(57 days)
LUCAS® External Cardiac Compressor is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontancous breathing and pulse, and loss of consciousness.
LUCAS® can be used in cases where manual chest compression would be used.
LUCAS® is only intended for temporary use.
LUCAS is a pneumatically powered mechanical chest compression system providing controlled automated chest compressions on adult patients who have acute circulatory arrest.
LUCAS consists of an upper part containing a pneumatically driven piston rod, which acts on the patient's chest via a pressure pad. The pressure pad is surrounded by a suction cup.
The support legs of the upper part are fastened to the back plate prior to starting compressions.
LUCAS can be powered by oxygen or air from a wall outlet in a hospital or an ambulance, or from a cylinder.
LUCAS is designed to provide:
- · Consistent and uninterrupted compressions according to the guidelines given by American Heart Association (AHA);
- · Good circulation during the patient transport process;
- · Safety during transportation for both emergency medical personnel and patient, allowing emergency medical personnel to wear safety belts during transportation while LUCAS delivers continuous, consistent and uninterrupted compressions;
- · Hands-free compressions in any situation.
LUCAS can be applied to the patient in less than 20 seconds.
This document, K053403, is a 510(k) summary for the LUCAS® external cardiac compressor. It outlines the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain information about the acceptance criteria or a specific study proving the device meets acceptance criteria.
The document states that "Appropriate product testing was conducted and included a number of function tests during different operating conditions. These tests demonstrated that the functionality, safety and capability of the LUCAS comply with the product specifications and supports substantial equivalence to predicate devices." However, it does not provide details of these tests, specific acceptance criteria, or the reported performance data in a quantifiable manner.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, or details regarding sample sizes, ground truth establishment, or specific study designs (such as MRMC or standalone studies), as this information is not present in the provided text.
The document primarily focuses on demonstrating substantial equivalence to existing predicate devices (Thumper 1007 and Autopulse model 100) based on similar function, indications for use, and materials, rather than presenting a performance study against novel acceptance criteria.
Key takeaway: This 510(k) summary does not include the detailed performance study information you are asking for. It asserts that testing was done and compliance achieved, but does not provide the specifics of those tests or results.
§ 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.