(63 days)
Not Found
No
The summary describes a microwave ablation system with hardware components, temperature sensors, and a cooling system. There is no mention of AI, ML, or any data-driven algorithms for decision-making or analysis.
Yes
The device is intended for the ablation (coagulation) of soft tissue, which is a therapeutic intervention.
No.
The "Intended Use / Indications for Use" states that the device is "intended for the ablation (coagulation) of soft tissue," which is a treatment or therapeutic function, not a diagnostic one.
No
The device description clearly outlines significant hardware components including a signal source generator, power amplifiers, probes with cannulas and antennas, a cooling system, and CO2 cylinders. While there is a touch-screen user interface, the core functionality and components are hardware-based.
Based on the provided text, 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 surgical settings. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The description details a system that generates microwave energy and delivers it via probes to ablate tissue. This is a physical intervention, not a diagnostic test performed on samples taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition. The device's function is to treat tissue, not to diagnose.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The NeuWave Medical Certus 140™ 2.45 GHz Ablation System and Accessories are intended 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 intended for use in cardiac procedures.
NeuWave recommends against the use of the Certus 140 2.45 GHz Ablation System in the following situations:
- Pregnant patients potential risks to patient and/or fetus have not been established .
- Patients with implantable pacemakers or other electronic implants. Implanted . electronic devices may be adversely affected by microwave power
- . Use on the central nervous system
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. Up to 3 microwave ablation probes can be connected to and powered by the system at one time. The maximum selectable power for the system is dependent on the probe type used. For Certus", Certus " and Certus " probes, the maximum power is 140W when one probe is connected, 95Wper probe when 2 probes are connected and 65W per probe when 3 probes are connected. When Certus® probes are used, the maximum power is 65W regardless of the number of probes connected. An intermediate iunction 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.
The ablation probe assembly contains 4 main sections: a handle, a cannula, a radiating section and a faceted tip for insertion. The probes have a triaxial antenna design is created from a coaxial monopole antenna passed through a hollow needle. The needle creates the triaxial structure and its tip is positioned approximately ¼ of a wavelength proximal to the monopole base. This positioning improves antenna efficiency and reduces fields flowing back on the coaxial outer conductor. In turn, more energy is deposited in the tissue.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue. Not for use on the central nervous system. Not for use in cardiac procedures.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Facility use, only 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)
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 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.
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.
Not Found
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.
0
| JAN - 4 2012 | ||
|---|---|---|
| Date: | ||
| Subject: | 10/31/11 | |
| 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 |
. IAN
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.
Intended Use
The NeuWave Medical Certus 140™ 2.45 GHz Ablation System and Accessories are intended 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 intended for use in cardiac procedures.
NeuWave recommends against the use of the Certus 140 2.45 GHz Ablation System in the following situations:
- . Pregnant patients – potential risks to patient and/or fetus have not been established
- . Patients with implantable pacemakers or other electronic implanted electronic devices may be adversely affected by microwave power
- . Use on the central nervous system
The system is designed for facility use and should only be used under the orders of a clinician.
Certus 140 510(k) Submission Safety Summary Page 1 of 3
1
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. The maximum selectable power for the system is dependent on the probe type used. For Certus", Certus " and Certus " probes, the maximum power is 140W when one probe is connected, 95Wper probe when 2 probes are connected and 65W per probe when 3 probes are connected. When Certus® probes are used, the maximum power is 65W regardless of the number of probes connected. An intermediate iunction 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.
The ablation probe assembly contains 4 main sections: a handle, a cannula, a radiating section and a faceted tip for insertion. The probes have a triaxial antenna design is created from a coaxial monopole antenna passed through a hollow needle. The needle creates the triaxial structure and its tip is positioned approximately ¼ of a wavelength proximal to the monopole base. This positioning improves antenna efficiency and reduces fields flowing back on the coaxial outer conductor. In turn, more energy is deposited in the tissue.
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.
Certus 140 510(k) Submission Safety Summary Page 2 of 3
2
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
- t 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.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing and tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Neuwave Medical, Incorporated % Mr. Dan Kosednar 3529 Anderson Street Madison, Wisconsin 53704 US
JAN - 4 2012
Re: K113237
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: Class II Product Code: NEY Dated: November 1, 2011 Received: November 2, 2011
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
E. Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative 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 intended 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 intended for use in cardiac procedures.
NeuWave recommends against the use of the Certus 140 2.45 GHz Ablation System in the following situations:
- Pregnant patients potential risks to patient and/or fetus have not been established .
- Patients with implantable pacemakers or other electronic implants. Implanted . electronic devices may be adversely affected by microwave power
- . Use on the central nervous system
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)
Signature Of
Page 1 of 1
(Division S Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K113237