DATEX ENGSTOM MANUAL RESUSCITATOR

{0} Datex Engstrom K970991 Non-Confidential Summary of Safety and Effectiveness page 1 of 3 March 12, 1997 JUN 16 Datex Engstrom AB Box 20109 S-16102 Bromma SWEDEN Tel - 011-46-8-629-3100 Fax - 011-46-8-298418 Official Contact: Arne Salo, President Proprietary or Trade Name: Datex Engstrom reusable manual resuscitator Common/Usual Name: Manual resuscitator Classification Name: Ventilator, Emergency, Manual (Resuscitator) Device: Datex Engstrom Reusable Manual Resuscitator Predicate Devices: Hudson RCI - Durable Manual resuscitator - K895589 Hudson RCI - PEEP valves - K902062 ## Device Description: The Datex Engstrom manual resuscitator is designed for use as an adjunct to artificial respiration and CPR. It can be used to ventilate the apnoeic patient and to augment ventilation and / or oxygen delivery to the spontaneously breathing patient. Indicated Use -- Provide assisted ventilation Environment of Use -- Emergency medical services, hospital, patient transport, Operating Room (OR), and where assisted ventilation may be required. Patient population -- Adult, child and infant ## Comparison to Predicate Devices: Datex-Engstrom AB Postadress/Postal address Box 20109 Gatuadress/Visiting address Karlskrona-ager 18 Telefon/Telephone Nat 08-629 31 00 Telefax Nat 08-29 84 18 Reg Nr/VAT No 536044-63-4 {1} # Non-Confidential Summary of Safety and Effectiveness (continued) page 2 of 3 March 12, 1997 | Attribute | Datex-Engstrom | Hudson RCI | | --- | --- | --- | | **Use** | | | | Intended for use an adjunct to artificial respiration and CPR | Yes | Yes | | Can be used to ventilate apnoeic patients | Yes | Yes | | Augment ventilation and / or oxygen delivery to spontaneously breathing patients | Yes | Yes | | Environment of use - Hospital, OR, anesthesia, PACU, ICU, transport, EMS, where assisted ventilation may be required or needed | Yes | Yes | | Intended for use by qualified medical and emergency personnel trained in pulmonary ventilation and advanced cardiac life support techniques | Yes | Yes | | Indicated for cleaning and reuse | Yes | Yes | | Indicated population - adult, child, infant | Yes | Yes | | **Design / Theory of Operation** | | | | Connects to a Face mask or endotracheal tube | Yes | Yes | | Has four major components | | | | Rebreathing valve, Silicone bag, Reservoir valve, Oxygen reservoir | Yes | Yes | | May incorporate a PEEP valve | Yes | Yes | | Available is three (3) sizes | Yes | Yes | | Has available oxygen reservoir | Yes | Yes | page 5 of 76 {2} Page 6 of 76 # Non-Confidential Summary of Safety and Effectiveness (continued) page 3 of 3 March 12, 1997 | Attribute | Datex-Engstrom | Hudson RCI | | --- | --- | --- | | **Design / Theory of Operation** | | | | Fits to standard 15 / 22 mm patient end fittings | Yes | Yes | | Offered with standard reusable face mask - various styles | Yes | Yes | | May be taken apart and cleaned | Yes | Yes | | Cleaning methods - autoclave, EtO | Yes | Yes | | **Materials** | | | | Bag and duckbill valve - silicone | Yes | Yes | | Patient connector, housing parts made of Polysulfone | Yes | Yes | | Pop-off valve - aluminum | Yes | Yes | | PEEP valve spring stainless steel | Yes | Yes | | Face mask - silicone or PVC | Yes | Yes | | Reservoir bag - PVC | Yes | Yes | | **Performance Standards / Specifications** | | | | Patient fittings - 15 / 22 mm ASTM 1054 / ISO 5356 | Yes | Yes | | Meets all specifications, testing and requirements of ASTM 920 / ISO 8382 | Yes | Yes | | **Differences between Other Legally Marketed Predicate Devices** | | | | There is no differences between the intended device and the predicate devices which would be significant to patient safety or effectiveness. | | | {3} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN 16 1997 Mr. Paul Dryden Datex Engstrom AB c/o ProMedic, Inc. 6329 W. Waterview Court McCordsville, Indiana 46055-9501 Re: K970991 Datex-Engstrom Medical Reusable Manual Resuscitator Regulatory Class: II (two) Product Code: 73 BTM Dated: March 13, 1997 Received: March 19, 1997 Dear Mr. Dryden: 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 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. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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 {4} Page 2 - Mr. Paul Dryden can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (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. 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 the labeling regulation (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/dsmamain.html". Sincerely yours, Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5} JUN 16 1991 # SECTION 3 INDICATIONS FOR USE Page 1 of 1 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: K970991 (To be assigned) Device Name: Reusable Manual Resuscitator Intended Use: To ventilate the apnoeic patient and to augment ventilation and / or oxygen delivery to the spontaneously breathing patient. For use as an adjunct to artificial respiration and cardiopulmonary resuscitation. Environment of use: Hospital - Emergency Medical Services, Operating Room, during patient transport, Intensive Care Units, where patient assisted ventilation may be administered or required. Concurrence of CDRH, Office of Device Evaluation (ODE) Christy Foreman (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number K970991 Prescription Use ☑ (Per CFR 801.109) or Over-the-counter use ☐ Page 10 of 76