(253 days)
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.
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.
This document describes the HEINE mini 3000® Ophthalmoscope and its compliance with relevant standards. Here's a breakdown of the requested information based on the provided text:
Acceptance Criteria and Device Performance
The device's acceptance criteria are based on safety limits for optical radiation hazards as defined by the "Ophthalmoscope Guidance" (ISO 10942) and "Ophthalmic instruments - Fundamental requirements and test methods" (ISO 15004-2). The study demonstrates that the HEINE mini 3000® Ophthalmoscope meets these safety requirements.
Table of Acceptance Criteria and Reported Device Performance:
| Parameter | Test Specification | Wavelength | Acceptance Limit (Group 2) | Reported Device Performance | Verdict |
|---|---|---|---|---|---|
| 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 nm | 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 nm | 1 J cm⁻² (t < 1000 s) | 0.019 µW cm⁻² | PASS |
| Unweighted corneal and lenticular infrared, EIR-CL | The corneal irradiance shall be evaluated by averaging the 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). | 770 - 2500 nm | 100 mW cm⁻² | 1.65 µW cm⁻² | PASS |
| Unweighted anterior segment visible and infrared, EVIR-AS, HVIR-AS | The unweighted anterior segment irradiance shall be evaluated by averaging the highest localized radiation power incident upon a circular area at the corneal plane with a diameter of 0.5 mm (2.0 x 10⁻³ cm²). | 380 - 1200 nm | 20 W cm⁻² | Not applicable | PASS |
| Weighted retinal radiance, Li, A-R | Measurements of radiance shall be the radiant power detectable through a 7 mm diameter aperture at the cornea and shall be averaged over a right circular cone field-of-view of 0.011 rad. However, if the instrument is designed to be used with an eye that is immobilized, a field-of-view of 0.001 75 rad shall be used instead of the 0.011 rad field-of-view. | 305 - 700 nm | 100 J cm⁻² sr⁻¹ | 11 mrad: 1216 mW cm⁻² sr⁻¹1.75 mrad: 2124 mW cm⁻² sr⁻¹ | PASS |
| Weighted retinal visible and infrared thermal radiance, LVIR-R | In the expression for the limit value, under normal intended use conditions, dr, expressed in millimetres, is the minimum retinal image diameter of the source based on the standard eye (see Annex D for instructions on the way to determine the value of dr). If the calculated value of dr is greater than 1.7 mm, the value 1.7 mm shall be used for dr. If the calculated value of dr is less than 0.03 mm, the value of 0.03 mm shall be used for dr. Measurements of radiance shall be the radiant power detectable through a 7 mm diameter aperture at the cornea and shall be averaged over a right circular cone field-of-view of 0.001 75 rad. | 380 - 1400 nm | 29.4 W cm⁻² sr⁻¹ | 1.75 mrad: 19.9 W cm⁻² sr⁻¹ | PASS |
Study Proving Device Meets Acceptance Criteria
The study conducted to prove the device meets the acceptance criteria is a Summary of Non-Clinical Performance Testing. This involved bench testing according to specific international standards.
1. Sample sized used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as this is non-clinical bench testing of the device itself, not a study involving human subjects or data sets. The testing focuses on the physical properties and emissions of a single device or device type.
- Data Provenance: The testing was conducted by Seibersdorf Laboratories in Germany (indicated by the report date "11.06.2013" and the "Issued by Seibersdorf Laboratories" line). This is non-clinical, prospective testing on the physical device.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is not a study requiring expert readers or interpretation of medical images. The ground truth is established by the specified international standards and measurement protocols, conducted by the testing laboratory.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study requiring adjudication of expert opinions. The measurements directly compare device performance against defined safety limits in established standards.
4. 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:
- Not applicable. This document describes a medical device (ophthalmoscope) and its safety compliance, not an AI-powered diagnostic system.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm. The testing is a standalone assessment of the device's physical properties.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth is defined by the safety limits and test specifications set forth in the international standards ISO 10942 and ISO 15004-2. These are established engineering and medical device safety standards.
7. The sample size for the training set:
- Not applicable. This is not a machine learning or AI-based device, so there is no "training set."
8. How the ground truth for the training set was established:
- Not applicable. As there is no training set, this question is not relevant.
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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. KGKientalstr. 782211 HerrschingGermany |
|---|---|
| Registration Number: | 1000379039 |
| Owner/Operator Number: | 9003020 |
| Official Contact Person: | Mr. Manfred Bartsch-TittmannDirector Regulatory AffairsHEINE Optotechnik GmbH & Co. KG82211 Herrsching, GermanyPhone: +49 8152 38 0 |
| US Agent (Contact): | Benoit St. JeanHEINE USA, Itd.10 Innovation WayDover, NH 03820 USAPhone: +1 603 7427217E-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
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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:-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 mmlarge circle D = 27,3 mmsemicirclemedium circle with reticle D = 23,1 mm | small circle D = 13,8 mmlarge circle D = 27,3 mmsemicirclemedium 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(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 cornealandlenticular UV, ES-CL, HS-CL | The corneal radiant exposure shallbe evaluated by averaginghighest localized radiation powerincident upon a circular area atthe corneal plane with a diameter of1 mm (7,9 x 10-3 cm²). | 250 - 400 | 3mJ cm-2 | 0,008µW cm-2 | PASS |
| Unweightedcorneal andlenticular UV,EUV-CL,HUV-CL | The corneal radiant exposure shallbe evaluated by averaginghighest localized radiation powerincident upon a circular area atthe corneal plane with a diameter of1 mm (7,9 x 10-3 cm²). | 360 - 400 | 1 J cm-2(t < 1000 s) | 0,019µW cm-2 | PASS |
| Unweightedcorneal andlenticular infrared,EIR-CL | The corneal irradiance shall beevaluated by averaging the highestlocalized radiation power incidentupon a circular area at thecorneal plane with a diameter of 1mm (7,9 x 10-3 cm²). | 770 - 2500 | 100mW cm-2 | 1,65µW cm-2 | PASS |
| Unweightedanteriorsegment visibleandinfrared, EVIR-AS,HVIR-AS | The unweighted anterior segmentirradiance shall be evaluated byaveraging the highest localizedradiation power incident upon acircular area at the corneal planewith a diameter of 0,5 mm(2,0 x 10-3 cm²). | 380 - 1200 | 20W cm-2 | Not applicable | PASS |
| Weighted retinalradiance, Li, A-R | Measurements of radiance shall bethe radiant power detectablethrough a 7 mm diameter aperture atthe cornea and shall beaveraged over a right circular conefield-of-view of 0,011 rad.However, if the instrument isdesigned to be used with an eye thatis immobilized, a field-of-view of0,001 75 rad shall be used insteadof the 0,011 rad field-of-view. | 305 - 700 | 100J cm-2 sr-1 | 11 mrad: 1216mW cm-2 sr-11,75 mrad:2124 mW cm-2sr-1 | PASS |
Bench Test Table 3:
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| Parameter | Test specification | Wavelength | Limit Group 2 | Test result | Verdict |
|---|---|---|---|---|---|
| Weighted retinalvisibleand infraredthermalradiance, LVIR-R | In the expression for the limit value,under normal intended useconditions, dr, expressed inmillimetres, is the minimum retinalimage diameter of the source basedon the standard eye(see Annex D for instructions on theway to determine the value ofdr). If the calculated value of dr isgreater than 1,7 mm, the value1,7 mm shall be used for dr. If thecalculated value of dr is less than0,03 mm, the value of 0,03 mm shallbe used for dr.Measurements of radiance shall bethe radiant power detectablethrough a 7 mm diameter aperture atthe cornea and shall beaveraged over a right circular conefield-of-view of 0,001 75 rad. | 380 - 1400 | 29,4¹W cm⁻² sr⁻¹ | 1,75 mrad; 19,9W 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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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'
§ 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.