The D.O.R.C. HEXON Illumination System consists of the Illumination Unit and accessories. The Illumination Unit uses a metal halide discharge lamp and utilizes an internal focusing system to focus the light into the end of the optical fiber. Accessories to the Illumination Unit include adapters and color filters. Accessories to the system include single use and reusable fiberoptic probes, fibers, and microinstruments which require storilization prior to use.

AI/ML Overview

The provided text is a 510(k) premarket notification summary for the D.O.R.C. HEXON Illumination System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full clinical study to prove novel performance or efficacy. Therefore, much of the requested information regarding acceptance criteria, specific study design, expert involvement, and detailed performance metrics as would be found in a clinical trial for a new therapeutic or diagnostic device is not applicable or not provided in this document.

Here's a breakdown based on the available information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a performance study with specific thresholds. Instead, it demonstrates performance by comparing the device's characteristics to those of predicate devices to establish substantial equivalence.

Characteristic	Acceptance Criteria (Implied by Predicate - "YES")	Reported Device Performance (HEXON Illum. System)
Indication: Endoillumination for vitreoretinal surgery	YES (Matches Predicate)	YES
Lamp Type	Acceptable (Differences noted vs. Grieshaber)	Metal Halide
Lamp Rating	Not specified by Predicate	24 watts
Light Output (lumens)	Not specified by Predicate	1850
Color Temperature (degrees K)	Acceptable (Similar to VitLite I)	4700
Variable Intensity	YES (Matches Predicate)	Yes
Wavelength Range (nm)	Acceptable (Similar to VitLite I)	400-800
UV filtration	YES (Matches Predicate)	Yes
Infrared filtration	YES (Matches Predicate)	Yes
Additional color filtration (Green, Yellow, Red, Blue)	YES (Matches Grieshaber)	Yes (for all listed)
Additional color filtration (Daylight)	Not specified by Predicate (HEXON offers it)	Yes
Multiple probe diameters	YES (Matches Predicate)	Yes
Panoramic light probe	YES (Matches VitLite I)	Yes
Straight probe	YES (Matches Predicate)	Yes
Illuminated accessories	YES (Matches Predicate)	Yes H

2. Sample size used for the test set and the data provenance

Sample Size: Not applicable. This is not a study assessing device performance on patient samples. The "test set" here refers to the characteristics of the device itself and its comparison to predicate devices, not data from patients.
Data Provenance: Not applicable in the context of clinical data. The data provenance relates to the specifications and characteristics of the D.O.R.C. HEXON Illumination System and the predicate devices (Grieshaber Light Source and Escalon VitLite I), derived from engineering specifications and existing market information.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth in a clinical or diagnostic sense is not being established. The "truth" here is the stated technical specifications of the devices being compared.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no expert adjudication of clinical findings in this type of submission. The comparison is based on documented device specifications.

5. 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 an ophthalmic illumination system, not an AI or diagnostic tool that would involve "human readers" or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a medical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this 510(k) submission is the technical specifications and intended use of the legally marketed predicate devices. The D.O.R.C. HEXON Illumination System demonstrates substantial equivalence by showing that it has similar technological characteristics and the same intended use as these predicates.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of device development for a 510(k) involving an illumination system.

9. How the ground truth for the training set was established

Not applicable. See point 8.

Summary

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K973229

e 2

510(k) Summary Dutch Ophthalmic, USA D.O.R.C. HEXON Illumination System (per 21 CFR 807.92)

NOV 2 5 1997

SUBMITTER NAME AND ADDRESS 1.

Dutch Ophthalmic, USA One Little River Roud P.O. Box 968 Kingston, NH 03848

Mark W. Furlong, President Contact Person: Telephone: 603-642-8468

August 26, 1997 Date Prepared: Date Amended: November 24, 1997

2. DEVICE NAME

Proprietary Name: HEXON Illumination System Common/Usual Name: Endoillumination System Ophthalmic Light Source Classification Name:

PREDICATE DEVICE/S 3.

Grieshaber Light Source Escalon VitLite I (K963417)

DEVICE DESCRIPTION 4.

INTENDED USE ડ.

The D.O.R.C. HEXON Illumination System is indicated for intraocular illumination in vitreoretinal surgery.

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1973220

BASIS FOR SUBSTANTIAL EQUIVALENCE 6.

Operational and technological cliaracteristics for the determination of aubstantial Operational and technological clisition with hegally marketed predicate
equivalence of the D.O.R.C. HEXON Illumination System with hegally marketed predicate equivalence of the D.O.R.C. HEXON Inumilation includes desoriptive information
devices. Information supplied in this prematical obserciptive information devices. Information supplied in this president includes . The following table about the intended use, operation and technological characteristics - HEXON Illumination System in
summarizes the toch of the D.O.R.C. HEXON Illumination System in comparison to the prodicate devices.

Comparison of HEXON Illumination System to Predicate Devices
		HEXONIllum. System	GrieshaberLight Source	EscalonVitLite
Characteristic
Indication: Endollumination forvitreoretinal surgery		YES	YES	YES
Lamp Type		Metal Halide	Halogen	Metal Halide
Lamp Rating		24 watts	not specified	not specified
Light Output (lumens)		1850	not specified	not specified
Color Temperature (degrees K)		4700	not specified	5300
Variable Intensity		Yes	Yes	Yes
Wavelength Range (nm)		400-800	not specified	450-700
UV filtration		Yes	Yes	Yes
Infrared filtration		Yes	Yes	Yes
Additional color filtration	Green	Yes	Yes	not specified
	Yellow	Yes	Yes	not specified
	Red	Yes	Yes	not specified
	Blue	Yes	Yes	not specified
	Daylight	Yes	not specified	not specified
Multiple probe diameters		Yes	Yes	Yes
Panoramic light probe		Yes	not specified	Yes
Straight probe		Yes	Yes	Yes
Illuminated accessories		Yes	Yes	Yes

D.O.R.C. HEXON Illumination System 510(k) 8/26/97

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2 5 1997 NOV

Mr. Mark W. Furlong Dutch Ophthalmic, U.S.A., Inc. One Little River Road P.O. Box 968 Kingston, NH 03848

Re: K973229

Trade Name: D.O.R.C. Hexon Illumination System Regulatory Class: II Product Code: 86 MPA Dated: August 25, 1997 Received: August 27, 1997

Dear Mr. Furlong:

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 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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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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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K973229 ----------------------------------------------------------------------------------------------------------------------------------------------------------------------510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

D.Q.R.C. Hexon Illumination System Device Name:

Indications For Use:

The D.O.R.C. Hexon Illumination System is indicated for intraocular illumination in vitreoretinal surgery.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bruce Drum

(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K973229

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use ------------

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.