PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500

K070287 · Photonic Optische Gerate GmbH & Cokg · EBA · Feb 12, 2007 · Dental

Device Facts

• Record ID: K070287
• Device Name: PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500
• Applicant: Photonic Optische Gerate GmbH & Cokg
• Product Code: EBA · Dental
• Decision Date: Feb 12, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4630
• Device Class: Class 1
• Attributes: 3rd-Party Reviewed

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!

Device Story

Plated culture medium; RPMI 1640 base supplemented with 35g/L MOPS, 2% glucose, and agar. Used with antibiotic gradient-based systems (preformed rectangular plastic strips impregnated with antifungal agents). Inoculated agar plate receives strip; agent releases into agar matrix creating exponential concentration gradient. After 24-48 hours aerobic incubation at 35°C, symmetrical inhibition ellipse forms around strip. Intersection of zone edge and strip indicates Minimum Inhibitory Concentration (MIC). Used in clinical microbiology laboratories by trained personnel. Output is MIC value (μg/ml) used by clinicians to determine antifungal susceptibility of Candida isolates, aiding therapeutic decision-making.

Clinical Evidence

No clinical data provided. Bench testing only; device meets international safety standards including IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, IEC 60601-2-41, UL2601-1, and FCC requirements.

Technological Characteristics

Plated medium: RPMI 1640 base, 35g/L MOPS, 2% glucose, agar. Principle: Dilution/diffusion gradient. Energy: Passive diffusion. Dimensions: 5 x 60 mm strip. Sterilization: Not specified. Software: None.

Indications for Use

Indicated for use with antibiotic gradient systems for quantitative determination of susceptibility to fluconazole, itraconazole, and flucytosine when testing Candida species.

Regulatory Classification

Identification

A dental operating light, including the surgical headlight, is an AC-powered device intended to illuminate oral structures and operating areas.

Predicate Devices

• Solartec Source ST270 (CL300) (K983714)
• Micro Link endoscopic fiber cable (K001698)
• 1300 XSBP (K022384)
• 1125 XSB (K052979)
• Fiber optic surgical headlight (K991572)
• fiberoptic cable (K991208)

Submission Summary (Full Text)

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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: [phone] 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<br>(CL300) | K983714 | II, FFS, 876.1500 |
| Cogent/WelchAllyn | Micro Link endoscopic<br>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<br>headlight | K991572 | II, HBI, 878.4580<br>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

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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 [phone]. 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 [phone] or [phone] 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

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# 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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