Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a basic ophthalmoscope with illumination and viewing optics, and there is no mention of AI, ML, image processing, or data analysis beyond standard optical and safety testing.

Therapeutic

No.
This device is described as an ophthalmoscope used for examination and diagnostic purposes, not for treatment or therapy.

Diagnostic

Yes
Explanation: The device is described as allowing medical professionals to "examine the media (cornea, aqueous, lens, vitreous) and the retina of the eye," which is a diagnostic activity. While it is a viewing tool, the purpose of the viewing is to obtain information about the patient's condition, making it diagnostic.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a battery-powered hand-held device with illumination and viewing optics, indicating it is a physical hardware device, not software only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device 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 mini 3000 Ophthalmoscope is a hand-held device used for direct examination of the eye's internal structures (media and retina). It provides illumination and viewing optics.
Lack of Sample Analysis: The device does not analyze any biological samples taken from the patient. It is used for visual inspection.

Therefore, the HEINE mini 3000 Ophthalmoscope falls under the category of a medical device used for examination, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The HEINE mini 3000 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.

Product codes

HLJ

Device Description

The HEINE mini 3000® Ophthalmoscope is a battery powered hand-held device to provide illumination and viewing optics in order to examine the media and the retina of a patient's eye. It consists of an instrument head and a battery handle that can be screwed onto the instrument head. The ophthalmoscope can be either operated by replaceable AA batteries or a rechargeable option in combination with the HEINE mini NT® charger.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Eye (cornea, aqueous, lens, vitreous, retina)

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 mini 3000® Ophthalmoscope was 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.

Bench test results were described in the following reports:

Standard: ISO 15004-2, Test Identification No.: ISO 15004-2_mini3000XHLOphth, Document No.: 18a
Standard: ISO 15004-2, Test Identification No.: NR. L-56_13 Heine Mini 3000 (Risk group classification), Document No.: 18b
Standard: ISO 10942, Test Identification No.: ISO 10942_mini3000XHL_Ophth, Document No.: 18c

Bench Test HEINE mini3000® Ophthalmoscope According to EN ISO 15004-2:2007:
Test results for various parameters with corresponding verdicts of PASS for all:

Weighted corneal and lenticular UV, ES-CL, HS-CL: 0.008 µW cm-2 (Limit Group 2: 3 mJ cm-2)
Unweighted corneal and lenticular UV, EUV-CL, HUV-CL: 0.019 µW cm-2 (Limit Group 2: 1 J cm-2 (t

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

K1319554

MAR - 7 2014

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: | Mr. Manfred Bartsch-Tittmann
Director Regulatory Affairs
HEINE Optotechnik GmbH & Co. KG
82211 Herrsching, Germany
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: | February, 2nd 2014 |
| Device(s) Identification:
Device Trade Name: | HEINE mini 3000® Ophthalmoscope |
| Common Name: | Ophthalmoscope |
| Classification of the device: | |

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

Ophthalmoscope HLJ Part 886.1570 Ophthalmic Devices (86) Class II

1

Device Description:

The HEINE mini 3000® Ophthalmoscope is a battery powered hand-held device to provide illumination and viewing optics in order to examine the media and the retina of a patient's eye. It consists of an instrument head and a battery handle that can be screwed onto the instrument head. The ophthalmoscope can be either operated by replaceable AA batteries or a rechargeable option in combination with the HEINE mini NT® charger.

Intended Use:

The HEINE mini 3000® Ophthalmoscope is a battery powered hand-held device for medical professionals, containing illumination and viewing optics intend to examine the media (cornea, aqueous, lens, vitreous) and the retina of the eye.

Predicate Device:

Device Trade Name:	HEINE mini 3000® LED
Applicant:	HEINE Optotechnik GmbH & Co. KG
510(k) No.:	K123587

The HEINE mini 3000® Ophthalmoscope is considered substantial equivalent to the HEINE mini 3000® LED Ophthalmoscope (K123587). There is no significant difference in intended use or technology.

2

HEINE mini3000 Ophthalmoscope	HEINE mini3000 LED Ophthalmoscope	Assessment
The HEINE mini3000 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.	The HEINE mini3000 LED 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.	Same
Monocular	Monocular	Same
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
Halogen filament bulb	LED	Different
Emission of 2.5 V halogen bulb	Emission of a white LED	Different3
315 lux	542 lux	Different3
Red free filter	Red free filter	Same
approx. 45 hours	unlimited	Different
+ 20D to -20D	+ 20D to -20D	Same
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	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	Same
small circle D = 13,8 mm
large circle D = 27,3 mm
semicircle
medium circle with reticle D = 23,1 mm	small circle D = 13,8 mm
large circle D = 27,3 mm
semicircle
medium circle with reticle D = 23,1 mm	Same
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
Correction lens adjustable with left / right hand	Yes	Same
2.5 V	2.5 V	Same
2 alkaline cells (size LR6/AA) / HEINE mini 2Z rechargeable battery	2 alkaline cells (size LR6/AA) / HEINE mini 2Z rechargeable battery	Same
none	none	Same
Maximum temperature of parts of the device held by the operator or accessible to the patient	Complies with IEC 60601-1 for temperatures of external surfaces and controls4	Complies with IEC 60601-1 for temperatures of external surfaces and controls4	Equivalent
Flammability of materials	Low probability. All measures have been taken to use self-extinguishing materials. The system is illuminated using a xhl lamp 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. The system is illuminated using a 3W LED lamp and all materials used in the vicinity are specially designed to safely operate in high temperature environments.	Equivalent

3

Summary of Non-Clinical Performance Testing:

The HEINE mini 3000® 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 mini 3000® 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.

Summary Report

The HEINE mini 3000® Ophthalmoscope is tested according to the "Ophthalmoscope Guidance" in respect to optical radiation hazard with ophthalmoscopes (DIN EN ISO 10942:2007). Additionally testing in accordance with applicable requirements of ISO DIN EN 15004-2:2007 *Ophthalmic instruments - Fundamental requirements and test methods" has been performed.

The bench test results are described in the following reports:

Standard	Test Identification No.	Document No.
ISO 15004-2	ISO 15004-2_mini3000XHLOphth	18a
	NR. L-56_13 Heine Mini 3000
(Risk group classification)	18b
ISO 10942	ISO 10942_mini3000XHL_Ophth	18c

4

Bench Test HEINE mini3000® Ophthalmoscope According to EN ISO 15004-2:2007

Based on Test Report NR. L-56_13 Heine Mini 3000 Issued by Seibersdorf Laboratories Date: 11.06.2013 (11th of June 2013)

Table 3 has been used for this report because it represents the worst case of intended use of the device and the results are caiculated according to the methods of DIN EN ISO 15004-2:2007.

The instructions for use contain the maximum time at maximum intensity up to 47 seconds (worst case) as specified in the test report.

Parameter	Test specification	Wavelength
Weighted corneal
and
lenticular UV, ES-
CL, HS-CL	The corneal radiant exposure shall
be evaluated by averaging
highest localized radiation power
incident upon a circular area at
the corneal plane with a diameter of
1 mm (7,9 x 10-3 cm²).	250 - 400	3
mJ cm-2	0,008
µW cm-2	PASS
Unweighted
corneal and
lenticular UV,
EUV-CL,
HUV-CL	The corneal radiant exposure shall
be evaluated by averaging
highest localized radiation power
incident upon a circular area at
the corneal plane with a diameter of
1 mm (7,9 x 10-3 cm²).	360 - 400	1 J cm-2
(t