Who is the manufacturer of Certus 140 2.45GHz Ablation System?

Neuwave Medical, Inc. filed the 510(k) submission for Certus 140 2.45GHz Ablation System (K173756).

What is the FDA product code for Certus 140 2.45GHz Ablation System?

NEY. It is classified under 21 CFR 878.4400 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for Certus 140 2.45GHz Ablation System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Certus 140 2.45GHz Ablation System?

Certus 140 2.45 GHz Ablation System and Accessories (K160936).

Who can help prepare an FDA 510(k) submission like Certus 140 2.45GHz Ablation System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Certus 140 2.45GHz Ablation System

K173756 · Neuwave Medical, Inc. · NEY · Oct 24, 2018 · General, Plastic Surgery

Device Facts

Record ID	K173756
Device Name	Certus 140 2.45GHz Ablation System
Applicant	Neuwave Medical, Inc.
Product Code	NEY · General, Plastic Surgery
Decision Date	Oct 24, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2
Attributes	Therapeutic

Intended Use

To thermally ablate soft tissue using microwave energy.

Device Story

Microwave ablation system for soft tissue coagulation; utilizes 2.45 GHz signal generator with three independent 140W power amplifiers. System includes touch-screen interface, optional footswitch, and Power Distribution Module (PDM). Sterile, single-patient use energy delivery accessories (ablation probes/surgical tools) feature trocar-tipped cannulas, cables, and connectors. CO2-based cooling system maintains non-active probe temperature and enables Tissu-Loc function for probe stabilization. Used in percutaneous, open, and laparoscopic settings by clinicians. System monitors temperature via sensors in accessories to ensure safety. Output power is software-limited based on probe type and number of connected accessories. Optional Ablation Confirmation software provides secondary monitor for procedure visualization. Benefits include precise ablation of soft tissue and non-resectable liver tumors.

Clinical Evidence

Evidence includes nonclinical bench testing, acute in-vivo porcine studies, and a systematic meta-analysis of 18 peer-reviewed studies (1,924 patients). Meta-analysis compared microwave ablation (MWA) to radiofrequency ablation (RFA) for liver tumors (HCC or metastasis). Primary endpoint was technique efficacy (complete tumor ablation) measured 1 week to 3 months post-procedure. Results supported the ability of the system to access and ablate liver tumors in percutaneous and laparoscopic settings.

Technological Characteristics

2.45 GHz microwave generator; 140W max power per channel. Accessories: 13-gauge to 17-gauge stainless steel cannulas, triaxial antenna design. Cooling: CO2-based. Sterilization: Ethylene Oxide (ISO 11135:2014). Connectivity: USB-based footswitch, optional secondary monitor for Ablation Confirmation. Software: V3.0.X, rule-based power control and monitoring. Biocompatibility: ISO 10993-1 compliant.

Indications for Use

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. Not indicated for cardiac procedures. Designed for facility use under clinician orders.

Regulatory Classification

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.

Predicate Devices

Certus 140 2.45 GHz Ablation System and Accessories (K160936)

Reference Devices

Covidien Cool-Tip RF Generator System and Accessories (K053290)

Related Devices

K130399 — CERTUS 140 CERTUSURGGT SURGICAL TOOL · Neuwave Medical, Inc. · Jul 18, 2013
K113237 — CERTUS 140 2.45GHZ ABLATION SYSTEM · Neuwave Medical, Inc. · Jan 4, 2012
K122217 — CERTUS 140 2.45GHZ ABLATION SYSTEM · Neuwave Medical, Inc. · Dec 19, 2012
K160936 — Certus 140 2.45GHz Ablation System · Neuwave Medical, Inc. · May 4, 2016
K072687 — VALLEYLAB MICROWAVE ABLATION GENERATOR · Covidien Lp, Formerly Know AS Valleylab, A Divison · Nov 25, 2008

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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 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 turnors. 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for NeuWave Medical. The logo consists of a green sphere with a white wave-like design on the left, followed by the text "NeuWave Medical" in a sans-serif font. Below the company name, there is a smaller text that reads "PART OF THE ETHICON™ FAMILY OF COMPANIES". | | K173756 | |--------------------|---------------------------------------------------------------------------------------------------------------------------------------| | Date: | 10/23/2018 | | 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: - . 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 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. Certus 140 Traditional 510(k) 510(k)Summary Page 1 of 9 {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for NeuWave Medical. The logo consists of a green circle with a white wave design inside, followed by the text "NeuWave Medical" in a simple, sans-serif font. Below the company name, the text "PART OF THE ETHICON™ FAMILY OF COMPANIES" is displayed in a smaller font size. #### Comparison of Intended Use and Indications for Use | | Subject Device, K173756 | Predicate Device, K160936 | |---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | To thermally ablate soft tissue using microwave energy. | To thermally ablate soft tissue using microwave energy. | | Indications for use | The NeuWave Medical Certus 140TM 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 140TM 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. | The NeuWave Medical Certus 140TM 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 140TM 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. | 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 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. Certus 140 Traditional 510(k) 510(k)Summary Page 2 of 9 {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for NeuWave Medical. The logo consists of a green circle with a white wave-like design inside, followed by the text "NeuWave Medical" in a simple, sans-serif font. Below the company name, there is smaller text that reads "PART OF THE ETHICON™ FAMILY OF COMPANIES". 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. | | Percutaneous Ablation | Laparoscopic Ablation | OpenSurgical Ablation | OpenSurgical Coagulation | |----------|--------------------------|--------------------------|--------------------------|-----------------------------| | 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 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. # 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 {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows a circular logo with a light green background. A stylized white wave-like design is prominently displayed in the center of the circle. The wave appears to be moving from left to right, creating a dynamic and fluid impression. # 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/impactonsafety andeffectiveness | | | | | impact on energy delivery, temperature measurement, CO2 cooling control or other risk mitigations or essential performance. All changes were made to address minor anomalies or make minor improvements to the user experience. Additionally, several changes were made to support CO2 tank configurations different from those sold in the US. These changes do not impact the function of US configured units. | | Generator Output Power | CertusLK, CertusLN and CertusSR Probes are limited to 140W for a single probe, 95W if 2 probes are selected and 65W if 3 probes are selected. CertusPR Probes Maximum of 65W per probe regardless of the number of probes when used in Ablation Mode. In Surgical Mode, the maximum power for CertusPR probes is 95W if 1 or 2 probes are used and 65W if 3 probes are used. | CertusLK, CertusLN and CertusSR Probes are limited to 140W for a single probe, 95W if 2 probes are selected and 65W if 3 probes are selected. CertusPR Probes Maximum of 65W per probe regardless of the number of probes when used in Ablation Mode. In Surgical Mode, the maximum power for CertusPR probes is 95W if 1 or 2 probes are used and 65W if 3 probes are used. | No changes in this 510(k) | | Antenna Design | Triaxial Antenna for CertusLK, CertusLN and CertusSR Modified Triaxial Antenna for CertusPR | Triaxial Antenna for CertusLK, CertusLN and CertusSR Modified Triaxial Antenna for CertusPR | No changes to the antenna design 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) for CertusPR probes (65W max in Ablation Mode) 20-140 (5 W increments) for CertusLK, CertusLN and CertusSR probes | 20-95 (5 W increments) for CertusPR probes (65W max in Ablation Mode) 20-140 (5 W increments) for CertusLK, CertusLN and CertusSR probes | This aspect of probe design has not been modified from the predicate device. | | Target Ablation Time | Up to 10 Min as limited by software. User may ablate for additional time after 10 minutes of ablation is complete. | Up to 10 Min as limited by software. User may ablate for additional time after 10 minutes of ablation is complete. | This aspect of probe design has not been modified from the predicate device. | | Planar Coagulation Time | 5 seconds - 1 Minute | 5 seconds – 1 Minute | This aspect of probe design has not been modified from the predicate device. | | Monitored Parameters | | | | | Accessories | Dual Probe Clip CT Table Mounting Adapter for PDM Surgical Table Mounting Adapter for PDM Foot switch (Locking USB or Standard USB) | Dual Probe Clip CT Table Mounting Adapter for PDM Surgical Table Mounting Adapter for PDM Foot switch (Locking USB or Standard USB) | No changes in this 510(k). | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for NeuWave Medical. The logo consists of a green circle with a white wave-like design inside, followed by the text "NeuWave Medical" in a sans-serif font. Below the company name, the text "PART OF THE ETHICON™ FAMILY OF COMPANIES" is written in a smaller font size. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for NeuWave Medical, a company that is part of the Ethicon family of companies. The logo consists of a green sphere with a white wave design inside of it, followed by the company name in black text. Below the company name, it states that it is part of the Ethicon family of companies. # 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. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for NeuWave Medical. The logo consists of a green circle with a white wave design inside, followed by the text "NeuWave Medical" in gray. Below the company name, it says "PART OF THE ETHICON™ FAMILY OF COMPANIES" also in gray. #### 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 {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for NeuWave Medical. The logo consists of a green sphere with a white wave design on the left, followed by the text "NeuWave Medical" in a sans-serif font. Below the text, there is a smaller text that says "PART OF THE ETHICON™ FAMILY OF COMPANIES". (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 {11}------------------------------------------------ Image /page/11/Picture/0 description: The image is a logo for NeuWave Medical. The logo features a green sphere with a white wave design on the left side. To the right of the sphere is the text "NeuWave Medical" in a sans-serif font, with the words stacked on top of each other. Below the company name is the phrase "PART OF THE ETHICON FAMILY OF COMPANIES" in a smaller font. 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.