(14 days)
Not Found
No
The document describes a standard dental operating light and its components, with no mention of AI or ML technologies.
No
The device is described as an AC-powered dental operating light intended to illuminate oral structures and operating areas, not to treat a medical condition or disease.
No
The device is described as an "AC-powered dental operating light" intended to "illuminate oral structures and operating areas." Its function is to provide light for surgical procedures, not to diagnose conditions.
No
The device description clearly outlines hardware components such as lamps, electronic ballasts, optical components (mirrors, lenses, filters, coatings), and fiber light guides. It is an AC-powered dental operating light, which is a physical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "illuminate oral structures and operating areas." This is a direct illumination function for visualization during procedures.
- Device Description: The description details a light source and fiber optic system for transmitting light. This aligns with an illumination device, not a device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing biological samples (blood, urine, tissue, etc.).
- Providing diagnostic information based on the analysis of samples.
- Reagents or assays.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely for illumination during surgical or dental procedures.
N/A
Intended Use / Indications for Use
The AC-powered dental operating light, which can be attached via optical fibers to a surgical headlight, is a device intended to illuminate oral structures and operating areas.
Product codes
EBA, EAZ, EAY
Device Description
The cold light sources of the PS series consist of short arc metal-halide or xenon lamps, driven by electronic ballasts. Optical components such as mirrors, lenses, filters and coatings focus the light to a very small diameter of typically 1.5-3mm, Fiber light guides (single or bundles) transmit the light to the application such as headlights, endoscopes or other lighted tools.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral structures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use only!
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)
No performance data is required for this Class I device nor requested by FDA (ODE).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K983714, K001698, K022384, K052979, K991572, K991208
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4630 Dental operating light.
(a)
Identification. A dental operating light, including the surgical headlight, is an AC-powered device intended to illuminate oral structures and operating areas.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
0
FEB 1 2 2007
113
្រី
/300/H20
b –
510(k) Summary of Safety and Effectiveness
Submitter
Photonic Optische Geräte GesmbH & CoKG Seeböckgasse 59 A-1160 Vienna, Austria Mr. Dieter Feger (GM) phone: +43(1)4865691-0 prepared: 13th March 2006
Device Submitted
Xenon/Metal halide light source with fiber and headlight
Proprietary Name
PS series
Common Name
Light source
Predicate Devices
| Applicant | Predicate Device | 510(k) | class, code, 21CFR |
|---|---|---|---|
| Cogent/WelchAllyn | Solartec Source ST270 | ||
| (CL300) | K983714 | II, FFS, 876.1500 | |
| Cogent/WelchAllyn | Micro Link endoscopic | ||
| fiber cable | K001698 | II, FFS&KOD 876.1500 | |
| Isolux America | 1300 XSBP | K022384 | II, HBI&FST, 878.4580 |
| Isolux America | 1125 XSB | K052979 | II, HET, 884.1720 |
| Isolux America | Fiber optic surgical | ||
| headlight | K991572 | II, HBI, 878.4580 | |
| I, EAZ, 872.4630 | |||
| Isolux America | fiberoptic cable | K991208 | II, FST, 878.4580 |
| Isolux America | fiberoptic cable | K991208 | II, HBI, 878.4580 |
Device Description
The cold light sources of the PS series consist of short arc metal-halide or xenon lamps, driven by electronic ballasts. Optical components such as mirrors, lenses, filters and coatings focus the light to a very small diameter of typically 1.5-3mm, Fiber light guides (single or bundles) transmit the light to the application such as headlights, endoscopes or other lighted tools.
Intended Use
The AC-powered dental operating light, which can be attached via optical fibers to a headlight, is a device intended to illuminate oral structures and operating areas. The device is intended for Prescription Use only!
Technological Characteristics Similarities
The light sources PS series with fibers and headlights are similar in use, design and function to those from Isolux and Cogent (WelchAllyn).
Performance Data
No performance data is required for this Class I device nor requested by FDA (ODE).
Safety
1
The device is designed for and fully meets following international safety standards:
- · IEC 60601-1:1988 +A1:1991 +A2:1995
- · IEC 60601-1-2:2001
- · IEC 60601-2-18:1996 +A1:2000
- UL2601-1:1997 .
- · CAN/CSA-C22.2 No. 601-1-M90
- · 47 CFR Ch.1 Part 15 (FCC)
- · IEC 60601-2-41:2000 (in accordance to UV measurements)
Effectiveness
Metal halide or xenon arc lamps produce white light similar to sunlight. All light transmitting elements such as mirrors, lenses, filters and coatings are determined not to change the color temperature of the system.
This device uses an extra short arc lamp, which improves the effectiveness of focusing the light with the help of optics into a small fiber (single or bundle) with diameters typically between 1-3mm. Other commercial equipment uses fiber bundles with diameter of typically 4-6mm to transmit the same light flux.
Conclusion
The technological differences to the predicate devices do not affect the safety or efficacy of the sumbitted devices, therefore leads to the conclusion, that the cold light series PS including fibers and headlights are substantial equivalent to the Predicate Devices.
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Photonic Optische Geräte GmbH & CoKG C/O Mr. Stefan Preiss Responsible Third Party Official TÜV SÜD America, Incorporated 1775 Old Hywy 8 NW New Brighton, Minnesota 55112-1891
FEB 1 2 2007
Re: K070287
Trade/Device Name: PS Series with Fiber Light Guide and Headlight Regulation Number: 872.4630 Regulation Name: Dental Operating Light Regulatory Class: I Product Code: EBA, EAZ, EAY Dated: January 23, 2007 Received: January 29, 2007
Dear Mr. Preiss:
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.
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Page 2 -Mr. Preiss
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.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Clars
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: PS series with fiber light guide and headlight
Indications For Use:
The AC-powered dental operating light, which can be attached via optical fibers to a surgical headlight, is a device intended to illuminate oral structures and operating areas.
Prescription Use: YES (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use: NO (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Gunson
Division of Gastroenterology
Beth Israel Deaconess Medical Hospital
670282
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