| 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
|
1-156
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| Standard | |
ISO 10079-3 Fourth edition 2022-03
Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source |
|
Scope/Abstract| This document specifies basic safety and performance requirements for medical suction equipment powered from a vacuum or positive pressure gas source generating venturi suction. It applies to suction equipment connected to medical gas pipeline systems or cylinders and venturi attachments and can be standalone or part of an integrated system. |
|
| Extent of Recognition
|
Rationale for Recognition
| This standard is relevant to medical devices and is recognized because it is scientifically and technically valid and not in conflict with existing regulatory policies. |
|
Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §868.6810 |
Catheters, Suction, Tracheobronchial
|
Class 1
|
BSY
|
| §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
|
| §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 |
Vacuum Powered Body Fluid Collection Kit
|
Class 2
|
OJR
|
| §878.4780 |
Negative Pressure Wound Therapy Powered Suction Pump
|
Class 2
|
OMP
|
| §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 |
Bottle, Collection And Trap, Breathing System (Uncalibrated)
|
Class 2
|
CBC
|
| §880.6740 |
Apparatus, Suction, Operating-Room, Wall Vacuum Powered
|
Class 2
|
GCX
|
| §880.6740 |
Regulator, Vacuum
|
Class 2
|
KDP
|
| §880.6740 |
Bottle, Collection, Vacuum
|
Class 2
|
KDQ
|
| §880.6740 |
Chest Drainage Kit
|
Class 2
|
PAD
|
|
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. ISO 10079-4 First edition 2021-08 Medical suction equipment - Part 4: General requirements.
3. 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)].
4. ISO 5356-1 Third edition 2004-05 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets.
5. ISO 10993-1 Fifth edition 2018-08 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
6. IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION Medical devices - Part 1: Application of usability engineering to medical devices.
7. ISO 5359 Fourth edition 2014-10 Anaesthetic and respiratory equipment - Low-pressure hose assemblies for use with medical gases [Including AMENDMENT 1 (2017)].
8. ISO 4135 Fourth edition 2022-01 Anaesthetic and respiratory equipment - Vocabulary.
9. Non-powered Suction Apparatus Device Intended for Negative Pressure Wound Therapy (NPWT) - Class II Special Controls Guidance for Industry and FDA Staff, issued November 2010.
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. |
