| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
060
|
Date of Entry 05/29/2023
|
|
FR Recognition Number
|
9-147
|
| Standard | |
ISO CIE 11664-2 First edition 2022-08
Colorimetry - Part 2: CIE standard illuminants |
|
Scope/Abstract| This document defines three CIE standard illuminants for use in colorimetry: CIE standard illuminant A for the representation of typical tungsten-filament lighting, CIE standard illuminant D65 for the representation of average daylight having a correlated colour temperature of approximately 6 500 K and CIE standard illuminant D50 for the representation of daylight with a correlated colour temperature of approximately 5 000 K. Values of the relative spectral power distribution of the three illuminants are included in this document. |
|
| 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. |
|
Transition Period
| FDA recognition of ISO, CIE 11664-2 S 014-2/E First edition 2007-10-15 Corrected version 2008-11-01 [Rec# 9-125] will be superseded by recognition of ISO, CIE 11664-2 First edition 2022-08 [Rec# 9-147]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 9-125] until July 6, 2025. After this transition period, declarations of conformity to [Rec# 9-125] will not be accepted. |
|
Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §864.1860 |
Automated Digital Image Manual Interpretation Microscope
|
Class 2
|
OEO
|
| §864.3700 |
Whole Slide Imaging System
|
Class 2
|
PSY
|
| §864.3700 |
Digital Pathology Display
|
Class 2
|
PZZ
|
| §864.3700 |
Digital Pathology Image Viewing And Management Software
|
Class 2
|
QKQ
|
| §874.4680 |
Bronchoscope (Flexible Or Rigid)
|
Class 2
|
EOQ
|
| §874.4710 |
Esophagoscope (Flexible Or Rigid)
|
Class 2
|
EOX
|
| §874.4760 |
Nasopharyngoscope (Flexible Or Rigid)
|
Class 2
|
EOB
|
| §876.1300 |
System, Imaging, Gastrointestinal, Wireless, Capsule
|
Class 2
|
NEZ
|
| §876.1300 |
System, Imaging, Esophageal, Wireless, Capsule
|
Class 2
|
NSI
|
| §876.1310 |
Magnetically Maneuvered Capsule Endoscopy System
|
Class 2
|
QKZ
|
| §876.1330 |
Colon Capsule Imaging System
|
Class 2
|
PGD
|
| §876.1500 |
Cystoscope And Accessories, Flexible/Rigid
|
Class 2
|
FAJ
|
| §876.1500 |
Sigmoidoscope And Accessories, Flexible/Rigid
|
Class 2
|
FAM
|
| §876.1500 |
Sigmoidoscope, Rigid, Electrical
|
Class 2
|
FAN
|
| §876.1500 |
Choledochoscope And Accessories, Flexible/Rigid
|
Class 2
|
FBN
|
| §876.1500 |
Cystourethroscope
|
Class 2
|
FBO
|
| §876.1500 |
Telescope, Rigid, Endoscopic
|
Class 2
|
FBP
|
| §876.1500 |
Enteroscope And Accessories
|
Class 2
|
FDA
|
| §876.1500 |
Colonoscope And Accessories, Flexible/Rigid
|
Class 2
|
FDF
|
| §876.1500 |
Duodenoscope And Accessories, Flexible/Rigid
|
Class 2
|
FDT
|
| §876.1500 |
Anoscope And Accessories
|
Class 2
|
FER
|
| §876.1500 |
Kit, Nephroscope
|
Class 2
|
FGA
|
| §876.1500 |
Ureteroscope And Accessories, Flexible/Rigid
|
Class 2
|
FGB
|
| §876.1500 |
Urethroscope
|
Class 2
|
FGC
|
| §876.1500 |
Resectoscope
|
Class 2
|
FJL
|
| §876.1500 |
Laparoscope, General & Plastic Surgery
|
Class 2
|
GCJ
|
| §876.1500 |
Endoscope, Rigid
|
Class 2
|
GCM
|
| §876.1500 |
Endoscope, Flexible
|
Class 2
|
GCQ
|
| §876.1500 |
Angioscope
|
Class 2
|
LYK
|
| §876.1500 |
Endoscope, Accessories, Narrow Band Spectrum
|
Class 2
|
NWB
|
| §876.1500 |
Endoscopic Cholangiogram Kit
|
Class 2
|
NWT
|
| §876.1500 |
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
|
Class 2
|
OCS
|
| §876.1500 |
Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
|
Class 2
|
ODE
|
| §876.1500 |
Endoscope, Accessories, Image Post-Processing For Color Enhancement
|
Class 2
|
PEA
|
| §876.1520 |
Gastrointesinal Lesion Software Detection System
|
Class 2
|
QNP
|
| §884.1600 |
Amnioscope, Transabdominal (Fetoscope) (And Accessories)
|
HDE
|
HFA
|
| §884.1630 |
Colposcope (And Colpomicroscope)
|
Class 2
|
HEX
|
| §884.1630 |
Vaginoscope And Accessories
|
Class 2
|
MOK
|
| §884.1640 |
Culdoscope (And Accessories)
|
Class 2
|
HEW
|
| §884.1690 |
Hysteroscope (And Accessories)
|
Class 2
|
HIH
|
| §884.1690 |
Falloposcope
|
Class 2
|
MKO
|
| §884.1720 |
Laparoscope, Gynecologic (And Accessories)
|
Class 2
|
HET
|
|
Relevant FDA Guidance and/or Supportive Publications*
1) Hysteroscopes and Gynecology Laparoscopes - Submission Guidance for a 510(k), issued March 7, 1996.
2) Guidance for Industry and FDA Staff: Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices, issued April 2016.
3) Wei‐Chung Cheng, Firdous Saleheen, and Aldo Badano. "Assessing color performance of whole‐slide imaging scanners for digital pathology." Color Research & Application 44.3 (2019): 322-334.
4) Lemaillet, Paul, and Wei-Chung Cheng. "Colorimetrical uncertainty of a hyperspectral imaging microscopy system for assessing whole-slide imaging devices." Biomedical Optics Express 11.3 (2020): 1449-1461.
5) Cheng, Wei-Chung, et al. "Evaluating whole-slide imaging viewers used in digital pathology." Electronic Imaging 32 (2020): 1-6.
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 Organizations
|
FDA Specialty Task Groups (STG)
| ObGyn/Gastroenterology/Urology (primary) |
| Radiology |
|
| *These are provided as examples and others may be applicable. |
|
|
