Recognized Consensus Standards

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

054

Date of Entry 07/06/2020 

FR Recognition Number

9-128

Standard

CIE ISO 11664-6 First edition 2014-02-01 Colorimetry - Part 6: CIEDE2000 colour-difference formula

Scope/Abstract

This CIE International Standard specifies the method of calculating colour differences according to the CIEDE2000 formula.

The Standard is applicable to input values of CIELAB L*, a*, b* coordinates calculated according to ISO 11664-4:2008(E)/CIE S 014-4/E:2007. The Standard may be used for the specification of the colour difference between two colour stimuli perceived as belonging to reflecting or transmitting objects. This includes displays, if they are being used to simulate reflecting or transmitting objects and if the tristimulus values representing the stimuli are appropriately normalized. The Standard does not apply to colour stimuli perceived as belonging to areas that appear to be emitting light as primary light sources, or that appear to be specularly reflecting such light.

Extent of Recognition

Complete standard

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
§876.1500	Angioscope	Class 2	LYK
§876.1500	Anoscope And Accessories	Class 2	FER
§876.1500	Choledochoscope And Accessories, Flexible/Rigid	Class 2	FBN
§876.1500	Colonoscope And Accessories, Flexible/Rigid	Class 2	FDF
§876.1500	Cystoscope And Accessories, Flexible/Rigid	Class 2	FAJ
§876.1500	Cystourethroscope	Class 2	FBO
§876.1500	Duodenoscope And Accessories, Flexible/Rigid	Class 2	FDT
§876.1500	Endoscope, Flexible	Class 2	GCQ
§876.1500	Endoscope, Rigid	Class 2	GCM
§876.1500	Enteroscope And Accessories	Class 2	FDA
§876.1500	Kit, Nephroscope	Class 2	FGA
§876.1500	Laparoscope, General & Plastic Surgery	Class 2	GCJ
§876.1500	Resectoscope	Class 2	FJL
§876.1500	Sigmoidoscope And Accessories, Flexible/Rigid	Class 2	FAM
§876.1500	Sigmoidoscope, Rigid, Electrical	Class 2	FAN
§876.1500	Telescope, Rigid, Endoscopic	Class 2	FBP
§876.1500	Ureteroscope And Accessories, Flexible/Rigid	Class 2	FGB
§876.1500	Urethroscope	Class 2	FGC
§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	Falloposcope	Class 2	MKO
§884.1690	Hysteroscope (And Accessories)	Class 2	HIH
§884.1720	Laparoscope, Gynecologic (And Accessories)	Class 2	HET
§864.1860	Automated Digital Image Manual Interpretation Microscope	Class 2	OEO
§864.3700	Digital Pathology Display	Class 2	PZZ
§864.3700	Digital Pathology Image Viewing And Management Software	Class 2	QKQ
§864.3700	Whole Slide Imaging System	Class 2	PSY

Relevant FDA Guidance and/or Supportive Publications*

* Submission Guidance for a 510(k): Hysteroscopes and Gynecologic Laparoscopes, Issued March 7, 1996.
* Guidance for Industry and FDA Staff: Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices, Issued April 2016.
* Cheng, W.C., Saleheen, F., and Badano, A. (2019). Assessing color performance of whole-slide imaging scanners for digital pathology. Color Research & Application, 44(3), 322-334.
* Lemaillet P. & Cheng W.C. (2020). Colorimetrical uncertainty of a hyperspectral imaging microscopy system for assessing whole-slide imaging devices. Biomedical Optics Express, 11(3), 1449-1461.

FDA Technical Contact

 Wei-Chung Cheng

  FDA/OC/CDRH/OSEL/DIDSR/

  301-796-5169

  Wei-Chung.Cheng@fda.hhs.gov

Standards Development Organizations

CIE	International Commission on Illumination	http://cie.co.at/
ISO	International Organization for Standardization	https://www.iso.org/

FDA Specialty Task Groups (STG)

ObGyn/Gastroenterology/Urology (primary)

Radiology

*These are provided as examples and others may be applicable.