(317 days)
No
The document describes a microwave ablation system with temperature sensors and a CO2 cooling system. It mentions "Ablation Confirmation software" but provides no details suggesting AI/ML is used for this function. The performance studies focus on ablation zone size, histological results, and a meta-analysis comparing microwave to radiofrequency ablation, none of which indicate the use of AI/ML.
Yes
The device is indicated for the "ablation (coagulation) of soft tissue," including "partial or complete ablation of non-resectable liver tumors," which directly treats a medical condition.
No
This device is described as an "Ablation System" used for the "ablation (coagulation) of soft tissue," which is a treatment or therapeutic procedure, not a diagnostic one.
No
The device description clearly outlines multiple hardware components including a signal source generator, power amplifiers, a touch-screen user interface, an optional footswitch, energy delivery accessories (probes and surgical tools), a junction box, a CO2 based cooling system, and CO2 cylinders. While it mentions optional "Ablation Confirmation software," the core device is a hardware system with integrated software for control and user interface.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the ablation (coagulation) of soft tissue in vivo (within the body) using microwave energy. This is a therapeutic procedure performed directly on the patient.
- Device Description: The device is a system that generates and delivers microwave energy through probes inserted into the body. It includes components like a generator, amplifiers, probes, and a cooling system. These are all designed for direct medical intervention.
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform such examinations on specimens outside the body.
The device is a therapeutic medical device used for tissue ablation, not an IVD.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
NEY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, liver tumors
Indicated Patient Age Range
Not Found
Intended User / Care Setting
facility use, used under the orders of a clinician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Testing:
Type: nonclinical acute in-vivo (porcine) studies
Sample Size: Not specified
Key Results: Ablation zone sizes and histological results were analyzed and evaluated.
Real World Evidence (RWE) Meta-analysis:
Type: Systematic review of literature and meta-analysis of peer-reviewed articles.
Sample Size: 1,924 patients from 18 included studies.
Data Source: MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials (CENTRAL).
Annotation Protocol: Data extracted by one reviewer and cross-checked by a second reviewer using a standardized data extraction form.
Study Outcomes: Technique efficacy (effectiveness) (defined as complete tumor ablation or complete response), measured at one week to three months post ablation.
Risk of Bias Assessment: Cochrane Risk of Bias (for RCTs) and Newcastle=Ottawa quality assessment Scale (NOS) (for observational studies).
Data Synthesis and Statistical Methods: DerSimonian–Laird random-effects model for meta-analysis, relative risk (RR) and 95% Cl calculation. Sub-group analyses for tumor size, type of liver tumor, impact of additional treatment, MWA frequency, and microwave ablation system. Sensitivity analyses performed. Publication bias examined using funnel plots.
Key Results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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
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)
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| 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
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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 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
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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.
| | 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
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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/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). |
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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 (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.