Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard optical device for eye examination and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.

Therapeutic

No.
The device is strictly for examination and diagnostic purposes, with no stated therapeutic function.

Diagnostic

Yes
Justification: The device is an ophthalmoscope intended to examine the media and retina of the eye, which is a diagnostic function to help medical professionals identify and assess conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a battery-powered indirect ophthalmoscope, which is a hardware device containing illumination and viewing optics.

IVD (In Vitro Diagnostic)

Based on the provided information, the HEINE SIGMA® 250 (M2) is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The HEINE SIGMA® 250 (M2) is an indirect ophthalmoscope used for direct examination of the eye's internal structures (media and retina). It does not involve testing samples taken from the body.
Intended Use: The intended use clearly states it's for examining the media and retina of the eye, which is a direct observation method, not an in vitro test.

Therefore, the HEINE SIGMA® 250 (M2) is a medical device used for direct examination, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

HLJ

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

the eye

Indicated Patient Age Range

Not Found

Intended User / Care Setting

medical professionals

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K123316

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

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

1

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:

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.

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. KG
Kientalstr. 7
82211 Herrsching
Germany
Registration Number: 1000379039
Owner/Operator Number: 9003020 |
|-------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact Person: | Mrs. Bettina Seim
Director Regulatory Affairs
HEINE Optotechnik GmbH & Co. KG
Phone: +49 8152 38 0
E-mail: bseim@heine.com |
| US Agent (Contact): | Belinda Labourdette
HEINE USA, Itd.
10 Innovation Way
Dover, NH 03820 USA
Phone: +1 603 842-6605
E-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.: | Ophthalmoscope
HLJ
Part 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:

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.

Intended Use:

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.

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 battery
powered indirect
ophthalmoscope for
medical professionals,
containing illumination
and viewing optics
intended to examine
the media (cornea,
aqueous, lens,
vitreous) and the
retina of the eye.	The HEINE SIGMA®
250 (M2) is a battery
powered indirect
ophthalmoscope for
medical professionals,
containing illumination
and viewing optics
intended to examine
the media (cornea,
aqueous, lens,
vitreous) and the
retina of the eye.	The indirect
ophthalmoscope HEINE
OMEGA® 500 is an AC-
powered or battery
powered device for
medical professionals,
containing illumination
and viewing optics
intended to examine the
media (cornea,
aqueous, lens, vitreous)
and the retina of the
eye.	Equivalent
Type	Binocular (Headband
and Spectacles
mounted)	Binocular (Headband
and Spectacles
mounted)	Binocular (Headband
mounted)	Similar
	SIGMA 250	SIGMA 250 M2	HEINE OMEGA® 500	Assessment
Method of
operation	Used to examine the
retina by an examiner
in a specified distance
to the eye	Used to examine the
retina by an examiner
in a specified distance
to the eye	Used to examine the
retina by an examiner in
a specified distance to
the eye	Equivalent
Illumination	White LED, 3V	White LED, 3V	White 6V, 5 Watt
LED,
Xenon
Halogen bulb	Equivalent
Selectable
filter	Red-free	Red-free	Blue, yellow, red-free,
diffuser	Similar
Safety filter IR
blocker	LED light source, no
IR radiation	LED light source, no
IR radiation	Permanent	Similar
Light Output¹	444lx (@ 210mA)
615lx (@ 350mA)	444lx (@ 210mA)
615lx (@ 350mA)	507 lx 258 lx (max.)
(max.)	Similar
Light
apertures¹	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 pupillary
distance
adjustment	47mm - 72mm	47mm - 72mm	46 - 74 mm	Similar
Data collection
and/or display
system	None	None	None	Equivalent
Lens power
viewing 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
Brightness
controls	Control dial	Control dial	Control dial	Equivalent
Maximum
temperature of
parts of the
device held by
the operator or
accessible to
the patient	Complies with IEC
60601-1	Complies with IEC
60601-1	Complies with IEC
60601-1	Equivalent
	SIGMA 250	SIGMA 250 M2	HEINE OMEGA® 500	Assessment
Flammability
of materials	Low probability. All
measures have been
taken to use self-
extinguishing
materials which are
either of flame
classification HB or V-
O (UL94). The system
is illuminated using a
LED and all materials
used in the vicinity are
specially designed to
safely operate in high
temperature
environments.	Low probability. All
measures have been
taken to use self-
extinguishing
materials which are
either of flame
classification HB or V-
O (UL94). The system
is illuminated using a
LED and all materials
used in the vicinity are
specially designed to
safely operate in high
temperature
environments.	Low probability. All
measures have been
taken to use self-
extinguishing materials
which are either of
flame classification HB
or V-0 (UL94). The
system is illuminated
using a LED or 5W XHL
Xenon Halogen lamp
and all materials used in
the vicinity are specially
designed to safely
operate in high
temperature
environments.	Equivalent

5

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.