Search Results
Found 3 results
510(k) Data Aggregation
K Number
K143203Device Name
AveCure Microwave Coagulation-Ablation Generator, AveCure Microwave Large Antenna-Probe, AveCure Microwave Medium Antenna-Probe, AveCure Microwave Small Antenna-Probe, AveCure Microwave Mini Antenna-Probe
Manufacturer
Date Cleared
2015-08-26
(292 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
MEDWAVES INCORPORATED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MedWaves AveCure™ Ablation System is intended for use in percutaneous, laparoscopic, and intraoperative coagulation-ablation of soft tissue.
The MedWaves AveCure™ Ablation System is not intended for use in cardiac procedures.
Device Description
The MedWaves AveCure® Ablation System is designed to deliver ultrahigh radiofrequency (RF) through an antenna placed next to or embedded into soft-tissue for coagulating a volume of that tissue.
The MedWaves AveCure® Ablation System is composed of a durable generator-controller, and single-patient-use sterile accessories consisting of four antenna sizes and extension cable sets.
Each antenna-probe assembly is composed of one of the four antennas mounted at the distal end of one of many shaft configurations that are stiff, flexible or combination of both. The extension cable set is used to connect antennas to the generator controller. The material compositions of antennas and extension cables are nonmagnetic in nature and MRI safe. Therefore, the devices can be used in intraoperative, laparoscopic and percutaneous methods with CT, MR and Ultrasound imaging techniques to positions the antenna for ablation of softtissues.
The MedWaves AveCure® Ablation System is very efficient in transmitting RF power from the generator-controller to the antenna. With the low-power loss, the system does not need cooling pump, CO- or other mechanism to irrigate the antenna shaft and RF transmission lines for patient and user safety.
Ask a Question
Ask a specific question about this device
K Number
K083537Device Name
MODIFICATION TO MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM
Manufacturer
Date Cleared
2009-01-15
(48 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
MEDWAVES INCORPORATED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MedWaves Microwave Coagulation/Ablation System is intended for general surgical use in open procedures for the coagulation and ablation of soft tissues. The system is not intended for use in cardiac procedures.
Device Description
The MedWaves Microwave Coagulation/Ablation System consists of a microwave generator and accessories used for the surgical ablation of soft tissue. The accessories include two types of sterile, handheld, single use surgical coagulation/ablation probes and required connector cables. The two versions of coagulation/ablation probes are 15-cm in length, 14gauge in diameter, configured into large or small handle. The large handle configuration is the original blue elongated egg-shaped plastic, and the small handle is white plastic handle with 90-degree cable exit (both are made of the same ASB plastic).
The MedWaves microwave generator operates at a frequency of 902 to 928 MHz. For general surgery applications, the generator is set by the manufacturer to deliver a maximum of 32 W and is user selectable up to 28W. The system is capable of being run in two primary modes: power control mode and temperature control mode. A dynamic monitoring system within the generator maintains the set point selected by the user (either a power or temperature control point) in order to provide consistent and expected coagulation/ablation performance.
The system incorporates several monitored parameters that alert the user to potentially unsafe conditions during operation. These parameters and condition alerts include: overtemperature, over-power, inefficient microwave delivery, catheter/probe disconnect and system errors. MedWaves microwave generator utilizes firmware to monitor these processes variables and posts the ablation parameters and progress for the user on an LCD screen.
MedWaves uses proprietary antenna technology coupled with a delivery system that efficiently transmits the microwave energy to the tip of the probe. The microwave antenna is 20 mm long mounted at the distal end. Efficiency of the system relieves the requirement of having high-powered generator in order to create the desired coagulation/ablation results. The efficiency of the system allows the incorporation of monitoring and controls on the microwave energy delivery in order to deliver the most optimal performance available.
Ask a Question
Ask a specific question about this device
K Number
K070356Device Name
MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM
Manufacturer
Date Cleared
2007-12-18
(315 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
MEDWAVES INCORPORATED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MedWaves Microwave Coagulation/Ablation System is intended for general surgery use in open procedures for the coagulation and ablation of soft tissues. The system is not intended for use in cardiac procedures.
Device Description
The MedWaves Microwave Coagulation/Ablation System consists of a microwave generator and accessories used for the surgical ablation of soft tissue. The accessories include two types of sterile, handheld, single use surgical coagulation/ablation probes and required connector cables. The two versions of coagulation/ablation probes include short and longer length devices. The MedWaves microwave generator operates at a frequency of 902 to 928 MHz. For general surgery applications the generator is set by the manufacturer to deliver a maximum of 32 W and is user selectable up to 28 W. The system is capable of being run in two primary modes: power control mode and temperature control mode. A dynamic monitoring system within the generator maintains the set point selected by the user (either a power or temperature control point) in order to provide consistent and expected coaqulation/ablation performance. The system incorporates several monitored parameters that alert the user to potentially unsafe conditions during operation. These parameters and condition alerts include: high temperature, high-power, inefficient microwave delivery, catheter/probe disconnect and system errors. MedWaves microwave generator utilizes firmware to monitor these processes and post the ablation parameters and progress for the user on an LCD screen. MedWaves uses proprietary antenna technology coupled with a delivery system that efficiently transmits the microwave energy to the tip of the probe. The microwave antenna is 20 mm long mounted at the distal end. Efficiency of the system relieves the requirement of having high powered generator in order to create the desired coagulation/ablation results. The efficiency of the system allows the incorporation of monitoring and controls on the microwave energy delivery in order to deliver the most optimal performance available.
Ask a Question
Ask a specific question about this device
Page 1 of 1