| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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034
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Date of Entry 01/30/2014
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FR Recognition Number
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9-89
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| Standard | |
ISO 8638 Third edition 2010-07-01
Cardiovascular implants and extracorporeal systems -- Extracorporeal blood circuit for hemodialyzers, hemodiafilters, and hemofilters |
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| U.S. Identical Adoption |
Scope/Abstract| ISO 8638:2010 specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (hereafter referred to as "the device") and (integral and non-integral) transducer protectors which are intended for use in haemodialysis, haemodiafiltration and haemofiltration. |
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Extent of Recognition
| Partial recognition. The following part(s) of the standard is (are) not recognized: |
| Section 4.4.9.1; Section 4.4.9.2; Section 5.5.6.1; Section 5.5.6.2; Section 5.5.9;Section 5.5.10; Section 6.1 NOTE; Section 6.2e NOTE; Section 6.2 NOTE; Section 6.3 NOTE; and Section 6.4 NOTE. |
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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.
FDA does not recognize these sections listed above because they are intended for quality control in hemodialysis clinics and not intended for a manufacturer to meet premarket requirements for these devices under the FD&C Act. |
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Transition Period
| FDA recognition of ISO 8638 Third edition 2010-07-01 [Rec# 9-89] will be superseded by recognition of ISO 8637-2 First Edition 2018-07 [Rec# 9-140]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 9-89] until December 17, 2023. After this transition period, declarations of conformity to [Rec# 9-89] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §876.5820 |
Accessories, Blood Circuit, Hemodialysis |
Class 2 |
KOC |
| §876.5820 |
Adaptor, Fistula |
Class 2 |
FKM |
| §876.5820 |
Adaptor, Y |
Class 2 |
FJP |
| §876.5820 |
Connector, Blood Tubing, Infusion T |
Class 2 |
FKB |
| §876.5820 |
Connector, Tubing, Dialysate |
Class 2 |
FKY |
| §876.5820 |
Declotting Tray, Kit (Including Contents) |
Class 2 |
FJZ |
| §876.5820 |
Filter, Blood, Dialysis |
Class 2 |
FKJ |
| §876.5820 |
Protector, Transducer, Dialysis |
Class 2 |
FIB |
| §876.5820 |
Set, Dialysis, Single Needle With Uni-Directional Pump |
Class 2 |
FIF |
| §876.5820 |
Set, Dialysis, Single Needle With Uni-Directional Pump, Reprocessed |
Class 2 |
NNG |
| §876.5820 |
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve |
Class 2 |
FJK |
| §876.5820 |
System Accessories, Extracorporeal |
Class 2 |
KXM |
| §876.5820 |
System, Blood, Extracorporeal And Accessories |
Class 2 |
LLB |
| §876.5820 |
Tray, Start/Stop (Including Contents), Dialysis |
Class 1 |
FKG |
| §876.5820 |
Tubing, Dialysate |
Class 2 |
FID |
| §876.5820 |
Tubing, Dialysate (And Connector) |
Class 2 |
KQQ |
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Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff: Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process, Issued June 2016.
Guidance for Industry and FDA Staff, Hemodialysis Blood Tubing Sets - Premarket Notification [510(k)] Submissions, Issued April 2008.
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 Contact
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| Standards Development Organization
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FDA Specialty Task Group (STG)
| ObGyn/Gastroenterology/Urology |
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| *These are provided as examples and others may be applicable. |
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