(60 days)
Haag-Streit Model BQ Slit Lamp w/accessories, Haag-Streit Model BM Slit Lamp w/accessories
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No
The summary describes a camera and video processor for image enhancement, but there is no mention of AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML devices. The "image processing" mentioned is likely standard digital signal processing for image quality.
No.
The "Intended Use" states that the device is for "enhanced imaging of the eye for ophthalmic examination, diagnosis, treatment definition and clarification, and patient education/proof of treatment need," which are diagnostic and procedural support functions, not therapeutic.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the system is intended for "diagnosis."
No
The device description explicitly states it consists of a camera and a video processor, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "enhanced imaging of the eye for opthalmic examination, diagnosis, treatment definition and clarification, and patient education/proof of treatment need." This describes a device used for in vivo examination of the eye, not for testing samples in vitro (outside the body).
- Device Description: The description details a camera and video processor designed to attach to a slit lamp biomicroscope, which is used for direct examination of the eye.
- Anatomical Site: The anatomical site is the "eye," which is an in vivo site.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostic testing.
Therefore, the Optronics EPIC System is an ophthalmic imaging accessory used for direct examination of the eye, not an IVD.
N/A
Intended Use / Indications for Use
The Optronics EPIC System is intended for use as an accessory to a slit lamp biomicroscope, providing enhanced imaging of the eye for opthalmic examination, diagnosis, treatment definition and clarification, and patient education/proof of treatment need
Product codes
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Device Description
The Optronics EPIC System consists of a camera and a video processor. The camera consists of a camera head with eyepiece and beamsplitter and an integral cable for electronic transmission of signals and power. The camera head consists of an outer aluminum shell housing the video sensor and optical elements. The cable is permanently attached to the camera head and connects to the processor. The processor consists of a finished aluminum housing containing the power supply, circuit boards, and interconnections necessary to process the video image.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
eye
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Haag-Streit Model BQ Slit Lamp w/accessories, Haag-Streit Model BM Slit Lamp w/accessories
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 886.1120 Ophthalmic camera.
(a)
Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.(b)
Classification. Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
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+805-968-1553 STORZ IMAGING A STATE FREE EN STATE THE CONSTITUTION STATES OF THE STATES OF THE STATES OF THE STATES OF THE STATES OF THE STATES OF THE STATES OF THE STATES OF THE FORMER AND A BRACE AND
09:13 107 P02/03 OCT 21 '96
Image /page/0/Picture/2 description: The image shows the logo for STORZ, with the words "STORZ" in large, bold letters at the top. Below that, in smaller letters, it says "KARL STORZ IMAGING". The logo is in black and white, and the text is clear and easy to read. The logo appears to be for a medical imaging company.
Karl Storz Imaging, Inc. 175 Cremona Drive, Croleta, CA 93117
510(k) SUMMARY
Image /page/0/Picture/5 description: The image shows a sequence of bold, black numbers and a letter. The sequence starts with the letter 'K', followed by the number '96', and then a series of '3's, specifically '33333'. The characters are large and take up most of the image.
| Submitted By:
(Contact person) | Mr. Terry Fernandez
KARL STORZ Imaging, Inc.
175 Cremona Drive
Goleta, CA 93117
(805) 968-5563 | OCT 22 1996 |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Summary Date: | August 14, 1996 | |
| Trade Name: | Optronics EPIC Color Television Camera System, Model S97340 | |
| Device Name: | Video camera accessory for AC-powered Slit Lamp Biomicroscope | |
| Classification Name: | Opthalmic camera/21 CFR 886.1120
AC-powered slitlamp biomicroscope/21 CFR 886.1850 | |
| Predicate Devices: | Haag-Streit Model BQ Slit Lamp w/accessories
Haag-Streit Model BM Slit Lamp w/accessories | |
| Device Description: | The Optronics EPIC System consists of a camera and a video processor. The camera consists of a camera head with eyepiece and beamsplitter and an integral cable for electronic transmission of signals and power. The camera head consists of an outer aluminum shell housing the video sensor and optical elements. The cable is permanently attached to the camera head and connects to the processor. The processor consists of a finished aluminum housing containing the power supply, circuit boards, and interconnections necessary to process the video image. | |
| Intended Use: | The Optronics EPIC System is intended for use as an accessory to a slit lamp biomicroscope, providing enhanced imaging of the eye for opthalmic examination, diagnosis, treatment definition and clarification, and patient education/proof of treatment need | |
1
Image /page/1/Picture/2 description: The image shows the logo for Karl Storz Imaging. The logo features the word "STORZ" in a stylized font, with the "O" represented by concentric circles. Below the word "STORZ" is the text "KARL STORZ IMAGING" in a smaller, sans-serif font. The background of the logo is a dark, textured pattern.
Karl Storz Imaging, Inc. 175 Cremona Drive, Goleta, CA 93117
Comparison to Predicate Devices:
The Optronics EPIC is equivalent to the Haag-Streit 900 BQ and 900 BM with respect to their intended uses. We believe, however, that the EPIC provides the practitioner with greater flexibility and ease of use by combining the biomicroscope interface and carnera into a 10X eyepiece which utilizes a 50/50 beam splitter to allow simultaneous viewing both on the video monitor and through the eyepiece. For a comparison of video system performance, please refer to the following table.
| Characteristic | EPIC | Haag-Streit 900 BQ | Haag-Streit 900 BM |
|---|---|---|---|
| CCD Type | 1/4 inch | 1/2 inch | 1/2 inch |
| Resolution | 470 TV lines | 450 TV lines | 450 TV lines |
| Sensitivity | 2 lux | 10 lux | 10 lux |
| Beam splitter | 50/50 | 50/50 or 70/30 | |
| (selectable) | Video adaptor is a | ||
| separate microscope | |||
| Eyepiece | |||
| magnification | 10X | 6.3, 10, 16, 25, 40X | 6.3, 10, 16, 25, 40X |