UNI-VENT (R) MODEL 731 SERIES PORTABLE CRITICAL CARE VENTILATOR

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for IMPACT Instrumentation Inc. The logo features the company name in bold, uppercase letters above a world map. The word "IMPACT" is also written in large, bold letters across the center of the world map. The image is in black and white. 27 Fairfield Place, West Caldwell, NJ 07006. P.O Box 508, West Caldwell, NJ 07007-0508 FEB 1 6 2012 # 510(k) Summary This 510(k) summary consists of a table with the information required in the 510(k) Summary Checklist from the FDA Guidance document. | Description of Required<br>Information | Information | |----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Owner's Name | Leslie H. Sherman (President) | | Address | 27 Fairfield Place, West Caldwell NJ 07006 | | Phone | 973-882-1212 | | Fax | 973-882-4993 | | Contact Person | Susan McNevin Ph.D., CQE/CQA<br>Quality Engineer, Impact Instrumentation, Inc. | | Date this Summary was<br>prepared | December 28, 2010 | | Trade name of device | Uni-Vent® Model 731 Series Portable Critical Care Ventilators<br>Versions:<br>EMV+®<br>EMV+®- MRI version<br>Eagle IITM<br>Eagle IITM - MRI version<br>AEV®<br>AEV®- MRI version | | Common name | ventilator | | Classification name | Continuous Ventilator (21 CFR 868.5895, Product Codes CBK,<br>DQA) | | Legally marketed device –<br>Equivalence Claim | Uni-Vent® Model 731 Series Portable Critical Care Ventilators<br>(K103318). | | Description of the device | The below is taken from the Operation Manual:<br>● The Model 731 Ventilators are a small, extremely<br>durable, full-featured portable mechanical ventilators | | Description of Required<br>Information | Information | | | designed to operate in hospitals or austere and under-<br>resourced environments. | | | The unit is a volume and pressure targeted, time or<br>flow cycled ventilator designed to use either oxygen (O2)<br>from a 55 psig source or fresh air using its internal<br>compressor to deliver a positive pressure breath. The unit contains a pulse oximeter which is intended<br>for continuous noninvasive monitoring of arterial<br>hemoglobin (SpO2) and pulse rate (measured by the SpO2<br>sensor). The unit contains various controls and indicators that<br>are placed to facilitate ease of use and visibility in all<br>operating environments. A liquid crystal display (LCD)<br>provides continuous display of control settings, operating<br>conditions, power, and alarm status information. The unit uses a comprehensive suite of alarms to alert<br>the operator and guide their actions to resolve the alarm<br>condition and assure patient safety. At the onset of an alarm,<br>the screen displays the alarm name and then a series of<br>context-sensitive help messages. These messages serve to<br>guide the operator by presenting suggestions as to the cause<br>and resolution of a particular alarm. When multiple alarms<br>occur they are prioritized and displayed based on the risk to<br>the patient. The unit offers a range of modes using both pressure<br>and volume targeting that can be selected to optimally<br>manage the patient. Assist/Control (AC): patient receives either controlled<br>or assisted breaths. When the patient triggers an<br>assisted breath they receive a breath based on either<br>the volume or pressure target.<br><br>Synchronized Intermittent Mandatory Ventilation<br>(SIMV): patient receives controlled breaths based on<br>the set breathing rate. Spontaneous breaths can be<br>either unsupported demand flow or supported using<br>Pressure Support. (This mode is not available in the<br>AEV® unit.)<br><br>Continuous Positive Airway Pressure (CPAP): patient<br>receives constant positive airway pressure while<br>breathing spontaneously. Spontaneous breaths can | | Description of Required<br>Information | Information | | | be either demand flow or supported using Pressure<br>Support. | | | • The unit contains a built-in back up ventilator mode<br>that is designed to provide a limited degree of operation<br>should certain types of failures occur to the primary<br>operating system. | | | • The unit can be used in environments where chemical<br>and/or biological toxins are present. To do this safely, all gas<br>delivered to the patient comes from either a pressurized<br>medical-grade O₂ source and/or filtered ambient air<br>entrained through the FRESH GAS/EMERGENCY AIR INTAKE.<br>Operators can chose between a bacterial/viral filter and a<br>chemical/biological filter based on the direction of the<br>Medical Control Officer. To prevent the patient from<br>breathing contaminated ambient air in the event of a<br>ventilator failure, the unit contains an internal anti-asphyxia<br>valve that allows the patient to inspire gas through the<br>external filter. | | | • The unit continuously monitors environmental<br>conditions (temperature and ambient pressure) and when<br>extreme environments are detected the operator is alerted<br>by a low priority alarm which defines the operating condition<br>and prompts the actions of the operator. | | | • The unit uses a rechargeable lithium-ion battery<br>which offers a wide temperature operating range, does not<br>exhibit "memory" characteristics (reduced capacity) or vent<br>hydrogen gas. | | | • The unit can use O₂ from low flow sources, O₂ flow<br>meters and O₂ concentrators, to provide supplemental O₂ to<br>patients. To do this, O₂ is entrained through the Fresh<br>Gas/Emergency Air Intake when the unit's internal<br>compressor cycles to deliver a breath. | | | • The testing in MRI environment was done with a 3.0 T<br>Siemens Trio scanner, which has a magnetic field of 0.2 T<br>(500 gauss) at a distance of slightly more than 1 meter (~3.3<br>feet) from the bore entrance. There was no effect on either<br>the ventilator functionality or the MRI performance at a<br>distance of 2 meters. | | Intended Use of Device | The Intended Use is taken from the Operation Manual:<br>The devices in the Model 731 Ventilator Series are indicated<br>for use in the management of infant through adult patients<br>weighing ≥5 kg with acute or chronic respiratory failure or | | Description of Required<br>Information | Information | | Comparison Technological<br>Characteristics to Predicate | during resuscitation by providing continuous positive-<br>pressure ventilation. They are appropriate for use in<br>hospitals, outside the hospital, during transport and in<br>austere environments where they may be exposed to rain,<br>dust, rough handling and extremes in temperature and<br>humidity. With an appropriate third-party filter in place, they<br>may be operated in environments where chemical and/or<br>biological toxins are present (see External Filter Use). When<br>marked with an “MRI conditional” label, they are suitable for<br>use in an MRI environment with appropriate precautions, as<br>defined in the Operation Manual. They are <b>not</b> intended to<br>operate in explosive environments. The Model 731<br>Ventilators are intended for use by skilled care providers with<br>knowledge of mechanical ventilation, emergency medical<br>services (EMS) personnel with a basic knowledge of<br>mechanical ventilation and by first responders under the<br>direction of skilled medical care providers. The EMV+® and<br>Eagle II™ (with and without MRI label) have a full range of<br>ventilation modes (AC, SIMV, CPAP with PS and NPPV-PPV).<br>The AEV® (with and without MRI label) provides specific<br>modes consistent with pre-hospital care provider’s operating<br>procedures (AC, CPAP with PS and PPV).<br><br>The only difference in this Intended Use from the Predicate is<br>the addition of operation in an MRI environment.<br>There is no change in either the software or the hardware.<br>The only difference is external conditional MRI label and<br>Operation Manual. | Section 5 – 510(k) Summary {1}------------------------------------------------ {2}------------------------------------------------ r . {3}------------------------------------------------ {4}------------------------------------------------ | Description of Required<br>Information | Information | |----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Non-Clinical Performance<br>data | It was demonstrated that there was no effect on<br>either the ventilator functionality or the MRI performance at<br>a distance of 2 meters from a 3.0 T Siemens Trio scanner,<br>which has a magnetic field of 0.2 T (500 gauss) at a distance<br>of slightly more than 1 meter. This test meets the acceptance criteria defined in<br>FDA Draft Guidance "A Primer on Medical Device<br>Interactions with Magnetic Resonance Imaging<br>systems" Location of testing: passed Imaging sequence: passed Effect on Medical Device: passed Generation of Artifact/Noise: passed The longer breathing circuit required for MRI<br>operation passed testing to ASTM F1100 requirements. Section 5.3 Waveform Performance: passed Section 5.4 Volume Performance: passed | | Clinical Performance | N/A. No clinical performance data is being submitted. | | Safe and Effective as | The testing demonstrates that these devices are as safe and | | Predicate | effective and performs as well as or better than the Predicate<br>device (K103318). | | Other Information requested | Impact Instrumentation, Inc. will provide the FDA with any | | by FDA | additional required information. | · · : . ، . {5}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. 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 resembling an eagle or bird in flight, composed of three curved lines. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002 Ms. Susan McNiven Quality Engineer Impact Instrumentation, Inc. 27 Fairfield Place West Caldwell, New Jersey 07006 FEB 1 6 2012 Re: K111473 Trade/Device Name: Uni-Vent® 731 Series Model Portable Critical Care Ventilator Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: September 2, 2011 Received: February 1, 2012 Dear Ms. McNevin: 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. {6}------------------------------------------------ Page 2 - Ms. McNevin 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 (reporting of measur 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 Somplikation" (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, hh for 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 {7}------------------------------------------------ ## Indications for Use 510(k) Number (if known): | | | | | 7 2 Device Name: Uni-Vent®) 731 Series Model Portable Critical Care Ventilator Indications For Use: (the text in red shows Additions to Predicate device) #### INTENDED USE The devices in the Model 731 Ventilator Series are indicated for use in the management of infant through adult patients weighing ≥5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure ventilation. They are appropriate for use in hospitals, outside the hospital, during transport and in austere environments where they may be exposed to rain, dust, rough handling and extremes in temperature and humidity. With an appropriate third-party filter in place, they may be operated in environments where chemical and/or biological toxins are present (see External Filter Use). When marked with an "MRI conditional" label, they are suitable for use in an MRI environment with appropriate precautions, as defined in the Operation Manual. The Model 731 Ventilators are intended for use by skilled care providers with knowledge of mechanical ventilation, emergency medical services (EMS) personnel with a basic knowledge of mechanical ventilation and by first responders under the direction of skilled medical care providers. The EMV+® and Eagle II'" (with and without MRI label) have a full range of ventilation modes (AC, SIMV, CPAP with PS and NPPV-PPV). The AEV® (with and without MRI label) has a more limited range of ventilation modes for less sophisticated operators (AC, CPAP with PS and PPV). AND/OR Over-The-Counter Use × Prescription Use (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) L. Schullte Division Sign-Off) ivision of Anesthesiology, General Hospital fection Control, Dental Devices 10(k) Number: K111473- Section 4 -- Statements of Indications for Use