HEINE MINI 3000(R) OPHTHALMOSCOPE

K131959 · Heine Optotechnik GmbH & Co. KG · HLJ · Mar 7, 2014 · Ophthalmic

Device Facts

• Record ID: K131959
• Device Name: HEINE MINI 3000(R) OPHTHALMOSCOPE
• Applicant: Heine Optotechnik GmbH & Co. KG
• Product Code: HLJ · Ophthalmic
• Decision Date: Mar 7, 2014
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 886.1570
• Device Class: Class 2

Intended 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.

Device Story

HEINE mini 3000 Ophthalmoscope is a battery-powered, hand-held diagnostic instrument; used by medical professionals in clinical settings. Device provides illumination and viewing optics to visualize ocular media and retina. Input: manual operation by clinician; light from 2.5V halogen filament bulb. Output: visual examination of patient eye. Clinician views retina through instrument head; adjustable correction lens (+20D to -20D) allows for refractive compensation. Device aids in ocular health assessment and diagnosis of retinal conditions. Power source: replaceable AA batteries or rechargeable battery via HEINE mini NT charger.

Clinical Evidence

Bench testing only. Device tested for optical radiation safety per ISO 10942 and ISO 15004-2 standards. Results confirm compliance with Group 2 limits for weighted retinal radiance and thermal radiance. No clinical data presented.

Technological Characteristics

Hand-held ophthalmoscope; 2.5V halogen filament bulb; battery-powered (2x AA or rechargeable); adjustable lens range +20D to -20D; monocular viewing; includes red-free filter and multiple aperture sizes (small, large, semicircle, medium with reticle). Complies with IEC 60601-1 for surface temperatures and ISO 15004-2/ISO 10942 for optical radiation safety.

Indications for Use

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

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

• HEINE mini 3000 LED (K123587)

Submission Summary (Full Text)

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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<br>Kientalstr. 7<br>82211 Herrsching<br>Germany |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Registration Number: | 1000379039 |
| Owner/Operator Number: | 9003020 |
| Official Contact Person: | Mr. Manfred Bartsch-Tittmann<br>Director Regulatory Affairs<br>HEINE Optotechnik GmbH & Co. KG<br>82211 Herrsching, Germany<br>Phone: [phone] |
| US Agent (Contact): | Benoit St. Jean<br>HEINE USA, Itd.<br>10 Innovation Way<br>Dover, NH 03820 USA<br>Phone: [phone]<br>E-mail: [e-mail] |
| Date Prepared: | February, 2nd 2014 |
| Device(s) Identification:<br>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

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#### 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.

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| 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:<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 | |
| small circle D = 13,8 mm<br>large circle D = 27,3 mm<br>semicircle<br>medium circle with reticle D = 23,1 mm | small circle D = 13,8 mm<br>large circle D = 27,3 mm<br>semicircle<br>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 |

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## 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<br>(Risk group classification) | 18b |
| ISO 10942 | ISO 10942_mini3000XHL_Ophth | 18c |

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# 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 | Limit Group 2 | Test result | Verdict |
|-----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|--------------------------|---------------------------------------------------------------------|---------|
| Weighted corneal<br>and<br>lenticular UV, ES-<br>CL, HS-CL | The corneal radiant exposure shall<br>be evaluated by averaging<br>highest localized radiation power<br>incident upon a circular area at<br>the corneal plane with a diameter of<br>1 mm (7,9 x 10-3 cm²). | 250 - 400 | 3<br>mJ cm-2 | 0,008<br>µW cm-2 | PASS |
| Unweighted<br>corneal and<br>lenticular UV,<br>EUV-CL,<br>HUV-CL | The corneal radiant exposure shall<br>be evaluated by averaging<br>highest localized radiation power<br>incident upon a circular area at<br>the corneal plane with a diameter of<br>1 mm (7,9 x 10-3 cm²). | 360 - 400 | 1 J cm-2<br>(t < 1000 s) | 0,019<br>µW cm-2 | PASS |
| Unweighted<br>corneal and<br>lenticular infrared,<br>EIR-CL | The corneal irradiance shall be<br>evaluated by averaging the highest<br>localized radiation power incident<br>upon a circular area at the<br>corneal plane with a diameter of 1<br>mm (7,9 x 10-3 cm²). | 770 - 2500 | 100<br>mW cm-2 | 1,65<br>µW cm-2 | PASS |
| Unweighted<br>anterior<br>segment visible<br>and<br>infrared, EVIR-AS,<br>HVIR-AS | The unweighted anterior segment<br>irradiance shall be evaluated by<br>averaging the highest localized<br>radiation power incident upon a<br>circular area at the corneal plane<br>with a diameter of 0,5 mm<br>(2,0 x 10-3 cm²). | 380 - 1200 | 20<br>W cm-2 | Not applicable | PASS |
| Weighted retinal<br>radiance, Li, A-R | Measurements of radiance shall be<br>the radiant power detectable<br>through a 7 mm diameter aperture at<br>the cornea and shall be<br>averaged over a right circular cone<br>field-of-view of 0,011 rad.<br>However, if the instrument is<br>designed to be used with an eye that<br>is immobilized, a field-of-view of<br>0,001 75 rad shall be used instead<br>of the 0,011 rad field-of-view. | 305 - 700 | 100<br>J cm-2 sr-1 | 11 mrad: 1216<br>mW cm-2 sr-1<br>1,75 mrad:<br>2124 mW cm-2<br>sr-1 | PASS |

Bench Test Table 3:

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| Parameter | Test specification | Wavelength | Limit Group 2 | Test result | Verdict |
|----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|----------------------|--------------------------------|---------|
| Weighted retinal<br>visible<br>and infrared<br>thermal<br>radiance, LVIR-R | In the expression for the limit value,<br>under normal intended use<br>conditions, dr, expressed in<br>millimetres, is the minimum retinal<br>image diameter of the source based<br>on the standard eye<br>(see Annex D for instructions on the<br>way to determine the value of<br>dr). If the calculated value of dr is<br>greater than 1,7 mm, the value<br>1,7 mm shall be used for dr. If the<br>calculated value of dr is less than<br>0,03 mm, the value of 0,03 mm shall<br>be used for dr.<br>Measurements of radiance shall be<br>the radiant power detectable<br>through a 7 mm diameter aperture at<br>the cornea and shall be<br>averaged over a right circular cone<br>field-of-view of 0,001 75 rad. | 380 - 1400 | 29,4¹<br>W cm⁻² sr⁻¹ | 1,75 mrad; 19,9<br>W cm⁻² sr⁻¹ | PASS |

*) = 20 mrad (worst case assumption)

## Summary:

.

The HEINE mini3000® Ophthalmoscope fulfills the requirements according to EN ISO 15004-2:2007, group 2.

The HEINE mini3000® Ophthalmoscope is safe and effective.

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Public Health Service

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

March 7, 2014 ·

HEINE Optotechnik GmbH & Co. KG c/o Ms. Belinda Labourdette Executive Assistant 10 Innovation Way Dover, NH 03820

Re: K131959

Trade/Device Name: HEINE Mini 30000 Ophthalmoscope Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: HLJ Dated: January 28, 2014 Received: February 4, 2014

Dear Ms. Labourdette:

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 - Ms. Belinda Labourdette

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 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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] 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.goy/MedicalDevices/Safetv/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.

# 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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510(k) number (if known): K131959

Device Name: HEINE mini 3000® Ophthalmoscope

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.

AND/OR Over-The-Counter Use Prescription Use × (Part 21 CFR 801 Subpart D) (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)

Marsha L.
Burke Nicholas
-S
Digitally signed by Marsha L. Bu
Nicholas -S
DN: c=US, o=U.S. Government,
ou=HHS, ou=FDA, ou=People,
0.9.2342.19200300.100.1.1-130
022, cn=Marsha L. Burke Nichol
Date: 2014.03.04 13:53:46 -05'00

Digitally signed by Marsha L. Burke Nicholas -S DN: c=US, o=U.S. Government, 0.9.2342.19200300.100.1.1=1300014 022, cn=Marsha L. Burke Nicholas -S Date: 2014.03.04 13:53:46 -05'00'