(57 days)
No
The document describes a diagnostic imaging device with reference databases for comparison, but there is no mention of AI or ML being used for image analysis, interpretation, or any other function. The modifications listed are hardware and software updates for basic functionality and data management.
No
The device is described as a "non-contact ophthalmic diagnostic imaging device" and its intended use is for "viewing the posterior segment of the eye" and as an "aid in the detection and management of various ocular diseases." These descriptions clearly indicate a diagnostic, rather than therapeutic, purpose.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The SPECTRALIS is a non-contact ophthalmic diagnostic imaging device." It further elaborates that it is "indicated as an aid in the detection and management of various ocular diseases."
No
The device description explicitly details hardware components like the OCT2 Module (replacement of Line Scan Camera and PC interface), Wide Field Objective 2 (WFO2), and mentions accessory objective lenses. It also describes the device as a "non-contact ophthalmic diagnostic imaging device," which inherently involves hardware for image acquisition. The modifications listed are primarily hardware or software updates to existing hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- SPECTRALIS Function: The SPECTRALIS is a non-contact ophthalmic diagnostic imaging device that directly images the posterior and anterior segments of the eye. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's for "viewing the posterior segment of the eye" and "to perform measurements of ocular anatomy and ocular lesions." This involves direct imaging of the eye itself.
Therefore, the SPECTRALIS falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
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 (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 agerelated macular degeneration, macular edema, diabetic 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.
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.
The modifications to the SPECTRALIS are:
-
- OCT2 Module (OCT2) replacement of the Line Scan Camera and PC interface. OCT2 was developed due to the discontinuation of components.
-
- Wide Field Objective 2 (WFO2) The WFO provides a 55° diameter circular field of view. The field of view can be reduced by the software to 35° and 25°. The AR-coating of the WFO was optimized in order to reduce the remaining reflections at the MultiColor wavelengths 486 nm. 518 nm and 815 nm. The AR-coating also allows for MultiColor imaging.
-
- An upgrade to the data and patient management system (Heyex 2). Heyex 2 has the same basic functionality as the data and patient management system of the cleared SPECTRALIS, Heyex 1. The main improvements of Heyex 2 compared to Heyex 1 are an up-to-date and more scalable underlying image database, and a modern User Interface.
-
- Windows 10 Operating System support.
-
- Labeling The user manual has been updated to (1) improve clarity, (2) improve grammar and (3) include the modifications made to the SPECTRALIS HRA+OCT and variants. The Intended Use/Indications for Use of the modified device, as described in the labeling has not changed as a result of the modifications.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical coherence tomography, fundus photography, fluorescence imaging (fluorescein angiography, indocyanine green angiography), autofluorescence imaging
Anatomical Site
posterior segment of the eye, anterior segment of the eye
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance summary indicates evaluation according to 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. The device was found to meet the requirements of the applicable parts.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is in blue and consists of the letters "FDA" and the words "U.S. Food & Drug Administration".
November 1, 2017
Heidelberg Engineering GmbH % Lena Sattler Consultant Orasi Consulting, LLC. 1655 Forest Dr. Medina, OH 44256
Re: K172649
Trade/Device Name: Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor Regulation Number: 21 CFR 886.1570
Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO, MYC Dated: October 20, 2017 Received: October 23, 2017
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. 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.
1
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Denise L. Hampton -S
for Malvina B. Eydelman, 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) K172649
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 (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 agerelated macular degeneration, macular edema, diabetic 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.
Type of Use (Select one or both, as applicable):
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 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.
510(K) SUMMARY - K172649
Date Prepared
October 29, 2017
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 Gerhard.Zinser@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 Proprietary and Confidential Information 510(k) Summary: SPECTRALIS Page 1 of 7
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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, with a red square on either side. The first line reads "HEIDELBERG" and the second line reads "ENGINEERING".
PRODUCT CODE: CLASSIFICATION / CFR TITLE
OBO, MYC:
Class II § 21 CFR 886.1570
LEGALLY MARKETED UNMODIFIED PREDICATE DEVICE
| Trade/Device Name: | SPECTRALIS HRA+OCT and variants |
|---|---|
| Applicant: | Heidelberg Engineering GmbH |
| 510(k) Premarket Notification number: | K152205 |
| Classification: | Class II |
| CFR Title: | 21 CFR 886.1570 |
| FDA Product Code(s): | OBO, MYC |
| Classification Name: | Ophthalmoscope, AC Powered |
| Ophthalmoscope, Laser, Scanning | |
| Common Name: | Optical Coherence Tomography |
| Medical Specialty: | Ophthalmic |
| Classification Panel: | 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.
The modifications to the SPECTRALIS are:
-
- OCT2 Module (OCT2) replacement of the Line Scan Camera and PC interface. OCT2 was developed due to the discontinuation of components.
-
- Wide Field Objective 2 (WFO2) The WFO provides a 55° diameter circular field of view. The field of view can be reduced by the software to 35° and 25°. The AR-coating of the WFO was optimized in order to reduce the remaining
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 on either side of the text.
reflections at the MultiColor wavelengths 486 nm. 518 nm and 815 nm. The AR-coating also allows for MultiColor imaging.
-
- An upgrade to the data and patient management system (Heyex 2). Heyex 2 has the same basic functionality as the data and patient management system of the cleared SPECTRALIS, Heyex 1. The main improvements of Heyex 2 compared to Heyex 1 are an up-to-date and more scalable underlying image database, and a modern User Interface.
-
- Windows 10 Operating System support.
-
- Labeling The user manual has been updated to (1) improve clarity, (2) improve grammar and (3) include the modifications made to the SPECTRALIS HRA+OCT and variants. The Intended Use/Indications for Use of the modified device, as described in the labeling has not changed as a result of the modifications.
INDICATIONS FOR USE
The SPECTRALIS is a non-contact ophthalmic diagnostic imaging device. It is intended for viewing the posterior segment of the eye, including two- and threedimensional imaging, cross-sectional imaging (SPECTRALIS HRA+OCT and SPECTRALIS OCT), fundus 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.
SUBSTANTIAL EQUIVALENCE
The modified SPECTRALIS HRA+OCT and variants is a device modification to the cleared SPECTRALIS HRA+OCT and variants (K152205) predicate device. The modified SPECTRALIS has the same Intended Use/Indications for Use and the same fundamental scientific technology as the predicate device.
Heidelberg Engineering GmbH Proprietary and Confidential Information
6
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 K152205.
The changes applied to the SPECTRALIS since the clearance in K152205 do not change the subject population for whom the device is used, the type of images to be acquired, 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/7/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.
INTENDED USE/INDICATIONS FOR USE STATEMENT CHART
| K152205
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
subjects. | 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
subjects. | Same | |
| | PREDICATE DEVICE
K152205
SPECTRALIS
HRA+OCT | SUBJECT DEVICE | Same or Different |
| 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,
or UWF objective lens | Yes, using standard, WFO
/ WFO2, or UWF
objective lens | Same; WFO2 was
introduced, which has an
enhanced anti-reflective
coating, but offers the same
field of view and has the
same optical design. |
| Images of
anterior
segment of
eye | With Anterior Segment
Module (K113129) | With Anterior Segment
Module (K113129) | Same |
| 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 |
8
Image /page/8/Picture/0 description: The image shows the logo for Heidelberg Engineering. The logo consists of two lines of text in a bold, sans-serif font. The first line reads "HEIDELBERG" and the second line reads "ENGINEERING". There is a red square to the left of the word "HEIDELBERG" and to the right of the word "ENGINEERING".
INTENDED USE CHARACTERISTICS CHART
9
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.
CONCLUSION
The modified SPECTRALIS is a device modification to the cleared SPECTRALIS predicate device. The modified SPECTRALIS has the same 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.