MICROSURGEON MICROWAVE TISSUE ABLATION DEVICE, MODEL MTAD-200

{0}------------------------------------------------ 082565 Page 1 of 4 FEB 1 2 2009 ## 510(k) Summary of Safety and Effectiveness for MicroSurgeon, Inc Microwave Tissue Ablation Device System ### 1. DATE SUMMARY PREPARED: January 2, 2009 #### 2. SUBMITTER'S NAME AND ADDRESS: MicroSurgeon, Inc 8489 West 3RD Street Suite 1044 Los Angeles, CA 90048 #### 3. CONTACT PERSON: Mr. Dudley Harris Quality & Regulatory Director Telephone:(323) 801-2209 Facsimile: (310) 423-1008 ## 4. DEVICE NAME: Class: Panel: Proprietary (trade) Name: MicroSurgeon Tissue Ablation Device Common Name: Microwave ablation device Classification Name: System, ablation, microwave and accessories, CFR 878.4400 Product Code: NEY II General & Plastic Surgery 1 {1}------------------------------------------------ 12 1256 #### 5. PREDICATE DEVICE: The legally marketed device/s to which equivalence is being claimed is: MicroSurgeon, Inc 8489 West 3RD Street Suite 1044 Los Angeles, CA 90048 K070023: Microwave Ablation System & Accessories #### 6. DEVICE DESCRIPTION The MicroSurgeon Microwave Tissue Ablation device model MTAD-200 is intended to be used by the physician for the ablation of soft tissue by the induction of thermal necrosis in the targeted tissue. The ablation occurs by direct application of microwave energy to the targeted tissue by use of a sterile hand held Disposable Patient Probe (DPP). Lesion sizes ablated by the system are determined by preset values within the system algorithm. The MTAD-200 allows the physician to use a minimally invasive procedure that is an alternative to surgical removal of solid tissue anomalies. It is to be used in conjunction with the clinician's knowledge of the patient as well as the results of a physical examination along with clinical findings as deemed pertinent. The MTAD-200 system is not to be used by untrained and unqualified users in a manner other than that for which it is labeled. The systems Microwave Generator Subsystem (MWGS) generates an RF 2.45GHz signal which is delivered to the Disposable Patient Probe DPP via related controlled electronics, and provides for required patient galvanic isolation. The MWGS component of the MTAD-200 was designed for exclusive use of, and to generate microwave energy to the patient disposable probe cited above. The one time use sterile DPP Hand-piece incorporates a Tip that is inserted directly into the tissue for localized energy delivery, and acts as a microwave radiator in a bipolar mode; thus near-field radiated energy is contained within a limited field with no currents flowing into the patient (as opposed to uni-polar RF Radiators in which current flows thru the patient's body). Two independent Thermo-sensors (provided for further redundancy of the system) located at the tip of the DPP are used to provide for localized temperature measurement during the ablation process. The CPS utilizes these temperature measurements to control the delivery of energy in order to {2}------------------------------------------------ P - f 2565- Page 3 of 4 achieve the desired ablation. The CPS, running a Microsoft Windows Operating System, provides for profile programming onto a patient data file; provides user interface and controls the MWGS unit based on predetermined settings. All MWGS functionality and temperature measurements are processed and displayed by this unit, and utilized to achieve a desired ablation. Additionally, it stores all relevant patient information and measured parameters for the procedure. #### Keyboard Functions The MTAD-200 contains a full-function keyboard that can be used for input of patient data and for controlling specific system functions such as testing. #### 7. INDICATIONS FOR USE The MicroSurgeon Microwave Tissue Ablation Device is intended to be used for the surgical ablation of soft tissue. ## 8. CLINICAL TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION The results of bench testing support the above indications for use as well as the claim of Substantial Equivalence to the predicate devices listed in item #5 above. ## 9. NON-CLINICAL TESTS USED IN DETERMINATION OF SUBSTANTIAL EQUIVALENCE The substantial equivalence of the Microwave ablation system is also demonstrated by the following non-clinical testing to the following applicable standards: - IEC 60601-1: Medical Electrical Equipment Part 1: General Requirements for Safety: . Safety Requirements for Medical Electrical Systems - IEC 60601-1-2 Medical Electrical Equipment Part 1-2: General Requirements for Safety: . Electromagnetic Compatibility (2004) - . IEC 60601-2-2: Particular Standard for the Safety of High Frequency Surgical Equipment, March, 2007 (2006). The performance, functionality, and reliability characteristics of the device followed established test procedures, and a quality design system. {3}------------------------------------------------ Page 4 of 4 ## 10. CONCLUSIONS FROM NON-CLINICAL TESTING The MicroSurgeon Microwave Tissue Ablation device (MTAD-200) has completed the testing listed above with acceptable results, demonstrating substantial equivalence. Kol 25-65 ### 11. SUBSTANTIAL EQUIVALENCE CONCLUSION In summary, Indications for Use, safety standards tested to, and the ablation performance data between the MicroSurgeon MTAD-200 system, and the predicate device listed in item #5 above shows nearly identical data. There are no new questions of safety or efficacy raised by the MTAD-200 system; therefore, the system supports a claim of Substantial Equivalence. {4}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an emblem featuring a stylized eagle with its wings spread, clutching a staff or caduceus. #### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MicroSurgeon, Inc. % Mr. Dudley Harris Quality & Regulatory Consultant 20363 Tulip Circle Montrose, Colorado 81403 FEB 1 2 2009 Re: K082565 Trade/Device Name: MicroSurgeon Microwave Tissue Ablation Device Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: NEY Dated: January 7, 2009 Received: January 12, 2009 Dear Mr. Harris: 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {5}------------------------------------------------ #### Page 2 - Mr. Dudley Harris 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 Compliance at (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 Postmarket 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, David Krone Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health {6}------------------------------------------------ # Indications for Use Statement 510(k) Number (if known): Device Name: MicroSurgeon Microwave Tissue Ablation Device MTAD-200 Model: Indications for Use: The MicroSurgeon Microwave Tissue Ablation Device is intended to be used for the surgical ablation of soft tissue. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-Fite-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) > Concurrence of CDRH, Office of Device Evaluation (ODE) As for An > > (Division Sign-Off) (Division of General, Restorative, and Neurological Devices 510(k) Number K082563