HLR MODEL 601 HEART LUNG RESUSCITATOR AND HEARTSAVER 100

{0}------------------------------------------------ # MEDICAL PRODUCTS MFG. LLC ## SPECIAL 510K ### 510(k) Summary HLR™ Model-601 Heart Lung Resuscitator and HeartSaver 100 ### 1. SPONSOR Medical Products Mfg., LLC. 6 Thacher Lane Wareham, MA 02571 508-291-1830 SEP 2 2 2006 Contact: John R. Driscoll, General Manager Date Prepared: July 24, 2006 ### DEVICE NAME 2. : : Proprietary Name: HLRTM Model-601 and HeartSaver 100 Common/Usual Name: Heart-lung resuscitator Classification Name: Unclassified #### PREDICATE DEVICES 3. Pre-Amendment HLR® PARA-MED™ Heart Lung Resuscitator #### DEVICE DESCRIPTION 4. HLR Model-601 Heart Lung Resuscitator and the HeartSaver 100 are modifications to the pre-Amendment HLR® PARA-MED™ Heart Lung Resuscitator. The HLR Model-601 Heart Lung Resuscitator and the HeartSaver 100 are compact, totally portable, automatic CPR Devices. The HLR Model-601 and the HeartSaver 100 are air-powered medical devices used for emergency resuscitation of patients who have stopped spontaneous breathing. The HLR Model-601 and the HeartSaver 100 provide automatic chest compressions and ventilation per the current American Heart Association Guidelines. The devices can control the depth of chest compressions and the volume of ventilation. The HLR Model-601 and the HeartSaver 100 allow the trained user three options of compression to ventilation ratios (30:2), (15:2) and continuous chest compressions without ventilation. July 24, 2006 {1}------------------------------------------------ MEDICAL PRODUCTS MFG. LLC. ### SPECIAL 510K #### ട്. INTENDED USE The HLR Model-601 Heart Lung Resuscitator and the HeartSaver 100 are intended to be used as adjuncts to manual CPR on patients in cardiac arrest. The HLR Model-601 and the HeartSaver 100 are designed for use on adults or large children and should be administered by trained medical personnel. #### 6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE The HLR Model-601 and the HeartSaver 100 are substantially equivalent to the parent device for intended use and indications for use as well as the basic overall functions. #### 7. PERFORMANCE TESTING Verification and validation testing demonstrated that the modified devices, the HLR Model-601 and the HeartSaver 100 conform to design and performance specifications. {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle. ### SEP 2 2 2006 Medical Products Manufacturing, LLC c/o Mr. John R. Driscoll General Manager 6 Thacher Lane Wareham, MA 02571 Re: K062119 HLRTM Model 601 Heart Lung Resuscitator and Heartsaver 100 Regulation Number: 21 CFR 870.5200 Regulation Name: External Cardiac Compressor Regulatory Class: Class II (two) Product Code: DRM Dated: September 14, 2006 Received: September 15, 2006 Dear Mr. Driscoll: 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. {3}------------------------------------------------ Page 2 - Mr. John R. Driscoll 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 that I Drineal statutes and regulations administered by other Federal agencies. You must or any i 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-dessions 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, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, prima R. Willing Image /page/3/Picture/6 description: The image shows a handwritten signature or symbol on the left, followed by the letters 'E' and 'D' on the right. The signature appears to be a stylized, looping design, possibly initials. The letters 'E' and 'D' are printed in a simple, sans-serif font and are positioned closely together. Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## MEDICAL PRODUCTS MFG. LLC. ### SPECIAL 510K K062119 510(k) Number (if known): Device Name: HLR™ Model-601 Heart Lung Resuscitator and HeartSaver 100 Indications For Use: The HLR™ Model-601 Heart Lung Resuscitator and the HeartSaver 100 are intended for use as adjuncts to manual CPR on patients who are non-breathing, unconscious, pulseless and in urgent need of cardiopulmonary resuscitation. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Duna R. V. Aunes (Division Sign-Off) Division of Cardiovascular Devices 510(k) Number_K 062119