HEINE MINI 3000 LED OPHTHALMOSCOPE

K123587 · Heine Optotechnik GmbH & Co. KG · HLJ · Mar 22, 2013 · Ophthalmic

Device Facts

• Record ID: K123587
• Device Name: HEINE MINI 3000 LED OPHTHALMOSCOPE
• Applicant: Heine Optotechnik GmbH & Co. KG
• Product Code: HLJ · Ophthalmic
• Decision Date: Mar 22, 2013
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 886.1570
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

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 Story

The HEINE mini 3000® LED Ophthalmoscope is a handheld, battery-powered monocular device used by medical professionals to examine the eye's media and retina. It consists of an instrument head and a battery handle (powered by AA batteries or a rechargeable option). The device provides illumination via a 3W LED lamp and viewing optics with adjustable diopters (+20D to -20D) and multiple apertures. The examiner holds the device at a specific distance from the patient's eye to visualize the fundus. The device includes a red-free filter to enhance contrast. It is a non-invasive diagnostic tool used in clinical settings to assist in ocular examinations. No software or automated analysis is involved.

Clinical Evidence

Bench testing only. Testing included optical radiation hazard assessment per ISO 10942 and fundamental requirements/test methods per ISO 15004-2. No clinical data was required or provided.

Technological Characteristics

Handheld monocular ophthalmoscope; 3W LED illumination; 2.5V supply voltage (AA batteries or rechargeable); diopter range +20D to -20D; multiple apertures (small, large, semicircle, medium with reticle); red-free filter; self-extinguishing materials; non-sterile; no software.

Indications for Use

Indicated for medical professionals to examine the media (cornea, aqueous, lens, vitreous) and retina of the eye in patients.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Piccolight® E50 (K070270)

Submission Summary (Full Text)

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HEINE Optotechnik GmbH & Co. KG · Kientalstr. 7 · 82211 Herrsching · Germany Tel. [phone] · Fax [phone] · E-Mail: [e-mail] · www.heine.com

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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: [phone]

Benoit St. Jean US Agent (Contact): HEINE USA, Itd. 10 Innovation Way Dover, NH 03820 USA Phone: [phone] E-mail: [e-mail]

## 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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## 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.

### Intended Use:

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.

## 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 is<br>a battery powered hand-held device for medical<br>professionals, containing illumination and<br>viewing optics intended to examine the media<br>(cornea, aqueous, lens, vitreous) and the retina<br>of the eye. | The Piccolight® E50 ophthalmoscope is<br>intended to be used to examine the cornea,<br>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 a<br>specific distance to the eye. | Used to examine the retina by an examiner in<br>a specific distance to the eye. | same |
| Illumination type | LED | Halogen filament bulb | refer to<br>justification 1 |
| Exposure parameters | Emission of a white LED | Emission of 2.5 V halogen bulb | refer to<br>justification 1 |
| Light output | 542 lux | 46 lux | refer to<br>justification 1 |
| Filter | Red free filter | none | refer to<br>justification 2 |
| Service life of<br>Illuminant | 50.000 hours | approx. 15 hours | refer to<br>justification 3 |
| Diopters | + 20D to -20D | + 20D to -20D | same |
| Lens power viewing<br>Optics | Diopter of used lens in steps:<br>-20, -15, -10, -8, -6, -4,-3, -2, -1,<br>0, 1, 2, 3, 4, 6, 8, 10, 15, 20 | Diopter of used lens in steps:<br>-20, -15, -10, -8, -6, -4,-3, -2, -1,<br>0, 1, 2, 3, 4, 6, 8, 10, 15, 20 | same |
| Light apertures | small circle D = 13,8 mm<br>large circle D = 27,3 mm<br>semicircle<br>medium circle with reticle D = 3,1 mm | Large circle D = 24,00 mm | refer to<br>justification 4 |
| Supply voltage | 2.5 V | 2.5 V | same |
| Power sources | 2 alkaline cells (size LR6/AA) /<br>HEINE mini 2Z rechargeable battery | Battery | refer to<br>justification 5 |
| Brightness controls | | | |
| Maximum<br>temperature of parts<br>of the device held by<br>the operator or<br>accessible to the<br>patient | none | Complies with IEC 60601-1 for temperatures<br>of external surfaces and controls3 | same |
| Flammability of<br>materials | Low probability. All measures have been taken<br>to use self-extinguishing materials. The system<br>is illuminated using a 3W LED lamp and all<br>materials used in the vicinity are specially<br>designed to safely operate in high temperature<br>environments. | Fiber-glass reinforced plastic Polyamide 6<br>GF30C | same |
| Cleaning and<br>Disinfection | Cleaning<br>Cleaning or disinfection by spraying or<br>immersion as well as sterilization is not allowed<br>and will damage the instrument! | Cleaning<br>In order to avoid dirt accumulation and dust<br>always store the unit in the packaging. The<br>outside of the unit can be cleaned with a<br>damp, soft and fluff-free fabric. For<br>disinfection, a fabric moistened with alcohol<br>can be used. If necessary, the pane of the<br>observation window can be cleaned with a<br>cotton plug and some alcohol. Please do not<br>press the pane! Never bring the<br>ophthalmoscope into contact with liquid and<br>make sure that no liquid penetrates the<br>housing! | same |
| | Instrument head<br>The housing can be wiped clean with a damped<br>cloth. Glass surfaces can be cleaned with a<br>cotton wool. | | |
| | Battery handle<br>The handle can be cleaned with a damp cloth<br>(e.g. alkaline or pH- neutral detergent). | | |
| | Disinfection<br>The instrument head and handle can be<br>disinfected with CIDEX® OPA by wiping it with<br>a soft cloth moistened with disinfectant for 5<br>minutes. | Since the ophthalmoscope is not desired for<br>operations, simple cleaning and/or<br>disinfection with a surface disinfectant on an<br>alcoholic base is sufficient. Do not use any<br>scrubbing cleaning agents! The unit cannot<br>be 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 aperture<br>Note 2: All power sources comply with the relevant standard of IEC 60601-1 and IEC 60601-1-2.<br>Note 3: Chapter 11 of this submission contains the corresponding test report No. E256178-A18-CB-1. Please refer to clause 42 of test<br>report E256178-A18-CB-1 for further details. |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Justification 1<br>The HEINE mini3000® LED Ophthalmoscope complies with requirements for group 2 instrument of ISO 15004-2:2007. |
| Justification 2<br>The Red free filter is used to enhance the contrast of the fundus image. Diagnosis is even possible without it, but may take longer. Thus<br>the Red-free filter does not influence the safety and effectiveness compared to the predicate device. |
| Justification 3<br>The minimum lifetime of the used LED in the HEINE mini3000® LED Ophthalmoscope is 50.000 hours. Assuming the use of the LED for a<br>continuous period of 10 hours at 220 working days a year, this would calculate to 22 years of use. Thus does not influence the<br>effectiveness and safety compared to the predicate device. |
| Justification 4<br>Offering several apertures with different diameters gives the examiner more flexibility to adjust the instrument to the examined eye. Thus<br>does not influence the effectiveness and safety compared to the predicate device. |
| Justification 5<br>The predicate device uses the same battery type as the HEINE mini3000® LED Ophthalmoscope. In addition, a rechargeable battery is<br>available for the HEINE mini3000® LED Ophthalmoscope. Thus does not influence the effectiveness and safety compared to the predicate<br>device. |

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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

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

#### 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 [phone] or [phone] 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:

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.

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