The HEINE mini 3000® 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.

Device Description

The HEINE mini 3000® LED Ophthalmoscope is a battery powered hand-held device to provide illumination and viewing optics in order to examine the retina of a patient's eve. 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.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device, the HEINE mini3000® LED Ophthalmoscope. It primarily focuses on demonstrating substantial equivalence to a predicate device (Piccolight® E50 Ophthalmoscope), rather than providing a detailed study proving the device meets specific acceptance criteria via clinical performance data.

Here's an analysis based on the provided text, addressing the points where information is available and noting where it is not:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present "acceptance criteria" in the typical sense of performance metrics for a diagnostic accuracy study (e.g., sensitivity, specificity, AUC). Instead, it compares the technical specifications and intended use of the HEINE mini3000® LED Ophthalmoscope to a predicate device, Piccolight® E50 Ophthalmoscope, to establish substantial equivalence.

Feature / Criterion	Predicate Device (Piccolight® E50) Performance	Proposed Device (HEINE mini3000® LED Ophthalmoscope) Performance	Assessment / Equivalence Claim
Intended Use	To examine the cornea, aqueous, lens, vitreous and retina of the eye.	To examine the media (cornea, aqueous, lens, vitreous) and the retina of the eye.	Same
Type	Monocular	Monocular	Same
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
Illumination type	Halogen filament bulb	LED	Refer to Justification 1 (complies with ISO 15004-2:2007)
Exposure parameters	Emission of 2.5 V halogen bulb	Emission of a white LED	Refer to Justification 1 (complies with ISO 15004-2:2007)
Light output	46 lux	542 lux	Refer to Justification 1 (complies with ISO 15004-2:2007)
Filter	none	Red free filter	Refer to Justification 2 (does not influence safety/effectiveness)
Service life of Illuminant	approx. 15 hours	50,000 hours	Refer to Justification 3 (does not influence effectiveness/safety)
Diopters	+20D to -20D (in specific steps)	+20D to -20D (in specific steps)	Same
Light apertures	Large circle D = 24.00 mm	small circle D = 13.8 mm, large circle D = 27.3 mm, semicircle, medium circle with reticle D = 3.1 mm	Refer to Justification 4 (more flexibility, no influence on safety/effectiveness)
Supply voltage	2.5 V	2.5 V	Same
Power sources	Battery	2 alkaline cells (size LR6/AA) / HEINE mini 2Z rechargeable battery	Refer to Justification 5 (same battery type, additional rechargeable option)
Maximum temperature of parts held by operator/accessible to patient	Complies with IEC 60601-1 for temperatures of external surfaces and controls3	None (implies compliance, referring to test report)	Same (implies compliance)
Flammability of materials	Fiber-glass reinforced plastic Polyamide 6 GF30C	Low probability. All measures have been taken to use self-extinguishing materials. System illuminated using a 3W LED lamp, materials designed to safely operate in high temperature environments.	Same
Cleaning and Disinfection	Cleaning via damp, soft, fluff-free fabric; disinfection with alcohol-moistened fabric; no liquid contact. Not sterilizable.	Cleaning with damped cloth (housing, handle); glass surfaces with cotton wool. Disinfection with CIDEX® OPA by wiping. Not allowed: spraying, immersion, sterilization.	Same
Applicable Standards	(Implied compliance with relevant standards, specifically IEC 60601-1)	Tested according to "Ophthalmoscope Guidance" (ISO 10942) and ISO 15004-2 "Ophthalmic instruments - Fundamental requirements and test methods". All power sources comply with IEC 60601-1 and IEC 60601-1-2. Test report No. E256178-A18-CB-1 for clause 42 of IEC 60601-1.	Compliance with relevant safety and performance standards.

Study Proving Acceptance Criteria:

The "study" proving the device meets the acceptance criteria is a premarket notification (510(k)) for substantial equivalence. It does not involve a clinical trial or performance study in the way a new diagnostic algorithm would. Instead, it argues that the HEINE mini3000® LED Ophthalmoscope is as safe and effective as a legally marketed predicate device (Piccolight® E50 Ophthalmoscope) because:

Its intended use is the same.
Its technological characteristics are similar, and any differences (e.g., LED vs. halogen, additional apertures, red-free filter) do not raise new questions of safety or effectiveness and in some cases offer benefits.
It complies with relevant consensus standards for medical devices and ophthalmic instruments (ISO 10942, ISO 15004-2, IEC 60601-1, IEC 60601-1-2).

Specific Information Requested:

A table of acceptance criteria and the reported device performance: See above. The acceptance criteria here are demonstrated "sameness" or justified differences compared to the predicate, and compliance with recognized standards.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable / No specific test set in the clinical performance sense. This submission is based on engineering design, technical specifications, and compliance with international standards, rather than clinical performance data from a "test set" of patients or images. The "data" provenance would be internal engineering tests and standard compliance reports.
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):
- Not applicable. No ground truth was established by experts for a clinical performance test set in this context.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set or adjudication was performed for this type of submission.
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:
- No. This device is a manual ophthalmoscope, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This device is not an algorithm; it's a physical medical instrument requiring human operation.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. The "ground truth" for this submission revolves around engineering specifications, safety testing (e.g., electrical safety, optical radiation hazards), and comparison to the predicate device's established safety and effectiveness.
The sample size for the training set:
- Not applicable. No "training set" in the context of machine learning or clinical study data was used.
How the ground truth for the training set was established:
- Not applicable.

In summary, this document demonstrates substantial equivalence for a medical device by comparing its design, intended use, and technical specifications to those of a legally marketed predicate device, and by showing compliance with relevant safety and performance standards. It is not a clinical study assessing diagnostic performance or AI effectiveness.

Summary

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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

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MAH 2 2 201

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K123587

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

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

Benoit St. Jean US Agent (Contact): 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 mini3000® LED Ophthalmoscope Ophthalmoscope

Classification of the device:

Device Classification Name:	O
Product Code:	H
Device Classification No.:	P
Panel:	O
Regulatory Status:	C

Ophthalmoscope HLJ Part 886.1570 Ophthalmic Devices (86) Class II

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Image /page/1/Picture/0 description: The image shows the word "HEINE" in bold, black letters. The letters are all capitalized and evenly spaced. The font appears to be sans-serif.

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ので、その他の出来ないという。この日、この時間を使いたとき、出来、も

Device Description:

Intended Use:

Predicate Device:

Device Trade Name:	Piccolight® E50
Applicant:	Kirchner & Wilhelm GmbH & CO. KG
510(k) No.:	K070270

The HEINE mini3000® LED Ophthalmoscope is considered substantial equivalent to the Piccolight® E50 Ophthalmoscope (K070270). There is no significant difference in intended use or technology.

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HEIME

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	HEINE mini3000® LED Ophthalmoscope	Piccolight® E50	Assessment
Intended Use	The HEINE mini3000® LED Ophthalmoscope isa battery powered hand-held device for medicalprofessionals, containing illumination andviewing optics intended to examine the media(cornea, aqueous, lens, vitreous) and the retinaof the eye.	The Piccolight® E50 ophthalmoscope isintended to be used to examine the cornea,aqueous, lens, vitreous and retina of the eye.	same
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 ina specific distance to the eye.	same
Illumination type	LED	Halogen filament bulb	refer tojustification 1
Exposure parameters	Emission of a white LED	Emission of 2.5 V halogen bulb	refer tojustification 1
Light output	542 lux	46 lux	refer tojustification 1
Filter	Red free filter	none	refer tojustification 2
Service life ofIlluminant	50.000 hours	approx. 15 hours	refer tojustification 3
Diopters	+ 20D to -20D	+ 20D to -20D	same
Lens power viewingOptics	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
Light apertures	small circle D = 13,8 mmlarge circle D = 27,3 mmsemicirclemedium circle with reticle D = 3,1 mm	Large circle D = 24,00 mm	refer tojustification 4
Supply voltage	2.5 V	2.5 V	same
Power sources	2 alkaline cells (size LR6/AA) /HEINE mini 2Z rechargeable battery	Battery	refer tojustification 5
Brightness controls
Maximumtemperature of partsof the device held bythe operator oraccessible to thepatient	none	Complies with IEC 60601-1 for temperaturesof external surfaces and controls3	same
Flammability ofmaterials	Low probability. All measures have been takento use self-extinguishing materials. The systemis illuminated using a 3W LED lamp and allmaterials used in the vicinity are speciallydesigned to safely operate in high temperatureenvironments.	Fiber-glass reinforced plastic Polyamide 6GF30C	same
Cleaning andDisinfection	CleaningCleaning or disinfection by spraying orimmersion as well as sterilization is not allowedand will damage the instrument!	CleaningIn order to avoid dirt accumulation and dustalways store the unit in the packaging. Theoutside of the unit can be cleaned with adamp, soft and fluff-free fabric. Fordisinfection, a fabric moistened with alcoholcan be used. If necessary, the pane of theobservation window can be cleaned with acotton plug and some alcohol. Please do notpress the pane! Never bring theophthalmoscope into contact with liquid andmake sure that no liquid penetrates thehousing!	same
	Instrument headThe housing can be wiped clean with a dampedcloth. Glass surfaces can be cleaned with acotton wool.
	Battery handleThe handle can be cleaned with a damp cloth(e.g. alkaline or pH- neutral detergent).
	DisinfectionThe instrument head and handle can bedisinfected with CIDEX® OPA by wiping it witha soft cloth moistened with disinfectant for 5minutes.	Since the ophthalmoscope is not desired foroperations, simple cleaning and/ordisinfection with a surface disinfectant on analcoholic base is sufficient. Do not use anyscrubbing cleaning agents! The unit cannotbe sterilized	same

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HEINE

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HEINE

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. . . ..

Note 1: Measurements taken 200 mm from output (direct ophthalmoscopes), large circle apertureNote 2: All power sources comply with the relevant standard of IEC 60601-1 and IEC 60601-1-2.Note 3: Chapter 11 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.
Justification 1The HEINE mini3000® LED Ophthalmoscope complies with requirements for group 2 instrument of ISO 15004-2:2007.
Justification 2The Red free filter is used to enhance the contrast of the fundus image. Diagnosis is even possible without it, but may take longer. Thusthe Red-free filter does not influence the safety and effectiveness compared to the predicate device.
Justification 3The minimum lifetime of the used LED in the HEINE mini3000® LED Ophthalmoscope is 50.000 hours. Assuming the use of the LED for acontinuous period of 10 hours at 220 working days a year, this would calculate to 22 years of use. Thus does not influence theeffectiveness and safety compared to the predicate device.
Justification 4Offering several apertures with different diameters gives the examiner more flexibility to adjust the instrument to the examined eye. Thusdoes not influence the effectiveness and safety compared to the predicate device.
Justification 5The predicate device uses the same battery type as the HEINE mini3000® LED Ophthalmoscope. In addition, a rechargeable battery isavailable for the HEINE mini3000® LED Ophthalmoscope. Thus does not influence the effectiveness and safety compared to the predicatedevice.

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HEINE

, 2014/04/20 10:00:00 ID: 00/08/2019 10:00 ID: 00/08/2019 10:00 ID: 00/0

Summary of Non-Clinical Performance Testing:

The HEINE mini 3000® LED 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® LED 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

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March 22, 2013

Public Health Service

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

HEINE Optotechnik GmbH & Co. KG % Mr. Alexander Schapovalov TUV America, Inc. 1775 Old Highway 8 NW, Suite 104 New Brighton, MN 55112

Re: K123587

Trade Name: HEINE mini3000® LED Ophthalmoscope Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: HLJ Dated: March 5, 2013 Received: March 7, 2013

Dear Mr. Schapovalov:

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.

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Page 2 – Mr. Alexander Schapovalov

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,

Image /page/7/Picture/7 description: The image shows the text "Deborah L. Falls - S FDA". The text is in a simple, sans-serif font and is arranged in a single line. The letters "FDA" are stylized with a geometric pattern.

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: K123587

Device Name:HEINE mini 3000® Ophthalmoscope

Indications For Use:

Prescription Use_ X

AND/OR

Over-The-Counter Use_

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

P(LEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dexiu-Shi

Digitally signed by Dexiu Shi -S
DN: c=US, o=U.S. Government,
ou=HHS, ou=FDA, ou=People,
cn=Dexiu Shi -S,
0.9.2342.19200300.100.1.1=130
0157347/
Date: 2013:03:15 16:45:33
-04'00'

(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices

510(k) Number_K123587

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.