AM-6000 ANESTHESIA MACHINE

{0}------------------------------------------------ # 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 SMDA 1990 and 21 CFR 807.92. 120075 The assigned 510(k) number is: Submitter Advanced Instrumentations, Inc. 6800 N.W. 77" Court Miami, FI 33166 305-477-6331 Telephone: 305-477-5351 Fax: Registration # 1066270 ### Official correspondent : Jorge Millan, PhD Email: jmillan@hiatec.org 601 West 20 St Hialeah, FL 33010 Phone : (305) 925-1260 Date Prepared: January 6, 2012 Device name and classification: - AM-6000 Anesthesia Machine . Device Name: - Classification Name: 868.5160 System, Gas-Machine, Anesthesia ● Product code: BSZ - II Regulatory Class: ● {1}------------------------------------------------ AM-6000 Anesthesia Machine. ### Predicate Device: Navigator Anesthesia Delivery System. K080175 Manufacturer: AS3000 Datascope Corp. ### Device Description: The AM-6000 Anesthesia Machine is a continuous flow Anesthesia Machine which offers manual or automatic vehtilation, easily adjustable fresh gas delivery, anesthetic agent delivery, ventilation monitoring, convenient ergonomics, and state-of-the-art safety systems. The AM-6000 is designed to decrease the risk of hypoxic mixtures and the inadvertent movement of the air flow control knobs. Additionally, the AM-6000 provides battery power in the event of an AC power outage. Multiple ventilation modes, i.e., CMV, PCV, SIMV and PSV, are offered by the AM-6000 with electronic PEEP available in each of the modes. The fresh gas dosing subsystem offers features of a traditional Anesthesia Machine along with dual flow tubes which display the gas flows at all times. The AM-6000 contains two vaporizers and a heated breathing system to minimize condensation and return moisture to the patient. #### Indications for Use: The AM-6000 Anesthesia machine is intended for general anesthesia use. The AM-6000 Anesthesia machine will delivery operator set concentrations of oxygen and anesthesia gases as well as deliver controlled breaths to the patient with either a constant or a deceleration flow pattern. AM-6000 Anesthesia machine is also intended to allow for the provision of manual ventilation. Intended operator: The AM-6000 Anesthesia machine is intended for use by Healthcare professionals who are trained in the administration of anesthesia. Intended Patient Populations: The AM-6000 Anesthesia machine is intended for use on the neonatal to adult patient populations in all ventilation modes. Intended Use Environment: The AM-6000 Anesthesia machine is intended to be used in the environments where anesthesia is to be administered by Healthcare professionals trained in administering anesthesia. {2}------------------------------------------------ # Effectiveness and Safety Contraindications: ### Clinical Test Clinical testing is not required ### Non-clinical test: Non-Childer, Color Anesthesia Machine has been tested and found to be in The AM-6000 Anesthesia Machine has been lested and found to and to and and compatibility standards. compansion in the been developed to identify potential hazards and document A risk and the becards. The device's software has been validated in A risk analysis has been developed to ldentify potchtian has been validated in the mitigation of the hazards. The device's software has been validated in A the mitigation of the hazards. The devices sontware for the Content accordance with the requirements set forth in the FDA Guidanes for the Content the more with the requirements set form in the PDA Guidanee Contained in Medical Devices (May 11, 2017) 2005). ### Comparison to the predicate device: on has similar technology characteristics and has the same The subject device to tarial components, same manufacturing process, same The subject device has similar technology charactering process, same intended use, same material components, same measurement mode and intended use, same material classification, same measurement mode and design principle, same electrication, same measurement mode and intended use, same electrical classifica design principle; sun predicate device. # Substantially Equivalent Determination: Verification and validation testing was done on the AM-6000 Anesthesia Verification and validation testing was done on "the "Ath" on the Press. Machine. This premarket notification demonstrates that AM-6000 Machine. This premains that starticles Machine. This premarket notification Submission Submittee device. {3}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Advanced Instrumentations, Incorporated C/O Dr. Jorge Millan Official Correspondent Hialeah Technology Center, Incorporated West 20th Street Hialeah, Florida 33010 JAN 2 6 2012 Re: K120075 Trade/Device Name: AM-6000 Anesthesia Machine Regulation Number: 21 CFR 868.5160 Regulation Name: Gas Machine for Anesthesia or Analgesia Regulatory Class: II Product Code: BSZ Dated: January 6, 2012 Received: January 10, 2012 Dear Dr. Millan: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Eederal Register. {4}------------------------------------------------ #### Page 2 - Dr. Millan 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. If 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.htm 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, Susan Runoie Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ### Indications for Use 510(k) Number (if known): Device Name: AM-6000 Anesthesia Machine Indications for Use: Indications for of on the is intended for general anesthesia use. The The AM-6000 Anesthesia machine is intended for generations of oxygen AM-6000 Anesthesia machine will delivery operator set concentrations of oxygen He All-6000 Anesthesia machine will deliver controlled breaths to the path with with with with with with with with AM-6000 And either a constant of a deceleration now pation of manual ventilation. also intended to allow for the provision of manual ventilation. Intended operator: Intended operator: The AM-6000 Anesthesia machine is intended for use by Healthcare the AM-6000 Annest sinced in the administration of anesthesia. The AM-6000 Anesthesia machine Is Internation of anesthesia. professionals who are trained in the administration of anesthesia. Intended Patient Populations: Intended Patient Populations The AM-6000 Anesthesia machine is intended for use on the neonatal to adult in the AM-6000 Anaily of vestigation modes The AM-6000 Ancothoold The All ventilation modes. Intended Use Environment:1 Intended Use Environment. The AM-6000 Anesthesia machine is intended to be used in the environments in The AM-6000 Anesthesia machine is intended to be used in the ender the comments. where anesthesia is to be administered by Healthcare professionals trained in administering anesthesia. inistering anesthesia. Prescription Use _X_ | resoription 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) L. Schulten (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices Page 1 of __ 1__ 510(k) Number: K120075