(315 days)
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.
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.
MedWaves Microwave Coagulation/Ablation System - Acceptance Criteria and Study Details
The provided documentation describes the MedWaves Microwave Coagulation/Ablation System, intended for surgical ablation of soft tissue. The "acceptance criteria" discussed are primarily related to general medical device standards and the device's functional performance in a lab setting, rather than clinical efficacy. The study focuses on demonstrating substantial equivalence to predicate devices through technical performance and compliance with relevant standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Standard/Test | Reported Device Performance |
|---|---|---|
| Electrical Safety/EMC | IEC 60601-1-2 Medical Electrical Equipment Part 1-2: General Requirements for Safety: Electromagnetic Compatibility | Complies with standard |
| IEC 60601-2-2 2007 Standard Requirement Tests | Complies with standard | |
| Biocompatibility | ISO 10993, Biological Evaluation of Medical Devices | Complies with standard |
| Sterility | ANSI/AAMI/ISO 11135:1994 Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization | Complies with standard |
| Packaging, Shelf Life | AAMI ANSI ISO 11607-1:2006 Packaging for Terminally Sterilized Medical Devices | Complies with standard |
| Mechanical Performance | MedWaves Catheter/Probes underwent mechanical and in vitro testing in accordance with the intended use. | Performed as expected and comparable to published performance of currently marketed products. |
| In Vitro Performance | MedWaves Catheter/Probes underwent mechanical and in vitro testing in accordance with the intended use. | Performed as expected and comparable to published performance of currently marketed products. |
| Firmware Testing | AAMI ANSI IEC 62304 Medical Device Software Software Lifecycle . Processes | Complies with standard |
| AAMI ANSI ISO 14971 & 14971 A1 Medical Devices Application of . Risk Management to Medical Devices | Complies with standard | |
| Substantial Equivalence | Comparison to predicate devices (Microsulis Tissue Ablation (MTA) System K052919, Tyco/Radionics Cool-Tip™ RF System K984552, VivaWave™ Microwave Ablation System K011676, VivaWave™ Microwave Ablation System K053535) | Device has the same intended use and general technological characteristics; performed comparably to a predicate device with respect to lesion size and tissue temperatures generated. No new questions of safety or efficacy raised. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a number of patients or cases. The "test set" primarily refers to physical units of the device (generator, probes, firmware) undergoing laboratory and in vitro testing.
- Data Provenance: The testing was conducted by MedWaves Incorporated. The context suggests these are internal company tests, typically performed in a controlled laboratory environment. No country of origin for a clinical data set is mentioned, as this is not a clinical study. The data is retrospective in the sense that it evaluates the manufactured device against pre-defined specifications and standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This document describes engineering and regulatory compliance testing, not a clinical study requiring expert consensus on clinical outcomes. Therefore, no "experts" in the sense of clinicians establishing ground truth for a test set of patient data are mentioned. The ground truth for functional performance and compliance is established by the specifications of the relevant international and national standards (e.g., IEC, ISO, AAMI, ANSI) and the device's design specifications. The "experts" would be the engineers and quality assurance personnel responsible for conducting and evaluating these technical tests. Their specific qualifications are not detailed.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies to resolve discrepancies between readers in assessing ground truth. This document pertains to technical performance and regulatory compliance, where outcomes are typically objectively measured against defined criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was not done. This 510(k) submission focuses on demonstrating substantial equivalence through technical performance and compliance with standards, not on clinical comparative effectiveness with human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
- Yes, a standalone performance assessment was effectively done for the device's technical aspects. The testing described (electrical safety, biocompatibility, sterility, mechanical, in vitro, firmware) evaluates the device itself (generator, probes, software) without human-in-the-loop clinical interaction. The "device performed as expected and comparable to the published performance of currently marketed products" based on these tests.
7. The Type of Ground Truth Used
- The ground truth for this submission is based on:
- Engineering specifications and design requirements for the device's components and overall function.
- International and national medical device standards (e.g., IEC 60601, ISO 10993, ANSI/AAMI/ISO 11135, AAMI ANSI ISO 11607, AAMI ANSI IEC 62304, AAMI ANSI ISO 14971).
- Published performance data of predicate devices used for comparison of "lesion size and tissue temperatures generated" in in vitro or bench testing.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/machine learning device that requires a "training set" of data. The device's "training" in this context would refer to its design and manufacturing process to meet specifications.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set mentioned for this type of medical device.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA1990 and 21 CFR 807.92(c).
1. Submitter Information
MedWaves Incorporated 16760 West Bernardo Drive San Diego, California Phone: (858) 946-0015 Fax: (858) 946-0016
Contact: Ted Ormsby
Date of preparation: December 15, 2007
DEC 1 8 2007
2. Device Name
Trade name: MedWaves Microwave Coagulation/Ablation System
Common name: Microwave Tissue Coagulation/Ablation System
Classification name and reference: Class II, 21 CFR 878.4400, Electrosurgical Cutting and Coagulation Device and Accessories, Panel 79, General and Plastic Surgery
Product Code: NEY
3. Predicate Devices
The MedWaves Microwave Coagulation/Ablation System is substantially equivalent to the following devices previously cleared via 510k by FDA:
- . Microsulis Tissue Ablation (MTA) System K052919
- Tyco/Radionics Cool-Tip™ RF System K984552
- VivaWave™ Microwave Ablation System K011676
- VivaWave™ Microwave Ablation System K053535
4. 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.
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Ko70356
MEDWAVES INCORPORATED 16760 West Bernardo Drive San Diego, CA 92127
Request for Revision of 510(k) Summary December 15, 2007
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.
5. Indications for 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.
6. Performance Data in Support of Substantial Equivalence
Performance testing was carried out to ensure that the MedWaves Microwave Coagulation/Ablation System functions as intended and meets design specifications. The MedWaves Microwave Coagulation/Ablation System was subjected to a battery of electrical, mechanical, functional and biocompatibility tests. In addition, the testing demonstrates that the MedWaves Microwave Coagulation/Ablation System complies with the following standards:
| Electrical Safety/EMC: | IEC 60601-1-2 Medical Electrical Equipment Part 1-2:General Requirements for Safety: ElectromagneticCompatibilityIEC 60601-2-2 2007 Standard Requirement Tests |
|---|---|
| Biocompatibility: | ISO 10993, Biological Evaluation of Medical Devices |
| Sterility: | ANSI/AAMI/ISO 11135:1994 Medical Devices -Validation and Routine Control of Ethylene OxideSterilization |
| Packaging, Shelf Life: | AAMI ANSI ISO 11607-1:2006 Packaging for TerminallySterilized Medical Devices |
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70356
Page 3 of 3
510k: K070356 Request for Revision of 510(k) Summary December 15, 2007
MedWaves Catheter/Probes underwent mechanical and in vitro testing in accordance with the intended use. The device performed as expected and comparable to the published performance of currently marketed products.
The MedWaves microwave generator underwent firmware testing in accordance with:
- AAMI ANSI IEC 62304 Medical Device Software Software Lifecycle . Processes
- AAMI ANSI ISO 14971 & 14971 A1 Medical Devices Application of . Risk Management to Medical Devices
Sufficient data were obtained to show the device is substantially equivalent to the predicate devices and meets safety and effectiveness criteria.
7. Substantial Equivalence Conclusion
Substantial equivalence is based on the MedWaves Microwave Coagulation/Ablation System having the same intended use and general technological characteristics as the predicate devices. There are no new fundamental technological differences between the MedWaves Microwave Coagulation/Ablation System and legally marketed devices.
There are no new questions of safety or efficacy raised by the MedWaves Microwaye Coagulation/Ablation System or any of its coagulation/ablation probes. Test data supplied and published literature showed that the MedWaves Microwave Coagulation/Ablation System performed comparably to a predicate device with respect to lesion size and tissue temperatures generated. Therefore, it can be concluded that the MedWaves Microwave Coagulation/Ablation System and accessories are substantially equivalent to the predicate devices.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, which is a traditional symbol of medicine.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 8 2007
MedWaves Incorporated % Mr. Ted Ormsby President and CTO 16760 W. Bernardo Drive San Diego, California 92127
Re: K070356
Trade/Device Name: MedWaves Microwave Coagulation/Ablation System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: NEY Dated: December 2, 2007 Received: December 4, 2007
Dear Mr. Ormsby:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set 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.
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Page 2 -- Mr. Ted Ormsby
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliary, pr (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarlet, Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N. Millman
- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K070356
Device Name: MedWaves Microwave Coagulation/Ablation System
Indications for 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.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ØN ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of D estorative.
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510(k) Number / K02
§ 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.