(150 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on software control and hardware for therapy delivery and monitoring, without mentioning AI/ML capabilities.
Yes
The device is described as a "microwave therapy delivery system" intended for "coagulation (ablation) of soft tissue," which is a therapeutic intervention.
No
The device is intended for soft tissue coagulation (ablation), which is a treatment or therapeutic procedure, not a diagnostic one.
No
The device description explicitly states that the system includes "hardware to control and monitor the therapy delivered to the target tissues" and lists hardware components such as a microwave generator (console), peristaltic pump assembly, and coolant Fluid Mount.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for "coagulation (ablation) of soft tissue." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The description details a system that delivers microwave therapy to target tissues. This is an active medical device used for treatment.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVDs are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) for treatment.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
NEY
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue (Not intended for use in cardiac procedures)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The system is designed for facility use and should only be used under the orders of a clinician.
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)
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.
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.
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.
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.
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.
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.
Biocompatibility:
Biocompatibility testing of the Ximitry Probe Assembly in accordance with ISO 10993-1 demonstrated that the patient-contacting components are biocompatible.
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.
Packaging Integrity and Shelf Life:
Packaging integrity and shelf-life testing was performed in accordance with ISO 11607-1 and ISO 11607-2.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Emprint Ablation System with Thermosphere Technology (K200796), Neuwave Certus 140 2.45 GHz Ablation System and Accessories (K100744)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
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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)
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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 | IEC 60601-1, 60601-2-2, 60601-2-6,
60601-1-2 | Same |
| Potential Equalization | Equalization terminal | Equalization terminal | Equalization terminal | Same |
| Electronic Interfaces for
Interoperability | 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 to
106 kPa | Atmospheric pressure range: 66kPa to
106 kPa | Atmospheric pressure range: 70kPA
to 106kPa | Similar |
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| Microwave Ablation Probe | ||||
|---|---|---|---|---|
| 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 | |||
| Compatible Microwave | ||||
| Ablation Probe | Ximitry Probe Assembly | Microwave ablation antenna with | ||
| Thermosphere™ Technology | Ablation probes include Models | |||
| CertusLN, CertusLK, CertusSR and | ||||
| CertusPR | See below comparison of the | |||
| features | ||||
| Antenna Connections | Single cable bundles integrating power | |||
| cable and coolant tubing (supply and | ||||
| return lines) | Separate power cable and coolant | |||
| tubing (supply and return lines) | Single cable bundles integrating | |||
| power cable and coolant tubing | ||||
| (supply and return lines) | Single cable bundle | |||
| Power Connection | Power cable connects directly to the | |||
| console | Power Cable connects to a reusable | |||
| cable that connects to the console | Power cable connects to a reusable | |||
| Power Distribution Module (PDM) | ||||
| is used between the probe and | ||||
| console | Different set for connection | |||
| Antenna Coolant Delivery | Coolant delivery connection via an | |||
| integrated Cassette | Coolant delivery connection via manual | |||
| connection to external peristaltic pump | Coolant delivery connection via an | |||
| integrated connector | Integrated coolant delivery | |||
| circuit | ||||
| Coolant Connection | Via spike to the coolant bag | Via spike to the coolant bag | Via gas fitting connection to 2 CO2 | |
| gas cylinders | Subject and predicate device | |||
| (K200796) have the same | ||||
| coolant 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 supportsoft |
| tissue ablations | ||||
| Antenna Shaft Diameter | 13.5 G (2.3mm) | 13 G (2.4mm) | 13G, 15G, 17G | Subject device has a thinner |
| shaft profile | ||||
| Right Angle Probe | Yes | Yes | Yes | Same |
| Antenna Shaft | ||||
| Construction | Fiberglass | Fiberglass | Stainless steel | Same |
| Probe Thermocouple | 3 integrated thermocouples at pre- | |||
| defined locations on the shaft and 2 | ||||
| internal temperature sensors within the | ||||
| probe handle | 1 internal temperature sensor with no | |||
| thermocouples on the shaft | 3 integrated thermocouples at pre- | |||
| defined locations on the shaft | Multiple temperature sensors | |||
| Patient Contacting | ||||
| Components | Antenna shaft, tip, adhesive and depth | |||
| guide are biocompatible | Antenna shaft, tip, adhesive and depth | |||
| guide are biocompatible. | Antenna shaft & tip are | |||
| biocompatible. | Same | |||
| Software | No | No | No | Same |
| Device Usage | Single-use, disposable | Single-use, disposable | Single-use, disposable | Same |
| Sterilization | ETO | ETO | ETO | Same |
| Packaging Configuration | ||||
| and Materials | Thermoform tray and retainer lid with a | |||
| single Tyvek sterile barrier lid within a | ||||
| SBS (solid bleached sulfate) shelf carton | ||||
| box sealed with a tamper paper tape. | Thermoform tray and single Tyvek | |||
| sterile barrier lid within a SBS (solid | ||||
| bleached sulfate) shelf carton box | ||||
| sealed with a tamper paper tape. | Thermoform tray and single Tyvek | |||
| sterile barrier lid within a SBS (solid | ||||
| bleached sulfate) shelf carton box | ||||
| sealed 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).