PICCOLIGHT E50,PICCOLIGHT E56,EUROLIGHT E10, EUROLIGHT E30, AND EUROLIGHT E36

K070270 · Kirchner & Wilhelm GmbH + Co.Kg · HLJ · Nov 5, 2007 · Ophthalmic

Device Facts

• Record ID: K070270
• Device Name: PICCOLIGHT E50,PICCOLIGHT E56,EUROLIGHT E10, EUROLIGHT E30, AND EUROLIGHT E36
• Applicant: Kirchner & Wilhelm GmbH + Co.Kg
• Product Code: HLJ · Ophthalmic
• Decision Date: Nov 5, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1570
• Device Class: Class 2

Intended Use

An ophthalmoscope is intended to be used to examine the cornea, aqueous, lens, vitreous and retina of the eye.

Device Story

Battery-powered handheld ophthalmoscopes (Piccolight E50/E56, Eurolight E10/E30/E36) used by clinicians to examine eye structures (cornea, aqueous, lens, vitreous, retina). Devices utilize vacuum or halogen bulbs (2.5V) to illuminate the eye; examiner views structures through a lens system with adjustable dioptre settings (-20 to +20). Piccolight models feature PA 6 GF 30% plastic handles; Eurolight models feature metal handles. Aperture configurations vary by model (single vs. six-aperture including slit, small/large circle, semi-circle, red-free, and fixing cross). Devices are operated manually by clinicians in clinical settings. Output is direct visualization of the ocular fundus, aiding in diagnosis of ocular conditions. Benefit includes non-invasive, portable visualization of internal eye structures.

Clinical Evidence

Bench testing only. Devices conform to ISO 10942 (ophthalmoscopes), IEC 60601-1 (general safety), and IEC 60601-1-2 (electromagnetic compatibility). No clinical data provided.

Technological Characteristics

Battery-powered handheld ophthalmoscopes. Materials: Polyamide 6 GF30% (Piccolight) or metal (Eurolight). Illumination: 2.5V vacuum or halogen bulbs. Dioptre range: -20 to +20. Apertures: 1 or 6 configurations. Standards: ISO 10942, IEC 60601-1, IEC 60601-1-2. No software or connectivity.

Indications for Use

Indicated for examination of the cornea, aqueous, lens, vitreous, and retina of the eye in patients requiring ophthalmoscopic evaluation. Prescription use only.

Regulatory Classification

Identification

An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.

Special Controls

*Classification.* Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

Predicate Devices

• Uni II (K925756)
• RI-MINI (K932503)
• Ophthalmoscope (K932503)
• Heine Beta 200S (Device Listed by Heine USA, Ltd.)

Reference Devices

• Riester ophthalmoscopes Pendiza Scope (K925757)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows a handwritten string of characters, "K070270". The characters are written in black ink on a white background. The handwriting is somewhat stylized, with the 'K' having a distinct shape.

NOV - 5 2007

Image /page/0/Picture/3 description: The image is a logo for a company called "KaWe Medizintechnik". The logo is a black parallelogram with the word "KaWe" in white letters at the bottom. Above the word "KaWe" is the word "MEDIZINTECHNIK" in smaller white letters. The background of the parallelogram is black.

KIRCHNER & WILHELM
GmbH + Co.

| Name and address of sponsor of the<br>510(k) submission: | Kirchner & Wilhelm GmbH & Co. KG<br><br>Eberhardstrasse 56<br>71679 Asperg<br>Germany |
|------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Official contact person for all<br>correspondence: | Matthias Dubb<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: Matthias.dubb@Kirchner & Wilhelm med.de |
| Date Prepared: | January 26, 2007 |
| Device Name: | Piccolight® E50, Piccolight® E56, Eurolight® E10,<br>Eurolight® E30, Eurolight® E36 |
| Generic name of the device: | Ophthalmoscope, battery-powered |
| Classification, Product Code and<br>CFR Regulation Number: | Class II<br>HLJ<br>21 CFR 886.1570 |
| Classification Panel: | Ophthalmic |
| Predicate Device Names and 510(k) numbers: | Uni II (K925756) |
| | RI-MINI (K932503) |
| | Ophthalmoscope (K932503) |
| | Heine Beta 200S (Device Listed by Heine USA, Ltd.,<br>establishment registration number: 1054443) |

510(k) Summary

### Device Description:

All Kirchner & Wilhelm ophthalmoscopes are battery powered. The Piccolight E50 and Eurolight E10 and E30 are single aperture ophthalmoscopes while the Piccolight E56 and Eurolight E36 have six apertures each. The Piccolight and Eurolight series are different in the handles, with Piccolight handles made of PA 6 GF 30% while Eurolight handles are made of metal. The Piccolight E50 and Eurolight E10 heads are same as the Eurolight E30 head except for the locking system. Similarly, but for the locking system, the Piccolight E56 and Eurolight E36 heads are the same.

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Image /page/1/Picture/0 description: The image is a logo for a company called "KaWe Medizintechnik". The logo is a square with the company name in bold, white letters at the bottom. The top of the square has the word "MEDIZINTECHNIK" in smaller letters. The background of the square is black.

## Comparison with Predicate Device:

| KIRCHNER & WILHELM | |
|--------------------|--|
| | |

| | Piccolight® E50 | Riester ophthalmoscopes Pendiza<br>Scope® (K925757) |
|----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Intended use | An ophthalmoscope is intended to<br>be used to examine the cornea,<br>aqueous, lens, vitreous and retina<br>of the eye. | Same |
| Method of<br>operation | Used to examine the retina by an<br>examiner in a specific distance to<br>the eye. | Same |
| Exposure<br>parameters | Emission of 2.5 V vacuum bulb | Emission of 2.7 V vacuum bulb |
| data collection<br>and/or display<br>systems | Dioptre of used lens in steps:<br>-20, -15, -10, -8, -6, -4,-3, -2, -1,<br>0, 1, 2, 3, 4, 6, 8, 10, 15, 20 | Same |
| Flammability of<br>materials | Fibre-glass reinforced plastic<br>Polyamide 6 GF30C | Same |
| maximum<br>temperature of<br>parts of the<br>device held by<br>the operator or<br>accessible to<br>the patient | Ambient temperature<br>Metal parts around the bulb:<br>Approx. max. 50°C | Same |
| brightness<br>controls | No | No |
| Supply voltage | 2.5 V | 2.7 V |
| Power supply | Battery powered | Same |
| Aperture | One aperture (large circle) | four aperture (large circle, Small<br>circle, semi-circle, large circle<br>with fixing cross) |

All main aspects regarding the safety and effectiveness are comparable. The main difference is the difference in the number of apertures and that is not a significant difference.

| | Piccolight® E56 | Riester ophthalmoscope ri- mini® (K932503) |
|------------------------|-------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|
| Intended use | An ophthalmoscope is intended to<br>be used to examine the cornea,<br>aqueous, lens, vitreous and retina<br>of the eye. | same |
| Method of<br>operation | Used to examine the retina by an<br>examiner in a specific distance to<br>the eye. | Same |

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| Exposure<br>parameters | Emission of 2.5 V halogen bulb | Emission of 2.5 V halogen bulb | Image: KaWe logo |
|----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|------------------|
| data collection<br>and/or display<br>systems | Dioptre of used lens in steps:<br>-20, -15, -10, -8, -6, -4,-3, -2, -1,<br>0, 1, 2, 3, 4, 6, 8, 10, 15, 20 | Same | |
| Flammability of<br>materials | Fibre-glass reinforced plastic<br>Polyamide 6 GF30C | Same | |
| maximum<br>temperature of<br>parts of the<br>device held by<br>the operator or<br>accessible to<br>the patient | Ambient temperature<br>Metal parts around the bulb:<br>Approx. max. 50°C | Same | |
| brightness<br>controls | No | No | |
| Supply voltage | 2.5 V | 2.5 V | |
| Power supply | Battery powered | Same | |
| Aperture | six aperture (slit diaphragm, large<br>circle, small circle, semi-circle,<br>red-free (green), large circle with<br>fixing cross)<br>Image: aperture options | four aperture (large circle, Small<br>circle, semi-circle, large circle<br>with fixing cross; additional red-<br>free (green)) | |
| | or<br>Image: aperture options | | |

All main aspects regarding the safety and effectiveness are comparable. The main difference is the difference in the number of apertures with one more aperture being there in Piccolight. The additional slit diaphragm is used to differentiate the level differences (e.g, in the case of tumors or papilloedema). This has no effect on the security of the subject device as compared to the predicate.

| | EUROLIGHT® E10<br>EUROLIGHT® E30 | Riester ophthalmoscope UNI®<br>II (K925756) |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Intended use | An ophthalmoscope is intended to<br>be used to examine the cornea,<br>aqueous, lens, vitreous and retina<br>of the eye. | Same |
| Method of<br>operation | Used to examine the retina by an<br>examiner in a specific distance to<br>the eye. | Same |
| Exposure<br>parameters | Emission of 2.5 V vacuum bulb | Emission of 2.7 V vacuum bulb,<br>2.5 V halogen bulb or 3.5 xenon<br>bulb |
| data collection<br>and/or display | Dioptre of used lens in steps:<br>-20, -15, -10, -8, -6, -4, -3, -2, -1 | Same |

and and the state

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| systems | 0, 1, 2, 3, 4, 6, 8, 10, 15, 20 | | Image: KaWe logo |
|----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|-----------------------------|------------------|
| Flammability of<br>materials | Fibre-glass reinforced plastic<br>Polyamide 6 GF30C | Metal housing | |
| maximum<br>temperature of<br>parts of the<br>device held by<br>the operator or<br>accessible to<br>the patient | Ambient temperature<br>Metal parts around the bulb:<br>Approx. max. 50°C | Same | |
| brightness<br>controls | Various | Various | |
| Supply voltage | 2.5 V | 2,5 V | |
| Power supply | Battery powered | Same | |
| Aperture | one aperture (large circle) | one aperture (large circle) | |

All main aspects regarding the safety and effectiveness are comparable. The UNI II can also be used with halogen and xenon light. Both are brighter than light from vacuum bulb. Therefore the optical radiation exposure for the eye during the examination is higher than by using a vacuum bulb. The different housing materials are not relevant for the safety of the instrument. The temperature which gets generated during examination is not able to inflame the used materials.

| | EUROLIGHT® E36 | HEINE BETA 200 S® ophthalmoscope |
|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Intended use | An ophthalmoscope is intended to be used to examine the cornea, aqueous, lens, vitreous and retina of the eye. | Same |
| Method of operation | Used to examine the retina by an examiner in a specific distance to the eye. | Same |
| Exposure parameters | Emission of 2.5 V halogen bulb | Emission of 2.5 V or 3.5 V xenon halogen bulb |
| data collection and/or display systems | Dioptre of used lens in steps: -20, -15, -10, -8, -6, -4,-3, -2, -1, 0, 1, 2, 3, 4, 6, 8, 10, 15, 20 | Dioptre of used lens in steps: + in 1D step 1-10, 15, 20, 40<br>- in 1D step 1-10, 15, 20, 25, 35 |
| Flammability of materials | Fibre-glass reinforced plastic Polyamide 6 GF30C | Polycarbonate |
| maximum temperature of parts of the device held by the operator or accessible to the patient | Ambient temperature<br>Metal parts around the bulb: Approx. max. 50°C | Same |
| brightness | Various | Various |

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| controls | | | |
|----------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Supply voltage | 2.5 V | 2.5 V or 3.5 V | |
| Power supply | Battery powered | Same | Image: KaWe logo<br>KIRCHNER & WILHELL<br>GmbH + Co<br>Medizintechnik, Germany |
| Aperture | six aperture<br>Image: aperture settings or<br>Image: aperture settings | six aperture<br>Image: aperture settings or<br>Image: aperture settings | |

All main aspects regarding the safety and effectiveness are comparable. The different housing materials are not relevant for the safety of the instrument.

#### Intended Use:

An ophthalmoscope is intended to be used to examine the cornea, aqueous, lens, vitreous and retina of the eye.

#### Non-Clinical Testing:

The ophthalmoscopes conform to ISO 10942; IEC 60601-1, and IEC 60601-1-2.

#### Clinical Testing:

Not applicable

#### Conclusion:

The ophthalmoscopes referred to in this 510(k) submission are substantially equivalent to the predicates and raise no issues of safety and effectiveness.

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Public Health Service

Image /page/5/Picture/2 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three tail feathers, representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 5 2007

Kirchner & Wilhelm GmbH & CO. KG c/o Natalya Valerio mdi Consultants Inc. 55 Northern Blvd., Suite 200 Great Neck, NY 11021

Re: K070270

Trade/Device Name: Piccolight E50 & E56 and Eurolight E10, E30 & E36 Regulation Number: 21 CFR 886.1750 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: HLJ Dated: October 18, 2007 Received: October 26, 2007

Dear Ms. Valerio:

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.

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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 promative hotification " 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Mcdical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-(Woulear Do not responsible 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,

M.B. Eglehus, MD

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

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# INDICATIONS FOR USE

Page _ 1 _ of _ 1

K070270

510(k) Number (if known): Not Assigned as of this time

Device Name: Piccolight® E50, Piccolight® E56, Eurolight® E10, Eurolight® E30, Eurolight® E36 Ophthalmascopes

#### Indications for Use:

An ophthalmoscope is intended to be used to examine the cornea, aqueous, lens, vitreous and retina of the eye.

Danilu 10/31/2007

(Division Sion-Off) Division of Ophthalmic Ear, Nose and Throat 510(k) Number

Prescription Use X (Per 21 CFR 801 Subpart D)

OR

Over-The Counter Use (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)