AUTOPULSE RESUSCITATION SYSTEM MODEL 1000

K112998 · Zoll Circulation · DRM · Mar 15, 2012 · Cardiovascular

Device Facts

• Record ID: K112998
• Device Name: AUTOPULSE RESUSCITATION SYSTEM MODEL 1000
• Applicant: Zoll Circulation
• Product Code: DRM · Cardiovascular
• Decision Date: Mar 15, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AutoPulse Resuscitation System Model 100 is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of spontaneous breathing and pulse.

Device Story

AutoPulse Resuscitation System Model 100 is an automated, battery-powered external cardiac compressor. Device consists of a reusable platform, single-use chest compression assembly (LifeBand), rechargeable battery, and multi-chemistry charger. Platform houses mechanical drive, control system, and electronics to generate chest compression force per AHA protocols. Used in clinical settings to provide blood flow during cardiac arrest. Operator (clinician) places device on patient; system performs automated compressions. Output is mechanical chest compression. Benefits include consistent, automated CPR delivery. Subject 510(k) introduces Li-Ion battery and multi-chemistry charger; no changes to platform, LifeBand, or core operating principles.

Clinical Evidence

Bench testing only. Verified system-level compatibility of new Li-Ion battery and multi-chemistry charger with existing AutoPulse platform. Testing confirmed identical performance to NiMH battery-powered system. Charger functionality verified for charging, battery maintenance, and end-of-life identification. Compliance with international standards (IEC 60601-1, IEC 60601-1-2, IEC 60068, IEC 61000, CISPR11, IEC 62133) confirmed via environmental, electrical safety, and electromagnetic compatibility testing.

Technological Characteristics

Electrically powered external cardiac compressor. Components: reusable platform, single-use non-sterile LifeBand, Li-Ion/NiMH rechargeable battery, multi-chemistry charger. Sensing/actuation: mechanical drive mechanism. Connectivity: none. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60068, IEC 61000, CISPR11, IEC 62133. Software: unchanged from predicate.

Indications for Use

Indicated for adult patients in clinical death (lack of spontaneous breathing and pulse) as an adjunct to manual CPR.

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

• AutoPulse Resuscitation System Model 100 (K072527)
• AutoPulse Resuscitation System Model 100 (K063602)
• AutoPulse Resuscitation System Model 100 (K040453)
• AutoPulse Resuscitation System Model 100 (K032852)
• AutoPulse Resuscitation System Model 100 (K022345)
• AutoPulse Resuscitation System Model 100 (K011046)

Submission Summary (Full Text)

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# 3 510(k) Summary

510(K) SUMMARY FOR AutoPulse® Resuscitation System Model 100

Submitter's Name, Address, Telephone Number, and Contact Person

ZOLL Circulation, Inc. 650 Almanor Avenue Sunnyvale, CA 94085 Establishment Registration Number: 3003793491

Contact: Sam Nanavati . Phone: [phone] Fax: [phone] Email: [e-mail]

## Name of Device

AutoPulse® Resuscitation System Model 100

## Common or Usual Name

Automatic Mechanical Chest Compressor

## Classification Name

21 CFR 870.5200 External cardiac compressor

## Device Class

Class III

## Predicate Devices

| Device Name | 510(k) # | Decision<br>Date | Decision |
|---------------------------------------------|----------|------------------|-------------------------------|
| AutoPulse Resuscitation<br>System Model 100 | K072527 | 03/19/2008 | Substantially equivalent (SE) |
| | K063602 | 12/21/2006 | Substantially equivalent (SE) |
| | K040453 | 03/11/2004 | Substantially equivalent (SE) |
| | K032852 | 11/12/2003 | Substantially equivalent (SE) |
| | K022345 | 08/15/2002 | Substantially equivalent (SE) |
| | K011046 | 10/25/2001 | Substantially equivalent (SE) |

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#### Indications for Use

The AutoPulse Resuscitation System Model 100 is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of spontaneous breathing and pulse.

The Indications for Use are unchanged.

#### Device Description

The AutoPulse Resuscitation System Model 100 is an automated, portable, batterv powered device that compresses the chest of an adult human as an adjunct to manual CPR. A brief description of the device is provided below.

The AutoPulse System consists of 4 primary components, a reusable Platform, a single use chest compression assembly (LifeBand), a rechargeable battery, and a battery charger. The AutoPulse Platform contains the mechanical drive mechanism, control system, software and electronics necessary to generate and control the force required to perform mechanical chest compressions. User controls and indicators are contained in the User Control Panel. The AutoPulse Platform and LifeBand are unchanged. A new battery and battery charger are the subject devices of this 510(k).

#### Principles of Operation

The principle of operation remains unchanged. The AutoPulse Resuscitation System Model 100 is an electrically powered external cardiac compressor that compresses the chest in the region of the heart per AHA recommended protocol to provide blood flow during cardiac arrest. This principle of operation of the modified AutoPulse System that is the subject device of this 510(k) is identical to the principal of operation of the currently marketed AutoPulse System.

#### Summary of Testing

The changes included in this 510(k) application include the introduction of new Li-lon battery and a multi-chemistry charger, capable of charging the current NiMH battery and the new Li-lon battery. The charger has the built-in functional testing features to automate battery testing and battery maintenance tasks. There were no changes made to the AutoPulse Model 100 hardware, software or the operating specifications. There were no changes to the LifeBand.

The changes were extensively tested to verify the safety and efficacy of the entire system. First, the system level compatibility was verified to ensure that the AutoPulse powered with the new Li-lon battery meets the operating parameters in a safe and intended manner. The data showed that the new battery chemistry did not alter functioning of the AutoPulse in any way and that it operates identically to the NiMH Battery powered AutoPulse.

Testing also included verification of the compatibility between the new multi-chemistry charger and the current NiMH battery. The bench testing showed that the new charger was capable of safely and consistently charging the NiMH battery, testing the battery and to

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correctly identify when the end of life has been reached. The new charger also successfully demonstrated its ability to charge, test, maintain and identify the end of life conditions per the Li-lon battery specifications.

Extensive bench testing was conducted to verify ability of the Li-Ion battery to meet the performance safety specifications. The testing included charging/discharging characteristics of the battery, ability to power the AutoPulse for the specified runtime throughout the specified life of the battery, environmental testing, electrical safety and electromagnetic compatibility. A partial list of international standards applied in the testing includes but is not limited to: applicable parts of IEC 60601-1, IEC 60601-1-2, IEC 60068 series, IEC 61000, CISPR11, IEC 62133 etc.

### Summary of the Basis for Finding of Substantial Equivalence

The proposed AutoPulse Resuscitation System Model 100 is identical to the previously cleared device. The proposed system:

- . has the same intended use;
- . uses the same operating principles;
- incorporates the same device design; .
- . has the same performance specifications;
- incorporates a new battery and battery charger which have . the same operating principles as those of the predicate device;
- . incorporates the same hardware and software functions.

## Rational for Equivalence

There are two (2) minor technological changes to the currently marketed AutoPulse System that are proposed in this 510(k):

- i) a new rechargeable battery pack using Lithium lon (Li-lon) chemistry battery cells; and
- a new battery charger (the AutoPulse Multi-Chemistry Charger) capable of ii) charging both the currently marketed nickel metal hydride (NiMH) battery and the new Li-lon Battery. The addition of the new battery to the AutoPulse System and charger will not alter the function or performance of the AutoPulse System.

There are no changes proposed to the Indications for Use, the AutoPulse Platform, and the single use, non-sterile LifeBand. The instructions for use are updated with directions for using the new battery and battery charger. Bench Testing results were sufficient to assure that the design changes raised no new issues of Safety and Effectiveness. The subject AutoPulse Resuscitation System Model 100 is thus substantially equivalent to its predicate.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MAR 1 5 2012

Zoll Circulation c/o Mr. Sam Nanavati Vice President, Quality & Regulatory Affairs 650 Almanor Avenue Sunnyvale, CA 94085

Re: K112998

AutoPulse Resuscitation System Model 100 Regulation Number: 21 CFR 870.5200 Regulation Name: External Cardiac Compressor Regulatory Class: Class III Product Code: DRM Dated: February 27, 2012 Received: February 28, 2012

Dear Mr. Nanavati:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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Page 2 - Mr. Sam Nanavati

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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

510(k) Number (if known): K112998

Device Name: AutoPulse Resuscitation System Model 100

Indications For Use:

The AutoPulse Resuscitation System Model 100 is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of spontaneous breathing and pulse.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

(Division Sign-Off) Division of Cardiovas 510(k) Number

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