MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTION

{0}------------------------------------------------ K991955 # Engineered Medical Systems ISO 9001 Certified 2055 EXECUTIVE DRIVE • INDIANAPOLIS, IN 46241 • (317) 246-5500 • FAX (317) 246-5501 Non-Confidential Summary of Safety and Effectiveness | | page 1 of 3 | |--------------------------------------------------------|------------------------------------------------------------------| | | May 28, 1999 | | Engineered Medical Systems, Inc.<br>2055 Executive Dr. | Tel - (317) 246-5500 | | Indianapolis, IN 46241 | Fax - (317) 246-5501 | | Official Contact: | Bonnie Holly - Quality Manager | | Proprietary or Trade Name: | EMS Disposable Manual Resuscitator with CO₂ Detection | | Common/Usual Name: | Disposable Manual Resuscitator with CO₂ Detection | | Classification Name: | Emergency Manual Ventilator Resuscitator | | Device: | EMS Disposable Manual Resuscitator with CO₂ Detection | | Predicate Devices: | EMS Disposable Manual Resuscitator with CO₂ Detection - | | | K912203B and K924610A | | | Nellcor Puritan Bennett - DMR2 Plus Manual Resuscitator with CO₂ | | | Detection - K973419 | | | Nellcor Puritan Bennett - EasyCap CO₂ Detector - K894053 and | | | K944400 | Device Description | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 12 - 102 The EMS Disposable Manual Resuscitator is a bag-valve-mask device with the capability of delivering supplemental oxygen. It incorporates a feature CO2 detection. Intended Use - - Real 11 - 30 | Indicated Use -- | Intended for use where pulmonary support resuscitation is indicated and<br>exhaled CO₂ detection is desirable. | |------------------|----------------------------------------------------------------------------------------------------------------| |------------------|----------------------------------------------------------------------------------------------------------------| Environment of Use --Hospital, Transport, Mobile and Home settings {1}------------------------------------------------ ## Non-Confidential Summary of Safety and Effectiveness page 2 of 3 #### May 28, 1999 # Comparison to Predicate Devices: 11 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - | Attribute | EMS DMR<br>with CO₂<br>(Modification) | EMS DMR<br>K912203B<br>K924610A | NPB DMR<br>Plus with<br>CO₂<br>K973419 | |----------------------------------------------------------------------------------|---------------------------------------|---------------------------------|----------------------------------------| | Use | | | | | Intended to provide manual<br>ventilatory support | Yes | Yes | Yes | | Intended to assist in verification of<br>tube placement by expired CO₂ detection | Yes | -- | Yes | | Used in hospitals, home, transport<br>mobile settings | Yes | Yes | Yes | | Single Patient Use | Yes | Yes | Yes | | Design | | | | | CO₂ detector placed on expiratory<br>port of manual resuscitator | Yes | -- | Yes | | CO₂ detection by color comparison | Yes | -- | Yes | | CO₂ detector good for up to 2 hours | Yes | -- | Yes | | Can be replaced if needed | Yes | -- | Yes | | Materials | | | | | Materials in CO₂ detection media the<br>exactly the same as predicate | Yes | -- | Yes | | All other materials exactly the<br>same as predicate | Yes | Yes | -- | | Packaging | | | | | Provided clean, non-sterile | Yes | Yes | Yes | | Performance Standards / Specifications | |----------------------------------------| |----------------------------------------| | None applicable under Section 514 | Yes | Yes | Yes | |-----------------------------------|-----|-----|-----| |-----------------------------------|-----|-----|-----| {2}------------------------------------------------ ## Non-Confidential Summary of Safety and Effectiveness page 3 of 3 May 28, 1999 ### Differences Between Other Legally Marketed Predicate Devices - Predicate Device College Co There are no differences between the proposed modification, that of adding CO2 detection capabilities to the exhalation port of the manual resuscitator, and the predicates. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three horizontal lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL - 6 1999 Ms. Bonnie Holly Engineered Medical Systems 2055 Executive Drive Indianapolis, IN 46241 Re: K991955 Disposable Manual Resuscitator with CO2 Detection Requlatory Class: II (two) Product Code: 73 BTM Dated: May 28, 1999 Received: June 1, 1999 Dear Ms. Holly: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {4}------------------------------------------------ Page 2 - Ms. Bonnie Holly This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 yours, Thomas J. Callahon Thomas J. Vallahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ #### INDICATIONS FOR USE Pursuant to the Notice of February 6, 1996 regarding listing of Indications for Use on a separate sheet, the following is per that request. | 510(k) Number: | (To be assigned) | |----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name: | EMS Disposable Resuscitator with CO2 Detector | | Intended Use : | Disposable manual resuscitator with CO2 detection for use with patients requiring manual ventilatory support. The CO2 detector is located on the expiratory port. It may be supplied separately and attached to any resuscitator expiratory port. The CO2 detector assists in verification of the endotracheal tube placing during endotracheal or nasotracheal intubation. The CO2 detector detects approximate ranges of CO2 by color comparison. It is intended for use by qualified healthcare professionals in any environment where pulmonary support resuscitation is indicated such as in the hospital, transport, mobile or home settings. | Concurrence of CDRH, Office of Device Evaluation (ODE) Arle A. Ciarkowski. Respiratory. Prescription Use _ > (Per CFR 801.109) or Over-the-counter use _________________________________________________________________________________________________________________________________________________________