| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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064
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Date of Entry 05/26/2025
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|
FR Recognition Number
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3-199
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| Standard | |
ASTM F1841-25
Standard Practice for Assessment of Hemolysis in Blood Pumps |
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Scope/Abstract1.1 This practice covers a protocol for the assessment of the hemolytic properties of continuous, intermittent, and pulsatile flow blood pumps used in circulatory assist, including extracorporeal, percutaneous, and implantable devices. An assessment is made based on the pump's effects on the erythrocytes over a certain period of time. Adopting current practices for this assessment, a 6 h in vitro test is performed on a pump placed in a device-specific recirculating blood loop that mimics the pressure and flow conditions of the expected worst-case clinical use of the device. If the ultimate goal of the testing is to evaluate the blood damage potential of a pump for clinical use, it is suggested that paired testing between the subject blood pump and a legally marketed comparator device be conducted using the same blood pool in a matched blood test loop so that a relative hemolysis comparison can be made.
1.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard. |
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| Extent of Recognition
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Rationale for Recognition
| This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. |
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Transition Period
| FDA recognition of ASTM F1841-19 [Rec# 3-165] will be superseded by recognition of ASTM F1841-25 [Rec# 3-199]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 3-165] until July 4, 2027. After this transition period, declarations of conformity to [Rec# 3-165] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §870.3545 |
Ventricular Bypass (Assist) Device
|
Class 3
|
OKR
|
| §870.3545 |
Pediatric Ventricular Assist Device
|
HDE
|
PCK
|
| §870.4100 |
Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure
|
Class 2
|
QJZ
|
| §870.4100 |
Blood Pump For Ecmo, Long-Term (> 6 Hours) Use
|
Class 2
|
QNR
|
| §870.4360 |
Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
|
Class 2
|
KFM
|
| §870.4360 |
Temporary Non-Roller Type Right Heart Support Blood Pump
|
Class 3
|
PYX
|
| §870.4370 |
Pump, Blood, Cardiopulmonary Bypass, Roller Type
|
Class 2
|
DWB
|
| N/A |
Ventricular (Assist) Bypass
|
Class 3
|
DSQ
|
| N/A |
Artificial Heart
|
Class 3
|
LOZ
|
| N/A |
Right Ventricular Bypass (Assist) Device
|
HDE
|
OJE
|
| N/A |
Temporary Non-Roller Type Left Heart Support Blood Pump
|
Class 3
|
OZD
|
|
Relevant FDA Guidance and/or Supportive Publications*
| Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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| FDA Technical Contacts
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
