LUCAS 3 Chest Compression System

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In the center of the seal is an abstract symbol that resembles a stylized human profile. # DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 November 09, 2016 Jolife AB % John Smith Partner Hogan Lovells US LLP 555 13th Street NW Washington, District of Columbia 20004 Re: K161768 Trade/Device Name: LUCAS 3 Chest Compression System Regulation Number: 21 CFR 870.5200 Regulation Name: External Cardiac Compressor Regulatory Class: Class II Product Code: DRM Dated: August 15, 2016 Received: August 15, 2016 Dear John Smith: 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 device {1}------------------------------------------------ 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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. M.R. Hilleman for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page 510(k) Number (if known) K161768 Device Name LUCAS 3 CHEST COMPRESSION SYSTEM Indications for Use (Describe) LUCAS Chest Compression System is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and loss of consciousness. LUCAS must only be used in cases where chest compressions are likely to help the patient. The LUCAS device is intended for use as an adjunct to manual CPR when effective manual CPR is not possible (e.g., during patient transport or extended CPR when fatigue may prohibit the delivery of effective/consistent compressions to the victim, or when insufficient EMS personnel are available to provide effective CPR). Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 16px;">☑</span> | |----------------------------------------------|-----------------------------------------| | Over-The-Counter Use (21 CFR 801 Subpart C) | <span style="font-size: 16px;">☐</span> | # CONTINUE ON A SEPARATE PAGE IF NEEDED. 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FORM FDA 3881 (8/14) Page 1 of 1 FDA PSC Publishing Services (301) 443-6740 EF {3}------------------------------------------------ # 510(k) SUMMARY Jolife's LUCAS 3 CHEST COMPRESSION SYSTEM # Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared Malin Melander Jolife AB Scheelevagen 17 Ideon Science Park SE-223 70 Lund Sweden Phone: +46 46 286 50 00 Cell Phone: +46 76 844 11 41 Facsimile: +46 46 286 50 10 Email: malin.melander@physio-control.com Contact Person: John J. Smith Hogan Lovell US LLP 555 13th Street NW Washington, DC 20004 Phone: +1 202 637 3638 Date Prepared: June 27, 2016 # Name of Device LUCAS 3 CHEST COMPRESSION SYSTEM #### Common or Usual Name External Cardiac Compressor #### Classification Name External Cardiac Compressor (21 CFR 870.5200) #### Predicate Devices LUCAS 2, Jolife AB (K090422) #### Indications for Use LUCAS Chest Compression System is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and loss of consciousness. LUCAS must only be used in cases where chest compressions are likely to help the patient. The LUCAS device is intended for use as an adjunct to manual CPR when effective manual CPR is not possible (e.g., during patient transport or extended CPR when fatique may prohibit the delivery of effective/consistent compressions to the victim, or when insufficient EMS personnel are available to provide effective CPR). {4}------------------------------------------------ # Technological Characteristics The LUCAS 3 Chest Compression System is a portable tool designed to serve as an adjunct to manual chest compressions. The LUCAS device assists rescuers by delivering effective, consistent and continuous chest compressions as recommended in the American Heart Association quidelines and the European Resuscitation Council quidelines. The LUCAS chest compression system can be used in a wide variety of situations and settings; on the scene, during patient movement, during transportation in road and air ambulances, in hospitals and catheterization laboratories. The device consists of the following components: - . A Back Plate which is positioned underneath the patient as a support for the external chest compressions. - An Upper Part which contains the proprietary and rechargeable LUCAS Battery and the ● compression mechanism with the disposable Suction Cup. - A Stabilization Strap which helps to secure the position of the device in relation to the ● patient. - A Carrying Case. ● In addition the following optional Accessories are offered as part of the system: - LUCAS Battery, Dark Grey ● - LUCAS Power Supply - LUCAS Car Power Cable, 12-28VDC ● - LUCAS PCI Back Plate ● - LUCAS Battery Charger ● - LUCAS Anti Slip, Slim Back Plate - o LUCAS Trolley The LUCAS 3 CHEST COMPRESSION SYSTEM captures data for post event review which may be transmitted locally using Bluetooth (transmission only available when device is powered OFF). LUCAS 3 has substantially the same performance characteristics as the predicate device LUCAS 2. # Purpose of 510(k) The purpose of this 510(k) is to modify the LUCAS 2 by addition of: - o a modified back plate, - a hard shell Carrying Case, 0 - new colors of exterior plastic parts and o - capability to transmit data for post event review (not available during patient ● treatment). # Performance Data Appropriate performance testing has been conducted by both external and internal parties. Performance testing concludes that the functionality, safety, efficacy and capability of LUCAS 3 support conformance with the product specification and substantial equivalence with the predicate device. {5}------------------------------------------------ LUCAS 3 has been tested by a 30 party accredited testing laboratory and found to comply with the recognized standard ANSI/AAMI ES 60601-1:2005(R)2012 for Medical Electrical Equipment, Part 1 General requirements for Basic Safety and essential performance, including collateral standards IEC 60601-1-2:2007/AC2010 Electromagnetic compatibility requirements and tests, IEC 60601-1-6:2010 + A1:2015 Usability, IEC 60601-1-8:2007 + A1:2013 Test and guidance for Alarms systems in MEE & MES and IEC 60601-1-12 MEE intended for use in emergency medical services environment. The LUCAS Battery complies with IEC 62133:2012 Secondary cells and batteries containing alkaline or other non-acid electrolytes – Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications. The LUCAS 3 also complies with the international standards for Medical Vehicles and their equipment for Road Ambulance EN 1789:2014 and Air Ambulances, EN 13718-1:2014. In all instances, the LUCAS 3 functioned as intended and demonstrated equivalent performance with the predicate device LUCAS 2. # Substantial Equivalence The LUCAS 3 has the same indications for use, similar technological characteristics and identical principles of operation as its predicate device LUCAS 2. The minor technological differences between the LUCAS 3 and its predicate devices do not raise different issues of safety or effectiveness. Performance data demonstrate that the LUCAS 3 is substantially equivalent. # Conclusions The LUCAS 3 is substantially equivalent to the predicate device.