The MicroThermX Microwave Ablation System (MTX) delivers microwave energy for coagulation (ablation) of soft tissue. The system is not intended for use in cardiac procedures. The SynchroWave antennas may be used in open surgical procedures and in laparoscopic and percutaneous ablation procedures, using image guidance, including partial or complete ablation of non-resectable liver tumors. An optional Temperature sensor may be used to monitor tissue temperatures.

Device Description

The MicroThermX® Microwave Ablation System (MTX) delivers 915 MHz microwave energy for coagulation (ablation) of soft tissue. The procedure time and power parameters are operator selected via a touchscreen monitor. The system consists of a generator and pump attached to a mobile cart or tabletop stand, sterile disposable SynchroWave antennas with cooling circuit, and optional disposable TempSure temperature sensors. The closed cooling circuit consists of a bag of sterile isotonic saline (not supplied by Perseon), disposable, single-use cooling circuit tubing and connectors; and fluid pathway channels within each single-use antenna. A reusable pump circulates isotonic saline through the cooling circuit.

AI/ML Overview

The provided text from the 510(k) submission for the MicroThermX Microwave Ablation System mainly focuses on regulatory compliance and substantial equivalence to a predicate device. It describes general performance testing against various IEC and ISO standards and internal requirements, but does not detail specific acceptance criteria for a clinical study comparing device performance to a predefined benchmark. The "Performance Testing" section primarily lists standards and does not offer explicit performance metrics or acceptance thresholds in the way a clinical study would for a specific diagnostic outcome (e.g., sensitivity, specificity).

However, it does mention a retrospective clinical study and animal study that supports the device's ability to treat non-resectable liver tumors.

Based on the provided document, here's what can be extracted and what information is missing regarding acceptance criteria and a study to prove they are met:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific acceptance criteria (e.g., target ablation size, success rate, sensitivity/specificity) from a clinical performance perspective in a measurable table format with clear thresholds.

It lists internal safety and performance requirements that were tested, but these are general categories rather than specific, quantifiable acceptance criteria.

Acceptance Criteria (Not explicitly quantified in text)	Reported Device Performance (Implied from studies)
Software control of delivered power	Conformance with internal requirements
Alerts and Shut-offs	Conformance with internal requirements
Temperature of applied parts	Conformance with internal requirements
Cooling circuit function	Conformance with internal requirements
Ablation zone sizes	Able to provide repeatable ablation zone geometries (based on non-perfused animal tissue studies); Confirmed in porcine study and retrospective human study.
Accuracy of temperature measurement by TempSure Temperature Sensors	Conformance with internal requirements
Usability	Conformance with internal requirements
Ablation of non-resectable liver tumors	"The data demonstrated that the MTX System can be used to treat non-resectable liver tumors."
Ability to perform ablations in liver and lung	Demonstrated in porcine study (18 ablations in liver, 22 in lung)
Performance as well as predicate systems	"the subject devices can be expected to perform at least as well as the predicate systems and are substantially equivalent."

2. Sample Size Used for the Test Set and Data Provenance

Test Set (Clinical Study):
- Sample Size: 51 lesions in 31 patients.
- Data Provenance: Retrospective clinical study. The country of origin is not specified.
Test Set (Animal Study):
- Sample Size: 18 ablations in liver and 22 ablations in lung.
- Data Provenance: Porcine study. No country of origin is specified.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document. The document refers to a "retrospective clinical study" but does not detail how the success or outcome of the ablations in this study was adjudicated or by whom.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improve with AI vs without AI Assistance

This document is for a microwave ablation system, which is a therapeutic device, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not applicable and was not performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable as the device is a medical instrument for direct therapeutic intervention, not an algorithm.

7. The Type of Ground Truth Used

For the clinical study on non-resectable liver tumors, the ground truth regarding the "ability to treat" these tumors is implied by the clinical outcome observations. The specific method for establishing this ground truth (e.g., biopsy for complete necrosis, follow-up imaging showing absence of viable tumor, etc.) is not explicitly stated.

For the animal study, the ground truth for "ablation zone sizes" and "performing ablations in liver and lung" likely referred to direct pathological examination of the ablated tissue ex-vivo, but this is also not explicitly stated.

8. The Sample Size for the Training Set

The document describes performance testing for a physical device, not a machine learning algorithm. Therefore, the concept of a "training set" in the context of AI/ML is not applicable. The device has undergone various engineering and pre-clinical tests but not "training" in the AI sense.

9. How the Ground Truth for the Training Set Was Established

As the concept of a "training set" for an AI/ML algorithm is not applicable here, this point is also not relevant.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 31, 2015

Perseon Coporation Dixie Toolson Sells VP Regulatory Affairs 2188 West 2200 South Salt lake City, UT 84119

Re: K141785

Trade/Device Name: MicroThermX (MTX) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: NEY Dated: February 17, 2015 Received: February 19, 2015

Dear Ms. Dixie Toolson Sells:

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. 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 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); good manufacturing practice requirements as set

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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Jennifer R. Stevenson -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K141785

Device Name

MicroThermX Microwave Ablation System

Indications for Use (Describe)

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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510(k) SUMMARY

SPONSOR

Perseon Corporation 2188 W 2200 S Salt Lake Citv UT 84119

CONTACT/ SUBMITTED BY

Dixie Toolson Sells, V.P., Regulatory Affairs Perseon Corporation 2188 West 2200 South Salt Lake City UT 84119 801 972 5555 (p) Ext 215 / 801 072 5930 (f) dsells@perseonmedical.com

DATE PREPARED

March 24, 2015

TRADE OR PROPRIETARY NAME

MicroThermX® Microwave Ablation System (MTX)

CLASSIFICATION/ NAME

Class II, (21CFR §878.4400), Electrosurgical cutting and coagulation device and accessories Product Code- NEY

PREDICATE DEVICES

MicroThermX Microwave Ablation System (MTX-180) (K100786).

Valleylab (Covidien) Microwave Ablation Generator (K072687). (System also referred to as Vivant Medical VivaWave Microwave System - K053535) Valleylab (Covidien) VivaRing Microwave Ablation Probe (K040279.)

DEVICE DESCRIPTION

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The closed cooling circuit consists of a bag of sterile isotonic saline (not supplied by Perseon), disposable, single-use cooling circuit tubing and connectors; and fluid pathway channels within each single-use antenna. A reusable pump circulates isotonic saline through the cooling circuit.

The MTX is designed to:

Provide repeatable ablation zone geometries for a given set of ablation parameters (based on studies conducted on non-perfused animal tissue).
· Be used in intraoperative procedures and in minimally-invasive laparoscopic or percutaneous procedures, using image guidance.
Utilize a single SynchroWave antenna or synchronous wave alignment operation of 2 or 3 SynchroWave antennas during a single procedure to induce larger zones of ablation.
Utilize an optional TempSure sensor to monitor the temperature of non-target tissue.

INTENDED USE

The MTX delivers microwave energy for coagulation (ablation) of soft tissue. The system is not intended for use in cardiac procedures. The SynchroWave antennas may be used in open surgical procedures and in laparoscopic and percutaneous ablation procedures, using image quidance, including partial or complete ablation of non-resectable liver tumors. An optional TempSure temperature sensor may be used to monitor tissue temperatures.

TECHNOLOGICAL COMPARISON

The MTX device with an expanded indication for use in laparoscopic procedures and for ablation of non-resected liver tumors has the same intended use and employs the same technology as the currently marketed MTX-180 devices. The expanded indication for use in laparoscopic procedures and for ablation of nonresected liver tumors are cleared indications for use of the Valleylab Microwave Ablation System.

PERFORMANCE TESTING

The design of the new MTX device is identical to that of the already cleared MTX-180 predicate device. However, additional testing was conducted to show compliance to FDA's new requirements established as part of Premarket Notification [510(k)] Submissions for Electrosurgical Devices for General Surgery - Draft Guidance for Industry and Food and Drug Administration Staff, issued on March 24, 2014. The MTX has been shown to meet the applicable portions of the following standards and guidance documents and in-house requirements.

IEC 60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007) IEC 60601-2-6:2012, . EN 60601-1:2006, Medical Electrical Equipment - Part 1: General Requirements For Basic Safety & Essential Performance,

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. IEC 60601-2-2 (ed. 5) 2009, Medical electrical equipment – Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
IEC 60601-2-6:2012, (ed. 2.0) Medical electrical equipment Part 2-6: Particular . requirements for the basic safety of microwave therapy equipment
IEC 60601-1-2 Medical Device (ed.3) (2007), EN 55011 Emissions Class A (2007), EN 61000-3-2 AC Current Harmonic Emissions (2006)A1(2009)A2(2009), EN 61000-3-3 Voltage Fluctuations Emissions (2008) Medical Electrical Equipment Part 1-2: General Requirements for Safety -Collateral Standard: Electromagnetic Compatibility - Requirements and Tests. (Includes compliance to CISPR 11 ed. 5.0 (2009), Limits and Methods of Measurement of Electromagnetic Disturbance Characteristics of Industrial, Scientific, and Medical (ISM) Radiofrequency Equipment.)
ISO 594-1:1986, Conical fittings with a 6% (Luer) taper for syringes, needles and ● certain other medical equipment - Part 1: General requirements.
ISO 594-2:1998, Conical fittings with 6% (Luer) taper for syringes, needles and . certain other medical equipment - Part 2: Lock fittings.
IEC 60601-2-18 Ed. 3.0 b:2009. Clause 201.11.101.2(c) Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
Premarket Notification [510(k)] Submissions for Electrosurgical Devices for ● General Surgery - Draft Guidance for Industry and Food and Drug Administration Staff, issued on March 24, 2014
Internal safety and performance requirements for: .
- o Software control of delivered power
- Alerts and Shut-offs o
- Temperature of applied parts O
- Cooling circuit function O
- Ablation zone sizes о
- Accuracy of temperature measurement by TempSure Temperature Sensors O
- o Usability

The results of all testing performed demonstrates conformance with applicable, external standards or internal requirements and/ or equivalence with the predicate device.

BIOCOMPATIBILITY ASSESSMENT

Patient-contacting materials used in the new MTX and currently marketed MTX-180 systems are identical, as are the processes used in their manufacture. The MTX has been shown to meet the applicable portions of the following biological safety standards, as modified by FDA Memo G95-1.

ISO 10993-1: 2009. Biological Evaluation of Medical Devices Part 1: . Evaluation and Testing within a Risk Management Process.

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ISO 10993-7: 2008, Biological Evaluation of Medical Devices Part 7: Ethylene . Oxide Sterilization Residuals

STERILIZATION METHOD

The new MTX and currently marketed MTX-180 systems are sterilized using identical validated 100% EO sterilization cycle parameters. The MTX Antenna Kits with Cooling Circuits and Temperature Sensor Kits are sterilized by 100% Ethylene Oxide (EO). The MTX has been shown to meet the applicable portions of the following standard.

ANSI/AAMI/ISO 11135-1:2007, Sterilization of health care products Ethylene . oxide – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.

ANIMAL AND CLINICAL TESTING

A retrospective clinical study provided data collected from the ablation of 51 lesions in 31 patients using the MTX System. The data demonstrated that the MTX System can be used to treat non-resectable liver tumors and confirmed the results of a porcine study in which the MTX was used to perform 18 ablations in liver and 22 ablations in lung. The results from this testing support a substantial equivalence decision.

SUMMARY OF SUBSTANTIAL EQUIVALENCE

The design characteristics of the subject devices do not raise any new types of questions of safety or effectiveness. From the evidence submitted in this 510(k). the subject devices can be expected to perform at least as well as the predicate systems and are substantially equivalent.

Regulation Number and Section

§ 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.