← Product Code [HKI](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKI) · K963333 # OPTRONICS EPIC COLOR TELEVISION CAMERA SYSTEM (S97340) (K963333) _Karl Storz Imaging, Inc. · HKI · Oct 22, 1996 · Ophthalmic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKI/K963333 ## Device Facts - **Applicant:** Karl Storz Imaging, Inc. - **Product Code:** [HKI](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKI.md) - **Decision Date:** Oct 22, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 886.1120 - **Device Class:** Class 2 - **Review Panel:** Ophthalmic ## 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 ophthalmic examination, diagnosis, treatment definition and clarification, and patient education/proof of treatment need. ## Device Story Optronics EPIC Color Television Camera System (Model S97340) functions as an accessory to AC-powered slit lamp biomicroscopes. System comprises a camera head with 10X eyepiece and 50/50 beamsplitter, and a video processor unit. Camera head houses video sensor and optical elements; processor contains power supply and circuit boards. Device captures optical images of the eye via the slit lamp, processes video signals, and outputs to a video monitor. Allows simultaneous viewing through the eyepiece and on the monitor. Used in clinical settings by ophthalmologists/clinicians to facilitate examination, diagnosis, treatment definition, and patient education. Benefits include enhanced visualization and documentation of ocular conditions. ## Clinical Evidence No clinical data provided; substantial equivalence based on technological comparison and performance specifications. ## Technological Characteristics System includes camera head and video processor with aluminum housings. Features 1/4 inch CCD sensor, 470 TV lines resolution, 2 lux sensitivity, and 10X eyepiece magnification. Utilizes 50/50 beam splitter for simultaneous optical and video viewing. AC-powered. ## Regulatory Identification An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area. ## Special Controls *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. ## Predicate Devices - Haag-Streit Model BQ Slit Lamp - Haag-Streit Model BM Slit Lamp ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} +805-968-1553 KARL STORZ IMAGING 107 P02/03 OCT 21 '96 09:13 KARL STORZ IMAGING Karl Storz Imaging, Inc. 175 Cremona Drive, Goleta, CA 93117 510(k) SUMMARY K963333 OCT 22 1996 Submitted By: (Contact person) Mr. Terry Fernandez KARL STORZ Imaging, Inc. 175 Cremona Drive Goleta, CA 93117 (805) 968-5563 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: Ophthalmic 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 ophthalmic examination, diagnosis, treatment definition and clarification, and patient education/proof of treatment need. Telephone (805) 968-5563 Customer Service Fax (805) 968-2046 Administration Fax (805) 968-1553 Engineering Fax (805) 968-2315 52 {1} +805-968-1553 KARL STORZ IMAGING 107 P03/03 OCT 21 '96 09:14 KARL STORZ IMAGING Karl Storz Imaging, Inc. 175 Cremona Drive, 'Soleto, 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 camera 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 | Telephone (805) 968-5563 Customer Service Fax (805) 968-2046 Administration Fax (805) 968-1553 Engineering Fax (805) 968-2315 52A --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKI/K963333](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKI/K963333) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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