HEINE BETA 200(R) OPHTHALMOSCOPE

K131961 · Heine Optotechnik GmbH & Co. KG · HLJ · Dec 4, 2013 · Ophthalmic

Device Facts

• Record ID: K131961
• Device Name: HEINE BETA 200(R) OPHTHALMOSCOPE
• Applicant: Heine Optotechnik GmbH & Co. KG
• Product Code: HLJ · Ophthalmic
• Decision Date: Dec 4, 2013
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 886.1570
• Device Class: Class 2

Intended Use

The HEINE BETA 2008 Ophthalmoscope is a battery powered hand-held device for medical professionals, containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, vitreous) and the retina of the eye.

Device Story

HEINE BETA 200 Ophthalmoscope is a battery-powered, hand-held diagnostic instrument used by medical professionals to examine the eye. Device consists of an instrument head and a battery handle. It provides illumination via a halogen filament bulb and viewing optics to visualize the retina and ocular media. The operator holds the device at a specific distance from the patient's eye to perform the examination. It features adjustable diopter lenses (+40D to -35D) and various apertures (slit, fixation star, cobalt blue, large/small circles, hemispot) to assist in clinical assessment. A rotary potentiometer allows for brightness control. By enabling direct visualization of the fundus, the device aids clinicians in diagnosing ocular conditions. It is intended for clinical use.

Clinical Evidence

Bench testing only. Testing included optical radiation hazard assessment per ISO 10942 and fundamental requirements/test methods per ISO 15004-2. Electrical safety and electromagnetic compatibility were verified against IEC 60601-1 and IEC 60601-1-2 standards.

Technological Characteristics

Battery-powered (2.5V/3.5V) hand-held ophthalmoscope. Illumination source: Halogen filament bulb. Optics: Monocular viewing with diopter range +40D to -35D. Apertures: Slit, fixation star, cobalt blue, large/small circles, hemispot. Materials: Self-extinguishing materials used for high-temperature environments. Connectivity: None. Sterilization: Not specified. Compliance: IEC 60601-1, ISO 10942, ISO 15004-2.

Indications for Use

Indicated for medical professionals to examine the eye, specifically the media (cornea, aqueous, lens, vitreous) and the retina.

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

• HEINE mini 3000® LED Ophthalmoscope (K123587)

Submission Summary (Full Text)

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K131961

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Regulatory Status:

HEINE Optotechnik GmbH & Co. KG · Kientalstr. 7 · 8221 1 Herrsching · Germany Tel. + 49(0)8152/38-0 · Fax [phone] · E-Mail: [e-mail] · www.heine.com

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### 510(k) Summary of Safety and Effectiveness

In accordance with the requirements of the Safe Medical Device Act, HEINE Optotechnik GmbH & Co. KG herewith submits a Summary of Safety and Effectiveness.

| Submitter Information: | HEINE Optotechnik GmbH & Co. KG<br>Kientalstr. 7<br>82211 Herrsching<br>Germany<br>Registration Number: 1000379039<br>Owner/Operator Number: 9003020 | DEC 0 4 2013 |
|-------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Official Contact Person: | Mr. Manfred Bartsch-Tittmann<br>Director Regulatory Affairs<br>HEINE Optotechnik GmbH & Co. KG<br>Phone: [phone] | |
| US Agent (Contact): | Benoit St. Jean<br>HEINE USA, Itd.<br>10 Innovation Way<br>Dover, NH 03820 USA<br>Phone: [phone]<br>E-mail: [e-mail] | |
| Date Prepared: | June 20th, 2013 | |
| Device(s) Identification:<br>Device Trade Name:<br>Common Name: | HEINE BETA 200® Ophthalmoscope<br>Ophthalmoscope | |
| Classification of the device:<br>Device Classification Name:<br>Product Code:<br>Device Classification No.: | Ophthalmoscope<br>HLJ<br>Part 886.1570 | |

Ophthalmic Devices (86)

Class II

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#### Device Description:

The HEINE BETA 200® Ophthalmoscope is a battery powered hand-held device to provide illumination and viewing optics in order to examine the retina of a patient's eye. It consists of an instrument head and a battery handle that can be attached to the instrument head.

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#### Intended Use:

The HEINE BETA 2008 Ophthalmoscope is a battery powered hand-held device for medical professionals, containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, vitreous) and the retina of the eye.

#### Predicate Device:

| Device Trade Name: | HEINE mini 3000® LED Ophthalmoscope |
|--------------------|-------------------------------------|
| Applicant: | HEINE Optotechnik GmbH & Co. KG |
| 510(k) No.: | K123587 |

The HEINE BETA 2008 Ophthalmoscope is considered substantial equivalent to the HEINE mini 3000® LED Ophthalmoscope (K123587). There is no significant difference in intended use or technology.

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HEIME

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| | HEINE BETA 200® Ophthalmoscope | HEINE mini3000® LED Ophthalmoscope | Assessment |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| Intended Use | The HEINE BETA 200® Ophthalmoscope is<br>a battery powered hand-held device for<br>medical professionals, containing<br>illumination and viewing optics intended to<br>examine the media (cornea, aqueous, lens,<br>vitreous) and the retina of the eye. | The HEINE mini3000® LED Ophthalmoscope<br>is a battery powered hand-held device for<br>medical professionals, containing illumination<br>and viewing optics intended to examine the<br>media (cornea, aqueous, lens, vitreous) and<br>the retina of the eye. | Same<br>(see rational<br>chapter 4) |
| Type | Monocular | Monocular | Same |
| Method of operation | Used to examine the retina by an examiner in a<br>specific distance to the eye. | Used to examine the retina by an examiner in a<br>specific distance to the eye. | Same |
| Illumination type | Halogen filament bulb | LED | Different |
| Exposure parameters | Emission of 2.5 V + 3,5V halogen bulb | Emission of a white LED | Different3 |
| Light output1 | 505 lux (2,5V) / 1180 lux (3,5V) | 542 lux | Different3 |
| Filter | Blue, Red free (Green) | Red free filter | Same |
| Service life of<br>Illuminant | approx. 45 hours | Unlimited | Different |
| Diopters | + 40D to -35D | + 20D to -20D | Different |
| Lens power viewing<br>optics | Diopter of used lens in steps:<br>+ in 1 D step 1-10, 15, 20, 40<br>- in 1 D step 1-10, 15, 20, 25, 35 | Diopter 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 | Different |
| _ight apertures1 | | | Equivalent |
| 1) Slit<br>2) Medium circle with reticle D= 23,2<br>(=fixation star with polar coordinates)<br>3) Cobalt blue filter<br>4) Large circle D= 29,3 (=large spot)<br>5) Small circle D= 19,2 (=small spot)<br>6) Hemispot (=semicircle)<br>+ Additional Red Free filter<br>BETA 200 apertures | Slit, fixation star with polar coordinates,<br>cobalt blue filter, large spot, small spot, hemispot<br><br>With red-free filter | small circle D = 13,8 mm<br>large circle D = 27,3 mm<br>semicircle<br>medium circle with reticle D = 23,1 mm | |
| Correction lens<br>adjustable with<br>left/right hand | Yes | Yes | Same |
| Supply voltage | 2.5 V / 3,5 V | 2.5 V | Equivalent |
| Power sources2 | Battery powered (2 (2,5V) or 3 (3,5V) alkaline cells (size LR6/AA) | 2 alkaline cells (size LR6/AA) /<br>HEINE mini 2Z rechargeable battery | Equivalent |
| Brightness controls | Rotary potentiometer (dimming rheostat) | none | Equivalent |
| Maximum temperature of parts<br>of the device held by<br>the operator or<br>accessible to the<br>patient | Complies with IEC 60601-1 for temperatures of external surfaces and controls8 | Complies with IEC 60601-1 for temperatures of external surfaces and controls | Equivalent |
| Flammability of<br>materials | | Equivalent | |
| Low probability. All measures have been taken<br>to use self-extinguishing materials. The system<br>is illuminated using a Halogen bulb and all<br>materials used in the vicinity are specially<br>designed to safely operate in high temperature<br>environments. | Low probability. All measures have been<br>taken to use self-extinguishing materials. The<br>system is illuminated using a 3W LED lamp<br>and all materials used in the vicinity are<br>specially designed to safely operate in high<br>temperature environments. | | |
| Note 1: Measurements taken 200 mm from output (direct ophthalmoscopes), large circle aperture | | | |
| Note 2: All power sources comply with the relevant standard of IEC 60601-1 and IEC 60601-1-2. | | | |
| Note 3: The XHL bulb is considered to be acceptable because of the following aspects: | | | |
| a) | The emission spectrum and the emission intensity of LED bulbs remains constant with respect to fluctuations of the power<br>supply and are constant over its whole lifetime. Is the battery voltage decreasing, the LED color temperature does not change,<br>which is the case with halogen. | | |
| b) | The color reproduction of the HEINE mini3000® LED Ophthalmoscope (color temperature 4000K) is comparable to that of a<br>halogen bulb. | | |
| c) | XHL has lower light output than LED. The maximum exposure time is specified in the instructions for use. | | |
| Note 4: Chapter 17 of this submission contains the corresponding test report No. E256178-A18-CB-1. Please refer to clause 42 of test<br>report E256178-A18-CB-1 for further details. | | | |

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## HEINE

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# HEINE

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#### Summary of Non-Clinical Performance Testing:

The HEINE BETA 200® Ophthalmoscope is tested according to the "Ophthalmoscope Guidance" in respect to optical radiation hazard with ophthalmoscopes (ISO 10942). Additionally testing in accordance with applicable requirements of ISO 15004-2 "Ophthalmic instruments – Fundamental requirements and test methods" has been performed.

#### Conclusion:

HEINE Optotechnik believes that the HEINE BETA 200® Ophthalmoscope is substantially equivalent to the currently legally marketed devices. It does not introduce new indications for use, have the same technological characteristics and do not introduce new potential hazards or safety risks.

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Image /page/6/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

December 4, 2013

HEINE Optotechnik GmbH & Co. KG Mr. Manfred Bartsch-Tittmann Director Regulatory Affairs Kientalstr. 7 82211 Hersching Germany

Re: K131961

HEINE BETA 200® Ophthalmoscopes (Models 2.5V and 3.5V) Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: HILJ Dated: October 10, 2013 Received: October 25, 2013

Dear Mr. Bartsch-Tittman:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Tile 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.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Conter - WO66-G609 Silver Spring, MI) 20993-0002

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#### Page 2 - Mr. Manfred Barsch-Tittmann

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

## Deborah L. Falls -S

for 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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K131961

#### Indications for Use

510(k) number (if known): Device Name: HEINE BETA 200@ Ophthalmoscope Indications For Use:

This instrument is designed for examination of the eye.

BETA handles are designed exclusively for use with medical examination instruments with bulb illumination.

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)

## Bradley S. Cunningham -S 2013.12.03 12:28:00 -05'00'

Division of Ophthalmic and Ear Nose and Throat Devices