The HEINE SIGMA® 250 (M2) are battery powered indirect ophthalmoscopes for medical professionals, containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, vitreous) and the retina of the eye.

Device Description

The HEINE SIGMA® 250 (M2) are indirect ophthalmoscopes, worn on the user's head to provide illumination and viewing optics in order to examine the media and the retina of a patient`s eye. The indirect ophthalmoscopes are battery operated.

AI/ML Overview

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) premarket notification for an ophthalmoscope, which is a physical diagnostic device, not an AI/software-based device.

Therefore, it does not include:

Acceptance criteria or device performance for an AI algorithm.
Sample sizes for test sets, data provenance, or details about training sets.
Information on expert involvement (number, qualifications, adjudication methods) for establishing ground truth.
Details on AI-specific studies like MRMC comparative effectiveness or standalone algorithm performance.
Types of ground truth used in the context of AI models (e.g., pathology, outcomes data).

The document focuses on demonstrating substantial equivalence to a predicate ophthalmoscope based on intended use, technological characteristics, and safety standards for the physical device. It mentions "non-clinical performance testing" for the ophthalmoscope itself, referring to compliance with ISO standards for optical radiation and fundamental requirements, not the performance of a diagnostic AI.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of a human figure in profile, with three overlapping faces suggesting a sense of community and support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the figure.

Public Health Service

January 29, 2015

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

HEINE Optotechnik GmbH & Co. KG Mrs. Bettina Seim Director, Regulatory Affairs Kientalstr. 7 Herrsching, Germany 82211

Re: K142837

Trade/Device Name: HEINE SIGMA® 250 and 250 M2 Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: HLJ Dated: December 17, 2014 Received: December 23, 2014

Dear Mrs. Seim:

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, 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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,

Kesia Y. Alexander -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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Indications for Use

510(k) number (if known): Device Name:

HEINE SIGMA ® 250 HEINE SIGMA ® 250 M2

Indications For Use:

xl 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)

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Image /page/3/Picture/1 description: The image shows a logo for Heine Optotechnik. The logo is an orange triangle with the word "HEINE" written in white, stylized to look like a snake wrapped around a lightning bolt. The snake and lightning bolt are also white. The logo is simple and recognizable.

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
Official Contact Person:	Mrs. Bettina SeimDirector Regulatory AffairsHEINE Optotechnik GmbH & Co. KGPhone: +49 8152 38 0E-mail: bseim@heine.com
US Agent (Contact):	Belinda LabourdetteHEINE USA, Itd.10 Innovation WayDover, NH 03820 USAPhone: +1 603 842-6605E-mail: blab@heine-na.com
Date Prepared:	September 22, 2014
Device(s) Identification:Device Trade Name:	HEINE SIGMA® 250 (M2)
Common Name:	(indirect) Ophthalmoscope
Classification of the device:Device Classification Name:Product Code:Device Classification No.:	OphthalmoscopeHLJPart 886.1570

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HEINE

Image /page/4/Picture/1 description: The image is a logo for Heine Optotechnik, a German manufacturer of medical diagnostic instruments. The logo features an orange triangle with the word "HEINE" written in white, stylized letters. A white caduceus symbol, commonly associated with medicine, is overlaid on the text. The caduceus has a lightning bolt running through it.

Panel: Requlatory Status:

Ophthalmic Devices (86) Class II

Device Description:

Intended Use:

Predicate Device:

Device Trade Name:	HEINE OMEGA® 500
Applicant:	HEINE Optotechnik GmbH & Co. KG
510(k) No.:	K123316

The indirect ophthalmoscopes HEINE SIGMA® 250 (M2) are considered substantial equivalent to the HEINE OMEGA® 500 Ophthalmoscope (K123316).

There is no significant difference in intended use or technology.

	SIGMA 250	SIGMA 250 M2	HEINE OMEGA® 500	Assessment
Intended Use	The HEINE SIGMA®250 (M2) is a batterypowered indirectophthalmoscope formedical professionals,containing illuminationand viewing opticsintended to examinethe media (cornea,aqueous, lens,vitreous) and theretina of the eye.	The HEINE SIGMA®250 (M2) is a batterypowered indirectophthalmoscope formedical professionals,containing illuminationand viewing opticsintended to examinethe media (cornea,aqueous, lens,vitreous) and theretina of the eye.	The indirectophthalmoscope HEINEOMEGA® 500 is an AC-powered or batterypowered device formedical professionals,containing illuminationand viewing opticsintended to examine themedia (cornea,aqueous, lens, vitreous)and the retina of theeye.	Equivalent
Type	Binocular (Headbandand Spectaclesmounted)	Binocular (Headbandand Spectaclesmounted)	Binocular (Headbandmounted)	Similar
	SIGMA 250	SIGMA 250 M2	HEINE OMEGA® 500	Assessment
Method ofoperation	Used to examine theretina by an examinerin a specified distanceto the eye	Used to examine theretina by an examinerin a specified distanceto the eye	Used to examine theretina by an examiner ina specified distance tothe eye	Equivalent
Illumination	White LED, 3V	White LED, 3V	White 6V, 5 WattLED,XenonHalogen bulb	Equivalent
Selectablefilter	Red-free	Red-free	Blue, yellow, red-free,diffuser	Similar
Safety filter IRblocker	LED light source, noIR radiation	LED light source, noIR radiation	Permanent	Similar
Light Output¹	444lx (@ 210mA)615lx (@ 350mA)	444lx (@ 210mA)615lx (@ 350mA)	507 lx 258 lx (max.)(max.)	Similar
Lightapertures¹	Small circle:n/a	Small circle:22,5mm	Small circle:18 mm	Similar
	Middle circle: 35mm	Middle circle:n/a	Middle circle:39 mm	Similar
	Large circle: 80mm	Large circle:83 mm	Large circle: 74 mm	Similar
Inter pupillarydistanceadjustment	47mm - 72mm	47mm - 72mm	46 - 74 mm	Similar
Data collectionand/or displaysystem	None	None	None	Equivalent
Lens powerviewing optics	+2 diopter	+2 diopter	+2 diopter	Equivalent
Power sources	n/a	n/a	Wireless battery pack	Not existing
	n/a	n/a	Wall mounted unit	Not existing
	Belt battery pack	Belt battery pack	Belt battery pack	Equivalent
Brightnesscontrols	Control dial	Control dial	Control dial	Equivalent
Maximumtemperature ofparts of thedevice held bythe operator oraccessible tothe patient	Complies with IEC60601-1	Complies with IEC60601-1	Complies with IEC60601-1	Equivalent
	SIGMA 250	SIGMA 250 M2	HEINE OMEGA® 500	Assessment
Flammabilityof materials	Low probability. Allmeasures have beentaken to use self-extinguishingmaterials which areeither of flameclassification HB or V-O (UL94). The systemis illuminated using aLED and all materialsused in the vicinity arespecially designed tosafely operate in hightemperatureenvironments.	Low probability. Allmeasures have beentaken to use self-extinguishingmaterials which areeither of flameclassification HB or V-O (UL94). The systemis illuminated using aLED and all materialsused in the vicinity arespecially designed tosafely operate in hightemperatureenvironments.	Low probability. Allmeasures have beentaken to use self-extinguishing materialswhich are either offlame classification HBor V-0 (UL94). Thesystem is illuminatedusing a LED or 5W XHLXenon Halogen lampand all materials used inthe vicinity are speciallydesigned to safelyoperate in hightemperatureenvironments.	Equivalent

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Image /page/5/Picture/0 description: The image shows the logo for Heine Optotechnik. The logo is an orange triangle with the word "HEINE" written in white, stylized letters. A white medical symbol, resembling a snake wrapped around a lightning bolt, is placed in front of the text.

HEINE

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HEINE

Image /page/6/Picture/1 description: The image shows the logo for Heine Optotechnik, a German manufacturer of medical diagnostic instruments. The logo features an orange triangle with the word "HEINE" written in a stylized, cursive font. A symbol resembling a snake wrapped around a lightning bolt is integrated into the text, adding a medical and technological element to the design. The logo is simple, recognizable, and reflects the company's focus on medical technology.

Note 1:

The measurements are taken from 500 mm in front of the instrument.

Summary of Non-Clinical Performance Testing:

The HEINE SIGMA® 250 (M2) indirect ophthalmoscopes were tested according to the "Ophthalmoscope Guidance" in respect to optical radiation hazard with ophthalmoscopes (ISO 10943). 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 SIGMA® 250 (M2) indirect ophthalmoscopes are substantially equivalent to the currently legally marketed devices. They do not introduce new indications for use, have the same technological characteristics, and do not introduce new potential hazards or safety risks.

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.