AUTOPULSE RESUSCITATION SYSTEM, MODEL 100

K040453 · Revivant Corp. · DRM · Mar 11, 2004 · Cardiovascular

Device Facts

• Record ID: K040453
• Device Name: AUTOPULSE RESUSCITATION SYSTEM, MODEL 100
• Applicant: Revivant Corp.
• Product Code: DRM · Cardiovascular
• Decision Date: Mar 11, 2004
• Decision: SESE
• Submission Type: Special
• 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 a portable, battery-powered automated chest compression device. It functions as an adjunct to manual CPR for adult patients in clinical death. The device comprises a reusable platform containing a drive mechanism, control system, and rechargeable battery, paired with a single-use chest compression assembly (CCA) including a patient liner. The system provides automated mechanical chest compressions. It is intended for use by healthcare providers in clinical settings. The device aims to support resuscitation efforts by providing consistent chest compressions.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Portable, battery-powered automated external cardiac compressor. Consists of a reusable platform (drive mechanism, control system, rechargeable battery) and a single-use chest compression assembly (CCA) with patient liner. Materials are biocompatible and previously cleared.

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

• Thumper™ Model 1005 (K851139)
• AutoPulse™ Resuscitation System Model 100 (K011046)
• AutoPulse™ Resuscitation System Model 100 (K022345)
• AutoPulse™ Resuscitation System Model 100 (K032852)

Submission Summary (Full Text)

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# MAR 1 1 2004

#### 510(k) Summary

General Information

| Classification | Class III |
|----------------|-------------------------------------------------------------------|
| Trade Name | AutoPulse™ Resuscitation System Model 100 |
| Submitter | Revivant Corporation<br>775 Palomar Avenue<br>Sunnyvale, CA 94085 |
| | 408-524-3500 |
| Contact | Bob H. Katz<br>Vice President, Operations |

#### 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.

#### Predicate Devices

| K851139 | Thumper™ Model 1005 |
|---------|-------------------------------------------|
| K011046 | AutoPulse™ Resuscitation System Model 100 |
| K022345 | AutoPulse™ Resuscitation System Model 100 |
| K032852 | AutoPulse™ Resuscitation System Model 100 |

#### Device Description

AutoPulse Resuscitation System Model 100 ("Device") is an automated, portable, battery powered device that compresses the chest of an adult human as an adjunct to manual CPR. The Device consists of a single use chest compression assembly (CCA) that includes a patient liner, and a reusable platform that contains a user control panel, a drive mechanism, a control system, and a power system (rechargeable battery).

#### Materials

All materials used in the manufacture of the AutoPulse Resuscitation System Model 100 are suitable for this use and have been used in numerous previously cleared products.

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#### Testing

Appropriate product testing was conducted to evaluate conformance to product specification and substantial equivalence to predicate devices.

### Summary of Substantial Equivalence

The AutoPulse Resuscitation System Model 100 is equivalent to the predicate products. The indications for use, basic overall function, and materials used are substantially equivalent.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

MAR 1 1 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Revivant Corporation c/o Mr. Bob H. Katz Vice President and Chief Operating Officer 775 Palomar Avenue Sunnyvale, CA 94085

Re: K040453

AutoPulse™ Resuscitation System Model 100 Regulation Number: 21 CFR 870.5200 Regulation Name: External Cardiac Compressor Regulatory Class: Class III (three) Product Code: DRM Dated: February 20, 2004 Received: February 27, 2004

Dear Mr. Katz:

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. Bob H. Katz

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 snecific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, 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 may be obtained 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/dsma/dsmamain.html

Sincerely vours.

Duna R. Vachner

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): Ko40453

AutoPulse™ Resuscitation System Model 100 Device Name:

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)

Diana R. Vachner

ivision Sir -Off) Division of Cardiovascular Devices

510/k) Nimber K040453

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