(160 days)
This instrument is designed for examination of the eye.
BETA handles are designed exclusively for use with medical examination instruments with bulb illumination.
The HEINE BETA 200® Ophthalmoscope is a battery powered hand-held device to provide illumination and viewing optics in order to examine the retina of a patient's eye. It consists of an instrument head and a battery handle that can be attached to the instrument head.
Here's an analysis of the provided text regarding the HEINE BETA 200® Ophthalmoscope, focusing on acceptance criteria and supporting studies:
Acceptance Criteria and Device Performance
The provided 510(k) summary does not outline specific, quantified acceptance criteria for performance; instead, it demonstrates substantial equivalence to a predicate device (HEINE mini 3000® LED Ophthalmoscope) mainly through comparisons of design, intended use, and technical specifications. The general acceptance criterion seems to be that the new device performs at least equivalently or acceptably based on known standards for ophthalmoscopes.
The focus is on demonstrating that the new device (HEINE BETA 200® Ophthalmoscope) does not introduce new safety or effectiveness concerns compared to the predicate. Therefore, the "reported device performance" is largely presented in the context of these comparative characteristics rather than discrete pass/fail metrics.
Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Predicate Device (HEINE mini 3000® LED) | New Device (HEINE BETA 200®) | Assessment (Implied Acceptance) |
|---|---|---|---|
| Intended Use | Examination of media (cornea, aqueous, lens, vitreous) and retina of the eye by medical professionals. | Examination of media (cornea, aqueous, lens, vitreous) and retina of the eye by medical professionals. | Same (Substantially Equivalent) |
| Type | Monocular | Monocular | Same (Substantially Equivalent) |
| Method of Operation | 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 (Substantially Equivalent) |
| Illumination Type | LED | Halogen filament bulb | Different (Justified as acceptable, see Note 3 below) |
| Exposure Parameters | Emission of a white LED | Emission of 2.5 V + 3,5V halogen bulb | Different (Justified as acceptable, see Note 3 below) |
| Light Output (at 200mm) | 542 lux | 505 lux (2,5V) / 1180 lux (3,5V) | Different (Justified as acceptable, see Note 3 below) |
| Filter | Red free filter | Blue, Red free (Green) | Same (additional filter in new device is an enhancement) |
| Service Life of Illuminant | Unlimited | approx. 45 hours | Different (Considered acceptable for a halogen bulb) |
| Diopters | + 20D to -20D | + 40D to -35D | Different (New device offers wider range, an enhancement) |
| Lens power viewing optics | Specific steps within +20D to -20D range. | Specific steps within +40D to -35D range. | Different (New device offers wider range, an enhancement) |
| Light Apertures | Slit, fixation star with polar coordinates, cobalt blue filter, large spot, small spot, hemispot, with red-free filter. | Slit, medium circle with reticle, cobalt blue filter, large circle, small circle, hemispot, additional Red Free filter. | Equivalent (Predicate lists general types, new device lists specific sizes. Overall functionality is equivalent.) |
| Correction Lens Adjustable | Yes | Yes | Same (Substantially Equivalent) |
| Supply Voltage | 2.5 V | 2.5 V / 3,5 V | Equivalent (New device offers 2 options) |
| Power Sources | 2 alkaline cells (size LR6/AA) / HEINE mini 2Z rechargeable battery | 2 (2,5V) or 3 (3,5V) alkaline cells (size LR6/AA) | Equivalent (Both battery powered, meet standards) |
| Brightness Controls | none | Rotary potentiometer (dimming rheostat) | Equivalent (New device offers control, which is an enhancement) |
| Max temperature of parts | Complies with IEC 60601-1 for temperatures of external surfaces and controls. | Complies with IEC 60601-1 for temperatures of external surfaces and controls. | Equivalent (Standard compliance) |
| Flammability of materials | Low probability. All measures have been taken to use self-extinguishing materials. System illuminated using 3W LED lamp. | Low probability. All measures have been taken to use self-extinguishing materials. System illuminated using Halogen bulb. Materials designed for high temp environments. | Equivalent (Measures taken to ensure safety) |
| Optical Radiation Hazard | Assumed to comply with ISO 10942 based on predicate's marketing. | Tested according to "Ophthalmoscope Guidance" in respect to optical radiation hazard with ophthalmoscopes (ISO 10942). Specific test report mentioned (E256178-A18-CB-1). | Complies (Demonstrated by testing) |
| Fundamental Requirements | Assumed to comply with ISO 15004-2 based on predicate's marketing. | Tested in accordance with applicable requirements of ISO 15004-2. | Complies (Demonstrated by testing) |
Note 3 Explanation for Differences in Illumination (from text):
a) LED color temperature is constant with changing battery voltage; halogen changes. This implies LED is superior in color consistency.
b) Color reproduction of LED (4000K) is comparable to halogen. This indicates that despite different technologies, the outcome in terms of color is equivalent.
c) XHL (halogen in new device) has lower light output than LED, but maximum exposure time is specified in instructions for use. This mitigates potential safety concerns due to light intensity.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily describes a desk-based substantial equivalence comparison against a predicate device and non-clinical performance testing (bench testing). It does not mention a clinical study with a "test set" of patients or data in the way an AI/software device would generally have.
The compliance testing against ISO standards (ISO 10942, ISO 15004-2) would involve testing individual devices or components, but details of sample sizes for these tests are not provided in this summary. The data provenance is implied to be from internal HEINE Optotechnik testing (Germany).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as the submission is for a hardware ophthalmoscope and relies on a substantial equivalence claim and non-clinical testing, not a study requiring expert-established ground truth on clinical images or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as there is no clinical study involving human readers or a test set requiring adjudication in the context of this 510(k) submission.
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
An MRMC comparative effectiveness study was not done. This 510(k) is for a hardware medical device (an ophthalmoscope), not an AI-powered diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study was not done. This is a hardware device; there is no a standalone "algorithm" to evaluate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically applied to AI or diagnostic imaging software is not applicable here. For this hardware device, the "ground truth" for its performance is established by its adherence to specified technical parameters, functionality, and compliance with recognized international standards (ISO 10942, ISO 15004-2, IEC 60601-1). These standards set benchmarks for device output (e.g., light intensity), safety (e.g., temperature), and performance characteristics.
8. The sample size for the training set
This information is not applicable as there is no AI algorithm or software being trained. The device is a traditional hardware ophthalmoscope.
9. How the ground truth for the training set was established
This information is not applicable as there is no AI algorithm or software being trained, and thus no training set or ground truth for it.
§ 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.