(57 days)
K972525, K04045
Not Found
No
The description focuses on mechanical and pneumatic operation, with no mention of AI/ML terms or functionalities like learning, adaptation, or data analysis for decision-making.
Yes.
The device performs external cardiac compressions which directly treats the circulatory arrest by circulating blood, thus providing a therapeutic effect.
No
The LUCAS® External Cardiac Compressor is designed to perform external cardiac compressions, a therapeutic intervention, rather than to diagnose a condition.
No
The device description clearly outlines a physical, pneumatically powered mechanical chest compression system with hardware components like a piston rod, pressure pad, suction cup, and support legs. It is powered by oxygen or air, indicating a hardware-dependent system.
Based on the provided information, the LUCAS® External Cardiac Compressor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done "in vitro" (in glass or outside the body).
- LUCAS Function: The LUCAS device performs external cardiac compressions directly on the patient's chest. It is a mechanical device that physically interacts with the body to provide life support.
- Intended Use: The intended use clearly states it's for "performing external cardiac compressions on adult patients." This is a therapeutic intervention, not a diagnostic test.
- Device Description: The description details a mechanical system with a piston rod and pressure pad that acts on the chest. There is no mention of analyzing biological samples.
Therefore, the LUCAS device falls under the category of a therapeutic or life-support medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 spontaneous 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.
Product codes (comma separated list FDA assigned to the subject device)
DMR
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult patients
Intended User / Care Setting
Not Found
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)
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.
In all instances, the LUCAS functioned as intended and all results observed were as expected.
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.
K972525, K04045
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.
Not Found
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
Kos3403
FEB 1
V. 510(K) SUMMARY
1
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510(k) Summary
This document provides a brief summary of the LUCAS® device and its supporting information.
General data 1
| 510(k) submitter | Jolife AB
Ingmar Malm
Ideon
Scheelevägen 17
SE-223 70 Lund
Sweden
Phone: + 46 46 286 50 00
Fax: + 46 46 286 50 10 |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person | Howard Holstein
Hogan & Hartson
Columbia Square
555 Thirteenth street NW
Washington DC 20004-1109
Phone: (202) 637-5600 |
| Date prepared | December 5, 2005 |
| Trade name | LUCAS |
| Common name | Mechanical chest compressor |
| Classification name | External cardiac compressor |
| Product code | DMR |
| Predicate devices | Thumper 1007 cleared under K972525
Autopulse model 100 cleared under K04045 |
Prepared by Jolife AB. Lund, Sweden
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Description of the device N
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.
Intended use / Indications for use 3
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 spontaneous 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.
র্ব Comparison to predicate devices
LUCAS, as well as the predicate devices, are able to provide chest compressions according to the guidelines given by the American Heart Associations (AHA).
LUCAS and Thumper are acting and functioning in the same way based on a pneumatically powered device equipped with a compression pad on a piston.
Autopulse provides chest compressions based on an electrical powered device where the compression pad is a part of a circumference belt.
3
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Summary of substantial equivalence 5
The comparison in this submission demonstrates that LUCAS is substantially equivalent to the predicate products. The indications for use, basic overall function, and materials used are substantially equivalent.
Materials 6
All materials used in the manufacture of LUCAS are suitable for its purpose and are well known and proven by use.
Testing 7
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.
In all instances, the LUCAS functioned as intended and all results observed were as expected.
4
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ﻟﻠﺤﻀﺮﻳﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤ
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 2006
Jolife AB c/o Mr. Howard Holstein 555 Hogan & Hartson Washington, DC 20004
Re: K053403
Jolife AB's LUCAS® External Cardiac Compressor Regulation Number: 21 CFR 870.5200 Regulation Name: External Cardiac Compressor Regulatory Class: Class II (Two) Product Code: DRM Dated: December 6, 2005 Received: December 6, 2005
Dear Mr. Holstein:
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.
5
Page 2 - Mr. Howard Holstein
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); 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 device to 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,
Donna R. Vachner
A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): --
Device Name: LUCAS®
Indications for Use:
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.
Prescription Use : X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use: AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duma R. Vachner
(Division Sian-Off) Division of Cardiovascular Devices
510(K) Number_K 05340
Page 1_of __ 1
(Posted November 13, 2003)
Prepared by Jolife AB, Lund, Sweden