# Presentation: 517271

## REGULATORY HISTORY OF CPR DEVICES

- Elizabeth Tritschler, MSE
- Circulatory Support and Prosthetics Devices Branch
- Division of Cardiovascular Devices

## REGULATORY HISTORY OF CPR DEVICES

- 1976

- 1984

- Early 1990s

- 1998

- 2004

**1st Generation: 1970’s-present**		  devices to mechanically *assist* in chest compression

**2nd Generation: 1980’s-present** devices to provide compression depth and rate *feedback*

**3rd Generation: 1990’s-present** devices to *enhance* CPR hemodynamics

- Tritschler

## 1st GENERATION CPR DEVICES:External Cardiac Compression Devices

**1976**

- 1984

- Early 1990s

- 1998

- 2004

- 1st GENERATION CPR DEVICES:***External Cardiac Compression Devices***

- Medical Devices Amendment to the Food, Drug, and Cosmetic Act
- First marketing clearance for an *External Cardiac Compression Device*

- May 28, 1976:

- December 9, 1976:

- Tritschler

## 1st GENERATION CPR DEVICES:External Cardiac Compression Devices

-  automated or manual
-  compressions at fixed or user-determined rates

- 1st GENERATION CPR DEVICES:***External Cardiac Compression Devices***

**1976**

- 1984

- Early 1990s

- 1998

- 2004

- Tritschler

## 1st GENERATION CPR DEVICES:External Cardiac Compression Devices

-  reducing work required to compress chest
-  distributing load evenly over sternum

- 1st GENERATION CPR DEVICES:***External Cardiac Compression Devices***

**1976**

- 1984

- Early 1990s

- 1998

- 2004

- Tritschler

## 1st GENERATION CPR DEVICES:External Cardiac Compression Devices

-  Class III
-  Product Code DRM
-  Marketing Application: 510(k) to demonstrate substantial equivalence to a predicate device
-  Clinical data generally not necessary

- 1st GENERATION CPR DEVICES:***External Cardiac Compression Devices***

**1976**

- 1984

- Early 1990s

- 1998

- 2004

- Tritschler

## 2nd GENERATION CPR DEVICES:Cardiopulmonary Resuscitation Aid Devices

- 1976

**1984**

- Early 1990s

- 1998

- 2004

- First marketing clearance for a *Cardiopulmonary Resuscitation Aid Device*

- August 24, 1984:

- 2nd GENERATION CPR DEVICES:***Cardiopulmonary Resuscitation Aid Devices***

- Tritschler

## 2nd GENERATION CPR DEVICES:Cardiopulmonary Resuscitation Aid Devices

-  visual indicators of compression depth (based on feedback from a force gauge)

- 2nd GENERATION CPR DEVICES:***Cardiopulmonary Resuscitation Aid Devices***

- 1976

**1984**

- Early 1990s

- 1998

- 2004

- Tritschler

## 2nd GENERATION CPR DEVICES:Cardiopulmonary Resuscitation Aid Devices

-  Providing feedback regarding rate and depth of compressions, thereby enhancing compliance with AHA Guidelines for CPR

- 2nd GENERATION CPR DEVICES:***Cardiopulmonary Resuscitation Aid Devices***

- 1976

**1984**

- Early 1990s

- 1998

- 2004

- Tritschler

## 2nd GENERATION CPR DEVICES:Cardiopulmonary Resuscitation Aid Devices

-  Class III
-  Product Code LIX
-  Marketing Application: 510(k) to demonstrate substantial equivalence to a predicate device
-  Clinical data generally not necessary

- 2nd GENERATION CPR DEVICES:***Cardiopulmonary Resuscitation Aid Devices***

- 1976

**1984**

- Early 1990s

- 1998

- 2004

- Tritschler

## 3rd GENERATION CPR DEVICES:Devices to Enhance CPR Hemodynamics

- 1976

- 1984

**Early 1990s**

- 1998

- 2004

- 3rd GENERATION CPR DEVICES:***Devices to Enhance CPR Hemodynamics***

- Examples:
-  interposed abdominal compression devices
-  active compression and decompression devices
-  circumferential chest compression devices
-  minimally invasive open-chest cardiac massage

- Alternative Cardiopulmonary Resuscitation Devices.  Prehospital Emergency Care 2003; 7:31-41.

- Tritschler

## 3rd GENERATION CPR DEVICES:Devices to Enhance CPR Hemodynamics

- 1976

- 1984

**Early 1990s**

- 1998

- 2004

- Regulatory Decisions made by the Agency:
-  No preamendment or previously cleared predicate device exists for CPR devices intended to enhance hemodynamics
-  Devices intended to enhance CPR hemodynamics require clinical data to support such claims

- 3rd GENERATION CPR DEVICES:***Devices to Enhance CPR Hemodynamics***

- Tritschler

## 3rd GENERATION CPR DEVICES:Devices to Enhance CPR Hemodynamics

-  End tidal carbon dioxide (EtCO2)
-  Presence of a pulse during CPR
-  Neurological evaluations at 30 days or 1 year based on CPC, Glascow Coma Score, and/or quality of life assessments

- Alternative Cardiopulmonary Resuscitation Devices.  Prehospital Emergency Care 2003; 7:31-41.

- Clinical Study Endpoints:

- 3rd GENERATION CPR DEVICES:***Devices to Enhance CPR Hemodynamics***

- Tritschler

## 3rd GENERATION CPR DEVICES:Devices to Enhance CPR Hemodynamics

- 1976

- 1984

- Early 1990s

**1998**

- 2004

- Meeting of Circulatory System Devices Panel regarding a PMA for an active compression and decompression (ACD) device
- Panel Recommendation:      *Not Approvable*

- June 19, 1998:

- 3rd GENERATION CPR DEVICES:***Devices to Enhance CPR Hemodynamics***

- Tritschler

## SUMMARY:Where are we TODAY?

- 1976

- 1984

- Early 1990s

- 1998

**2004**

-  over 30 external cardiac compression devices cleared for marketing
-  a handful of cardiopulmonary resuscitation aid devices cleared for marketing
-  no devices intended to *enhance* CPR hemodynamics have been approved for marketing in the U.S.

- SUMMARY:***Where are we TODAY?***

- Tritschler