microwave Ablation System and Accessories The following information is provided as required by 21 CFR 807.92 #### Submitter's Information: l. | Name and Address: | Varian Medical Systems Inc. 9825 Spectrum Drive, Building 2 Austin, TX 78717 | |-------------------|---------------------------------------------------------------------------------| | Contact Name: | Lynn Allman, Senior Director Regulatory Affairs | | E-mail: | submissions.support@varian.com | | Date Prepared: | July 17, 2024 | #### ll. Device Information: | Proprietary Name: | IntelliBlate Microwave Ablation System and Accessories | |-----------------------|----------------------------------------------------------------| | Common/ Usual Name: | System, Ablation, Microwave and Accessories | | Classification Name: | Electrosurgical cutting and coagulation device and accessories | | Classification Panel: | General & Plastic Surgery | | Regulation Number: | 21 CFR 878.4400 | | Product Code | NEY | #### III. Predicate Devices: Emprint Ablation System with Thermosphere Technology (K200796) Neuwave Certus 140 2.45 GHz Ablation System and Accessories (K100744) #### IV. Subject Device Description: The IntelliBlate Microwave Ablation System is a software-controlled microwave therapy delivery system with graphical user interface and hardware to control and monitor the therapy delivered to the target tissues. The system consists of a 2.45 GHz microwave generator (console) with an integrated peristaltic pump assembly for coolant fluid delivery, a coolant Fluid Mount and an optional mobile cart for the console. Accessories for the system include IntelliBlate Ximitry Probe Assembly - a sterile, single-use disposable microwave ablation assembly with ablation probes and a cassette for coolant fluid tubing (closed cooling circuit). {5}------------------------------------------------ #### V. Intended Use/ Indications of Use Statement: ### IntelliBlate Microwave Ablation System The IntelliBlate Microwave Ablation System is intended for coagulation (ablation) of soft tissue. The IntelliBlate Microwave Ablation System is not intended for use in cardiac procedures. ### IntelliBlate Ximitry Probe Assembly The IntelliBlate Ximitry Probe Assembly, used with the IntelliBlate Microwave Ablation System is intended for coagulation (ablation) of soft tissue. The IntelliBlate Ximitry Probe Assembly is not intended for use in cardiac procedures. #### VI. Substantial Equivalence Discussion: The following table compares the subject device to the predicate devices with respect to indications for use, principles of operation, technological characteristics, materials, and performance, and forms the basis for the determination of substantial equivalence. ### Table 1: Comparison of Technological Characteristics between subject and predicate devices {6}------------------------------------------------ | Features/ Characteristics | Subject Device IntelliBlate Microwave Ablation System and Accessories | Predicate Device Emprint Ablation System with Thermosphere Technology (K200796) | Predicate Device Neuwave Certus 140 2.45 GHz Ablation System and Accessories (K100744) | Comparison | |-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product code, FDA regulation and device class | NEY, 21 CFR 878.4400 and Class II | NEY, 21 CFR 878.4400 and Class II | NEY, 21 CFR 878.4400 and Class II | Same | | 510(k) clearance(s) | No prior 510(k) clearances | K200796 | K100744 | Subject device is a new device with no prior regulatory clearances. | | Manufacturer | Varian Medical Systems | Covidien | Neuwave Medical Inc. | Different manufacturer | | Prescription (Rx only) | Yes | Yes | Yes | Same | | Intended Use | Intended for coagulation (ablation) of soft tissue in laparoscopic, intraoperative, and percutaneous ablation procedures | Intended for coagulation (ablation) of soft tissue in laparoscopic, intraoperative, and percutaneous ablation procedures. | The Neuwave Medical Certus 140 2.45 GHz Ablation System and Accessories are intended for the ablation (coagulation) of soft tissue. The Certus 140™ 2.45 GHz Ablation System is not intended for use in cardiac procedures. NeuWave recommends against the use of the Certus 140 2.45 GHz Ablation System in the following situations: * Pregnant patients - potential risks to patient and/or fetus have not been established * Patients with implantable pacemakers or other electronic implants. Implanted electronic devices may be adversely affected by microwave power The system is designed for facility use and should only be used under the orders of a clinician. | Same indication of use -subject and predicate devices are indicated for coagulation (ablation) of soft tissue. Subject device does not include percutaneous, laparoscopic, endoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of nonresectable liver tumors. | | Features/ Characteristics | Subject Device IntelliBlate Microwave Ablation System and Accessories | Predicate Device Emprint Ablation System with Thermosphere Technology (K200796) | Predicate Device Neuwave Certus 140 2.45 GHz Ablation System and Accessories (K100744) | Comparison | | Indications for Use Statement for IntelliBlate Microwave Ablation System | The IntelliBlate Microwave Ablation System is intended for coagulation (ablation) of soft tissue. The IntelliBlate Microwave Ablation System is not intended for use in cardiac procedures. | The Emprint™ Ablation System is intended for use in percutaneous, laparoscopic, endoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of nonresectable liver tumors. The Emprint™ Ablation System is not intended for use in cardiac procedures. | The Neuwave Medical Certus 140 2.45 GHz Ablation System and Accessories are intended for the ablation (coagulation) of soft tissue. The Certus 140™ 2.45 GHz Ablation System is not intended for use in cardiac procedures. NeuWave recommends against the use of the Certus 140 2.45 GHz Ablation System in the following situations: * Pregnant patients - potential risks to patient and/or fetus have not been established * Patients with implantable pacemakers or other electronic implants. Implanted electronic devices may be adversely affected by microwave power The system is designed for facility use and should only be used under the orders of a clinician. | Same indication of use –subject and predicate devices are indicated for coagulation (ablation) of soft tissue. Subject device does not include percutaneous, laparoscopic, endoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of nonresectable liver tumors. | | Indications for Use Statement for IntelliBlate Ximitry Probe Assembly | The IntelliBlate Ximitry Probe Assembly, used with the IntelliBlate Microwave Ablation System is intended for coagulation (ablation) of soft tissue. The IntelliBlate Ximitry Probe Assembly is not intended for use in cardiac procedures. | The Covidien Emprint™ Ablation System is intended for use in percutaneous, laparoscopic, endoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of nonresectable liver tumors. The Covidien Emprint™ Ablation System is not intended for use in cardiac procedures. | The Neuwave Medical Certus 140 2.45 GHz Ablation System and Accessories are intended for the ablation (coagulation) of soft tissue. The Certus 140™ 2.45 GHz Ablation System is not intended for use in cardiac procedures. NeuWave recommends against the use of the Certus 140 2.45 GHz Ablation System in the following situations. | Same indication of use -subject and predicate devices are indicated for coagulation (ablation) of soft tissue. Subject device does not include percutaneous, laparoscopic, endoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of nonresectable liver tumors. | | Features/ Characteristics | Subject Device | Predicate Device | Predicate Device | Comparison | | | IntelliBlate Microwave Ablation System and Accessories | Emprint Ablation System with Thermosphere Technology (K200796) | Neuwave Certus 140 2.45 GHz Ablation System and Accessories (K100744) | | | | | | * Pregnant patients - potential risks to patient and/or fetus have not been established * Patients with implantable pacemakers or other electronic implants. Implanted electronic devices may be adversely affected by microwave power The system is designed for facility use and should only be used under the orders of a clinician. | | | Operating Principle for microwave ablation | Microwave ablation is heating of the target tissue based on agitation of water molecules inducing cellular death via coagulation (ablation) necrosis | Microwave ablation is heating of the target tissue based on agitation of water molecules inducing cellular death via coagulation (ablation) necrosis | Microwave ablation is heating of the target tissue based on agitation of water molecules inducing cellular death via coagulation (ablation) necrosis | Same | | System Configuration | | | | | | Generator | Tabletop Generator (console) | Cart mounted Generator | Cart mounted Generator | Same | | No of independent ablation channels | 2 | 1 | 3 | Subject device supports 2 independent ablation channels | | Cooling System | Peristaltic Pump Assembly integrated into the generator for each ablation channel | Peristaltic Pump Assembly separate and external to the generator | CO2 based cooling system | Subject and predicate device (K200796) has peristaltic pump assembly for cooling of the ablation probes. | | Touch Screen/ Graphical User Interface | Yes | No (Physical Buttons and digital display) | Yes | GUI/ Touch Screen | | Accessories | | | | | | Ablation Probe Assembly | Includes ablation probe, coolant tubing, coolant spike, integrated cassette for coolant delivery and power cable. | Includes ablation probe, coolant tubing, coolant spike and power cable. Coolant delivery is external via manual connection to the external pump. | Includes a probe handle, a 1.4M cable, CO2 gas coolant tubing and a connector assembly. An intermediate junction box or Power Distribution | Subject device does not need an additional reusable cable to connect probe to the generator. | | Features/ Characteristics | Subject Device IntelliBlate Microwave Ablation System and Accessories | Predicate Device Emprint Ablation System with Thermosphere Technology (K200796) | Predicate Device Neuwave Certus 140 2.45 GHz Ablation System and Accessories (K100744) | Comparison | | | Optional accessories – laser alignment disc and depth guides for ablation probes | | Module (PDM) is used between the probe and console. | | | Optional Accessories | Temperature sensor probe, mobile cart | Remote Temperature Probe, mobile cart, footswitch | Footswitch | Similar optional accessories | | Ablation | | | | | | Ablation features | Ablation, Track Ablation and Needle Lock | Ablation. Device can be used for track ablation as a use workflow. | Ablation, Cauterize (track ablation), Tissue Loc, Planar Coagulation | Additional pre-configured ablation features in subject device | | Target Ablation time | Up to 10 minutes. | Up to 10 minutes | Up to 10 minutes | Same | | Generator | | | | | | Device Usage | Multi-use | Multi-use | Multi-use | Same | | Compatible Disposable/ Single Use Devices | Microwave ablation probe (up to 2) Optional Temperature Sensor Probe (up to 2) | Microwave ablation probe (1) Optional Remote Temperature Probe (1) | Microwave ablation probe (up to 3) | Subject device can connect up to 2 probes | | Generator Output Frequency | 2.45GHz ± 50MHz | 2.45GHz ± 50MHz | 2.45GHz ± 25MHz | Same | | Maximum RF power for ablation (measured at output port): | 170W (single needle ablation) 2x 150W (double needle ablation) | 150W (single needle ablation) | 140W (single needle ablation) 2x 95W (double needle ablation) 3x 65W (triple needle ablation) | Increased output power to compensate for cable losses. | | Power Settings | Adjusts microwave power setpoint in 5-watt increments | Adjusts microwave power setpoint in 5-watt increments. | Adjusts microwave power setpoint in 5-watt increments | Same | | Temperature Monitoring | Yes | Yes | Yes | Same | | Safety Feature - Automatic system Shutdown when ablation probe temperature | Yes | Yes | Yes | Same | | Features/ Characteristics | Subject Device | Predicate Device | Predicate Device | Comparison | | | IntelliBlate Microwave Ablation System and Accessories | Emprint Ablation System with Thermosphere Technology (K200796) | Neuwave Certus 140 2.45 GHz Ablation System and Accessories (K100744) | | | exceed limits and due to high reflected power | | | | | | Safety Standard Compliance | IEC 60601-1, 60601-1-6, 60601-2-6, 60601-1-2 | IEC 60601-1, 60601-1-6, 60601-2-6, 60601-1-2…