(276 days)
No
The summary describes a diagnostic imaging device and its modifications, focusing on hardware (objective lenses, spectrometer) and software for data management and viewing. There is no mention of AI or ML being used for image analysis, interpretation, or any other function. The reference databases mentioned are for quantitative comparison to normal subjects, which is a standard statistical approach, not necessarily AI/ML.
No
Explanation: The device is described as a "non-contact ophthalmic diagnostic imaging device" and its intended use is to aid in the "detection and management of various ocular diseases" and "performing measurements of ocular anatomy and ocular lesions". There is no mention of treating or preventing diseases.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The SPECTRALIS is a non-contact ophthalmic diagnostic imaging device."
No
The device description clearly states it is a "device used to image the anterior and posterior segments of the human eye" and mentions hardware components like objective lenses, a spectrometer, and a laser light source. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, the SPECTRALIS device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens taken from the human body. The SPECTRALIS is a non-contact imaging device that directly views and images the eye. It does not analyze blood, tissue, or other samples removed from the patient.
- The intended use and device description clearly state it's for imaging and viewing the eye. The device captures images and performs measurements of ocular anatomy and lesions.
- The device is indicated as an aid in the detection and management of diseases. While it provides information that helps in diagnosis and management, it doesn't perform a diagnostic test on a biological sample.
- The performance studies focus on imaging resolution and system properties. This is consistent with an imaging device, not an IVD.
Therefore, the SPECTRALIS falls under the category of an ophthalmic imaging device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The SPECTRALIS is a non-contact ophthalmic diagnostic imaging device. It is intended for:
- viewing the posterior segment of the eye, including two- and 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)
Product codes
OBO, MYC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical Coherence Tomography, Infrared, Blue Reflectance, MultiColor imaging, Fluorescence imaging (fluorescein angiography, indocyanine green angiography), Autofluorescence imaging
Anatomical Site
Posterior segment of the eye, anterior segment of the eye, human eye, retinal nerve fiber layer, optic nerve head, retina
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Ophthalmologist, office setting
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
optical lateral resolution: average value of 13um for the SO, and of 18um for the WFO.
Predicate Device(s)
Reference Device(s)
K101223, K121993, K152205, K113129
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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
2
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.
3
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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
5
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 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
Heidelberg Engineering GmbH
6
(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.
7
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)
8
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.
9
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 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 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 | 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 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 | The Indications
for Use statement
has been updated
for clarification:
1.) Formatting for
improved
readability
2.) "fundus
photography"
changed to
"fundus imaging"
for clarity
3.) Removed
statement related
to neuro-
degenerative
diseases upon
FDA request, to
not imply the use
of the device to
diagnose
neurological-based
diseases/
conditions.
4.) Clarification
on RDBs included
in the device | |
| subjects. | 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) | | |
| | PREDICATE DEVICE
K172649 | SUBJECT DEVICE | Same or Different |
| | SPECTRALIS HRA+OCT | | |
| User | Ophthalmologist, office
setting | Ophthalmologist, office
setting | Same |
| Eye contact
required? | No | No | Same |
| Dilation of
pupil required? | No | No | Same |
| Working
position | The patient is sitting straight
in front of the device. The
examiner is sitting opposite
the patient. | The patient is sitting straight
in front of the device. The
examiner is sitting opposite
the patient. | Same |
| Images of
posterior
segment of eye | Yes, using standard,
WFO/WFO2, or UWF
objective lens | Yes, using standard,
WFO/WFO2, or UWF
objective lens | Same |
| Images of
anterior
segment of eye | With Anterior Segment
Module (K113129) | With Anterior Segment
Module (K113129) | Same |
| OCT imaging
of the anterior
and posterior
segment | Anterior segment: With
Anterior Segment Module
(K113129)
Posterior Segment:
30° OCT field of view with
standard objective | Anterior segment: With
Anterior Segment Module
(K113129)
Posterior Segment:
30° OCT field of view with
standard objective, 55° OCT
field of view with
WFO/WF02 | Different; optional
OCT imaging with
WFO/WFO2 was
introduced |
| RNFL
Reference
Database | RNFL thickness in reference
database for 12° circle scans
(K101223)
RNFL thickness in reference
database for fixed diameter
circle scans (K152205) | RNFL thickness in reference
database for 12° circle scans
(K101223)
RNFL thickness in reference
database for fixed diameter
circle scans (K152205) | Same |
| ONH Reference
Database | 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
11
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.
12
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.