ROSC-U Mini Chest Compressor (RMCC)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 30, 2016 Resuscitation International, LLC Havden Fleming Chairman and CEO 17797 N Perimeter Drive, Suite #105 Scottsdale, AZ 85255 Re: K153628 Trade/Device Name: ROSC-U Mini Chest Compressor (RMCC) Regulation Number: 21 CFR 870.5200 Regulation Name: External Cardiac Compressor Regulatory Class: Class III Product Code: DRM Dated: December 18, 2015 Received: December 22, 2015 Dear Mr. Fleming: 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 Federal Register. 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 {1}------------------------------------------------ device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, M.A. Willemsen for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use Statement | DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 | |-----------------------------------------|-----------------------------------| | Food and Drug Administration | Expiration Date: January 31, 2017 | | Indications for Use | See PRA Statement below. | | 510(k) Number ( <i>if known</i> ) | | |-----------------------------------|--| |-----------------------------------|--| K153628 Device Name ROSC-U Mini Chest Compressor (RMCC) Indications for Use (Describe) To perform Cardiopulmonary Resuscitation (CPR) on adult patients and only adult patients in cases of clinical death as defined by a lack of spontaneous breathing and pulse. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) ___ Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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FORM FDA 3881 (8/14) Page 1 of 1 PSC Publishing Services (301) 443-6740 EB {3}------------------------------------------------ # 510(k) Summary | 510(k) Owner | Resuscitation International, LLC<br>17797 N Perimeter Drive, Suite #105<br>Scottsdale, AZ 85255<br>Phone: (949) 580.1266<br>Fax: (949) 580.1270 | |-------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact person | Hayden Fleming<br>Resuscitation International, LLC<br>17797 N Perimeter Drive, Suite #105<br>Scottsdale, AZ 85255<br>Phone: (949) 580.1266<br>Fax: (949) 580.1270<br>Email: hayden@resusintl.com | | Submission date | December 18, 2015 | | Product Code:<br>Common Name<br>Trade Name<br>Classification Name<br>Regulation<br>Class<br>Panel<br>Product Code | Mechanical Cardiopulmonary Resuscitator<br>ROSC-U Mini Chest Compressor (RMCC)<br>compressor, cardiac, external<br>870.5200<br>Class III<br>General & Plastic Surgery<br>DRM | | Primary Predicate<br>(MCC) | K102068 - Miniaturize Chest Compressor | | Secondary Predicate | K090422 - LUCAS 2 | | Description | The RMCC is an automated, portable chest compressor, which provides<br>continuous chest compressions as an adjunct to performing manual CPR. It is<br>powered by a battery powered Control Unit. The RMCC provides consistent<br>CPR support for cardiac arrest patients under conditions which might otherwise<br>hinder the effectiveness of manual techniques. | - 1. Compressor Assembly: contains a motor that drives the compressor pad to depress a patient's chest. - 2. Control Unit: contains the battery, power ON/OFF switch, Function Control Panel and umbilical power cord connecting it to the compressor assembly. Note: The battery charger is a separate unit. - 3. Torso Restraint: is placed underneath and around the back of the patient to firmly secure the compressor assembly to the patient. {4}------------------------------------------------ ## Description (con't) - 4. Stabilizer: serves a dual purpose; providing a head support and also attaches to the torso restraint to provide stability during continuous operation of the RMCC especially during patient transport. #### Intended Use The ROSC-U Mini Chest Compressor (RMCC) is intended for use as a Mechanical Cardiopulmonary Resuscitator for cardiac arrest patients under conditions which might otherwise hinder the effectiveness of manual techniques. #### Indications for Use To perform Cardiopulmonary Resuscitation (CPR) on adult patients and only adult patients in cases of clinical death as defined by a lack of spontaneous breathing and pulse. ### Technological Characteristics The predicate and the RMCC were compared in the following areas and found to have similar technological characteristics and to be equivalent: | | RMCC | MCC | LUCAS 2 | |--------------------------|------|------|---------| | User Population | Same | Same | Same | | Compression Depth | Same | Same | Same | | Compression Frequency | Same | Same | Same | | Compression Duty Cycle | Same | Same | Same | | Compression Modes | Same | Same | Same | | Battery Voltage | Same | Same | Same | | Follows AHA Guidelines | Same | Same | Same | | Intended Use | Same | Same | Same | | Contraindications | Same | Same | Same | | Torso Restraint | Same | Same | Same | | Stabilizer | Same | Same | Same | | Electromechanical Design | Same | Same | Same | The predicate and the RMCC were compared in the following areas and found to have minor different technological characteristics. The following differences have been determined to not have any impact on the safety or efficacy of the RMCC. | | RMCC | MCC | LUCAS 2 | |------------------------------|--------------------|-------------------|----------------| | Initial Battery Runtime | 3.0 hours | | 45 minutes | | Backplate | No<br>Backplate | | Backplate | | Suction Cup | No Suction<br>Cup | | Suction<br>Cup | | Compressed Air Piston Design | Battery<br>Powered | Compressed<br>Air | | | Electromechanical Design | Electrical | Pneumatic | | {5}------------------------------------------------ The following non-clinical performance tests were conducted: | Functional verification | PASS | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------| | IEC 60601-1 (2012): Medical Electrical Equipment –<br>Part 1: General Requirements for Safety | PASS | | IEC 60601-1-2 (2007): Medical Electrical Equipment<br>– Part 1-2: General Requirements for Basic Safety<br>and Essential Performance - Collateral Standard:<br>Electromagnetic Compatibility – Requirements and<br>Tests. | PASS | Conclusions from non-clinical performance data After performing non-clinical performance studies, the data shows that the RMCC is substantially equivalent to the predicates as an external cardiac compressor.