| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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056
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Date of Entry 06/07/2021
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|
FR Recognition Number
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9-131
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| 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 |
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Scope/AbstractThis 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. |
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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.
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. |
|
Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §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
|
| §876.1500 |
Endoscope, Accessories, Narrow Band Spectrum
|
Class 2
|
NWB
|
| §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 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.
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 Organization
|
FDA Specialty Task Group (STG)
| ObGyn/Gastroenterology/Urology |
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| *These are provided as examples and others may be applicable. |
