The design of the NEUWAVE Flex Microwave Ablation System (FLEX) is an evolution of the design of the legally marketed Certus 140 2.45GHz Ablation System (K160936). The FLEX is a fully featured soft tissue ablation system that uses small diameter flexible ablation probes, a single microwave source operating at 2.45 GHz, a CO2-based cooling system, a Power Distribution Module (PDM), and a support arm designed to hold the PDM in a user-selected position. Microwave energy is applied to the target tissue via a single flexible ablation probe, heating the tissue to the point of necrosis.

The FLEX is designed to be used in Target Ablation involves placing a probe into a substantial target and then ablating for up to several minutes until the target tissue is necrotic. The FLEX is designed for ablations in soft tissue in percutaneous (via an introducer) procedures, open surgical procedures, and procedures in which the target tissue is accessed via a lumen or scope such as an endoscope or laparoscopic port.

Two microwave ablation probes are available for use with the NEUWAVE Flex Microwave Ablation System: the FLEX4 and the FLEX6. They are comprised of a conical tip on the end of a flexible cable and a connector assembly. The probe with the sharper tip (FLEX6) is designed for easier tissue penetration while the probe with the less sharp (FLEX4) tip designed for improved navigation. Both FLEX probe models are French gauge 6 (outer diameter of less than 2 mm) and 150 cm long. Both probe models have the same antenna design and ablation performance characteristics.

Each probe contains three (3) temperature measurement sensors that help monitor performance and ensure patient and operator safety.

The FLEX probe antenna was designed to produce an ablation zone substantially equivalent to the predicate Certus® probe but within a flexible probe shaft. Like the predicate Certus® probe, the FLEX probes are designed to produce ablations that encompass the tip of the probe while limiting the overall length of the ablation. Testing in ex-vivo liver, lung and kidney tissue confirm that the FLEX probes produce ablations that are substantially equivalent to the predicate probes.

A PDM and Accessories Support Arm (The Arm) holds the PDM in a user-selected position. The Arm attaches to an imaging/procedure table via a rail mount. This allows the PDM and probe to move with the patient, greatly reducing the potential for patient injury due to accidental probe movement.

The Arm is comprised of three jointed lengths with two tension knobs that allow the user to maneuver and fix the Arm at the user-selected position. The PDM mount on the ARM has a dovetail design with magnetic retention for quick and easy mounting. Additionally, the Arm has a grasping mechanism that can be used to hold a scope such as an endoscope (if used) in a fixed position for an extended period of time.

A CO2 based cooling system ensures the non-active portion of the probe does not exceed temperature requirements.

The system uses two (2) customer supplied E-sized CO2 cylinders. The system monitors the pressure of the tanks and heats the tanks to maintain the desired tank pressure. The FLEX System will select which cylinder to initially use based upon tank pressures.

AI/ML Overview

The provided document is a 510(k) summary for the NEUWAVE Flex Microwave Ablation System and Accessories. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of an AI or algorithmic device. Therefore, many of the requested criteria (e.g., sample size for test set, number of experts for ground truth, MRMC study, sample size for training set, ground truth for training set) are not applicable or cannot be extracted directly from this document.

However, the document does contain information about performance data and acceptance criteria related to its electrosurgical function.

Here's an attempt to answer the questions based on the available information:

1. A table of acceptance criteria and the reported device performance

The document mentions that "The system passed all pre-determined acceptance criteria identified in the test plan." and "Ex-vivo ablation sizes for the FLEX system were deemed to be substantially equivalent to the predicate devices."
While specific numerical acceptance criteria for ablation size are not explicitly stated in a table, the performance is reported in relation to the predicate device.

Acceptance Criterion (Implied)	Reported Device Performance
Compliance with standards (e.g., IEC 60601-1, IEC 60601-2-2)	"The system passed all pre-determined acceptance criteria identified in the test plan." and "The NEUWAVE Flex Microwave Ablation System and Accessories has been designed to comply with the applicable portions of various International Standards..."
Ablation zone substantial equivalence to predicate device	"Testing in ex-vivo liver, lung and kidney tissue confirm that the FLEX probes produce ablations that are substantially equivalent to the predicate probes." "Ex-vivo ablation sizes for the FLEX system were deemed to be substantially equivalent to the predicate devices."
Non-active probe temperature (via CO2 cooling system)	"A CO2 based cooling system ensures the non-active portion of the probe does not exceed temperature requirements."
Monitoring and alarm functionality	"The following parameters are monitored and will cause the FLEX system to stop delivering power if values are unacceptable: Gas Coolant Level, Generator Temperature, Probe Temperature, Reflected Power Level, Probe Communication, Probe Authentication." (This implies these monitored parameters must remain within acceptable limits during operation).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: The document mentions "Testing in ex-vivo liver, lung and kidney tissue" but does not specify the number of samples (e.g., how many livers, lungs, or kidneys were tested, or how many ablation procedures were performed on them).
Data Provenance: The data is "ex-vivo" (meaning outside a living organism, likely in a lab setting) and was conducted for comparison to predicate devices and for data to be included in the Instructions for Use. The country of origin is not specified but the company is US-based (Madison, Wisconsin). The testing described is prospective in the sense that it was specifically conducted for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a medical device for tissue ablation, not an AI/algorithmic device for diagnosis or image interpretation. The "ground truth" here relates to physical parameters and performance (e.g., ablation size, temperature, power output) which are measured directly, not established by expert consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not an AI/algorithmic device involving subjective interpretation or expert consensus. Performance is measured against engineering specifications and comparison to a predicate device.

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

Not applicable. This is a medical device for tissue ablation, not an AI/algorithmic device requiring human reader studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm. Its "standalone" performance would be its ability to ablate tissue according to specifications, which was tested ex-vivo.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance would be:

Direct physical measurements (e.g., ablation zone dimensions, temperature readings, power output).
Compliance with pre-determined engineering and safety specifications.
Substantial equivalence to the performance characteristics of the legally marketed predicate device.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/machine learning device that requires a training set.

Summary

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

March 9, 2017

NeuWave Medical, Inc. Mr. Dan Kosednar Director of Regulatory Affairs 3529 Anderson Street Madison, Wisconsin 53704

Re: K163118

Trade/Device Name: NEUWAVE Flex Microwave Ablation System and Accessories 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, 2017 Received: February 21, 2017

Dear Mr. Kosednar:

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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,

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) K163118

Device Name

NEUWAVE Flex Microwave Ablation System and Accessories

Indications for Use (Describe)

The NEUWAVE™ Flex Microwave Ablation System and Accessories are indicated for the ablation (coagulation) of soft tissue.

The NEUWAVE™ Flex Microwave Ablation System is not indicated for use in cardiac procedures.

The system is designed for facility use and should only be used under the orders of a physician.

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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Date:	03/06/2017
Subject:	510(k) Summary of Safety and Effectiveness Information for theNEUWAVE Flex Microwave Ablation System and Accessories
Company:	NeuWave Medical, Inc.3529 Anderson StreetMadison, WI 53704
FDA Establishment#	3008769756
Contact:	Dan Kosednar, Director of Regulatory AffairsP - 608-512-1592F - 608-512-1509
Proprietary:	NEUWAVE Flex Microwave Ablation System and Accessories
Common:	System, Ablation, Microwave and Accessories
Classification:	Surgical Devices, 73 NEY, 21 CFR 878.4440

The 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 1992.

Predicate Devices

The NEUWAVE Flex Microwave Ablation System and Accessories is substantially equivalent to the following currently marketed device:

. Certus 140 2.45 GHz Ablation System and Accessories – Class II – 21CFG878.4400 which has been the subject of a cleared 510(k) with the FDA log number K100744, K113237, K122217, K130399 and K160936.

Indications For Use

The NEUWAVE™ Flex Microwave Ablation System and Accessories are indicated for the ablation (coagulation) of soft tissue.

The NEUWAVE™ Flex Microwave Ablation System is not indicated for use in cardiac procedures.

The system is designed for facility use and should only be used under the orders of a physician.

Device Description

The FLEX is designed to be used in Target Ablation involves placing a probe into a substantial target and then ablating for up to several minutes until the target tissue is necrotic. The FLEX

FLEX 510(k) Submission Safety Summary Page 1 of 6

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is designed for ablations in soft tissue in percutaneous (via an introducer) procedures, open surgical procedures, and procedures in which the target tissue is accessed via a lumen or scope such as an endoscope or laparoscopic port.

Each probe contains three (3) temperature measurement sensors that help monitor performance and ensure patient and operator safety.

A CO2 based cooling system ensures the non-active portion of the probe does not exceed temperature requirements.

Comparison to Predicate

The FLEX Microwave Ablation System is an evolution of the predicate Certus 140 2.45GHz Ablation System and Accessories. Below is a tabular comparison of the similarities and differences:

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K163118

Feature/Specification	NEUWAVE Flex MicrowaveAblation System	Predicate Certus 140 AblationSystem and Accessories (K160936)	Comments/impact onsafety andeffectiveness
Indication for Use	The NEUWAVE Flex MicrowaveAblation System and Accessoriesis indicated for the ablation(coagulation) of soft tissue.The NEUWAVE Flex is notindicated for use in cardiacprocedures.	The NeuWave Medical Certus 140™2.45 GHz Ablation System andAccessories are indicated for theablation (coagulation) of soft tissue inpercutaneous, open surgical and inconjunction with laparoscopic surgicalsettings.The Certus 140 is not indicated for usein cardiac procedures.	The FLEX indications foruse are a subset of thepredicate indications.
Energy Source	2.45 GHz Frequency ModulatedSource Microwave	2.45 GHz Frequency Modulated SourceMicrowave	No change frompredicate
Power DistributionModule (PDM)	PDM mounts to the PDM andAccessories Support Arm andallows for the connection of asingle (1) FLEX ablation probe.	PDM mounts to the imaging table railand allows for the connection of up tothree (3) ablation probes	The PDM concept andconstruct is similar tothe predicate. However,the FLEX system onlysupports the use of asingle ablation probe ata time.
Probe applications	The FLEX ablation probes can beused in multiple applications,including percutaneous (via anintroducer), open surgical andprocedures in which the targettissue is accessed via a lumen orscope such as an endoscope orcoaxial introducer.	Percutaneous, open surgical and inconjunction with laparoscopic.	The nature of theflexible probe enablesthe FLEX system to beused in additionalapplications in which thetarget tissue is accessedvia a lumen or scopesuch as an endoscope orcoaxial introducer.
Probe dimensions	French 6 diameter and 150cm inlength.	CertusLK, CertusLN and CertusPR probesare 17 gauge and available in 15 and20cm lengths.CertusSR probe is 13 gauge andavailable only in a 25cm length.CertuSurgGT has a 17 gauge cannulaand is only available in one length.	The FLEX system uses aflexible ablation probeinstead of the metalcannula-basedpercutaneous probes ofthe predicate.
Feature/Specification	NEUWAVE Flex MicrowaveAblation System	Predicate Certus 140 AblationSystem and Accessories (K160936)	Comments/impact onsafety andeffectiveness	K163118
Generator OutputPower	The FLEX system allows an outputof 40W – 100W. The user controlsthe power setting on the userinterface and can adjust in 5Watts increments.	CertusLK, CertusLN and CertusSR Probesare limited to 140W for a single probe,95W if 2 probes are selected and 65Wif 3 probes are selected.CertusPR Probes Maximum of 65W perprobe regardless of the number ofprobes when used in Ablation Mode.In Surgical Mode, the maximum powerfor CertusPR probes is 95W if one ortwo probes are used and 65W if threeprobes are used.	The power levelsavailable on the FLEX area subset of the powerlevels on the predicate.
		For the CertuSurgGT, the maximumpower is 110W for a single probe, 95Wif two probes are used and 65W if 3probes are used.
Antenna Design	Coaxial Antenna Flex probe	Triaxial Antenna for CertusLK, CertusLNand Certus SRModified Triaxial Antenna for CertusPRand CertuSurgGT	The FLEX probe antennawas designed to producean ablation zonesubstantially equivalentto the predicate CertusPRprobe but within aflexible probe shaft.Testing in ex-vivo liver,lung and kidney tissueconfirm that the FLEXprobes produceablations that aresubstantially equivalentto the predicate probes.
Cooling Mechanism	CO2 cooling using the Joule-Thompson effect of high pressureCO2 gas	CO2 cooling using the Joule-Thompsoneffect of high pressure CO2 gas	The same CO2 coolingmethod is employed tokeep the non-activeportions of the probe atacceptabletemperatures.
Tissu-Loc Feature	No Tissu-Loc feature	Tissu-Loc feature	The predicate employs aTissu-Loc feature toadhere the probe totissue prior to deliveringmicrowave energy. Thisfeature is not availableon the FLEX system.
Feature/Specification	NEUWAVE Flex MicrowaveAblation System	Predicate Certus 140 AblationSystem and Accessories (K160936)	Comments/impact onsafety andeffectiveness
Sterilization/Packaging
Probe Sterilization Method	Ethylene Oxide	Ethylene Oxide	This aspect ofsystem/probe design hasnot been modified fromthe predicate device.
Probe Packaging	Thermoformed plastic tray withTyvek Lid, with E-flute outer box.	Thermoformed plastic tray with TyvekLid, with E-flute outer box.	The packaging used onthe FLEX probes uses thesame tray and lid as thepredicate.
MonitoredParameters
Elapsed TimeProbe TemperatureCoolant LevelPower in WattsCoolant Pressure	Yes	Yes	This aspect ofsystem/probe design hasnot been modified fromthe predicate device.
Alarms	The following parameters aremonitored and will cause the FLEXsystem to stop delivering power ifvalues are unacceptable:Gas Coolant LevelGenerator TemperatureProbe TemperatureReflected Power LevelProbe CommunicationProbe Authentication	The following parameters aremonitored and will cause the Certus140 to stop delivering power if valuesare unacceptable:Gas Coolant LevelGenerator TemperatureProbe TemperatureReflected Power LevelProbe CommunicationProbe Authentication	This aspect ofsystem/probe design hasnot been modified fromthe predicate device.

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K163118

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K163118

Performance Data

The NEUWAVE Flex Microwave Ablation System and Accessories has been designed to comply with the applicable portions of various International Standards, including:

IEC 60601-1:2005 + CORR 1:2006, CORR 2:2007 + Amendment 1:2012 ●
IEC 60601-2-2:2009
IEC 60601-2-6:2012
. IEC 60601-1-2:2007/AC:2010
EN ISO 11607-1:2009
ISO 10993-1: 2009

The NEUWAVE Flex Microwave Ablation System and Accessories and the predicate devices are substantially equivalent in design concepts, technologies and materials. The NEUWAVE Flex Microwave Ablation System and Accessories has been verified through rigorous testing that, in part, supports the compliance of NEUWAVE Flex Microwave Ablation System and Accessories to the standards listed above.

The system passed all pre-determined acceptance criteria identified in the test plan. Ex-vivo testing in bovine liver and lung and porcine kidney was conducted to produce data for the Instructions for Use and to compare to the predicate devices. Ex-vivo ablation sizes for the FLEX system were deemed to be substantially equivalent to the predicate devices.

FLEX 510(k) Submission Safety Summary Page 5 of 6

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Verification and validation testing were completed in accordance with the company's Design Control process in compliance with 21 CFR Part 820.30, which included testing that fulfills the requirements of FDA "Guidance on Software Contained in Medical Devices". Potential risks were analyzed and satisfactorily mitigated in the device design.

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.