MODIFICATION TO LUCAS

K062401 · Jolife AB · DRM · Sep 28, 2006 · Cardiovascular

Device Facts

• Record ID: K062401
• Device Name: MODIFICATION TO LUCAS
• Applicant: Jolife AB
• Product Code: DRM · Cardiovascular
• Decision Date: Sep 28, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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® must only be used in cases where manual chest compression would be used. LUCAS® is only intended for temporary use.

Device Story

LUCAS® is a pneumatically powered mechanical chest compression system for adult patients in acute circulatory arrest. The device consists of an upper unit with a piston rod and a back plate. A pressure pad integrated into a suction cup acts on the patient's chest to provide automated, consistent, and uninterrupted compressions. Powered by compressed air from wall outlets or cylinders, the device is applied to the patient in under 20 seconds. It allows for hands-free operation and enables emergency personnel to remain safely belted during patient transport. By providing consistent compressions according to AHA guidelines, the device aims to maintain circulation during transport and resuscitation efforts. Healthcare providers use the device to replace manual compressions, potentially improving the quality and consistency of CPR while ensuring provider safety.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by functional bench testing conducted under various operating conditions to verify compliance with product specifications.

Technological Characteristics

Pneumatically powered mechanical chest compressor. Features a piston-driven compression pad integrated with a suction cup for active decompression (limited to 3lbs). System includes an upper unit and back plate. Operates via compressed air (hospital wall outlet or cylinder).

Indications for Use

Indicated for adult patients experiencing acute circulatory arrest (absence of spontaneous breathing, pulse, and consciousness) requiring external cardiac compression. Intended for temporary use in scenarios where manual chest compression is indicated.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• Lucas (K053403)
• Thumper model 1007 (K972525)

Reference Devices

• Autopulse model 100 (K040453)

Submission Summary (Full Text)

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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 AB<br>Ingmar Malm<br>Ideon<br>Scheelevägen 17<br>SE-223 70 Lund<br>Sweden | | SE |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|----|
| | Phone:<br>Fax: | + 46 46 286 50 00<br>+ 46 46 286 50 10 | |
| Contact person | Howard Holstein<br>Hogan & Hartson<br>Columbia Square<br>555 Thirteenth street NW<br>Washington DC 20004-1109<br>Phone: [phone] | | |
| 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)<br>• 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® 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.

### 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 [phone]. 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 [phone] or [phone] 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)

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