(147 days)
Not Found
No
The summary describes a microwave ablation system with power amplifiers, a user interface, probes with temperature sensors, and a cooling system. There is no mention of AI or ML in the device description, intended use, or performance studies. The focus is on the hardware and its physical properties for tissue ablation.
Yes
The device is indicated for the "ablation (coagulation) of soft tissue", which is a therapeutic intervention to treat tissue.
No
The "Intended Use / Indications for Use" section states that the device is "indicated for the ablation (coagulation) of soft tissue," which is a treatment procedure, not a diagnostic one.
No
The device description clearly outlines multiple hardware components including a signal source generator, power amplifiers, probes with cannulas and sensors, a cooling system, and CO2 cylinders.
Based on the provided text, the NeuWave Medical Certus 140™ 2.45 GHz Ablation System and Accessories is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "ablation (coagulation) of soft tissue in percutaneous, open surgical and in conjunction with laparoscopic surgical settings." This describes a therapeutic procedure performed directly on the patient's body.
- Device Description: The device description details a system that delivers energy (microwave ablation) to tissue within the body. It includes probes that are inserted into the patient.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide diagnostic information. IVDs are used to perform tests on these types of samples.
Therefore, the device is a therapeutic medical device used for treating soft tissue, not a diagnostic device used for testing samples in vitro.
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.
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
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. Up to 3 microwave ablation probes 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.
Probes are provided sterile and are intended for single patient use only. Ablation probes are comprised of a sharp trocar on the end of a cannula, a probe handle, a 1.4 meter cable and a connector assembly.
Models Certus", Certus", and Certus" have 17 gauge cannula and are available in 15 cm and 20 cm lengths.
Model Certus®, has a 13 gauge cannula and is available in a 25 cm length only.
Each probe contains three (3) temperature measurement sensors that help monitor performance and ensure patient and operator safety.
Additionally, different 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.
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 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:
- new software to improve the ease of use during open surgical procedures, specifically . surgical coagulation and Planar Coagulation applications. The new software interface has distinct "Ablation Mode" and "Surgical Mode".
- A footswitch is now available to control probe delivery in Surgical Mode ●
- A new Dual Probe Clip accessory was developed to hold two 17 gauge Certus probes. ●
- In Surgical Mode, the maximum power setting for Certus" probes has changed from 65W to 95W if one or two probes are active
- The generator frequency output is 2.450GHz +/- .025GHz, nominal
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, liver, kidney tissue, lung tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinician, facility use
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)
Ex-vivo studies were conducted to compare the performance of the Certus 140 2.45 GHz Ablation System and Accessories to a predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
510k Summary
K12211
DEC 1 9 2012
| Date: | 12/13/2012 |
|---|---|
| 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: | General and Plastic Surgery, 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 and K113237.
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.
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. Up to 3 microwave ablation probes 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.
Certus 140 510(k) Submission Safety Summary Page 1 of 3
1
Probes are provided sterile and are intended for single patient use only. Ablation probes are comprised of a sharp trocar on the end of a cannula, a probe handle, a 1.4 meter cable and a connector assembly.
Models Certus", Certus", and Certus" have 17 gauge cannula and are available in 15 cm and 20 cm lengths.
Model Certus®, has a 13 gauge cannula and is available in a 25 cm length only.
Each probe contains three (3) temperature measurement sensors that help monitor performance and ensure patient and operator safety.
Additionally, different 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.
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 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:
- new software to improve the ease of use during open surgical procedures, specifically . surgical coagulation and Planar Coagulation applications. The new software interface has distinct "Ablation Mode" and "Surgical Mode".
- A footswitch is now available to control probe delivery in Surgical Mode ●
- A new Dual Probe Clip accessory was developed to hold two 17 gauge Certus probes. ●
- In Surgical Mode, the maximum power setting for Certus" probes has changed from 65W to 95W if one or two probes are active
- The generator frequency output is 2.450GHz +/- .025GHz, nominal
Performance Data Certus 140 510(k) Submission Safety Summary Page 2 of 3
2
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.
Certus 140 510(k) Submission Safety Summary Page 3 of 3
3
Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of an eagle.
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
Neu Wave Medical, Incorporated % Mr. Dan Kosednar Director, Regulatory Affairs and Quality Assurance 3529 Anderson Street Madison, Wisconsin 53704
December 19, 2012
Re: K122217
Trade/Device Name: Certus 140 Microwave Ablation System and Accessories Regulation Number: 21 CFR 878.4400
Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II
Product Code: NEY
Dated: December 13, 2012
Received: December 14, 2012
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 – Mr. Dan Kosednar
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K
Device Name: Certus 140 Microwave Ablation System and Accessories
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.
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
Peter D. Rumm -S
Concurrence for the Division of Surgical Devices/ODE/CDRH