SPECTRALIS with Flex Module

K241163 · Heidelberg Engineering GmbH · OBO · Oct 11, 2024 · Ophthalmic

Device Facts

• Record ID: K241163
• Device Name: SPECTRALIS with Flex Module
• Applicant: Heidelberg Engineering GmbH
• Product Code: OBO · Ophthalmic
• Decision Date: Oct 11, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1570
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The SPECTRALIS with Flex Module is a non-contact ophthalmic diagnostic imaging device intended to aid in the visualization of the posterior segment structures of the eye and vasculature of the retina and choroid. SPECTRALIS with Flex Module is intended for imaging of adults and pediatric patients in supine position.

Device Story

SPECTRALIS with Flex Module is a non-contact ophthalmic diagnostic imaging device; utilizes confocal laser-scanning ophthalmoscopy (cSLO) and spectral-domain optical coherence tomography (SD-OCT) to visualize posterior segment structures and vasculature of retina and choroid. Device consists of an adjustable camera arm mounted on a wheeled base, allowing imaging of patients in supine position. Operated by clinicians in clinical settings. Input: laser light reflected from ocular tissues; Output: 2D/3D images displayed on PC monitor. Healthcare providers use images to aid in visualization of ocular anatomy and identification of structural/vascular abnormalities. Benefits include ability to image patients unable to sit upright, such as pediatric or unconscious patients. Device shares core imaging engine with tabletop SPECTRALIS (K223557).

Clinical Evidence

Prospective, observational study (S-2018-3) at a single US site (n=76 effectiveness population). Compared SPECTRALIS with Flex to tabletop SPECTRALIS. Primary endpoints: image quality (100% OCT, 100% IR cSLO, 97.2% OCTA rated better than 'Poor') and diagnostic agreement for structural/vascular abnormalities. Agreement rates ≥84.3% for OCT and ≥85.1% for OCTA. Results demonstrate substantial equivalence in image quality, visibility of anatomic structures, and abnormality detection. No adverse events reported.

Technological Characteristics

Confocal scanning laser ophthalmoscope (cSLO) and spectral-domain OCT. Light sources: diode lasers (486-815 nm) and superluminescence diode (840-920 nm). Mobile instrumentation mount with swivel arms. Connectivity: Thunderbolt-3 interface. Software: Windows 10/11. Biocompatibility per ISO 10993. Electrical safety per IEC 60601-1:2020; EMC per IEC 60601-1-2:2020. Laser safety per ANSI Z80.36:2021.

Indications for Use

Indicated for visualization of posterior segment structures and vasculature of retina and choroid in adult and pediatric patients, including those in supine position (conscious or unconscious).

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• SPECTRALIS HRA+OCT and variants (K223557)
• Bioptigen ENVISU Spectral Domain Ophthalmic Imaging System (K120057)

Submission Summary (Full Text)

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October 11, 2024

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

Heidelberg Engineering GmbH % Lena Sattler Consultant Orasi Consulting, LLC. 226 1st Street Bonita Springs, Florida 34134

Re: K241163

Trade/Device Name: SPECTRALIS with Flex Module Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO, MYC Dated: April 26, 2024 Received: April 26, 2024

Dear Lena Sattler:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

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Sincerely,

# Elvin Y. Ng -S

Elvin Ng Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K241163

Device Name SPECTRALIS with Flex Module

### Indications for Use (Describe)

The SPECTRALIS with Flex Module is a non-contact ophthalmic diagnostic imaging device intended to aid in the visualization of the posterior segment structures of the eye and vasculature of the retina and choroid. SPECTRALIS with Flex Module is intended for imaging of adults and pediatric patients in supine position.

Type of Use (Select one or both, as applicable)

| <span></span> | <span></span> Prescription Use (Part 21 CFR 801 Subpart D) |
|---------------|------------------------------------------------------------|
| <span></span> | <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/4/Picture/1 description: The image contains the logo for Heidelberg Engineering. The logo consists of two lines of text, with a red square on either side. The first line reads "HEIDELBERG" and the second line reads "ENGINEERING". The text is in a bold, sans-serif font.

### 510(K) SUMMARY

Date Prepared

September 09, 2024

### SPONSOR/510(K) OWNER/ MANUFACTURER

Heidelberg Engineering GmbH Max-Jarecki-Strasse 8 69115 Heidelberg, Germany Telephone: Facsimile: Email: Establishment Registration No.:

+49 6221 / 64 63 0 +49 6221 / 64 63 62 [e-mail] 8043762

### OFFICIAL CONTACT PERSON

Lena Sattler Orasi Consulting, LLC. 226 1st Street Bonita Springs, FL 34134 Telephone: Facsimile: E-mail:

[phone] [phone] [e-mail]

### COMMON/USUAL NAME

Optical Coherence Tomography

### PROPRIETARY OR TRADE NAMES

SPECTRALIS with Flex Module

### CLASSIFICATION INFORMATION

| Classification Name: | Tomography, Optical Coherence<br>Ophthalmoscope, Laser, Scanning |
|-----------------------|------------------------------------------------------------------|
| Medical Specialty: | Ophthalmic |
| Device Class: | II |
| Classification Panel: | Ophthalmic Device Panel |
| Product Codes: | OBO, MYC |

### PRODUCT CODE: CLASSIFICATION / CFR TITLE

OBO, MYC: Class II § 21 CFR 886.1570

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### PRIMARY PREDICATE DEVICE

SPECTRALIS HRA+OCT and variants (K223557), Heidelberg Engineering GmbH

### SECONDARY PREDICATE DEVICE

Bioptigen ENVISU Spectral Domain Ophthalmic Imaging System (K120057)

### INDICATIONS FOR USE

The SPECTRALIS with Flex Module is a non-contact ophthalmic diagnostic imaging device intended to aid in the visualization of the posterior segment structures of the eye and vasculature of the retina and choroid. SPECTRALIS with Flex Module is intended for imaging of adults and pediatric patients in supine position.

### GENERAL DEVICE DESCRIPTION

The Heidelberg Engineering SPECTRALIS with Flex Module is based on the predicate SPECTRALIS HRA+OCT consisting of an accessory device mount allowing imaging of patients in supine position. The SPECTRALIS with Flex Module is intended for visualization of the posterior segments of the human eye. The SPECTRALIS with Flex Module is using the identical technologies as the predicate SPECTRALIS tabletop configuration (K223557), i.e. it is a combination of a confocal laser-scanning ophthalmoscope (cSLO, the HRA portion) and a spectral-domain optical coherence tomographer (SD-OCT).

### COMPARISON BETWEEN THE SUBJECT AND THE PREDICATE DEVICE

The modifications made to the SPECTRALIS HRA+OCT with the introduction of the optional accessory, the Flex Module do not change the applied technologies (OCT, cSLO) and the imaging modes of SPECTRALIS. The main differences between the SPECTRALIS with Flex Module and the predicate tabletop configuration cleared in K223557 are that the SPECTRALIS with Flex Module is for visualization only and allows imaging of supine patients. The imaging of supine patients expands the patient profile by including patients unable to follow simple instructions (e.g., unconscious, pediatrics). The tabletop SPECTRALIS with headrest requires upright sitting and thus awake patients able to follow simple instructions and provides measurements and includes reference databases.

The application of a non-contact ophthalmic OCT device for imaging of conscious or unconscious pediatrics and adults in supine position is also supported by the secondary predicate device, the Bioptigen ENVISU Imaging System which was cleared in K120057. The Bioptigen ENVISU device consists of a handheld, lightweight camera (scan head) which can be also mounted and provides a mobile cart for the optical engine and power supply. Due to the principle of using a handheld camera the physical dimensions and layout is different for the Bioptigen ENVISU and the subject and predicate SPECTRALIS devices, respectively.

Accordingly, due to its use for imaging supine patients, the mobile Flex Module has a different layout as well as larger dimensions and weight than the fixed camera mount

Heidelberg Engineering

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used for the tabletop. All other components to be used with the SPECTRALIS device are unchanged for the SPECTRALIS with Flex Module and are similar for the Bioptigen ENVISU. The SPECTRALIS with Flex Module uses an identical camera, the same power supply and touch panel as the predicate tabletop SPECTRALIS.

The Substantial Equivalence summary tables below illustrate the comparisons of the subject SPECTRALIS to the predicate devices.

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Image /page/7/Picture/0 description: The image contains the logo for Heidelberg Engineering. The logo consists of two lines of text, with a red square on either side. The first line reads "HEIDELBERG" and the second line reads "ENGINEERING".

### INDICATIONS FOR USE STATEMENT CHART

| Subject Device<br>SPECTRALIS with Flex Module<br>(K241163) | Primary Predicate Device<br>SPECTRALIS<br>(K223557) | Secondary Predicate Device<br>Bioptigen ENVISUTM Spectral<br>Domain Ophthalmic Imaging<br>System (K120057) | Same, similar or<br>different |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| The SPECTRALIS with Flex Module is a non-<br>contact ophthalmic diagnostic imaging device<br>intended to aid in the visualization of the posterior<br>segment structures of the eye and vasculature of<br>the retina and choroid. SPECTRALIS with Flex<br>Module is intended for imaging of adults and<br>pediatric patients in supine position. | The SPECTRALIS is a non-contact ophthalmic<br>diagnostic imaging device. It is intended for:<br>• viewing the posterior segment of the eye,<br>including two- and three-dimensional imaging<br>• cross-sectional imaging (SPECTRALIS<br>HRA+OCT and SPECTRALIS OCT)<br>• fundus imaging<br>• fluorescence imaging (fluorescein<br>angiography, indocyanine green angiography;<br>SPECTRALIS HRA+OCT, SPECTRALIS HRA)<br>• autofluorescence imaging (SPECTRALIS<br>HRA+OCT, SPECTRALIS HRA and<br>SPECTRALIS OCT with BluePeak)<br>• performing measurements of ocular anatomy<br>and ocular lesions.<br>The device is indicated as an aid in the detection<br>and management of various ocular diseases,<br>including:<br>• age-related macular degeneration<br>• macular edema<br>• diabetic retinopathy<br>• retinal and choroidal vascular diseases<br>• glaucoma<br>The device is indicated for viewing geographic<br>atrophy.<br>The SPECTRALIS OCT Angiography Module is<br>indicated as an aid in the visualization of vascular<br>structures of the retina and choroid. The<br>SPECTRALIS HRA+OCT and SPECTRALIS<br>OCT include the following reference databases:<br>• a retinal nerve fiber layer thickness reference | Bioptigen ENVISUTM Spectral Domain<br>Ophthalmic Imaging System (SDOIS) is<br>intended to acquire, process, display and<br>save depth-resolved images of ocular<br>tissue microstructure using Spectral<br>Domain Optical Coherence Tomography<br>(SD-OCT). The ENVISU SDOIS is<br>indicated for use as an aid in the<br>diagnosis of physiologic and pathologic<br>conditions of the eye through non-contact<br>optical imaging. Imaging of the various<br>tissues of the eye is supported through<br>the use of interchangeable lenses. It is<br>indicated for use on patient populations<br>from premature and neonatal infants to<br>adult, and is suitable for patients<br>ambulatory or confined. The system is<br>indicated for use in upright or supine<br>imaging, handheld or mounted, and is<br>suited for imaging patients under<br>anesthesia. | K223557: Different<br>(measurements,<br>upright patients)<br><br>K120057: Similar<br>(visualization only,<br>pediatric and<br>supine patients) |

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### iheidelberg 는! 15/11 1는문! || 16

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

### TECHNOLOGICAL CHARACTERISTICS COMPARISON CHART

| Feature | Subject Device<br>SPECTRALIS with Flex<br>Module | Primary Predicate Device<br>SPECTRALIS<br>(K223557) | Secondary Predicate<br>Device<br>Bioptigen ENVISU Spectral<br>Domain Ophthalmic Imaging<br>System (K120057) | Same, similar or different |
|---------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>classification<br>name | Optical Coherence Tomographer<br>(OCT) | Optical Coherence Tomographer<br>(OCT) | Optical Coherence Tomographer<br>(OCT) | K223557, K120057: Same |
| Technology and<br>optical setup | Confocal Scanning Laser<br>Ophthalmoscope (SLO) and<br>Spectral-Domain Optical<br>Coherence Tomograph (OCT) | Confocal Scanning Laser<br>Ophthalmoscope (SLO) and<br>Spectral-Domain Optical<br>Coherence Tomograph (OCT) | Spectral-Domain Optical<br>Coherence Tomograph (OCT) | K223557: Same<br>K120057: Similar (OCT only) |
| Physical<br>Dimensions | Laser scanning camera: 235 mm x<br>100 mm x 205 mm<br>Weight camera head: 5.6 kg<br>Flex Module:<br>Height 1690 plus 300 swivel range<br>in mm, width 1467 mm maximum<br>Operation panel:<br>170 mm x 185 mm x 100 mm | Laser scanning camera: 235 mm x<br>100 mm x 205 mm<br>Weight camera head: 5.6 kg<br>Camera Mount:<br>470 mm x 325 mm x 550 mm<br>Operation panel:<br>170 mm x 185 mm x 100 mm | OCT Scan head: 170 mm high x 80<br>mm wide x 230 mm long (incl. lens)<br>Scan head weight: 1.6 kg<br>Cart footprint:<br>Height 953 mm alone, 1549 mm with<br>monitor, width 787 mm, depth 559<br>mm | K223557: Different<br>K120057: Different:<br>The Flex Module for supine<br>patients has other<br>dimensions than the<br>predicate tabletop mount with<br>headrest (K223557). The<br>predicate Bioptigen<br>(K120057) is a handheld |
| Feature | Subject Device<br>SPECTRALIS with Flex<br>Module | Primary Predicate Device<br>SPECTRALIS<br>(K223557) | Secondary Predicate<br>Device<br>Bioptigen ENVISU Spectral<br>Domain Ophthalmic Imaging<br>System (K120057) | Same, similar or different |
| | Power supply including<br>spectrometer:<br>180 mm x 335 mm x 165 mm | Power supply including<br>spectrometer: 180 mm x 335mm x<br>165 mm | mountable camera with a<br>mobile cart. | |
| Lights sources<br>and wavelength<br>of light emitted | Near infrared reflectance images:<br>diode laser, 815 nm,<br>Blue light reflectance images: diode<br>laser, 486 nm, or optically pumped<br>semiconductor laser, 488 nm<br>Green light reflectance<br>images: diode laser, 518 nm<br>Fluorescein angiography: diode<br>laser, 486 nm, or optically pumped<br>semiconductor laser, 488nm<br>Indocyanine green angiography:<br>diode laser, 786 nm<br>Optical coherence tomography:<br>superluminescence diode, 840 nm<br>to 920 nm (weighted average 880<br>nm) | Near infrared reflectance images:<br>diode laser, 815 nm,<br>Blue light reflectance images: diode<br>laser, 486 nm, or optically pumped<br>semiconductor laser, 488 nm<br>Green light reflectance<br>images: diode laser, 518 nm<br>Fluorescein angiography: diode<br>laser, 486 nm, or optically pumped<br>semiconductor laser, 488nm<br>Indocyanine green angiography:<br>diode laser, 786 nm<br>Optical coherence tomography:<br>superluminescence diode, 840 nm<br>to 920 nm (weighted average 880<br>nm) | No Laser Scanning (cSLO)<br>available<br><br>Optical coherence tomography:<br>superluminescence diode, 760 nm<br>to 930 nm (860 nm) | K223557: Same (cSLO)<br>K120057: N/A (cSLO)<br><br>K223557: Same (OCT)<br>K120057: Similar (OCT) |
| Amount of light<br>irradiated to<br>retina (exposure) | Low amount, does not exceed<br>Class I laser accessible emission<br>limits | Low amount, does not exceed<br>Class I laser accessible emission<br>limits | Class 1 LED | K223557, K120057: Same |
| Lateral optical<br>resolution (OCT) | 14 μm (standard objective), 24 μm<br>(WFO2) | 14 μm (standard objective), 24 μm<br>(WFO2) | Retina: 20 μm in tissue | K223557: Same<br>K120057: Similar |
| Focus<br>adjustment<br>range | Correction of patient's refractive<br>errors: minimum range: -12 to +12<br>diopters | Correction of patient's refractive<br>errors: minimum range: -12 to +12<br>diopters | Not known | K223557: Same<br>K120057: N/A |
| Optical depth<br>resolution (OCT) | 7 μm | 7 μm | ≤ 6 μm (High Resolution, HR)<br>< 4 μm (Very High Resolution,<br>VHR) | K223557: Same<br>K120057: Similar |
| OCT acquisition<br>speed (Maximum<br>A-scan rate) | 40 kHz (Firewire),<br>85 kHz (Thunderbolt) | 40 kHz (Firewire),<br>85 kHz (Thunderbolt) | 32 kHz | K223557: Same<br>K120057: Similar |
| Feature | Subject Device<br>SPECTRALIS with Flex<br>Module | Primary Predicate Device<br>SPECTRALIS<br>(K223557) | Secondary Predicate<br>Device<br>Bioptigen ENVISU Spectral<br>Domain Ophthalmic Imaging<br>System (K120057) | Same, similar or different |
| OCT acquisition<br>modes | Standard, Enhanced Depth Imaging<br>(EDI), Enhanced Vitreous Imaging<br>(EVI) | Standard, Enhanced Depth Imaging<br>(EDI), Enhanced Vitreous Imaging<br>(EVI) | N/A, no different acquisition modes<br>available | K223557: Same<br>K120057: N/A |
| cSLO imaging<br>modes for<br>artifact<br>suppression | Reflectance (R), Cross-Polarization<br>(XP), Widefield Reflectance (WR) | Reflectance (R), Cross-Polarization<br>(XP), Widefield Reflectance (WR) | N/A, no cSLO imaging available | K223557: Same<br>K120057: N/A |
| OCTA scan<br>types | Volume OCTA, Scout OCTA, DART<br>Volume OCTA, DART Line | Volume OCTA, Scout OCTA, DART<br>Volume OCTA, DART Line | N/A, no OCT-Angiography available | K223557: Same<br>K120057: N/A |
| Lateral field of<br>view (SLO) | SO (standard objective):<br>15°x15° to 30 x30°<br>HMM: 8°x8°<br>WFO2: 25°x25° to Ø 55°<br>UWF Objective: 51°x 1° to Ø102° | SO (standard objective):<br>15°x15° to 30 x30°<br>HMM: 8°x8°<br>WFO2: 25°x25° to Ø 55°<br>UWF Objective: 51°x 1° to Ø102° | N/A, no cSLO imaging available | K223557: Same<br>K120057: N/A |
| Lateral field of<br>view (OCT) | Standard objective lens: 15°-30°,<br>WFO2: 25°-55° | Standard objective lens: 15°-30°,<br>WFO2: 25°-55° | Posterior retina: 70° | K223557: Same<br>K120057: Different |
| Lateral digital<br>resolution (SLO) | High speed mode: 3 um (HMM), 11<br>um (SO) to 40 µm (UWF), High<br>resolution mode: 1.5µm (HMM), 6<br>um (SO) to 20 µm (UWF) | High speed mode: 3 um (HMM), 11<br>um (SO) to 40 µm (UWF), High<br>resolution mode: 1.5µm (HMM), 6<br>um (SO) to 20 um (UWF) | N/A, no cSLO imaging available | K223557: Same<br>K120057: N/A |
| Lateral digital<br>resolution (OCT) | Standard and WFO2 objective<br>lenses: same as SLO | Standard and WFO2 objective<br>lenses: same as SLO | Posterior retina: 11 µm | K223557: Same<br>K120057: Similar |
| Axial digital<br>image size | 496 pixels | 496 pixels | 512 pixels or 1024 pixles | K223557: Same<br>K120057: Similar |
| Digital axial<br>resolution (pixel<br>size OCT) | 3.9 µm | 3.9 µm | 1.6 µm or 2.4 µm (1024 pixels) | K223557: Same<br>K120057: Similar |
| Scan depth | 1.9 mm | 1.9 mm | 1.7 mm (High Resolution) or 2.5<br>mm (Very High Resolution) | K223557: Same<br>K120057: Different |
| Acquisition of<br>three-<br>dimensional<br>images | Yes, HRA: stacks of confocal<br>section images; OCT: OCT volume<br>scan | Yes, HRA: stacks of confocal<br>section images; OCT: OCT volume<br>scan | Yes, OCT volume scan | K223557, K120057: Same |
| Feature | Subject Device<br>SPECTRALIS with Flex<br>Module | Primary Predicate Device<br>SPECTRALIS<br>(K223557) | Secondary Predicate<br>Device<br>Bioptigen ENVISU Spectral<br>Domain Ophthalmic Imaging<br>System (K120057) | Same, similar or different |
| Measurements | Measured data points are not<br>displayed | Measured data points are displayed | No measurements | K223557: Different<br>K120057: Same<br>(visualization only) |
| Image<br>compression | No | No | No | K223557, K120057: Same |
| Display of the<br>data | Images are visible on a standard<br>PC-Monitor | Images are visible on a standard<br>PC-Monitor | Images are visible on a standard<br>PC-Monitor | K223557, K120057: Same |
| Physical layout | • Mobile instrumentation mount<br>with swivel arms for camera and<br>accessories<br>• Optical camera head<br>• Power supply and spectrometer<br>unit<br>• Touch panel<br>• Computer with monitor, keyboard,<br>mouse, and printer | • Fixed camera mount with<br>headrest and joystick<br>• Optical camera head<br>• Power supply and spectrometer<br>unit<br>• Touch panel<br>• Computer with monitor, keyboard,<br>mouse, and printer | • Mobile cart<br>• Handheld or mounted scanning<br>(camera) head<br>• Power supply, optical engine<br>(spectromerter, LED light)<br>• Computer with monitor | K223557:<br>Different (tabletop mount)<br>Same (other components)<br>K120057:<br>Different (handheld camera,<br>mobile cart),<br>Similar (other components) |
| Patient Profile | • No special assumptions about<br>the ethnicity, body weight,<br>biological sex, or age of the<br>patient<br>• Patients in supine position<br>• Patients, able to follow simple<br>instructions including pediatrics<br>and adults<br>• Patients not able to follow simple<br>instructions (unconscious and<br>anesthetized patients patients)<br>including pediatrics and adults | • No special assumptions about the<br>ethnicity, body weight, biological<br>sex, or age of the patient<br>• Patients sitting upright in front of<br>the device<br>• Awake patients, able to follow<br>simple instructions including<br>pediatrics and adults | • Pediatric patients<br>• Adult patients<br>• Supine patients<br>• Upright sitting patients<br>• Any patient that finds it difficult to<br>sit upright or where it is clinically<br>preferable to image without the<br>constraint of a chin<br>• Anesthetized patients | K223557:<br>Different (awake, upright)<br>K120057:<br>Similar (pediatric, supine) |
| Thunderbolt<br>Interface | Thunderbolt-3 Interface | Thunderbolt-3 Interface | N/A (not known) | K223557: Same<br>K120057: N/A |
| Flammability of<br>the materials | The metal housing of the device<br>prevents flammability | The metal housing of the device<br>prevents flammability | The metal housing of the device<br>prevents flammability | K223557: Same<br>K120057: Similar |
| Feature | Subject Device<br>SPECTRALIS with Flex<br>Module | Primary Predicate Device<br>SPECTRALIS<br>(K223557) | Secondary Predicate<br>Device<br>Bioptigen ENVISU Spectral<br>Domain Ophthalmic Imaging<br>System (K120057) | Same, similar or different |
| Standard<br>Objective Lens | 19.5 mm working distance, 31 mm<br>length, 49 outer mm diameter | 19.5 mm working distance, 31 mm<br>length, 49 outer mm diameter | 13 mm working distance (posterior<br>retina) | K223557: Same<br>K120057: Different |
| High<br>Magnification<br>Module (HMM) | 50 mm working distance, 29 mm<br>length, 49 mm outer diameter; not<br>used for measurements; | 50 mm working distance, 29 mm<br>length, 49 mm outer diameter; not<br>used for measurements; | N/A | K223557: Same<br>K120057: N/A |
| Anterior<br>Segment Module<br>(ASM) Objective<br>Lens | Not available | 12 mm working distance, 65 mm<br>length, 49.5 mm outer diameter, 30° field of view, not used for<br>measurements…