The NeuWave Medical Certus 140™ 2.45 GHz Ablation System and Accessories are indicated for the ablation (coagulation) of soft tissue in percutaneous, open surgical and in conjunction with laparoscopic surgical settings, including the partial or complete ablation of non-resectable liver tumors.

The Certus 140™ 2.45 GHz 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 clinician.

Device Description

The system has a single 2.45 GHz signal source generator and three (3) independent power amplifiers, each capable of producing up to 140W each. One, easy to use, touch-screen user interface controls the system. The User Interface can be set for either Ablation Mode. An optional footswitch can be connected to the system to control power delivery in Surgical Mode. Up to three (3) energy delivery accessories can be connected to and powered by the system at one time. An intermediate junction box or Power Distribution Module (PDM) reduces system set up complexity.

A variety of sterile, single-patient use energy delivery accessories (ablation probes and surgical tools) are available for use with the Certus 140. All are comprised of a sharp trocar on the end of a cannula, a cable and a connector assembly.

Models Certus", and Certus " ablation probes are available in either 17- gauge cannulas and are available in 15 cm and 20 cm lengths. These probes have a cable length of 1.4m.

Models Certus™ ablation probes are available only in 17-gauge cannulas and are available in 15 cm and 20 cm lengths. These probes have a cable length of 1.4m.

The model Certus® ablation probe has a 13-gauge cannula and is available in a 25 cm length only. Certus® probes have a cable length of 1.4m.

Each energy delivery accessory contains temperature measurement sensors that help monitor performance and ensure patient and operator safety.

The antenna of the Certus °° probe is designed to limit the length of the ablation for instances when a shorter ablation zone is desired. Certus Probes were developed to provide physicians with an additional ablation probe designed specifically for creating smaller ablation zones than the Certus" and Certus" probes. The Certus® probes are designed to produce ablations that encompass the tip of the probe while limiting the overall length of the ablation. Certus °° probes will enable physicians to ablate smaller lesions while limiting necrosis of adjacent tissue when compared to other Certus probes.

The Certus® probes length and gauge size result in a probe for use in laparoscopic applications.

A CO2 based cooling system ensures the non-active portion of the probe does not exceed temperature requirements. Additionally, the CO2 enables the Tissu-Loc function, which can be used to adhere or stick the probe in place prior to starting ablation therapy.

The system uses two (2) E-sized CO2 cylinders. When a tank in use empties, the system will automatically switch to using the other tank and notify the user to replace the empty tank.

An accessory, a small plastic probe clip that can hold two 17-gauge probes and allow the user to easily hold both while performing planar coagulation, is available.

Ablation Confirmation software (K171022) is available as an option on the Certus 140. When this option is supplied, a second monitor is provided with the system which hosts the Ablation Confirmation user interface.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Certus 140 2.45 GHz Ablation System, based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance Table:

It's important to note that the provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a comprehensive clinical trial with specific performance metrics against pre-defined acceptance criteria. The "acceptance criteria" here are inferred from the demonstrated equivalence and the nature of the modifications. The performance is largely shown through the comparison and the conclusion of equivalence.

Acceptance Criteria (Inferred)	Reported Device Performance
Device Safety: Compliance with relevant international standards and biocompatibility.	Compliant: The device complies with IEC60601-1:2005, IEC60601-2-2:2006, IEC60601-2-6:2012, IEC60601-1-2:2014, ENISO 11607-1:2009, and ISO 10993-1:2009. Biocompatibility testing (Cytotoxicity, Sensitization, Irritation) demonstrated the ablation probes are biocompatible. Ethylene Oxide sterilization validated to SAL of 10^-6, with residual EO and ECH levels below FDA recognized limits. 48-month shelf life validated by accelerated aging tests. Potential risks analyzed and satisfactorily mitigated.
Device Effectiveness for Soft Tissue Ablation: Equivalent performance to predicate for general soft tissue ablation.	Equivalent through Substantial Equivalence: Features (probe applications, UI modes, power delivery, accessories, probe dimensions, generator output power, antenna design, power, target ablation time, planar coagulation time) are reported as unchanged or having no impact on safety and effectiveness compared to the predicate (K160936). Nonclinical acute in-vivo (porcine) studies concluded similar technological performance (ablation zone sizes and histological results) compared to the reference predicate (K053290 Cool-Tip™).
Device Effectiveness for Non-Resectable Liver Tumors: Ability to access and effectively ablate non-resectable liver tumors.	Demonstrated by Real-World Evidence (RWE) Meta-analysis and Nonclinical Testing: RWE meta-analysis, encompassing 18 studies and 1,924 patients, consistently showed technique efficacy (complete tumor ablation/complete response) of microwave ablation for liver tumors (HCC or metastasis). Nonclinical acute in-vivo (porcine) studies confirmed the ability of the system and probes to reach target tumors. The meta-analysis supported that the device could reliably access liver tumors in percutaneous and laparoscopic settings.
Software Functionality: Software changes do not impact essential performance or safety.	No Significant Impact: Software version updated from V2.0.X to V3.0.X. Changes were made to address minor anomalies, improve user experience, and support CO2 tank configurations outside the US. These changes are stated to have no impact on energy delivery, temperature measurement, CO2 cooling control, other risk mitigations, or essential performance of US configured units.

Study Details:

Sample Size used for the test set and the data provenance:
- Nonclinical Acute In-Vivo (porcine) Studies: Sample size not explicitly stated in the summary, but it involved animal testing. Data provenance is implied to be internal (conducted by or for NeuWave Medical).
- Real-World Evidence (RWE) Meta-analysis:
  - Sample Size: 1,924 patients across 18 studies.
  - Data Provenance: Retrospective, derived from published peer-reviewed literature. The studies included both randomized controlled trials (RCTs) and observational studies. Specific countries of origin are not detailed beyond "peer-reviewed articles," but such literature typically comes from various international sources.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the nonclinical in-vivo studies, the summary mentions "histological results were analyzed and evaluated." However, the number and qualifications of experts interpreting these results are not specified.
- For the Real-World Evidence Meta-analysis, the "ground truth" was the reported clinical outcome of "technique efficacy (effectiveness) (defined as complete tumor ablation or complete response), measured at one week to three months post ablation" as reported in the individual studies included in the meta-analysis. The meta-analysis itself was conducted by "two independent reviewers" with "adjudication from a third reviewer" for discrepancies in study selection and data extraction. Their qualifications are not explicitly stated, but for a systematic review and meta-analysis, they would typically be researchers or statisticians with expertise in clinical evidence synthesis.
Adjudication method for the test set:
- For the nonclinical in-vivo studies, no specific adjudication method is mentioned.
- For the Real-World Evidence Meta-analysis, "Records were evaluated for eligibility by two independent reviewers and discrepancies were resolved either through consensus, or by adjudication from a third reviewer." This is a standard adjudication method for systematic reviews, often referred to as a "2+1" method for disagreement.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study was done in the context of AI assistance. This device is an ablation system, not an AI-powered diagnostic or assistive tool for human readers. The meta-analysis compared microwave ablation (MWA) to radiofrequency ablation (RFA), not human readers with or without AI.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. The Certus 140 is a medical device for tissue ablation, not a standalone algorithm. Its performance is directly tied to the physical ablation process.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the nonclinical in-vivo studies, the ground truth appears to be histological results and ablation zone sizes, which would be assessed by trained histopathologists and researchers.
- For the Real-World Evidence Meta-analysis, the primary ground truth was clinical outcomes data reported in the included studies, specifically "complete tumor ablation or complete response" as assessed by clinical follow-up imaging. This would typically be based on radiologic assessment (e.g., CT, MRI) often interpreted by radiologists, potentially with expert consensus within those original studies.
The sample size for the training set:
- This information is not explicitly provided in the 510(k) summary. Given that the device is a physical ablation system (not an AI algorithm requiring a training set), this concept of a "training set" in the machine learning sense is not directly relevant for device performance. Training would refer to the development and refinement of the device's design and operating parameters, which would involve various benchtop and animal studies over time, but not a distinct "training set" like in AI.
How the ground truth for the training set was established:
- As with the training set size, this question is not directly applicable to a physical ablation device in the way it is for an AI algorithm. The "ground truth" during device development (analogous to training) would typically involve engineering specifications, safety standards, and performance benchmarks derived from technical knowledge, predicate devices, and early-stage experimental data (benchtop, ex-vivo, in-vivo animal studies).

Summary

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October 24, 2018

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

Re: K173756

Trade/Device Name: Certus 140 2.45GHz 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: September 13, 2018 Received: September 14, 2018

Dear Dan 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. 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/cfpmr/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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 803) for devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 entiled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Jennifer R. Stevenson -S3

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)

K173756

Device Name Certus 140 2.45 GHz Ablation System and Accessories

Indications for Use (Describe)

The Certus 140™ 2.45 GHz 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 clinician.

Type of Use (Select one or both, as applicable)

Description Use (Part 21 CFR 601 Subpart D)	Over-The-Counter Use (21 CFR 300)
---------------------------------------------	-----------------------------------

Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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	K173756
Date:	10/23/2018
Subject:	510(k) Summary of Safety and Effectiveness Information for the NeuWaveMedical Certus 140 2.45 GHz Ablation System and Accessories
Company:	NeuWave Medical, Inc. 3529Anderson StreetMadison, WI 53704
FDA Establishment#	3008769756
Contact:	Dan Kosednar, Director of Regulatory Affairs and Quality Assurance P – 608-512-1592F-608-512-1509
Proprietary:	Certus 140 2.45 GHz 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 Certus 140 2.45 GHz Ablation System and Accessories is substantially equivalent to the following currently marketed device:

. Primary Predicate - 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 K160936.
. Reference Device - Covidien Cool-Tip™ RF Generator System and Accessories, Class II – 21CFR878.4400 which has been subject of a cleared 510(k) with FDA log number K053290.

Indications for Use

The Certus 140™ 2.45 GHz 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 clinician.

Certus 140 Traditional 510(k) 510(k)Summary Page 1 of 9

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Comparison of Intended Use and Indications for Use

	Subject Device, K173756	Predicate Device, K160936
Intended Use	To thermally ablate soft tissue usingmicrowave energy.	To thermally ablate soft tissueusing microwave energy.
Indications for use	The NeuWave Medical Certus 140TM2.45 GHz Ablation System andAccessories are indicated for theablation (coagulation) of soft tissue inpercutaneous, open surgical and inconjunction with laparoscopic surgicalsettings, including the partial orcomplete ablation of non-resectableliver tumors.The Certus 140TM 2.45 GHz AblationSystem is not indicated for use incardiac procedures. The system isdesigned for facility use and shouldonly be used under the orders of aclinician.	The NeuWave Medical Certus140TM 2.45 GHz Ablation Systemand Accessories are indicated forthe ablation (coagulation) of softtissue in percutaneous, opensurgical and in conjunction withlaparoscopic surgical settings.The Certus 140TM 2.45 GHz AblationSystem is not indicated for use incardiac procedures. The system isdesigned for facility use andshould only be used under theorders of a clinician.

The subject and the predicate devices are similar in terms of technological characteristics as microwave devices used to ablate soft tissue. The subject device differs from the predicate device by a modifications for Use as shown in the above table and the associated changes to the technological characteristics otherwise remain the same. To support that the change in indications for use does not change the intended use of the subject device when compared to the predicate device, the sponsor provided nonclinical bench, in-vivo animal testing and Real-World Evidence meta (clinical data from published peer-reviewed literature papers). Results of nonclinical testing and Real-World Evidence demonstrated the subject device has the same intended use as the predicate device.

Device Description

Models Certus", and Certus " ablation probes are available in either 17- gauge cannulas and are available in 15 cm and 20 cm lengths. These probes have a cable length of 1.4m.

Models Certus™ ablation probes are available only in 17-gauge cannulas and are available in 15 cm and 20 cm lengths. These probes have a cable length of 1.4m.

Certus 140 Traditional 510(k) 510(k)Summary Page 2 of 9

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The model Certus® ablation probe has a 13-gauge cannula and is available in a 25 cm length only. Certus® probes have a cable length of 1.4m.

	PercutaneousAblation	LaparoscopicAblation	OpenSurgicalAblation	OpenSurgicalCoagulation
CertusLK	X		X	X
CertusLN	X		X
CertusPR	X		X	X
CertusSR		X	X

Ablation Probe Design Application Overview

Each energy delivery accessory contains temperature measurement sensors that help monitor performance and ensure patient and operator safety.

The Certus® probes length and gauge size result in a probe for use in laparoscopic applications.

The system uses two (2) E-sized CO2 cylinders. When a tank in use empties, the system will automatically switch to using the other tank and notify the user to replace the empty tank.

An accessory, a small plastic probe clip that can hold two 17-gauge probes and allow the user to easily hold both while performing planar coagulation, is available.

Modifications

No significant design changes were made to the Certus 140 to support this 510(k) was submitted to update the Certus 140 indications for use to include the partial or complete ablation of nonresectable livertumors.

Certus 140 Traditional 510(k) 510(k)Summary Page 3 of 9

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NeuWave Medical®

PART OF THE ETHICON™ FAMILY OF COMPANIES

Comparison to Predicate

Feature/Specification	Certus 140 with V3.0.X	Certus 140 with V2.0.X SW (K160396)	Comments/impacton safety and effectiveness
Probe applications	Percutaneous, open surgical and in conjunction with laparoscopic. The CertuSurgGT surgical tool is for open surgical	Percutaneous, open surgical and in conjunction with laparoscopic. The CertuSurgGT surgical tool is for open surgical procedures only.	This 510(k) includes no modifications to the Certus probe applications.
User Interface Modes	Surgical and Ablation	Surgical and Ablation	No changes in this 510(k)
Power Delivery Initiation Method	User Interface or Footswitch (Footswitch available in Surgical Mode only) or Finger- Switch	User Interface or Footswitch (Footswitch available in Surgical Mode only) or Finger-Switch	No changes in this 510(k)
Available Energy Delivery Accessories	CertusLK, CertusLN,CertusSR, CertusPR Probes and CertuSurgGT	CertusLK, CertusLN, CertusSR,CertusPR Probes and CertuSurgGT	No new probe types in this 510(k)
Probe dimensions	CertusLK and CertusPR probes are available in 15 gauge or 17 gauge and available in 15 and 20cm lengths.CertusLN probes are 17 gauge and available in 15 and 20cm lengths.CertusSR probe is 13 gauge and available only in a 25cm length.	CertusLK and CertusPR probes are available in 15 gauge or 17 gauge and available in 15 and 20cm lengths.CertusLN probes are 17 gauge and available in 15 and 20cm lengths.CertusSR probe is 13 gauge and available only in a 25cm length.	No changes in this 510(k)
Software Version	V3.0.X software	V2.0.X software	No significant change to the system SW was made since the previous 510(k) clearance (K160936). Changes made had no
Feature/Specification	Certus 140 with V3.0.X SW	Certus 140 with V2.0.X SW(K160396)	Comments/impactonsafetyandeffectiveness
			impact on energy delivery,temperature measurement, CO2cooling control or other riskmitigations or essentialperformance. All changes weremade to address minoranomalies or make minorimprovements to the userexperience. Additionally, severalchanges were made to supportCO2 tank configurations differentfrom those sold in the US. Thesechanges do not impact thefunction of US configured units.
Generator Output Power	CertusLK, CertusLN andCertusSR Probes are limited to140W for a single probe, 95Wif 2 probes are selected and65W if 3 probes are selected.CertusPR Probes Maximum of65W per probe regardless ofthe number of probes whenused in Ablation Mode. InSurgical Mode, the maximumpower for CertusPR probes is95W if 1 or 2 probes are usedand 65W if 3 probes are used.	CertusLK, CertusLN and CertusSRProbes are limited to 140W fora single probe, 95W if 2 probesare selected and 65W if 3probes are selected.CertusPR Probes Maximum of65W per probe regardless ofthe number of probes whenused in Ablation Mode. InSurgical Mode, the maximumpower for CertusPR probes is95W if 1 or 2 probes are usedand 65W if 3 probes are used.	No changes in this 510(k)
Antenna Design	Triaxial Antenna for CertusLK,CertusLN and CertusSRModified Triaxial Antenna forCertusPR	Triaxial Antenna for CertusLK,CertusLN and CertusSRModified Triaxial Antenna forCertusPR	No changes to the antennadesign in this 510(k).
Feature/Specification	Certus 140 with V3.0.X SW	Certus 140 with V2.0.X SW(K160396)	Comments/impact on safety and effectiveness
Power	20-95 (5 W increments) forCertusPR probes (65W max inAblation Mode)20-140 (5 W increments) forCertusLK, CertusLN andCertusSR probes	20-95 (5 W increments) forCertusPR probes (65W max inAblation Mode)20-140 (5 W increments) forCertusLK, CertusLN and CertusSRprobes	This aspect of probe design hasnot been modified from thepredicate device.
Target Ablation Time	Up to 10 Min as limited bysoftware. User may ablate foradditional time after 10minutes of ablation iscomplete.	Up to 10 Min as limited bysoftware. User may ablate foradditional time after 10minutes of ablation iscomplete.	This aspect of probe design hasnot been modified from thepredicate device.
Planar Coagulation Time	5 seconds - 1 Minute	5 seconds – 1 Minute	This aspect of probe design hasnot been modified from thepredicate device.
Monitored Parameters
Accessories	Dual Probe ClipCT Table Mounting Adapterfor PDMSurgical Table MountingAdapter for PDMFoot switch (Locking USB orStandard USB)	Dual Probe ClipCT Table Mounting Adapter forPDMSurgical Table MountingAdapter for PDMFoot switch (Locking USB orStandard USB)	No changes in this 510(k).

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Sterilization:

Certus 140 Microwave Ablation Probes are provided to customers sterile. The probes are packed in thermoform plastic trays containing a single probe and sealed with a Tyvek lid prior to sterilization. The product is over-packed in an e-flute box to further protect the sterile barrier.

The validated sterilization method for Certus 140 ablation probes is Ethylene Oxide. Device specific methods were developed using the "overkill" approach and validated per ISO 11135:2014. Results demonstrated a Sterility Assurance Level (SAL) of 10-°.

Testing conducted determined the worst case residual Ethylene Oxide (EO) level and the residual Ethylene Chlorohydrin (ECH) level to be below the FDA recognized limits of AAMI/ANSI/ISO 10993-7.

Shelf Life:

Accelerated aging tests were conducted to confirm the validity of the 48-month shelf life.

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Biocompatibility:

The Certus Microwave Ablation Probes are classified as an External Communicating Device, Tissue/bone/dentin patient contact, with a contact duration of (<24) hours. Based on this categorization, per Table A.1 of Annex A of ISO 10993-1, Cytotoxicity, Sensitization, and Irritation tests were performed. The results of all testing demonstrated that the Ablation Probes are biocompatible.

Standards Testing

The Certus 140 2.45 GHz Ablation System and Accessories has been designed to comply with the applicable portions of various International Standards, including:

IEC60601-1:2005
IEC60601-2-2:2006 ●
IEC60601-2-6:2012
IEC60601-1-2:2014
ENISO 11607-1:2009
ISO 10993-1: 2009

The Certus 140 2.45 GHz Ablation System and Accessories and the predicate device are substantially equivalent in design concepts, technologies and materials. The Certus 140 Ablation 2.45 GHz System and Accessories has been verified through testing that supports the compliance of Certus 140 2.45 GHz Ablation System and Accessories to the standards listed above.

Performance Data

Nonclinical Testing

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.

Nonclinical acute in-vivo (porcine)studies were conducted to compare the technological performance of the Certus 140 2.45 GHz Ablation System and Accessories to the reference device (K053290 Cool-Tip™). Ablation zone sizes and histological results were analyzed and evaluated.

Real World Evidence (RWE) Meta-analysis

The RWE was used to supplement the nonclinical performance testing (e.g., animal study) to conclude that the subject device can access and ablate liver tumors in open surgical, percutaneous and laparoscopic settings.

A review of peer-reviewed articles involving the use of the Certus 140 2.45 GHz Ablation System demonstrate microwave ablation technique efficacy (effectiveness) of the ablation of nonresectable liver tumors.

A systematic review of literature and meta-analysis was conducted to compare the technique efficacy (effectiveness) of microwave ablation to radiofrequency ablation for the treatment of liver tumors. This meta-analysis included both randomized and observational studies. Technique efficacy

Certus 140 Traditional 510(k) 510(k)Summary Page 7 of 9

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(effectiveness) is demonstrated by clinical follow up during which imaging is performed to ascertain complete ablation of tumor including an ablative margin. Technique efficacy (effectiveness) was used to confirm that the subject devices could reliably access liver tumors in percutaneous and laparoscopic settings.

Search Strategy:

The search strategy used three databases which are well-recognized as publication sources for systematic literature reviews. A systematic search of MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials (CENTRAL) was conducted for relevant systematic reviews, randomized controlled trials (RCTs), and observational studies (prospective cohort and casecontrol studies) using a search that involved controlled vocabulary and keywords related to our research question (e.g., "Liver Neoplasms", "Microwave", "Ablation Techniques").

Study Selection:

Specific inclusion criteria were defined according to PICOS (i.e., population, intervention, comparator, outcomes, and study design). Studies were considered for inclusion in the meta-analysis if they were RCTs or observational studies comparing MWA with RFA in adults (≥18 years) with confirmed HCC or liver metastasis who either refused or were ineligible for surgery. Records were evaluated for eligibility by two independent reviewers and discrepancies were resolved either through consensus, or by adjudication from a third reviewer.

Data Extraction:

The sponsor indicates that the baseline characteristics and outcomes from the included studies were extracted using a standardized data extraction form developed in Microsoft Excel. The following study details were retrieved: study authors, publication year, study design, country of origin, sample size, key patient characteristics (e.g., age, diagnosis, average tumor size, average number of ablated tumors, and duration of follow-up, etc.), intervention and comparator details [e.g., microwave system, frequency, utilization of trans arterial chemoembolization (TACE), etc.], and detailed outcomes data. If studies did not report the number at risk at each time point, the denominator for number treated was assumed to be the initial sample size. Data were extracted by one reviewer and then cross-checked for accuracy and completeness by a second reviewer.

Study Outcomes

The outcome of interest was technique efficacy (effectiveness) (defined as complete tumor ablation or complete response), measured at one week to three months post ablation.

Risk of Bias Assessment

Risk of bias assessment is acceptable because well-recognized risk of bias methodologies was used. The quality of studies included in the meta-analysis was assessed using the Cochrane Risk of Bias (RCTs and the Newcastle=Ottawa quality assessment Scale (NOS) for observational studies.

Data Synthesis and Statistical Methods

The DerSimonian–Laird random-effects model was used for the meta-analysis and a forest plot was generated. The relative risk (RR) and the corresponding 95% Cl were calculated. All analyses were conducted for RCTs alone, observational studies alone, and the combination of RCTs and observational studies.

Certus 140 Traditional 510(k) 510(k)Summary Page 8 of 9

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An 12 value was generated to describe the percentage of variance attributable to heterogeneity among studies. Regardless of the observed statistical heterogeneity, the following sub-group analyses were conducted if there were at least two studies informing each subgroup : 1) tumor size (<2.5 versus >2.5 cm); 2) type of liver tumor (HCC versus metastasis); 3) impact of adding another treatment to both arms (MWA and RFA versus MWA+TACE and RFA+TACE); 4) MWA frequency (915 versus 2450 MHz); and 5) microwave ablation system (NeuWave versus non-NeuWave). Additionally, several sensitivity analyses were performed to assess the impact of alternative methods (i.e., fixed effects model) and study quality (i.e., exclusion of lower quality studies, defined as any RCT with high risk for any domain of the RoB tool or any observational study with ≤7 stars on the NOS). Publication bias was examined using funnel plots. Data were analyzed using STATA (Version 15.1, Texas, USA)

Results

A total of 1,379 citations were identified from database searching. After screening, eighteen studies consisting of a total of 1,924 patients were included in the meta-analysis. Fifteen studies used a percutaneous approach for ablation and three studies used a laparoscopic approach. A PRISM Flow Diagram to visualize the RWE evaluation procedure (i.e., Identification, Screening, Eligibility, and Included Studies) was utilized.

The nonclinical data and Real-World Evidence demonstrate that Certus 140 microwave ablation system and probes can reach target tumors in the liver using the open, percutaneous and laparoscopic tissue access methods.

Conclusion

The subject device differs from the predicate device by modifications for Use and the associated changes to the labeling. The change in the indications for use does not result into a new intended use, and, hence, the intended use is substantially equivalent to the intended use of the predicate device as demonstrated by nonclinical bench, in-vivo animal testing and Real-World Evidence meta-analysis. There are minor differences in technological characteristics, but they do not impact the essential performance of the subject device system and accessories. Hence, the subject device is substantially equivalent to the predicate device.

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.