| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
054
|
Date of Entry 07/06/2020
|
|
FR Recognition Number
|
9-126
|
| Standard | |
ISO CIE 11664-3 First edition 2019-06
Colorimetry - Part 3: CIE tristimulus values |
|
Scope/AbstractThis document specifies methods of calculating the tristimulus values of colour stimuli for which the spectral distributions are provided. These colour stimuli can be produced by self-luminous light sources or by reflecting or transmitting objects.
This document requires that the colour stimulus function be tabulated at measurement intervals of 5 nm or less in a wavelength range of at least 380 nm to 780 nm. Extrapolation methods are suggested for cases where the measured wavelength range is less than 380 nm to 780 nm.
The standard method is defined as summation at 1 nm intervals over the wavelength range from 360 nm to 830 nm. Alternative abridged methods are defined for larger intervals (up to 5 nm) and shorter ranges (down to 380 nm to 780 nm). The alternative methods are to be used only when appropriate and when the user has reviewed the impact on the final results.
This document can be used in conjunction with the CIE 1931 standard colorimetric observer or the CIE 1964 standard colorimetric observer.
|
|
| 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 |
| §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
|
| §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
|
| §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*
* 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.
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. |
