| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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054
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Date of Entry 07/06/2020
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FR Recognition Number
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9-125
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| Standard | |
ISO CIE 11664-2 S 014-2/E First edition 2007-10-15 Corrected version 2008-11-01
Colorimetry - Part 2: CIE standard illuminants |
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Scope/AbstractThis International Standard specifies two illuminants for use in colorimetry. The illuminants, which are defined in clauses 4 and 5 of this International Standard, are as follows:
a) CIE standard illuminant A
This is intended to represent typical, domestic, tungsten-filament lighting. Its relative spectral power distribution is that of a Planckian radiator at a temperature of approximately 2 856 K. CIE standard illuminant A should be used in all applications of colorimetry involving the use of incandescent lighting, unless there are specific reasons for using a different illuminant.
b) CIE standard illuminant D65
This is intended to represent average daylight and has a correlated colour temperature of approximately 6 500 K. CIE standard illuminant D65 should be used in all colorimetric calculations requiring representative daylight, unless there are specific reasons for using a different illuminant. Variations in the relative spectral power distribution of daylight are known to occur, particularly in the ultraviolet spectral region, as a function of season, time of day, and geographic location. However, CIE standard illuminant D65 should be used pending the availability of additional information on these variations. |
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| Extent of Recognition
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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. |
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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recognition of ISO, CIE 11664-2 S 014-2/E First edition 2007-10-15 Corrected version 2008-11-01 [Rec# 9-125] will be superseded by recognition of ISO, CIE 11664-2 First edition 2022-08 [Rec# 9-147].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. |
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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
|
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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. |
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| FDA Technical Contact
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| Standards Development Organizations
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FDA Specialty Task Groups (STG)
| ObGyn/Gastroenterology/Urology (primary) |
| Radiology |
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| *These are provided as examples and others may be applicable. |
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