(27 days)
Not Given
Not Found
No
The summary describes a standard slitlamp with accessories for measurement and documentation, and there is no mention of AI, ML, or image processing capabilities.
No
The device is indicated as a noninvasive aid in the examination and diagnosis of eye conditions and in the fitting of contact lenses, which are diagnostic purposes, not therapeutic.
Yes
The "Intended Use / Indications for Use" states that the device is indicated as an "aid in the examination and diagnosis of eye conditions".
No
The device description explicitly states it is an instrument consisting of a microscope and a light source, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a "noninvasive aid in the examination and diagnosis of eye conditions and in the fitting of contact lenses." It uses a light source and microscope to directly examine the eye.
- No Sample Analysis: There is no mention of analyzing samples taken from the patient. The examination is performed directly on the eye.
Therefore, this device falls under the category of a medical device used for direct examination and diagnosis, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The device and accessories are indicated as a noninvasive aid in the examination and diagnosis of eye conditions and in the fitting of contact lenses. The indications are the same as those claimed for the predicate devices.
Product codes
Not Found
Device Description
The Rodenstock brand RO 5000 and RO 4000 slitlamps are instruments used for eye examination and the fitting of contact lenses. Each device consists of a microscope combined with a light source that can be narrowed into a slit for illumination of the eye. Each is available with accessories to measure characteristics of the eye and to document actual shapes. The device is powered by 6.3 to 12v AC and 50-60 Hz.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Haag-Streit brand slitlamp 900® BQ, Topcon brand slitlamp model SL-2ED
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.1850 AC-powered slitlamp biomicroscope.
(a)
Identification. An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.(b)
Classification. Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
0
JUL 25 1998
ﮐﺴﺎﻧ
510 (k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.
- The submitter of this premarket notification is:
David M. Link, Vice President EXPERTech™ Associates, Inc. 100 Main Street, Suite 120 Concord, MA 01742-5307 (508) 371-0066 Telephone: Fax: (508) 371-1676
This Summary was prepared on May 31, 1996.
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The name of the device is the Rodenstock RO 5000 and RO 4000 Slitlamp. Its common name is the slitlamp and the classification name is the AC-powered slitlamp biomicroscope.
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The RO 5000 device is substantially equivalent to the Haag-Streit brand slitlamp 900® BQ and the RO 4000 device is substantially equivalent to the Topcon brand slitlamp model SL-2ED .
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The Rodenstock brand RO 5000 and RO 4000 slitlamps are instruments used for eye examination and the fitting of contact lenses. Each device consists of a microscope combined with a light source that can be narrowed into a slit for illumination of the eye. Each is available with accessories to measure characteristics of the eye and to document actual shapes. The device is powered by 6.3 to 12v AC and 50-60 Hz.
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The device and accessories are indicated as a noninvasive aid in the examination and diagnosis of eye conditions and in the fitting of contact lenses. The indications are the same as those claimed for the predicate devices.
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The technological characteristics are the same or similar to those found with the predicate devices where the eye is examined by projecting light onto it. Additionally, standard accessories are used for tonometry, examining the vitreous and fundus of the eye and contact lens fitting as those claimed for the predicate devices.
000090