SPECTRALIS HRA+OCT and variants

K223557 · Heidelberg Engineering GmbH · OBO · Oct 20, 2023 · Ophthalmic

Device Facts

• Record ID: K223557
• Device Name: SPECTRALIS HRA+OCT and variants
• Applicant: Heidelberg Engineering GmbH
• Product Code: OBO · Ophthalmic
• Decision Date: Oct 20, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1570
• Device Class: Class 2

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 Story

Non-contact ophthalmic diagnostic imaging device; combines confocal laser-scanning ophthalmoscope (cSLO) and spectral-domain optical coherence tomographer (SD-OCT). Inputs: laser reflectance (blue, green, infrared), fluorescence (fluorescein/indocyanine green), and SD-OCT interferometry. Transforms inputs into 2D/3D cross-sectional and fundus images. Used in clinical settings by eye care professionals. Output: visual images and quantitative measurements of ocular anatomy/lesions. Aids clinicians in detecting/managing ocular diseases. Benefits: enables visualization of retinal/choroidal vascular structures and structural analysis for glaucoma and macular conditions. Modifications include Widefield Reflectance mode, regression analysis in Glaucoma Module, Thunderbolt 3 interface, and process-separated acquisition software.

Clinical Evidence

No clinical data included; substantial equivalence supported by non-clinical performance testing and software verification/validation.

Technological Characteristics

Combination cSLO and SD-OCT. Light sources: laser diodes (486-815 nm) and superluminescent diode (840-920 nm). Connectivity: Thunderbolt 3. Software: Windows 10/11 compatible, process-separated acquisition module. Standards: ISO 14971, AAMI/ANSI ES 60601-1, IEC 60601-1-2, IEC 62304.

Indications for Use

Indicated for patients requiring posterior segment eye imaging, including 2D/3D, cross-sectional, fundus, fluorescence, and autofluorescence imaging. Aids in detection/management of age-related macular degeneration, macular edema, diabetic retinopathy, retinal/choroidal vascular diseases, glaucoma, and geographic atrophy. Includes reference databases for retinal nerve fiber layer and optic nerve head neuroretinal rim measurements for Caucasian and diverse USA populations.

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 (K201252)

Submission Summary (Full Text)

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October 20, 2023

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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

Re: K223557

Trade/Device Name: SPECTRALIS HRA+OCT and variants Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO, MYC Dated: September 15, 2023 Received: September 15, 2023

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.

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).

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

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Enclosure

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# Indications for Use

510(k) Number (if known) K223557

### Device Name SPECTRALIS HRA+OCT and variants

### Indications for Use (Describe)

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)

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

> Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/5/Picture/1 description: The image contains the logo for Heidelberg Engineering. The logo consists of two lines of text in a bold, sans-serif font. The first line reads "HEIDELBERG" and the second line reads "ENGINEERING". There is a red square to the left of the word "HEIDELBERG" and to the right of the word "ENGINEERING".

# 510(K) SUMMARY

### Date Prepared

October 20, 2023

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

Heidelberg Engineering GmbH Max-Jarecki-Strasse 8 69115 Heidelberg, Germany Telephone: +49 6221 / 64 63 0 Facsimile: +49 6221 / 64 63 62 Email: [e-mail] Establishment Registration No.: 8043762

## OFFICIAL CONTACT PERSON

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

### COMMON/USUAL NAME

Optical Coherence Tomography

## PROPRIETARY OR TRADE NAMES

SPECTRALIS HRA+OCT and variants

### CLASSIFICATION INFORMATION

| Classification Name: | Tomography, Optical Coherence |
|-----------------------|---------------------------------|
| | 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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## PREDICATE DEVIC

SPECTRALIS HRA+OCT and variants (K201252), Heidelberg Engineering GmbH

# INDICATIONS FOR 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 threedimensional 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)

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# GENERAL 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

## COMPARISON BETWEEN THE SUBJECT AND THE PREDICATE DEVICE

The modified SPECTRALIS HRA+OCT is a device modification to the cleared SPECTRALIS HRA+OCT and variants (K201252) predicate device. Technological detail characteristics of the device are unchanged except for the modification as stated in the General Device Description. The modified SPECTRALIS has the same Indications for Use and maintains the same fundamental scientific technology as the predicate device.

The Substantial Equivalence summary tables below illustrate the comparisons of the modified SPECTRALIS to the predicate device.

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# INDICATIONS FOR USE STATEMENT CHART

| K221252 PREDICATE DEVICE | SUBJECT DEVICE | Same or<br>Different | |
|-------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| The SPECTRALIS is a non-contact ophthalmic | The SPECTRALIS is a non-contact ophthalmic | Same | |
| diagnostic imaging device. It is intended for: | diagnostic imaging device. It is intended for: | | |
| • viewing the posterior segment of the eye, | • viewing the posterior segment of the eye, | | |
| including two- and three-dimensional imaging | including two- and three-dimensional imaging | | |
| • cross-sectional imaging (SPECTRALIS | • cross-sectional imaging (SPECTRALIS | | |
| HRA+OCT and SPECTRALIS OCT) | HRA+OCT and SPECTRALIS OCT) | | |
| • fundus imaging | • fundus imaging | | |
| • fluorescence imaging (fluorescein | • fluorescence imaging (fluorescein | | |
| angiography, indocyanine green angiography; | angiography, indocyanine green angiography; | | |
| SPECTRALIS HRA+OCT, SPECTRALIS | SPECTRALIS HRA+OCT, SPECTRALIS | | |
| HRA) | HRA) | | |
| • autofluorescence imaging (SPECTRALIS | • autofluorescence imaging (SPECTRALIS | | |
| HRA+OCT, SPECTRALIS HRA and | HRA+OCT, SPECTRALIS HRA and | | |
| SPECTRALIS OCT with BluePeak) | SPECTRALIS OCT with BluePeak) | | |
| • performing measurements of ocular anatomy | • performing measurements of ocular anatomy | | |
| and ocular lesions. | and ocular lesions. | | |
| The device is indicated as an aid in the | The device is indicated as an aid in the | | |
| detection and management of various ocular | detection and management of various ocular | | |
| diseases, including: | diseases, including: | | |
| • age-related macular degeneration | • age-related macular degeneration | | |
| • macular edema | • macular edema | | |
| • diabetic retinopathy | • diabetic retinopathy | | |
| • retinal and choroidal vascular diseases | • retinal and choroidal vascular diseases | | |
| • glaucoma | • glaucoma | | |
| The device is indicated for viewing geographic | The device is indicated for viewing geographic | | |
| atrophy. | atrophy. | | |
| The SPECTRALIS OCT Angiography Module | The SPECTRALIS OCT Angiography Module | | |
| is indicated as an aid in the visualization of | is indicated as an aid in the visualization of | | |
| vascular structures of the retina and choroid. | vascular structures of the retina and choroid. | | |
| The SPECTRALIS HRA+OCT and | The SPECTRALIS HRA+OCT and | | |
| SPECTRALIS OCT include the following | SPECTRALIS OCT include the following | | |
| reference databases: | reference databases: | | |
| • a retinal nerve fiber layer thickness reference | • a retinal nerve fiber layer thickness reference | | |
| database, which is used to quantitatively | database, which is used to quantitatively | | |
| compare the retinal nerve fiber layer in the | compare the retinal nerve fiber layer in the | | |
| human retina to values of Caucasian normal | human retina to values of Caucasian normal | | |
| subjects – the classification result being valid | subjects - the classification result being valid | | |
| only for Caucasian subjects | only for Caucasian subjects | | |
| • a reference database for retinal nerve fiber | • a reference database for retinal nerve fiber | | |
| layer thickness and optic nerve head | layer thickness and optic nerve head | | |
| neuroretinal rim parameter measurements, | neuroretinal rim parameter measurements, | | |
| which is used to quantitatively compare the | which is used to quantitatively compare the | | |
| retinal nerve fiber layer and neuroretinal rim in | retinal nerve fiber layer and neuroretinal rim in | | |
| the human retina to values of normal subjects | the human retina to values of normal subjects | | |
| of different races and ethnicities representing | of different races and ethnicities representing | | |
| the population mix of the USA (Glaucoma | the population mix of the USA (Glaucoma | | |
| Module Premium Edition) | Module Premium Edition) | | |
| | PREDICATE DEVICE<br>K201252 SPECTRALIS | SUBJECT DEVICE | Same or<br>Different |
| | HRA+OCT | | |
| Device<br>classification<br>name | Optical Coherence<br>Tomographer (OCT) | Optical Coherence<br>Tomographer (OCT) | Same |
| Technology<br>and optical<br>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) | Same |
| Physical<br>Dimensions | • Laser scanning camera: 235<br>mm x 100 mm x 205 mm<br>• Instrumentation Mount<br>(KT):<br>470 mm x 325 mm<br>x 550 mm<br>• Power supply including<br>spectrometer: 180 mm x 335<br>mm x 165 mm Operation<br>panel:<br>170 mm x 185 mm x 100 mm…