MISTRAL CRITICAL CARE JET VENTILATOR AND ACCESSORIES

{0}------------------------------------------------ | AUG | 01 2002 | |-----|---------| |-----|---------| K012693 1 of 6 0074 # 510(k) Summary MISTRAL **ACUTRONIC** MEDICAL SYSTEMS rev1 This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. #### Submitter's name, address, telephone number, contact person, and date summary 1. prepared: - ACUTRONIC Medical Systems AG a. Fabrik im Schiffli CH 8816 Hirzel Tel. 0041 1 729 70 80 Fax. 0041 1 729 70 81 e-mail: p.cavelti@acutronic-medical.ch - Contact Person: Pius Cavelti b. Director Sales / Marketing - Date Summary Prepared: 21.06.2002 C. #### Name of device, including trade name and classification name: 2. - Trade/Proprietary Name: MISTRAL a. - Classification Name: Ventilator Continuous b. - ldentification of the predicate device or legally marketed device or devices to which 3. substantial equivalence is being claimed: | Company: | ACUTRONIC Medical Systems AG | |---------------|----------------------------------| | Device: | VS-200s Universal Jet Ventilator | | 510(k): | K900745C | | Date Cleared: | 04/29/91 | - A description of the device that is the subject of the 510(k), including explanation of 4. how the device functions, basic scientific concepts, significant physical and performance characteristics (design, material, physical properties): ### Airway pressure measurement: One of the key features of the MISTRAL is the safety concept to avoid having excessive pressures occurring in the patient's airways. To reach this goal, a high pressure resistant sensor with excellent resolution in the working range of 1 to 200 mbar is used. ### Display: A medium sized screen displays the main parameters of ventilation and allows quick information of the anaesthetist about the status of the ventilation. A graphic indication of the airway pressure makes quantitative reading possible and allows quick access for parameter changes. Special functions are activated in menus and displayed on the screen. | File: 510(k) Summary MISTRAL rev1 | Date: 15.02.2001 | Index: 01 | |-----------------------------------|------------------|-----------| |-----------------------------------|------------------|-----------| {1}------------------------------------------------ 0075 #### Air / Oxygen blender: The MISTRAL has a built in blender, which allows concentrations between 21 and 100 % oxygen. The access for changes is via a knob on the front panel. This parameter is accessible without going into menus, to allow a rapid change in case of emergency. The MISTRAL uses an oxygen sensor, which is calibrated each time the unit, is switched on. If the ventilator can't reach the selected FiO2, an alarm message appears on the screen, informing about a problem in the gas supply. #### Bypass flow: The MISTRAL has an additional outlet for gas, which is mechanically adjusted to 15 LPM and a concentration between 21 % and 100 %. This feature allows mask ventilation of the patient for induction in anaesthesia. #### Microprocessor and Memory: H8 532 (manufactured by Hitachi) Memory devices: 27C512 (several types available) DS1386 (manufactured by Dallas) 64kB EPROM 32kB RAM timekeeper external watchdoq Clock frequency 10MHz #### Sensors: 200 cmH2O pp-pressure sensor (Honeywell) monitoring pressure condition in Jet tube sampling on jet frequency max 2.5 samples per second 72.5 PSI driving-pressure sensor (Honeywell) monitoring driving pressure sampling rate maximum 200 ms #### Fault-Detection: #### PP sensor is periodically checked for disconnection, shortcut and defective membrane (period: depending on frequency setting) failure results in error message Driving pressure sensor is checked for disconnection & shortcut (period: depending on frequency setting) failure results in error message Oxygen sensor is periodically checked for disconnection, shortcut and capacity (period: depending on actual requlated difference capacity only in auto calibration mode (startup routine)) failure results in error message Full time gas input detection failure results in alarm message fully regulated oxygen concentration with timeout function failure results in alarm message | Company of the consisted on the comments of the comments of the comments of the comments of | | | |---------------------------------------------------------------------------------------------|------------------|-----------| | File: 510(k) Summary MISTRAL rev1 | Date: 15.02.2001 | Index: 01 | | | | | {2}------------------------------------------------ #### Alarm functions General information In case of an alarm, the Mistral will display the alarm message on the screen and an acoustic alarm sounds. The acoustic alarm is ceased as soon as the alarm condition is cleared. However, the screen message remains until it is confirmed by pressing the alarm reset button. If you press alarm reset button while the alarm conditions is not cleared, there is an alarm mute for 1 minute activated, which depresses the acoustic alarm for this period. The screen inverses to make the user aware that the alarm mute is active. ### The Mistral has an alarm concept to allow a safe use of the equipment for patient and operator. The following section shows the different alarm types and their sources: #### PP too high: This alarm is activated if the pressure in the Jet line remains above the set limit for the PP pressure. This alarm is a safety feature for the use of Jet Ventilation with single lumen catheters. It allows a security shut-off of the Jet Ventilator in case of an airway obstruction. #### System alarms #### General information - These alarms signal the user a state of improper function of the device. There is no immediate danger to the patient but the device should be replaced and serviced by authorised personal (exception: low level of pressure input). Specification and characteristics of the ventilation alarm #### Application: The ventilation device makes sure that max. oxygen level in the Jet ventilator is below a level of concern. The ventilation is periodically checked for ether disconnect (alarm level 1) or overload (alarm level 2)of the fan. This is an alarm which can not be disabled. Specification and characteristics of the FIO2 not adjustable alarm #### Application: The Flo2 not adjustable alarm is evoked as soon as the O2 level can not be adjusted because of any other reason than missing ether O2 or airway pressure. There could be a mechanical problem or a system malfunction of the O2 requlation. If the O2 sensor could not be calibrated this alarm is also set active. Specification and characteristics of the low O2 pressure alarm #### Application: The O2 pressure is continuously watched by the controller and goes on if there is not enough pressure on the O2 inlet. This is an alarm which can not be disabled. The alarm resets itself if pressure is sufficient. | File: 510(k) Summary MISTRAL rev1 | Date: 15.02.2001 | Index: 01 | |-----------------------------------|------------------|-----------| |-----------------------------------|------------------|-----------| {3}------------------------------------------------ Specification and characteristics of the low air pressure alarm #### Application: The air pressure is continuously watched by the controller and goes on if there is not enough pressure on the air inlet. This is an alarm which can not be disabled. The alarm resets itself if pressure is sufficient. Specification and characteristics of low bat alarm #### Application: Battery level is measured and in case of a worn out battery the message "low bat" is displayed instead of the time and date. There is no alarm going off because the battery is not used unless the power failure fault. This battery has not a data backup function. In case of "low bat" a replacement of the battery is sufficient. Specification and characteristics of Power failure alarm #### Application: Main line is less than 95 VAC the beeper on the back panel sounds with interval supplied by battery power. This is an alarm, which can not be disabled. Specification and characteristics of MAINTENANCE REQUIRED alarm #### Application: Mistral has an integrated timer function for servicing intervals. After one year, on the display the message "MAINTENANCE REQUIRED" appears. The unit may still be used, however, a service engineer must be called for servicing of the equipment to assure a proper function. ### Error functions #### Overview The error message signals a system malfunction. The error messages can be reset by the alarm button but if the malfunction is still detected the message immediately returns to the screen. In any of these cases the Monsoon needs a service. | Type of error | characteristic | |----------------------|--------------------------------------------------------------------| | PP sensor | the PP sensor is out of range (probably<br>disconnected or defect) | | DP sensor | the DP sensor is out of range (probably<br>disconnected or defect) | | O2 sensor is<br>weak | O2 signal is getting to weak replace the<br>sensor | | File: 510(k) Summary MISTRAL rev1 | Date: 15.02.2001 | Index: 01 | |-----------------------------------|------------------|-----------| |-----------------------------------|------------------|-----------| ## 0077 {4}------------------------------------------------ #### న. Statement of intended use: The MISTRAL Universal Jet Ventilator is designed to use for short term application in bronchoscopy and laryngoscopy. Indication for Use Jet ventilation applied with the Mistral Universal Jet Ventilator is useful in airway surgery, as it is performed in thoracic surgery units and ENT surgery. Jet ventilation is the optimal ventilation technique during the application of LASER light, where the presence of an ETT bears the risk for ignition, airway fire and burn injuries. Jet ventilation is useful for the removal of foreign bodies from the airway (e.g. after accidental aspiration of foreign bodies) via rigid bronchoscopes, for supplemental oxygenation during lung surgery (when the operated lung must be recruited for additional oxygenation, but may not be ventilated conventionally for surgical reasons), for surgery of the lower trachea close to the carina (when during the reconstruction phase, no tight airway sealing can be achieved), for radiation therapy of lung metastasis (when the tidal movements of the chest during spontaneous respiration or conventional ventilation would preclude the focusing of the radiation beam onto the target. # 0078 | File: 510(k) Summary MISTRAL rev 1 | Date: 15.02.2001 | Index: 01 | |------------------------------------|------------------|-----------| |------------------------------------|------------------|-----------| {5}------------------------------------------------ # 510(k) Summary MISTRAL 6 of 6 #### Statement of how the technological characteristics of the device compare to those 6. of the predicate or legally marketed device. | Technical feature | VS-200S | MISTRAL | Comment | |------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------| | EEP Limit<br>End Expiratory<br>Pressure Limit | Yes, measured in between<br>the pulses of Jet<br>insufflations. Valve opens<br>during pause to direct<br>pressure on pressure sensor | Yes, measured with a high<br>pressure resistant<br>pressure sensor.<br>Resolution 1 mbar | Due to<br>availability of<br>high pressure<br>resistant sensor,<br>quicker response<br>of the pressure<br>limit = increased<br>patient safety | | Display of EEP<br>pressure level | No | Yes, displayed after each<br>jet insufflation | Allows trend<br>information on<br>EEP pressure. | | Bypass flow | No | Yes, adjusted at factory<br>upon customer request.<br>Allows driving of nebulizer<br>or for continues flow for<br>anaesthesia induction | No need for<br>conventional<br>anaesthesia<br>machine for<br>induction | | Built-in air-oxygen<br>blender | No. Use of Bird blender | Yes, electronic blender | Compact size<br>without need for<br>external tubings | | Oxygen measurement | No. Need of separate<br>oxygen monitor | Yes, with automatic<br>calibration of sensor<br>during start-up procedure | Ease of use. | | Humidification | Yes, injection of distilled<br>water into jet nozzle | No | Experiences in<br>the past have<br>shown, that<br>injection of water<br>may create some<br>lesions in the<br>trachea if drop<br>size is too big. | | In-service information | No | Yes, message appears on<br>display when maintenance<br>is needed | Facilitates the in<br>hospital control<br>of equipment<br>servicing<br>conditions | | Flexible software for<br>future improvements | No, digital electronic, no<br>microprocessor | Yes, allows use of different<br>language for operator<br>without change of front<br>label. | Menu driven<br>operators<br>interface | | Inlet pressure<br>controlled by servo<br>valve | No | Yes, if pressure limit is<br>exceeded for more then 3<br>s, the inlet pressure valves<br>close for patient safety | In case of a jet<br>valve failure, the<br>inlet pressure is<br>shut off<br>automatically to<br>avoid<br>overpressure in<br>the patients lung | | File: 510(k) Summary MISTRAL rev1 | Date: 15.02.2001 | Index: 01 | 007 | |-----------------------------------|------------------|-----------|-----| |-----------------------------------|------------------|-----------|-----| {6}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, with the profiles overlapping each other. The logo is black and white. #### Public Health Service ## AUG 0 1 2002 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Acutronic Medical Systems AG C/O Terry Torzala, R.A.C. Official Correspondent Medical Equipment Development, Incorporated P.O. Box 85820 Tucson, Arizona 85754-5820 - K012693 Re: Trade/Device Name: Mistral Critical Care Jet Ventilator and Accessories Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: June 26, 2002 Received: June 26, 2002 Dear Mr. Torzala: 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. {7}------------------------------------------------ ## Page 2 - Mr. Torzala 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. 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely, Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ ## INDICATIONS FOR USE STATEMENT ### 510(k) Number (if known): K012693 Device Name: Mistral Universal Jet Ventilator . • . Indications For Use: 1. 1 The Mistral Universal Jet Ventilator is intended for use during bronchoscopy or laryngoscopy for applications up to 45 minutes duration on adults in a hospital or other clinical setting. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) CAuha Dental, Infection Control. neral Hospital Devi 510(k) Number K0612693 Prescription Use (Per 21 CFR 801.109) √ Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ A - 2 OR