(119 days)
Not Found
No
The description focuses on the mechanical and electrical aspects of the device for automated chest compressions. There is no mention of AI, ML, image processing, or any data-driven decision-making processes. The performance studies described are functional tests, not studies evaluating the performance of an AI/ML algorithm.
Yes
The device is used to perform external cardiac compressions on patients with acute circulatory arrest, which is a therapeutic intervention aimed at restoring circulation and improving patient outcome.
No
Explanation: The device is described as a "Chest Compression System" that performs "external cardiac compressions." Its purpose is to provide automated chest compressions, which is a therapeutic intervention, not a diagnostic one. It does not analyze patient data or provide information to aid in diagnosis.
No
The device description clearly states it is an "electrically powered mechanical chest compression system" with physical components like a piston rod, pressure pad, suction cup, and support legs, indicating it is a hardware device.
Based on the provided information, the LUCAS 2 Chest Compression System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- LUCAS 2 Function: The LUCAS 2 is a mechanical device that performs external chest compressions directly on the patient's body. It does not analyze biological samples.
- Intended Use: The intended use clearly states it's for "performing external cardiac compressions on adult patients." This is a therapeutic/supportive function, not a diagnostic one.
Therefore, the LUCAS 2 falls under the category of a therapeutic or life-support medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
LUCAS 2 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 2 must only be used in cases where chest compressions are likely to help the patient.
Product codes (comma separated list FDA assigned to the subject device)
DRM
Device Description
LUCAS 2 is an electrically powered mechanical chest compression system providing controlled automated chest compressions on adult patients who have acute circulatory arrest,
LUCAS 2 consists of an upper part containing the electrically driven piston rod, which acts on the patients 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 2 is designed to:
- · Provide effective, consistent and uninterrupted compressions according to the guidelines given by American Heart Association (AHA);
- · Provide good circulation during the patient transport process;
- · Provide safety during transportation for both emergency medical personnel and patient, allowing emergency medical personnel to wear safety belts during transportation while LUCAS 2 delivers continuous, consistent and uninterrupted compressions;
- · Provide hands-free compressions in any situation.
- · Be applied to the patient with interruption of less than 20 seconds.
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 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, efficacy and capability of LUCAS 2 comply with the product specifications and safety standards and support substantial equivalence to predicate devices.
In all instances, the LUCAS 2 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.
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
2009-02-16
jolife
1090422
JUN 1 7 2009
510(k) SUMMARY
Jolife's LUCAS 2
This document provides a brief summary of the LUCAS 2 device and its supporting information.
1) GENERAL DATA
510(k) submitter
Jolife AB Ingmar Malm Ideon Scheelevägen 17 SE-223 70 Lund Sweden
Phone: + 46 46 286 50 00 Cell phone: + 46 70 721 22 24 Fax: + 46 46 286 50 10
e-mail: ingmar.malm@jolife.com
Contact person
Howard Holstein Hogan & Hartson Columbia Square 555 Thirteenth street NW Washington DC 20004-1109
Phone: (202) 637-5813
Date when prepared
February 13, 2009
Trade name
LUCAS 2
DRM
Common name
Chest Compression System
Classification name
Product code
Predicate devices
● Lucas 1 cleared under K062401
- Thumper model 1008 cleared under K073079
External cardiac compressor (21 CFR 870.5200)
Autopulse model 100 cleared under K072527 ●
JOLIFE AB, Ideon Science Park, SE-223 70 Lund, Swedon, Visiting Address: Scheelevagen 17 Tel: +46 (0) 46 286 50 00, Fax: +46 (0) 46 286 50 10, E-mail: info@jotife.com, jolife.com 1 (3)
0017
1
Image /page/1/Picture/2 description: The image shows the word "jolife" in a stylized font, with a circular graphic to the left of the word. The graphic consists of a circle with a line passing through it. The word "jolife" is written in a font that appears to be textured or dotted. The image is in black and white.
2) DESCRIPTION OF THE DEVICE
LUCAS 2 is an electrically powered mechanical chest compression system providing controlled automated chest compressions on adult patients who have acute circulatory arrest,
LUCAS 2 consists of an upper part containing the electrically driven piston rod, which acts on the patients 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 2 is designed to:
- · Provide effective, consistent and uninterrupted compressions according to the guidelines given by American Heart Association (AHA);
- · Provide good circulation during the patient transport process;
- · Provide safety during transportation for both emergency medical personnel and patient, allowing emergency medical personnel to wear safety belts during transportation while LUCAS 2 delivers continuous, consistent and uninterrupted compressions;
- · Provide hands-free compressions in any situation.
- · Be applied to the patient with interruption of less than 20 seconds.
3) INTENDED USE / INDICATIONS FOR USE
LUCAS 2 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 2 must only be used in cases where chest compressions are likely to help the patient.
4) COMPARISON TO PREDICATE DEVICES
The LUCAS 2 and its predicates have basically the same performance characteristics.
The LUCAS 2 has the same performance characteristics as the previuosly cleared LUCAS 1 device.
The LUCAS 2 and Thumper 1008 act on the chest via a pressure pad, while Autopulse acts on the chest via a circumferential belt.
The LUCAS 2 and Autopulse are battery powered, while the Thumper 1008 is powered by compressed oxygen while the previously cleared LUCAS 1 is powered by compressed air.
JOLIFE AB, Ideon Science Park, SE-223 70 Lund, Sweden, Visiting Address: Scheelevägen
Tel: +46 (0) 46 286 50 00, Fax: +46 (0) 46 286 50 10, E-mail: info@jolife.com. jolife.co
2 (3)
0018
2
Image /page/2/Picture/2 description: The image shows the word "jolife" in a stylized font, with a logo to the left of the word. The logo consists of a circle with lines running through it. The letters in the word "jolife" are outlined in black, with a white fill.
5) SUMMARY OF SUBSTANTIAL EQUIVALENCE
LUCAS 2 is substantially equivalent to the predicate devices. The LUCAS 2 has the same intended use and substantially similar indications for use, basic overall function, and performance as its predicate devices.
6) MATERIALS
All materials used in the manufacture of LUCAS 2 are suitable for its purpose and are well known and are the same as those materials and intended use as the materials included in the 510(k)-cleared LUCAS I (K062401). .
7) TESTING
. (
Appropriate product testing was conducted and included a number of function tests during different operating conditions. These tests demonstrated that the functionality, safety, efficacy and capability of LUCAS 2 comply with the product specifications and safety standards and support substantial equivalence to predicate devices.
In all instances, the LUCAS 2 functioned as intended and all results observed were as expected,
JOLIFE AB, Ideon Science Park, SE-223 70 Lund, Sweden, Visiting Address: Scheelevagen 17 Tel: +46 (0) 46 286 50 00, Fax: +48 (0) 46 286 50 10, E-mail: Info@jolife.com, Jolife.com 3 (3)
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle or bird symbol, with three curved lines forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR 3 1 2011
Jolife AB c/o Mr. Howard M. Holstein Hogan Lovells US LLP Columbia Square 555 13" Street, NW Washington, DC 20004
Re: K090422
LUCAS 2 Regulation Number: 21 CFR 870.5200 Regulation Name: External Cardiac Compressor Regulatory Class: Class III Product Code: DRM Dated: May 18, 2009 Received: May 18, 2009
Dear Mr. Holstein:
This letter corrects our substantially equivalent letter of June 17, 2009.
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 (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 additional controls. Existing major regulations affecting your device can be
4
Page 2 - Mr. Howard M. Holstein
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-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
M. S. Kelleher
An Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) LUCAS 2
Image /page/5/Picture/2 description: The image shows the word "jolife" next to a circular graphic. The graphic is a circle with a line going through it. The text is in a sans-serif font and appears to be slightly pixelated. The image is black and white.
Indications for Use ·
510(k) Number (if known): _ Ko9 0 422
Device Name: LUCAS 2
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.
| Prescription Use | X | AND/OR | Over-The-Counter Use |
|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (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)
(Division Sign-Off)
Division of Cardiovascular Devices
| 510(k) Number | K090922 |
|---|---|
| --------------- | --------- |
JOLIFE AB, Ideon Science Park, SE-223 70 Lund, Sweden, Visiting Address: Scheelevägen 17
Tel: +46 (0) 46 286 50 00, Fax: +46 (0) 46 286 50 10, E-mail: info@lolife.com, www.jolife.com
1 (1)
3