| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
058
|
Date of Entry 05/30/2022
|
|
FR Recognition Number
|
9-139
|
| Standard | |
CIE ISO 11664-5:2016
Colorimetry - Part 5: CIE 1976 L*u*v* colour space and u',v' uniform chromaticity scale diagram |
|
Scope/AbstractISO/CIE 11664-5:2016 specifies the method of calculating the coordinates of the CIE 1976 L*u*v* colour space including correlates of lightness, chroma, saturation and hue. It includes two methods for calculating Euclidean distances in this space to represent the relative perceived magnitude of colour differences. It also specifies the method of calculating the coordinates of the u′,v′ uniform chromaticity scale diagram.
ISO/CIE 11664-5:2016 is applicable to tristimulus values calculated using the colour-matching functions of the CIE 1931 standard colorimetric system or the CIE 1964 standard colorimetric system. This part of ISO/CIE 11664 may be used for the specification of colour stimuli perceived as belonging to a reflecting or transmitting object, where a three-dimensional space more uniform than tristimulus space is required. This includes self-luminous displays, like cathode ray tubes, if they are being used to simulate reflecting or transmitting objects and if the stimuli are appropriately normalized. This part of ISO/CIE 11664, as a whole, does not apply to colour stimuli perceived as belonging to an area that appears to be emitting light as a primary light source or that appears to be specularly reflecting such light. Only the u′,v′ uniform chromaticity scale diagram defined in 4.1 and the correlates of hue and saturation defined in 4.3 apply to such colour stimuli. |
|
| Extent of Recognition
|
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*
1. Hysteroscopes and Gynecologic Laparoscopes - Submission Guidance for a 510(k), issued March 7, 1996.
2. Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices - Guidance for Industry and FDA Staff, issued April 2016.
3. 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.
4. 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. |
|
|
