The D.O.R.C. SOLUX Light Source uses a halogen lamp and 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.

AI/ML Overview

This 510(k) summary (K973757) describes the D.O.R.C. SOLUX Light Source, an ophthalmic light source intended for intraocular illumination in vitreoretinal surgery. The submission establishes substantial equivalence to existing predicate devices (Grieshaber Light Source and Escalon VitLite I) primarily based on operational and technological characteristics, rather than clinical performance studies with acceptance criteria in the typical sense of AI/software devices.

Here's an analysis based on the provided document, addressing your specific points:

#	Information Requested	Details from K973757
1	Table of acceptance criteria and reported device performance	Acceptance Criteria (Implied by Predicate Comparison): The device (SOLUX Light Source) must have technological and operational characteristics similar to legally marketed predicate devices, particularly in areas like intended use (intraocular illumination for vitreoretinal surgery), lamp type (Halogen), variable intensity, UV filtration, and ability to adapt to multiple accessories. While specific numerical "acceptance criteria" are not explicitly stated for each characteristic in the way one would for a diagnostic accuracy study, the implicitly accepted performance is that which is "substantially equivalent" to the predicate devices. Reported Device Performance (SOLUX Light Source):- Indication: Endoillumination for vitreoretinal surgery (YES)- Lamp Type: Halogen- Lamp Rating: 100 watts- Light Output (lumens): High: 3800, Low: 3200- Color Temperature (degrees K): High: 3220, Low: 3160- Variable Intensity: Yes- Wavelength Range (nm): 400-800- UV filtration: Yes- Additional color filtration: Green, Yellow, Red, Blue, Daylight (all Yes)- Adapts to multiple accessories: Yes
2	Sample size for the test set and data provenance	This is a conventional medical device (light source), not a software/AI device. Therefore, there is no "test set" or "data provenance" in the context of diagnostic performance evaluation. The substantial equivalence is based on engineering specifications and comparison to predicate devices, not on data from patient cases.
3	Number of experts to establish ground truth for test set and qualifications	Not applicable. No test set for ground truth establishment.
4	Adjudication method for the test set	Not applicable. No test set.
5	MRMC comparative effectiveness study	Not applicable. This is a light source, not a diagnostic AI system where human readers would improve with AI assistance.
6	Standalone (algorithm only) performance study	Not applicable. This is a hardware device, not an algorithm. Standalone performance for such a device would refer to its electrical, optical, and mechanical specifications as an engineering product, which were implicitly demonstrated or compared to predicates to establish substantial equivalence.
7	Type of ground truth used	Not applicable. The "ground truth" for this type of device is its physical specifications and functionality, which are compared against known capabilities of predicate devices. There is no diagnostic "ground truth" from pathology, expert consensus, or outcomes data in this context.
8	Sample size for the training set	Not applicable. This is not an AI/ML device. There is no "training set."
9	How the ground truth for the training set was established	Not applicable. No training set.

Summary of the Study and Acceptance Criteria:

The "study" in this context is a 510(k) premarket notification which aims to demonstrate substantial equivalence to legally marketed predicate devices. The primary method is a comparison of technological and operational characteristics.

Acceptance Criteria (Implied): The D.O.R.C. SOLUX Light Source is accepted if its technical specifications and intended use are similar enough to the predicate devices (Grieshaber Light Source and Escalon VitLite I) that it can be considered equally safe and effective. The comparison table (page 1) serves as the core of this demonstration. For instance, having "YES" for "Indication: Endoillumination for vitreoretinal surgery" for all devices shows alignment in intended use. The fact that its lamp type is Halogen, like the Grieshaber, and its wavelength range (400-800 nm) encompasses that of the Escalon VitLite (450-700 nm), along with features like UV and color filtration, contribute to this claim of equivalence.
Proof of Meeting Criteria: The provided table titled "Comparison of SOLUX Light Source to Predicate Devices" directly shows how the D.O.R.C. SOLUX Light Source's characteristics align with or are similar to the predicate devices across various attributes like lamp type, variable intensity, filtration, and intended use. The FDA's letter (page 2-3) confirming "substantial equivalence" is the official recognition that the device meets these implied acceptance criteria based on the information provided in the 510(k) submission.

This 510(k) is characteristic of traditional medical device clearances based on engineering comparisons rather than clinical performance data typical of AI/ML-powered diagnostic devices.

Summary

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K973757

NOV - 7 1997

510(k) Summary Dutch Ophthalmic, USA D.O.R.C. SOLUX Light Source (per 21 CFR 807.92)

SUBMITTER NAME AND ADDRESS

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

Contact Person:	Mark W. Furlong, PresidentTelephone: 603-642-8468
Date Prepared:	October 1, 1997
Date Amended:	November 3, 1997

DEVICE NAME

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

PREDICATE DEVICE/S

Grieshaber Light Source Escalon VitLite I (K963417)

DEVICE DESCRIPTION

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INTENDED USE

نه

The D.O.R.C. SOLUX Light Source is indicated for intraocular illumination in vitreoretinal surgery.

BASIS FOR SUBSTANTIAL EQUIVALENCE

Operational and technological characteristics form the basis for the determination of substantial equivalence of the D.O.R.C. SOLUX Light Source with legally marketed predicate devices. Information supplied in this premarket notification includes descriptive information about the intended use, operation and technological characteristics. The following table summarizes the technological characteristics of the D.O.R.C. SOLUX Light Source in comparison to the predicate devices.

Comparison of SOLUX Light Source to Predicate Devices
Characteristic	SOLUXLight Source	GrieshaberLight Source	EscalonVitLite
Indication: Endoillumination forvitreoretinal surgery	YES	YES	YES
Lamp Type	Halogen	Halogen	Metal Halide
Lamp Rating	100 watts	not specified	not specified
Light Output (lumens)	High: 3800Low: 3200	not specified	not specified
Color Temperature (degrees K)	High: 3220Low: 3160	not specified	5300
Variable Intensity	Yes	Yes	Yes
Wavelength Range (nm)	400-800	not specified	450-700
UV 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	Yes	not specified
Adapts to multiple accessories	Yes	Yes	Yes

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Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three stylized human profiles facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 7 1997

Mr. Mark W. Furlong President Dutch Opthalmic, USA One Little River Road P.O. Box 968 Kingston, NH 03848

Re: K973757

Trade Name: D.O.R.C. Solux Light Source Regulatory Class: II Product Code: 86 MPA Dated: September 29, 1997 Received: October 2, 1997

DEPARTMENT OF HEALTH & HUMAN SERVICES

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 (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 - Mr. Furlong

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): ____________________________________________________________________________________________________________________________________________________

D.O.R.C. SOLUX Light Source Device Name:

Indications For Use:

The D.O.R.C. SOLUX Light Source is indicated for intraocular illumination in vitreoretinal surgery.

Darryl L. Lewis
Division Sign-Off

Sivision of Ophthalmic Yk) Number

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use × (Per 21 CFR 801.109) OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

10/1/97 Confidential D.O.R.C. SOLUX Light Source 510(k)

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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.