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.

AI/ML Overview

Here's an analysis of the provided text regarding the HEINE BETA 200® Ophthalmoscope, focusing on acceptance criteria and supporting studies:

Acceptance Criteria and Device Performance

The provided 510(k) summary does not outline specific, quantified acceptance criteria for performance; instead, it demonstrates substantial equivalence to a predicate device (HEINE mini 3000® LED Ophthalmoscope) mainly through comparisons of design, intended use, and technical specifications. The general acceptance criterion seems to be that the new device performs at least equivalently or acceptably based on known standards for ophthalmoscopes.

The focus is on demonstrating that the new device (HEINE BETA 200® Ophthalmoscope) does not introduce new safety or effectiveness concerns compared to the predicate. Therefore, the "reported device performance" is largely presented in the context of these comparative characteristics rather than discrete pass/fail metrics.

Table of Acceptance Criteria and Reported Device Performance

Characteristic	Predicate Device (HEINE mini 3000® LED)	New Device (HEINE BETA 200®)	Assessment (Implied Acceptance)
Intended Use	Examination of media (cornea, aqueous, lens, vitreous) and retina of the eye by medical professionals.	Examination of media (cornea, aqueous, lens, vitreous) and retina of the eye by medical professionals.	Same (Substantially Equivalent)
Type	Monocular	Monocular	Same (Substantially Equivalent)
Method of Operation	Used to examine the retina by an examiner in a specific distance to the eye.	Used to examine the retina by an examiner in a specific distance to the eye.	Same (Substantially Equivalent)
Illumination Type	LED	Halogen filament bulb	Different (Justified as acceptable, see Note 3 below)
Exposure Parameters	Emission of a white LED	Emission of 2.5 V + 3,5V halogen bulb	Different (Justified as acceptable, see Note 3 below)
Light Output (at 200mm)	542 lux	505 lux (2,5V) / 1180 lux (3,5V)	Different (Justified as acceptable, see Note 3 below)
Filter	Red free filter	Blue, Red free (Green)	Same (additional filter in new device is an enhancement)
Service Life of Illuminant	Unlimited	approx. 45 hours	Different (Considered acceptable for a halogen bulb)
Diopters	+ 20D to -20D	+ 40D to -35D	Different (New device offers wider range, an enhancement)
Lens power viewing optics	Specific steps within +20D to -20D range.	Specific steps within +40D to -35D range.	Different (New device offers wider range, an enhancement)
Light Apertures	Slit, fixation star with polar coordinates, cobalt blue filter, large spot, small spot, hemispot, with red-free filter.	Slit, medium circle with reticle, cobalt blue filter, large circle, small circle, hemispot, additional Red Free filter.	Equivalent (Predicate lists general types, new device lists specific sizes. Overall functionality is equivalent.)
Correction Lens Adjustable	Yes	Yes	Same (Substantially Equivalent)
Supply Voltage	2.5 V	2.5 V / 3,5 V	Equivalent (New device offers 2 options)
Power Sources	2 alkaline cells (size LR6/AA) / HEINE mini 2Z rechargeable battery	2 (2,5V) or 3 (3,5V) alkaline cells (size LR6/AA)	Equivalent (Both battery powered, meet standards)
Brightness Controls	none	Rotary potentiometer (dimming rheostat)	Equivalent (New device offers control, which is an enhancement)
Max temperature of parts	Complies with IEC 60601-1 for temperatures of external surfaces and controls.	Complies with IEC 60601-1 for temperatures of external surfaces and controls.	Equivalent (Standard compliance)
Flammability of materials	Low probability. All measures have been taken to use self-extinguishing materials. System illuminated using 3W LED lamp.	Low probability. All measures have been taken to use self-extinguishing materials. System illuminated using Halogen bulb. Materials designed for high temp environments.	Equivalent (Measures taken to ensure safety)
Optical Radiation Hazard	Assumed to comply with ISO 10942 based on predicate's marketing.	Tested according to "Ophthalmoscope Guidance" in respect to optical radiation hazard with ophthalmoscopes (ISO 10942). Specific test report mentioned (E256178-A18-CB-1).	Complies (Demonstrated by testing)
Fundamental Requirements	Assumed to comply with ISO 15004-2 based on predicate's marketing.	Tested in accordance with applicable requirements of ISO 15004-2.	Complies (Demonstrated by testing)

Note 3 Explanation for Differences in Illumination (from text):
a) LED color temperature is constant with changing battery voltage; halogen changes. This implies LED is superior in color consistency.
b) Color reproduction of LED (4000K) is comparable to halogen. This indicates that despite different technologies, the outcome in terms of color is equivalent.
c) XHL (halogen in new device) has lower light output than LED, but maximum exposure time is specified in instructions for use. This mitigates potential safety concerns due to light intensity.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily describes a desk-based substantial equivalence comparison against a predicate device and non-clinical performance testing (bench testing). It does not mention a clinical study with a "test set" of patients or data in the way an AI/software device would generally have.

The compliance testing against ISO standards (ISO 10942, ISO 15004-2) would involve testing individual devices or components, but details of sample sizes for these tests are not provided in this summary. The data provenance is implied to be from internal HEINE Optotechnik testing (Germany).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the submission is for a hardware ophthalmoscope and relies on a substantial equivalence claim and non-clinical testing, not a study requiring expert-established ground truth on clinical images or diagnoses.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as there is no clinical study involving human readers or a test set requiring adjudication in the context of this 510(k) submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC comparative effectiveness study was not done. This 510(k) is for a hardware medical device (an ophthalmoscope), not an AI-powered diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

A standalone performance study was not done. This is a hardware device; there is no a standalone "algorithm" to evaluate.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" as typically applied to AI or diagnostic imaging software is not applicable here. For this hardware device, the "ground truth" for its performance is established by its adherence to specified technical parameters, functionality, and compliance with recognized international standards (ISO 10942, ISO 15004-2, IEC 60601-1). These standards set benchmarks for device output (e.g., light intensity), safety (e.g., temperature), and performance characteristics.

8. The sample size for the training set

This information is not applicable as there is no AI algorithm or software being trained. The device is a traditional hardware ophthalmoscope.

9. How the ground truth for the training set was established

This information is not applicable as there is no AI algorithm or software being trained, and thus no training set or ground truth for it.

Summary

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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

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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. KGKientalstr. 782211 HerrschingGermanyRegistration Number: 1000379039Owner/Operator Number: 9003020	DEC 0 4 2013
Official Contact Person:	Mr. Manfred Bartsch-TittmannDirector Regulatory AffairsHEINE Optotechnik GmbH & Co. KGPhone: +49 8152 38 0
US Agent (Contact):	Benoit St. JeanHEINE USA, Itd.10 Innovation WayDover, NH 03820 USAPhone: +1 603 7427217E-mail: Bstjean@heine-na.com
Date Prepared:	June 20th, 2013
Device(s) Identification:Device Trade Name:Common Name:	HEINE BETA 200® OphthalmoscopeOphthalmoscope
Classification of the device:Device Classification Name:Product Code:Device Classification No.:	OphthalmoscopeHLJPart 886.1570

Ophthalmic Devices (86)

Class II

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HEINE 000年,但是在线上的

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. . . .

Device Description:

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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 isa battery powered hand-held device formedical professionals, containingillumination and viewing optics intended toexamine the media (cornea, aqueous, lens,vitreous) and the retina of the eye.	The HEINE mini3000® LED Ophthalmoscopeis a battery powered hand-held device formedical professionals, containing illuminationand viewing optics intended to examine themedia (cornea, aqueous, lens, vitreous) andthe retina of the eye.	Same(see rationalchapter 4)
Type	Monocular	Monocular	Same
Method of operation	Used to examine the retina by an examiner in aspecific distance to the eye.	Used to examine the retina by an examiner in aspecific 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 ofIlluminant	approx. 45 hours	Unlimited	Different
Diopters	+ 40D to -35D	+ 20D to -20D	Different
Lens power viewingoptics	Diopter of used lens in steps:+ in 1 D step 1-10, 15, 20, 40- in 1 D step 1-10, 15, 20, 25, 35	Diopter of used lens in steps:-20, -15, -10, -8, -6, -4,-3, -2, -1,0, 1, 2, 3, 4, 6, 8, 10, 15, 20	Different
_ight apertures1			Equivalent
1) Slit2) Medium circle with reticle D= 23,2(=fixation star with polar coordinates)3) Cobalt blue filter4) Large circle D= 29,3 (=large spot)5) Small circle D= 19,2 (=small spot)6) Hemispot (=semicircle)+ Additional Red Free filterBETA 200 apertures	Slit, fixation star with polar coordinates,cobalt blue filter, large spot, small spot, hemispotWith red-free filter	small circle D = 13,8 mmlarge circle D = 27,3 mmsemicirclemedium circle with reticle D = 23,1 mm
Correction lensadjustable withleft/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) /HEINE mini 2Z rechargeable battery	Equivalent
Brightness controls	Rotary potentiometer (dimming rheostat)	none	Equivalent
Maximum temperature of partsof the device held bythe operator oraccessible to thepatient	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 ofmaterials		Equivalent
Low probability. All measures have been takento use self-extinguishing materials. The systemis illuminated using a Halogen bulb and allmaterials used in the vicinity are speciallydesigned to safely operate in high temperatureenvironments.	Low probability. All measures have beentaken to use self-extinguishing materials. Thesystem is illuminated using a 3W LED lampand all materials used in the vicinity arespecially designed to safely operate in hightemperature 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 powersupply and are constant over its whole lifetime. Is the battery voltage decreasing, the LED color temperature does not change,which is the case with halogen.
b)	The color reproduction of the HEINE mini3000® LED Ophthalmoscope (color temperature 4000K) is comparable to that of ahalogen 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 testreport E256178-A18-CB-1 for further details.

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HEINE

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្រុងប្រ

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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.

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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.

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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 (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

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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

Regulation Number and Section

§ 886.1570 Ophthalmoscope.

(a)
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.(b)
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.