PM-1000F+PATIENT MONITOR

{0}------------------------------------------------ # 510(K) Summary JAN 1 6 2009 This summary of 510(k) safety and effectiveness information is being submitted ın accordance with the requirements of SMDA 1990 and 21 CFR 807 92 The assıgned 510(k) number ıs K082887 | Submitter / Distributor | Advanced Instrumentations, Inc<br>6800 N W 77th Court<br>Miami, Fl 33166 | | | |-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|--| | | Registration # 1066270 | | | | | Telephone<br>Fax | 305-477-6331<br>305-477-5351 | | | Contact Person: | Jorge Millan, PhD<br>Email jmillan@hiatec org | | | | Manufacturer | Shenzhen Mindray Bio-medical Electronics Co , LTD<br>Mindray Building, Keji 12th Road South, Hi-tech<br>Industrial Park, Nanshan, Shenzhen, 518057, P R<br>China | | | | | Registration # | 3004365718 | | | | Tel<br>Fax | + 86-755-2658-2888<br>+ 86-755-2658-2680 | | - January 15, 2009 Date Prepared . # Name of the device: - Trade/Proprietary Name PM-1000F+ Patient Monitor . - Patient Monitor Common Name: . #### Classification. . | 21 CFR 870 2300 | Cardiac monitor (including cardiotachometer and rate alarm) | Class I | |-----------------|-------------------------------------------------------------|---------| | 21 CFR 870 1025 | Arrhythmia detector and alarm | Class I | | 21 CFR 870 1025 | Detector and Alarm, Arrhythmia | Class I | | 21 CFR 870 1025 | Monitor, ST Segment with Alarm | Class I | | 21 CFR 870 1130 | Non-Invasive blood pressure measurement system | Class I | | 21 CFR 870 1110 | Blood pressure computer | Class I | {1}------------------------------------------------ | 21 CFR 870 2910 | Clinical Electronic Thermometers-<br>Temperature Monitor with Probe | Class II | |-----------------|---------------------------------------------------------------------|----------| | 21 CFR 870 2700 | Oximeter, Pulse | Class II | | 21 CFR 870 2710 | Ear Oximeter, Pulse | Class II | | 21 CFR 868 1400 | Carbon Dioxide Gas Analyzer | Class II | | 21 CFR 868 1500 | Enflurane gas analyzer | Class II | | 21 CFR 868 1620 | Halothane gas analyzer | Class II | | 21 CFR 868 1700 | Nitrous Oxide gas analyzer | Class II | | 21 CFR 868 1720 | Oxygen gas analyzer | Class II | ### Legally Marketed Predicate Device. - PM-8000 Patient Monitor, Shenzhen Mindray Bro-medical K043348 Electronics Co . Ltd - PM-9000 Express Patient Monitor, Shenzhen Mindray Bio-medical K053234 Electronics Co . Ltd - PM Series Patient Monitors, Shenzhen Mindray Bıo-medical K070791 Electronics Co . Ltd #### Device Description. The PM-1000 F+ Patient Monitor is a battery or line-powered patient monitor The Patient Monitor acquires the physiological signals such as ECG, respiration (RES), non-invasive blood pressure (NIBP), saturation of pulse oxygen (SpO2), temperature (TEMP), invasive pressure (IBP), carbon dioxide (CO2) and anesthetic gases (AG) These physiological signals are converted into digital data and processed The PM 1000F+ Patient Monitor examines the data for alarm conditions and presents them on the color TFT display The Patient Monitor also provides advantageous operating control for the user The optional built-in recorder, the optional CF memory card provides hard copies of all digital data and waveforms as well as tabular and graphic trend information, and storage the previous monitoring data information when power off accidentally #### Statement of Intended Use. The PM-1000F+ Patient Monitor is a vital sıgns monıtor used on human patıents The target populations are adult, pediatric and neonatal patients The PM-1000F+ Patient Monitor has many features and functions Its use is through an ıntegrated keypad. knob, and intuitive menu system The patient parameters that can be monitored by the PM-1000F+ are ECG (3-Lead or 5-Lead selectable), arrhythmia detection, ST segment analysis Heart Rate (HR), Respiration Rate (RESP), Non-invasive Blood Pressure (NIBP), Pulse Oxygen Saturation (SpO2), Temperature (TEMP), Invasive Blood Pressure (IBP), Carbon Dioxide (CO2), and Anaesthetic Gases (AG) Its design allows the operator to adjust the settings of parameter alarms that audibly and visually notify the operator when an excursion occurs {2}------------------------------------------------ The PM-1000F+ Patient Monitor is intended for use in hospital clinical areas such as intensive care units, cardiac care units, operating room, emergency department, to provide additional information to the medical and nursing staff about the physiological condition of the patient The PM-1000F+ Patient Monitor ıs intended to be used only under regular supervision of clinical personnel and by qualified medical personnel trained in the use of the equipment The intended location of use is clinics The PM-1000F+ Patient Monitor is not intended or recommended for use in a patient's home or residence, or when it has not been ordered by a physician ## Comparison of Technological Characteristics: The PM-1000F+ Patient Monitor is substantially equivalent to systems currently marketed predicate devices The design, components, storage technology and energy source the PM-1000F+ Patient Monitor are similar to the predicate devices The PM-1000F+ provides a means for interfacing with a patient, collecting parameter specific physiological data, and processing the data for alarm generation and display of numeric values and waveforms on a bedside or central monitoring system The parameter's specification of the PM-1000F+ ıncludıng ECG, RESP, HR, PR, RESP, NIBP, SpO2, CO2, TEMP, IBP, IS ıdentıcal to the predicate devices ## Testing Testing was conducted to validate and verify that the PM-1000F+ Patient Monitor met all design specifications and was substantially equivalent to the predicate devices Testing was performed to demonstrate compliance with the ANSI/AAMI standards EC13-2002, "Cardiac monitors, heart rate meters, and alarms " The PM-1000F+ has also been tested to assure compliance with the requirements of various published standards, including IEC60601-1, IEC60601-1-1, IEC60601-1-2, IEC60601-1-4, IEC60601-2-27, IEC60601-2-30 and ISO14971 ## Conclusion: The conclusions drawn form clinical and bench testing of the PM-1000F+ Patient Monitor demonstrates that the device is as safe, as effective, and performs as well to the legally marketed predicate device {3}------------------------------------------------ Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Advanced Instrumentations, Inc c/o Jorge Millan, PhD Hialeah Technology Center 601 W 20th Street Hialeah, FL 33010 JAN 1 6 2009 K082887 Re PM-1000F+ Patient Monitor Regulation Number 21 CFR 870 2300 Regulation Name Cardiac monitor (including cardiotachometer and alarm) Regulatory Class Class II (two) Product Code DSIMWI Dated December 22, 2008 Received December 22, 2008 Dear Dr Mıllan 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, Insting 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 1151-1600 - 115 11 25 25 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 {4}------------------------------------------------ Page 2- Dr Jorge Millan 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 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 Office of Compliance at (240) 276-0120 Also, please note the regulation entitled, "Mısbrandıng by reference to premarket notification" (21CFR Part 807 97) You may obtain other general information on your responsibilities under the Dryision 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, and the may be the state of the minister Bram D Žuckerman, M D Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure IKE LA 18 12 2017 {5}------------------------------------------------ #### Indications for Use #### 510(k) Number (if known) K082887 #### Device Name PM-1000F+ Patient Monitor #### Indications For Use The PM-1000F+ Patient Monitor is a vital signs monitor used on human patients The target populations are adult, pediatric and neonatal patients The patient parameters that can be monitored with the PM-1000F+ Patient Monitor are ECG(3-lead or 5-lead selectable), Heart rate (HR), Pulse Rate (PR), Respiration rate (RESP), Non-invasive blood pressure (NIBP), Saturation of Pulse Oxygen (SpO2), Temperature (TEMP), Invasive Blood pressure (IBP), Carbon dioxide (CO2) and Anaesthetic gases (AG) Its design allows the operator to adjust the settings of parameter alarms that audibly and visually notify the operator when an excursion occurs This monitor is intended for use in a health care facility setting It is intended for use by qualified medical personnel trained in the use of the equipment The PM-1000F+ Patient Monitor is not recommended for use in a patient's home or residence, or when it has not been ordered by a physician 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) **510(k) Number** K082587