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.

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 or Surgical 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 handle, 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. Certus56 probes have a cable length of 1.4m.

Certusurged surgical tool is hand-held and has a 6cm, 17 gauge cannula designed specifically for surgical coagulation (including Planar Coagulation) in open surgical settings. This device has a finger-activated power delivery mechanism and a cable length of 2.9m.

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

Additionally, the different percutaneous ablation probes have been designed to optimize the energy transfer efficiency from the probe into different types of tissue based on known electrical properties of each tissue.

Certus™ probes are designed to perform optimally, in terms of efficiently transferring energy into tissue, in liver and kidney tissue. Certus™ probes are designed to perform optimally, in terms of efficiently transferring energy into tissue, in lung tissue.

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 ablating smaller lesions. The Certus® probes are designed to produce ablations that quickly 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 sturdy probe ideal for use in laparoscopic applications.

The CertuSurg67 surgical tool is designed to produce focal, rapid coagulation of soft tissue in open surgical applications, including planar coagulation performed prior to tissue resection.

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. This function is similar in use to the stick function available on cryogenic ablation systems. The CertuSurg®T surgical tool does not have the Tissu-Loc function.

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 (K150313) 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

The provided text describes a medical device, the NeuWave Medical Certus 140 2.45 GHz Ablation System, and its accessories. It details its indications for use, device description, modifications, and performance data from a 510(k) summary. However, it does not contain explicit "acceptance criteria" or a "study that proves the device meets the acceptance criteria" in the format typically requested for AI/ML device evaluation.

The document discusses performance data in the context of substantial equivalence to predicate devices and compliance with international standards for electrical safety, electromagnetic compatibility, and biocompatibility.

Based on the provided text, here's what can be extracted and what is missing:

Missing Information:
The document does not provide:

A table of explicit acceptance criteria with reported device performance in the context of diagnostic accuracy (e.g., sensitivity, specificity, AUC).
Sample sizes used for a "test set" or data provenance for a diagnostic/AI study.
Number of experts, their qualifications, or adjudication methods for ground truth establishment specific to a diagnostic study.
Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or an effect size for human readers with and without AI assistance.
Whether a standalone (algorithm only) performance study was done for AI.
Details on the sample size for a "training set" or how ground truth for a "training set" was established, as these terms are relevant to AI/ML development, which is not the focus of this 510(k) summary for a microwave ablation system.

Information Extracted from the Document:

A table of acceptance criteria and the reported device performance:
The document states: "The system passed all pre-determined acceptance criteria identified in the test plan." It also mentions "Ablation sizes for 15 gauge probe variants were deemed to be substantially equivalent to the predicate devices."
However, specific numerical acceptance criteria and their corresponding reported performance values are not detailed in this summary. The criteria are general for compliance and functional equivalence.

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with IEC 60601-1:2005 (Electrical Safety)	Passed applicable portions
Compliance with IEC 60601-2-2:2006 (High Frequency Surgical Equipment)	Passed applicable portions
Compliance with IEC 60601-2-6:1984 (Microwave Therapy Equipment)	Passed applicable portions
Compliance with IEC 60601-1-2:2007 (Electromagnetic Compatibility)	Passed applicable portions
Compliance with EN ISO 11607-1:2009 (Sterilization Packaging)	Passed applicable portions
Compliance with ISO 10993-1: 2009 (Biocompatibility)	Passed applicable portions
Ablation size equivalence for 15 gauge probe variants	Deemed substantially equivalent to predicate devices (ex-vivo)
System passed all pre-determined acceptance criteria	System passed all pre-determined acceptance criteria identified in the test plan.
Verification and Validation Testing	Completed in accordance with company's Design Control process (21 CFR Part 820.30) and FDA Guidance on Software Contained in Medical Devices. Potential risks analyzed and mitigation.

Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size (Test Set): Not specified in terms of patient/case count. Testing involved ex-vivo studies.
- Data Provenance: Ex-vivo testing in bovine liver and lung and porcine kidney. This implies laboratory-controlled experiments rather than human clinical data from a specific country or retrospective/prospective human study.
- The document also mentions "Ablation Confirmation software (K150313) is available as an option on the Certus 140." This suggests an AI/ML component might exist, but the performance data section describes testing for the ablation system itself, not specifically the "Ablation Confirmation software." If this software were to be evaluated as an AI/ML device, the detailed information requested would be critical. However, this 510(k) is not for the AI software, but rather for the overall ablation system and its hardware modifications.
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 to the type of ex-vivo performance testing described. Ground truth was likely established through direct measurement of ablation zones in the ex-vivo tissue rather than expert consensus on diagnostic images.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.
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. This type of study is not mentioned as this document is for an ablation device, not an AI diagnostic/assessment tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The performance testing is for the ablation system's physical effects.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the ex-vivo studies, the ground truth would have been direct physical measurement of the ablation zone size in the tissue samples.
The sample size for the training set:
Not applicable, as this is not an AI/ML device approval focusing on a training set. The "design concepts, technologies and materials" were evaluated against predicate devices.
How the ground truth for the training set was established:
Not applicable.

Summary of what this document actually provides:
This document is a 510(k) summary for a microwave ablation system, focusing on its substantial equivalence to previously cleared predicate devices and its compliance with relevant medical device standards. The "performance data" section primarily discusses engineering and basic functional testing (e.g., electrical safety, electromagnetic compatibility, biocompatibility, and ex-vivo ablation size equivalence). It is not a document evaluating an AI/ML diagnostic or prognostic device, and thus many of the questions related to AI/ML study design are not addressed.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

May 4, 2016

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

Re: K160936

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: April 1, 2016 Received: April 4, 2016

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

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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 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 vours.

Jennifer R. Stevenson -A

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)

K160936

Device Name

Certus 140 2.45GHz 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)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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Date:	05/04/2016
Subject:	510(k) Summary of Safety and Effectiveness Information for theNeuWave Medical Certus 140 2.45 GHz Ablation System and Accessories
Company:	NeuWave Medical, Inc.3529 Anderson StreetMadison, WI 53704
FDA Establishment#	3008769756
Contact:	Dan Kosednar, Director of Regulatory Affairs and Quality AssuranceP – 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:

. 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 and K130399.

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.

Device Description

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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. Certus56 probes have a cable length of 1.4m.

	PercutaneousAblation	LaparoscopicAblation	Open SurgicalAblation	Open SurgicalCoagulation
CertusLK	X		X	X
CertusLN	X		X
CertusPR	X		X	X
CertusSR		X	X
CertuSurgGT			X*	X

Ablation Probe/Surgical Tool Design Application Overview

The CertuSurgGT is not recommended for Target Ablation procedures lasting more than 1 minute.

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 sturdy probe ideal for use in laparoscopic applications.

The CertuSurg67 surgical tool is designed to produce focal, rapid coagulation of soft tissue in open surgical applications, including planar coagulation performed prior to tissue resection.

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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

This 510(k) was submitted to update the Certus 140 system with the following modifications:

New 15 gauge probe variants for Certus® and Certus™ probe types in 15cm and 20cm lengths.
Minor updates to system cart including mechanical support for a second monitor display required for Ablation Confirmation (K150313)

Performance Data

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

IEC 60601-1:2005
IEC 60601-2-2:2006
IEC 60601-2-6:1984
IEC 60601-1-2:2007
EN ISO 11607-1:2009
ISO 10993-1: 2009

The Certus 140 2.45 GHz Ablation System and Accessories and the predicate devices are substantially equivalent in design concepts, technologies and materials. The Certus 140 Ablation 2.45 GHz System and Accessories has been verified through rigorous testing that, in part, supports the compliance of Certus 140 2.45 GHz 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. Ablation sizes for 15 gauge probe variants were deemed to be substantially equivalent to the predicate devices.

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.

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Ex-vivo studies were conducted to compare the performance of the Certus 140 2.45 GHz Ablation System and Accessories to a 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.