The Discam® Digital Imaging System is intended to be used as an ophthalmic diagnostic tool, which is complimentary to other accepted diagnostic technologies, to track the progress of glaucoma, relative to monitoring changes in the appearance (size and shape) of the Optic Disc.

The Discam® Digital Imaging System is intended to be used to evaluate the Optic Disc, (Optic Nerve Head). It is used in the same fashion as a Fundus camera, except that it's field of view is narrower, in order to focus exclusively on the Optic Disc, (Optic Nerve Head). Evaluation of changes in the size and shape of the Optic Disc, (Optic Nerve Head), is useful in monitoring the progress of patients with Ocular Hypertension, and Glaucoma.

Device Description

The Discam® Digital Imaging System consists of a CCD Stereo Camera that captures stereo images through an image capture board interfaced with a PC with the minimum requirements mages arough an RAM, 1 GB Hard Disc, 133 MHz CPU, Windows® 95 OS. The CCD stereo camera and housing is mounted on a standard rise and fall table, along with a standard adjustable patient chin rest.

The patient fixates on fixation lights, (fixed LEDs), and the operator views the image on the PC's monitor. Image capture, which is accomplished in 0.2 seconds, is initiated by pushing a iov stick.

Windows® based software allows basic analysis, (measurement of cup and Disc, cup to Disc ratio), of the captured images, using either our optional analysis software, or third party software with user developed algorithms, and data archiving.

The camera measures 370 mm Depth x 360 mm Height x 108 mm Width. It is powered by a switch mode power supply 100 V to 220 V, 50 Hz to 60 Hz.

Illumination is from a 12 Volt 55 Watt Halogen Lamp. There is no flash.

AI/ML Overview

The provided text does not contain acceptance criteria or a study proving the device meets acceptance criteria in the traditional sense of a clinical performance study with defined endpoints and statistical analysis.

Instead, the submission K974535 for the DISCAM® DIGITAL IMAGING SYSTEM focuses on demonstrating substantial equivalence to existing predicate devices.

Here's an analysis based on the information provided:

Table of acceptance criteria and the reported device performance:
The document does not present a table of specific acceptance criteria with numerical targets (e.g., sensitivity, specificity, accuracy thresholds). Instead, it provides a comparative table (Table 3) of technological characteristics between the Discam® Digital Imaging System and its predicate devices to demonstrate substantial equivalence.

Characteristic	Marcher Enterprises, Ltd Discam®	Kowa Optimed Fundus Camera FX-500	Laser Diagnostic Technologies TopSS	Heidelberg Eng. Retina Tomograph	Ophthalmic Imaging Systems DFC-512
Intended Use: To view, capture and archive images of the human fundus.	YES	YES	YES	YES	YES
Ability to measure changes in Optic Disc/Cup size and shape	YES	YES (1)	YES	YES	YES
Halogen Illumination Source	YES	YES	NO	NO	YES
Confocal Laser Scanning	NO	NO	YES	YES	NO
PC Interface	YES	YES (1)	YES	YES	YES
CCD Camera	YES	YES (2)	NO	NO	YES
Maximum Field of View	10°	60°	30°	30°	60°

(1) With Optional PC Interface and Software (2) With Optional 35 mm Film Based or Digital CCD

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
No clinical test set or patient data is described for the Discam® Digital Imaging System. The submission relies on "Published data indicate that viewing and capturing images of the Fundus and Optic Nerve Head/Optic Disc with Digital Imaging Systems is safe and effective" to support its claims for safety and effectiveness. This implies a reliance on existing literature and the known performance of predicate devices, rather than a new clinical study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
Not applicable, as no dedicated clinical test set with independent ground truth establishment is described for the Discam® Digital Imaging System in this document.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable, as no dedicated clinical test set with adjudication is described.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a digital imaging system, not an AI-powered diagnostic aide. No MRMC study is mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is an imaging system, not a standalone algorithm. Its "basic analysis" software is mentioned for "measurement of cup and Disc, cup to Disc ratio," but no performance study for this software is detailed.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable, as no specific ground truth for a clinical performance study of the Discam® device is mentioned. The submission relies on the established safety and effectiveness of its predicate devices and general published data.
The sample size for the training set:
Not applicable, as no algorithm training is mentioned in the context of a dataset.
How the ground truth for the training set was established:
Not applicable.

Summary of the "Study" and "Acceptance Criteria" presented in the document:

The "study" conducted for the Discam® Digital Imaging System for its 510(k) submission is primarily a comparison of technological characteristics and intended use to predicate devices, along with non-clinical testing for power and luminance levels.

Acceptance Criteria (Implicit for Substantial Equivalence): The implicit acceptance criteria are that the Discam® Digital Imaging System's technological characteristics and intended use are similar enough to existing legally marketed predicate devices such that any differences "do not raise any issue of safety or effectiveness." This is evidenced by the "YES" entries in Table 3 for key functionalities, and the justification that differences (like field of view or inclusion/exclusion of confocal laser scanning) don't alter the fundamental safety or effectiveness for its intended use.
Reported Device Performance:
- Non-Clinical Testing: "The Discam® Digital Imaging System was tested to assure that the power and luminance levels delivered in every mode of operation were within specification." (No specific numerical specifications are given in this summary.)
- Clinical Performance (Reference to Published Data): "Published data indicate that viewing and capturing images of the Fundus and Optic Nerve Head/Optic Disc with Digital Imaging Systems is safe and effective." This is a general statement referencing the body of evidence for similar devices, rather than specific performance data for the Discam® itself.
- Substantial Equivalence: The primary "performance" is its demonstrated substantial equivalence to the listed predicate devices based on the comparison of characteristics. The ability to measure cup and disc parameters is mentioned as a feature, akin to predicate devices.

Summary

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AUG 17 1998

K974535

510(k) Summary of Safety and Effectiveness Information Marcher Enterprises, Ltd.

DISCAM® DIGITAL IMAGING SYSTEM

Applicant/Manufacturer

Marcher Enterprises, Ltd. Twyford Road, Unit 449 Rotherwas Industrial Estate Hereford HR2 6JR United Kingdom

Contact Name: Patrick Kirby

Tel: (44) 1432 278 400 Fax: (44) 1432 354218

Date of Summary Preparation: October 23, 1997

Device Name

Proprietary Name: Discam® Digital Imaging System Common Name: Ophthalmic Digital Camera Classification Name: Camera, Ophthalmic, AC-Powered

Predicate Device

· KOWA OPTIMED, INC .: KOWA PROFESSIONAL FUNDUS CAMERA MODELS FX-500 (K954780, cleared 12/01/95)
· OPHTHALMIC IMAGING SYSTEMS, INC .: DFC-512 DIGITAL IMAGING SYSTEM (K913929, cleared 11/27/91)
· LASER DIAGNOSTIC TECHNOLOGIES, INC .: TOPOGRAPHIC SCANNING SYSTEM (K923742, cleared 03/26/93)
· HEIDELBERG ENGINEERING: HEIDELBERG RETINA TOMOGRAPH (K912891, cleared 09/27/91)

510(k) SUMMARY OF SAFETY AND EFF DISCAM® DIGITAL IMAGI

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Device Description

The patient fixates on fixation lights, (fixed LEDs), and the operator views the image on the PC's monitor. Image capture, which is accomplished in 0.2 seconds, is initiated by pushing a iov stick.

The camera measures 370 mm Depth x 360 mm Height x 108 mm Width. It is powered by a switch mode power supply 100 V to 220 V, 50 Hz to 60 Hz.

Illumination is from a 12 Volt 55 Watt Halogen Lamp. There is no flash.

Intended Use

Comparison of the Technological Characteristics of the Device to the Predicate.

The determination of the substantial equivalence of the Discam® Digital Imaging System is based upon the following:

· Intended Use
· Operational Characteristics
· Technological Characteristics

A side by side comparison of the characteristics of the Discam® Digital Imaging System to the predicate devices listed above is provided in Table 3.

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TABLE 3: COMPARISON OF DEVICE

	MarcherEnterprises, LtdDiscam®	Kowa OptimedFundus CameraFX-500
Intended Use: To view, capture andarchive images of the human fundus.	YES	YES
Ability to measure changes inOptic Disc/Cup size and shape	YES	YES (1)
Halogen Illumination Source	YES	YES
Confocal Laser Scanning	NO	NO
PC Interface	YES	YES (1)
CCD Camera	YES	YES (2)
Maximum Field of View	10°	60°

Note (1): With Optional PC Interface and Software Note (2): With Optional 35 mm Film Based or Digital CCD

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CHARACTERISTICS

а сталогія страдае пасадае парадаецца парасміна такцыя выяванн

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

ser DiagnosticTechnologiesTopSS	Heidelberg Eng.RetinaTomograph	OphthalmicImaging SystemsDFC-512
YES	YES	YES
YES	YES	YES
NO	NO	YES
YES	YES	NO
YES	YES	YES
NO	NO	YES
30°	30°	60°

Table 3

e la personal programments on the comments of the comments of the summer a AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AN

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Testing

· Non-Clinical Testing
The Discam® Digital Imaging System was tested to assure that the power and luminance levels delivered in every mode of operation were within specification.
· Clinical Testing
Published data indicate that viewing and capturing images of the Fundus and Optic Nerve Head/Optic Disc with Digital Imaging Systems is safe and effective.
Conclusions Drawn
Marcher Enterprises Ltd. believes that the Discam® Digital Imaging System is substantially equivalent to those predicate devices cited above, that any differences are minor, and that these differences do not raise any issue of safety or effectiveness.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 4 1998

Tim Dawson Development Director Marcher Enterprises LTD Unit 2, Clearview Court, Twyford Road Rotherwas, Hereford HR2 6JR UK

Re: K974535 Trade Name: Discam Digital Imaging System Regulatory Class: II Product Code: 86 HKI Dated: July 20, 1998 Received: July 22, 1998

Dear Mr. Dawson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .

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Page 2 - Tim Dawson

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Discam® Digital Imaging System

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY ) ャー・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Everett Been

(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K974535

Regulation Number and Section

§ 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.