(329 days)
The SPECTRALIS is a non-contact ophthalmic diagnostic imaging device. It is intended for:
- · viewing the posterior segment of the eye, including two- and three-dimensional imaging
- · cross-sectional imaging (SPECTRALIS HRA+OCT and SPECTRALIS OCT)
- · fundus imaging
- · fluorescence imaging (fluorescein angiography, indocyanine green angiography; SPECTRALIS HRA+OCT, SPECTRALIS HRA)
- · autofluorescence imaging (SPECTRALIS HRA+OCT, SPECTRALIS HRA and SPECTRALIS OCT with BluePeak)
- · performing measurements of ocular anatomy and ocular lesions.
The device is indicated as an aid in the detection and management of various ocular diseases, including:
- age-related macular degeneration
- macular edema
- · diabetic retinopathy
- · retinal and choroidal vascular diseases
- glaucoma
The device is indicated for viewing geographic atrophy.
The SPECTRALIS OCT Angiography Module is indicated as an aid in the visualization of vascular structures of the retina and choroid.
The SPECTRALIS HRA+OCT and SPECTRALIS OCT include the following reference databases:
- · a retinal nerve fiber layer thickness reference database, which is used to quantitatively compare the retinal nerve fiber layer in the human retina to values of Caucasian normal subjects – the classification result being valid only for Caucasian subjects
- · a reference database for retinal nerve fiber layer thickness and optic nerve head neuroretinal rim parameter measurements, which is used to quantitatively compare the retinal nerve fiber layer and neuroretinal rim in the human retina to values of normal subjects of different races and ethnicities representing the population mix of the USA (Glaucoma Module Premium Edition)
The Heidelberg Engineering SPECTRALIS HRA+OCT is a device used to image the anterior and posterior segments of the human eye. The SPECTRALIS HRA+OCT is a combination of a confocal laser-scanning ophthalmoscope (cSLO, the HRA portion) and a spectral-domain optical coherence tomographer (SD-OCT). The confocal laserscanning part of the device allows for acquisition of reflectance images (with blue, green or infrared light), conventional angiography images (using fluorescein or indocyanine green dye) and autofluorescence images. The different imaging modes can be used either alone or simultaneously. The SD-OCT part of the device acquires cross-sectional and volume images, together with an HRA cSLO image.
A blue laser is used for fluorescein angiography, autofluorescence imaging, and blue reflectance imaging, and two infrared lasers are used for indocyanine green angiography and infrared reflectance imaging. A green laser is used for MultiColor imaging ("composite color images"). MultiColor imaging is the simultaneous acquisition of infrared, green and blue reflectance images that can be viewed separately or as a composite color image. For SD-OCT imaging, an infrared superluminescent diode and a spectral interferometer are used to create the cross-sectional images.
The following changes have been applied to the device subject of this 510(k):
- Widefield Reflectance mode for artifacts suppression
- Regression analysis in Glaucoma Module Premium Edition
- Thunderbolt 3 interface
- Thunderbolt cable fan
- Process separation of acquisition software module
- Windows 11 Support
The provided text describes a 510(k) summary for the SPECTRALIS HRA+OCT and variants, which is a non-contact ophthalmic diagnostic imaging device. It does not contain information about acceptance criteria or a specific study proving the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device (K201252) through non-clinical performance testing and a comparison of technological characteristics.
Therefore, I cannot provide the requested table and information based on the given text.
Here's what the document does provide regarding non-clinical performance testing:
Non-Clinical Performance Testing:
The modified SPECTRALIS device underwent non-clinical performance testing to ensure its safety and efficacy. This testing was guided by several FDA-recognized consensus standards:
- ISO 14971: 2019: Medical Devices - Application of Risk Management to Medical Devices.
- AAMI / ANSI ES 60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 Edition 3.1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- IEC 60601-1-2 Edition 4.0 2014-02: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
- IEC 62304 Edition 1.1 2015-06: Medical Device Software Software Life Cycle Processes.
The testing found that the device met the requirements of these applicable standards, demonstrating that the safety and efficacy of the modified device are comparable to the predicate.
Additionally, the following documentation was provided and verification/validation conducted:
- Software documentation, verification, and validation: Conducted as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
- Cybersecurity documentation: Submitted as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices".
Changes from the Predicate Device:
The modifications to the device since its previous clearance (K201252) include:
- Widefield Reflectance mode for artifact suppression.
- Regression analysis in Glaucoma Module Premium Edition.
- Thunderbolt 3 interface.
- Thunderbolt cable fan.
- Process separation of acquisition software module.
- Windows 11 Support.
The document explicitly states: "No data from human clinical studies has been included to support the substantial equivalence of the modified SPECTRALIS HRA+OCT and variants with the cleared SPECTRALIS device (K201252)." This indicates that a clinical study with acceptance criteria for device performance as typically understood (e.g., sensitivity, specificity, accuracy against a ground truth) was not performed or provided in this submission to support these specific modifications. The substantial equivalence is based on the claim that these modifications do not change the fundamental technology, acquired images, patient populations, or aid to clinical evaluation, and are supported by non-clinical verification.
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October 20, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Heidelberg Engineering GmbH % Lena Sattler Consultant Orasi Consulting, LLC. 226 1st Street Bonita Springs, Florida 34134
Re: K223557
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: September 15, 2023 Received: September 15, 2023
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Elvin Y. Ng -S
Elvin Ng Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Enclosure
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Indications for Use
510(k) Number (if known) K223557
Device Name SPECTRALIS HRA+OCT and variants
Indications for Use (Describe)
The SPECTRALIS is a non-contact ophthalmic diagnostic imaging device. It is intended for:
- · viewing the posterior segment of the eye, including two- and three-dimensional imaging
- · cross-sectional imaging (SPECTRALIS HRA+OCT and SPECTRALIS OCT)
- · fundus imaging
· fluorescence imaging (fluorescein angiography, indocyanine green angiography; SPECTRALIS HRA+OCT, SPECTRALIS HRA)
- · autofluorescence imaging (SPECTRALIS HRA+OCT, SPECTRALIS HRA and SPECTRALIS OCT with BluePeak)
- · performing measurements of ocular anatomy and ocular lesions.
The device is indicated as an aid in the detection and management of various ocular diseases, including:
- age-related macular degeneration
- macular edema
- · diabetic retinopathy
- · retinal and choroidal vascular diseases
- glaucoma
The device is indicated for viewing geographic atrophy.
The SPECTRALIS OCT Angiography Module is indicated as an aid in the visualization of vascular structures of the retina and choroid.
The SPECTRALIS HRA+OCT and SPECTRALIS OCT include the following reference databases:
· a retinal nerve fiber layer thickness reference database, which is used to quantitatively compare the retinal nerve fiber layer in the human retina to values of Caucasian normal subjects – the classification result being valid only for Caucasian subjects
· a reference database for retinal nerve fiber layer thickness and optic nerve head neuroretinal rim parameter measurements, which is used to quantitatively compare the retinal nerve fiber layer and neuroretinal rim in the human retina to values of normal subjects of different races and ethnicities representing the population mix of the USA (Glaucoma Module Premium Edition)
Type of Use (Select one or both, as applicable)
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/5/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 red square to the left of the word "HEIDELBERG" and to the right of the word "ENGINEERING".
510(K) SUMMARY
Date Prepared
October 20, 2023
SPONSOR/510(K) OWNER/ MANUFACTURER
Heidelberg Engineering GmbH Max-Jarecki-Strasse 8 69115 Heidelberg, Germany Telephone: +49 6221 / 64 63 0 Facsimile: +49 6221 / 64 63 62 Email: aschoess@hdeng.de Establishment Registration No.: 8043762
OFFICIAL CONTACT PERSON
Lena Sattler Orasi Consulting, LLC. 226 1st Street Bonita Springs, FL 34134 Telephone: (440) 554-3706 Facsimile: (866) 904-4315 E-mail: lena@orasiconsulting.com
COMMON/USUAL NAME
Optical Coherence Tomography
PROPRIETARY OR TRADE NAMES
SPECTRALIS HRA+OCT and variants
CLASSIFICATION INFORMATION
| Classification Name: | Tomography, Optical Coherence |
|---|---|
| Ophthalmoscope, Laser, Scanning | |
| Medical Specialty: | Ophthalmic |
| Device Class: | II |
| Classification Panel: | Ophthalmic Device Panel |
| Product Codes: | OBO, MYC |
PRODUCT CODE: CLASSIFICATION / CFR TITLE OBO, MYC: Class II § 21 CFR 886.1570
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PREDICATE DEVIC
SPECTRALIS HRA+OCT and variants (K201252), Heidelberg Engineering GmbH
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 imaging .
- . fluorescence imaging (fluorescein angiography, indocyanine green angiography; SPECTRALIS HRA+OCT, SPECTRALIS HRA)
- autofluorescence imaging (SPECTRALIS HRA+OCT, SPECTRALIS HRA . and SPECTRALIS OCT with BluePeak)
- performing measurements of ocular anatomy and ocular lesions. .
The device is indicated as an aid in the detection and management of various ocular diseases, including:
- age-related macular degeneration .
- macular edema
- diabetic retinopathy .
- retinal and choroidal vascular diseases .
- . glaucoma
The device is indicated for viewing geographic atrophy.
The SPECTRALIS OCT Angiography Module is indicated as an aid in the visualization of vascular structures of the retina and choroid.
The SPECTRALIS HRA+OCT and SPECTRALIS OCT include the following reference databases:
- a retinal nerve fiber layer thickness reference database, which is used to ● quantitatively compare the retinal nerve fiber layer in the human retina to values of Caucasian normal subjects - the classification result being valid only for Caucasian subjects
- a reference database for retinal nerve fiber layer thickness and optic nerve head . neuroretinal rim parameter measurements, which is used to quantitatively compare the retinal nerve fiber layer and neuroretinal rim in the human retina to values of normal subjects of different races and ethnicities representing the population mix of the USA (Glaucoma Module Premium Edition)
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GENERAL DEVICE DESCRIPTION
The Heidelberg Engineering SPECTRALIS HRA+OCT is a device used to image the anterior and posterior segments of the human eye. The SPECTRALIS HRA+OCT is a combination of a confocal laser-scanning ophthalmoscope (cSLO, the HRA portion) and a spectral-domain optical coherence tomographer (SD-OCT). The confocal laserscanning part of the device allows for acquisition of reflectance images (with blue, green or infrared light), conventional angiography images (using fluorescein or indocyanine green dye) and autofluorescence images. The different imaging modes can be used either alone or simultaneously. The SD-OCT part of the device acquires cross-sectional and volume images, together with an HRA cSLO image.
A blue laser is used for fluorescein angiography, autofluorescence imaging, and blue reflectance imaging, and two infrared lasers are used for indocyanine green angiography and infrared reflectance imaging. A green laser is used for MultiColor imaging ("composite color images"). MultiColor imaging is the simultaneous acquisition of infrared, green and blue reflectance images that can be viewed separately or as a composite color image. For SD-OCT imaging, an infrared superluminescent diode and a spectral interferometer are used to create the cross-sectional images.
The following changes have been applied to the device subject of this 510(k):
- Widefield Reflectance mode for artifacts suppression ●
- Regression analysis in Glaucoma Module Premium Edition .
- Thunderbolt 3 interface ●
- . Thunderbolt cable fan
- Process separation of acquisition software module ●
- Windows 11 Support
COMPARISON BETWEEN THE SUBJECT AND THE PREDICATE DEVICE
The modified SPECTRALIS HRA+OCT is a device modification to the cleared SPECTRALIS HRA+OCT and variants (K201252) predicate device. Technological detail characteristics of the device are unchanged except for the modification as stated in the General Device Description. The modified SPECTRALIS has the same Indications for Use and maintains the same fundamental scientific technology as the predicate device.
The Substantial Equivalence summary tables below illustrate the comparisons of the modified SPECTRALIS to the predicate device.
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INDICATIONS FOR USE STATEMENT CHART
| K221252 PREDICATE DEVICE | SUBJECT DEVICE | Same orDifferent | |
|---|---|---|---|
| The SPECTRALIS is a non-contact ophthalmic | The SPECTRALIS is a non-contact ophthalmic | Same | |
| diagnostic imaging device. It is intended for: | diagnostic imaging device. It is intended for: | ||
| • viewing the posterior segment of the eye, | • viewing the posterior segment of the eye, | ||
| including two- and three-dimensional imaging | including two- and three-dimensional imaging | ||
| • cross-sectional imaging (SPECTRALIS | • cross-sectional imaging (SPECTRALIS | ||
| HRA+OCT and SPECTRALIS OCT) | HRA+OCT and SPECTRALIS OCT) | ||
| • fundus imaging | • fundus imaging | ||
| • fluorescence imaging (fluorescein | • fluorescence imaging (fluorescein | ||
| angiography, indocyanine green angiography; | angiography, indocyanine green angiography; | ||
| SPECTRALIS HRA+OCT, SPECTRALIS | SPECTRALIS HRA+OCT, SPECTRALIS | ||
| HRA) | HRA) | ||
| • autofluorescence imaging (SPECTRALIS | • autofluorescence imaging (SPECTRALIS | ||
| HRA+OCT, SPECTRALIS HRA and | HRA+OCT, SPECTRALIS HRA and | ||
| SPECTRALIS OCT with BluePeak) | SPECTRALIS OCT with BluePeak) | ||
| • performing measurements of ocular anatomy | • performing measurements of ocular anatomy | ||
| and ocular lesions. | and ocular lesions. | ||
| The device is indicated as an aid in the | The device is indicated as an aid in the | ||
| detection and management of various ocular | detection and management of various ocular | ||
| diseases, including: | diseases, including: | ||
| • age-related macular degeneration | • age-related macular degeneration | ||
| • macular edema | • macular edema | ||
| • diabetic retinopathy | • diabetic retinopathy | ||
| • retinal and choroidal vascular diseases | • retinal and choroidal vascular diseases | ||
| • glaucoma | • glaucoma | ||
| The device is indicated for viewing geographic | The device is indicated for viewing geographic | ||
| atrophy. | atrophy. | ||
| The SPECTRALIS OCT Angiography Module | The SPECTRALIS OCT Angiography Module | ||
| is indicated as an aid in the visualization of | is indicated as an aid in the visualization of | ||
| vascular structures of the retina and choroid. | vascular structures of the retina and choroid. | ||
| The SPECTRALIS HRA+OCT and | The SPECTRALIS HRA+OCT and | ||
| SPECTRALIS OCT include the following | SPECTRALIS OCT include the following | ||
| reference databases: | reference databases: | ||
| • a retinal nerve fiber layer thickness reference | • a retinal nerve fiber layer thickness reference | ||
| database, which is used to quantitatively | database, which is used to quantitatively | ||
| compare the retinal nerve fiber layer in the | compare the retinal nerve fiber layer in the | ||
| human retina to values of Caucasian normal | human retina to values of Caucasian normal | ||
| subjects – the classification result being valid | subjects - the classification result being valid | ||
| only for Caucasian subjects | only for Caucasian subjects | ||
| • a reference database for retinal nerve fiber | • a reference database for retinal nerve fiber | ||
| layer thickness and optic nerve head | layer thickness and optic nerve head | ||
| neuroretinal rim parameter measurements, | neuroretinal rim parameter measurements, | ||
| which is used to quantitatively compare the | which is used to quantitatively compare the | ||
| retinal nerve fiber layer and neuroretinal rim in | retinal nerve fiber layer and neuroretinal rim in | ||
| the human retina to values of normal subjects | the human retina to values of normal subjects | ||
| of different races and ethnicities representing | of different races and ethnicities representing | ||
| the population mix of the USA (Glaucoma | the population mix of the USA (Glaucoma | ||
| Module Premium Edition) | Module Premium Edition) | ||
| PREDICATE DEVICEK201252 SPECTRALIS | SUBJECT DEVICE | Same orDifferent | |
| HRA+OCT | |||
| Deviceclassificationname | Optical CoherenceTomographer (OCT) | Optical CoherenceTomographer (OCT) | Same |
| Technologyand opticalsetup | Confocal Scanning LaserOphthalmoscope (SLO) andSpectral- Domain OpticalCoherence Tomograph (OCT) | Confocal Scanning LaserOphthalmoscope (SLO) andSpectral- Domain OpticalCoherence Tomograph (OCT) | Same |
| PhysicalDimensions | • Laser scanning camera: 235mm x 100 mm x 205 mm• Instrumentation Mount(KT):470 mm x 325 mmx 550 mm• Power supply includingspectrometer: 180 mm x 335mm x 165 mm Operationpanel:170 mm x 185 mm x 100 mm | • Laser scanning camera: 235mm x 100 mm x 205 mm• Instrumentation Mount(KT):470 mm x 325 mmx 550 mm• Power supply includingspectrometer: 180 mm x 335mm x 165 mm• Operation panel: 170 mm x185 mm x 100 mm | Same |
| Lights sourcesand wavelengthof light emitted | • Near infrared reflectance images:diode laser, 815 nm,• Blue light reflectance images:diode laser, 486 nm, oroptically pumpedsemiconductor laser, 488 nm• Green light reflectanceimages: diode laser, 518 nm• Fluorescein angiography: diodelaser, 486 nm, or opticallypumped semiconductor laser, 488nm• Indocyanine greenangiography: diode laser,786 nmOptical coherence tomography:superluminescence diode, 840 nmto 920 nm (weighted average 880nm) | • Near infrared reflectance images:diode laser, 815 nm,• Blue light reflectance images:diode laser, 486 nm, oroptically pumpedsemiconductor laser, 488 nm• Green light reflectanceimages: diode laser, 518 nm• Fluorescein angiography: diodelaser, 486 nm, or opticallypumped semiconductor laser, 488nm• Indocyanine green angiography:diode laser,786 nmOptical coherence tomography:superluminescence diode, 840 nmto 920 nm (weighted average 880nm) | Same |
| Wavelength oflight detected | • Near infrared reflectance images:815 nm• Blue light reflectance images:486-488 nm• Green light reflectance images:518 nm• Fluorescein angiography: 500 nmto 720 nm• Indocyanine green angiography:800 nm to 900 nm• Optical coherence tomography: | • Near infrared reflectance images:815 nm• Blue light reflectance images:486-488 nm• Green light reflectance images:518 nm• Fluorescein angiography: 500 nmto 720 nm• Indocyanine green angiography:800 nm to 900 nm• Optical coherence tomography: | Same |
| Type of lightsource used | Laser diodes (LD) andsuperluminescence diode (SLD) | Laser diodes (LD) andsuperluminescence diode (SLD) | Same |
| Amount oflight irradiatedto retina(exposure) | Low amount, does not exceedClass I laser accessible emissionlimits | Low amount, does not exceedClass I laser accessible emissionlimits | Same |
| Lateral opticalresolution(OCT) | 14 um (standard objective)24 um (WFO2) | 14 um (standard objective)24 um (WFO2) | Same |
| Focusadjustmentrange | Correction of patient'srefractive errors:minimum range: -12to +12 diopters | Correction of patient'srefractive errors:minimum range: -12to +12 diopters | Same |
| Optical depthresolution(OCT) | 7 um | 7 um | Same |
| OCTacquisitionspeed(Maximum A-scan rate) | 40 kHz (Firewire)85 kHz (Thunderbolt) Haspossibility for higher speeds(future submission) | 40 kHz (Firewire)85 kHz (Thunderbolt) Haspossibility for higher speeds(future submission) | Same |
| OCTacquisitionmodes | Standard Enhanced DepthImaging (EDI)Enhanced Vitreous Imaging(EVI) | Standard Enhanced DepthImaging (EDI)Enhanced Vitreous Imaging(EVI) | Same |
| cSLO imagingmodes forartifactsuppression | Reflectance (R)Cross-Polarization (XP) | Reflectance (R)Cross-Polarization (XP)Widefield Reflectance (WR) | Different;the WR filterhas beenintroducedfor themodifieddevice as analternativeoption to XP |
| OCTA scantypes | Volume OCTA ScoutOCTA DART VolumeOCTA DART Line | Volume OCTA ScoutOCTA DART VolumeOCTA DART Line | Same |
| Lateral field ofview (SLO) | SO (standard objective):15°x15° to 30 x30°HMM: 8°x8°WFO2: 25°x25° to Ø 55°UWF Objective: 51°x 1°to Ø102° | SO (standard objective):15°x15° to 30 x30°HMM: 8°x8°WFO2: 25°x25° to Ø 55°UWF Objective: 51°x 1°to Ø102° | Same |
| Lateral field ofview (OCT) | Standard objective lens: 15°-30°WFO2: 25°-55° | Standard objective lens: 15°-30°WFO2: 25°-55° | Same |
| Lateral digitalresolution(SLO) | high speed mode: 3um (HMM),11 um (SO) to 40 um (UWF)high resolution mode:1.5µm (HMM), 6 µm(SO) to 20 um (UWF) | high speed mode: 3um (HMM),11 um (SO) to 40 um (UWF)high resolution mode:1.5µm (HMM), 6 µm(SO) to 20 um (UWF) | Same |
| Lateral digitalresolution(OCT) | Standard and WFO2 objectivelenses: same as SLO | Standard and WFO2 objectivelenses: same as SLO | Same |
| Digital axialresolution (pixelsize OCT) | 3.9 μm | 3.9 μm | Same |
| Digital imagesize (SLO) | high speed mode: 384x384pixels to 768x768 pixelshigh resolution mode: 768x768 to1536 x1536 pixels | high speed mode: 384x384pixels to 768x768 pixelshigh resolution mode: 768x768 to1536 x1536 pixels | Same |
| Acquisition ofthree-dimensionalimages | Yes,HRA: stacks of confocalsection images;OCT: OCT volume scan | YesHRA: stacks of confocalsection images;OCT: OCT volume scan | Same |
| GlaucomaModule: BMO-MRW andRNFL thickness | Measured data points are displayed | Regression line is displayed formeasured data points | Different,regressionline has beenadded formeasureddata |
| Start of theacquisitionmodule software | The acquisition module software isloaded by HEYEX as DLL file | New proxy DLL is loaded byHeyex and starts the acquisitionmodule software as a new process | Different;the HEYEXand AQMsoftwarememoryhave beenseparated |
| Imagecompression | No | No | Same |
| Display of thedata | Images are visible on a standardPC- Monitor | Images are visible on a standardPC- Monitor | Same |
| Physical layout | Instrumentation mount withheadrest optical camera head power supply and spectrometerunit touch panel computer with monitor,keyboard, mouse, and printer | Instrumentation mount withheadrest optical camera head power supply and spectrometerunit touch panel computer with monitor,keyboard, mouse, and printer | Same |
| ThunderboltInterface | • Thunderbolt-2 Interface | • Thunderbolt-3 Interface withadditional fan | Different;TDI-3 isappliedbecause ofdiscontinuedTDI-2,additionalcooling ofThunderboltcable |
| Flammability ofthe materials | The metal housing of the device | The metal housing of the device | Same |
| StandardObjective Lens | 19.5 mm working distance, 31 mmlength, 49 outer mm diameter | 19.5 mm working distance, 31 mmlength, 49 outer mm diameter | Same |
| HighMagnificationModule (HMM) | 50mm working distance, 29mmlength, 49mm outer diameter;not used for measurements | 50mm working distance, 29mmlength, 49mm outer diameter;not used for measurements; | Same |
| AnteriorSegmentModule (ASM)Objective Lens | 12 mm working distance, 65 mmlength, 49.5 mm outer diameter30° field of viewnot used for measurements | 12 mm working distance, 65 mmlength, 49.5 mm outer diameter30° field of viewnot used for measurements | Same |
| Wide FieldObjective(WFO2) | 10 mm workingdistance, 46 mm length, 49 mmouter diameter;55° field of view; not used for | 10 mm workingdistance, 46 mm length, 49 mmouter diameter;55° field of view; not used formeasurements;WFO2 has the same design andoptical layout as WFO, but animproved anti-reflective coating | Same |
| Ultra-Widefield(UWF)AccessoryObjective Lens | 7.8 mm workingdistance, 167 mm length, 80 mmouter diameter;102° field of view;not used for measurements | 7.8 mm workingdistance, 167 mm length, 80 mmouter diameter;102° field of view;not used for measurements | Same |
| SupportedOperatingSystem | Windows 10 | Windows 10Windows 11 | Different;Windows 11is supportedin additionto Windows10 |
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TECHNOLOGICAL CHARACTERISTICS COMPARISON CHART
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NON-CLINICAL PERFORMANCE TESTING
The modified SPECTRALIS was evaluated according to the requirements of FDA recognized consensus standards:
- . ISO 14971: 2019 Medical Devices - Application of Risk Management to Medical Devices,
- AAMI / ANSI ES 60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and . A2:2010/(R)2012 Edition 3.1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance,
- . IEC 60601-1-2 Edition 4.0 2014-02, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests,
- IEC 62304 Edition 1.1 2015-06: Medical Device Software Software Life ● Cycle Processes,
and was found to meet the requirements of the applicable parts, demonstrating that the safety and efficacy of the modified device is comparable to the predicate.
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Software documentation was provided, and software verification and validation was conducted as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
Documentation regarding cybersecurity was submitted as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices".
CLINICAL PERFORMANCE TESTING
No data from human clinical studies has been included to support the substantial equivalence of the modified SPECTRALIS HRA+OCT and variants with the cleared SPECTRALIS device (K201252).
CONCLUSION
The modified SPECTRALIS HRA+OCT and variants measures the same ophthalmic features as the cleared SPECTRALIS HRA+OCT in K201252. The changes applied to the SPECTRALIS since the clearance in K201252 introduce an additional cSLO imaging suppression mode, a regression line for measured data in the Glaucoma Module, Thunderbolt-3 interface with cable fan and a separated start of the acquisition software module. They do not change the fundamental technology, the type of acquired images, the intended patient populations, or that the SPECTRALIS may be used as an aid to clinical evaluation.
Non-clinical performance testing was conducted on the modified SPECTRALIS HRA+OCT to verify that the device is safe and effective for its intended use and indications for use.
The modifications to the device do not raise issues of safety and effectiveness. A comparison of technological characteristics and non-clinical performance testing demonstrate that the modified SPECTRALIS device is substantially equivalent to the predicate device.
§ 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.