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

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.

AI/ML Overview

The provided text describes the acceptance criteria and the study that proves the device meets those criteria for the ANTERION device (K230897).

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a table format with specific thresholds for each parameter. Instead, it presents extensive "Repeatability and Reproducibility" data (precision analyses) from two clinical studies (B-2018-3 and B-2018-5). The implication is that the demonstrated precision values meet the internal acceptance criteria for the device's performance.

Therefore, the table below will present the reported device performance, which is implicitly what the device "met" to achieve clearance. It's important to note that specific numerical acceptance thresholds are not explicitly defined in the provided text. The reported values are the performance demonstrated by the device in the studies.

Table 1: Reported Device Performance (Repeatability and Reproducibility)

Parameter (ANTERION App)	Eye Population Category	Repeatability CV% (min-max across tables)	Reproducibility CV% (min-max across tables)
Metrics App	Open Angle Eyes	4.696% (SSA 750 Nasal) - 35.515% (Lens Vault)	6.219% (SSA 750 Nasal) - 45.011% (Lens Vault)
Metrics App	Narrow Angle Eyes	0.511% (STS Distance) - 18.363% (AOD 500 Temporal)	0.662% (STS Distance) - 24.415% (AOD 500 Temporal)
Cataract App (Biometry)	Normal Eyes	0.018% (Axial Length) - 0.270% (Lens Thickness)	0.027% (Axial Length) - 0.749% (CCT)
Metrics App (Biometry)	Normal Eyes	0.202% (CCT) - 0.742% (AC Volume)	0.362% (ACD) - 1.978% (AC Volume)
Cataract App (Biometry)	Cataract Eyes	0.081% (Axial Length) - 0.446% (CCT)	0.081% (Axial Length) - 0.819% (CCT)
Metrics App (Biometry)	Cataract Eyes	0.142% (Lens Thickness) - 0.621% (AC Volume)	0.208% (Lens Thickness) - 1.171% (AC Volume)
Cataract App (Biometry)	Eyes with Corneal Abnormalities	0.049% (Axial Length) - 0.854% (Thinnest Point Thickness)	0.067% (Axial Length) - 1.086% (Thinnest Point Thickness)
Metrics App (Biometry)	Eyes with Corneal Abnormalities	0.217% (CCT) - 0.599% (AC Volume)	0.438% (ACD) - 1.455% (CCT)
Cataract App (Biometry)	Post-Keratorefractive Surgery Eyes	0.018% (Axial Length) - 0.259% (Thinnest Point Thickness)	0.028% (Axial Length) - 0.966% (CCT)
Metrics App (Biometry)	Post-Keratorefractive Surgery Eyes	0.182% (Lens Thickness) - 0.677% (AC Volume)	0.275% (ACD) - 1.394% (AC Volume)
Cataract App (Biometry)	Eyes without Crystalline Lens	0.027% (Lens Thickness) - 0.148% (CCT)	0.111% (Lens Thickness) - 0.634% (CCT)
Metrics App (Biometry)	Eyes without Crystalline Lens	0.223% (CCT)	0.632% (CCT)

Note regarding Acceptance Criteria: The document states, "The device met all pre-determined acceptance criteria" under "Non-Clinical Performance Testing". For clinical performance, it states, "Results of the clinical performance testing demonstrate a favorable clinical performance profile that supports a determination of substantial equivalence." This implies that the demonstrated repeatability and reproducibility values, as detailed in the tables, were considered acceptable for the device's intended use. Specific numerical thresholds for each parameter are not provided.

2. Sample Size Used for the Test Set and Data Provenance

The provided text details the sample sizes for the clinical studies which serve as the test sets for the device's performance.

Study Protocol B-2018-3:
- Sample Size:
  - Group A (open angle): 29 participants completed, data from 25 for precision analyses (225 scans). 27 for agreement analyses.
  - Group B (narrow angle): 27 participants completed, data from 27 for precision analyses (234 scans). 26 for agreement analyses.
  - Total enrolled: 30 Group A, 28 Group B.
- Data Provenance: Single clinical site in the United States. The study was prospective, observational clinical study.
Study Protocol B-2018-5:
- Sample Size: 176 participants enrolled, 172 completed.
  - Group A (normal anterior segment): 27 participants.
  - Group B (cataract): 33 participants.
  - Group C (corneal abnormalities): 45 participants (38-43 for specific parameters in precision analysis tables).
  - Group D (post-keratorefractive surgery): 29 participants (28-29 for specific parameters).
  - Group E (pseudophakic/aphakic eyes): 41 participants (39-40 for specific parameters).
  - Scans: Varied per parameter and group, ranging from ~243 to 378 scans for precision analysis.
- Data Provenance: Single clinical site in the United States. The study was prospective, observational clinical study.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The provided text does not explicitly state the number of experts or their qualifications used to establish ground truth for the test set.

It mentions:

"Manual correction of ANTERION segmentation and manual editing of the scleral spur and angle recess points were performed as needed" for Protocol B-2018-3.
"Manual correction of ANTERION segmentation was performed by an independent reading center and manual placement of the angle recess points were performed" for Protocol B-2018-5.

While it mentions manual correction and an "independent reading center," it does not specify the number of experts, their specialty (e.g., ophthalmologists, optometrists, or technicians), or their years of experience for establishing this ground truth.

4. Adjudication Method for the Test Set

The document mentions "Manual correction of ANTERION segmentation and manual editing of the scleral spur and angle recess points were performed as needed" and "Manual correction of ANTERION segmentation was performed by an independent reading center and manual placement of the angle recess points were performed."

However, it does not describe a formal adjudication method (e.g., 2+1, 3+1, majority vote, etc.) for resolving disagreements among multiple readers or for establishing the final "ground truth" if multiple experts were involved in these manual corrections. It implies that a single "manual correction" was applied, but the process for achieving a single corrected state from potentially multiple reviewers or iterations is not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a standard MRMC comparative effectiveness study was not performed as described for AI assistance.

The studies compared the ANTERION device's measurements not to human readers' performance, but to other devices (CIRRUS HD-OCT 5000 and Pentacam AXL) for accuracy and to itself for precision (repeatability and reproducibility). The ANTERION is an imaging and measurement device, not an AI-assisted diagnostic tool that aids human readers in interpretation. Therefore, a study of how human readers improve with AI vs without AI assistance is not applicable in the context described.

The studies assessed the ANTERION's ability to consistently and accurately measure ophthalmological parameters.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

The performance results presented (Repeatability and Reproducibility) for the ANTERION device represent its standalone performance as a measurement device. The reported CV% values reflect the device's inherent precision in generating these measurements.

While manual corrections of ANTERION segmentation were performed in the studies, this was described as a step in processing the acquired images to enable measurements, rather than human "interpretation" of the algorithm's output for diagnostic purposes in a human-in-the-loop scenario. The repeatability and reproducibility are derived from the measurements produced by the device, sometimes after such manual adjustments. The overall goal was to demonstrate the consistent and accurate measurement capability of the device rather than a diagnosis assistance system.

7. The Type of Ground Truth Used

The ground truth for the clinical performance assessment appears to be based on:

Comparison to legally marketed devices: The studies performed "agreement analyses" with CIRRUS HD-OCT 5000 and Pentacam AXL, implying these served as reference or comparative ground truth for measurement accuracy. The details of these agreement analyses (e.g., Bland-Altman, Deming regression) are mentioned, but the specific numerical outcomes of these agreement analyses are not provided in the excerpt.
Manual correction by experts/independent reading center: For measurements derived from image segmentation (e.g., angle parameters, corneal thickness, chamber depth), "manual correction of ANTERION segmentation" and "manual placement of the angle recess points" were performed. This suggests that the ground truth for these segmented features was established by manual review, presumably by qualified personnel, even though their qualifications are not specified.

Therefore, the ground truth is a combination of comparison to established ophthalmic devices and expert manual correction/review of segmented images. It is not pathology or outcomes data.

8. The Sample Size for the Training Set

The provided document describes the clinical studies for device validation/testing. It does not provide information on the sample size used for the training set of the ANTERION's algorithms. As a measurement device rather than an AI diagnostic algorithm in the typical sense, it's possible that its internal algorithms rely on established physical/optical models and calibration, not necessarily a large-scale "training set" of images in the machine learning context. However, if machine learning was used for segmentation, the training set details are not provided.

9. How the Ground Truth for the Training Set Was Established

Since no information is provided about a "training set" or the use of machine learning for its algorithms, there is no information on how the ground truth for any hypothetical training set was established.

Summary

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October 11, 2023

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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"

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(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

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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) 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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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).

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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.

This submission is to seek clearance for the Metrics App, Cataract App and Cornea App.

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

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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 DEVICEANTERION	PREDICATE DEVICEANTERION(K211817)	DISCUSSION
Intended use/ Indicationsfor use	The ANTERION is a non-contact ophthalmicimaging and analysis devicefor the eye. It is intendedfor visualization andmeasurement of theanterior segment and themeasurement of the axiallength.The analysis covers:• Cornea thickness• Anterior segmento Anterior chamberwidth, depth,volume, and angleparameterso Lens thickness• Axial Length	The ANTERION is a non-contact ophthalmicimaging and analysisdevice for the eye. It isintended for visualizationof the anterior segment.	Different:Predicate deviceis only forimaging of theanterior segment.The subjectdevice providesautomatedmeasurements ofcornealthickness,anterior chamberwidth, depth, andvolume, anteriorsegment angle,lens thicknessand vault, andaxial length; thepredicate devicedoes not provideautomatedmeasurements ofany anteriorsegmentparameters.
Device classification name	Optical CoherenceTomographer (OCT)	Optical CoherenceTomographer (OCT)	Same
Main Technology	Swept Source OCTTechnology	Swept Source OCTTechnology	Same
Supporting Technologies	Infrared Camera	Infrared Camera	Same
OCT center wave length	1310 nm	1310 nm	Same
OCT axial resolution	<10 μm (tissue)	<10 μm (tissue)	Same
OCT lateral resolution	30 μm, 45 μm	30 μm	Similar:45μm only forCornea App
Scan length	5 - 16.5 mm	5 - 16.5 mm	Same

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Number of A-Scans per B-Scan	256; 512; 768; 1024	256; 512; 768; 1024	Same
A-scan rate	50,000 Hz	50,000 Hz	Same
Number of B- Scans	1-65	1-65	Same
Scan Pattern	Line, Volume, Arc, Radial	Line, Volume, Arc, Radial	Same
Scan Center	Adjustable	Adjustable	Same
Tracking	Available	Available	Same
Number of averaged Scans	1; 2; 4; 8	1; 2; 4; 8	Same
IR camera image size (px)	768 x 576	768 x 576	Same
Dilation of pupil required?	No	No	Same
Eye contact required?	No	No	Same
Fixation light	Internal, external	Internal, external	Same
Working position	Upright sitting position ofthe patient, using chin rest	Upright sitting position ofthe patient, using chin rest	Same
User Interface	Joystick for user to move andalign device, device has GUI(Graphical user interface) fordisplay and analysis of data	Joystick for user to move andalign device, device has GUI(Graphical user interface) fordisplay and analysis of data	Same

NON-CLINICAL PERFORMANCE TESTING

Software documentation was provided, and software verification and validation was conducted as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

Documentation regarding cybersecurity was submitted as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" and an overall risk assessment regarding security and safety of the device was conducted due to ISO 14971:2019.

Laser safety testing for the light sources used in ANTERION was provided and showed that the requirements according to FDA recognized standards IEC-60825-1:2007 and ANSI Z80.36:2016 were fulfilled.

Bench verification testing was conducted to demonstrate OCT spatial performance, device sensitivity, depth attenuation and performance of auxiliary functions. The device met all pre-determined acceptance criteria.

Biocompatibility of the device was demonstrated by cytotoxicity testing and chemical analysis according to ISO 10993-5:2009 and ISO 10993-18:2005, respectively, and supported by biocompatibility assessment according to 10993-1:2018.

Tests for electrical safety (ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012) and electromagnetic compatibility (IEC 60601-1- 2 Edition 4.0 2014-02) were performed with the ANTERION device and passed the relevant requirements of the applied standards.

Heidelberg Engineering GmbH Proprietary Information

Traditional 510(k): ANTERION Page 5 of 13

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CLINICAL PERFORMANCE TESTING

Two prospective, observational clinical studies were conducted at a single clinical site in the United States to compare the clinical performance of the ANTERION Metrics App between the ANTERION and the CIRRUS HD-OCT 5000 devices (Protocol B-2018-3) and the clinical performance of the ANTERION Cataract and Metrics App between the ANTERION and the Pentacam AXL and a reading center (Protocol B-2018-5).

For 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). Participants were excluded if they had active infection of 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 that included manifest refraction, slit-lamp biomicroscopy, assessment of best-corrected visual acuity (BCVA), gonioscopy, tonometry, and cataract grading (where applicable) 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 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. Repeatability and reproducibility of measurements was estimated using a two-way, random-effects analysis of variance (ANOVA) model. Agreement was characterized using Bland-Altman and Deming regression analyses.

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. The mean age in the safety population was 45.6 ± 16.9 years overall (mean 37.1±12.7 years in Group A, 55.1±16.0 years in Group B). 68.4% (39/57) were women (60.0% [18/30] Group A, 77.8% [21/27] Group B). 44% (25/57) were Caucasian (50.0% [15/30] in Group A, 37.0% [10/27] in Group B), 21% (12/57) were Black/African American (16.7% [5/30] Group A, 25.9% [7/27] Group B), 22.8% (13/57) were Asian (30.0% [9/30] Group A, 14.8% [4/27] Group B). 28.1% (16/57) were Hispanic/Latino

Heidelberg Engineering GmbH Proprietary Information

Traditional 510(k): ANTERION Page 6 of 13

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(16.7% [5/30] Group A, 40.7% [11/27] Group B). Demographics are similar for the Precision Analysis Population and the Agreement Analysis Population. There were no adverse events related to this study. 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.

The following quantitative parameters were evaluated:

Spur-to-Spur Distance ●
Angle-to-Angle Distance
Scleral Spur Angle 500/750 [°] (nasal and temporal) ●
Angle Opening Distance 500/750 [um] (nasal and temporal) ●
Trabecular Iris Space Area 500/750 [mm2] (nasal and temporal) ●
Anterior Chamber Angle 500/750 [°] (nasal and temporal) ●
Lens Vault ●

ANTERION precision results are presented in the tables below:

			TABLE 1 B-2018-3 REPEATABILITY AND REPRODUCIBILITY OF ANTERION PRECISION
ANALYSIS POPULATION OF OPEN ANGLE EYES

Eye Population	# of	# of			Repeatability			Reproducibility
Parameter	Subjects	Scans	Intercept	SD	Limit	CV%	SD	Limit	CV%
Eye(s) with open angle
ACA 500 Nasal (°)	25	225	41.876	2.892	8.098	6.906	3.772	10.561	9.007
ACA 750 Nasal (°)	25	225	41.222	2.115	5.921	5.130	2.565	7.183	6.223
AOD 500 Nasal (mm)	25	225	0.561	0.048	0.135	8.584	0.067	0.188	11.945
AOD 750 Nasal (mm)	25	225	0.742	0.046	0.130	6.244	0.062	0.174	8.397
TISA 500 Nasal (mm²)	25	225	0.195	0.017	0.047	8.665	0.022	0.063	11.463
TISA 750 Nasal (mm²)	25	225	0.347	0.025	0.070	7.192	0.035	0.097	9.935
SSA 500 Nasal (°)	25	225	46.956	3.143	8.799	6.693	4.297	12.032	9.152
SSA 750 Nasal (°)	25	225	44.920	2.109	5.906	4.696	2.794	7.822	6.219
ACA 500 Temporal (°)	25	225	44.391	3.145	8.807	7.086	3.937	11.023	8.869
ACA 750 Temporal (°)	25	225	43.524	2.222	6.222	5.105	3.069	8.593	7.051
AOD 500 Temporal (mm)	25	225	0.588	0.062	0.173	10.523	0.087	0.245	14.856
AOD 750 Temporal (mm)	25	225	0.803	0.046	0.128	5.706	0.084	0.234	10.413
TISA 500 Temporal (mm²)	25	225	0.201	0.021	0.060	10.622	0.032	0.089	15.746
TISA 750 Temporal (mm²)	25	225	0.368	0.028	0.079	7.660	0.046	0.130	12.605
SSA 500 Temporal (°)	25	225	48.867	2.811	7.871	5.753	4.458	12.483	9.124
SSA 750 Temporal (°)	25	225	46.613	2.072	5.802	4.445	3.318	9.290	7.118
STS Distance (mm)	25	225	11.920	0.051	0.143	0.428	0.072	0.201	0.602
ATA Distance (mm)	25	225	12.009	0.060	0.167	0.497	0.065	0.181	0.539
Lens Vault (mm)	25	225	0.072	0.026	0.072	35.515	0.032	0.091	45.011

All statistics are estimated (REML) from two-way random-effect ANOVA model with random effects operator/device. eye and interaction between operator/device and eye.

Reproducibility SD = Square root of the operator/device variance, the interaction variance and the residual variance

Repeatability limit = 2.8 × Repeatability CV% = (Repeatability SD)/Intercept × 100%. Reproducibility limit = 2.8 x Reproducibility SD. Reproducibility CV% = (Reproducibility SD)/Intercept × 100%. ACA = Anterior Chamber Angle. AOD = Angle Opening Distance. TISA = Trabecular-Iris Space Area. SSA = Scleral Spur-Angle. STS Distance = Spur-to-Spur Distance. ATA Distance = Angle-to-Angle Distance.

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TABLE 2 B-2018-3 REPEATABILITY AND REPRODUCIBILITY OF ANTERION PRECISION ANALYSIS POPULATION OF NARROW ANGLE EYES

Eye Population	# of	# of			Repeatability		Reproducibility
Parameter	Subjects	Scans	Intercept	SD	Limit	CV%	SD	Limit	CV%
Eye(s) with narrow angle
ACA 500 Nasal (°)	26	234	15.722	2.631	7.367	16.735	3.145	8.806	20.004
ACA 750 Nasal (°)	26	234	15.235	1.918	5.371	12.591	2.307	6.460	15.144
AOD 500 Nasal (mm)	26	234	0.164	0.024	0.068	14.870	0.033	0.092	19.965
AOD 750 Nasal (mm)	26	234	0.227	0.030	0.083	13.105	0.035	0.097	15.266
TISA 500 Nasal (mm²)	26	233	0.059	0.010	0.027	16.181	0.012	0.033	20.102
TISA 750 Nasal (mm²)	26	233	0.106	0.014	0.040	13.387	0.017	0.049	16.478
SSA 500 Nasal (°)	26	234	18.145	2.728	7.640	15.037	3.569	9.993	19.668
SSA 750 Nasal (°)	26	234	16.906	2.077	5.814	12.283	2.445	6.847	14.465
ACA 500 Temporal (°)	26	234	15.145	2.621	7.340	17.308	3.404	9.531	22.475
ACA 750 Temporal (°)	26	234	15.350	1.913	5.355	12.460	2.908	8.142	18.943
AOD 500 Temporal (mm)	26	234	0.152	0.028	0.078	18.363	0.037	0.104	24.415
AOD 750 Temporal (mm)	26	234	0.226	0.031	0.088	13.926	0.048	0.134	21.274
TISA 500 Temporal (mm²)	26	233	0.058	0.009	0.026	16.316	0.012	0.033	20.448
TISA 750 Temporal (mm²)	26	233	0.104	0.014	0.040	13.828	0.020	0.056	19.106
SSA 500 Temporal (°)	26	234	16.949	2.883	8.073	17.010	3.951	11.062	23.309
SSA 750 Temporal (°)	26	234	16.671	2.239	6.269	13.430	3.391	9.496	20.343
STS Distance (mm)	26	234	11.870	0.061	0.170	0.511	0.079	0.220	0.662
ATA Distance (mm)	26	234	11.994	0.085	0.237	0.706	0.095	0.267	0.795
25	225	0.756	0.029	0.082	3.860	0.045	0.127	5.980

All statistics are estimated (REML) from two-way random-effect ANOVA model with random effects operator/device, eye and interaction between operator/device and eye.

Reproducibility SD = Square root of the operator/device variance, the interaction variance and the residual variance

Repeatability limit = 2.8 × Repeatability CV% = (Repeatability CV% = (Repeatability SD)/Intercept × 100%.

Reproducibility limit = 2.8 x Reproducibility SD. Reproducibility CV% = (Reproducibility SD)/Intercept x 100%.

ACA = Anterior Chamber Angle. AOD = Angle Opening Distance. TISA = Trabecular-Iris Space Area. SSA = Scleral Spur-Angle. STS Distance = Spur-to-Spur Distance. ATA Distance = Angle-to-Angle Distance.

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ibelB SIMEETIL

For the second study 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 that included manifest refraction, slit-lamp biomicroscopy, assessment of best-corrected visual acuity (BCVA), tonometry, and cataract grading (where applicable) was performed 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. Repeatability and reproducibility of measurements was estimated using a two-way, random-effects analysis of variance (ANOVA) model. Agreement was characterized using Bland-Altman and Deming regression analyses.

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. The mean age was 52.6 ± 18.8 years (range 23 to 87 years). The mean age in Group A was 36.1±10.4 years (range 23 to 59); Group B, 66.9±6.8 years (range 48 to 80); Group C, 41.4±14.7 years (range 23 to 71); Group D, 43.1±13.9 years (range 24 to 72); Group E, 70.8±12.5 years (range 30 to 87). 65.1% (114/175) were women (55.6% [15/27] in Group A; 72.7% [24/33] in Group B; 57.8% [26/45] in Group C; 72.4% [21/29] in Group D; 68.3% [28/41] in Group E).

27.4% (48/175) of the safety population were Caucasian (44.4% [12/27] in Group A; 15.2% [5/33] in Group B; 26.7% [12/45] in Group C; 31.0% [9/29] in Group D; 24.4% [10/41] in Group E). 49.1% (86/175) were Black/African American (18.5% [5/27] Group A; 81.8% [27/33] Group B; 46.7% [21/45] Group C; 27.6% [8/29] Group D; 61.0% [25/41] Group E). 10.9% (19/175) were Asian (18.5% [5/27] Group A; 6.1% [2/33] Group B; 2.2% [1/45] Group C; 31.0% [9/29] Group D; 4.9% [2/41] Group E). 9.1% (16/175) were Native American/Alaskan Native (14.8% [4/27] Group A; 20.0% [9/45] Group C; 6.9% [2/29] Group D; 2.4% [1/41] Group E). 24.6% (43/175) were Hispanic/Latino (40.7% [11/27] Group A; 9.1% [3/33] Group

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B; 33.3% [15/45] Group C; 24.1% [7/29] Group D; 17.1% [7/41] Group E). 95.1% (39/41) of Group E participants were pseudophakic and two Group E participants (4.9%) were aphakic. 67% (30/45) of Group B participants had nuclear sclerosis of grade 1.5+ or higher and 29% (13/45) had cortical cataracts. 69% (31/45) of Group C participants had keratoconus. 72% of Group D participants had prior laser-assisted in situ keratomileusis (LASIK) and the remainder had prior photorefractive keratectomy (PRK), radial keratotomy (RK), small-incision lenticular extraction, or corneal inlay implantation. Demographics are similar for the Precision Analysis Population and the Agreement Analysis Population. There were no adverse events related to this study. Manual segmentation correction/extension was performed in 2.9% (7/243), 10.1% (30/297), 11.6% (44/378), and 2.3% (6/261) of Metrics App scans for Groups A, B, C, and D, respectively. Manual segmentation correction was performed in 0.4% (1/243), 3.7% (11/297), 17.1% (64/375), 3.8% (10/261), and 3.5% (12/345) of Cataract App scans for Groups A, B, C, D, and E, respectively.

The following quantitative parameters were evaluated:

Anterior Corneal Topography (3 mm ring and 6 mm zone) ●
Posterior Corneal Topography (3 mm ring and 6 mm zone)
. Central Corneal Thickness (CCT) [um]
. Thinnest Point Thickness [um]
Lens Thickness [mm]
Anterior Chamber Depth [mm] (ANTERION Aqueous Depth plus CCT) ●
. Pupil Diameter [mm]
. White-to-White Distance [mm]
Axial Length [mm]
Anterior Chamber Volume [mm3] ●

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Image /page/14/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 top line reads "HEIDELBERG" and the bottom line reads "ENGINEERING". There is a red square to the left of the top line and to the right of the bottom line.

ANTERION precision results are presented in the tables below:

TABLE 3 B-2018-5 REPEATABILITY AND REPRODUCIBILITY OF ANTERION BIOMETRY MEASUREMENTS PRECISION ANALYSIS POPULATION OF NORMAL EYES

	# of	# of		Repeatability			Reproducibility
Parameter	Subjects	Scans	Intercept	SD	Limit	CV%	SD	Limit	CV%
Cataract App: Biometry
Central corneal thickness [µm]	27	243	545.621	0.775	2.170	0.142	4.088	11.446	0.749
Thinnest point thickness [µm]	27	243	542.226	0.703	1.968	0.130	3.728	10.439	0.688
Anterior chamber depth [mm]	27	243	3.635	0.009	0.026	0.255	0.014	0.040	0.389
Axial length [mm]	27	243	24.513	0.004	0.012	0.018	0.006	0.018	0.027
Lens thickness [mm]	27	243	3.982	0.011	0.030	0.270	0.015	0.042	0.377
Metrics App: Biometry
Central corneal thickness [µm]	27	243	546.679	1.106	3.096	0.202	4.181	11.706	0.765
Anterior chamber depth [mm]	27	243	3.636	0.009	0.024	0.239	0.013	0.037	0.362
Anterior chamber volume [mm³]	27	243	185.507	1.377	3.856	0.742	3.670	10.275	1.978
Lens thickness [mm]	27	243	3.988	0.010	0.027	0.239	0.015	0.041	0.371

All statistics are estimated (REML) from two-way random-effect ANOVA model with random effects operator/device, eye and interaction between operator/device and eye.

Reproducibility SD = Square root of the operator/device variance, the interaction variance and the residual variance Repeatability limit = 2.8 x Repeatability CV% = (Repeatability CV% = (Repeatability SD)/Intercept x 100%.

Reproducibility limit = 2.8 × Reproducibility SD. Reproducibility CV% = (Reproducibility SD)/Intercept × 100%.

TABLE 4 B-2018-5 REPEATABILITY AND REPRODUCIBILITY OF ANTERION BIOMETRY MEASUREMENTS PRECISION ANALYSIS POPULATION OF CATARACT EYES

Parameter	# ofSubjects	# ofScans	Intercept	Repeatability			Reproducibility
				SD	Limit	CV%	SD	Limit	CV%
Cataract App: Biometry
Central corneal thickness [ $\mu m$ ]	33	297	527.694	2.351	6.584	0.446	4.321	12.100	0.819
Thinnest point thickness [ $\mu m$ ]	33	297	522.104	0.672	1.881	0.129	3.412	9.554	0.654
Anterior chamber depth [mm]	33	297	3.128	0.011	0.030	0.337	0.016	0.045	0.512
Axial length [mm]	33	297	23.852	0.019	0.054	0.081	0.019	0.054	0.081
Lens thickness [mm]	33	295	4.661	0.012	0.034	0.262	0.015	0.042	0.325
Metrics App: Biometry
Central corneal thickness [ $\mu m$ ]	33	297	529.101	1.277	3.574	0.241	3.972	11.122	0.751
Anterior chamber depth [mm]	33	297	3.130	0.006	0.016	0.186	0.010	0.028	0.320
Anterior chamber volume [ $mm^3$ ]	33	295	132.199	0.821	2.298	0.621	1.548	4.335	1.171
Lens thickness [mm]	33	297	4.670	0.007	0.019	0.142	0.010	0.027	0.208

All statistics are estimated (REML) from two-way random-effect ANOVA model with random effects operator/device, eye and interaction between operator/device and eye.

Reproducibility SD = Square root of the operator/device variance, the interaction variance and the residual variance Repeatability limit = 2.8 × Repeatability CV% = (Repeatability CV% = (Repeatability SD)/Intercept × 100%.

Reproducibility limit = 2.8 x Reproducibility SD. Reproducibility CV% = (Reproducibility SD)/Intercept × 100%.

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Image /page/15/Picture/0 description: The image shows the logo for Heidelberg Engineering. The logo consists of two lines of text in a bold, futuristic font. The first line reads "HEIDELBERG" and the second line reads "ENGINEERING". There is a red square to the left of the word "HEIDELBERG" and to the right of the word "ENGINEERING".

TABLE 5 B-2018-5 REPEATABILITY AND REPRODUCIBILITY OF ANTERION BIOMETRY MEASUREMENTS PRECISION ANALYSIS POPULATION OF EYES WITH CORNEAL ABNORMALITIES

Parameter	# ofSubjects	# ofScans	Intercept	Repeatability			Reproducibility
				SD	Limit	CV%	SD	Limit	CV%
Cataract App: Biometry
Central corneal thickness [μm]	43	363	495.294	1.872	5.243	0.378	4.367	12.227	0.882
Thinnest point thickness [μm]	43	363	470.957	4.023	11.263	0.854	5.116	14.325	1.086
Anterior chamber depth [mm]	43	363	3.746	0.014	0.039	0.370	0.019	0.052	0.498
Axial length [mm]	43	366	24.548	0.012	0.034	0.049	0.017	0.046	0.067
Lens thickness [mm]	40	337	4.001	0.016	0.045	0.399	0.018	0.051	0.457
Metrics App: Biometry
Central corneal thickness [μm]	38	331	513.923	1.117	3.129	0.217	7.479	20.942	1.455
Anterior chamber depth [mm]	38	331	3.668	0.011	0.031	0.306	0.016	0.045	0.438
Anterior chamber volume [mm³]	39	339	187.635	1.124	3.148	0.599	2.669	7.472	1.422
Lens thickness [mm]	36	313	4.039	0.012	0.035	0.308	0.018	0.049	0.434

All statistics are estimated (REML) from two-way random-effect ANOVA model with random effects operator/device, eye and interaction between operator/device and eye.

Reproducibility limit = 2.8 x Reproducibility SD. Reproducibility CV% = (Reproducibility SD)/Intercept × 100%.

TABLE 6 B-2018-5 REPEATABILITY AND REPRODUCIBILITY OF ANTERION BIOMETRY MEASUREMENTS PRECISION ANALYSIS POPULATION OF POST-KERATOREFRACTIVE SURGERY EYES

	# of	# of		Repeatability			Reproducibility
Parameter	Subjects	Scans	Intercept	SD	Limit	CV%	SD	Limit	CV%
Cataract App: Biometry
Central corneal thickness [ $\mu m$ ]	29	261	479.893	1.076	3.012	0.224	4.637	12.984	0.966
Thinnest point thickness [ $\mu m$ ]	29	261	473.157	1.224	3.427	0.259	4.394	12.304	0.929
Anterior chamber depth [mm]	29	261	3.568	0.008	0.024	0.236	0.012	0.033	0.328
Axial length [mm]	29	261	25.264	0.004	0.012	0.018	0.007	0.020	0.028
Lens thickness [mm]	29	260	4.110	0.009	0.024	0.209	0.013	0.037	0.322
Metrics App: Biometry
Central corneal thickness [ $\mu m$ ]	28	251	489.173	1.062	2.975	0.217	4.485	12.558	0.917
Anterior chamber depth [mm]	28	251	3.555	0.007	0.020	0.196	0.010	0.027	0.275
Anterior chamber volume [mm $^3$ ]	28	251	177.715	1.203	3.368	0.677	2.477	6.935	1.394
Lens thickness [mm]	28	250	4.124	0.007	0.021	0.182	0.012	0.035	0.300

All statistics are estimated (REML) from two-way random-effect ANOVA model with random effects operator/device, eye and interaction between operator/device and eye.

Reproducibility limit = 2.8 × Reproducibility CV% = (Reproducibility SD)/Intercept × 100%.

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Image /page/16/Picture/0 description: The image contains the words "HEIDELBERG" on the top line and "ENGINEERING" on the bottom line. There is a red square on the left side of the word "HEIDELBERG" and on the right side of the word "ENGINEERING". The words are in a sans-serif font.

TABLE 7 B-2018-5 REPEATABILITY AND REPRODUCIBILITY OF ANTERION BIOMETRY MEASUREMENTS PRECISION ANALYSIS POPULATION OF EYES WITHOUT A CRYSTALLINE LENS

	# of	# of		Repeatability			Reproducibility
Parameter	Subjects	Scans	Intercept	SD	Limit	CV%	SD	Limit	CV%
Cataract App: Biometry
Central corneal thickness [um]	39	345	539.041	0.800	2.241	0.148	3.420	9.576	0.634
Thinnest point thickness [um]	39	345	533.188	0.753	2.110	0.141	3.015	8.443	0.566
Lens thickness [mm]	39	345	24.175	0.007	0.018	0.027	0.027	0.075	0.111
Metrics App: Biometry
Central corneal thickness [um]	40	358	540.115	1.202	3.365	0.223	3.413	9.555	0.632

All statistics are estimated (REML) from two-way random-effect ANOVA model with random effects operator/device, eye and interaction between operator/device and eye.

Reproducibility limit = 2.8 × Reproducibility SD. Reproducibility CV% = (Reproducibility SD)/Intercept × 100%.

CONCLUSION

ANTERION (with software version 1.2.4) has the same intended use as the legally marketed predicate device identified in this 510(k) notification. The Indications for Use (IFU) statement differs from those of the predicate device, but these differences do not change the intended use of the device. The technological characteristics of the ANTERION V1.2.4 differ from those of the predicate device, however, the differences do not raise new or different questions of safety or effectiveness. Results of the non-clinical performance testing demonstrate that the ANTERION V1.2.4 functions as intended. Results of the clinical performance testing demonstrate a favorable clinical performance profile that supports a determination of substantial equivalence. The non-clinical and clinical performance testing demonstrate that the device is as safe, as effective, and performs as well or better than the legally marketed predicate.

Regulation Number and Section

§ 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.