(124 days)
The indirect ophthalmoscope HEINE OMEGA® 500 is an AC-powered or battery powered 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 OMEGA® 500 is an indirect ophthalmoscope, worn on the user's head to provide illumination and viewing optics in order to examine the retina of a patient's eve. The ophthalmoscope can be operated either by rechargeable battery or directly by mains power supply. The HEINE OMEGA® 500 allows wireless comfortable movement for the user and mobile charging (depending on chosen power source).
The provided document is a 510(k) summary for the HEINE OMEGA® 500 indirect ophthalmoscope. This type of submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance criteria through clinical studies. Therefore, the information regarding acceptance criteria and performance studies in the traditional sense of a clinical trial (e.g., sample size, expert reader qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment) is not present.
However, the document does provide information that can be interpreted as demonstrating the device meets certain performance expectations by showing its similarity to already cleared predicate devices. The "acceptance criteria" here are effectively the characteristics and performance levels of the predicate devices which the HEINE OMEGA® 500 aims to match or justify as equivalent.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission uses a comparative table to demonstrate substantial equivalence to predicate devices across various technical and safety parameters. The "Acceptance Criteria" for the HEINE OMEGA® 500 are implied by the characteristics of the predicate devices, and the "Reported Device Performance" is the stated characteristic of the HEINE OMEGA® 500.
| Acceptance Criteria (from predicate devices) | HEINE OMEGA® 500 Reported Performance | Assessment (relative to predicates) |
|---|---|---|
| Intended Use: Examine media (cornea, aqueous, lens, vitreous) and retina of the eye. | Examine media (cornea, aqueous, lens, vitreous) and retina of the eye. | Same |
| Method of Operation: Examine retina by an examiner in a specified distance to the eye. | Examine retina by an examiner in a specified distance to the eye. | Same |
| Technology: Two main elements: Illumination and Viewing. | Two main elements: Illumination and Viewing. | Same |
| Type/Design: Indirect ophthalmoscope, Binocular (Headband mounted). | Indirect ophthalmoscope, Binocular (Headband mounted). | Same |
| Exposure Parameter (Light Output, max): Ranging from 600 lx (Welch Allyn) to 913 lx (NEITZ). | 507 lx (max.) / 258 lx (max.). | Justification 1: Lower but deemed sufficient (see below). |
| Min. Irradiance (for retinal imaging): Ranging from 54.87 mW/cm² (Keeler LED) to 22.10 mW/cm² (Welch Allyn LED) for LED, or 26.53 mW/cm² (NEITZ Halogen). | LED: 8.81 mW/cm². | Justification 1: Lower but deemed sufficient (see below). |
| Max. Irradiance (for retinal imaging): Ranging from 423.29 mW/cm² (Welch Allyn Halogen) to 597.66 mW/cm² (NEITZ LED). | LED: 323.54 mW/cm². Halogen: 465.77 mW/cm². | Justification 1: Lower but deemed sufficient (see below). |
| Selectable Filter: Blue, red-free, diffuser (Keeler); Cobalt blue, red-free (NEITZ); Cobalt blue, yellow, red-free, diffusor (Welch Allyn). | Blue, yellow, red-free, diffuser. | Same (offers similar range of filters). |
| Power Sources: Various battery and mains options. | Wireless battery pack mPack, Wall mounted unit, Belt battery pack. | Similar array of power sources. |
| Biocompatibility: No contact to the patient. | No contact to the patient. | Same |
| Material: Aluminum, Leather, Brass, Steel, Plastics. | Aluminum, Leather, Brass, Steel, Plastics. | Same |
| Standard for Electrical Safety: Complies with IEC 60601-1 (or equivalent). | Complies with IEC 60601-1. | Same |
| Flammability of materials: Use of self-extinguishing materials (HB or V-0 UL94). | Uses self-extinguishing materials (HB or V-0 UL94). | Same |
| Performance based on Ophthalmoscope Guidance for industry and ISO 10943: Fulfilled. | Fulfilled. | Same |
| Illumination: White LED (Keeler, Welch Allyn), Xenon Halogen (Keeler, NEITZ). | White LED, 6V; 4.65V, 12 Watt Halogen bulb (implicitly, by offering LED or XHL Xenon Halogen lamp options). | Similar illumination sources. |
| Light aperturesNote1: Ranges (e.g., 23-68mm for Keeler). | Small circle: 18 mm, Middle circle: 39 mm, Large circle: 74 mm. | Refer to Justification 2: Slightly smaller "small circle" diameter, but does not affect safety/effectiveness. |
| Interpupillary distance adjustment: Ranges (e.g., 48-76mm for Keeler). | 46 - 74 mm. | Refer to Justification 3: Allows smaller IPD, does not affect safety/effectiveness. |
| Data collection and/or display system: None. | None. | Same |
| Lens power viewing optics: +2 diopter. | +2 diopter. | Same (for available info). |
| Brightness controls: Control dial. | Control dial. | Same |
| Maximum temperature of parts of the device: Complies with IEC 60601-1 (or equivalent). | Complies with IEC 60601-1. | Same |
| Cleaning/Disinfection Methods: Manual cleaning, no autoclaving. | Manual cleaning methods specified. No autoclaving allowed. | Same |
Justification for differences (Justification 1, 2, 3):
- Justification 1 (Light Output/Irradiance): The HEINE OMEGA® 500 has lower maximum light output (lx) and retinal irradiance (mW/cm²) compared to some predicate devices. The justification argues that this lower output is acceptable because:
- The FDA guidance advises using the minimal brightness needed for visualization.
- Lower levels allow for longer exposure durations and reduce potential ocular damage.
- Referenced literature ([12b]) suggests a minimum retinal irradiance of 6.3 mW/cm² is needed for viewing human fundi. The HEINE OMEGA® 500's measured irradiance (323.54 mW/cm² for LED and 465.77 mW/cm² for Halogen) is significantly higher than this minimum (51-74 times higher).
- Therefore, the lower light output is considered safe and effective, and the device is equivalent.
- Justification 2 (Light apertures): The HEINE OMEGA® 500 has a slightly smaller "small circle" diameter for light apertures compared to the NEITZ IO-a. This difference is stated not to affect the safety or effectiveness of the device.
- Justification 3 (Interpupillary distance adjustment): The HEINE OMEGA® 500 allows for a smaller minimum interpupillary distance (46 mm) compared to predicate devices, benefiting users with eyes that are close together. This is stated not to affect the safety or effectiveness of the device.
2. Sample size used for the test set and the data provenance
Not applicable. This is a 510(k) submission based on substantial equivalence, not a clinical study involving a test set of patient data to evaluate algorithmic performance. The "testing" referred to is non-clinical performance and safety testing (e.g., electrical safety, optical radiation hazard).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth was established by experts for a test set in the context of this 510(k) submission.
4. Adjudication method for the test set
Not applicable. No test set requiring adjudication was used.
5. 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 device is an ophthalmoscope, a diagnostic instrument that is directly used by a medical professional. It does not incorporate AI or provide assistance to human readers in the way an AI-powered image analysis tool would. Therefore, an MRMC comparative effectiveness study regarding AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The HEINE OMEGA® 500 is a physical medical device, an indirect ophthalmoscope, and does not have an "algorithm-only" or "AI" component to be evaluated in standalone performance.
7. The type of ground truth used
Not applicable in the context of a clinical performance study. The "ground truth" here is the established performance and safety characteristics of the predicate devices and relevant industry standards (e.g., IEC 60601-1, ISO 10943). The device's compliance with these standards and its similarity to predicate performance data are the basis for equivalence.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device requiring a training set.
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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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FEB 2 6 2013
Image /page/0/Picture/4 description: The image shows a logo with a triangle shape. Inside the triangle, there is a stylized letter 'S' that forms a snake-like shape. The word 'HEINE' is written in a stylized font across the base of the 'S' and the triangle. The logo appears to be a company or brand identifier.
510(k) 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 Correspondent:
Mr. Jörg Rönnau Director Regulatory Affairs HEINE Optotechnik GmbH & Co. KG 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:
Common Name:
September 3rd, 2012
Device(s) Identification: Device Trade Name:
HEINE OMEGA® 500 Indirect ophthalmoscope
Classification of the device:
Device Classification Name: Product Code: Device Classification No.: Panel: Regulatory Status:
Ophthalmoscope HLI (AC) and HLJ (DC) Part 886.1570 Ophthalmic Devices (86) Class II
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Image /page/1/Picture/1 description: The image shows a logo for Heine. The logo is a triangle with a snake wrapped around a staff inside of it. The word "HEINE" is written in a stylized font across the middle of the triangle.
Device Description:
The HEINE OMEGA® 500 is an indirect ophthalmoscope, worn on the user's head to provide illumination and viewing optics in order to examine the retina of a patient's eve. The ophthalmoscope can be operated either by rechargeable battery or directly by mains power supply.
The HEINE OMEGA® 500 allows wireless comfortable movement for the user and mobile charging (depending on chosen power source).
Intended Use:
The indirect Ophthalmoscope HEINE OMEGA® 500 is an AC-powered or battery powered 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 devices: |
|---|
| Device Trade Name:Vantage Plus Binocular Indirect Ophthalmoscope |
| Applicant:Keeler Instruments Inc. |
| 510(k) No.:K060822 |
| Device Trade Name:NEITZ Binocular Indirect Ophthalmoscope IO-A |
| Applicant:NEITZ Instruments Company, Ltd. |
| 510(k) No.:K942712 |
| Device Trade Name:Model #12000 Binocular Indirect Ophthalmoscope |
| Applicant:Welch Allyn, Inc. |
| 510(k) No.:K930023 |
The HEINE OMEGA 500 is considered substantial equivalent to the Vantage Plus Binocular Indirect Ophthalmoscope (K060822), NEITZ Binocular Indirect Ophthalmoscope IO-A (K942712) and Welch Allyn Model #12000 Binocular Indirect Ophthalmoscope (K930023).
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| And and the coupling of the state of program with are and the second of the10 1 1 18 1882 1974 1991 1991 1992 1992 1991 1991 19 11 |
| 510(k) applied(predicatedevices) | HEINE OMEGA 500 | Keeler Vantage Plus | NEITZ IO-a LED | Welch Allyn Model #12000 | Assessment |
|---|---|---|---|---|---|
| Indication foruse | New device, for which a510(k) is applied | 510(k) Number:K060822 | 510(k) Number:K942713 | 510(k) Number:K930023 | same |
| The indirect OphthalmoscopeHEINE OMEGA® 500 is anAC-powered or batterypowered device for medicalprofessionals, containingillumination and viewing opticsintended to examine themedia (cornea, aqueous, lens,vitreous) and the retina of theeye | The Keeler Vantage PlusIndirect Ophthalmoscope isintended to be used toexamine the Cornea,aqueous, lens vitreous andretina of the eye. | An ophthalmoscope is anAC-powered or battery-powered device containingillumination and viewingoptics intended to examinethe media (cornea, aqueous,lens, and vitreous) and theretina of the eye. | An ophthalmoscope is anAC-powered or battery-powered device containingillumination and viewingoptics intended to examinethe media (cornea, aqueous,lens, and vitreous) and theretina of the eye. | same | |
| Source: Instructions for use | Source: 510(k) K060822 | Source: 510(k) K942713,Regulation Number:886.1570 | Source: 510(k) K930023,Regulation Number:886.1570 | ||
| Method ofoperation | Used to examine the retina byan examiner in a specifieddistance to the eye | Used to examine the retinaby an examiner in a specifieddistance to the eye | Used to examine the retinaby an examiner in a specifieddistance to the eye | Used to examine the retinaby an examiner in a specifieddistance to the eye | same |
| Technology | The HEINE OMEGA 500indirect ophthalmoscope hastwo main elements:1. The illuminationelement2. The viewing element | The Keeler Vantage Plus,indirect ophthalmoscope hastwo main elements:1. The illuminationelement2. The viewing element | The Neitz IO-a LED indirectophthalmoscope has twomain elements:1. The illuminationelement2. The viewing element | The Welch Allyn Model#12000 indirectophthalmoscope has twomain elements:1. The illuminationelement2. The viewing element | same |
| Type / Design | indirect ophthalmoscopeBinocular (Headbandmounted)Permanent | indirect ophthalmoscopeBinocular (Headbandmounted)Permanent | indirect ophthalmoscopeBinocular (Headbandmounted)Not available | indirect ophthalmoscopeBinocular (Headbandmounted)Not available | same |
| ExposureParameter | |||||
| SafetyInfrared Filter(IR Blocker) |
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HEINE
HEIME
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| HEINE OMEGA 500 | Keeler Vantage Plus | NEITZ IO-a LED | Welch Allyn Model #12000 | Assessment | |||
|---|---|---|---|---|---|---|---|
| Selectable filter | Blue, yellow, red-free, diffuser | Blue, red-free, diffuser | Cobalt blue, red-free | Cobalt blue, yellow, red-free, diffusorInformation not available | same | ||
| ExposureParameterEnergyDelivered(Light Output) | 507 lx (max.) 258 lx (max.) | 901 lx (max.) | 913 lx (max.) | 600 lx (max.) | refer tojustification 1) | ||
| Measured in adistance of 500 mm | |||||||
| min. Irradiance(for retinalimaging) | LED$8,81 mW/cm^2$ | LED$54,87 mW/cm^2$ | Halogen$26,53 mW/cm^2$ | LED$22,10 mW/cm^2$ | Information not available | refer tojustification 1) | |
| max. Irradiance(for retinalimaging) | LED$323,54 mW/cm^2$ | Halogen$465,77 mW/cm^2$ | LED$597,66 mW/cm^2$ | Halogen$423:29 mW/cm^2$ | LED$515,03 mW/cm^2$ | Information not available | refer tojustification 1) |
| Power sources(Energy used) | Wireless battery pack mPackunplugged:Nominal voltage: 7.4V1850mAhWall mounted unit(EN50 mPack/EN50)Mains voltage: 100-240VacBelt battery pack (mPack):Nominal voltage: 7.2V4200mAH | Wireless battery pack(Standard Lithium battery):Nominal voltage: 7.4V1800mAhWall packInput mains data: 100-240VacBelt battery pack (Smartpack):Nominal voltage: 7.2V 2500mAh | Wireless battery pack (sameas 2400RD): nominalvoltage: 2.4 V min. 1900mAhNot availableBelt battery pack (2400RD)Nominal voltage: 2.4V min.1900mAH | Not AvailableWall/Desk Power Source:Input: 96-130VacBelt battery pack (PortablePower Source): nominalvoltage: 4.8V 1800mAh | same | ||
| Biocompatibility | No contact to the patient | No contact to the patient | No contact to the patient | No contact to the patient | same | ||
| Material | AluminumLeatherBrassSteelPlastics | AluminumLeatherBrassSteelPlastics | AluminumLeatherBrassSteelPlasticsInformation not available | AluminumBrassSteelPlastics | same | ||
| Standard forelectrical safety | Complies with IEC 60601-1 | Complies with BS EN ISO60601-1 | Information not available | Complies with IEC 601-1 | same | ||
| HEINE OMEGA 500 | Keeler Vantage Plus | NEITZ IO-a LED | Welch Allyn Model #12000 | Assessment | |||
| Flammability of materials | Low probability. All measures have been taken to use self-extinguishing materials which are either of flame classification HB or V-0 (UL94). The system is illuminated using a LED or 5W XHL Xenon Halogen 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 which are either of flame classification HB or V-0 (UL94). The system is illuminated using a LED and all materials used in the vicinity are specially designed to safely operate in high temperature environments. | not available | not available | same | ||
| Performance based on Ophthalmo-scope Guidance for industry and ISO 10943 | Fulfilled, refer to 510(k) chapter 18c | Fulfilled | Fulfilled | Fulfilled | same | ||
| Illumination | White LED, 6V | White Xenon Halogen LED, 6V bulb | 6V, 5 Watt Xenon filament bulb | White LED | 4,65V, 12 Watt Halogen bulb | same | |
| Light aperturesNote1 | Small circle: 18 mmMiddle circle: 39 mmLarge circle: 74 mm | 23 mm51 mm68 mm | 19 mm50 mm80 mm | 20 mm50 mm80 mm | refer to justification 2) | ||
| Inter pupillary distance adjustment | 46 - 74 mm | 48 - 76 mm | 54 - 74 mm | 49 - 74 mm | refer to justification 3) | ||
| Data collection and/or display system | None | None | None | None | same | ||
| Lens power viewing optics | +2 diopter | +2 diopter | not available | +2 diopter | same | ||
| Brightness controls | Control dial | Control dial | Control dial | Control dial | same |
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| HEINE OMEGA 500 | Keeler Vantage Plus | NEITZ IO-a LED | Welch Allyn Model #12000 | Assessment | |
|---|---|---|---|---|---|
| Maximum temperature of parts of the device held by the operator or accessible to the patient Product viewsNote2 | Complies with IEC 60601-1 | Complies with BS EN ISO 60601-1 | Information not available | Complies with IEC 601-1 | same |
| Total view | Image: HEINE OMEGA 500 Total view | Image: Keeler Vantage Plus Total view | Image: NEITZ IO-a LED Total view | Image: Welch Allyn Model #12000 Total view | same |
| Operator's view | Image: HEINE OMEGA 500 Operator's view | Image: Keeler Vantage Plus Operator's view | Image: NEITZ IO-a LED Operator's view | Image: Welch Allyn Model #12000 Operator's view | |
| Left side | Image: HEINE OMEGA 500 Left side | Image: Keeler Vantage Plus Left side | Image: NEITZ IO-a LED Left side | Image: Welch Allyn Model #12000 Left side | |
| Backside of the headband | Image: HEINE OMEGA 500 Backside of the headband | Image: Keeler Vantage Plus Backside of the headband | Image: NEITZ IO-a LED Backside of the headband | Image: Welch Allyn Model #12000 Backside of the headband | |
| HEINE OMEGA 500 | Keeler Vantage Plus | NEITZ IO-a LED | Welch Allyn Model #12000 | Assessment | |
| Cleaning | Before cleaning, disconnect from thepower source.The instrument and the loupe may bewiped clean with a non-sheddingdamp or dry cloth.Wipe the headband with a clean,absorbent, non-shedding clothdampened with a water/detergentsolution (2% by volume). Ensure thatexcess solution does not enter theinstrument. Use caution to ensurecloth is not saturated with solution.The XHL / LED lamp can be cleaned,with a dry cloth if necessary. | Only manual non-immersioncleaning as described below shouldbe used for the instrument. Do notautoclave or immerse in cleaningfluids. Always disconnect powersupply from source before cleaning.Wipe external surface with a cleanabsorbent, non-shedding clothdampened with a water/detergentsolution (2% by volume) orwater/isopropyl alcohol solution(70% by volume).Ensure that excess solution does notenter the instrument. Use caution toensure cloth is not saturated withsolution.Surfaces should be carefully handdried using a clean non sheddingcloth.Safely dispose of used cleaningmaterials. | The newly adopted Head Pad of WetSuit Material secures the durablewearing of the head band and theutmost comfort. This Washablematerial is ideal for keeping yourinstrument neat and clean in use. | The glass cover on the front of theBIO, the glass lenses in the ocularsand the teaching mirror can becleaned with a soft cloth moistenedwith alcohol. The leather cushionson the headband may be removedand wiped with soapy water. Theremainder of the BIO may be wipedwith a soft cloth that has beenmoistened in alcohol. Avoid usingharsh cleaning fluids or cloth whichare excessively moist on any part ofthis instrument. | same |
| Disinfection | The instrument headband can bedisinfected with CIDEX® OPA bywiping it with a soft cloth moistenedwith disinfectant for 5 minutes.The use of a spray disinfectant andsoaking or disinfection in a machine isnot permitted.Sterilisation of OMEGA® 500 is notallowed | Do not autoclave or immerse incleaning fluids.No further information denoted | no information denoted | no information denoted | same |
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| Note 1: | The measurements are taken from 500 mm in front of the instrument. |
|---|---|
| Note 2: | Assessment concerning safety statements |
| Justification 1: | The light output values stated in the table above are the maximum possible values of the devices. The light output value of each device is adjustable from a minimum level up to 100% by an integrated control dial. |
| The FDA Guidance of Industry "Ophthalmoscope Guidance" advises the manufacturer to provide the following information to the user: "[...] the brightness setting should not exceed what is needed to provide clear visualization of the target structures. [...]". This reflects the market experience of HEINE that doctors accept or even prefer using low levels of illumination. Moreover, these low levels provide the advantage of longer exposure durations until the limits of radiation hazards are reached. Therefore, the probability of ocular damage is less in comparison to exposures with higher illumination. The high light output of the Keeler device was also discussed critically in [12a]. | |
| The "minimum retinal irradiance required for viewing human fundi in indirect ophthalmoscopy" is discussed in [12b]. The authors concluded "... that the minimum retinal irradiance needed for viewing human fundi is less than... 6,3mW/cm²)". | |
| To determine the maximum retinal irradiance of the HEINE OMEGA 500 we set the brightness control of our device to the maximum level in the same way as we did for the determination of exposure parameter in the comparison table above. Then we determined the irradiance according to the test method published in [12c]. | |
| The measured retinal irradiance of HEINE OMEGA 500 ophthalmoscopes is 323,54 mW/cm² (approximately 51 times higher than the required minimum level) for the device equipped with LED illumination and 465,77 mW/cm² (approximately 74 times higher than the required minimum level) for the device equipped with XHL Xenon Halogen Bulb. [12d] | |
| The irradiance of 323,54 mW/cm² of the HEINE OMEGA 500 with LED is lower than the irradiance of the predicate devices. However as indicated [12b] a minimum retinal irradiance of 6,3 mW/cm² is needed for viewing the human fundi. Taking into account these facts we believe, that the light output level of the HEINE OMEGA 500 does not affect the safety or the effectiveness of the device compared to the predicate devices. We regard our device as equivalent. | |
| The different ratios between the measured exposure parameters for the energy delivered (Light Output) measured in lux and the Min and Max. Irradiance measured in mW/cm² can be explained by the following facts: | |
| 1. The lux (symbol: lx) is the Sl unit of illuminance and luminous emittance, measuring luminous flux per unit area. It is equal to one lumen per square meter. In photometry, this is used as a measure of the intensity, as perceived by the human eye, of light that hits or passes through a surface. It is analogous to the radiometric unit watts per square meter, but with the power at each wavelength weighted according to the luminosity function, a standardized model of human visual brightness perception. In English, "lux" is used in both singular and plural. | |
| 2. The Irradiance is a physical parameter measured in "mW/cm²" solely based on physical parameters without human visual brightness perception. Therefore there is no direct correlation between the values measured in lux and the values measured in "mW/cm²" because the lux values depend heavily on the wavelength of the light whereby the Irradiance measures the power of the light in "mW/cm²" without human visual brightness perception. Both values are measured values and therefore calculations can't be provided. | |
| References: | |
| [12a] | Kossol J, Cole C, Dayhaw-Barker P.: "Spectral irradiances of and maximal permissible exposures to two indirect ophthalmoscopes" in Am J Optom Physiol Opt. 1983 Jul;60(7):616-21 |
| [12b] | Rockefeller S. L. Young, Morton F. Goldberg, Gerald A. Fishman: "Letter to the editor" in Investigative Ophthalmology & Visual Science, Volume 20, Number 4, May 1981 |
| [12c] | Joseph L. Calkins and Bernard F. Hochmeier: "Retinal light exposure from ophthalmoscopes, slit lamps, and overhead surgical lamps" in Investigative |
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| [12d] | Ophthalmology & Visual Science, Volume 19, Number 9, September 1980Test report - Estimation of irradiance in the retinal plane of HEINE OMEGA 500 indirect ophthalmoscope", Version 1.0, 2012-10-18; HEINEOptotechnik |
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| Justification 2:Different patients have different anatomical pupil sizes. Therefore the possibility of adjustment of the light apertures of binocular indirect ophthalmoscopesenables the user of the device to adjust the diameter of the illuminated spot individually to the patient's eye. The HEINE OMEGA® 500 offers a slightly smallerdiameter of the "small circle" than the NEITZ IO-a. The differences between the new device and the predicate devices do not affect the safety or effectivenessof the device and we regard our device as equivalent to the predicate devices | |
| Justification 3:The interpupillary distance adjustment of binocular indirect ophthalmoscopes allows the individual user of the device to match the distance of the oculars to theinterpupillary distance of his eyes to get a singular focused image. The HEINE OMEGA® 500 provides the possibility to adjust the smallest inter pupillarydistance of 46 mm. This enables users with eyes that are close together to get an optimal view through the instrument. This does not affect the safety oreffectiveness of the device and we regard our device as equivalent to the predicate devices. |
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Labeling on the products:
HEINE OMEGA 500
Image /page/9/Picture/4 description: The image shows a head-mounted binocular indirect ophthalmoscope. The device is black and has a head strap that goes around the user's head. There are two eyepieces that the user looks through, and a light source that shines into the patient's eye. The ophthalmoscope is used to examine the retina and other structures of the eye.
total view from behind
Image /page/9/Picture/6 description: The image shows a close-up of a binocular indirect ophthalmoscope. The device is black and has two eyepieces with adjustable interpupillary distance. The manufacturer's name, "HEINE," and the country of origin, "GERMANY," are printed on the device. The serial number, "SN11200026728," is also visible.
operator's view
Image /page/9/Picture/8 description: The image shows a close-up of a piece of equipment, possibly a camera or some other type of device. The equipment is mostly gray and black in color. The device has a number of different parts, including a lens, a viewfinder, and a number of buttons and dials. The equipment appears to be in good condition and is well-maintained.
view from the left
Image /page/9/Picture/10 description: The image shows a close-up of a black, padded object. The object has a V-shaped design in the center, and it is surrounded by a black frame. The frame has several openings, and the object appears to be made of a soft material.
backside of the headband
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Image /page/10/Picture/1 description: The image shows a gray triangle with a white border. Inside the triangle is a white symbol that resembles a stylized letter "S" with a lightning bolt running through it. Below the symbol, the word "HEINE" is written in white, block letters. The logo appears to be for a company or organization, possibly in the medical or electrical field.
Keeler Vantage Plus
Image /page/10/Picture/3 description: The image shows a close-up of a piece of equipment, possibly a measuring tool or a component of a larger machine. The device has a dark gray or black color and features a rectangular body with the word "VANTAGE" printed on it. The equipment also has a T-shaped base with two white buttons visible on the front.
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total view
Image /page/10/Picture/5 description: The image shows a close-up of a head-mounted surgical headlight. The headlight is attached to a black headband. The light source is rectangular and has a lens on the left side. There is a knob on the side of the light source that is used to adjust the focus of the light.
operator's view
Image /page/10/Picture/7 description: The image shows a Keeler brand head-mounted binocular indirect ophthalmoscope. The ophthalmoscope is black and silver, and it is mounted on a white headband. The Keeler logo is visible on the headband. The ophthalmoscope is positioned on a white surface, and there are some blurry objects in the background.
view from the left
Image /page/10/Picture/9 description: The image shows a black electronic device with a curved shape and a strap. The device has a small, round component attached to the bottom. The strap is connected to the device on both sides, and it appears to be made of a flexible material.
backside of the headband
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Image /page/11/Picture/0 description: The image shows the word "HEINE" in a bold, sans-serif font. The letters are all capitalized and appear to be a dark gray or black color. The background is a light color, providing contrast to the text.
Image /page/11/Picture/1 description: The image shows the HEINE logo, which is a gray triangle with a white outline. Inside the triangle, there is a white caduceus symbol with the word "HEINE" written in white letters across the middle. The caduceus symbol is a medical symbol that features a staff with two snakes coiled around it.
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Image /page/11/Picture/3 description: The image shows a close-up of a medical device, possibly a head-mounted surgical lamp or similar instrument. The device is gray and has several adjustable components, including a central block with the word "HEINE" printed on it. The lower part of the device has the word "LED" on the left and the number "20-05" on the right.
Image /page/11/Picture/4 description: The image shows a close-up of a gray optical instrument. The instrument has two lenses on the front, with knobs on either side. There are also some numbers and markings on the top of the instrument. The instrument appears to be in good condition.
total view
operator's view
Image /page/11/Picture/7 description: The image shows a close-up of a piece of equipment. The equipment has a boxy shape with a few knobs and buttons on the side. There are also some wires connected to the equipment. The equipment is mounted on a stand, and there is a blurry object in the background.
view from the left
Image /page/11/Picture/9 description: The image shows a piece of equipment with a black control box on top of a black strap. The control box has a knob on top and a white button on the front. There are several wires connected to the control box, and the strap appears to be part of a head-mounted device.
backside of the headband
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Image /page/12/Picture/1 description: The image shows a logo with a triangle shape. Inside the triangle, there is a symbol of a snake winding around a staff, which is a common symbol associated with medicine and healthcare. Below the snake and staff symbol, the word "HEINE" is written in a stylized font. Below the word "HEINE" is another word that is difficult to read due to the image quality.
Summary of Non-Clinical Performance Testing:
The HEINE OMEGA®500 indirect ophthalmoscope is tested according to the "Ophthalmoscope Guidance" in respect to optical radiation hazard with ophthalmoscopes (ISO 10943). 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 OMEGA® 500 is substantially equivalent to the currently legally marketed devices. They do 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/13/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes extending from its back, representing the department's mission to promote health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol. The logo is presented in black and white.
February 26, 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 Sud America, Inc. 1775 Old Highway 8 NW New Brighton, MN 55112-1891
Re: K123316
Trade/Device Name: Heine Omega 500 Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: HLI, HLJ Dated: February 1, 2013 Received: February 11, 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.
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
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Page 2 - Mr. Alexander Schapovalov
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 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,
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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Indications for Use
510(k) number (if known): Device Name: Indications For Use:
HEINE OMEGA® 500
The indirect ophthalmoscope HEINE OMEGA® 500 is an AC-powered or battery powered 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 (part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Kesia Y. Alexander 2013.02.26 174.18:03 305'00'
(Division Sign-Off) Division of Ophthalmic and Ear, Nose, and Throat Devices 510(k) Number: K123316
§ 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.