(194 days)
No
The summary describes a diagnostic imaging device based on SS-OCT and IR technology with software for image acquisition, viewing, and measurement. While it performs analysis and measurements, there is no mention of AI or ML being used in the image processing, analysis, or measurement algorithms. The focus is on the imaging modalities and the software applications for specific measurements.
No
The device is described as a "non-contact ophthalmic imaging and analysis device" and a "diagnostic imaging device." Its intended use is for "visualization and measurement of the anterior segment and measurement of the axial length," which are diagnostic functions. There is no mention of treating or alleviating a condition.
Yes
The "Device Description" section explicitly states, "The ANTERION is a diagnostic imaging device for the eye."
No
The device description explicitly states that the ANTERION includes both "ANTERION Hardware (Imager/Base)" and "ANTERION Software (V.1.2.4) (PC)". The hardware components are detailed, including imaging hardware, a touch screen, a head rest, a joystick, a stepper motor, and an external fixation light. The software controls the hardware and processes the data acquired by the hardware.
Based on the provided information, the ANTERION device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring, or compatibility purposes.
- ANTERION's Function: The ANTERION is a non-contact ophthalmic imaging and analysis device that directly images and measures the anterior segment and axial length of the eye in vivo (within the living body). It does not analyze specimens derived from the body.
- Imaging Modality: The device uses optical coherence tomography (OCT) and an infrared camera, which are imaging modalities that interact directly with the patient's eye, not with a collected specimen.
- Intended Use: The intended use is for visualization and measurement of anatomical structures within the eye, not for analyzing biological samples.
Therefore, the ANTERION falls under the category of an in vivo diagnostic imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ANTERION is a non-contact ophthalmic imaging and analysis device for the eye. It is intended for visualization and measurement of the anterior segment and measurement of the axial length.
The analysis covers:
- Cornea Thickness
- Anterior Segment
- Anterior chamber width, depth, volume and angle parameters
- Lens Thickness
- Axial Length
Product codes (comma separated list FDA assigned to the subject device)
OBO
Device Description
The ANTERION is a diagnostic imaging device for the eye. The technology is based on swept-source optical coherence tomography (SS-OCT) technology. The device itself has two basic component groups:
- ANTERION Hardware (Imager/Base) with integrated forehead/ chin rest: The hardware includes imaging hardware (e.g., laser, LEDs, optics, detectors, hardware for spatial encoding) as well as a touch screen.
- ANTERION Software (V.1.2.4) (PC): The ANTERION Software includes the main user interface. The software allows for device control, such as selection of examination(s) and imaging parameter(s). The ANTERION software provides an interface for a Medical Image Management and Processing System.
The ANTERION hardware is separated in three parts: the Base (bottom part), the Imager (top part), and the Head Rest (forehead/chin rest).
For examinations, the patient places his/her head in the forehead/chin rest. The Head Rest is mechanically and electronically connected to the Base and controlled via a joystick. Placed within the stand are a stepper motor with additional mechanical parts and a controller board, allowing the operator to move the motorized chin rest up or down for optimally positioning the patients' eye. An external fixation light is mounted at the forehead rest.
The Base mainly contains the power supply and PC connection of the device. In the Imager, the components for scanning, signal generation, and signal processing are contained.
The operator directly accesses two software modules, which are named AQM (acquisition module) and VWM (viewing module). The AQM allows selecting between examinations. The VWM shows acquired images, parameters, and reports.
The ANTERION device contains two imaging modalities, a scanning optical coherence tomography (OCT) modality and an infrared (IR) camera. The OCT modality allows for cross-sectional imaging and biometry, while the IR camera allows for en-face imaging of a patient's eye.
The ANTERION device provides four separate software applications (Apps) to acquire various imaging and measurements of the anterior segment of the eye: (1) the Imaging App (cleared under K211817), (2) the Cornea App, (3) the Cataract App and (4) the Metrics App. The Cornea App provides tomographic data and measurements paraments for the patient's individual corneal geometry and corneal characteristics. The Cornea App provides tomographic data and parameters, such as corneal curvature and thickness. The Cataract App provides key measurements for the cataract surgery planning, such as corneal thickness, anterior chamber depth and axial length. The Metrics App generates OCT images and scan parameters for the anterior chamber such as anterior chamber angle and volume. The four ANTERION Apps are locked/unlocked independently by a license mechanism for each App. The software implementation of these Apps is realized within the AQM and VWM.
This submission is to seek clearance for the Metrics App, Cataract App and Cornea App.
To function as intended, the ANTERION must be connected to a Medical Image Management and Processing system (MIMPS) with compatible interface. To date, HEYEX 2 / HEYEX PACS is the only available MIMPS with compatible interface.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical Coherence Tomography (OCT), Infrared (IR) camera
Anatomical Site
eye / anterior segment
Indicated Patient Age Range
The clinical studies included subjects aged 22 to 87 years.
Intended User / Care Setting
Not Found
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
Two prospective, observational clinical studies were conducted at a single clinical site in the United States.
Protocol B-2018-3:
Eligible participants age 22 or older were assigned to one of two sub-groups: 1) eyes with open angle (Group A), 2) eyes with narrow angle (Group B).
Exclusion Criteria: active infection or inflammation in either eye, insufficient tear film or corneal reflex, rigid gas permeable (RGP) contact lens wear during the two weeks prior to the study visit, and/or soft CL wear within one hour of the study visit.
A baseline eye examination included manifest refraction, slit-lamp biomicroscopy, assessment of best-corrected visual acuity (BCVA), gonioscopy, tonometry, and cataract grading (where applicable) to verify eligibility. One eye per participant was randomly selected as the study eye. Three ANTERION and three CIRRUS 5000 HD-OCT devices were used. These six instruments were paired with three operators to form three device-operator configurations. All participants were imaged repeatedly on all three configurations. Three replicates per acquisition type, per configuration were obtained from each participant. The order of imaging by configuration order, device order within configuration, and by acquisition type was randomized. Image quality was assessed by the operator after each acquisition. Manual correction of ANTERION segmentation and manual editing of the scleral spur and angle recess points were performed as needed. Image quality assessment of CIRRUS images was performed as consistent with the CIRRUS instructions for use.
Sample size: 30 participants were enrolled into Group A and 28 participants were enrolled into Group B. 29 Group A participants and 27 Group B participants completed the study. Data from 225 scans of 25 Group A participants and 234 scans of 27 Group B participants were included in precision analyses, respectively. Data from 27 Group A and 26 Group B participants were included in the agreement analyses, respectively.
Protocol B-2018-5:
Eligible participants age 22 or older were assigned to one of five sub-groups: 1) eyes with "normal anterior segment" (Group A), 2) eyes with cataract (Group B), 3) eyes with corneal abnormalities such as corneal ectasias (Group C), 4) eyes that were post-keratorefractive surgery (Group D), 5) pseudophakic/aphakic eyes (Group E).
Exclusion criteria were similar to those described for Protocol B-2018-3.
A baseline eye examination included manifest refraction, slit-lamp biomicroscopy, assessment of best-corrected visual acuity (BCVA), tonometry, and cataract grading (where applicable) to verify eligibility. One eye per participant was randomly selected as the study eye. Three ANTERION and three Pentacam AXL devices were used. These six instruments were paired with three operators to form three device-operator configurations. All participants were imaged repeatedly on all three configurations. Three replicates per acquisition type, per configuration were obtained from each participant. The order of imaging by configuration order, device order within configuration, and by acquisition type was randomized. Image quality was assessed by the operator after each acquisition. Manual correction of ANTERION segmentation was performed by an independent reading center and manual placement of the angle recess points were performed. Image quality assessment of Pentacam images was performed as consistent with the Pentacam's instructions for use.
Sample size: 176 participants were enrolled and 172 completed the study. In the safety population, there were 27 in Group A, 33 in Group B, 45 in Group C, 29 in Group D, and 41 in Group E.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Two prospective, observational clinical studies were conducted.
Protocol B-2018-3:
Study Type: Clinical Study on Repeatability and Reproducibility and Agreement.
Sample Size:
Open Angle Eyes (Group A): 25 subjects for precision analysis, 27 subjects for agreement analysis. 225 scans for precision analysis.
Narrow Angle Eyes (Group B): 27 subjects for precision analysis, 26 subjects for agreement analysis. 234 scans for precision analysis.
Key Results:
Repeatability and Reproducibility of ANTERION Metrics App were presented for various parameters (ACA, AOD, TISA, SSA, STS Distance, ATA Distance, Lens Vault) in both open angle and narrow angle eyes using standard deviation (SD) and coefficient of variation (CV%). Example: For Open Angle Eyes, ACA 500 Nasal (°) had a repeatability SD of 2.892 and CV% of 6.906; reproducibility SD of 3.772 and CV% of 9.007. For Narrow Angle Eyes, ACA 500 Nasal (°) had a repeatability SD of 2.631 and CV% of 16.735; reproducibility SD of 3.145 and CV% of 20.004.
Manual segmentation/extension of ANTERION images was performed on 21.8% (59/271) of scans of open-angle study eyes and 74.5% (181/243) of scans of narrow-angle study eyes.
Protocol B-2018-5:
Study Type: Clinical Study on Repeatability and Reproducibility and Agreement.
Sample Size:
Normal Eyes (Group A): 27 subjects, 243 scans (Cataract App Biometry), 243 scans (Metrics App Biometry).
Cataract Eyes (Group B): 33 subjects, 297 scans (Cataract App Biometry), 297 scans (Metrics App Biometry), 295 scans (Metrics App Anterior chamber volume).
Eyes with Corneal Abnormalities (Group C): 43 subjects, 363-366 scans (Cataract App), 36-40 subjects, 313-339 scans (Metrics App).
Post-Keratorefractive Surgery Eyes (Group D): 29 subjects, 260-261 scans (Cataract App), 28 subjects, 250-251 scans (Metrics App).
Eyes Without a Crystalline Lens (Group E): 39 subjects, 345 scans (Cataract App), 40 subjects, 358 scans (Metrics App).
Key Results:
Repeatability and Reproducibility of ANTERION Biometry Measurements were presented for various parameters (Central corneal thickness, Thinnest point thickness, Anterior chamber depth, Axial length, Lens thickness, Anterior chamber volume) across all five eye groups for both Cataract App and Metrics App. Example: For Normal Eyes using Cataract App, Central corneal thickness had a repeatability SD of 0.775 and CV% of 0.142; reproducibility SD of 4.088 and CV% of 0.749.
Manual segmentation correction/extension was performed in 2.9% to 11.6% of Metrics App scans across Groups A-D, and 0.4% to 17.1% of Cataract App scans across Groups A-E.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Repeatability and Reproducibility (Standard Deviation and Coefficient of Variation) were reported as key metrics.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
ANTERION (K211817)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
CIRRUS HD-OCT 5000 (K150977), Pentacam AXL (K152311)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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October 11, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the full name. The full name of the agency is "U.S. Food & Drug Administration".
Heidelberg Engineering GmbH % Lena Sattler Consultant Orasi Consulting, LLC. 226 1st Street Bonita Springs, Florida 34134
Re: K230897
Trade/Device Name: Anterion Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO Dated: August 31, 2023 Received: August 31, 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"
1
(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 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
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K230897
Device Name ANTERION
Indications for Use (Describe)
The ANTERION is a non-contact ophthalmic imaging and analysis device for the eye. It is intended for visualization and measurement of the anterior segment and measurement of the axial length.
The analysis covers:
- · Cornea Thickness
- · Anterior Segment
- o Anterior chamber width, depth, volume and angle parameters
- o Lens Thickness
- · Axial Length
| 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
Date Prepared
October 10, 2023
SPONSOR/510(K) OWNER/ MANUFACTURER
Heidelberg Engineering GmbH Max-Jarecki-Strasse 8 69115 Heidelberg, Germany +49 6221 / 64 63 0 Telephone: 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
ANTERION
CLASSIFICATION INFORMATION
| Regulation Number: | 21 CFR 886.1570 |
|---|---|
| Classification name: | Ophthalmoscope |
| Device Class: | II |
| Common name: | Optical Coherence Tomography |
| Product Codes, Name: | OBO (Tomography, Optical Coherence) |
| Medical Specialty: | Ophthalmic |
| Classification Panel: | Ophthalmic Device Panel |
Heidelberg Engineering GmbH
Traditional 510(k): ANTERION Page 1 of 13
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Image /page/5/Picture/0 description: The image contains 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". The text is in a bold, sans-serif font.
PREDICATE DEVICE
ANTERION (K211817), Heidelberg Engineering GmbH
REFERENCE DEVICES
CIRRUS HD-OCT 5000 (K150977), Carl Zeiss Meditec Inc.
Pentacam AXL (K152311), Oculus Optikgerate GmbH
INDICATIONS FOR USE
The ANTERION is a non-contact ophthalmic imaging and analysis device for the eye. It is intended for visualization and measurement of the anterior segment and the measurement of the axial length.
The analysis covers:
- Cornea thickness ●
- Anterior segment
- o Anterior chamber width, depth, volume, and angle parameters
- o Lens thickness
- Axial Length ●
GENERAL DEVICE DESCRIPTION
The ANTERION is a diagnostic imaging device for the eye. The technology is based on swept-source optical coherence tomography (SS-OCT) technology. The device itself has two basic component groups:
- ANTERION Hardware (Imager/Base) with integrated forehead/ chin rest: The . hardware includes imaging hardware (e.g., laser, LEDs, optics, detectors, hardware for spatial encoding) as well as a touch screen.
- . ANTERION Software (V.1.2.4) (PC): The ANTERION Software includes the main user interface. The software allows for device control, such as selection of examination(s) and imaging parameter(s). The ANTERION software provides an interface for a Medical Image Management and Processing System.
The ANTERION hardware is separated in three parts: the Base (bottom part), the Imager (top part), and the Head Rest (forehead/chin rest).
For examinations, the patient places his/her head in the forehead/chin rest. The Head Rest is mechanically and electronically connected to the Base and controlled via a joystick. Placed within the stand are a stepper motor with additional mechanical parts Heidelberg Engineering GmbH Traditional 510(k): ANTERION
6
HEIDELE engineering
and a controller board, allowing the operator to move the motorized chin rest up or down for optimally positioning the patients' eye. An external fixation light is mounted at the forehead rest.
The Base mainly contains the power supply and PC connection of the device. In the Imager, the components for scanning, signal generation, and signal processing are contained.
The operator directly accesses two software modules, which are named AQM (acquisition module) and VWM (viewing module). The AQM allows selecting between examinations. The VWM shows acquired images, parameters, and reports.
The ANTERION device contains two imaging modalities, a scanning optical coherence tomography (OCT) modality and an infrared (IR) camera. The OCT modality allows for cross-sectional imaging and biometry, while the IR camera allows for en-face imaging of a patient's eye.
The ANTERION device provides four separate software applications (Apps) to acquire various imaging and measurements of the anterior segment of the eye: (1) the Imaging App (cleared under K211817), (2) the Cornea App, (3) the Cataract App and (4) the Metrics App. The Cornea App provides tomographic data and measurements paraments for the patient's individual corneal geometry and corneal characteristics. The Cornea App provides tomographic data and parameters, such as corneal curvature and thickness. The Cataract App provides key measurements for the cataract surgery planning, such as corneal thickness, anterior chamber depth and axial length. The Metrics App generates OCT images and scan parameters for the anterior chamber such as anterior chamber angle and volume. The four ANTERION Apps are locked/unlocked independently by a license mechanism for each App. The software implementation of these Apps is realized within the AQM and VWM.
This submission is to seek clearance for the Metrics App, Cataract App and Cornea App.
To function as intended, the ANTERION must be connected to a Medical Image Management and Processing system (MIMPS) with compatible interface. To date, HEYEX 2 / HEYEX PACS is the only available MIMPS with compatible interface.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS BETWEEN THE SUBJECT AND THE PREDICATE DEVICE
The predicate ANTERION (K211817) and the subject ANTERION do not share identical technological characteristics. However, the differences in design are marginal and do not raise different questions of safety and effectiveness. The software of both devices, the predicate ANTERION (K211817) and the subject ANTERION, includes all available imaging functions (Imaging App, Cornea App, Cataract App, Metrics App) which are locked/ unlocked independently by a license mechanism for
Heidelberg Engineering GmbH Proprietary Information
Traditional 510(k): ANTERION Page 3 of 13
7
each App. The main difference between both devices is that the predicate ANTERION (K211817) only provides the Imaging App to the customer, and the other Apps were not made available for the customer. For the subject ANTERION, all software Apps are available which expand the indications for use of the device and allow measurements regarding the anterior segment. Regarding the OCT specifications, the subject device additionally provides a lateral resolution of 45 um which is specific for the Cornea App and therefore is not applicable for the predicate ANTERION. Only minor hardware changes regarding the assembling of the power supply, replacement of light sources and of the housing coating, were implemented for the subject device which have no impact on the technology and performance of the ANTERION.
| | SUBJECT DEVICE
ANTERION | PREDICATE DEVICE
ANTERION
(K211817) | DISCUSSION |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use/ Indications
for use | The ANTERION is a non-contact ophthalmic
imaging and analysis device
for the eye. It is intended
for visualization and
measurement of the
anterior segment and the
measurement of the axial
length.
The analysis covers:
• Cornea thickness
• Anterior segment
o Anterior chamber
width, depth,
volume, and angle
parameters
o Lens thickness
• Axial Length | The ANTERION is a non-contact ophthalmic
imaging and analysis
device for the eye. It is
intended for visualization
of the anterior segment. | Different:
Predicate device
is only for
imaging of the
anterior segment.
The subject
device provides
automated
measurements of
corneal
thickness,
anterior chamber
width, depth, and
volume, anterior
segment angle,
lens thickness
and vault, and
axial length; the
predicate device
does not provide
automated
measurements of
any anterior
segment
parameters. |
| Device classification name | Optical Coherence
Tomographer (OCT) | Optical Coherence
Tomographer (OCT) | Same |
| Main Technology | Swept Source OCT
Technology | Swept Source OCT
Technology | Same |
| Supporting Technologies | Infrared Camera | Infrared Camera | Same |
| OCT center wave length | 1310 nm | 1310 nm | Same |
| OCT axial resolution |