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Guidance for IndustrySlit Lamp 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 General 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 1242 when prompted for the document shelf number.
Slit Lamp Guidance1
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Common Name: | AC-Powered Slitlamp Biomicroscope |
Class: | II |
Classification Panel: | 86 |
Product Code: | HJO |
Regulation Number: | 886.1850 |
Description: | An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into the patient's eye through a control diaphragm a thin, intense beam of light. |
Inclusions/Exclusions: | Including all accessories. |
An AC-powered slitlamp biomicroscope is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.
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:
(4) the optical radiation hazards as defined by ISO 15004 for:
"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 slit lamps, 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 10939 | - Ophthalmic instruments - Slit-lamp microscopes |
ISO 15004 | - Ophthalmic instruments - General requirements and test methods |
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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.
APPENDIX I
Checklist for Slit Lamps
Information for the following items should be provided in a 510(k) submission:
General Requirements:
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:
APPENDIX II
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
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