pump

Classification and Regulation of
Classification and Regulation of
Non-roller Type Cardiopulmonary
Non-roller Type Cardiopulmonary
Bypass Blood Pumps
Bypass Blood Pumps
21 CFR 870.4360
21 CFR 870.4360

Catherine P. Wentz, M.S.
Division of Cardiovascular Devices
Office of Device Evaluation
Food and Drug Administration
Circulatory System Devices Panel Meeting
December 6, 2012

Objective of This Panel Meeting
Objective of This Panel Meeting
Non-Roller type Cardiopulmonary Bypass Blood Pumps are currently Class III, but marketed through the 510(k) process

Do we have sufficient evidence of safety and effectiveness?
&
Can special controls be established to mitigate the risks?

Yes
Down-classify to Class II
(510(k)

No
Remain as Class III
(PMA)

FDA Team Presenters
FDA Team Presenters
Catherine Wentz, MS
Introduction, Regulatory history, risks to health,
FDA concluding remarks/recommendation
Erika Avila Tang, PhD, MHS
Epidemiology review
John Laschinger, MD
Clinical review
3

Outline
Outline
 Definition
 Device Description(s)
 Cleared indications and Clinical Use
 Regulatory History
 Industry Response to 515(i) Order
 Clinical Evidence
 Concluding Remarks
4

Regulatory Definition
Regulatory Definition
§870.4360 Non-roller type cardiopulmonary bypass blood pump
“A non-roller type cardiopulmonary bypass blood pump is a device that uses a method other than revolving rollers to pump the blood through the cardiopulmonary bypass circuit during bypass surgery.”
Class III

5

Device Description
Device Description
 Centrifugal Design

 Catheter-based Axial
Pump Design

6

Indications
Indications
Traditional cardiopulmonary bypass use
The [device] is intended to be used in an extracorporeal bypass circuit during cardiopulmonary bypass procedures for periods of up to six hours.

7

Expanded Indications
Expanded Indications
“…indicated to pump blood through the extracorporeal