(150 days)
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.
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).
The provided text does not contain detailed acceptance criteria for the IntelliBlate Microwave Ablation System that would typically be found in a clinical study report or a more extensive submission. The document primarily focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and non-clinical testing summaries.
However, based on the information provided, we can infer some general acceptance criteria related to safety and performance, and describe the studies conducted as reported in the "Performance Data" section.
Here's an attempt to structure the information based on the provided text, acknowledging the limitations in detail for many of the requested points:
Implicit Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Performance Data) | Reported Device Performance (as stated in the document) |
|---|---|
| Functional Design and Performance: Device meets established design criteria. | The subject devices successfully completed functional testing. |
| Ablation Performance in Ex-vivo Tissues: Ablation performance is substantially equivalent to predicate devices in various tissues. | Ex-vivo testing of the devices at single, double, and track ablation settings in porcine liver, kidney, and muscle demonstrated that the differences in design and system characteristics do not affect the ablation performance of the subject device in comparison to the predicate device. |
| Usability and Performance (Acute Animal Model): Devices are usable and perform as expected in living tissue models. | Acute GLP studies validated usability and performance of the devices on porcine soft tissue models. |
| Reliability: Device maintains consistent operation over time. | The subject devices successfully completed reliability testing. |
| Electrical Safety: Device complies with relevant electrical safety standards. | The IntelliBlate Microwave Ablation System and its accessories comply with applicable IEC 60601 series of standards: IEC 60601-1, IEC 60601-1-6, IEC 60601-2-6, and IEC 60601-1-2. |
| Electromagnetic Compatibility: Device complies with relevant electromagnetic compatibility standards. | The IntelliBlate Microwave Ablation System and its accessories comply with applicable IEC 60601 series of standards: IEC 60601-1, IEC 60601-1-6, IEC 60601-2-6, and IEC 60601-1-2. |
| Sterility: Ximitry Probe Assembly achieves a minimum sterility assurance level of 10^-6. | Ximitry Probe Assembly is sterilized utilizing 100% ethylene oxide gas to ensure a minimum sterility assurance level of 10^-6 in accordance with ISO 11135, ISO 10993-7, ISO 11138-1, ISO 11737-1, and ISO 11737-2. |
| Software Verification: Software functions are verified according to medical device software standards and FDA guidance. | Software verification was conducted in accordance with IEC 62304 and FDA guidance "Content of Premarket Submissions for Device Software Functions." |
| Cybersecurity: Cybersecurity requirements are assessed and addressed per FDA guidance. | Cybersecurity requirements were assessed per FDA guidance's "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, Postmarket Management of Cybersecurity in Medical Devices." |
| Thermal Effects and Temperature Monitoring: Thermal performance is substantially equivalent to predicate devices and monitoring is effective. | Comparison of thermal effects between IntelliBlate Microwave Ablation System and its predicate demonstrated that the performance of the subject device is substantially equivalent to the predicate device. Thermal effects and temperature monitoring testing were completed in accordance with FDA Guidance. |
| Biocompatibility: Patient-contacting components are biocompatible. | Biocompatibility testing of the Ximitry Probe Assembly in accordance with ISO 10993-1 demonstrated that the patient-contacting components are biocompatible. |
| Packaging Integrity and Shelf Life: Packaging maintains integrity and device remains viable for its intended shelf life. | Packaging integrity and shelf-life testing was performed in accordance with ISO 11607-1 and ISO 11607-2. |
Here's a breakdown of the other requested information based on the provided text. Please note that many of these details are not explicitly stated in the summary document.
2. Sample size used for the test set and the data provenance:
- Test set sample size: Not explicitly stated for specific non-clinical tests. For the ex-vivo ablation performance study, it mentions testing in "porcine liver, kidney and muscle," but no specific numbers of samples or experimental runs are provided.
- Data provenance:
- Ex-vivo ablation performance: Porcine tissues. Origin of the pigs not specified.
- Acute animal testing: Porcine soft tissue models. Conducted in accordance with GLP Regulations (21 CFR Part 58) in the United States.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The studies mentioned (ex-vivo, animal GLP) would likely involve trained personnel or researchers, but their specific qualifications or role in establishing "ground truth" (e.g., assessing ablation zones) are not described. The document primarily focuses on engineering and animal model performance rather than human expert interpretation of results.
4. Adjudication method for the test set:
- This information is not provided in the document. Given the nature of the non-clinical and animal studies described, a formal adjudication method (like 2+1 or 3+1 often used for diagnostic AI) is very unlikely to have been applied. The evaluation would be based on direct measurements and observations by the researchers.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. The IntelliBlate Microwave Ablation System is a hardware-based therapeutic device, not an AI diagnostic or assistance tool for human readers. Therefore, this type of study is irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This device is a physical system for microwave ablation. The "software" mentioned in the document is for controlling the device's functions and user interface, not for standalone diagnostic or interpretive performance. Therefore, the concept of "standalone (algorithm only)" as it applies to AI diagnostics is not applicable here. The device's performance is inherently "standalone" in its therapeutic action, but this is not an algorithm acting independently of human control.
7. The type of ground truth used:
- For Ex-vivo Ablation Performance: The "ground truth" would be the actual measured ablation zone characteristics (e.g., volume, size, shape) in the porcine tissues, determined by direct observation or histological analysis post-ablation.
- For Acute Animal Testing: The "ground truth" would be the observed acute effects of ablation in porcine soft tissues, assessed through direct observation, physiological measurements, and potentially necropsy/histopathology.
- For Sterilization, Biocompatibility, Electrical Safety, etc.: The "ground truth" is adherence to specified standards and objective measurements (e.g., sterility assurance level, physical/chemical properties, electrical performance).
8. The sample size for the training set:
- This information is not applicable in the context of the studies described. The device is a microwave ablation system, and the testing described (functional, ex-vivo, animal, electrical, etc.) are verification and validation studies against pre-defined engineering and safety criteria, not training of a machine learning model.
9. How the ground truth for the training set was established:
- This information is not applicable for the reasons stated in point 8. There is no mention of a "training set" for a machine learning model. The "training" that occurs is in the development and refinement of the device's design and operational parameters based on engineering principles and iterative testing.
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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.
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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
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OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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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)
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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).
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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
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| Features/ Characteristics | Subject DeviceIntelliBlate Microwave Ablation Systemand Accessories | Predicate DeviceEmprint Ablation System withThermosphere Technology (K200796) | Predicate DeviceNeuwave Certus 140 2.45 GHzAblation System and Accessories(K100744) | Comparison |
|---|---|---|---|---|
| Product code, FDAregulation and deviceclass | 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 devicewith no prior regulatoryclearances. |
| Manufacturer | Varian Medical Systems | Covidien | Neuwave Medical Inc. | Different manufacturer |
| Prescription (Rx only) | Yes | Yes | Yes | Same |
| Intended Use | Intended for coagulation (ablation) ofsoft tissue in laparoscopic,intraoperative, and percutaneousablation procedures | Intended for coagulation (ablation) ofsoft tissue in laparoscopic,intraoperative, and percutaneousablation procedures. | The Neuwave Medical Certus 1402.45 GHz Ablation System andAccessories are intended for theablation (coagulation) of soft tissue.The Certus 140™ 2.45 GHz AblationSystem is not intended for use incardiac procedures.NeuWave recommends against theuse of the Certus 140 2.45 GHzAblation System in the followingsituations:* Pregnant patients - potential risksto patient and/or fetus have notbeen established* Patients with implantablepacemakers or other electronicimplants. Implanted electronicdevices may be adversely affected bymicrowave powerThe system is designed for facility useand should only be used under theorders of a clinician. | Same indication of use -subjectand predicate devices areindicated for coagulation(ablation) of soft tissue.Subject device does not includepercutaneous, laparoscopic,endoscopic, and intraoperativecoagulation (ablation) of softtissue, including partial orcomplete ablation ofnonresectable liver tumors. |
| Features/ Characteristics | Subject DeviceIntelliBlate Microwave Ablation Systemand Accessories | Predicate DeviceEmprint Ablation System withThermosphere Technology (K200796) | Predicate DeviceNeuwave Certus 140 2.45 GHzAblation System and Accessories(K100744) | Comparison |
| Indications for UseStatement for IntelliBlateMicrowave AblationSystem | The IntelliBlate Microwave AblationSystem is intended for coagulation(ablation) of soft tissue.The IntelliBlate Microwave AblationSystem is not intended for use incardiac procedures. | The Emprint™ Ablation System isintended for use in percutaneous,laparoscopic, endoscopic, andintraoperative coagulation (ablation) ofsoft tissue, including partial orcomplete ablation of nonresectableliver tumors.The Emprint™ Ablation System is notintended for use in cardiac procedures. | The Neuwave Medical Certus 1402.45 GHz Ablation System andAccessories are intended for theablation (coagulation) of soft tissue.The Certus 140™ 2.45 GHz AblationSystem is not intended for use incardiac procedures.NeuWave recommends against theuse of the Certus 140 2.45 GHzAblation System in the followingsituations:* Pregnant patients - potential risksto patient and/or fetus have notbeen established* Patients with implantablepacemakers or other electronicimplants. Implanted electronicdevices may be adversely affected bymicrowave powerThe system is designed for facility useand should only be used under theorders of a clinician. | Same indication of use –subjectand predicate devices areindicated for coagulation(ablation) of soft tissue.Subject device does not includepercutaneous, laparoscopic,endoscopic, and intraoperativecoagulation (ablation) of softtissue, including partial orcomplete ablation ofnonresectable liver tumors. |
| Indications for UseStatement for IntelliBlateXimitry Probe Assembly | The IntelliBlate Ximitry Probe Assembly,used with the IntelliBlate MicrowaveAblation System is intended forcoagulation (ablation) of soft tissue.The IntelliBlate Ximitry Probe Assemblyis not intended for use in cardiacprocedures. | The Covidien Emprint™ Ablation Systemis intended for use in percutaneous,laparoscopic, endoscopic, andintraoperative coagulation (ablation) ofsoft tissue, including partial orcomplete ablation of nonresectableliver tumors.The Covidien Emprint™ AblationSystem is not intended for use incardiac procedures. | The Neuwave Medical Certus 1402.45 GHz Ablation System andAccessories are intended for theablation (coagulation) of soft tissue.The Certus 140™ 2.45 GHz AblationSystem is not intended for use incardiac procedures.NeuWave recommends against theuse of the Certus 140 2.45 GHzAblation System in the followingsituations. | Same indication of use -subjectand predicate devices areindicated for coagulation(ablation) of soft tissue.Subject device does not includepercutaneous, laparoscopic,endoscopic, and intraoperativecoagulation (ablation) of softtissue, including partial orcomplete ablation ofnonresectable liver tumors. |
| Features/ Characteristics | Subject Device | Predicate Device | Predicate Device | Comparison |
| IntelliBlate Microwave Ablation Systemand Accessories | Emprint Ablation System withThermosphere Technology (K200796) | Neuwave Certus 140 2.45 GHzAblation System and Accessories(K100744) | ||
| * Pregnant patients - potential risksto patient and/or fetus have notbeen established* Patients with implantablepacemakers or other electronicimplants. Implanted electronicdevices may be adversely affected bymicrowave powerThe system is designed for facility useand should only be used under theorders of a clinician. | ||||
| Operating Principle formicrowave ablation | Microwave ablation is heating of thetarget tissue based on agitation ofwater molecules inducing cellular deathvia coagulation (ablation) necrosis | Microwave ablation is heating of thetarget tissue based on agitation ofwater molecules inducing cellular deathvia coagulation (ablation) necrosis | Microwave ablation is heating of thetarget tissue based on agitation ofwater molecules inducing cellulardeath via coagulation (ablation)necrosis | Same |
| System Configuration | ||||
| Generator | Tabletop Generator (console) | Cart mounted Generator | Cart mounted Generator | Same |
| No of independentablation channels | 2 | 1 | 3 | Subject device supports 2independent ablation channels |
| Cooling System | Peristaltic Pump Assembly integratedinto the generator for each ablationchannel | Peristaltic Pump Assembly separate andexternal to the generator | CO2 based cooling system | Subject and predicate device(K200796) has peristaltic pumpassembly for cooling of theablation probes. |
| Touch Screen/ GraphicalUser 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 forcoolant delivery and power cable. | Includes ablation probe, coolant tubing,coolant spike and power cable. Coolantdelivery is external via manualconnection to the external pump. | Includes a probe handle, a 1.4Mcable, CO2 gas coolant tubing and aconnector assembly. An intermediatejunction box or Power Distribution | Subject device does not need anadditional reusable cable toconnect probe to the generator. |
| Features/ Characteristics | Subject DeviceIntelliBlate Microwave Ablation Systemand Accessories | Predicate DeviceEmprint Ablation System withThermosphere Technology (K200796) | Predicate DeviceNeuwave Certus 140 2.45 GHzAblation 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 OutputFrequency | 2.45GHz ± 50MHz | 2.45GHz ± 50MHz | 2.45GHz ± 25MHz | Same |
| Maximum RF power forablation (measured atoutput 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 systemShutdown when ablationprobe temperature | Yes | Yes | Yes | Same |
| Features/ Characteristics | Subject Device | Predicate Device | Predicate Device | Comparison |
| IntelliBlate Microwave Ablation Systemand Accessories | Emprint Ablation System withThermosphere Technology (K200796) | Neuwave Certus 140 2.45 GHzAblation System and Accessories(K100744) | ||
| exceed limits and due tohigh reflected power | ||||
| Safety StandardCompliance | IEC 60601-1, 60601-1-6, 60601-2-6,60601-1-2 | IEC 60601-1, 60601-1-6, 60601-2-6,60601-1-2 | IEC 60601-1, 60601-2-2, 60601-2-6,60601-1-2 | Same |
| Potential Equalization | Equalization terminal | Equalization terminal | Equalization terminal | Same |
| Electronic Interfaces forInteroperability | USB | USB | USB | Same |
| Operating Conditions | Temperature: 10 to 25 °C | Temperature: 10 to 30°C | Temperature: 18 to 28°C | Similar |
| Relative Humidity: 30% to 75% (non-condensing) | Relative Humidity: 20% to 80% (non-condensing) | Relative Humidity: 10% to 90% (non-condensing) | Similar | |
| Atmospheric pressure range: 60kPa to106 kPa | Atmospheric pressure range: 66kPa to106 kPa | Atmospheric pressure range: 70kPAto 106kPa | Similar |
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| Microwave Ablation Probe | ||||
|---|---|---|---|---|
| Features/ Characteristics | Subject DeviceIntelliBlate Microwave Ablation Systemand Accessories | Predicate DeviceEmprint Ablation System withThermosphere Technology (K200796) | Predicate DeviceNeuwave Certus 140 2.45 GHzAblation System and Accessories(K100744) | Comparison |
| Compatible MicrowaveAblation Probe | Ximitry Probe Assembly | Microwave ablation antenna withThermosphere™ Technology | Ablation probes include ModelsCertusLN, CertusLK, CertusSR andCertusPR | See below comparison of thefeatures |
| Antenna Connections | Single cable bundles integrating powercable and coolant tubing (supply andreturn lines) | Separate power cable and coolanttubing (supply and return lines) | Single cable bundles integratingpower cable and coolant tubing(supply and return lines) | Single cable bundle |
| Power Connection | Power cable connects directly to theconsole | Power Cable connects to a reusablecable that connects to the console | Power cable connects to a reusablePower Distribution Module (PDM)is used between the probe andconsole | Different set for connection |
| Antenna Coolant Delivery | Coolant delivery connection via anintegrated Cassette | Coolant delivery connection via manualconnection to external peristaltic pump | Coolant delivery connection via anintegrated connector | Integrated coolant deliverycircuit |
| Coolant Connection | Via spike to the coolant bag | Via spike to the coolant bag | Via gas fitting connection to 2 CO2gas cylinders | Subject and predicate device(K200796) have the samecoolant connection. |
| Cooling medium | Sterile water/ saline | Sterile saline | CO2 gas | Additional coolant option |
| Distal Tip configuration | Ceramic Trocar Tip | Ceramic Trocar tip | Ceramic Trocar tip | Same |
| Antenna shaft length(s) | 15 cm, 20 cm, 27 cm | 15 cm, 20 cm, 30 cm | 6cm, 15cm, 20cm, 25cm | Variable lengths to supportsofttissue ablations |
| Antenna Shaft Diameter | 13.5 G (2.3mm) | 13 G (2.4mm) | 13G, 15G, 17G | Subject device has a thinnershaft profile |
| Right Angle Probe | Yes | Yes | Yes | Same |
| Antenna ShaftConstruction | Fiberglass | Fiberglass | Stainless steel | Same |
| Probe Thermocouple | 3 integrated thermocouples at pre-defined locations on the shaft and 2internal temperature sensors within theprobe handle | 1 internal temperature sensor with nothermocouples on the shaft | 3 integrated thermocouples at pre-defined locations on the shaft | Multiple temperature sensors |
| Patient ContactingComponents | Antenna shaft, tip, adhesive and depthguide are biocompatible | Antenna shaft, tip, adhesive and depthguide are biocompatible. | Antenna shaft & tip arebiocompatible. | Same |
| Software | No | No | No | Same |
| Device Usage | Single-use, disposable | Single-use, disposable | Single-use, disposable | Same |
| Sterilization | ETO | ETO | ETO | Same |
| Packaging Configurationand Materials | Thermoform tray and retainer lid with asingle Tyvek sterile barrier lid within aSBS (solid bleached sulfate) shelf cartonbox sealed with a tamper paper tape. | Thermoform tray and single Tyveksterile barrier lid within a SBS (solidbleached sulfate) shelf carton boxsealed with a tamper paper tape. | Thermoform tray and single Tyveksterile barrier lid within a SBS (solidbleached sulfate) shelf carton boxsealed with a tamper paper tape. | Same |
| Optional Accessories | Laser alignment disc and depth guide | Depth guide | No optional accessories | Additional optional accessories |
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Performance Data: VII.
1. Non-clinical Testing:
IntelliBlate Microwave Ablation System and its accessories underwent non-clinical testing to demonstrate the design and performance of the devices meet the established design criteria and are substantial equivalent to the predicate devices. The subject devices successfully completed functional, ablation performance ex-vivo tissues, reliability, and electrical testing.
Substantial equivalence in performance between the subject and predicate device cleared via K200796 was demonstrated by side-by-side testing of the subject and predicate devices for ablation. The ex-vivo testing of the devices at single, double and track ablation settings in porcine liver, kidney and muscle demonstrate that the differences in design and system characteristics do not affect the ablation performance of the subject device in comparison to the predicate device.
2. Non-clinical Animal Testing:
Animal testing with IntelliBlate Microwave Ablation System and its accessories were completed in accordance with the United States Food and Drug Administration Good Laboratory Practice (GLP) Regulations, 21 CFR Part 58 and included:
- Acute GLP studies to validate usability and performance of the devices on porcine soft tissue models.
3. Literature Review:
Systematic literature review conducted in support of indications of use with the predicate device identified a total of 1,628 patients and 2,438 tumors included in the 23 publications. The outcome and complication rates summarized from the predicate device published literature is comparable to the meta-analyses reviewed. The meta-analyses contain published literature comparing various microwave ablation systems to radio-frequency ablation, cryoablation or surgical resection. The literature search strategy was based on an SLR approach; both SLR sections, per unique studies and published SLRs/ meta-analyses, suggested the safe and effective use of microwave ablation for the soft tissue coagulation (ablation) of tumors.
4. Sterilization:
Ximitry Probe Assembly is sterilized utilizing 100% ethylene oxide gas to ensure a minimum sterility assurance level of 10 ° in accordance with ISO 11135, ISO 10993-7, ISO 11138-1, ISO 11737-1 and ISO 11737-2.
5. Software, Cybersecurity, and Interoperability
Software verification was conducted in accordance with IEC 62304 – "Medical device software - Software life cycle processes" and FDA guidance "Content of Premarket Submissions for Device Software Functions.
Cybersecurity requirements were assessed per FDA guidance's Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, Postmarket Management of Cybersecurity in Medical Devices.
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6. Thermal Effects and Temperature Monitoring:
Thermal effects and temperature monitoring testing were completed in accordance with FDA Guidance - Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery.
Comparison of thermal effects between IntelliBlate Microwave Ablation System and its predicate demonstrated that the performance of the subject device is substantially equivalent to the predicate device.
7. Biocompatibility:
Biocompatibility testing of the Ximitry Probe Assembly in accordance with ISO 10993-1 demonstrated that the patient-contacting components are biocompatible.
8. Electrical Safety and Electromagnetic Compatibility:
The IntelliBlate Microwave Ablation System and its accessories comply with applicable IEC 60601 series of standards: IEC 60601-1, IEC 60601-1-6, IEC 60601-2-6, and IEC 60601-1-2.
9. Packaging Integrity and Shelf Life:
Packaging integrity and shelf-life testing was performed in accordance with ISO 11607-1 and ISO 11607-2.
VIII. Conclusion:
The subject device and predicate device(s) technological characteristics are equivalent. The nonclinical verification and validation performance data supports the safety and effectiveness of the subject device as indicated for use. Varian considers the IntelliBlate Microwave Ablation System and its accessories technological characteristics to be as safe and effective as the predicate device(s) and therefore, substantially equivalent to the predicate device(s).
§ 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.