(147 days)
No
The document describes standard image processing and analysis techniques for OCT and IR imaging, but does not mention any AI or ML algorithms being used for image analysis, diagnosis, or other functions. The performance study focuses on image quality and agreement with a predicate device and slit lamp examination, not on the performance of any AI/ML-driven analysis.
No
The device is described as a "diagnostic imaging device" and is intended for "visualization of the anterior segment." Its functions include acquiring, storing, and displaying data for diagnostic purposes, not for treating conditions.
Yes
The "Intended Use" states it is "a non-contact ophthalmic imaging and analysis device for the eye. It is intended for visualization of the anterior segment." The "Device Description" then explicitly calls it "a diagnostic imaging device for the eye."
No
The device description explicitly states that the ANTERION includes both hardware components (Imager/Basis with integrated forehead/chin rest, laser, LEDs, optics, detectors, touch screen, stepper motor, controller board, external fixation light, power supply, PC connection) and software components (ANTERION Software, AQM, VWM, Imaging App). It is not solely software.
Based on the provided information, the ANTERION device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- ANTERION's Function: The ANTERION is a non-contact ophthalmic imaging and analysis device that directly images the anterior segment of the eye using OCT and IR technology. It does not analyze samples taken from the body.
- Intended Use: The intended use is for "visualization of the anterior segment," which is a direct imaging and diagnostic process, not an in vitro test.
- Device Description: The description focuses on the hardware and software for acquiring and displaying images of the eye.
- Performance Studies: The performance studies compare the image quality and ability to identify abnormalities in vivo (within the living eye) against a reference device and slit lamp examination.
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 of the anterior segment.
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/Basis) 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 (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 PC software additionally stores, receives, and displays the acquired data.
The ANTERION hardware is separated in three parts: the Basis (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 Basis and controlled via a ioystick. 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 Basis 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, while the IR camera allows for en-face imaging of a patient's eye.
The Imaging App, the subject of this submission, is the foundation of the ANTERION platform, and focuses on the high-resolution visualization of the entire anterior segment, from the anterior surface of the cornea to the posterior surface of the lens.
The Imaging App delivers swept-source OCT images that allow visualization of anterior segment pathologies and evidence of surgical interventions, e.g. keratoplasty, LASIK, implanted IOLs, and phakic lenses.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical Coherence Tomography (OCT), Infrared (IR) Camera
Anatomical Site
Anterior segment of the eye, Cornea, lens.
Indicated Patient Age Range
No restrictions regarding patient groups
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
A prospective, clinical study was conducted at a single clinical site in the United States. 87 participants age 22 or older meeting eligibility criteria in at least one eye were enrolled into two study cohorts, the "Normal Anterior Segment group" (without abnormality present in the anterior segment of the eye) and the "Abnormal Anterior Segment group" (those anterior segment abnormalities identified with the slit lamp exam such as glaucoma and corneal surgeries). One eye of each subject was selected to be the study eye, (randomly determined when both eyes were eligible). Imaging was performed by the site operators based on randomization. The first acceptable scans were sent to the Reading Center for grading. Each grader graded each image for image quality and for identification and assessment of abnormality (if applicable). The images were presented to three independent graders, who were blinded to the subject identification, population allocation, eye examination results and to each other's grading results. Majority rule was applied to get consensus. For each device and acquisition type (if applicable), three qualified graders graded the OCT images for quality into categorical groups (1 = poor, 2 = fair, 3 = good). In each image the visibility of following structures was assessed: Cornea/Conjunctiva, Iris (temporal/nasal), Anterior Lens Surface, Scleral Spur (temporal/nasal), Angles (temporal/nasal). The graders also graded for presence or absence of pre-defined key abnormalities, specified on the grading form. Eighty-seven subjects were enrolled in this study. Thirty-four in the Normal Anterior Segment population and fifty-three in the Abnormal Anterior Segment population. The mean age was 45.7 ± 16.1 years overall, with the Abnormal Anterior Segment population subjects being older. The study population gender distribution was 67.9% male and 32.1% female. Sixty-seven percent (67%) were not Hispanic or Latino, 34% were Caucasian and 42% African American. The study eyes were fairly equally distributed between right and left eyes (51% right, 49% left).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A prospective, clinical study was conducted at a single clinical site in the United States to compare the clinical performance of the ANTERION Imaging App between the ANTERION and the CIRRUS HD-OCT 5000 devices. 87 participants age 22 or older meeting eligibility criteria in at least one eye were enrolled into two study cohorts, the "Normal Anterior Segment group" (without abnormality present in the anterior segment of the eye) and the "Abnormal Anterior Segment group" (those anterior segment abnormalities identified with the slit lamp exam such as glaucoma and corneal surgeries).
The following endpoints were evaluated:
- The image quality grade of the acquired images.
- Agreement in identification of abnormality between the B-Scan images using the slit lamp examination as the reference.
Image Quality: Overall, the ANTERION shows superiority in image quality compared to each of the three CIRRUS scans. For the cornea/conjunctiva, 83.3% of ANTERION scans were rated as good, while only 52.6% of CIRRUS scans were rated as good.
Abnormality Identification: Overall, the ANTERION shows superiority compared to each of the three CIRRUS scans in identifying the abnormality in reference with the slit lamp examination.
There were no adverse events occurring during the course of the study.
The results of this study illustrated that when using OCT to visualize the anterior segment, ANTERION's overall OCT image quality and ability to visualize key anatomical structures on OCT images was similar to or better than CIRRUS for all scan patterns and all subject populations. Furthermore, using the slit lamp examination as a reference, the results indicate that ANTERION offers an equal or superior ability in identifying each pre-specified abnormality as compared to CIRRUS.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
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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November 5, 2021
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Heidelberg Engineering GmbH % Lena Sattler Consultant Orasi Consulting, LLC. 226 1st Street Bonita Springs, Florida 34134
Re: K211817
Trade/Device Name: Anterion Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO Dated: September 24, 2021 Received: September 27, 2021
Dear Lena Sattler:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976. the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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 located at https://www.accessdata.fda.gov/scripts/cdrl/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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to 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 Ng Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211817
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 of the anterior segment.
Type of Use (Select one or both, as applicable)
| Descriptive Use (Part 21 CFR 601 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 601 Subpart C) |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the logo for Heidelberg Engineering. The logo consists of two lines of text in a bold, sans-serif font. The first line reads "HEIDELBERG" and the second line reads "ENGINEERING". There is a red square to the left of the first line and to the right of the second line.
510(K) SUMMARY
Date Prepared
June 10, 2021
SPONSOR/510(K) OWNER/ MANUFACTURER
Heidelberg Engineering GmbH Max-Jarecki-Strasse 8 69115 Heidelberg, Germany Telephone: +49 6221 / 64 63 0 Facsimile: +49 6221 / 64 63 62 Email: aschoess@hdeng.de Establishment Registration No.: 8043762
OFFICIAL CONTACT PERSON
Lena Sattler Orasi Consulting, LLC. 226 1st Street Bonita Springs, FL 34134 Telephone: (440) 554-3706 Facsimile: (866) 904-4315 E-mail: lena@orasiconsulting.com
COMMON/USUAL NAME
Optical Coherence Tomography
PROPRIETARY OR TRADE NAMES
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
4
PREDICATE DEVICE
Visante OCT (K051789), Carl Zeiss Meditec Inc.
REFERENCE DEVICE
CIRRUS HD-OCT 5000 (K150977), Carl Zeiss Meditec Inc.
INDICATIONS FOR USE
The ANTERION is a non-contact ophthalmic imaging and analysis device for the eye. It is intended for visualization of the anterior segment.
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/Basis) 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 (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 PC software additionally stores, receives, and displays the acquired data.
The ANTERION hardware is separated in three parts: the Basis (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 Basis and controlled via a ioystick. 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 Basis 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.
Heidelberg Engineering GmbH
Traditional 510(k): ANTERION
5
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, while the IR camera allows for en-face imaging of a patient's eye.
The Imaging App, the subject of this submission, is the foundation of the ANTERION platform, and focuses on the high-resolution visualization of the entire anterior segment, from the anterior surface of the cornea to the posterior surface of the lens.
The Imaging App delivers swept-source OCT images that allow visualization of anterior segment pathologies and evidence of surgical interventions, e.g. keratoplasty, LASIK, implanted IOLs, and phakic lenses.
SUBSTANTIAL EQUIVALENCE
The Substantial Equivalence Summary tables below illustrate the comparisons of the ANTERION to the predicate device and the reference device.
The imaging function of the ANTERION is similar to the anterior imaging function of the predicate device Visante OCT (K051789) and the reference device CIRRUS HD-OCT 5000 (K150977) in intended use and technological characteristics.
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Image /page/6/Picture/0 description: The image shows the logo for Heidelberg Engineering. The logo consists of two lines of text in a bold, sans-serif font. The first line reads "HEIDELBERG" and the second line reads "ENGINEERING". There is a red square to the left of the first line and to the right of the second line.
| SUBJECT DEVICE | PREDICATE DEVICE | REFERENCE DEVICE | Discussion |
|---|---|---|---|
| ANTERION | Visante OCT (K051789) | CIRRUS HD-OCT 5000 (K150977) | |
| The ANTERION is a non-contact | |||
| ophthalmic imaging and analysis | |||
| device for the eye. It is intended | |||
| for visualization of the anterior | |||
| segment. | The Visante™ OCT is a non-contact, high | ||
| resolution tomographic and biomicroscopic | |||
| device indicated for the in vivo imaging and | |||
| measurement of ocular structures in the | |||
| anterior segment, such as corneal and | |||
| LASIK flap thickness. | The CIRRUS™ HD-OCT is a non-contact, | ||
| high resolution tomographic and | |||
| biomicroscopic imaging device intended for | |||
| in-vivo viewing, axial cross-sectional, and | |||
| three-dimensional imaging of anterior and | |||
| posterior ocular structures. The device is | |||
| indicated for visualizing and measuring | |||
| anterior and posterior ocular structures, | |||
| including cornea, retina, retinal nerve fiber | |||
| layer, ganglion cell plus inner plexiform | |||
| layer, macula, and optic nerve head. The | |||
| CIRRUS normative databases are | |||
| quantitative tools indicated for the | |||
| comparison of retinal nerve fiber layer | |||
| thickness, macular thickness, ganglion cell | |||
| plus inner plexiform layer thickness, and | |||
| optic nerve head measurements to a | |||
| database of normal subjects. The CIRRUS | |||
| OCT Angiography is indicated as an aid in | |||
| the visualization of vascular structures of | |||
| the retina and choroid. The CIRRUS HD- | |||
| OCT is indicated as a diagnostic device to | |||
| aid in the detection and management of | |||
| ocular diseases including, but not limited to, | |||
| macular holes, cystoid macular edema, | |||
| diabetic retinopathy, age-related macular | |||
| degeneration, and glaucoma. | Similar. All devices | ||
| support imaging of the | |||
| anterior segment of the | |||
| eye. |
INTENDED USE/INDICATIONS FOR USE STATEMENT CHART
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TECHNOLOGICAL CHARACTERISTICS COMPARISON CHART
(*specific data for the Anterior Segment module of CIRRUS HD-OCT 5000)
| | SUBJECT DEVICE
ANTERION | PREDICATE DEVICE
Visante OCT (K051789) | REFERENCE DEVICE
CIRRUS HD-OCT 5000
(K150977) | Discussion |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device classification
name | Optical Coherence Tomographer
(OCT) | Optical Coherence Tomographer
(OCT) | Optical Coherence Tomographer
(OCT) | Same |
| Main Technology | Swept Source OCT Technology | Time Domain OCT Technology | Spectral Domain OCT
Technology | The OCT technologies
are different, but the
resulting images show
comparable structures |
| Supporting
Technologies | Infrared Camera | Video camera | Infrared Camera | Similar. Their main
usage is to support a
proper OCT
acquisition. |
| OCT center wave
length | 1310 nm | 1310 nm | 750 nm | Similar. The OCT
wavelength of the
ANTERION and
Visante OCT are
intended for anterior
segment imaging. The
CIRRUS HD-OCT
5000 is optimized for
posterior segment
imaging but can also
be used to create
anterior segment |
| | SUBJECT DEVICE
ANTERION | PREDICATE DEVICE
Visante OCT (K051789) | REFERENCE DEVICE
CIRRUS HD-OCT 5000
(K150977) | Discussion |
| | | | | images using a special
lens module. |
| OCT axial resolution |