(84 days)
No
The description focuses on mechanical compression and does not mention any AI/ML components or functionalities.
Yes
The device is used to perform external cardiac compressions on patients experiencing acute circulatory arrest, which directly treats a medical condition.
No
The LUCAS Chest Compression System is designed to perform external cardiac compressions, acting as an adjunct to manual CPR, not to diagnose medical conditions.
No
The device description clearly outlines multiple hardware components including a back plate, upper part with battery and compression mechanism, stabilization strap, and carrying case, in addition to optional accessories. This indicates it is a physical medical device with integrated software, not a software-only device.
Based on the provided information, the LUCAS Chest Compression System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- LUCAS Function: The LUCAS Chest Compression System is a mechanical device that performs external cardiac compressions directly on the patient's chest. It does not analyze any biological specimens.
- Intended Use: The intended use clearly states it's for performing external cardiac compressions on patients experiencing circulatory arrest. This is a therapeutic intervention, not a diagnostic test.
Therefore, the LUCAS Chest Compression System falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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 fatigue may prohibit the delivery of effective/ consistent compressions to the victim, or when insufficient EMS personnel are available to provide effective CPR).
Product codes
DRM
Device Description
The LUCAS Chest Compression System is a portable tool designed to overcome problems identified with manual chest compressions. The LUCAS device assists rescuers by delivering effective, consistent and continuous chest compressions as recommended in the American Heart Association guidelines and the European Resuscitation Council guidelines.
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 main parts of the LUCAS Chest Compression System include:
- . 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
- o LUCAS Battery Charger
- o LUCAS Anti Slip, Slim Back Plate
- . LUCAS Trolley
The LUCAS 3 version 3.1 is the same device as the cleared LUCAS 3 device (K161768) with exception of the option to change device factory default settings according to local protocols. LUCAS 3 version 3.1 in its factory default settings has identical performance characteristics as the predicate device LUCAS 3.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Chest
Indicated Patient Age Range
Adult
Intended User / Care Setting
Rescuers, EMS personnel, Hospitals, Catheterization laboratories.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification and validation testing have been performed for LUCAS 3 version 3.1 with approved result. Nonclinical performance testing under simulated physiological conditions has been performed demonstrating the reliability of delivering specific compression depth and rate over the intended duration of use. Additional verification and validation activities are recorded in system and, where appropriate, unit test reports.
In all instances, the LUCAS 3 version 3.1 functioned as intended and results observed were as expected.
No new clinical testing has been performed for this version.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Jolife AB's LUCAS 3 CHEST COMPRESSION SYSTEM (K161768), Michigan Instrument's Thumper Model 1005 (K851139)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Jolife AB's LUCAS 2 CHEST COMPRESSION SYSTEM (K090422)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.5200 External cardiac compressor.
(a)
Identification. An external cardiac compressor is an externally applied prescription device that is electrically, pneumatically, or manually powered and is used to compress the chest periodically in the region of the heart to provide blood flow during cardiac arrest. External cardiac compressor devices are used as an adjunct to manual cardiopulmonary resuscitation (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).(b)
Classification. Class II (special controls). The special controls for this device are:(1) Nonclinical performance testing under simulated physiological conditions must demonstrate the reliability of the delivery of specific compression depth and rate over the intended duration of use.
(2) Labeling must include the following:
(i) The clinical training necessary for the safe use of this device;
(ii) Adjunctive use only indication prominently displayed on labels physically placed on the device and in any device manuals or other labeling;
(iii) Information on the patient population for which the device has been demonstrated to be effective (including patient size and/or age limitations,
e.g., adult, pediatric and/or infant); and(iv) Information on the time necessary to deploy the device as demonstrated in the performance testing.
(3) For devices that incorporate electrical components, appropriate analysis and testing must demonstrate that the device is electrically safe and electromagnetically compatible in its intended use environment.
(4) Human factors testing and analysis must validate that the device design and labeling are sufficient for effective use by the intended user, including an evaluation for the time necessary to deploy the device.
(5) For devices containing software, software verification, validation, and hazard analysis must be performed.
(6) Components of the device that come into human contact must be demonstrated to be biocompatible.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 8, 2018
Jolife AB % John Smith Partner Hogan Lovells US LLP 555 Thirteenth Street NW Washington, District of Columbia 20004
Re: K173553
Trade/Device Name: LUCAS 3 Version 3.1 Chest Compression System Regulation Number: 21 CFR 870.5200 Regulation Name: External cardiac compressor Regulatory Class: Class II Product Code: DRM Dated: December 11, 2017 Received: December 11, 2017
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
1
801); medical device reporting of medical 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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Nicole G. Ibrahim -S
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) K173553
Device Name
LUCAS 3 CHEST COMPRESSION SYSTEM version 3.1
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)
区 Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
Jolife's LUCAS 3 CHEST COMPRESSION SYSTEM version 3.1
Submitter 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@stryker.com
Contact Person: John J. Smith Hogan Lovell US LLP 555 13th Street NW Washington, DC 20004
Phone: +1 202 637 3638
Date Prepared: February 6, 2018
Name of Device: LUCAS 3 CHEST COMPRESSION SYSTEM
Model: version 3.1
Common or Usual Name: External Cardiac Compressor
Classification Name: External Cardiac Compressor (21 CFR 870.5200)
Regulatory Class: Class II
Product Code: DRM
Predicate Devices
Jolife AB's LUCAS 3 CHEST COMPRESSION SYSTEM (K161768)
Michigan Instrument's Thumper Model 1005 (K851139)
Reference Devices
Jolife AB's LUCAS 2 CHEST COMPRESSION SYSTEM (K090422)
4
Intended Use/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 poss 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).
Device Description
The LUCAS Chest Compression System is a portable tool designed to overcome problems identified with manual chest compressions. The LUCAS device assists rescuers by delivering effective, consistent and continuous chest compressions as recommended in the American Heart Association guidelines and the European Resuscitation Council guidelines.
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 main parts of the LUCAS Chest Compression System include:
- . 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
- o LUCAS Battery Charger
- o LUCAS Anti Slip, Slim Back Plate
- . LUCAS Trolley
The LUCAS 3 version 3.1 is the same device as the cleared LUCAS 3 device (K161768) with exception of the option to change device factory default settings according to local protocols. LUCAS 3 version 3.1 in its factory default settings has identical performance characteristics as the predicate device LUCAS 3.
5
The LUCAS 3 version 3.1 factory default settings and setup options are consistent with 2015 American Heart Association (AHA) and European Resuscitation Council (ERC) guidelines. Setup options should be changed only under the direction of a physician knowledgeable in cardiopulmonary resuscitation who is familiar with the literature in this area.
The compression rate and depth of the LUCAS 3 version 3.1 can be configured wirelessly using Bluetooth or WiFi to different fixed values. Other changeable settings include number of ventilation alerts, audible alert signal on/off, compression to ventilation ratio, ventilation pause duration, and automatic adjustment of the Pressure Pad. The new option to change device factory default settings is not available during treatment.
The device can also be configured to alter between different compression rates by pushing the ACTIVE (continuous or 30:2) key during ongoing compressions.
The LUCAS 3 version 3.1 captures device data for post event review in Physio-Control data management tools (LIFENET K102757 or internal service tool), which may be transmitted wirelessly using Bluetooth or WiFi (transmission is only available when device is powered OFF).
Summary of Technological Characteristics
The modified device LUCAS 3 version 3.1 has the same technological characteristics as the cleared predicate device LUCAS 3. Just as LUCAS 3, the LUCAS 3 version 3.1 delivers consistent and continuous chest compressions as recommended in the American Heart Association guidelines and the European Resuscitation Council guidelines.
Both devices share the identical principles of operations. The actuator of both devices is a suction cup which in turn is actuated by the nut of a ball screw drive. An electric motor drives the ball screw drive via a cog belt driven transmission.
The intelligence of the system is made up of four CPUs installed on four different subsystems i.e., the control system, the protective system, the charger system and the communication system. The protective and the charger systems share the same physical area of one PCB whereas the control system constitutes its own PCB.
The following technological differences exist between the subject and predicate devices:
- The LUCAS 3 version 3.1 software supports changing the device factory default settings . by receiving data wirelessly using Bluetooth or WiFi.
- . The LUCAS 3 version 3.1 setup options are similar to the options of the predicate device Thumper model 1005, but is limited to ranges that are consistent with 2015 American Heart Association (AHA) and European Resuscitation Council (ERC) guidelines.
- . The LUCAS 3 version 3.1 software provide the possibility to wirelessly transmit captured device data for post event review using Bluetooth or WiFi when the device is in Power OFF mode, whereas the predicate device LUCAS 3 only supports transmission by Bluetooth.
Wireless reception and transmission of data is only available when the device is in the powered OFF mode, not during treatment.
6
The communication system differs slightly as LUCAS 3 version 3.1 can use WiFi for both transmission and reception of data whereas the predicate device LUCAS 3 only transmits data using Bluetooth. Identical for both devices are that the communication system cannot be activated during device use.
The LUCAS 3 version 3.1 factory default settings and setup options are consistent with 2015 American Heart Association (AHA) and European Resuscitation Council (ERC) guidelines. Setup options should be changed only under the direction of a physician knowledgeable in cardiopulmonary resuscitation who is familiar with the literature in this area.
Set up of the device is made by reception of configuration data from Physio-Control data management program using WiFi or Bluetooth. The device can only communicate with the external software when the device is in inactive mode (powered off). The device can only be set up in safe combinations of parameters as assessed in the Risk management file. The assessments are based on already available clinical data in combination with recommendations by the American Heart Association (AHA).
The described modifications substantially follow the established guidelines for CPR and have hence not raised any different questions regarding safety or effectiveness.
Purpose of 510(k)
The purpose of this 510(k) is to modify the LUCAS 3 Chest Compression System by introducing the option to change device factory default settings according to local protocols such as compression rate and depth, number of ventilation alerts, audible alert signal on/off, compression to ventilation ratio, ventilation pause duration, and automatic adjustment of the Pressure Pad. The device can also be configured to alter between compression rates by pushing the ACTIVE (continuous or 30:2) key during ongoing compressions.
Performance Data
Device Set up is controlled by software. The LUCAS 3 version 3.1 software is a modification of the software for the predicate device LUCAS 3 (K161768). The LUCAS 3 software has been developed based on the methods of IEC 62304: 2006 + A1:2015, the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Device, Guidance for Industry - Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software and Guidance for Off-the-Shelf Software use in Medical Devices. In addition the FDA guidance documents addressing Content of Premarket Submissions for Management of Cybersecurity in Medical Devices and Post market Management of Cybersecurity in Medical Devices have been used during the software development process.
Verification and validation testing have been performed for LUCAS 3 version 3.1 with approved result. Nonclinical performance testing under simulated physiological conditions has been performed demonstrating the reliability of delivering specific compression depth and rate over the intended duration of use. Additional verification and validation activities are recorded in system and, where appropriate, unit test reports.
In all instances, the LUCAS 3 version 3.1 functioned as intended and results observed were as expected.
7
The device can only be set up in safe combinations of parameters as assessed in the Risk management file. The assessments are based on already available clinical data in combination with recommendations by the American Heart Association (AHA). No new clinical testing has been performed for this version. LUCAS 3 version 3.1 has a safety and effectiveness profile that is similar to the predicate devices.
Conclusions
The LUCAS 3 version 3.1 has the same intended use and indications, technological characteristics and principles of operation and is as safe and effective as the predicate device LUCAS 3. The LUCAS 3 version 3.1 also has similar technological characteristics with set-able compression parameters as its predicate device Thumper Model 1005.
In addition, the minor technological differences between the LUCAS 3 version 3.1 and its predicate devices raise no new issues of safety or effectiveness.
Performance data demonstrate that the LUCAS 3 version 3.1 is as safe and effective as the predicate devices. Thus, the LUCAS 3 version 3.1 is substantially equivalent.