HEINE BETA 200(R) OPHTHALMOSCOPE

{0}------------------------------------------------ K131961 Image /page/0/Picture/1 description: The image shows the word "HEINE" in bold, sans-serif font. The letters are all capitalized and evenly spaced. The word is horizontally oriented and appears to be a logo or brand name. Panel: Regulatory Status: HEINE Optotechnik GmbH & Co. KG · Kientalstr. 7 · 8221 1 Herrsching · Germany Tel. + 49(0)8152/38-0 · Fax +49(0)8152/38-202 · E-Mail: info@heine.com · www.heine.com Image /page/0/Picture/3 description: The image shows a logo for Heine. The logo is a triangle with the word "HEINE" written inside. The "H" is stylized with a curved line through it. Below the word "HEINE" is another word that is not clear. The logo is black and white. ### 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: +49 8152 38 0 | | | US Agent (Contact): | Benoit St. Jean<br>HEINE USA, Itd.<br>10 Innovation Way<br>Dover, NH 03820 USA<br>Phone: +1 603 7427217<br>E-mail: Bstjean@heine-na.com | | | 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 {1}------------------------------------------------ ## HEINE 000年,但是在线上的 Image /page/1/Picture/1 description: The image shows a logo with a black triangle and the word "HEINE" written in white inside the triangle. The word "HEINE" is stylized with a cursive font and a curved line extending from the top of the "H" to the bottom of the "E". The logo appears to be a company or brand identifier. . . . . #### 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. す。 #### 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. {2}------------------------------------------------ HEIME Image /page/2/Picture/3 description: The image shows a logo with the word "HEINE" written vertically. The word is written in a stylized font, with the letters connected by a flowing line. The logo is set against a dark triangle, which is pointing to the left. The logo is simple and modern. | | 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. | | | | {3}------------------------------------------------ ## HEINE Image /page/3/Picture/1 description: The image shows a logo with a triangle shape. Inside the triangle, there is a stylized design that includes a curved line resembling a sine wave. The word "HEINE" is written vertically along the right side of the triangle, integrated into the design. ្រុងប្រ {4}------------------------------------------------ # HEINE Image /page/4/Picture/1 description: The image shows a black triangle with the word "HEINE" written vertically in white letters. A white, stylized line drawing of a medical instrument is in front of the word. The triangle is oriented so that one point is facing left. : : {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows a black and white logo of the company Heine. The logo is a black triangle with the word "HEINE" written in white cursive letters inside. The "H" in Heine is stylized with a loop at the top. The logo is simple and recognizable. #### 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. {6}------------------------------------------------ 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 {7}------------------------------------------------ #### 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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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 {8}------------------------------------------------ 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