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® must only be used in cases where manual chest compression would be used.

LUCAS® is only intended for temporary use.

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 patients chest via a pressure pad integrated into the suction cup.

The support legs of the upper part are fastened to the back plate prior to starting compressions.

LUCAS® is powered by compressed air from a wall outlet in a hospital or an ambulance, or from a cylinder.

AI/ML Overview

The provided text describes the 510(k) summary for Jolife's Modified LUCAS® external cardiac compressor. It does not contain information about acceptance criteria, device performance metrics, or a study that proves the device meets specific criteria in the format requested.

The document is a regulatory submission for premarket notification (510(k)) to demonstrate substantial equivalence to predicate devices, not a clinical study report with detailed performance metrics against acceptance criteria.

Based on the provided text, the requested information cannot be fully extracted as it is not present.

Here's a breakdown of what can be inferred or stated about the requested points, and what is explicitly missing:

1. A table of acceptance criteria and the reported device performance

Missing from the text. The document states that the device provides compressions "according to the guidelines given by the American Heart Association (AHA)," but it does not specify quantitative acceptance criteria (e.g., minimum compression depth, rate, or recoil) or report specific device performance metrics against such criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Missing from the text. No information on a test set sample size or data provenance is provided. The document mentions "Appropriate product testing was conducted and included a number of function tests during different operating conditions," but these appear to be engineering/functional tests rather than clinical or performance studies with a "test set" of patients or data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Missing from the text. No information about experts establishing ground truth for a test set is provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Missing from the text. No adjudication method for a test set is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Missing from the text. This device is a mechanical chest compressor, not an AI-assisted diagnostic tool for human "readers." Therefore, an MRMC study related to human interpretation with/without AI assistance would not be applicable to this product.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Partially addressed/Inferred: The device is a standalone mechanical compressor. Its performance is described as "consistent and uninterrupted compressions according to the guidelines given by the American Heart Association (AHA)" and it allows for "hands-free compressions." The testing section (Section 6) states, "These tests demonstrated that the functionality, safety and capability of LUCAS® comply with the product specifications and support substantial equivalence to predicate devices. In all instances, the LUCAS® functioned as intended and all results observed were as expected." This indicates standalone functional testing was performed, but no specific performance metrics are reported.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Inferred/Contextual: The "ground truth" for this device, which performs chest compressions, would be its ability to deliver compressions that meet established medical guidelines for CPR (e.g., AHA guidelines for depth, rate, recoil). The text does not elaborate on how this "ground truth" was explicitly measured or used in the "functional tests."

8. The sample size for the training set

Missing from the text. No training set is mentioned as this is a mechanical device, not a machine learning algorithm requiring a training set in the typical sense.

9. How the ground truth for the training set was established

Missing from the text. See point 8.

Summary of Device and Regulatory Context (from the provided text):

Device Name: Jolife's Modified LUCAS® External Cardiac Compressor (referred to as LUCAS®)
Intended Use: Performing external cardiac compressions on adult patients with acute circulatory arrest (absence of spontaneous breathing and pulse, loss of consciousness), where manual chest compression would be used. Intended for temporary use.
Mechanism: Pneumatically powered mechanical chest compression system with an upper part containing a pneumatically driven piston rod and a pressure pad integrated into a suction cup.
Modification in K062401: This 510(k) is for a modification to re-introduce "active decompression" by eliminating holes in the suction cup, which were previously added to "deactivate" this component. The sponsor states active decompression will be limited to 3lbs. The FDA considered this a "change in fundamental scientific technology as compared to the predicate [compression only] device" and required clinical data for the active decompression component.
Predicate Devices: Lucas (K053403), Thumper model 1007 (K972525), Autopulse model 100 (K040453).
Substantial Equivalence: The submission claims substantial equivalence based on indications for use, basic overall function, and materials used being equivalent to predicate products.
Testing: "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 LUCAS® comply with the product specifications and support substantial equivalence to predicate devices. In all instances, the LUCAS® functioned as intended and all results observed were as expected."

Conclusion:

The provided 510(k) summary focuses on demonstrating substantial equivalence of the modified LUCAS® device to predicate devices through functional testing and comparison of core features, rather than presenting detailed acceptance criteria and a study demonstrating the device's performance against those criteria in a quantitative, clinical manner. It highlights the FDA's concern regarding the active decompression feature, deeming it a "fundamental scientific change" that would typically require clinical data, but the document does not present such data.

Summary

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510(k) SUMMARY

Jolife's Modified LUCAS®

This document provides a brief summary of the LUCAS® device and its supporting information.

1) GENERAL DATA

SEP 2 8 2006

510(k) submitter	Jolife ABIngmar MalmIdeonScheelevägen 17SE-223 70 LundSweden
	Phone:Fax:	+ 46 46 286 50 00+ 46 46 286 50 10
Contact person	Howard HolsteinHogan & HartsonColumbia Square555 Thirteenth street NWWashington DC 20004-1109Phone: (202) 637-5600
Date when prepared	August 7, 2006
Trade name	LUCAS
Common name	Mechanical chest compressor
Classification name	External cardiac compressor
Product code	DRM
Predicate devices	• Lucas (K053403)• Thumper model 1007 (K972525)

Autopulse model 100 (K040453) .

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2) DESCRIPTION OF THE DEVICE

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 patients chest via a pressure pad integrated into the suction cup.

The support legs of the upper part are fastened to the back plate prior to starting compressions.

LUCAS® is powered by compressed air from a wall outlet in a hospital or an ambulance, or from a cylinder.

LUCAS® is designed to provide:

Effective, consistent and uninterrupted compressions according to the guidelines given by the American Heart Association (AHA).
· Good circulation during the patient transport process.
· Safety during transportation for both 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.

3) INTENDED USE / INDICATIONS FOR USE

LUCAS® must only be used in cases where manual chest compression would be used.

LUCAS® is only intended for temporary use.

4) COMPARISON TO PREDICATE DEVICES

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LUCAS®, as well as the predicate devices, are able to provide chest compressions P. 3 of 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 - 3 according to the guidelines given by the AHA.

LOG2401

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 electrically powered device where the compression pad is a part of a circumferential belt.

5) SUMMARY OF SUBSTANTIAL EQUIVALENCE

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.

6) TESTING

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 LUCAS® comply with the product specifications and support substantial equivalence to predicate devices.

In all instances, the LUCAS® functioned as intended and all results observed were as expected.

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Form for Converting a Special 510(k) to a Traditional or Abbreviated 510(k)

August 28, 2006 Date:

Catheirne Wentz Reviewer:

K062401 510(k) Number:

Device Name: JoLife LUCAS External Cardiac Compressor

This application for a CPR aid device, was submitted as a special. The Reason for Conversion: modifications made to the device (addition of active decompression) constitutes a change in fundamental scientific technology as compared to the predicate [compression only] device. Prior to clearance of their predicate device (K053403), the sponsor received an NSE due to the active decompression component of the device. Active decompression has been determined to require clinical data due to the potential hemodynamic effects of active decompression. The predicate device (K053403) contains a suction cup which the sponsor put holes in to "deactivate" the decompression component of the device. This special serves to notify the FDA that the sponsor now wishes to eliminate the holes, thus returning the device to it's original design. The sponsor does state that the active decompression component will be limited to 3lbs, however, the active decompression component is a fundamental scientific change in technology as compared to the predicate [compression only] device.

A Division Director Concurrence/Name: (Please get this before calling or e-mailing POS) During D. Jochures - D. Jochures -

Date of POS Concurrence (please document POS contact):

Date of Phone Conversation:

***Please add this to the file

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three lines representing the branches of government. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 8 2006

Jolife AB c/o Mr. Howard M. Holstein --Hogan & Hartson LP 555 13th Street, NW Washington, DC 20004

Re: K062401

JoLife LUCAS External Cardiac Compressor Regulation Number: 21 CFR 870.5200 Regulation Name: External Cardiac Compressor Regulatory Class: Class III (three) Product Code: DRM Dated: August 16, 2006 Received: August 16, 2006

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, Jrug 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, UDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Howard M. 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) prematice wotification. The FDA-finding of substantial-squivalence 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,

una R. Holmes

Image /page/5/Picture/6 description: The image contains a handwritten text fragment. The text includes the word "Bra" followed by the word "Dir" on the next line. There is also a squiggly line to the left of the text.

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):_KO6240)

Device Name: LUCAS®

Indications for Use:

LUCAS® External Cardiac Compressor is to be used for performing external cardiac LOCAS · External Ouranat Compress who have acute circulatory arrest defined as compressions on acreathing and pulse, and loss of consciousness.

LUCAS® must only be used in cases where manual chest compression would be used.

LUCAS® is only intended for temporary use.

Prescription Use __ X (Per 21 C.F.R. 801.109) AND/OR

Over-The-Counter Use_ (Per 21 C.F.R. 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

uma R. Vachnel

Division Sign-Off) (Division Sign-Sil)
Division of Cardiovascular Devices

510(k) Number_ko6240)

\\DC - 019831/000001 - 2350141 v2

Regulation Number and Section

§ 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.