Recognized Consensus Standards

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

054

Date of Entry 07/06/2020 

FR Recognition Number

9-124

ISO CIE 11664-1:2019 Colorimetry - Part 1: CIE standard colorimetric observers

Scope/Abstract

This document specifies colour-matching functions for use in colorimetry. Two sets of colour-matching functions are specified.

a) Colour-matching functions for the CIE 1931 standard colorimetric observer.

This set of colour-matching functions is representative of the colour-matching properties of observers with normal colour vision for visual field s of angular subtense from about 1° to about 4°, for vision at photopic levels of adaptation.

b) Colour-matching functions for the CIE 1964 standard colorimetric observer.

This set of clour-matching functions is representative of the colour-matching properties of observers with normal colour vision for visual field s of angular subtense greater than about 4°, for vision at sufficiently high photopic levels and with spectral power distributions such that no participation of the rod receptors of the retina is to be expected.

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

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

FDA Specialty Task Groups (STG)

ObGyn/Gastroenterology/Urology (primary)

Radiology

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