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 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 thickness and optic nerve head neuroretinal rim paramements, which is used to quantitatively compare the retinal nerve fiber layer and neuroretinal rim in the human retina to values of normal subjects of different races and ethnicities representing the population mix of the USA (Glaucoma Module Premium Edition)

Device Description

The Heidelberg Engineering SPECTRALIS HRA+OCT is a device used to image the anterior and posterior segments of the human eye and to aid in the assessment and management of various diseases of the posterior segment, such as age-related macular degeneration, diabetic retinopathy, and glaucoma. The device is capable of acquiring infrared and blue reflectance images (K101223), as well as a composite color image referred to as "MultiColor image" due to addition of a green laser light source (K121993). New reference data for peripapillary retinal nerve fiber layer thickness and optic nerve head parameters have been added in K152205, as well as two (2) new accessory objective lenses (Wide Field, Ultra-Widefield), and OCT Enhanced Depth Imaging mode. In K172649, an updated 55° objective lens (WFO2) with enhanced anti-reflective coating was added to allow for Widefield MultiColor imaging, as well as an updated and faster spectrometer, called OCT2 module, a replacement of the patient and data management system, named Heyex 2, restructured user documentation, and Windows 10 support.

The modification to the SPECTRALIS is:
Widefield OCT - In addition to OCT imaging with the standard objective (for posterior segment imaging; 30° field of view) and the Anterior Segment Objective (anterior segment imaging; 30° field of view), OCT imaging is enabled with the Wide Field Objective (WFO) and Wide Field Objective 2 (WFO2). Both objectives provide a 55° diameter circular field of view. The field of view can be reduced by software to 35° and 25°. The only difference between WFO and WFO2 is an enhanced antireflective coating to allow for MultiColor imaging on the WFO2 (cleared in K172649). Both coatings cover the OCT wavelength, so OCT imaging can be enabled for both objective lenses.

AI/ML Overview

This document describes the 510(k) summary for the SPECTRALIS HRA+OCT and variants, a medical device for ophthalmic diagnostic imaging.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria described for this device are primarily related to non-clinical performance (bench testing) and maintaining substantial equivalence to a predicate device. There are no explicit quantitative clinical acceptance criteria provided in the document in the format of a table with reported device performance against them.

However, based on the "NON-CLINICAL PERFORMANCE SUMMARY" and "OPTICAL RESOLUTION TESTING" sections, we can infer some criteria and reported performance:

Acceptance Criteria	Reported Device Performance
Compliance with FDA Recognized Consensus Standards	The modified SPECTRALIS was evaluated according to ISO 14971, AAMI/ANSI ES60601-1:2005, IEC 60601-1-2 Edition 3: 2007-03, ISO 10993-1, AAMI/ANSI/ISO 10993-5:2009/(R) 2014, ISO 10993-12 Fourth Edition 2012-07-01, ISO 10993-18:2005, IEC 60825-1 Edition 2.0 2007-03, and AAMI/ANSI/IEC 62304:2006.
Safety and Effectiveness	"was found to meet the requirements of the applicable parts."
Design Control Compliance	Heidelberg Engineering designed and developed the modified SPECTRALIS per the company's Design Control procedure, complying with FDA Quality System Regulations CFR Part 820 and ISO 13485:2012, and Risk Management procedures complying with ISO 14971:2007.
Risk Assessment	Risk assessment was conducted on the modified SPECTRALIS; impact of design modifications assessed on the predicate 510(k) cleared device.
Manufacturing and Testing Equivalence	The modified SPECTRALIS is manufactured and tested in the exact manner as the predicate 510(k) cleared device.
Functional Equivalence	Bench testing (including light safety, image geometry, image quality assessment) and software verification/validation confirmed the modified SPECTRALIS HRA+OCT functions equivalently to the predicate SPECTRALIS HRA+OCT.
Optical Lateral Resolution (for WFO lens)	Average optical lateral resolution for the Standard Objective (SO) was 13µm. Average optical lateral resolution for the Wide Field Objective (WFO) was 18µm. (This indicates an acceptable loss of optical lateral resolution, roughly 3 resolution elements, consistent with theoretical evaluations for the wide-field lens).

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a test set involving human subjects or clinical data in the traditional sense for evaluating device performance against a diagnostic endpoint. The performance evaluation is based on non-clinical bench testing.

Sample Size for Test Set: Not applicable, as performance was assessed through bench testing on the device itself and a resolution test chart, not a separate clinical test set.
Data Provenance: Not applicable, as it's not clinical data. The testing was performed by Heidelberg Engineering GmbH as part of their design control process.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not explicitly applicable to this submission, as the evaluation is primarily for technical performance and substantial equivalence based on bench testing. There is no mention of "ground truth" derived from expert consensus for clinical disease states in this context. The "ground truth" for optical resolution, for example, is established by the known properties of the 1951 USAF resolution test chart.

4. Adjudication Method for the Test Set

Not applicable, as there was no clinical test set requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or reported in this document. This submission focuses on the technical modifications and substantial equivalence of the device, not an AI-assisted diagnostic workflow.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This device, the SPECTRALIS HRA+OCT, is a diagnostic imaging device that produces images for human interpretation and aids in detection and management. It is not an "algorithm only" device in the sense of AI-driven interpretation. Therefore, a standalone algorithm-only performance study is not directly relevant to this device's function as described. Its performance is related to its ability to acquire high-quality images and measurements, which are then used by clinicians.

7. The Type of Ground Truth Used

For the bench testing described, the "ground truth" effectively refers to physical standards and theoretical evaluations:

Physical standards: Use of a 1951 USAF resolution test chart to objectively quantify optical lateral resolution.
Theoretical evaluations: The measured optical resolution values were compared to theoretical expectations.
Predicate device's established performance: The primary "ground truth" for this 510(k) is the performance and safety profile of the legally marketed predicate device (K172649), to which the modified device claims substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This document describes a modification to an existing imaging device, not a machine learning or AI algorithm that requires a training set of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI algorithm mentioned for this device submission.

Summary

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

August 30, 2018

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

Re: K173648

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: May 30, 2018 Received: June 1, 2018

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

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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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerelv.

Alexander Beylin -S 2018.08.30 13:12:03 -04'00'

for Malvina B. Evdelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K173648

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 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 thickness and optic nerve head neuroretinal rim paramements, which is used to quantitatively compare the retinal nerve fiber laver 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/1 description: The image shows the logo for Heidelberg Engineering. The logo consists of two lines of text in a stylized, blocky font. The top line reads "HEIDELBERG" and the bottom line reads "ENGINEERING". A maroon square is on the left of the top line and on the right of the bottom line.

510(K) SUMMARY

Date Prepared

June 12, 2018

SPONSOR/510(K) OWNER/ MANUFACTURER

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

+49 6221 64630 +49 6221 / 64 63 62 Christoph.Schoess@HeidelbergEngineering.com 8043762

OFFICIAL CONTACT PERSON

Lena Sattler Orasi Consulting, LLC. 1655 Forest Dr. Medina, OH 44256 Telephone: Facsimile: E-mail:

(440) 554-3706 (866) 904-4315 lena@orasiconsulting.com

COMMON/USUAL NAME

Optical Coherence Tomography

PROPRIETARY OR TRADE NAMES

SPECTRALIS HRA+OCT and variants

CLASSIFICATION INFORMATION

Classification Name:	Ophthalmoscope, AC Powered
	Ophthalmoscope, Laser, Scanning
Medical Specialty:	Ophthalmic
Device Class:	II
Classification Panel:	Ophthalmic Device Panel
Product Codes:	OBO, MYC

Heidelberg Engineering GmbH

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Image /page/5/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 top line reads "HEIDELBERG" and the bottom line reads "ENGINEERING". There is a red square to the left of the top line and to the right of the bottom line.

PRODUCT CODE: CLASSIFICATION / CFR TITLE

OBO. MYC:

Class II § 21 CFR 886.1570

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 K172649 Class II 21 CFR 886.1570 OBO, MYC Ophthalmoscope, AC Powered Ophthalmoscope, Laser, Scanning Optical Coherence Tomography Ophthalmic Ophthalmic Device Panel

The device name and classification information for the modified device is identical to the cleared device.

GENERAL DEVICE DESCRIPTION

The modification to the SPECTRALIS is:

Widefield OCT - In addition to OCT imaging with the standard objective (for posterior segment imaging; 30° field of view) and the Anterior Segment Objective

Heidelberg Engineering GmbH

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(anterior segment imaging; 30° field of view), OCT imaging is enabled with the Wide Field Objective (WFO) and Wide Field Objective 2 (WFO2). Both objectives provide a 55° diameter circular field of view. The field of view can be reduced by software to 35° and 25°. The only difference between WFO and WFO2 is an enhanced antireflective coating to allow for MultiColor imaging on the WFO2 (cleared in K172649). Both coatings cover the OCT wavelength, so OCT imaging can be enabled for both objective lenses.

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 threedimensional imaging, cross-sectional imaging (SPECTRALIS HRA+OCT and SPECTRALIS OCT), fundus photography, fluorescence imaging (fluorescein angiography, indocyanine green angiography; SPECTRALIS HRA+OCT, SPECTRALIS HRA), autofluorescence imaging (SPECTRALIS HRA+OCT, SPECTRALIS HRA and SPECTRALIS OCT with BluePeak) and to perform 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, and for viewing geographic atrophy as well as changes in the eye that result from neurodegenerative diseases. The SPECTRALIS HRA+OCT and SPECTRALIS OCT include reference databases for retinal nerve fiber layer thickness and optic nerve head neuroretinal rim parameter measurements, which are used to quantitatively compare the retinal nerve fiber layer and neuroretinal rim in the human retina to values found in normal subjects.

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INDICATIONS FOR USE – MODIFIED SPECTRALIS

The Indications for Use for the modified SPECTRALIS is only slightly modified to the Indications for Use of the cleared SPECTRALIS predicate device for clarification. The modified Indication for Use statement is:

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 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 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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SUBSTANTIAL EQUIVALENCE

The modified SPECTRALIS HRA+OCT and variants is a device modification to the cleared SPECTRALIS HRA+OCT and variants (K172649) predicate device. The modified SPECTRALIS has a slightly modified Intended Use/Indications for Use and 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.

The modified SPECTRALIS HRA+OCT and variants measures the same ophthalmic features and parameters as the cleared SPECTRALIS HRA+OCT and variants in K172649.

The changes applied to the SPECTRALIS since the clearance in K172649 do not change the subject population for whom the device is used, the type of images to be acquired, the disease or condition to be diagnosed, or the usefulness of the SPECTRALIS as a quantitative aid to an ophthalmologic examination of the eye.

Technological detail characteristics of the device are unchanged except for the modifications as stated in the General Device Description.

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Image /page/9/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". A red square is on the left side of the first line and the right side of the second line.

INTENDED USE/INDICATIONS FOR USE STATEMENT CHART

K172649 PREDICATE DEVICE	SUBJECT DEVICE	Same orDifferent
The SPECTRALIS is a non-contactophthalmic diagnostic imaging device. It isintended for viewing the posterior segmentof the eye, including two- and three-dimensional imaging, cross-sectionalimaging (SPECTRALIS HRA+OCT andSPECTRALIS OCT), fundus photography,fluorescence imaging (fluoresceinangiography, indocyanine greenangiography; SPECTRALIS HRA+OCT,SPECTRALIS HRA), autofluorescenceimaging (SPECTRALIS HRA+OCT,SPECTRALIS HRA and SPECTRALISOCT with BluePeak) and to performmeasurements of ocular anatomy and ocularlesions. The device is indicated as an aid inthe detection and management of variousocular diseases, including age-relatedmacular degeneration, macular edema,diabetic retinopathy, retinal and choroidalvascular diseases, glaucoma, and forviewing geographic atrophy as well aschanges in the eye that result fromneurodegenerative diseases. TheSPECTRALIS HRA+OCT andSPECTRALIS OCT include referencedatabases for retinal nerve fiber layerthickness and optic nerve head neuroretinalrim parameter measurements, which areused to quantitatively compare the retinalnerve fiber layer and neuroretinal rim in thehuman retina to values found in normal	The SPECTRALIS is a non-contact ophthalmicdiagnostic imaging device. It is intended for:• viewing the posterior segment of the eye,including two- and three-dimensional TheSPECTRALIS is a non-contact ophthalmicdiagnostic imaging device. It is intended for:• viewing the posterior segment of the eye,including two- and three-dimensional imaging• cross-sectional imaging (SPECTRALISHRA+OCT and SPECTRALIS OCT)• fundus imaging• fluorescence imaging (fluoresceinangiography, indocyanine green angiography;SPECTRALIS HRA+OCT, SPECTRALIS HRA)• autofluorescence imaging (SPECTRALISHRA+OCT, SPECTRALIS HRA andSPECTRALIS OCT with BluePeak)• performing measurements of ocular anatomyand ocular lesions.The device is indicated as an aid in the detectionand management of various ocular diseases,including:• age-related macular degeneration• macular edema• diabetic retinopathy• retinal and choroidal vascular diseases• glaucomaThe device is indicated for viewing geographicatrophy.The SPECTRALIS HRA+OCT andSPECTRALIS OCT include the following	The Indicationsfor Use statementhas been updatedfor clarification:1.) Formatting forimprovedreadability2.) "fundusphotography"changed to"fundus imaging"for clarity3.) Removedstatement relatedto neuro-degenerativediseases uponFDA request, tonot imply the useof the device todiagnoseneurological-baseddiseases/conditions.4.) Clarificationon RDBs includedin the device
subjects.	reference databases:• a retinal nerve fiber layer thickness referencedatabase, which is used to quantitatively compare
	the retinal nerve fiber layer in the human retina tovalues of Caucasian normal subjects - theclassification result being valid only forCaucasian subjects• a reference database for retinal nerve fiberthickness and optic nerve head neuroretinal rimparameter measurements, which is used toquantitatively compare the retinal nerve fiber
	layer and neuroretinal rim in the human retina tovalues of normal subjects of different races andethnicities representing the population mix of theUSA (Glaucoma Module Premium Edition)
	PREDICATE DEVICEK172649	SUBJECT DEVICE	Same or Different
	SPECTRALIS HRA+OCT
User	Ophthalmologist, officesetting	Ophthalmologist, officesetting	Same
Eye contactrequired?	No	No	Same
Dilation ofpupil required?	No	No	Same
Workingposition	The patient is sitting straightin front of the device. Theexaminer is sitting oppositethe patient.	The patient is sitting straightin front of the device. Theexaminer is sitting oppositethe patient.	Same
Images ofposteriorsegment of eye	Yes, using standard,WFO/WFO2, or UWFobjective lens	Yes, using standard,WFO/WFO2, or UWFobjective lens	Same
Images ofanteriorsegment of eye	With Anterior SegmentModule (K113129)	With Anterior SegmentModule (K113129)	Same
OCT imagingof the anteriorand posteriorsegment	Anterior segment: WithAnterior Segment Module(K113129)Posterior Segment:30° OCT field of view withstandard objective	Anterior segment: WithAnterior Segment Module(K113129)Posterior Segment:30° OCT field of view withstandard objective, 55° OCTfield of view withWFO/WF02	Different; optionalOCT imaging withWFO/WFO2 wasintroduced
RNFLReferenceDatabase	RNFL thickness in referencedatabase for 12° circle scans(K101223)RNFL thickness in referencedatabase for fixed diametercircle scans (K152205)	RNFL thickness in referencedatabase for 12° circle scans(K101223)RNFL thickness in referencedatabase for fixed diametercircle scans (K152205)	Same
ONH ReferenceDatabase	ONH parameters (BMO-MRW, BMO-MRA)reference database(K152205)	ONH parameters (BMO-MRW, BMO-MRA)reference database(K152205)	Same

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Image /page/10/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 dark red square on either side of the text.

INTENDED USE CHARACTERISTICS 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 to the left of the first line and to the right of the second line.

NON-CLINICAL PERFORMANCE SUMMARY

The modified SPECTRALIS was evaluated according to the requirements of FDA recognized consensus standards ISO 14971, AAMI / ANSI ES60601-1:2005, IEC 60601-1-2 Edition 3: 2007-03, ISO 10993-1 Fourth Edition 2009-10-15, AAMI/ANSI/ISO 10993-5:2009/(R) 2014, ISO 10993-12 Fourth Edition 2012-07-01, ISO 10993-18:2005, IEC 60825-1 Edition 2.0 2007-03, and AAMI / ANSI / IEC 62304:2006 and was found to meet the requirements of the applicable parts.

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 13485:2012. 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 light safety, image geometry, and image quality assessment - and software verification and validation, to confirm that the modified SPECTRALIS HRA+OCT functions equivalently to the predicate SPECTRALIS HRA+OCT.

OPTICAL RESOLUTION TESTING

Bench testing was performed in order to assess all the relevant system properties (resolution, scaling, image quality etc.) for the WFO lens. In particular, a 1951 USAF resolution test chart (MIL-STD-150A) was used to objectively quantify the loss of optical lateral resolution comparing wide-field OCT scans with standard objective (SO) OCT patterns.

The bench testing resulted in an average value of 13um for the SO, and of 18um for the WFO. Compared to the standard lens, the WFO causes a loss in optical lateral resolution of about 3 resolution elements on a USAF 1951 resolution target. These values are in agreement with the theoretical evaluation.

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CONCLUSION

The modified SPECTRALIS is a device modification to the cleared SPECTRALIS predicate device. The modified SPECTRALIS has a slightly modified Intended Use/Indications for Use and the same fundamental scientific technology as the cleared SPECTRALIS predicate device.

In summary, Heidelberg Engineering GmbH is of the opinion that the modified SPECTRALIS HRA+OCT and variants, does not introduce any new potential safety risks, is as effective as the cleared SPECTRALIS HRA+OCT and variants and concludes that the modified SPECTRALIS HRA+OCT and variants, is substantially equivalent to the predicate device.

This 510(k) summary for the Heidelberg Engineering SPECTRALIS HRA+OCT and variants is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR§807.92.

Regulation Number and Section

§ 886.1570 Ophthalmoscope.

(a)
Identification. An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.(b)
Classification. Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.