(36 days)
Grieshaber Light Source, K963417
Not Found
No
The device description and lack of mentions of AI, ML, or related concepts indicate a traditional light source technology.
No
The device is a light source for illumination during surgery, not a therapeutic device. It aids in visualization rather than directly treating a condition.
No
The device is described as a light source for intraocular illumination during surgery, which is a therapeutic function, not a diagnostic one. It does not mention any ability to detect, diagnose, or monitor a disease or condition.
No
The device description explicitly states it uses a halogen lamp and an internal focusing system, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "intraocular illumination in vitreoretinal surgery." This describes a device used during a surgical procedure to provide light, not a device used to test samples (like blood, urine, or tissue) outside the body to diagnose a condition.
- Device Description: The description details a light source and its components, which are consistent with a surgical illumination device.
- Lack of IVD Characteristics: The provided information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information based on the analysis of samples.
- Using reagents or assays.
The device is clearly intended for surgical use to aid the surgeon's visualization during a procedure.
N/A
Intended Use / Indications for Use
The D.O.R.C. SOLUX Light Source is indicated for intraocular illumination in vitreoretinal surgery.
Product codes
MPA
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intraocular
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Grieshaber Light Source, K963417
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
ټ
| Contact Person: | Mark W. Furlong, President
Telephone: 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
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.
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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 | SOLUX | |||
| Light Source | Grieshaber | |||
| Light Source | Escalon | |||
| VitLite | ||||
| Indication: Endoillumination for | ||||
| vitreoretinal surgery | YES | YES | YES | |
| Lamp Type | Halogen | Halogen | Metal Halide | |
| Lamp Rating | 100 watts | not specified | not specified | |
| Light Output (lumens) | High: 3800 | |||
| Low: 3200 | not specified | not specified | ||
| Color Temperature (degrees K) | High: 3220 | |||
| Low: 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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