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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 056 Date of Entry 06/07/2021 
FR Recognition Number 9-131
Standard
ISO 8600-5 Second Edition 2020-10
Optics and photonics - Medical endoscopes and endotherapy devices - Part 5: Determination of optical resolution of rigid endoscopes with optics
Scope/Abstract
This document applies to rigid endoscopes designed for use in the practice of medicine. Endoscopes having a fibre-optic or opto-electronic imaging system are excluded. It specifies a test method for determining the optical resolution of endoscopes.

This document provides a measurement method for characterizing three aspects of the optical resolution of a rigid endoscope. Characteristic A is used to provide a simple measurement of the limiting resolution of the endoscope image. Characteristic B provides a measurement of low spatial frequency resolution and characterizes the sharpness, or contrast, of the endoscope image. Characteristic C provides a measurement of the spatial frequency response of the endoscope image.
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.

Note: Characteristic A is a single-valued subjective metric primarily designed for rapid manufacturing testing, and therefore it would not be appropriate for use to provide endoscope optical performance data in regulatory submissions.
Transition Period
FDA recognition of ISO 8600-5 First edition 2005-03-15 [Rec# 9-39] will be superseded by recognition of ISO 8600-5 Second Edition 2020-10 [Rec# 9-131]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 9-39] until July 10, 2022. After this transition period, declarations of conformity to [Rec# 9-39] will not be accepted.
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, Accessories, Narrow Band Spectrum Class 2 NWB
§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
Relevant FDA Guidance and/or Supportive Publications*
1. Hysteroscopes and Gynecologic Laparoscopes: Submission Guidance for a 510(k), Issued March 1996.
2. Feltz, J. C. (1990). "Development of the modulation transfer function and contrast transfer function for discrete systems, particularly charge-coupled devices." Optical Engineering 29(8): 893-904.
3. Lucke, R. L. (1998). "Deriving the Coltman correction for transforming the bar transfer function to the optical transfer function (or the contrast transfer function to the modulation transfer function)." Applied Optics 37(31): 7248-7252.
4. ISO 12233 (2017): Photography - Electronic still picture imaging - Resolution and spatial frequency responses, the International Organization for Standardization.
FDA Technical Contact
 Quanzeng Wang
  FDA/OC/CDRH/OSEL/DBP/
  301-796-2612
  quanzeng.wang@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
ObGyn/Gastroenterology/Urology
*These are provided as examples and others may be applicable.
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