PULSIOFLEX

{0}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of a bird-like figure. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-GG09 Silver Spring, MD 20993-0002 Pulsion Medical Systems, Inc. c/o Dr. Jamie Sulley US Agent 1511 Essex Road Westbrook, CT 06498 SEP 22 2011 Re: KI12448 RT.12440 Trade/Device Name: PulsioFiex, Model Number PC4000 Regulatory Number: 21 CFR 870,1435 Regulatory Number. 21 CFR 070.11199 Regulation Name: Single-function, Preprogrammed Diagnostic Computer Regulatory Class: II (two) Product Code: 74 DXG Dated: August 19, 2017 Received: August 25, 2011 Dear Dr. Sulley: We have reviewed your Section 510(k) premarket notification of intent to market the undicati We have reviewed your Section 510(A) premater is substantially equivalent (for the indications referenced above and have determined the device is subscan devices in interstat referenced above and have determined the devices marketed in interstate for use stated in the enclosure) to legally manced province device Amendments, or to commerce prior to May 28, 1976, the enactment and the Federal Food. Drug. commerce prof to May 28, 1976, the enactinent with the provisions of the Federal Food, Drug, devices that have been reclassment approval of a proval approval application (PMA). and Cosmetic Act (Act) that do not require approval sonvelions of the Act. The and Cosmetic Act (Act) that do not require approven controls provisions of the Act. The Act. The Act. The Act. The You may, therefore, market the device, soojed to the gening misting of the gol general controls provisions of the Act include requires arginst mistvanding and general controls provisions of the Act mendo requirements. 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).) ff your device is classified (sec above) mitor regulations affecting your device can be it may be subject to additional controls. Extran it may be subject to additional controls. Existing major 10 and 10 addition, FDA may found in the Code of Federal Regulations, Title 21, Parts 800 to 898 - Regiter found in the Code of Tederal Regarations) This device in the Federal Register, {1}------------------------------------------------ Page 2 - Dr. Jamie Sulley 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. ff you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Bram D. Zuckerman, M.D. -Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Appendix B # Indications for Use Statement 510(k) Number (if known): Device Name: PulsioFlex Monitoring System with Optional CeVox ™ Accessories ### Indications for Use: With the optional CeVox™ oximetry module connected to a compatible PulsioFlex oximetry probe, PulsioFlex measures oxygen saturation to assess oxygen delivery in adults. The following tabular shows the parameters measured by the PulsioFlex monitor and its specifications: | Label | Unit | Lower Limit | Upper Limit | Accuracy* | Remark | |-------|------|-------------|-------------|-----------|-------------------| | SO2 | % | 1 | 99 | $\pm$ 2% | Valid from 40-99% | | SvO2 | % | 1 | 99 | $\pm$ 2% | Valid from 40-99% | | ScvO2 | % | 1 | 99 | $\pm$ 2% | Valid from 40-99% | 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 OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) · / (Division Sign-Off) Division of Cardiovascular Devices 510(k) Number Page 1 of 1 (Posted November 13, 2003)