Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard indirect ophthalmoscope with illumination and viewing optics. There is no mention of image processing, AI, ML, or any related concepts. The performance studies focus on optical radiation hazard and fundamental requirements, not algorithmic performance.

Therapeutic

No
The device is described as an indirect ophthalmoscope intended to examine parts of the eye, which is a diagnostic function, not a therapeutic one.

Diagnostic

Yes

The device is intended to "examine the media (cornea, aqueous, lens, vitreous) and the retina of the eye," which is a diagnostic purpose to evaluate the condition of the eye.

SaMD (Software as a Medical Device)

No

The device description clearly states it is an indirect ophthalmoscope, which is a physical medical device worn on the head and contains illumination and viewing optics. It also mentions power sources (battery or mains) and physical testing according to ISO standards. This indicates it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
Device Function: The HEINE OMEGA® 500 is an ophthalmoscope used for direct visualization of the internal structures of the eye. It does not analyze any samples taken from the patient.
Intended Use: The intended use clearly states it's for examining the media and retina of the eye, which is a direct examination of the patient's body.

Therefore, based on the provided information, the HEINE OMEGA® 500 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 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.

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

HLI, HLJ

Device Description

The HEINE OMEGA® 500 is an indirect ophthalmoscope, worn on the user's head to provide illumination and viewing optics in order to examine the retina of a patient's eve. The ophthalmoscope can be operated either by rechargeable battery or directly by mains power supply.

The HEINE OMEGA® 500 allows wireless comfortable movement for the user and mobile charging (depending on chosen power source).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

media (cornea, aqueous, lens, vitreous) and the retina of 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 OMEGA®500 indirect ophthalmoscope is 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.

K060822, K942713, K930023

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

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K123316

HEINE Optotechnik GmbH & Co. KG · Kientalstr. 7 · 82211 Herrsching · Germany Tel. +49(0)8152/38-0 · Fax +49(0)8152/38-202 · E-Mail: info@heine.com · www.heine.com

.

FEB 2 6 2013

Image /page/0/Picture/4 description: The image shows a logo with a triangle shape. Inside the triangle, there is a stylized letter 'S' that forms a snake-like shape. The word 'HEINE' is written in a stylized font across the base of the 'S' and the triangle. The logo appears to be a company or brand identifier.

510(k) 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 Correspondent:

Mr. Jörg Rönnau Director Regulatory Affairs HEINE Optotechnik GmbH & Co. KG Phone: +49 8152 38 0

US Agent (Contact):

Benoit St. Jean HEINE USA, Itd. 10 Innovation Way Dover, NH 03820 USA Phone: +1 603 7427217 ·· E-mail: Bstjean@heine-na.com

Date Prepared:

Common Name:

September 3rd, 2012

Device(s) Identification: Device Trade Name:

HEINE OMEGA® 500 Indirect ophthalmoscope

Classification of the device:

Device Classification Name: Product Code: Device Classification No.: Panel: Regulatory Status:

Ophthalmoscope HLI (AC) and HLJ (DC) Part 886.1570 Ophthalmic Devices (86) Class II

1

Image /page/1/Picture/1 description: The image shows a logo for Heine. The logo is a triangle with a snake wrapped around a staff inside of it. The word "HEINE" is written in a stylized font across the middle of the triangle.

Device Description:

The HEINE OMEGA® 500 is an indirect ophthalmoscope, worn on the user's head to provide illumination and viewing optics in order to examine the retina of a patient's eve. The ophthalmoscope can be operated either by rechargeable battery or directly by mains power supply.

The HEINE OMEGA® 500 allows wireless comfortable movement for the user and mobile charging (depending on chosen power source).

Intended Use:

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.

Predicate devices:
Device Trade Name:
Vantage Plus Binocular Indirect Ophthalmoscope
Applicant:
Keeler Instruments Inc.
510(k) No.:
K060822
Device Trade Name:
NEITZ Binocular Indirect Ophthalmoscope IO-A
Applicant:
NEITZ Instruments Company, Ltd.
510(k) No.:
K942712
Device Trade Name:
Model #12000 Binocular Indirect Ophthalmoscope
Applicant:
Welch Allyn, Inc.
510(k) No.:
K930023

The HEINE OMEGA 500 is considered substantial equivalent to the Vantage Plus Binocular Indirect Ophthalmoscope (K060822), NEITZ Binocular Indirect Ophthalmoscope IO-A (K942712) and Welch Allyn Model #12000 Binocular Indirect Ophthalmoscope (K930023).

2

HEINE
CEINE ------------------------------------------------------------------------------------------------------------------------------------------------------------------

| Следия владии с Анар. ССРАСАНИЯСТ РАСОВОМОСРЕДАРА ССАВААЛ И. В МАРА . 1. 4

- - - - |
        |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
        | .
        i |
        | And and the coupling of the state of program with are and the second of the
        10 1 1 18 1882 1974 1991 1991 1992 1992 1991 1991 19 11 |

| 510(k) applied
(predicate

devices)	HEINE OMEGA 500	Keeler Vantage Plus	NEITZ IO-a LED
Indication for
use	New device, for which a
510(k) is applied	510(k) Number:
K060822	510(k) Number:
K942713	510(k) Number:
K930023	same
	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	The Keeler Vantage Plus
Indirect Ophthalmoscope is
intended to be used to
examine the Cornea,
aqueous, lens vitreous and
retina of the eye.	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.	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.	same
	Source: Instructions for use	Source: 510(k) K060822	Source: 510(k) K942713,
Regulation Number:
886.1570	Source: 510(k) K930023,
Regulation Number:
886.1570
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	Used to examine the retina
by an examiner in a specified
distance to the eye	same
Technology	The HEINE OMEGA 500
indirect ophthalmoscope has
two main elements:

The illumination
element
The viewing element | The Keeler Vantage Plus,
indirect ophthalmoscope has
two main elements:
The illumination
element
The viewing element | The Neitz IO-a LED indirect
ophthalmoscope has two
main elements:
The illumination
element
The viewing element | The Welch Allyn Model
#12000 indirect
ophthalmoscope has two
main elements:
The illumination
element
The viewing element | same |
| Type / Design | indirect ophthalmoscope
Binocular (Headband
mounted)
Permanent | indirect ophthalmoscope
Binocular (Headband
mounted)
Permanent | indirect ophthalmoscope
Binocular (Headband
mounted)
Not available | indirect ophthalmoscope
Binocular (Headband
mounted)
Not available | same |
| Exposure
Parameter | | | | | |
| Safety
Infrared Filter
(IR Blocker) | | | | | |

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HEINE
HEIME

Image /page/3/Picture/5 description: The image is a black and white logo. The logo is a triangle with the text "HEINE" written vertically inside. There is a stylized design to the left of the text that appears to be a cursive letter.

	HEINE OMEGA 500	Keeler Vantage Plus	NEITZ IO-a LED	Welch Allyn Model #12000	Assessment
Selectable filter	Blue, yellow, red-free, diffuser	Blue, red-free, diffuser	Cobalt blue, red-free	Cobalt blue, yellow, red-free, diffusor
Information not available	same
Exposure
Parameter
Energy
Delivered
(Light Output)	507 lx (max.) 258 lx (max.)	901 lx (max.)	913 lx (max.)	600 lx (max.)	refer to
justification 1)
Measured in a
distance of 500 mm
min. Irradiance
(for retinal
imaging)	LED
$8,81 mW/cm^2$	LED
$54,87 mW/cm^2$	Halogen
$26,53 mW/cm^2$	LED
$22,10 mW/cm^2$	Information not available	refer to
justification 1)
max. Irradiance
(for retinal
imaging)	LED
$323,54 mW/cm^2$	Halogen
$465,77 mW/cm^2$	LED
$597,66 mW/cm^2$	Halogen
$423:29 mW/cm^2$	LED
$515,03 mW/cm^2$	Information not available	refer to
justification 1)
Power sources
(Energy used)	Wireless battery pack mPack
unplugged:
Nominal voltage: 7.4V
1850mAh

Wall mounted unit
(EN50 mPack/EN50)
Mains voltage: 100-240Vac
Belt battery pack (mPack):
Nominal voltage: 7.2V
4200mAH | Wireless battery pack
(Standard Lithium battery):
Nominal voltage: 7.4V
1800mAh

Wall pack
Input mains data: 100-
240Vac

Belt battery pack (Smart
pack):
Nominal voltage: 7.2V 2500
mAh | Wireless battery pack (same
as 2400RD): nominal
voltage: 2.4 V min. 1900mAh

Not available

Belt battery pack (2400RD)
Nominal voltage: 2.4V min.
1900mAH | Not Available

Wall/Desk Power Source:
Input: 96-130Vac

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Image /page/4/Picture/5 description: The image shows a logo with the word "HEINE" written in a stylized font. The logo is set against a triangular background. The word "HEINE" is written in a cursive style, with the letters intertwined. The logo appears to be for a company or brand named "HEINE".

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Image /page/5/Picture/1 description: The image shows a gray triangle with the word "HEINE" written vertically inside. A wavy line is drawn across the word. The number 19.00 is written below the triangle.

	HEINE OMEGA 500	Keeler Vantage Plus	NEITZ IO-a LED	Welch Allyn Model #12000	Assessment
Maximum temperature of parts of the device held by the operator or accessible to the patient Product viewsNote2	Complies with IEC 60601-1	Complies with BS EN ISO 60601-1	Information not available	Complies with IEC 601-1	same
Total view	Image: HEINE OMEGA 500 Total view	Image: Keeler Vantage Plus Total view	Image: NEITZ IO-a LED Total view	Image: Welch Allyn Model #12000 Total view	same
Operator's view	Image: HEINE OMEGA 500 Operator's view	Image: Keeler Vantage Plus Operator's view	Image: NEITZ IO-a LED Operator's view	Image: Welch Allyn Model #12000 Operator's view
Left side	Image: HEINE OMEGA 500 Left side	Image: Keeler Vantage Plus Left side	Image: NEITZ IO-a LED Left side	Image: Welch Allyn Model #12000 Left side
Backside of the headband	Image: HEINE OMEGA 500 Backside of the headband	Image: Keeler Vantage Plus Backside of the headband	Image: NEITZ IO-a LED Backside of the headband	Image: Welch Allyn Model #12000 Backside of the headband
	HEINE OMEGA 500	Keeler Vantage Plus	NEITZ IO-a LED	Welch Allyn Model #12000	Assessment
Cleaning	Before cleaning, disconnect from the
power source.
The instrument and the loupe may be
wiped clean with a non-shedding
damp or dry cloth.

Wipe the headband with a clean,
absorbent, non-shedding cloth
dampened with a water/detergent
solution (2% by volume). Ensure that
excess solution does not enter the
instrument. Use caution to ensure
cloth is not saturated with solution.
The XHL / LED lamp can be cleaned,
with a dry cloth if necessary. | Only manual non-immersion
cleaning as described below should
be used for the instrument. Do not
autoclave or immerse in cleaning
fluids. Always disconnect power
supply from source before cleaning.
Wipe external surface with a clean
absorbent, non-shedding cloth
dampened with a water/detergent
solution (2% by volume) or
water/isopropyl alcohol solution
(70% by volume).
Ensure that excess solution does not
enter the instrument. Use caution to
ensure cloth is not saturated with
solution.
Surfaces should be carefully hand
dried using a clean non shedding
cloth.
Safely dispose of used cleaning
materials. | The newly adopted Head Pad of Wet
Suit Material secures the durable
wearing of the head band and the
utmost comfort. This Washable
material is ideal for keeping your
instrument neat and clean in use. | The glass cover on the front of the
BIO, the glass lenses in the oculars
and the teaching mirror can be
cleaned with a soft cloth moistened
with alcohol. The leather cushions
on the headband may be removed
and wiped with soapy water. The
remainder of the BIO may be wiped
with a soft cloth that has been
moistened in alcohol. Avoid using
harsh cleaning fluids or cloth which
are excessively moist on any part of
this instrument. | same |
| Disinfection | The instrument headband can be
disinfected with CIDEX® OPA by
wiping it with a soft cloth moistened
with disinfectant for 5 minutes.

The use of a spray disinfectant and
soaking or disinfection in a machine is
not permitted.
Sterilisation of OMEGA® 500 is not
allowed | Do not autoclave or immerse in
cleaning fluids.

No further information denoted | no information denoted | no information denoted | same |

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HEINE ------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Image /page/6/Picture/4 description: The image shows a logo with the word "HEINE" written in a stylized font. The logo is set inside a triangle. The triangle is filled with a textured pattern, possibly representing a rough or grainy surface. The overall design appears to be a company logo or brand mark.

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