| Part B: Supplementary Information Sheet (SIS) |
|
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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1-158
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| Standard | |
ISO 10079-4 First edition 2021-08
Medical suction equipment - Part 4: General requirements |
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Scope/AbstractThis document specifies general requirements for medical suction equipment that are common to all parts of the ISO 10079 series.
This document is not applicable to the following:
a) end-pieces such as suction catheters, drains, curettes, Yankauer suckers and suction tips;
b) syringes;
c) dental suction equipment;
d) anaesthetic gas scavenging systems;
e) laboratory suction;
f) autotransfusion systems;
g) mucus extractors including neonatal mucus extractors;
h) suction equipment where the collection container is downstream of the vacuum pump;
i) ventouse (obstetric) equipment;
j) suction equipment marked for endoscopic use only; and
k) plume evacuation systems.
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|
| Extent of Recognition
|
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. |
|
Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §870.5050 |
Apparatus, Suction, Patient Care
|
Class 2
|
DWM
|
| §870.5910 |
Esophageal Thermal Regulation And Gastric Suctioning Device
|
Class 2
|
PLA
|
| §874.5350 |
Device, Antichoke, Suction
|
Class 3
|
EWT
|
| §876.1500 |
Endoscopic Irrigation/Suction System
|
Class 2
|
OCX
|
| §878.4680 |
Apparatus, Suction, Single Patient Use, Portable, Nonpowered
|
Class 1
|
GCY
|
| §878.4683 |
Negative Pressure Wound Therapy Non-Powered Suction Apparatus
|
Class 2
|
OKO
|
| §878.4780 |
Pump, Portable, Aspiration (Manual Or Powered)
|
Class 2
|
BTA
|
| §878.4780 |
Apparatus, Suction, Ward Use, Portable, Ac-Powered
|
Class 2
|
JCX
|
| §878.4780 |
Wound Drain Catheter System
|
Class 2
|
OTK
|
| §878.5040 |
System, Suction, Lipoplasty
|
Class 2
|
MUU
|
| §878.5040 |
System, Suction, Lipoplasty For Removal
|
Class 2
|
QPB
|
| §880.6740 |
Regulator, Vacuum
|
Class 2
|
KDP
|
|
Relevant FDA Guidance and/or Supportive Publications*
1. Guidance for Industry and FDA Reviewers/Staff: Guidance Document for Powered Suction Pump 510(k)s, issued September 1998.
2. ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)].
3. ISO 5356-1 Third edition 2004-05 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets.
4. ISO 10993-1 Fifth edition 2018-08 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
5. IEC 62366-1 Edition 1.1 2020-06 Medical devices - Part 1: Application of usability engineering to medical devices.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
|
| FDA Technical Contact
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
