AUTOPULSE RESUSCITATION SYSTEM

K022345 · Revivant Corp. · DRM · Aug 15, 2002 · Cardiovascular

Device Facts

• Record ID: K022345
• Device Name: AUTOPULSE RESUSCITATION SYSTEM
• Applicant: Revivant Corp.
• Product Code: DRM · Cardiovascular
• Decision Date: Aug 15, 2002
• 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 an automated, portable, battery-powered external cardiac compressor. Device consists of 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. Used as an adjunct to manual CPR to provide chest compressions to adult patients experiencing clinical death. Operated by healthcare personnel. Device provides mechanical chest compressions to support circulation during resuscitation efforts. Benefits include consistent, automated compression delivery compared to manual-only CPR.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Portable, battery-powered external cardiac compressor. Components: reusable platform (drive mechanism, control system, power system) and single-use chest compression assembly (CCA) with patient liner. Materials are biocompatible and previously cleared. Operates via mechanical chest compression.

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 Model 100 (K011046)
• Thumper Model 1005 (K851139)

Submission Summary (Full Text)

{0}------------------------------------------------

# AUG 1 5 2002

# Special 510(k): Device Modification

### 510(k) Summary

K022345

General Information

| Classification | Class III |
|----------------|-----------------------------------------------------------------------------------|
| Trade Name | AutoPulse™ Resuscitation System Model 100 |
| Submitter | Revivant Corporation<br>775 Palomar Avenue<br>Sunnyvale, CA 94085<br>408-524-3500 |
| Contact | Susanne T. Smith, M.S.<br>Vice President, Clinical & Regulatory Affairs |

#### 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

| K011046 | AutoPulse Model 100 |
|---------|---------------------|
| K851139 | Thumper Model 1005 |

#### 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.

{1}------------------------------------------------

# Special 510(k): Device Modification

## 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.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the top half of the circle. Inside the circle is a stylized design featuring three abstract human profiles facing to the right, with flowing lines extending above and below the profiles.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 5 2002

Ms. Susanne T. Smith VP Clinical and Regulatory Affairs Revivant Corporation 775 Palomar Avenue Sunnyvale, CA 94085

Re: K022345

> Trade/Device Name: AutoPulse Resuscitation System, Model 100 Regulation Number: 21 CFR 870.5200 Regulation Name: External cardiac compressor Regulatory Class: III Product Code: DRM Dated: July 18, 2002 Received: July 19, 2002

Dear Ms. Smith:

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.

{3}------------------------------------------------

Page 2 - Ms. Smith

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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,

Susan Runser

Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

## Indications for Use

| 510(k) Number (if known): | This application K022345 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | AutoPulse™ Resuscitation System Model 100 |
| Indications for Use: | The AutoPulse Resuscitation System Model 100 is<br>intended to be used as an adjunct to manual CPR, on adult<br>patients only, in cases of clinical death as defined by lack<br>of spontaneous breathing and pulse. |

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

### Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109) OR

and the same of the same of the same of the same of the same of the same of the states of the states of the states of the states of the states of the states of the states of

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96)

St. Westerlund
(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _KOZZ 345