SPECTRALIS HRA+OCT and variants

• K Number: K223557
• Device Name: SPECTRALIS HRA+OCT and variants
• Manufacturer: Heidelberg Engineering GmbH
• Date Cleared: 2023-10-20 ( 329 days)
• Product Code: OBO , CLA , MYC
• Regulation Number: 886.1570
• Type: Traditional
• Panel: OP
• Reference & Predicate Devices: K201252

Intended Use

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 imaging
• · fluorescence imaging (fluorescein angiography, indocyanine green angiography; SPECTRALIS HRA+OCT, SPECTRALIS HRA)
• · autofluorescence imaging (SPECTRALIS HRA+OCT, SPECTRALIS HRA and SPECTRALIS OCT with BluePeak)
• · performing 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

The device is indicated for viewing geographic atrophy.

The SPECTRALIS OCT Angiography Module is indicated as an aid in the visualization of vascular structures of the retina and choroid.

The SPECTRALIS HRA+OCT and SPECTRALIS OCT include the following reference databases:

• · a retinal nerve fiber layer thickness reference database, which is used to quantitatively compare the retinal nerve fiber layer in the human retina to values of Caucasian normal subjects – the classification result being valid only for Caucasian subjects
• · a reference database for retinal nerve fiber layer thickness and optic nerve head neuroretinal rim parameter measurements, which is used to quantitatively compare the retinal nerve fiber layer and neuroretinal rim in the human retina to values of normal subjects of different races and ethnicities representing the population mix of the USA (Glaucoma Module Premium Edition)

Device Description

The Heidelberg Engineering SPECTRALIS HRA+OCT is a device used to image the anterior and posterior segments of the human eye. The SPECTRALIS HRA+OCT is a combination of a confocal laser-scanning ophthalmoscope (cSLO, the HRA portion) and a spectral-domain optical coherence tomographer (SD-OCT). The confocal laserscanning part of the device allows for acquisition of reflectance images (with blue, green or infrared light), conventional angiography images (using fluorescein or indocyanine green dye) and autofluorescence images. The different imaging modes can be used either alone or simultaneously. The SD-OCT part of the device acquires cross-sectional and volume images, together with an HRA cSLO image.

A blue laser is used for fluorescein angiography, autofluorescence imaging, and blue reflectance imaging, and two infrared lasers are used for indocyanine green angiography and infrared reflectance imaging. A green laser is used for MultiColor imaging ("composite color images"). MultiColor imaging is the simultaneous acquisition of infrared, green and blue reflectance images that can be viewed separately or as a composite color image. For SD-OCT imaging, an infrared superluminescent diode and a spectral interferometer are used to create the cross-sectional images.

The following changes have been applied to the device subject of this 510(k):

• Widefield Reflectance mode for artifacts suppression
• Regression analysis in Glaucoma Module Premium Edition
• Thunderbolt 3 interface
• Thunderbolt cable fan
• Process separation of acquisition software module
• Windows 11 Support

AI/ML Overview

The provided text describes a 510(k) summary for the SPECTRALIS HRA+OCT and variants, which is a non-contact ophthalmic diagnostic imaging device. It does not contain information about acceptance criteria or a specific study proving the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device (K201252) through non-clinical performance testing and a comparison of technological characteristics.

Therefore, I cannot provide the requested table and information based on the given text.

Here's what the document does provide regarding non-clinical performance testing:

Non-Clinical Performance Testing:

The modified SPECTRALIS device underwent non-clinical performance testing to ensure its safety and efficacy. This testing was guided by several FDA-recognized consensus standards:

• ISO 14971: 2019: Medical Devices - Application of Risk Management to Medical Devices.
• AAMI / ANSI ES 60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 Edition 3.1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
• IEC 60601-1-2 Edition 4.0 2014-02: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
• IEC 62304 Edition 1.1 2015-06: Medical Device Software Software Life Cycle Processes.

The testing found that the device met the requirements of these applicable standards, demonstrating that the safety and efficacy of the modified device are comparable to the predicate.

Additionally, the following documentation was provided and verification/validation conducted:

• Software documentation, verification, and validation: Conducted as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
• Cybersecurity documentation: Submitted as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices".

Changes from the Predicate Device:

The modifications to the device since its previous clearance (K201252) include:

• Widefield Reflectance mode for artifact suppression.
• Regression analysis in Glaucoma Module Premium Edition.
• Thunderbolt 3 interface.
• Thunderbolt cable fan.
• Process separation of acquisition software module.
• Windows 11 Support.

The document explicitly states: "No data from human clinical studies has been included to support the substantial equivalence of the modified SPECTRALIS HRA+OCT and variants with the cleared SPECTRALIS device (K201252)." This indicates that a clinical study with acceptance criteria for device performance as typically understood (e.g., sensitivity, specificity, accuracy against a ground truth) was not performed or provided in this submission to support these specific modifications. The substantial equivalence is based on the claim that these modifications do not change the fundamental technology, acquired images, patient populations, or aid to clinical evaluation, and are supported by non-clinical verification.

Regulation Number and Section

§ 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.