(16 days)
Not Found
No
The description focuses on the hardware components (Xenon lamp, focusing systems, filters) and their function (providing illumination). There is no mention of AI, ML, image processing, or any data-driven decision-making or analysis.
No.
The device provides illumination during surgery but does not directly treat a disease or condition. Its function is supportive, not therapeutic.
No
The device is an illumination system used during surgery, not to diagnose a condition.
No
The device description clearly outlines hardware components such as an Illumination Unit, Xenon Short Arc Lamp, internal focusing systems, optical fibers, and accessories like probes and instruments. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to provide intraocular illumination in vitreoretinal surgery." This describes a device used during a surgical procedure to illuminate the surgical field within the eye.
- Device Description: The description details a light source (Xenon lamp) and optical fibers used to deliver light. This is consistent with a surgical illumination device.
- Lack of IVD Characteristics: The description does not mention any of the key characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on the analysis of samples
- Performing tests in vitro (outside the body)
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Xenon BrightStar Illumination System is a surgical tool used in vivo (within the body) for visualization during surgery.
N/A
Intended Use / Indications for Use
The Xenon BrightStar Illumination System is intended to provide intraocular illumination in vitreoretinal surgery.
Product codes (comma separated list FDA assigned to the subject device)
MPA, GCT
Device Description
The Xenon BrightStar Illumination System consists of the Illumination Unit and accessories. The Illumination Unit uses a Xenon Short Arc Lamp and utilizes two internal focusing systems to focus the light into the end of an optical fiber of two individually controlled ports. Both ports can be individually controlled by choice of an UV cut-off filter and a light intensity setting. Accessories trother system include single use and reusable fiber optic probes, fibers and micro instruments which are delivered sterile or require sterilization prior to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
510(k) Summary
0C1 1 3 2006
1. COMPANY NAME AND ADDRESS
Dutch Ophthalmic Research Center International by Scheijdelveweg 2 3214 VN Zuidland The Netherlands
Contact: Mr. Ger Vijfvinkel, President Phone Fax : +31 181 458090 Date of summary: September 15, 2006
2. DEVICE NAME
| Trade Name | : Xenon BrightStar Illumination System |
|---|---|
| Common Name | : Ophthalmic Light Source |
| Classification Name | : Endoilluminator (21 CFR 876.1500, |
| Product Code MPA, GCT) |
3. PREDICATE DEVICE
D.O.R.C. HEXON ILLUMINATION SYSTEM (K973229)
4. DEVICE DESCRIPTION
The Xenon BrightStar Illumination System consists of the Illumination Unit and accessories. The Illumination Unit uses a Xenon Short Arc Lamp and utilizes two internal focusing systems to focus the light into the end of an optical fiber of two individually controlled ports. Both ports can be individually controlled by choice of an UV cut-off filter and a light intensity setting. Accessories trother system include single use and reusable fiber optic probes, fibers and micro instruments which are delivered sterile or require sterilization prior to use.
5. INTENDED USE
The Xenon BrightStar Illumination System is intended to provide intraocular illumination in vitreoretinal surgery.
1
6. BASIS FOR SUBSTANTIAL EQUIVALENCE
The following table summarizes the technological characteristics of the Xenon BrightStar Illumination System in comparison to the predicate D.O.R.C. Hexon Illumination System.
| Comparison of Xenon BrightStar Illumination System to Predicate Device | |||
|---|---|---|---|
| Characteristic | Xenon BrightStar | ||
| Illum. System | |||
| 1266.XIII | D.O.R.C. Hexon | ||
| Illum. System | |||
| 1266.XII | |||
| Indication: Endoillumination for | |||
| vitreoretinal surgery | YES | YES | |
| Lamp Type | Xenon Short Arc | Metal Halide | |
| Lamp rating (Watts) | 75 | 24 | |
| Light Output (lumens) | Min. 850 | 1850 | |
| Color Temperature (degrees K) | Approx. 6000 | 4700 | |
| Variable intensity | YES | YES | |
| Intensity displayed | YES | NO | |
| Wavelength Range (nm) | 410-700 | 400-800 | |
| UV filtration (nm) | 420 | YES | NO |
| 435 | YES | YES | |
| 475 | YES | YES | |
| 515 | YES | NO | |
| Infrared filtration | YES | YES | |
| Additional color filtration | NO | YES | |
| Sterilizable knobs | YES | NO | |
| Multiple probe diameters | YES | YES | |
| Panoramic light probes | YES | YES | |
| Straight Probes | YES | YES | |
| Illuminated accessories | YES | YES | |
| Illumination ports | 2 | 1 | |
| Dimensions of unit (mm) | 350 x 250 x 300 | 150 x 257 x 256 | |
| Weight of unit (kgs) | 15 | 6 |
2
Image /page/2/Picture/1 description: The image shows a circular logo for the Department of Health & Human Services. The logo features the department's name in a circular arrangement around the perimeter. In the center of the circle is a stylized image of an eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dutch Ophthalmic Research Center International c/o Ms. Fran Carleton One Little River Rd. Kingston, NH 03848
OCT 1 3 2006
Re: K062895
Trade/Device Name: Xenon BrightStar Illumination System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoilluminator Regulatory Class: Class II Product Code: MPA Dated: September 25, 2006 Received: September 27, 2006
Dear Ms. Carleton:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will and w you to obgan mating of substantial equivalence of your device to a legally prematicated 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), please If you desire sportio acrite 10. Jour 240) 276-0115. Also, please note the regulation entitled, eonialor the Office of Course to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
MB. EgclehmisiwD
Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
APPENDIX 1
Indications for Use
510(k) Number (if known): K062895
Device Name: _XENON BRIGHTSTAR ILLUMINATION SYSTEM
Indications for Use:
The Xenon BrightStar Illumination System is intended to provide intraocular illumination in vitreoretinal surgery.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dennis L. McCarthy
Division of Ophthalmic Ear,
Nose and Throat Devices
510(k) Number K062845