Spectralis HRA+OCT and Variants

K192391 · Heidelberg Engineering GmbH · OBO · Sep 26, 2019 · Ophthalmic

Device Facts

• Record ID: K192391
• Device Name: Spectralis HRA+OCT and Variants
• Applicant: Heidelberg Engineering GmbH
• Product Code: OBO · Ophthalmic
• Decision Date: Sep 26, 2019
• Decision: SESE
• Submission Type: Special
• 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

SPECTRALIS HRA+OCT 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. Operation: cSLO uses diode/semiconductor lasers; SD-OCT uses infrared superluminescent diode and spectral interferometer. Output: 2D/3D images, cross-sectional scans, and ocular measurements. Used in clinical settings by eye care professionals. Output aids clinicians in detecting/managing ocular diseases by visualizing retinal/choroidal structures and comparing measurements against normative databases (RNFL thickness, neuroretinal rim). Benefits: non-contact diagnostic imaging for improved disease management.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via electrical safety (AAMI/ANSI ES60601-1), EMC (IEC 60601-1-2), laser safety (IEC 60825-1), and OCT imaging properties (sensitivity ≥ 95 dB, rolloff ≤ 5 dB/1.6 mm).

Technological Characteristics

Combination cSLO and SD-OCT. Light sources: diode lasers (486/488nm, 518nm, 786nm, 815nm) and superluminescent diode (840-920nm). Interface: Thunderbolt 2. OCT acquisition speed: 85 kHz. Standards: IEC 60601-1-2 Ed 4.0, AAMI/ANSI ES60601-1 Ed 3.1, ISO 14971, ISO 13485. Software: AAMI/ANSI/IEC 62304 compliant.

Indications for Use

Indicated for patients requiring diagnostic imaging of the posterior eye segment to aid in detection and management of ocular diseases including age-related macular degeneration, macular edema, diabetic retinopathy, retinal/choroidal vascular diseases, and glaucoma. Includes visualization of geographic atrophy and vascular structures of retina/choroid.

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 (K182569)

Submission Summary (Full Text)

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

Re: K192391

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: August 30, 2019 Received: September 3, 2019

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 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.

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

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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 (OS) 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-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,

Tieuvi Nguyen, Ph.D. Director (Acting) 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) K192391

### Device Name

SPECTRALIS HRA+OCT and variants with High Magnification Module

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.

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

# 510(K) SUMMARY

Date Prepared:

September 18, 2019

### 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

| 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

Heidelberg Engineering GmbH

Special 510(k): SPECTRALIS Page 1 of 10

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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, with a red square on either side. The first line reads "HEIDELBERG" and the second line reads "ENGINEERING", both in a stylized, blocky font.

### LEGALLY MARKETED UNMODIFIED PREDICATE DEVICE

Trade/Device Name: Applicant: 510(k) Premarket Notification number: Classification: CFR Title: FDA Product Code(s): Classification Name:

Common Name: Medical Specialty: Classification Panel:

SPECTRALIS HRA+OCT and variants Heidelberg Engineering GmbH K182569 Class II 21 CFR 886.1570 OBO. MYC Tomography, Optical Coherence 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 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.

Because of discontinuation of device components, the following changes have been applied to the device:

- . Replacement of the OCT line camera in the spectrometer with an equivalent camera from the same manufacturer, and comparable specifications;
- . Update of the digital device interface from Thunderbolt to Thunderbolt 2;
- With the update of the TDI, the device complies with electromagnetic о compatibility standard IEC 60601-1-2 Edition 4.0.

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The modified device with the updated components will replace the cleared device (K182569) with OCT2 module (Thunderbolt). Manufacturing of the device with FireWire interface will soon be discontinued.

The purpose of this premarket notification [510(k)] is to modify the SPECTRALIS HRA+OCT with the updated OCT line camera and digital device interface.

Besides the updated hardware, the SPECTRALIS device is unchanged.

## 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

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normal subjects of different races and ethnicities representing the population mix of the USA (Glaucoma Module Premium Edition)

## 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.

## NON-CLINICAL PERFORMANCE TESTING

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,
- AAMI / ANSI / IEC 62304:2006: Medical Device Software - Software Life Cycle Processes, and

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.

## DESIGN CONTROL

Heidelberg Engineering designed and developed the modified SPECTRALIS per the company's Design Control procedure, which complies with the FDA Quality System Regulations CFR Part 820 and ISO 13485:2016. The Design Control procedure also incorporates Risk Management procedures, which comply with ISO 14971:2007.

Risk assessment was conducted on the modified SPECTRALIS, and the impact of the design modifications were assessed on the predicate 510(k) cleared device.

The modified SPECTRALIS is manufactured and tested in the exact manner as the predicate 510(k) cleared device.

Heidelberg Engineering performed bench testing including electrical safety testing, EMC testing, 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.

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## SUBSTANTIAL EQUIVALENCE

The modified SPECTRALIS HRA+OCT is a device modification to the cleared SPECTRALIS HRA+OCT and variants (K182569) 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.

| K182569 PREDICATE DEVICE | SUBJECT DEVICE | Same or Different |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| 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 | 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 | Same |

## INDICATIONS FOR USE STATEMENT CHART

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| K182569 PREDICATE DEVICE | SUBJECT DEVICE | Same or<br>Different |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| 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 thickness and optic nerve head<br>neuroretinal rim parameter measurements,<br>which is used to quantitatively compare the<br>retinal nerve fiber layer and neuroretinal rim in<br>the human retina to values of normal subjects<br>of different races and ethnicities representing<br>the population mix of the USA (Glaucoma<br>Module Premium Edition) | 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 thickness and optic nerve head<br>neuroretinal rim parameter measurements,<br>which is used to quantitatively compare the<br>retinal nerve fiber layer and neuroretinal rim in<br>the human retina to values of normal subjects<br>of different races and ethnicities representing<br>the population mix of the USA (Glaucoma<br>Module Premium Edition) | |

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Image /page/10/Picture/1 description: The image shows the logo for Heidelberg Engineering. The logo consists of the words "HEIDELBERG" on the top line and "ENGINEERING" on the bottom line. There is a red square to the left of the word "HEIDELBERG" and to the right of the word "ENGINEERING".

| | PREDICATE DEVICE<br>K182569 SPECTRALIS<br>HRA+OCT | SUBJECT DEVICE | Discussion |
|---------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Device<br>classification<br>name | Optical Coherence<br>Tomographer (OCT) | Optical Coherence<br>Tomographer (OCT) | Same |
| Technology and<br>optical 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<br>and wavelength<br>of light emitted | Near infrared reflectance images: diode laser, 815 nm Blue light reflectance images: diode laser, 486 nm, or optically pumped semiconductor laser, 488 nm Green light reflectance images: diode laser, 518 nm Fluorescein angiography: diode laser, 486 nm, or optically pumped semiconductor laser, 488 nm Indocyanine green angiography: diode laser, 786 nm Optical coherence tomography: superluminescence diode, 840 nm to 920 nm (weighted average 880 nm) | Near infrared reflectance images: diode laser, 815 nm Blue light reflectance images: diode laser, 486 nm, or optically pumped semiconductor laser, 488 nm Green light reflectance images: diode laser, 518 nm Fluorescein angiography: diode laser, 486 nm, or optically pumped semiconductor laser, 488 nm Indocyanine green angiography: diode laser, 786 nm Optical coherence tomography: superluminescence diode, 840 nm to 920 nm (weighted average 880 nm) | Same |
| Amount of light<br>irradiated to<br>retina (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<br>objective lenses<br>(besides<br>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>K182569 SPECTRALIS<br>HRA+OCT | SUBJECT DEVICE | Discussion |
| Lateral field of<br>view (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<br>resolution (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 |
| Digital image<br>size (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 |
| Digital device<br>interface | FireWire (OCT(1) module)<br>Thunderbolt (OCT2 module) | Thunderbolt 2 | Different; the<br>Firewire device<br>will be<br>discontinued;<br>device interface<br>updated to<br>Thunderbolt 2 |
| OCT acquisition<br>speed<br>(Maximum A-<br>scan rate) | 40 kHz (OCT(1) module)<br>85 kHz (OCT2 module) | 85 kHz | Different; the<br>Firewire device<br>will be<br>discontinued; |
| 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<br>resolution (OCT) | 7 µm | 7 µm | Same |

## TECHNOLOGICAL CHARACTERISTICS COMPARISON CHART

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Image /page/11/Picture/1 description: The image shows 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 on the left side of the first line and a red square on the right side of the second line.

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Image /page/12/Picture/1 description: The image shows the logo for Heidelberg Engineering. The logo consists of the words "HEIDELBERG" and "ENGINEERING" stacked on top of each other. There is a red square to the left of "HEIDELBERG" and to the right of "ENGINEERING."

The modified SPECTRALIS HRA+OCT and variants measures the same ophthalmic features and parameters as the cleared SPECTRALIS HRA+OCT in K182569. The changes applied to the SPECTRALIS since the clearance in K182569 do not change the intended patient populations, the type of acquired images, or how the SPECTRALIS may be used as an aid to clinical evaluation.

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 following performance testing was conducted:

| Test | Verification /<br>Validation<br>Method(s) | Acceptance<br>Criteria | Summary of Results |
|----------------------------------------------------------|----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Electrical Safety | According to<br>AAMI / ANSI<br>ES60601-1:2005<br>Edition 3.1 | According to<br>AAMI / ANSI<br>ES60601-1:2005<br>Edition 3.1 | All tests passed, and<br>the device was found<br>to comply |
| Electromagnetic<br>Compatibility | According to IEC<br>60601-1-2<br>Edition 4.0 | According to<br>IEC 60601-1-2<br>Edition 4.0 | All tests passed, and<br>the device was found<br>to comply |
| Laser Safety<br>Analysis | According to IEC<br>60825-1:2007 | According to<br>IEC 60825-<br>1:2007 | The total accessible<br>emission under all<br>circumstances is<br>below the accessible<br>emission limit for a<br>Class I laser product. |
| System and<br>software<br>validation and<br>verification | According to 21<br>CFR 820.30 and<br>AAMI / ANSI /<br>IEC 62304:2006 | According to 21<br>CFR 820.30 and<br>AAMI / ANSI /<br>IEC 62304:2006 | All tests passed, and<br>the device performed<br>according to the<br>requirements |
| Bench testing:<br>OCT Sensitivity | Quantification of<br>absolute SNR | Sensitivity ≥ 95<br>dB, with<br>variation < 2dB | Pass for both criteria |
| Bench testing:<br>OCT Signal<br>Rolloff | Quantification of<br>SNR as a function<br>of reference arm<br>length | Decay in<br>absolute<br>sensitivity ≤ 5 dB<br>for an increase in<br>reference arm<br>length of 1.6 mm | Rolloff ≈ 2 dB/mm,<br>thus passed |

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Non-clinical performance test results were compared to the results of the predicate device and showed that the modified device is functionally equivalent to the predicate device, and is as safe and efficient as the predicate device.

Risk assessment was conducted on the modified SPECTRALIS, and the impact of the design modifications were assessed on the predicate 510(k) cleared device. There were no newly identified risks due to the modification.

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.