FDA Home Page | CDRH Home Page | Search | A-Z Index | ||
Guidance for Industry Ophthalmoscope Guidance -
|
Document issued on: July 8, 1998
U.S. Department Of Health And Human Services Food and Drug Administration Center for Devices and Radiological Health Diagnostic and Surgical Devices Branch |
Comments and suggestions may be submitted at any time for Agency consideration to, Division of Ophthalmic Devices, HFZ-460, 9200 Corporate Blvd, Rockville, MD 20850. Comments may not be acted upon by the Agency until the document is next revised or updated. For questions regarding the use or interpretation of this guidance contact Everette T. Beers, Ph.D. at (240) 276-4200 or by e-mail at everette.beers@fda.hhs.gov.
World Wide Web/CDRH/ home page: http://www.fda.gov/cdrh or CDRH Facts on Demand at 1-800-899-0381 or 301-827-0111, specify number 1241 when prompted for the document shelf number.
Ophthalmoscope Guidance1
|
Common Name: |
Ophthalmoscope |
Class: |
II |
Classification Panel: |
86 |
Product Code: |
HLI (AC) and HLJ (DC) |
Regulation Number: |
886.1570 |
Description: |
An ophthalmoscope is an ac or battery powered device containing illumination and viewing optics to examine the cornea, aqueous, lens, vitreous, and the retina of the eye. It may be hand-held or mounted on the user's head. |
Inclusions/Exclusions: |
Includes scanning laser ophthalmoscopes and any accessories. |
An ophthalmoscope is intended to be used to examine the cornea, aqueous, lens, vitreous and retina of the eye.
1 This document is intended to provide guidance. It represents the Agency's current thinking on the above. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statue, regulations, or both.
Device Trade or Proprietary Name
Device Common or Usual Name
Establishment Registration Number (if establishment registered)
Class
Classification Panel
Action taken to comply with Section 514 of the Act
Proposed labels, labeling, and Advertisements (if available) which describe the device, its intended use, and directions for use
Truthful and Accurate Statement
510(k) Statement or Summary
Indications for Use Form
The Marketed Device(s) to which equivalence is claimed including labeling and description of the device(s) and 510(k) number(s), if known.
Statement, table or chart of similarities and differences with Marketed Device(s)
Submitter's Name and Address
Contact Person, Telephone and Fax Number
Table of Contents with Pagination
Address of Manufacturing Facility/Facilities, and Sterilization Facility (if appropriate)
(1) beam geometry (solid angle subtended by the initial condensing lens at the source, significant light losses in the optical path, and retinal area illuminated);
(2) the light source and its operating characteristics (electrical power and effective color temperature); and
(3) the optical characteristics of all components including spectral transmittance and the reflective/transmissive properties of any lenses, glass diffusion windows or filters. Also include the names and model identifications of the manufacturers of the critical components.
(1) the relative spectral radiant power distribution or any other relative spectral radiometric distribution over the wavelength range from 400 nm to 700 nm;
(2) the maximum photometric luminance; and either
(3) the maximum radiometric quantities:
(i) spectral irradiance or spectral radiance over the ultraviolet (UV) wavelength range from 250 nm to 400 nm, and,
(ii) irradiance for infrared (IR) wavelengths greater than 700 nm; or
(4) the optical radiation hazards as defined by ISO 15004 for:
(i) ultraviolet and infrared radiation, and
(ii) visible light and near IR radiation (blue-light weighted radiance and aphakic weighted radiance).
"Because prolonged intense light exposure can damage the retina, the use of the device for ocular examination should not be unnecessarily prolonged, and the brightness setting should not exceed what is needed to provide clear visualization of the target structures. This device should be used with filters that eliminate UV radiation (< 400 nm) and, whenever possible, filters that eliminate short-wavelength blue light (<420 nm).
"The retinal exposure dose for a photochemical hazard is a product of the radiance and the exposure time. If the value of radiance were reduced in half, twice the time would be needed to reach the maximum exposure limit.
"While no acute optical radiation hazards have been identified for direct or indirect ophthalmoscopes, it is recommended that the intensity of light directed into the patient's eye be limited to the minimum level which is necessary for diagnosis. Infants, aphakes and persons with diseased eyes will be at greater risk. The risk may also be increased if the person being examined has had any exposure with the same instrument or any other ophthalmic instrument using a visible light source during the previous 24 hours. This will apply particularly if the eye has been exposed to retinal photography."
IEC 60601- 1 |
- Medical electrical equipment - Part 1: General requirements for safety |
IEC 60601- 1- 4 |
- Medical electrical equipment - Part 1: General requirements for safety - 4. Collateral Standard: Programmable electrical medical systems. |
ISO 10942 |
- Direct Ophthalmoscopes |
ISO 10943 |
- Indirect Ophthalmoscopes |
ISO 15004 |
- Ophthalmic instruments - General requirements and test methods |
|
|
UL 544 |
- Professional Medical and Dental Equipment |
UL 2601-1 |
- Medical electrical equipment - Part 1: General requirements for safety |
Reviewer Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review (August 29, 1991)
ODE Guidance for the Content of Premarket Submission Containing Software - Draft Document (available at http://www.fda.gov/cdrh/ode/software.pdf)
1998 TLVs and BEIs: Threshold Limit Values for Chemical Substances and Physical Agents and Biological Exposure Indices, American Conference of Governmental Industrial Hygienists, (ACGIH, Cincinnati, OH), 1998.
ANSI/IESNA RP 27.1-96: Recommended Practice for Photobiological Safety for Lamps & Lamp Systems - General Requirements.
ANSI/IESNA RP 27.3-96: Recommended Practice for Photobiological Safety for Lamps - Risk Group Classification & Labeling.
Checklist for Ophthalmoscopes
Information for the following items should be provided in a 510(k) submission:
General Requirements:
Submitter's Name and Address
Contact Person, Telephone and Fax Number
Table of Contents with Pagination
Address of Manufacturing Facility/Facilities, and Sterilization Facility
(if appropriate)
Device Trade or Proprietary Name
Device Common or Usual Name
Establishment Registration Number (if establishment registered)
Class
Classification Panel
Action taken to comply with Section 514 of the Act
Proposed labels, labeling, and Advertisements (if available) which describe
the device, its intended use, and directions for use
Truthful and Accurate Statement
510(k) Statement or Summary
Indications for Use Form
The Marketed Device(s) to which equivalence is claimed including labeling
and description of the device(s) and 510(k) number(s), if known.
Device Specific Requirements:
Materials (no flammable materials near light source)
Side-by-side comparison with predicate(s) (statement, table or chart of
similarities and differences with Marketed Device(s)
Optical equivalency and radiation safety certification or measurements
Electrical safety
Software certification
Disinfection information
Labeling: prescription device caution; disinfection procedures; phototoxicity
information; laser product labeling
Declaration of Conformity to a Recognized Standard
In preparing a declaration of conformity to recognized standards, manufacturers should refer to the guidance document entitled, "Guidance on the Recognition and Use of Consensus Standards." In accordance with this guidance, declarations of conformity to recognized standards should include the following:
Uploaded on September 21, 1998
CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page
Center for Devices and Radiological Health / CDRH