(178 days)
Multi-Point Thermal Sensor (K060390)
No
The summary describes a computer-controlled system for delivering microwave energy for tissue ablation. While it uses a computer and a touch screen interface, there is no mention of AI, ML, or any algorithms that learn or adapt based on data. The control and monitoring appear to be based on pre-programmed parameters and user input.
Yes.
The device is intended for the ablation (coagulation) of soft tissue, which is a therapeutic intervention meant to treat or alleviate a medical condition.
No
The device is intended for ablation (coagulation) of soft tissue, which is a therapeutic intervention, not a diagnostic one. While it uses imaging guidance for placement, it does not diagnose conditions.
No
The device description explicitly states it is comprised of a console, microwave ablation needles, optional thermal sensor, and related accessories, all of which are hardware components. While the console is computer-controlled with a touch screen interface, the system is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the ablation (coagulation) of soft tissue in surgical settings. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device delivers microwave energy to tissue via needles inserted into the body. It is used for thermal tissue ablation.
- Lack of In Vitro Activity: IVD devices are used to examine specimens from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
The HEATfx Microwave Ablation System is a therapeutic device used for surgical intervention, not for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The HEATfx Microwave Ablation System and Accessories are intended for the ablation (coagulation) of soft tissue in percutaneous, open surgical, and laparoscopic surgical settings.
The HEATfx Microwave Ablation System is not intended for use in cardiac procedures.
Product codes (comma separated list FDA assigned to the subject device)
NEY
Device Description
The HEATfx Microwave Ablation System is a mobile system intended to deliver microwave energy for thermal tissue ablation using a minimally invasive procedure. The HEATfx Microwave Ablation System is comprised of a console with optional cart, microwave ablation needles with cooling water manifold, optional thermal sensor, and related accessories.
The HEATfx console is computer-controlled with a touch screen user interface that allows the user to control and monitor the procedure. The HEATfx System utilizes three 2450 MHz, 145W generators to deliver microwave energy to up to three HEATfx Needles.
The HEATfx Microwave Ablation Needles are inserted into the target lesion under ultrasound or CT image guidance during laparoscopic procedures, or using direct visualization during surgical procedures, and operated using the console. The needles incorporate an antenna that transmits the microwave energy uniformly around the needle shaft. When connected to the HEATfx console, the console's internal pump and a disposable water manifold circulate sterile water through the needle for needle cooling and facilitating a uniform ablation zone.
The optional Multi-Point Thermal Sensor allows the user to monitor tissue temperatures near critical structures during an ablation procedure.
The system must be used with an irrigation baq of sterile water (not provided with the system).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound or CT image guidance
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
percutaneous, open surgical, and laparoscopic surgical settings.
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)
A full battery of verification and validation testing was conducted on the HEATfx Microwave Ablation System to ensure that the design, functionality, and performance met all the specified requirements and that the features of the system satisfy its intended use. Testing was conducted according to protocols based on international standards and in-house requirements. The following types of testing were conducted: System Testing, Mechanical Testing, Electrical Testing, Software Testing, Needle Testing, Multi-Point Thermal Sensor Testing, Ex-Vivo Testing, In-Vivo Testing, Biocompatibility Testing, Usability Testing, Packaging Testing, and Sterility Testing, Pyrogenicity Testing.
Test results demonstrated that the HEATfx Microwave Ablation System meets defined specifications, is substantially equivalent to the predicate device, and does not raise any new issues of safety and effectiveness for its intended use.
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 (K133821), Emprint Ablation System (K163105)
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.
Multi-Point Thermal Sensor (K060390)
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 9, 2020
Galil Medical Inc. Amy McKinney Sr. Regulatory Affairs Manager 4364 Round Lake Road Arden Hills, Minnesota 55112
Re: K200061
Trade/Device Name: HEATfx Microwave Ablation System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: NEY Dated: June 2, 2020 Received: June 3, 2020
Dear Amy McKinney:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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 located 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.
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
1
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 (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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.
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices 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) K200061
Device Name HEATfx Microwave Ablation System
Indications for Use (Describe)
The HEATfx Microwave Ablation System and Accessories are intended for the ablation (coagulation) of soft tissue in percutaneous, open surgical, and laparoscopic surgical settings.
The HEATfx Microwave Ablation System is not intended for use in cardiac procedures.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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K200061 510(k) SUMMARY
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.
| Submitter: | Galil Medical Inc.
4364 Round Lake Road
Arden Hills, MN 55112 |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact Person: | Amy McKinney
Sr. Manager, Regulatory Affairs
Galil Medical Inc.
Phone: 651-402-0008
Fax: 651-846-4555
Email: Amy.McKinney@btgplc.com |
| Alternate Contact Person: | Rebeka Stoltman
Director, Regulatory Affairs
Galil Medical Inc.
Phone: 651-287-5020
Fax: 877-510-7757
Email: Rebeka.stoltman@btgplc.com |
| Device Name: | HEATfx Microwave Ablation System |
| Device Classification Name: | System, ablation, microwave and accessories |
| Regulation Number: | 21 CFR 878.4400 |
| Product Code: | NEY |
| Predicate Devices: | Emprint Ablation System (K133821)
Emprint Ablation System (K163105) |
| Reference Devices: | Multi-Point Thermal Sensor (K060390) |
| Date of Preparation: | July 7, 2020 |
Device Description:
The HEATfx Microwave Ablation System is a mobile system intended to deliver microwave energy for thermal tissue ablation using a minimally invasive procedure. The HEATfx Microwave Ablation System is comprised of a console with optional cart, microwave ablation needles with cooling water manifold, optional thermal sensor, and related accessories.
The HEATfx console is computer-controlled with a touch screen user interface that allows the user to control and monitor the procedure. The HEATfx System utilizes three 2450 MHz, 145W generators to deliver microwave energy to up to three HEATfx Needles.
The HEATfx Microwave Ablation Needles are inserted into the target lesion under ultrasound or CT image guidance during laparoscopic procedures, or using direct visualization during surgical procedures, and operated using the console. The needles incorporate an antenna that transmits the microwave energy uniformly around the needle shaft. When connected to the HEATfx console, the console's internal pump and a disposable water manifold circulate sterile water through the needle for needle cooling and facilitating a uniform ablation zone.
The optional Multi-Point Thermal Sensor allows the user to monitor tissue temperatures near critical structures during an ablation procedure.
4
The system must be used with an irrigation baq of sterile water (not provided with the system).
Indications for Use / Intended Use:
The HEATfx Microwave Ablation System is indicated for use in the ablation (coagulation) of soft tissue in percutaneous, open surgical, and laparoscopic surgical settings.
The HEATfx Microwave Ablation System is not intended for use in cardiac procedures.
Technological Characteristics:
The HEATfx Microwave Ablation System operates at 2.45 MHz and can deliver up to 145 W of microwave energy on up to 3 channels. The user has the ability to set desired power and time limits based on the desired ablation zone for the target tissue using the ablation zone model data presented in the Instructions for Use. The table below provides a summary of the technological characteristics of the HEATfx Microwave Ablation System as compared with the predicate device.
Optional accessories available for use with the HEATfx System include a cart and a Multi-Point Thermal Sensor. The HEATfx Needles are packaged with Cable Clips, Cable Adhesives, and an Adjustable Depth Guide, for optional use.
| Feature /
Specification | HEATfx Microwave Ablation
System (K200061) | Emprint Ablation System
(K133821 and K163105) | Comments /
Rationale |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications | The HEATfx Microwave Ablation
System is indicated for use in the
ablation (coagulation) of soft
tissue in percutaneous, open
surgical, and laparoscopic
surgical settings.
The HEATfx Microwave Ablation
System is not intended for use in
cardiac procedures. | The Covidien Emprint Ablation System
is intended for use in percutaneous,
laparoscopic, 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. | Substantially
equivalent; The
HEATfx System
indications are a
subset of the
predicate device
indications. |
| Principles of
Operation | User-controlled microwave
energy delivery to tissue and
needle cooling mechanism | User-controlled microwave energy
delivery to tissue and needle cooling
mechanism | Same as predicate |
| Generator
Frequency | 2.45GHz +/- 50 MHz | 2.45GHz +/- 50 MHz | Same as predicate |
| System Output
Power
Range | Up to 145 Watt per channel | Up to 100 watts | Substantially
equivalent:
The differences were
verified not to be
clinically significant. |
| Console
General
Features | Software controlled generator
with touchscreen interface;
Integrated peristaltic pump for
water cooling;
Automatic pump start/stop;
3 Channels | Generator with analog and digital
circuits; no software or firmware;
Separate peristaltic pump for saline
cooling;
Manual pump start/stop;
1 Channel | Substantially
equivalent;
The difference in
features is directly
related to HEATfx
proprietary software
incorporating
automated controls
and multiple channel
capability. |
| Temperature
Monitoring
Capability | Up to 2 Multi-Point Thermal
Sensors for a total of 8 external
temperature measurements | Single temperature sensor for 1
external temperature measurement | Substantially
equivalent:
The HEATfx System
provides the user with |
5
| Feature /
Specification | HEATfx Microwave Ablation
System (K200061) | Emprint Ablation System
(K133821 and K163105) | Comments /
Rationale |
|--------------------------------|-----------------------------------------------|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | greater flexibility and
procedure
information. |
| Cooling Circuit
and Fluid | Yes; sterile water | Yes; saline | Substantially
equivalent;
The difference in fluid
option between
HEATfx and the
predicate does not
present any adverse
clinical consequences
for the patient. |
| Needle Shaft
Length | 15, 20 cm | 15, 20, 30 cm | Substantially
equivalent;
Galil has elected not
to provide a longer
length needle shaft. |
| Needle Shaft
Outer Diameter | 14 G (2.1 mm) | 13 G (2.4 mm) | Substantially
equivalent;
The diameters of the
needle shafts are
comparable. |
Summary of Performance Data and Substantial Equivalence:
A full battery of verification and validation testing was conducted on the HEATfx Microwave Ablation System to ensure that the design, functionality, and performance met all the specified requirements and that the features of the system satisfy its intended use. Testing was conducted according to protocols based on international standards and in-house requirements. The table below summarizes the verification and validation testing conducted on the HEATfx System.
| Type of Testing | Objective |
|---|---|
| System Testing | Verified functional requirements of the complete system |
| Mechanical Testing | Verified the mechanical robustness of the console, including |
| functional testing of cooling circuit, dimensional verification, | |
| mechanical safety testing, and packaging and labelling testing | |
| Electrical Testing | Verified ability of the system to drive the pump and apply |
| microwave power to the antenna and verified electrical safety | |
| and electromagnetic compatibility and immunity in accordance | |
| with IEC 60601-2-6 and FDA-recognized versions of IEC | |
| 60601-1, IEC 60601-1-2, and IEC 60601-2-2 | |
| Software Testing | Verified functionality of units of software and of the entire |
| software package in accordance with FDA-recognized IEC | |
| 62304 standard and FDA Guidance documents "Guidance for | |
| the Content of Premarket Submissions for Software Contained | |
| in Medical Devices" (2005) and "Content of Premarket | |
| Submissions for Management of Cybersecurity in Medical | |
| Devices" (2014) | |
| Needle Testing | Verified safety and functionality of the HEATfx Needles |
| Multi-Point Thermal | Verified the requirements and functionality of Multi-Point |
6
| Type of Testing | Objective |
|---|---|
| Sensor Testing | Thermal Sensor to monitor ablation temperatures |
| Ex-Vivo Testing | Verified and validated ablation zone dimensions and |
| comparability to the predicate | |
| In-Vivo Testing | Validated the use of the HEATfx system and workflow in an in- |
| vivo model and realistic operating room environment | |
| Biocompatibility Testing | Verified biocompatibility of materials per applicable ISO 10993 |
| standards | |
| Usability Testing | Verified usability of the system in compliance with applicable |
| FDA-recognized versions of AAMI / ANSI / IEC 62366 and | |
| AAMI / ANSI HE75 standards, as well as FDA Guidance | |
| "Applying Human Factors and Usability Engineering to Medical | |
| Devices" (2016) | |
| Packaging Testing | Validated performance and stability of the HEATfx Needle |
| packaging in accordance with FDA-recognized versions of ISO | |
| 11607-1 and ISO 11607-2 standards | |
| Sterility Testing | Validated sterilization parameters to ensure the sterility of the |
| HEATfx Needles in accordance with FDA-recognized versions | |
| of ISO 11737-1, ISO 11737-2, and ISO 11135 standards | |
| Pyrogenicity Testing | Verified that the HEATfx Needles do not produce material- |
| mediated pyrogenicity |
The software/firmware for HEATfx Microwave Ablation System was developed to maintain medical device functionality and safety by considering the cybersecurity framework core functions as outlined in FDA's Guidance document titled "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices." Cybersecurity vulnerabilities were identified, and controls were implemented to mitigate the risks and vulnerabilities. Cybersecurity will continue to be monitored throughout the lifecycle of the HEATfx System.
Test results demonstrated that the HEATfx Microwave Ablation System meets defined specifications, is substantially equivalent to the predicate device, and does not raise any new issues of safety and effectiveness for its intended use.
The HEATfx Microwave Ablation System was shown to be similar in technology, indications for use, materials, and performance as the predicate devices. Differences between the two devices were verified via comparison testing not to be clinically significant. The HEATfx System is substantially equivalent to the Emprint System.
Conclusion:
The information and data provided in this Traditional 510(k) Premarket Notification establish that the HEATfx Microwave Ablation System is substantially equivalent to the legally marketed predicate device with regard to performance, safety, and effectiveness for its intended use.