(185 days)
The TOPCON 3D Optical Coherence Tomography 3D OCT-1 (Type:Maestro2) is a noncontact, high resolution tomographic and biomicroscopic imaging device that incorporates a digital camera for photographing, displaying and storing the data of the retina and surrounding parts of the eye to be examined under Mydriatic and non-Mydriatic conditions.
The TOPCON 3D Optical Coherence Tomography 3D OCT-1 (Type:Maestro2) is indicated for in vivo viewing, axial cross sectional, and three-dimensional imaging and measurement of posterior ocular structures, including retina, retinal nerve fiber layer, macula and optic disc as well as imaging of anterior ocular structures.
It also includes a Reference Database for posterior ocular measurements which provide for the quantitative comparison of retinal nerve fiber layer, optic nerve head, and the macula in the human retina to a database of known normal subjects.
The TOPCON 3D Optical Coherence Tomography 3D OCT-1 (Type:Maestro2)is indicated for use as a diagnostic device to aid in the diagnosis, documentation and management of ocular health and diseases in the adult population.
3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) is a non-contact ophthalmic device combining spectral-domain optical coherence tomography (SD-OCT) with digital color fundus photography. Maestro2 includes an optical system of OCT, fundus camera (color, IR and Red-free image), and anterior observation camera. The color fundus camera acquires color images of the posterior segment of the eye under mydriatic or non-mydriatic conditions.
This document is a 510(k) premarket notification for the TOPCON 3D Optical Coherence Tomography 3D OCT-1 (Type: Maestro2). It aims to demonstrate substantial equivalence to a legally marketed predicate device (TOPCON 3D OCT-1, K170164). The document indicates that clinical performance data was NOT required for this 510(k). Therefore, the device's acceptance criteria and the study proving it meets them do not involve clinical trials or human-in-the-loop performance studies as typically seen with AI-powered diagnostics.
Instead, the performance data provided focuses on verifying the device functions as intended through engineering tests against a set of FDA-recognized, voluntary consensus standards and in-house specifications. The substantial equivalence argument relies on the similarity of intended use, indications for use, operating principle, and technological characteristics to the predicate device.
Therefore, based on the provided document, the following points regarding acceptance criteria and studies are applicable primarily to the technical performance and substantial equivalence to a predicate device, rather than a clinical performance study of a novel AI algorithm.
1. A table of acceptance criteria and the reported device performance:
The document doesn't present a specific "acceptance criteria" table with precise numerical values for clinical performance metrics. Instead, it demonstrates compliance with recognized technical standards for ophthalmic devices and general medical electrical equipment. The "reported device performance" is implicitly that the device meets these standards and performs equivalently to the predicate.
Here's an interpretation based on the provided information, focusing on functional specifications, as no clinical performance data was provided or required:
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (Implied from "Substantial Equivalence" discussion) |
|---|---|---|
| General Safety & Performance | Compliance with: - IEC 60601-1-2:2014+AMD1:2020 (Medical electrical equipment - Electromagnetic disturbances)- ANSI AAMI ES60601-1:2005/(R)2012 (Medical electrical equipment - Basic safety and essential performance)- ISO 15004-1:2020 (Ophthalmic instruments - General requirements) | Device performs as intended and complies with these standards, demonstrating substantial equivalence. |
| Ophthalmic Instrument Specifics | Compliance with: - ISO 10940:2009 (Ophthalmic instruments - Fundus cameras)- ANSI Z80.36-2021 (Light Hazard Protection for Ophthalmic Instruments) | Device performs as intended and complies with these standards, demonstrating substantial equivalence. Specifically "Device testing confirmed Maestro2 fulfills the standard for fundus camera." |
| Usability | Compliance with: - IEC 60601-1-6:2013 (Usability)- IEC 62366-1:2015+AMD1:2020 (Application of usability engineering) | Device performs as intended and complies with these standards. |
| Laser Safety | Compliance with: - IEC 60825-1:2007 (Safety of laser products) | Device performs as intended and complies with these standards. |
| Biocompatibility (if applicable) | Compliance with: - ISO 10993-1:2018 (Biological evaluation - General)- ISO 10993-5:2009 (Biological evaluation - Cytotoxicity)- ISO 10993-10:2010 (Biological evaluation - Irritation and skin sensitization) | Device performs as intended and complies with these standards. |
| Software Performance | Compliance with: - IEC 62304:2015 (Medical device software - Software life cycle processes) | Software verification and validation testing were performed and documentation provided. "Software for Maestro2 was concluded to be a Moderate level of concern." "software testing confirmed Maestro2 functions as intended with the updated windows OS version." |
| Interoperability | Compliance with: - NEMA PS 3.1 - 3.20 2021e (Digital Imaging and Communications in Medicine (DICOM) Set) | Device performs as intended and complies with this standard. |
| Functional Equivalence | Match or demonstrate equivalent performance for: - Type of photography (Color, Red-free, IR)- Picture angle- Operating distance- Observable/photographable pupil diameter- Scan range and pattern- Scan speed- Lateral and In-depth resolution- Fixation target- Absence/presence of movable IR filter (with justification for difference)- Focal length of relay lens (with justification for difference)- Camera specifications (Resolution, Sensor type, IF, Pixel size) | "The results of the testing support substantial equivalence by demonstrating that the device performs as intended and complies with the same standards as the predicate device." Differences in camera, IR filter, focal length, and OS are addressed with verification testing deeming them equivalent or not affecting SE. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Since no clinical data was required or submitted, there is no "test set" of patient data in the clinical sense. The testing performed was primarily engineering and validation testing of the device's technical specifications and compliance with standards. The document does not specify sample sizes for these technical tests (e.g., how many units were tested for electrical safety or image resolution), nor does it describe data provenance in terms of patient demographics or study design (retrospective/prospective, country of origin).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the submission did not rely on a clinical test set with ground truth established by medical experts. The ground truth for technical tests would be established by engineering specifications and reference standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no clinical test set requiring medical expert adjudication was used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. The device is an imaging device (OCT) and does not appear to incorporate AI for diagnostic assistance according to the provided summary, nor was a comparative effectiveness study involving human readers required or conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is an imaging system, not presented as an "algorithm only" diagnostic tool. Its performance characterization is based on technical specifications and adherence to engineering standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this submission refers to the technical and performance specifications outlined in the relevant FDA-recognized consensus standards (e.g., IEC, ISO, ANSI) and the manufacturer's in-house specifications. For example, for image resolution, the ground truth is a specific lines/mm measurement that the device must achieve.
8. The sample size for the training set:
Not applicable. This document is for an imaging device, not an AI model that requires a "training set" of data for learning.
9. How the ground truth for the training set was established:
Not applicable, as there is no "training set" for this device.
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October 30, 2023
Topcon Corporation % Lena Sattler President Orasi Consulting, LLC 226 1st Street Bonita Springs, Florida 34134
Re: K231222
Trade/Device Name: 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2), Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO, HKI Dated: September 28, 2023 Received: September 28, 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.
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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).
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 QS 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
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DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)
Indications for Use (Describe) 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)
The TOPCON 3D Optical Coherence Tomography3D OCT-1 (Type:Maestro2) is a noncontact, high resolution tomographic and biomicroscopic imaging device that incorporates a digital camera for photographing, displaying and storing the data of the retina and surrounding parts of the eye to be examined under Mydriatic conditions.
The 3D Optical Coherence Tomography 3D OCT-1 (Type:Maestro2) is indicated for in vivo viewing, axial cross sectional, and three-dimensional imaging and measurement of posterior ocular structures, including retinal nerve fiber layer, macula and optic disc as well as imaging of anterior ocular structures.
It also includes a Reference Database for posterior ocular measurements which provide for the quantitative comparison of retinal nerve fiber layer, optic nerve head, and the macula in the human retina to a database of known normal subjects.
The 3D Optical Cherence Tomography 3D OCT-1 (Type:Maestro2) is indicated for use as a diagnostic device to aid in the diagnosis, documentation and management of ocular health and diseases in the adult population.
| 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) |
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510(k) SUMMARY TOPCON CORPORATION Traditional 510(k) for: 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)
GENERAL INFORMATION
Submitter's information: TOPCON Corporation 75-1 Hasunuma-cho, Itabashi-ku Tokyo, 174-8580, Japan
Contact person:
Lena Sattler President, Orasi Consulting Phone: 440-554-3706
Date Prepared:
October 27, 2023
DEVICE INFORMATION
SUBJECT DEVICE: 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)
| Name of Device: | 3D OPTICAL COHERENCE TOMOGRAPHY3D OCT-1(type: Maestro2) |
|---|---|
| Device Class: | Class II |
| Classification Name: | 21 C.F.R. § 886.1570, Ophthalmoscope |
| Product Code: | OBO, HKI |
PREDICATE DEVICE:
3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2):
| Company | Topcon Corporation |
|---|---|
| Device | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 |
| 510(k) No. | K170164 |
Brief Device Description
3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)
3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) is a non-contact ophthalmic device combining spectral-domain optical coherence tomography (SD-OCT) with digital color fundus photography. Maestro2 includes an optical system of OCT, fundus camera (color, IR and Red-free image), and anterior observation camera. The color fundus camera acquires color images of the posterior segment of the eye under mydriatic or non-mydriatic conditions.
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Intended Use / Indications for Use
3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)
The TOPCON 3D Optical Coherence Tomography 3D OCT-1 (Type:Maestro2) is a noncontact, high resolution tomographic and biomicroscopic imaging device that incorporates a digital camera for photographing, displaying and storing the data of the retina and surrounding parts of the eye to be examined under Mydriatic and non-Mydriatic conditions.
The TOPCON 3D Optical Coherence Tomography 3D OCT-1 (Type:Maestro2) is indicated for in vivo viewing, axial cross sectional, and three-dimensional imaging and measurement of posterior ocular structures, including retina, retinal nerve fiber layer, macula and optic disc as well as imaging of anterior ocular structures.
It also includes a Reference Database for posterior ocular measurements which provide for the quantitative comparison of retinal nerve fiber layer, optic nerve head, and the macula in the human retina to a database of known normal subjects.
The TOPCON 3D Optical Coherence Tomography 3D OCT-1 (Type:Maestro2)is indicated for use as a diagnostic device to aid in the diagnosis, documentation and management of ocular health and diseases in the adult population.
Performance Data
It has been verified that the subject devices function as intended by tests or evaluations based on the following FDA-recognized, voluntary consensus standards, and the in-house test specification. The results of the testing support substantial equivalence by demonstrating that the device performs as intended and complies with the same standards as the predicate device.
| FDA-recognized, voluntary consensus standards | |
|---|---|
| IEC 60601-1-2:2014+AMD1:2020 | Medical electrical equipment - Part 1-2:General requirements for basic safety and essential performance -Collateral standard: Electromagnetic disturbances - Requirementsand tests |
| ANSI AAMI ES60601- 1:2005/(R)2012 andA1:2012, C1:2009/(R)2012 andA2:2010/(R)2012 | Medical electrical equipment - Part 1: General requirements forbasic safety and essential performance |
| ISO 15004-1:2020 | Ophthalmic instruments - Fundamental requirements and testmethods - Part 1: General requirements applicable to allophthalmic instruments |
| ISO 10940:2009 | Ophthalmic instruments - Fundus cameras |
| ANSI Z80.36-2021 | American National Standard for Ophthalmics - Light HazardProtection for Ophthalmic Instruments |
| IEC 60601-1-6: 2013 | Medical electrical equipment - Part 1-6: General requirements forbasic safety and essential performance - Collateral standard:Usability |
| IEC62366-1:2015+AMD1:2020 | Medical devices - Part 1: Application of usability engineering tomedical devices |
3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)
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| FDA-recognized, voluntary consensus standards | |
|---|---|
| IEC 60825-1: 2007 | Safety of laser products - Part 1: Equipment classification, and requirements |
| ISO 10993-1:2018 | Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process |
| ISO 10993-5:2009 | Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity |
| ISO 10993-10:2010 | Biological evaluation of medical devices-Part 10: Tests for irritation and skin sensitization |
| IEC 62304:2015 | Medical device software - Software life cycle processes |
| NEMA PS 3.1 - 3.20 2021e | Digital Imaging and Communications in Medicine (DICOM) Set |
Software for Maestro2 was concluded to be a Moderate level of concern. Software verification and validation testing were performed, and documentation was provided as recomment Guidance document Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (issued on May 11, 2005).
Clinical Performance Data
This section is not applicable because clinical data was not required for this 510(k)
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Substantial Equivalence
The subject device is substantially equivate device because the intended use indications for use, operation principle and technological characteristics of the subject device is substantially equivalent to the predicate device as shown in Table 1 below.
| Model Number | Subject Device3D OCT-1 Maestro2 | Predicate device3D OCT-1 | SubstantialEquivalenceDiscussion |
|---|---|---|---|
| Trade Name | 3D OPTICAL COHERENCE TOMOGRAPHY | 3D OPTICAL COHERENCE TOMOGRAPHY | N/A |
| 3D OCT-1(type: Maestro2) | 3D OCT-1 | ||
| 510(k)submitter/holder | TOPCON Corporation | TOPCON Corporation | Same |
| 510(k) Number | TBD | K170164 | N/A |
| Product code | OBO, HKI | OBO, HKI | Same |
| Regulation No. | 21 C.F.R. § 886.1570 | 21 C.F.R. § 886.1570 | Same |
| Product class | II | II | Same |
| Indications forUse | The TOPCON 3D Optical Coherence Tomography 3D OCT-1(Type:Maestro2) is a noncontact, high resolution tomographic andbiomicroscopic imaging device that incorporates a digital camerafor photographing, displaying and storing the data of the retina andsurrounding parts of the eye to be examined under Mydriatic andnon-Mydriatic conditions.The 3D Optical Coherence Tomography 3D OCT-1(Type:Maestro2) is indicated for in vivo viewing, axial crosssectional, and three-dimensional imaging and measurement ofposterior ocular structures, including retina, retinal nerve fiberlayer, macula and optic disc as well as imaging of anterior ocularstructures.It also includes a Reference Database for posterior ocularmeasurements which provide for the quantitative comparison of | The TOPCON 3D OCT-1 Maestro is a non-contact, high resolutiontomographic and biomicroscopic imaging device that incorporatesa digital camera for photographing, displaying and storing the dataof the retina and surrounding parts of the eye to be examined underMydriatic and non-Mydriatic conditions.The 3D OCT-1 Maestro is indicated for in vivo viewing, axial crosssectional, and three-dimensional imaging and measurement ofposterior ocular structures, including retina, retinal nerve fiberlayer, macula and optic disc as well as imaging of anterior ocularstructures.It also includes a Reference Database for posterior ocularmeasurements which provide for the quantitative comparison of | DifferentThere is adifference inproduct namewhere "(type:Maestro2)" wasadded. However,a difference inproduct namedoes not affect SEof subject deviceand predicatedevice. |
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| Model Number | Subject Device3D OCT-1 Maestro2 | Predicate device3D OCT-1 | SubstantialEquivalenceDiscussion | ||||
|---|---|---|---|---|---|---|---|
| retinal nerve fiber layer, optic nerve head, and the macula in the human retina to a database of known normal subjects. | retinal nerve fiber layer, optic nerve head, and the macula in the human retina to a database of known normal subjects. | ||||||
| The 3D Optical Coherence Tomography 3D OCT-1(Type:Maestro2) is indicated for use as a diagnostic device to aid in the diagnosis, documentation and management of ocular health and diseases in the adult population. | The 3D OCT-1 Maestro is indicated for use as a diagnostic device to aid in the diagnosis, documentation and management of ocular health and diseases in the adult population. | ||||||
| Item | Device Specification | Item | Device Specification | Same | |||
| Observation & photographing of the fundus | Observation & photographing of the fundus | ||||||
| Type of photography | Color, Red-free (Note 1) & IR (Note 3) | Type of photography | Color, Red-free (Note 1) & IR (Note 3) | ||||
| DeviceSpecifications | Picture angle forobservation/photography | 45° ±5% or less 30° or equivalent(digital zoom) | Picture angle forobservation/photography | 45° ±5% or less 30° or equivalent(digital zoom) | |||
| Operating distance | 34.8 ±0.1mm (when taking a picture of fundus) | Operating distance | 34.8 ±0.1mm (when taking a picture of fundus) | ||||
| Observable/photographable diameter of pupil | φ4.0mm or more: When small pupil diaphragm is NOT used.φ3.3mm or more: When small pupil diaphragm is used. | Observable/photographable diameter of pupil | φ4.0mm or more: When small pupil diaphragm is NOT used.φ3.3mm or more: When small pupil diaphragm is used. | ||||
| Fundus image resolution (on fundus) | Optical FunctionCenter: 60 lines/mm or moreMiddle (r/2): 40 lines/mm or morePeriphery (r): 25 lines/mm or more | Fundus image resolution (on fundus) | With Camera FunctionCenter: 50 lines/mm or moreMiddle (r/2): 40 lines/mm or morePeriphery (r): 25 lines/mm or more |
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| Model Number | Subject Device3D OCT-1 Maestro2 | Predicate device3D OCT-1 | SubstantialEquivalenceDiscussion | |
|---|---|---|---|---|
| or moreIR photography: Center: 5 lines/mmor more (Note 3) | or moreIR photography: Center: 5 lines/mm ormore (Note 3) | |||
| Observation & photographing of the fundustomogram | Observation & photographing of the fundustomogram | |||
| Scan range(on fundus) | Horizontal direction 3 - 12mm ±5% or lessVertical direction 3 – 9mm ±5% or less | Horizontal direction 3 - 12mm ±5% or lessVertical direction 3 – 9mm ±5% or less | ||
| Scan pattern | 3D scan (horizontal)Linear scan (Line-scan/Cross-scan) | 3D scan (horizontal)Linear scan (Line-scan/Cross-scan) | ||
| Scan speed | 50,000 A-Scans per second | 50,000 A-Scans per second | ||
| Lateralresolution | 20μm | 20μm | ||
| In-depthresolution | 6μm | 6μm | ||
| Photographable diameter ofpupil | φ2.5mm or more | φ2.5mm or more | ||
| Observation & photographing of the fundusimage/fundus tomogram | Observation & photographing of the fundusimage/fundus tomogram | |||
| Fixationtarget | Internal fixation target:Dot matrix type organic EL displayThe display position can be changedand adjusted. The displaying methodcan be changed. | Internal fixation target:Dot matrix type organic EL displayThe display position can be changedand adjusted. The displaying methodcan be changed. |
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| Model Number | Subject Device3D OCT-1 Maestro2 | Predicate device3D OCT-1 | SubstantialEquivalenceDiscussion |
|---|---|---|---|
| Peripheral fixation target:This is displayed according to theinternal fixation target displayedposition.External fixation target | Peripheral fixation target:This is displayed according to theinternal fixation target displayedposition.External fixation target | ||
| Observation & photographing of anterior segment | Observation & photographing of anterior segment | ||
| Type ofphotography | Color & IR (Note 3) | Color & IR (Note 3) | |
| Operatingdistance | 62.6 ±0.1mm (when taking a pictureof anterior segment) (Note 2) | 62.6 ±0.1mm (when taking a pictureof anterior segment) (Note 2) | |
| Observation & photographing of the anteriorsegment tomogram | Observation & photographing of the anteriorsegment tomogram | ||
| Operatingdistance | 62.6 ±0.1mm (when taking a pictureof anterior segment) (Note 2) | 62.6 ±0.1mm (when taking a pictureof anterior segment) (Note 2) | |
| Scan range(on cornea)(Note 2) | Horizontal direction 3 – 6mm ±5% orlessVertical direction 3 – 6mm ±5% or les | Horizontal direction 3 – 6mm ±5% orlessVertical direction 3 – 6mm ±5% or les | |
| Scan pattern | Linear scan (Line-scan/Radial-scan) | Linear scan (Line-scan/Radial-scan) | |
| Scan speed | 50,000 A-Scans per second | 50,000 A-Scans per second | |
| Fixationtarget | External fixation target | External fixation target | |
| (Note 1) Digital red-free photography that processes a colorimage and displays it in pseudo-red-free condition. | (Note 1) Digital red-free photography that processes a colorimage and displays it in pseudo-red-free condition. |
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| Model Number | Subject Device3D OCT-1 Maestro2 | Predicate device3D OCT-1 | SubstantialEquivalenceDiscussion | |
|---|---|---|---|---|
| (Note 2) When the attachment for anterior segment is included inthe system configuration.(Note 3) This is used only for recording the position where atomogram is captured. | (Note 2) When the attachment for anterior segment is included inthe system configuration.(Note 3) This is used only for recording the position where atomogram is captured. | |||
| Cameras for imaging and IR observation | Color fundus imaging | Different | ||
| Resolution: 6M pixelsSensor type: CMOSIF: USB3.0IR observation: | Resolution: 5M pixelsSensor type: CMOSIF: GigEPixel size: 2.2 um×2.2 µm | The 3D OCT-1predicateincorporated twocameras. One forfundus image | ||
| Pixel size: 9.6 um×9.6 um | IR observation camera | capture and one | ||
| Specification ofCameras forimaging andobservation | Color:Pixel size: 2.4 um×2.4 um | Resolution: 0.3M pixelsSensor type: CMOSIF: Parallel 8-bitPixel size: 5.6 µm×5.6 µm | for IRobservation. Thesubject device(Maestro2) hasone camera whichfunctions ascamera for bothfundus imagecapture and IRobservation.This differencedoes not affect theSE discussionbecause devicetesting confirmedMaestro2 fulfillsthe standard forfundus camera;therefore, |
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|---|---|---|---|
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| Model Number | Subject Device3D OCT-1 Maestro2 | Predicate device3D OCT-1 | SubstantialEquivalenceDiscussion |
|---|---|---|---|
| technicallyequivalent with3D OCT-1. | |||
| DifferentIn accordancewith themodification tothe camera,Maestro2 isequipped withmovable IR filterwhile 3D OCT-1is equipped withfixed IR filter. | |||
| Movable IR filter | YES | NO | This differencedoes not affect theSE discussionbecause thespectral propertiesof the IR filteritself is the samewith 3D OCT-1and Maestro2.Device testingconfirmedMaestro2 fulfillsthe standard forfundus camera;therefore,technicallyequivalent with |
| Model Number | Subject Device3D OCT-1 Maestro2 | Predicate device3D OCT-1 | SubstantialEquivalenceDiscussion |
| 3D OCT-1. | |||
| DifferentThe pixel sizebetween thecamera for the 3DOCT-1 predicateand the Maestro2is different. Thispixel size changecaused by the | |||
| Focal length ofrelay lens ofimaging opticalsystem | IR wavelengthWavelength used: 760 nm to 780 nmView angle of fundus camera:within 45°±5%Horizontal magnification of fundus camera: 0.20Horizontal resolution of fundus camera:Center: 5 line/mm or more | IR wavelength:Wavelength used: 760 nm to 780 nmView angle of fundus camera:within 45°±5%Horizontal magnification of fundus camera: 0.35Horizontal resolution of fundus camera:Center: 5 lines/mm or more | magnificationbetween thefundus and thecamera on thefundus camera.The focal lengthof the relay lensof the imagecapture opticalsystem wasmodified tomaintain the sizeof the fundus perpixel. |
| This differencedoes not affect theSE discussionbecause thedevice testingconfirmed |
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| Model Number | Subject Device3D OCT-1 Maestro2 | Predicate device3D OCT-1 | SubstantialEquivalenceDiscussion |
|---|---|---|---|
| ExternalAppearance | Image: Subject Device | Image: Predicate Device | the standard forfundus camera;therefore,technicallyequivalent with3D OCT-1.DifferentThere is adifference in theexternalappearance.However, thisdifference doesnot affect safetyand effectivenessof the device;therefore, doesnot affect SEdiscission ofsubject device andpredicate device. |
| OverallDimensions | 340-480mm (W) × 543-680mm (D) × 500-735mm(H) | 307-442mm (W) × 472 -668mm (D) × 518 -722mm(H) | DifferentThere is adifference in theoveralldimensions due toa modification ofthe external cover.However, thisdifference doesnot affect safetyand effectiveness |
510(k) Summary: 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)
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| Page | 12 | of | 12 | |
|---|---|---|---|---|
| -- | ------ | ---- | ---- | ---- |
| Model Number | Subject Device3D OCT-1 Maestro2 | Predicate device3D OCT-1 | SubstantialEquivalenceDiscussion |
|---|---|---|---|
| of the device;therefore, doesnot affect SEdiscission ofsubject device andpredicate device | |||
| Windowsoperating system | MS Windows 10 | MS Windows 7, 8.1 | DifferentThere is adifference inversion ofwindowsoperating systems.This differencedoes not affect theSE discussionbecause softwaretesting confirmedMaestro2functions asintended with theupdated windowsOS version;therefore,technicallyequivalent with3D OCT-1. |
§ 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.