| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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059
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Date of Entry 12/19/2022
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|
FR Recognition Number
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3-183
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| Standard | |
ISO 11658 First edition 2012-05-15
Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems |
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U.S. Identical AdoptionANSI AAMI ISO 11658: 2012
Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems |
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Scope/AbstractThis International Standard specifies requirements for the physical, biological and performance testing of biocompatible modifications on extracorporeal devices. This International Standard is applicable to components of heart-lung bypass equipment and of extracorporeal life support equipment that carry blood and have modifications on the blood and tissue-contacting surfaces of the device.
The assumption is that these devices will be used at conventional ranges of hypothermia and normothermia. If hyperthermia (>37 °C) applications are indicated, then testing is performed over the indicated range. |
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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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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §870.1250 |
Catheter, Angioplasty, Peripheral, Transluminal
|
Class 2
|
LIT
|
| §870.1250 |
Catheter, Percutaneous
|
Class 2
|
DQY
|
| §870.4100 |
Oxygenator, Long Term Support Greater Than 6 Hours
|
Class 2
|
BYS
|
| §870.4100 |
Dual Lumen Ecmo Cannula
|
Class 2
|
PZS
|
| §870.4100 |
Single Lumen Ecmo Cannula
|
Class 2
|
QHW
|
| §870.4100 |
Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure
|
Class 2
|
QJZ
|
| §870.4210 |
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
|
Class 2
|
DWF
|
| §870.4230 |
Defoamer, Cardiopulmonary Bypass
|
Class 2
|
DTP
|
| §870.4240 |
Heat-Exchanger, Cardiopulmonary Bypass
|
Class 2
|
DTR
|
| §870.4260 |
Filter, Blood, Cardiopulmonary Bypass, Arterial Line
|
Class 2
|
DTM
|
| §870.4270 |
Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass
|
Class 2
|
JOD
|
| §870.4350 |
Oxygenator, Cardiopulmonary Bypass
|
Class 2
|
DTZ
|
| §870.4360 |
Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
|
Class 2
|
KFM
|
| §870.4390 |
Tubing, Pump, Cardiopulmonary Bypass
|
Class 2
|
DWE
|
| §870.4400 |
Reservoir, Blood, Cardiopulmonary Bypass
|
Class 2
|
DTN
|
| §880.5200 |
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
|
Class 2
|
FOZ
|
| §880.5200 |
Catheter, Umbilical Artery
|
Class 2
|
FOS
|
| §880.5200 |
Central Venous Catheter Dressing Change Kit
|
Class 2
|
PEZ
|
| §880.5200 |
Heparin Flush In 0.45% Sodium Chloride
|
Class 2
|
PEF
|
| §880.5200 |
Heparin, Vascular Access Flush
|
Class 2
|
NZW
|
| §880.5200 |
Peripheral Catheter Insertion Kit
|
Class 2
|
OWL
|
| §880.5200 |
Saline, Vascular Access Flush
|
Class 2
|
NGT
|
| §880.5200 |
Water, Vascular Access Flush
|
Class 2
|
NZX
|
| §880.5970 |
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
|
Class 2
|
LJS
|
|
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions; Final Guidance for Industry and FDA Staff, issued November 2000.
Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions; Final Guidance for Industry and FDA, issued November 2000.
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
|
| Standards Development Organization
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| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
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