(57 days)
The SPECTRALIS is a non-contact ophthalmic diagnostic imaging device. It is intended for viewing the posterior segment of the eye, including two- and three-dimensional imaging, cross-sectional imaging (SPECTRALIS HRA+OCT and SPECTRALIS OCT), fundus photography, fluorescence imaging (fluorescein angiography, indocyanine green angiography; SPECTRALIS HRA+OCT, SPECTRALIS HRA), autofluorescence imaging (SPECTRALIS HRA+OCT, SPECTRALIS HRA and SPECTRALIS OCT with BluePeak) and to perform measurements of ocular anatomy and ocular lesions. The device is indicated as an aid in the detection and management of various ocular diseases, including age-related macular degeneration, macular edema, diabetic retinopathy, retinal and choroidal vascular diseases, glaucoma, and for viewing geographic atrophy as well as changes in the eye that result from neurodegenerative diseases. The SPECTRALIS HRA+OCT and SPECTRALIS OCT include reference databases for retinal nerve fiber layer thickness and optic nerve head neuroretinal rim parameter measurements, which are used to quantitatively compare the retinal nerve fiber layer and neuroretinal rim in the human retina to values found in normal subjects.
The Heidelberg Engineering SPECTRALIS HRA+OCT is a device used to image the anterior and posterior segments of the human eye and to aid in the assessment and management of various diseases of the posterior segment, such as age-related macular degeneration, diabetic retinopathy, and glaucoma. The device is capable of acquiring infrared and blue reflectance images (K101223), as well as a composite color image referred to as "MultiColor image" due to addition of a green laser light source (K121993). New reference data for peripapillary retinal nerve fiber layer thickness and optic nerve head parameters have been added in K152205, as well as two (2) new accessory objective lenses (Wide Field, Ultra-Widefield), and OCT Enhanced Depth Imaging mode.
The modifications to the SPECTRALIS are:
- OCT2 Module (OCT2) replacement of the Line Scan Camera and PC interface. OCT2 was developed due to the discontinuation of components.
- Wide Field Objective 2 (WFO2) The WFO provides a 55° diameter circular field of view. The field of view can be reduced by the software to 35° and 25°. The AR-coating of the WFO was optimized in order to reduce the remaining reflections at the MultiColor wavelengths 486 nm. 518 nm and 815 nm. The AR-coating also allows for MultiColor imaging.
- An upgrade to the data and patient management system (Heyex 2). Heyex 2 has the same basic functionality as the data and patient management system of the cleared SPECTRALIS, Heyex 1. The main improvements of Heyex 2 compared to Heyex 1 are an up-to-date and more scalable underlying image database, and a modern User Interface.
- Windows 10 Operating System support.
- Labeling The user manual has been updated to (1) improve clarity, (2) improve grammar and (3) include the modifications made to the SPECTRALIS HRA+OCT and variants. The Intended Use/Indications for Use of the modified device, as described in the labeling has not changed as a result of the modifications.
This FDA 510(k) summary does not contain information about a study that assesses a device's performance against specific acceptance criteria. Instead, it details modifications made to an existing device (SPECTRALIS HRA+OCT and variants) and argues for its substantial equivalence to a previously cleared predicate device (K152205).
The document's primary argument is that the modifications (OCT2 Module replacement, Wide Field Objective 2, Heyex 2 software upgrade, Windows 10 support, and labeling updates) do not change the intended use, indications for use, or fundamental scientific technology of the device. Therefore, no new clinical studies demonstrating performance against acceptance criteria are presented.
Here's a breakdown of why the requested information cannot be fully provided from this document:
- Acceptance Criteria & Reported Performance: No specific acceptance criteria or performance metrics (like sensitivity, specificity, accuracy) are defined or reported. The document focuses on demonstrating that the modified device functions similarly to its predicate.
- Sample Sizes (Test/Training) & Data Provenance: No test or training sets are mentioned, as this is not a study assessing new clinical performance.
- Expert Ground Truth & Adjudication: These concepts are relevant to clinical performance studies, which are not detailed here.
- MRMC Comparative Effectiveness Study: There is no mention of a comparative effectiveness study, with or without AI assistance, as AI is not a component of this device as described.
- Standalone Performance: The document doesn't describe a 'standalone' performance study in the context of an algorithm's diagnostic accuracy. It's about ensuring the modified hardware and software components maintain the proven functionality of the predicate.
- Type of Ground Truth: Not applicable, as no performance study is being presented.
- Training Set Sample Size & Ground Truth: Not applicable, as no machine learning algorithm is being trained for diagnostic purposes in this context.
In essence, this 510(k) submission relies on the concept of substantial equivalence, where the modified device is deemed safe and effective because its changes are minor and do not alter its fundamental nature or intended use compared to a device already cleared by the FDA. The "study" here is more accurately described as a technical and risk assessment to confirm that the modifications do not negatively impact the device's established safety and effectiveness.
The "Non-Clinical Performance Summary" section mentions evaluations against recognized consensus standards (ISO 14971, AAMI/ANSI ES60601-1, IEC 60601-1-2, ISO 10993 series, IEC 60825-1, and AAMI/ANSI/IEC 62304). These standards cover aspects like:
- Risk management (ISO 14971)
- Medical electrical equipment safety (AAMI / ANSI ES60601-1)
- Electromagnetic compatibility (IEC 60601-1-2)
- Biocompatibility (ISO 10993 series)
- Laser product safety (IEC 60825-1)
- Medical device software lifecycle processes (AAMI / ANSI / IEC 62304)
Meeting these standards serves as the "acceptance criteria" for the non-clinical aspects of the device's modifications, ensuring that the new components and software continue to meet established safety and quality requirements. However, these are not tied to specific diagnostic performance metrics (e.g., sensitivity/specificity for disease detection) because the device's core diagnostic capabilities are considered unchanged from the predicate.
§ 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.