SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR

{0}------------------------------------------------ # ન દ ## 9. Summary of Safety and Effectiveness - "510 (k) Summary" - A. Submitter Information SOPRO ZAC Athélia Avenue des Genévriers 13705 La Ciotat Cedex FRANCE Telephone: 33 (0) 442 98 01 01 Fax: 33 (0) 442 71 76 90 DEC 1 3 2007 | Contact Person: | Steve Salesky | |-----------------|------------------------------------------| | | SOPRO | | | c/o ACTEON, Inc. | | | 124 Gaither Drive, Suite 140 | | | Mt. Laurel, NJ 08054 | | | Tel: 800 289-6367 Ext. 40 | | | Fax: 856 222-4726 | | | E-mail: steve.salesky@us.acteongroup.com | Date Prepared: March 13, 2007 B. Device Identification Classification Name: Laparoscopic Insufflator Common Usual Name: Laparoscopic CO2 Insufflator Proprietary Name: SOPRO 640 laparoscopic Insufflator C. Identification of Predicate Device | Device | Applicant | 510(k) No. | Date Cleared | |----------------|-------------------------------|------------|---------------| | HI-FLO THERME | WISAP | K031014 | June 27, 2003 | | PNEU 45, WISAP | GESELLSCHAFT<br>FUR | | | | #7083, 7083V | WISSENSCHAFTL.<br>APP. BAU MB | | | The SOPRO 640 laparoscopic Insufflator is substantially equivalent to the predicate device by WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MB, the HI-FLO THERME PNEU 45, WISAP #7083, 7083V (K031014) previously cleared by the FDA and currently marketed. #### D. Device Description The SOPRO 640 insufflator supplies CO2 gas from cylinders to build up a pneumoperitoneum with CO2 Gas for diagnostic or operative Laparoscopy with a maximum flow rate of 20, 30 or 45 liters per minute dependent on the model selected. {1}------------------------------------------------ The insufflation pressure is user adjustable between 0 and 24 mmHg. The safety features include acoustic and visual alarms for overpressure and low gas supply. #### E. Intended Use The SOPRO 640 Laparoscopic Insufflator may only be used by qualified physicians for building up a pneumoperitoneum with CO2 Gas for diagnostic or operative Laparoscopy. ### F. Substantial Equivalence The SOPRO 640 laparoscopic Insufflator and the predicate device by WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MB, the HI-FLO THERME PNEU 45, WISAP #7083, 7083V (K031014) are both laparoscopic insufflators for use in diagnostic and/or operative laparoscopy by qualified physicians. Differences that exist between the devices relating to technical specifications, performances, and intended use are minor and do not affect the safety and effectiveness of the SOPRO 640 Laparoscopic Insufflator. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines. Public Health Service DEC 1 3 2007 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 #### SOPRO % Mr. Steven Salesky Quality Manager ACTEON North America, Inc. 124 Gaither Drive, Suite 140 MOUNT LAUREL NJ 08054 Re: K070783 Trade Name: SOPRO 640 Laparoscopic Insufflator Regulation Number: 21 CFR 884.1730 Regulation Name: Laparoscopic insufflator Product Code: HIF Dated: November 28, 2007 Received: November 29, 2007 Dear Mr. Salesky: 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. {3}------------------------------------------------ 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 or any I vith 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 Orth 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. 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 11 you abon conter for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter. | 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |-----------------|----------------------------------|--------------| | 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 892.xxxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | 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 (ther 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, Nancy C Brogdon Nancy C. Brogdon Director. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use 510(k) Number: K070783 Device Name: SOPRO 640 Laparoscopic Insufflator Indications for Use: The SOPRO 640 Laparoscopic Insufflator may only be used by qualified physicians for building up a pneumoperitoneum with CO2 Gas for diagnostic or operative Laparoscopy. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-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) Hala Leun ision Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number