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™, Certus ", and Certus " ablation probes have 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 6 probes have a cable length of 1.4m.

CertuSurg" 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 CertuSurg " 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. CertuSurg" 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.

AI/ML Overview

The provided document describes the NeuWave Medical Certus 140 2.45 GHz Ablation System and Accessories, which is indicated for the ablation (coagulation) of soft tissue. The submission is a 510(k) to update the system with a new surgical tool (CertuSurgST) and associated software updates.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of specific performance metrics or thresholds (e.g., minimum ablation size, maximum temperature, etc.) for the device. Instead, it refers to compliance with international standards and substantial equivalence to a predicate device.

The reported device performance is general, focusing on the functionality and design of the various probes and the overall system.

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with International Standards (UL 60601-1, IEC 60601-1, IEC 60601-2-2, IEC 60601-2-6, IEC 60601-1-2, EN ISO 11607-1, ISO 10993-1)	System has been "verified through rigorous testing that, in part, supports the compliance" to these standards.
Substantial Equivalence to Predicate Device (Certus 140 2.45 GHz Ablation System and Accessories - K100744, K113237, K122217)	"The Certus 140 2.45 GHz Ablation System and Accessories and the predicate devices are substantially equivalent in design concepts, technologies and materials." Ex-vivo studies were conducted to compare performance.
Optimal energy transfer/ablation characteristics for various tissues and lesion sizes	"Certus" probes for liver and kidney; "Certus" probes for lung tissue; "Certus" probes for shorter ablations/smaller lesions; "Certus" probes for quickly encompassing tip while limiting overall length; "Certus" probes for laparoscopic applications.
Temperature monitoring and patient/operator safety	Energy delivery accessories contain temperature measurement sensors; CO2 based cooling system ensures non-active portion doesn't exceed temperature requirements.
Functionality of new features (CertuSurgST surgical tool, Tissu-Loc)	CertuSurgST for focal, rapid coagulation in open surgical applications including planar coagulation. Tissu-Loc (except for CertuSurgST) for adhering/sticking probe in place.

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

The document states: "Ex-vivo studies were conducted to compare the performance of the Certus 140 2.45 GHz Ablation System and Accessories to a predicate device."

Sample Size for Test Set: Not specified. The document does not provide any numerical details about the sample size (e.g., number of ablation procedures, number of tissue samples, number of devices tested).
Data Provenance: Ex-vivo. This indicates the studies were performed on excised tissue rather than living organisms. The country of origin is not specified.

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

Not applicable/Not specified. The evaluations appear to be objective, physical measurements or comparisons in an ex-vivo setting. There is no mention of human experts establishing "ground truth" for the performance characteristics.

4. Adjudication Method for the Test Set

Not applicable/Not specified. As the "ground truth" was not established by human experts, there would be no need for an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document does not describe an MRMC study or any study involving human readers or comparative effectiveness with or without AI assistance. The device is a microwave ablation system, not a diagnostic imaging AI.

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

Not applicable. This device is a physical medical device (ablation system), not an algorithm or AI system. The performance testing described (ex-vivo studies) would be considered "standalone" in the sense that the device's physical capabilities are being
evaluated.

7. The Type of Ground Truth Used

For the ex-vivo studies, the "ground truth" would likely involve objective physical measurements of ablation outcomes, such as:

Ablation Zone Dimensions: Size, shape, and volume of the coagulated tissue.
Temperature Measurements: Within and around the ablation zone.
Tissue Specificity: How effectively the device ablates target tissue while sparing adjacent tissue.
Power Delivery Characteristics: Stability and accuracy of energy output.

The document does not explicitly detail the specific measurements used, but these are typical for such devices.

8. The Sample Size for the Training Set

Not applicable/Not specified. This device is hardware for medical procedures, not a machine learning model that requires a "training set."

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

Not applicable. As there is no machine learning model or "training set," this question is not relevant.

Summary

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K130399 Page 1 of 3

JUL	1	8	2013
-----	---	---	------

Date:	02/15/2013
Subject:	510(k) Summary of Safety and Effectiveness Information for the
	NeuWave Medical Certus 140 2.45 GHz Ablation System and Accessories
Company:	NeuWave Medical, Inc.
	3529 Anderson Street
	Madison, WI 53704
FDA Establishment#	3008769756
Contact:	Dan Kosednar, Director of Regulatory Affairs and Quality Assurance
	P - 608-512-1592
	F - 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 and K122217.

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

Certus 140 510(k) Submission Safety Summary Page 1 of 3

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Models Certus™, Certus ", and Certus " ablation probes have 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 6 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

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 CertuSurg " 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.

Modifications

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

The new CertuSurgST surgical tool. .
Software updates associated with the use of the CertuSurg® surgical tool. .

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:

. UL 60601-1:2003
IEC 60601-1:1988 Plus Amendments .
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.

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

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

July 18, 2013

Neu Wave Medical, Inc. % Dan Kosednar, RAC Director, Regulatory Affairs and Quality Assurance 3529 Anderson Street Madison, Wisconsin 53704

Re: K130399

Trade/Device Name: Certus 140 2.45GHz 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: June 18, 2013 Received: June 20, 2013

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 mav 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

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Page 2 - Dan Kosednar, RAC

device-related 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -S

Mark N. Melkerson Acting 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): K

Device Name: Certus 140 2.45GHz Ablation System and Accessories

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.

Prescription Use XXX (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

DSD-DIVISION SIGN-OFF	Joshua C. Nipper
Division of Surgical Devices
510(k) Number:	K130399

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.