LUCAS

K053403 · Jolife AB · DRM · Feb 1, 2006 · Cardiovascular

Device Facts

• Record ID: K053403
• Device Name: LUCAS
• Applicant: Jolife AB
• Product Code: DRM · Cardiovascular
• Decision Date: Feb 1, 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® can 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; provides automated, consistent, uninterrupted compressions for adult patients in acute circulatory arrest. System comprises an upper unit with a pneumatically driven piston rod and pressure pad (with suction cup) and a back plate. Powered by oxygen or air (wall outlet, ambulance supply, or cylinder). Used in clinical or transport settings; operated by emergency medical personnel. Device allows hands-free operation and enables personnel to remain safely belted during patient transport. Output is mechanical compression of the chest; replaces manual compressions to ensure consistent circulation according to AHA guidelines.

Clinical Evidence

Bench testing only. Functional testing conducted under various operating conditions demonstrated that the device performs as intended, meets product specifications, and provides compressions consistent with AHA guidelines.

Technological Characteristics

Pneumatically powered mechanical chest compressor. Components include a piston rod, pressure pad with suction cup, and back plate. Energy source: external oxygen or air supply. Form factor: portable system for use in hospital or ambulance. Materials are described as suitable and proven. No software or electronic sensing/actuation described.

Indications for Use

Indicated for adult patients experiencing acute circulatory arrest (absence of spontaneous breathing, pulse, and consciousness). Intended for temporary use in scenarios where manual chest compressions are 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

• Thumper 1007 (K972525)
• Autopulse model 100 (K04045)

Submission Summary (Full Text)

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# Kos3403

FEB 1

## V. 510(K) SUMMARY

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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<br>Ingmar Malm<br>Ideon<br>Scheelevägen 17<br>SE-223 70 Lund<br>Sweden<br><br>Phone: + 46 46 286 50 00<br>Fax: + 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 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<br>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.

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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.

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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.

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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 [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,

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

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(Posted November 13, 2003)

Prepared by Jolife AB, Lund, Sweden