(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.
§ 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.