SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEM

{0}------------------------------------------------ ### 510(k) Summary . ## K070779 ### 510(k) Summary Page 1 42 | Sponsor's Name,<br>Address, Phone &<br>Fax: | MISONIX INCORPORATED<br>1938 New Highway, Farmingdale, NY 11735<br>Phone: 631 694 9555 x 123<br>Fax: 631 694 1322 | |----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Ronald R. Manna | | Date Prepared: | 7/7/08 | | Device Trade Name | Sonatherm 600i Ultrasonic Lesion Generating System | | Device Common<br>Name: | Sonatherm 600i | | Proposed Class,<br>Classification Name<br>and Number, and<br>Product Code: | Class II<br>Electrosurgical cutting and coagulation device and accessories<br>21 CFR 878.4400<br>Product Code: NTB | | Predicate Devices: | Sonatherm 600 Ultrasonic Lesion Generating System, K042096<br>Endocare CryoCare™ Surgical System with CryoGuide™<br>K002615<br>Endocare CryoCare CS Surgical System K032333<br>Endocare CryoCare CS Surgical System K050347 | | Device Description : | The Sonatherm 600i is a modification of the previously cleared<br>Sonatherm 600 (K 042096). The Sonatherm 600i uses the same<br>HIFU transducer, with the same ultrasonic lesion generating<br>power output as the Sonatherm 600.<br><br>The Sonatherm 600i operates in the same manner as the<br>Sonatherm 600. The Sonatherm 600i operates by utilizing a<br>focused ultrasound transducer positioned at the surface of the<br>targeted ablation area to create a thermal lesion from the focal<br>point of the transducer back to the surface of the targeted area in<br>an open field or laparoscopic scenario.<br><br>The Sonatherm 600i incorporates three changes to the<br>Sonatherm 600: a microprocessor controlled LCD user interface;<br>a visually aided focal point targeting system; an integrated<br>transducer positioning device<br><br>The microprocessor controlled LCD user interface incorporates a<br>graphical interface that makes the operation of the device easier.<br>The integrated positioning device allows the user to verify the<br>positioning of the Sonatherm 600i probe over the intended target<br>volume. This reduces the chance for operator error. | | Intended Use: | The Sonatherm is indicated for the laparoscopic or intraoperative<br>ablation of soft tissue from the ultrasound focal zone back to the<br>surface of the targeted ablation area in General Surgery. The<br>Sonatherm is not to be used for non-invasive ablation, i.e.<br>leaving intervening tissue spared, and it is not indicated for the<br>ablation of Prostate tissue | | Summary of<br>Technological<br>Characteristics: | The Sonatherm 600i operates in the same manner as the<br>Sonatherm 600. The Sonatherm 600i operates by utilizing a<br>focused ultrasound transducer positioned at the surface of the<br>targeted ablation area to create a thermal lesion from the focal<br>point of the transducer back to the surface of the targeted area in<br>an open field or laparoscopic scenario. | | Summary of<br>nonclinical tests | Sonatherm 600i Targeting Accuracy Test Report<br>Thermal Mapping of Ablation Region<br>Validation of Imaging Operation<br>Total Acoustic Power Tests of Transducers | | Summary of clinical<br>tests | No clinical testing is required because product did not change<br>HIFU power output or type. Note: clinical data was also not<br>required to clear the original device. | | Conclusions from<br>nonclinical and<br>clinical tests | Based upon an analysis of the operating characteristic<br>specifications, Risk Analysis, and Voluntary Consensus<br>Standard Investigations, Misonix, Inc. has concluded that the<br>Sonatherm 600i is substantially equivalent to the predicate<br>devices and introduces no new safety or efficacy concerns | {1}------------------------------------------------ # K 070 719 -------------------------------------------------------------------------------------------------------------------------------------------------------------------- . : {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in a circular arrangement. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ### JUL - 9 2008 Misionix Incorporated % Mr. Ronald Manna VP, Regulatory Affairs 1938 New Highway Farmingdale, New York 11735 Re: K070779 Trade/Device Name: Sonatherm 600i Ultrasonic Lesion Generating System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: NTB Dated: April 9, 2008 Received: April 11, 2008 Dear Mr. Manna: 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. {3}------------------------------------------------ #### Page 2 - Mr. Ronald Manna 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. Mark M. Millican - Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ### Indications for Use K070779 Device Name: Sonatherm 600i Ultrasonic Lesion Generating System Indications for Use: : The Sonatherm is indicated for the laparoscopic or intraoperative ablation of soft tissue from the ultrasound focal zone back to the surface of the targeted ablation area in General Surgery. The Sonatherm is not to be used for non-invasive ablation, i.e. leaving intervening tissue spared, and it is not indicated for the ablation of Prostate tissue. Prescription Use X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Calvare bucuro Division of General, Restorative, and Neurological Devices **510(k) Number** K670779 Page 1 of l