OPTRONICS EPIC COLOR TELEVISION CAMERA SYSTEM (S97340)

K963333 · Karl Storz Imaging, Inc. · HKI · Oct 22, 1996 · Ophthalmic

Device Facts

• Record ID: K963333
• Device Name: OPTRONICS EPIC COLOR TELEVISION CAMERA SYSTEM (S97340)
• Applicant: Karl Storz Imaging, Inc.
• Product Code: HKI · Ophthalmic
• Decision Date: Oct 22, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1120
• Device Class: Class 2

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.

Indications for Use

Indicated for use as an accessory to a slit lamp biomicroscope for ophthalmic examination, diagnosis, treatment planning, and patient education in patients requiring eye imaging.

Regulatory Classification

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)

{0}

[phone] 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
[phone]

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 [phone]

Customer Service Fax [phone]

Administration Fax [phone]

Engineering Fax [phone]

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{1}

[phone] 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 [phone]
Customer Service Fax [phone]
Administration Fax [phone]
Engineering Fax [phone]
52A