(253 days)
No
The summary describes standard image acquisition, processing, and measurement techniques using SS-OCT and IR imaging. There is no mention of AI, ML, or any related concepts in the device description, intended use, or performance studies. The analysis focuses on traditional statistical methods for evaluating precision and agreement.
No.
The device is described as a non-contact ophthalmic imaging and analysis device intended for visualization and measurement, and a diagnostic imaging device. There is no indication of it providing any treatment or therapy.
Yes
The "Device Description" explicitly states, "The ANTERION is a diagnostic imaging device for the eye."
No
The device description explicitly states it includes "ANTERION Hardware (Imager/Base)" which contains imaging hardware, a touch screen, and mechanical components like a joystick and stepper motor. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, the ANTERION device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device is for "visualization and measurement of the anterior segment and measurement of the axial length" of the eye. This is a direct measurement and imaging of a living biological structure within the body, not the examination of specimens derived from the human body.
- Device Description: The device description details hardware for imaging the eye using OCT and an infrared camera. It describes placing the patient's head in a rest and acquiring images and measurements directly from the eye.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze samples such as blood, urine, tissue, or other bodily fluids or substances in vitro (outside the body).
The ANTERION is a diagnostic imaging device used in vivo (within the living body) to assess the structure and dimensions of the eye. This falls under the category of medical devices, but not specifically In Vitro Diagnostics.
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
- o Anterior chamber width, depth, volume and angle parameters
- o Lens Thickness
- · Axial Length
Product codes
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.1.5) (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. Within its stand, a stepper motor with additional mechanic parts and a controller board are placed, 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 eve.
The ANTERION device provides four separate software functionalities (Apps) to acquire various imaging and measurements of the anterior segment of the eye: (1) the Imaging App. (2) the Cornea App. (3) the Cataract App and (4) the Metrics App. The Cornea App provides tomographic data and measurements 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 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.
The following modification has been applied to the device, subject of this 510(k):
- · Addition of the Epithelial Thickness Module (separate License in the Cornea App) with maps and parameters of the corneal epithelial and stromal thickness.
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
Swept-source optical coherence tomography (SS-OCT), Infrared (IR) camera
Anatomical Site
Eye / Anterior segment of the eye
Indicated Patient Age Range
Not Found
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
The analysis population of this study included 115 subjects: thirty-two (32) in the Normal Cornea population and eighty-two (82) in the Abnormal Cornea population which include; twenty-five (25) in the Keratoconus subgroup, twenty (20) in the Contact Lens Wearer subgroup, eighteen (18) in the Status Post-Keratorefractive Surgery subgroup, and nineteen (19) in the Dry Eye Disease subgroup. One eye was not allocated to a group before screen failure. Data from 32 Group A participants and 81 Group B participants were included in the precision analyses, respectively. Data from 32 Group A and 80 Group B participants were included in the agreement analyses, respectively. The mean age in the safety population was 46.3 ± 15.7 years overall (mean 41.6±15.4 years in Group A, 48.2±15.5 years in Group B). 63.2% (72/114) were women (62.5% [20/32] Group A, 63.4% [52/82] Group B). 91.2% (104/114) were Caucasian (93.8% [30/32] in Group A, 90.2% [74/82] in Group B), 6.1% (7/114) were Black/African American (6.3% [2/32] Group A, 6.1% [5/82] Group B), 4.4% (5/114) were Asian (9.4% [3/32] Group A, 2.4% [2/82] Group B). 11.4% (13/114) were Hispanic/Latino (12.5% [4/32] Group A, 11.0% [9/82] Group B). Demographics are similar for the Precision Analysis Population and the Agreement Analysis Population. There were no adverse events related to this study.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
B-2020-1 was a prospective, randomized precision and agreement clinical study conducted at one diverse clinical site, located in the United States. In the study, the investigational ANTERION device (Cornea App with Epithelial Thickness Module) was compared with Cirrus HD-OCT 5000 with Anterior Segment Premier Module (K181534). For Protocol B-2020-1, eligible participants age 22 or older were assigned to one of two groups: eyes with normal cornea (Group A), eyes with abnormal cornea (Group B). Participants in the eyes with abnormal cornea population had at least one eye with at least one of the following: keratoconus, contact lens wearer, status postkeratorefractive surgery and/or dry eye disease. One eye of each study subject was enrolled. Eyes enrolled in the study that met all inclusion criteria and did not meet any exclusion criteria were assigned to the corresponding subject population and subgroup. Any enrolled subject that did not meet inclusion/exclusion criteria was screen failed. A baseline eye examination that included manifest refraction, slit-lamp biomicroscopy, assessment of best-corrected visual acuity (BCVA), OSDI score, Keratograph, tonometry was performed 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 and device order within configuration were randomized. Image quality was assessed by the operator after each acquisition. Image quality assessment of CIRRUS images were performed consistent with the CIRRUS instructions for use. Repeatability and reproducibility of measurements were estimated using a two-way, random-effects analysis of variance (ANOVA) model. Agreement was characterized using Bland-Altman and Deming regression analyses.
The analysis population of this study included 115 subjects: thirty-two (32) in the Normal Cornea population and eighty-two (82) in the Abnormal Cornea population which include; twenty-five (25) in the Keratoconus subgroup, twenty (20) in the Contact Lens Wearer subgroup, eighteen (18) in the Status Post-Keratorefractive Surgery subgroup, and nineteen (19) in the Dry Eye Disease subgroup. Data from 32 Group A participants and 81 Group B participants were included in the precision analyses, respectively. Data from 32 Group A and 80 Group B participants were included in the agreement analyses, respectively.
Key results:
Rates of acquisition acceptability, as determined by the investigator/operator, were higher for ANTERION Cornea App acquisitions (83.0%) than Cirrus Pachymetry Scans (66.3%) for all eyes. These acceptance rates were similar between the Normal Cornea Eyes and Abnormal Cornea Eyes populations, for both devices.
Precision: For all populations and subgroups, ANTERION repeatability SD values ranged 0.59um to 1.59um, and reproducibility SD values ranged 0.59um to 1.81um, except in the 7mm Zone parameters (ranges for repeatability from 1.49µm to 2.32um and for reproducibility from 1.64um to 2.48um). Comparing to Cirrus, the ANTERION SD values were generally lower. The repeatability and reproducibility results summarized as SD ratio plots generally demonstrate similar or better precision on ANTERION for both the Normal Cornea Eyes and the Abnormal Cornea Eyes populations. The precision results for CV% also generally demonstrate similar or better precision on ANTERION as compared to Cirrus for both the Normal Cornea Eyes and the Abnormal Cornea Eyes populations, with most CV%s for ANTERION within or around 1-4%.
Agreement: ANTERION was observed to measure, in general, slightly thicker values for corneal epithelial thickness compared to the Cirrus for both populations (mean difference 1.3um to 5.1µm thicker). For Deming Regression of all parameters, the 95%Cl for intercept included 0 and the 95%CI for slope included 1 for all populations and subgroups with exceptions for a few specific parameters in the Keratoconus Eyes, Post Keratorefractive Surgery Eyes and Dry Eye Disease subgroups.
Safety: No adverse events were reported during the clinical study.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Repeatability Standard Deviation (SD), Reproducibility Standard Deviation (SD), Coefficient of Variation (CV%), Repeatability Limit, Reproducibility Limit, Mean Bias, Limit of Agreement (LoA), 95% Confidence Interval (CI) of LoA.
Predicate Device(s)
ANTERION (K230897)
Reference Device(s)
CIRRUS HD-OCT 5000 (K181534)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.1570 Ophthalmoscope.
(a)
Identification. An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.(b)
Classification. Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
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December 13, 2024
Heidelberg Engineering GmbH % Lena Sattler Consultant Orasi Consulting, LLC. 226 1st Street Bonita Springs, Florida 34134
Re: K240924
Trade/Device Name: Anterion Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO Dated: April 4, 2024 Received: November 5, 2024
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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.
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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,
2024.12.13 Alexander Beylin -S 12:23:06 -05'00'
for 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
Enclosure
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Indications for Use
| Submission Number ( if known ) | |
|---|---|
| --------------------------------------- | -- |
K240924
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)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/0 description: The image shows the logo for Heidelberg Engineering. The logo consists of two lines of text, with a red square on either side. The first line says "HEIDELBERG" and the second line says "ENGINEERING".
510(K) SUMMARY
Date Prepared
December 10, 2024
SPONSOR/510(K) OWNER/ MANUFACTURER
Heidelberg Engineering GmbH Max-Jarecki-Strasse 8 69115 Heidelberg, Germany Telephone: Facsimile: Email: Establishment Registration No.:
+49 6221 / 64 63 0 +49 6221 / 64 63 62 arianna.schoess.varqas@heidelberqenqineering.com 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
PROPRIETARY OR TRADE NAMES
ANTERION
CLASSIFICATION INFORMATION
| Regulation Number: | 21 CFR 886.1570 |
|---|---|
| Classification name: | Ophthalmoscope, |
| Tomography, Optical Coherence | |
| Medical Specialty | Ophthalmic |
| Device Class: | II |
| Classification Panel: | Ophthalmic Device Panel |
| Product Code: | OBO |
PREDICATE DEVICE
ANTERION (K230897), Heidelberg Engineering GmbH
REFERENCE DEVICE
CIRRUS HD-OCT 5000 (K181534), Carl Zeiss Meditec Inc.
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Image /page/5/Picture/1 description: The image shows the logo for Heidelberg Engineering. The logo consists of two lines of text, with a red square on either side. The first line of text says "HEIDELBERG", and the second line of text says "ENGINEERING". The text is in a bold, sans-serif font.
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.1.5) (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. Within its stand, a stepper motor with additional mechanic parts and a controller board are placed, 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
6
for en-face imaging of a patient's eve.
The ANTERION device provides four separate software functionalities (Apps) to acquire various imaging and measurements of the anterior segment of the eye: (1) the Imaging App. (2) the Cornea App. (3) the Cataract App and (4) the Metrics App. The Cornea App provides tomographic data and measurements 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 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.
The following modification has been applied to the device, subject of this 510(k):
- · Addition of the Epithelial Thickness Module (separate License in the Cornea App) with maps and parameters of the corneal epithelial and stromal thickness.
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 (K230897) 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 (K230897) 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 each App. The main difference between both devices is a software modification which provides measurements of the epithelial and stromal thickness in the Cornea App for the subject device. This change, i.e. the addition of the Epithelial Thickness Module, doesn't change the data acquisition process, the intended use/ indications for use or the used imaging technologies (OCT, IR camera) of ANTERION. Regarding the hardware, only maintenance changes regarding assembling processes were implemented for the subject device which have no impact on the technology and performance of the ANTERION.
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Image /page/7/Picture/1 description: The image shows the logo for Heidelberg Engineering. The logo consists of two lines of text, with a red square on either side. The first line reads "HEIDELBERG" and the second line reads "ENGINEERING".
| | SUBJECT DEVICE
ANTERION | PREDICATE DEVICE
ANTERION(K230897) | Same, similar or
different |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| 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 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 | 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 |