Spectralis HRA+OCT and variants

K201252 · Heidelberg Engineering GmbH · OBO · Sep 9, 2020 · Ophthalmic

Device Facts

• Record ID: K201252
• Device Name: Spectralis HRA+OCT and variants
• Applicant: Heidelberg Engineering GmbH
• Product Code: OBO · Ophthalmic
• Decision Date: Sep 9, 2020
• 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: reflectance images (blue, green, infrared), angiography (fluorescein, indocyanine green), autofluorescence, and cross-sectional/volume OCT scans. Operates via infrared super-luminescent diode and spectral interferometer; uses lasers for cSLO imaging. Output: 2D/3D images, cross-sectional scans, and ocular measurements. Used in clinical settings by eye care professionals to visualize ocular anatomy/lesions and manage diseases like AMD, diabetic retinopathy, and glaucoma. Updated camera head, beam splitter, and scanner controller improve image acquisition and scan precision. Enhanced Vitreous Imaging (EVI) and new OCTA scan patterns (Scout, DART) provide additional diagnostic views. Clinicians use outputs to assess retinal/choroidal structures, aiding clinical decision-making and patient management.

Clinical Evidence

Bench testing only. Evaluation included OCT imaging property verification, validation activities, and adherence to consensus standards (ISO 14971, AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 62304). No clinical data presented.

Technological Characteristics

Combination cSLO and SD-OCT. Light sources: diode lasers (486nm, 488nm, 518nm, 786nm, 815nm) and super-luminescent diode (840-920nm). Features updated OCT scanner controller and modified beam splitter coating. Connectivity via Firewire/Thunderbolt. Software lifecycle per IEC 62304. Class I laser safety. Accessories: ASM, WFO, UWF, HMM.

Indications for Use

Indicated for patients requiring posterior segment imaging, including 2D/3D imaging, cross-sectional imaging, fundus imaging, fluorescence/autofluorescence imaging, and ocular measurements. Aids in detection/management of age-related macular degeneration, macular edema, diabetic retinopathy, retinal/choroidal vascular diseases, glaucoma, and geographic atrophy. OCT Angiography module aids visualization of retinal/choroidal vascular structures.

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 (K192391)

Submission Summary (Full Text)

{0}------------------------------------------------

September 9, 2020

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

Heidelberg Engineering GmbH % Lena Sattler Consultant Orasi Consulting, LLC. 1655 Forest Drive Medina, Ohio 44256

Re: K201252

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: June 10, 2020 Received: June 11, 2020

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 (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 located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Actinclude 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.

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

{1}------------------------------------------------

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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-devices/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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 Ng Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K201252

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)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

{3}------------------------------------------------

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for Heidelberg Engineering. The logo consists of the word "HEIDELBERG" stacked on top of the word "ENGINEERING". To the left of each word is a red square. The text is in a bold, sans-serif font.

# 510(K) SUMMARY

Date Prepared

August 18, 2020

#### 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. 1655 Forest Dr. Medina, OH 44256 Telephone: Facsimile: E-mail:

[phone] [phone] [e-mail]

### COMMON/USUAL NAME

Optical Coherence Tomography

### PROPRIETARY OR TRADE NAMES

SPECTRALIS HRA+OCT and variants

### CLASSIFICATION INFORMATION

| Regulation Number: | 21 CFR 886.1570 |
|-----------------------|------------------------------------------------------------------------------|
| Classification name: | Ophthalmoscope |
| Device Class: | II |
| Common name: | Optical Coherence Tomography |
| Product Codes, Name: | OBO (Tomography, Optical Coherence)<br>MYC (Ophthalmoscope, Laser, Scanning) |
| Medical Specialty: | Ophthalmic |
| Classification Panel: | Ophthalmic Device Panel |

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for Heidelberg Engineering. The logo consists of two lines of text, with a red square on either end. The first line reads "HEIDELBERG" and the second line reads "ENGINEERING".

#### LEGALLY MARKETED UNMODIFIED PREDICATE DEVICE

Trade/Device Name: Applicant: 510(k) Premarket Notification number: Classification: Regulation Number: Product Codes, Name:

Common Name: Medical Specialty: Classification Panel:

SPECTRALIS HRA+OCT and variants Heidelberg Engineering GmbH K192391 Class II 21 CFR 886.1570 OBO (Tomography, Optical Coherence) MYC (Ophthalmoscope, Laser, Scanning) Optical Coherence Tomography Ophthalmic Ophthalmic Device Panel

#### 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 laser-scanning 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 super-luminescent diode and a spectral interferometer are used to create the cross-sectional images.

### DEVICE MODIFICATIONS

The purpose of this premarket notification [510(k)] is to modify the SPECTRALIS HRA+OCT with the updated camera head and OCT controller, the additional OCT scan mode, and predefined OCTA scan pattern.

The following changes have been applied to the device:

- . Camera head hardware update
- O Modified beam splitter coating to allow for more light in the OCT reference arm
- Improved OCT scanner controller O

{6}------------------------------------------------

- Enhanced Vitreous Imaging OCT acquisition mode ●
- Additional predefined scan patterns ●
- OCT Angiography Scout scan: A fast overview OCTA scan o
- OCT Angiography Dense ART (DART) scans: Narrow OCTA B-scans with flow O overlav

## INDICATIONS FOR USE – SPECTRALIS PREDICATE DEVICE

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)

{7}------------------------------------------------

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

## INDICATIONS FOR USE – MODIFIED SPECTRALIS

The Indications for Use for the modified SPECTRALIS is identical to the Indications for Use of the cleared SPECTRALIS predicate device.

## SUBSTANTIAL EQUIVALENCE

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

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image shows the logo for Heidelberg Engineering. The logo consists of two lines of text in a stylized, blocky font. The first line reads "HEIDELBERG" and the second line reads "ENGINEERING". There is a red square on the left side of the first line and on the right side of the second line.

# INDICATIONS FOR USE STATEMENT CHART

| K192391 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 detection | The device is indicated as an aid in the detection | |
| and management of various ocular diseases, | and management of various ocular diseases, | |
| including: | 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 is | The SPECTRALIS OCT Angiography Module is | |
| indicated as an aid in the visualization of | 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 neuroretinal | layer thickness and optic nerve head neuroretinal | |
| rim parameter measurements, which is used to | rim parameter measurements, which is used to | |
| quantitatively compare the retinal nerve fiber | quantitatively compare the retinal nerve fiber | |
| layer and neuroretinal rim in the human retina to | layer and neuroretinal rim in the human retina to | |
| values of normal subjects of different races and | values of normal subjects of different races and | |
| ethnicities representing the population mix of the | ethnicities representing the population mix of the | |
| USA (Glaucoma Module Premium Edition) | USA (Glaucoma Module Premium Edition) | |

{9}------------------------------------------------

Image /page/9/Picture/0 description: The image contains the logo for Heidelberg Engineering. The logo consists of the company name in a stylized, blocky font. There are two red squares on either side of the company name.

# TECHNOLOGICAL CHARACTERISTICS COMPARISON CHART

| | PREDICATE DEVICE<br>K192391 SPECTRALIS<br>HRA+OCT | SUBJECT DEVICE | Discussion |
|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Device classification<br>name | Optical Coherence<br>Tomographer (OCT) | Optical Coherence<br>Tomographer (OCT) | Same |
| Technology and optical<br>setup | Confocal Scanning Laser<br>Ophthalmoscope (SLO) and<br>Spectral-Domain Optical<br>Coherence Tomograph<br>(OCT) | Confocal Scanning Laser<br>Ophthalmoscope (SLO) and<br>Spectral-Domain Optical<br>Coherence Tomograph<br>(OCT) | Same |
| Lights sources and<br>wavelength of light<br>emitted | Near infrared reflectance<br>images: diode laser, 815<br>nm Blue light reflectance<br>images: diode laser, 486<br>nm, or optically pumped<br>semiconductor laser, 488<br>nm Green light reflectance<br>images: diode laser, 518<br>nm Fluorescein angiography:<br>diode laser, 486 nm, or<br>optically pumped<br>semiconductor laser, 488<br>nm Indocyanine green<br>angiography: diode laser,<br>786 nm Optical coherence<br>tomography:<br>superluminescence diode,<br>840 nm to 920 nm<br>(weighted average 880<br>nm) | Near infrared reflectance<br>images: diode laser, 815<br>nm Blue light reflectance<br>images: diode laser, 486<br>nm, or optically pumped<br>semiconductor laser, 488<br>nm Green light reflectance<br>images: diode laser, 518<br>nm Fluorescein angiography:<br>diode laser, 486 nm, or<br>optically pumped<br>semiconductor laser, 488<br>nm Indocyanine green<br>angiography: diode laser,<br>786 nm Optical coherence<br>tomography:<br>superluminescence diode,<br>840 nm to 920 nm<br>(weighted average 880<br>nm) | Same |
| Amount of light<br>irradiated to retina<br>(exposure) | Low amount, does not<br>exceed Class I laser<br>accessible emission limits | Low amount, does not<br>exceed Class I laser<br>accessible emission limits | Same |
| Accessory objective<br>lenses (besides Standard<br>Objective) | Anterior Segment Module<br>(ASM)<br>Wide Field Objective (WFO)<br>Ultra Widefield Objective<br>(UWF)<br>High Magnification Module<br>(HMM) | Anterior Segment Module<br>(ASM)<br>Wide Field Objective (WFO)<br>Ultra Widefield Objective<br>(UWF)<br>High Magnification Module<br>(HMM) | Same |
| | PREDICATE DEVICE<br>K192391 SPECTRALIS<br>HRA+OCT | SUBJECT DEVICE | Discussion |
| Lateral field of view<br>(SLO) | SO (standard objective):<br>$15°$ x $15°$ to $30°$ x $30°$<br>HMM:<br>$8°$<br>WFO/WFO2:<br>$25°$ x $25°$ to Ø $55°$<br>UWF Objective:<br>$51°$ x $51°$ to Ø $102°$ | SO (standard objective):<br>$15°$ x $15°$ to $30°$ x $30°$<br>HMM:<br>$8°$<br>WFO/WFO2:<br>$25°$ x $25°$ to Ø $55°$<br>UWF Objective:<br>$51°$ x $51°$ to Ø $102°$ | Same |
| Lateral digital resolution<br>(SLO) | high speed mode: 3µm<br>(HMM), 11 µm (SO) to 40<br>µm (UWF)<br>high resolution mode: 1.5µm<br>(HMM), 6 µm (SO) to 20 µm<br>(UWF) | high speed mode: 3µm<br>(HMM), 11 µm (SO) to 40<br>µm (UWF)<br>high resolution mode: 1.5µm<br>(HMM), 6 µm (SO) to 20 µm<br>(UWF) | Same |
| Lateral optical<br>resolution (OCT) | 14 µm (standard objective)<br>24 µm (WFO/WFO2) | 14 µm (standard objective)<br>24 µm (WFO/WFO2) | Same |
| Optical depth resolution<br>(OCT) | 7 µm | 7 µm | Same |
| Digital image size<br>(SLO) | High Speed mode: 384x384<br>pixels to 768x768 pixels;<br>(with HMM: 768x768 pixels<br>only)<br>High Resolution mode:<br>768x768 to 1536 x 1536<br>pixels; (with HMM: 1536 x<br>1536 pixels only) | High Speed mode: 384x384<br>pixels to 768x768 pixels;<br>(with HMM: 768x768 pixels<br>only)<br>High Resolution mode:<br>768x768 to 1536 x 1536<br>pixels; (with HMM: 1536 x<br>1536 pixels only) | Same |
| OCT acquisition speed<br>(Maximum A-scan rate) | 40 kHz (Firewire)<br>85 kHz (Thunderbolt) | 40 kHz (Firewire)<br>85 kHz (Thunderbolt) | Same |
| OCT Scanner Controller | Standard controller | Updated controller | Different; the<br>updated<br>controller<br>reduces scanner<br>non-linearity,<br>repositioning<br>error and settle<br>times |
| | PREDICATE DEVICE<br>K192391 SPECTRALIS<br>HRA+OCT | SUBJECT DEVICE | Discussion |
| OCT Beam Splitter | Standard coating | Modified coating | Different;<br>coating<br>modified to<br>allow more<br>light to the<br>reference arm |
| OCT imaging modes | Standard<br>Enhanced Depth Imaging<br>(EDI) | Standard<br>Enhanced Depth Imaging<br>(EDI)<br>Enhanced Vitreous Imaging<br>(EVI) | Different:<br>Addition of<br>EVI mode |
| OCTA scan types | Volume | Volume<br>OCTA Scout<br>OCTA DART Volume<br>OCTA DART Line | Different:<br>Additional<br>predefined<br>OCTA scan<br>pattern |

{10}------------------------------------------------

Image /page/10/Picture/0 description: The image contains the logo for Heidelberg Engineering. The logo consists of two lines of text in a stylized, blocky font. The first line reads "HEIDELBERG" and the second line reads "ENGINEERING". There is a dark red square to the left of the first line and to the right of the second line.

{11}------------------------------------------------

Image /page/11/Picture/0 description: The image contains the logo for Heidelberg Engineering. The logo consists of two lines of text in a stylized, blocky font. The first line reads "HEIDELBERG" and the second line reads "ENGINEERING". There is a red square on the left side of the first line and a red square on the right side of the second line.

# SUBSTANTIAL EQUIVALENCE DISCUSSION

The modified SPECTRALIS HRA+OCT is a device modification to the cleared SPECTRALIS HRA+OCT and variants (K192391) predicate device. Technological detail characteristics of the device are unchanged except for the modification as stated above. The modified SPECTRALIS has the same Indications for Use and maintains the same fundamental scientific technology as the predicate device.

The modified SPECTRALIS HRA+OCT and variants measures the same ophthalmic features as the cleared SPECTRALIS HRA+OCT in K192391. The changes applied to the SPECTRALIS since the clearance in K192391 do not change the intended patient populations, the type of acquired images, or that the SPECTRALIS may be used as an aid to clinical evaluation.

The light sources integrated into the modified device are the same as the predicate (unmodified) device. The modification of the OCT beam splitter coating to the predicate (unmodified) device does not alter the optical pathway, nor does it change the patient light exposure.

The addition of additional scan patterns, updated OCT scanner controller, and of Enhanced Vitreous Imaging mode, do not change the basic scientific technology of the predicate (unmodified) device.

{12}------------------------------------------------

Non-clinical performance testing was conducted on the modified SPECTRALIS HRA+OCT to verify that the device is safe and effective for its intended use and indications for use. The modified SPECTRALIS was evaluated according to the requirements of FDA recognized consensus standards:

- . ISO 14971: Medical Devices - Application of Risk Management to Medical Devices,
- AAMI / ANSI ES60601-1:2005 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,

and was found to meet the requirements of the applicable parts, demonstrating that the safety and efficacy of the modified device is comparable to the predicate.

Heidelberg Engineering performed bench testing including bench testing of OCT imaging properties, validation and verification activities, and ongoing quality control, to confirm that the modified SPECTRALIS HRA+OCT functions equivalently to the predicate SPECTRALIS HRA+OCT.

The modifications to the device do not raise issues of safety and effectiveness. A comparison of technological characteristics and non-clinical performance testing demonstrate that the SPECTRALIS device is substantially equivalent to the unmodified predicate device.

# CONCLUSION

Comparison of technological characteristics and evaluation of non-clinical performance testing show that the modifications to the SPECTRALIS HRA+OCT and variants do not introduce any new potential safety risk and the device is as safe and effective as the predicate devices, therefore supporting a determination of substantial equivalence.