Pentacam® Cornea OCT
Device Facts
| Record ID | K251848 |
|---|---|
| Device Name | Pentacam® Cornea OCT |
| Applicant | Oculus Optikgeräte GmbH |
| Product Code | MXK · Ophthalmic |
| Decision Date | Mar 13, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.1850 |
| Device Class | Class 2 |
Intended Use
The Pentacam® Cornea OCT is a multifunction ophthalmic imaging device designed to acquire images of the anterior segment using Scheimpflug imaging (digital CMOS camera with slit-lamp illumination) and OCT. Scheimpflug imaging provides anterior segment visualization and quantitative anterior segment measurements. The OCT component of the system uses broadband Multi-SLD and is intended for the in vivo imaging, cross-sectional, and the three-dimensional imaging and measurement of corneal epithelium. The Pentacam® Cornea OCT is indicated for use as a diagnostic device to aid in the detection and management of ocular diseases affecting the anterior segment of the eye.
Device Story
Multifunction ophthalmic imaging device; combines Scheimpflug imaging (digital CMOS camera with slit-lamp illumination) and spectral-domain OCT. Operates by rotating around the eye to capture Scheimpflug images and OCT tomograms simultaneously. Inputs: light backscattered from anterior segment tissue structures. Outputs: 3D mathematical model of anterior segment; epithelial thickness maps. Used in clinical settings by eye care professionals. Scheimpflug images provide anterior segment visualization and quantitative measurements; OCT provides cross-sectional and 3D imaging of corneal epithelium. Data transmitted to connected PC for analysis. Quality specification (QS) indicates measurement reliability. Assists clinicians in detecting and managing anterior segment ocular diseases. Benefits include precise, non-invasive corneal epithelial thickness mapping and anterior segment assessment.
Clinical Evidence
Prospective, observational study at a single U.S. site (n=80; 40 normal, 40 corneal pathology). Evaluated repeatability and reproducibility of epithelial thickness measurements (ETM) across 25 sections. Compared Pentacam Cornea OCT to Optovue Solix. Results showed high agreement; mean differences between devices were <2μm across all sectors. Repeatability and reproducibility CV% values met predefined performance goals.
Technological Characteristics
Spectral-Domain OCT (SD-OCT) and Scheimpflug imaging. OCT light source: broadband Multi-SLD (780-1000nm). Scheimpflug camera: digital CMOS. Standards: IEC 60601-1, IEC 60601-1-2, ISO 15004-1/2, ANSI Z80.36-2016, IEC 60825-1. Connectivity: PC-based. Sterilization: non-sterile.
Indications for Use
Indicated for use as a diagnostic device to aid in the detection and management of ocular diseases affecting the anterior segment of the eye, specifically for in vivo imaging, cross-sectional, and 3D imaging and measurement of the corneal epithelium.
Regulatory Classification
Identification
An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.
Special Controls
*Classification.* Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
Predicate Devices
- Optovue, Inc., SOLIX (K222166)
Reference Devices
- OCULUS Optikgeräte GmbH, Pentacam® AXL Wave (K201724)
Related Devices
- K201724 — Pentacam AXL Wave · Oculus Optikgerate GmbH · Oct 21, 2020
- K252633 — UNITY DX (UDX) · Cylite Pty. , Ltd. · Dec 23, 2025
- K221601 — MS-39 · C.S.O. S.R.L. · Sep 1, 2023
- K231222 — 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) · Topcon Corporation · Oct 30, 2023
- K230897 — Anterion · Heidelberg Engineering GmbH · Oct 11, 2023
Submission Summary (Full Text)
{0}
FDA U.S. FOOD & DRUG ADMINISTRATION
March 13, 2026
OCULUS Optikgeräte GmbH
% Randy Prebula
Partner
Hogan Lovells
555 Thirteenth Street NW
Washington, District of Columbia 20004
Re: K251848
Trade/Device Name: Pentacam® Cornea OCT
Regulation Number: 21 CFR 886.1570
Regulation Name: Ophthalmoscope
Regulatory Class: Class II
Product Code: OBO, MXK
Dated: January 26, 2026
Received: January 26, 2026
Dear Randy Prebula:
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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
{1}
K251848 - Randy Prebula
Page 2
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 (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-reporting-combination-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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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.
{2}
K251848 - Randy Prebula
Page 3
See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/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,
BRADLEY S. CUNNINGHAM -S
CAPT Brad Cunningham, MSE, RAC
Acting 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
{3}
Pentacam® Cornea OCT
Indications for Use Statement
OCULUS
# Indications for Use Statement
510(k) Number (if known): K251848
Device Name: Pentacam® Cornea OCT
Indications for Use:
The Pentacam® Cornea OCT is a multifunction ophthalmic imaging device designed to acquire images of the anterior segment using Scheimpflug imaging (digital CMOS camera with slit-lamp illumination) and OCT.
Scheimpflug imaging provides anterior segment visualization and quantitative anterior segment measurements.
The OCT component of the system uses broadband Multi-SLD and is intended for the in vivo imaging, cross-sectional, and the three-dimensional imaging and measurement of corneal epithelium.
The Penatcam® Cornea OCT is indicated for use as a diagnostic device to aid in the detection and management of ocular diseases affecting the anterior segment of the eye.
Prescription Use ☐ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use ☐ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
{4}
Pentacam® Cornea OCT 510(k) Summary OCULUS
510(k) SUMMARY
OCULUS Pentacam® Cornea OCT
K251848
## General Information
### Applicant
OCULUS Optikgeräte GmbH
Müncholzhäuserstr. 29
35582 Wetzlar
Germany
Phone: +49(0)641 2005-0
Fax: +49(0)641 2005-255
### Contact Person
Agata Kufel
Senior Regulatory Affair Manager
OCULUS Optikgeräte GmbH
Müncholzhäuserstr. 29
35582 Wetzlar
Germany
Phone: +49(0)641 2005-0
Fax +49(0)641 2005-255
Summary Prepared: March 4, 2026
## Device Information
Classification Name: Device, tomography, optical coherence
Ophthalmoscope.
Trade/Propriety Name: Pentacam® Cornea OCT
Regulation Number: 21 C.F.R. §886.1570
Device class: II
Product Code: OBO, MXK
## Predicate Devices
Primary Predicate: Optovue, Inc., SOLIX (K222166)
Reference Device: OCULUS Optikgeräte GmbH, Pentacam® AXL Wave (K201724)
{5}
Pentacam® Cornea OCT 510(k) Summary OCULUS
# Intended Use / Indications for Use
The Pentacam® Cornea OCT is a multifunction ophthalmic imaging device designed to acquire images of the anterior segment using Scheimpflug imaging (digital CMOS camera with slit-lamp illumination) and OCT.
Scheimpflug imaging provides anterior segment visualization and quantitative anterior segment measurements.
The OCT component of the system uses broadband Multi-SLD and is intended for the in vivo imaging, cross-sectional, and the three-dimensional imaging and measurement of corneal epithelium.
The Pentacam® Cornea OCT is indicated for use as a diagnostic device to aid in the detection and management of ocular diseases affecting the anterior segment of the eye.
# Product Description/Technological Characteristics
The Pentacam® Cornea OCT combines functions of the Scheimpflug technology of the cleared Oculus GmbH Pentacam® AXL Wave device (K201724), which is used for evaluating anterior segment of the eye, with the additional functionality of optical coherence tomography (OCT). The device is intended for using both systems together (Scheimpflug imagining and OCT) by two parallel scans for evaluating anterior segment (cornea, pupil, anterior chamber and lens of the eye) of the eye by Scheimpflug and in vivo imaging, cross-sectional and three-dimensional imaging, and measurement of corneal epithelium.
While rotating around the eye, the Pentacam® Cornea OCT captures Scheimpflug images of the anterior eye segment through varying axes. The Scheimpflug images created during an examination are transmitted to the connected PC. Scheimpflug images are captured within two seconds.
Up to 138,000 (optional 276,000) genuine height values are measured and analyzed from the Scheimpflug images. The Scheimpflug images are the basis for the height data which are used to calculate a mathematical 3D model of the anterior eye segment. At same time any eye movements are recorded and taken into account. A quality specification (QS) indicates the quality of the measurement taken.
The mathematical 3D model, corrected for eye movements, provides the basis for all subsequent analysis.
Spectral domain OCT technology scans in parallel with the digital CMOS camera with slit lamp illumination (Scheimpflug). OCT uses broadband Multi-SLD scan with wavelength between 780-1000nm. The OCT functionality is an addition to the prior cleared Oculus Pentacam® AXL Wave device (K201724).
The OCT system creates images (tomograms) simultaneously with the Scheimpflug system while rotating around the eye.
Three-dimensional images are obtained by scanning laterally over the sample through varying axes.
{6}
Pentacam® Cornea OCT 510(k) Summary OCULUS
The Pentacam® Cornea OCT is specifically designed for use in scanning the corneal epithelium of the human eye. The OCT component of the system is not intended for retinal imaging or analyses.
The cornea OCT scans will be in 25 sections / sectional planes, similar to the Scheimpflug sections produced from the Scheimpflug camera and will provide an epithelial thickness map which will provide tissue thickness information in different sections.
The OCT system operates in conjunction with the Scheimpflug system, capturing images as it rotates around the eye and measures light backscattered from tissue structures
## Performance Data
EMC and electrical safety of the subject devices were evaluated using the following consensus standards: IEC 60601-1; IEC 60601-1-2.
Testing performed in accordance with ISO 15004-1, ISO 15004-2, ANSI Z80.36-2016 and IEC 60825-1 demonstrated compliance with these standards.
## Summary of Clinical Results
Clinical Agreement and Precision Study of the Pentacam® Cornea OCT Compared to the Optovue Solix (K222166)
Clinical studies were conducted according to Clinical investigation of medical devices for human subjects – Good Clinical Practice to validate the agreement and precision of the measured parameters for the subject device Pentacam® Cornea OCT. This was a prospective, observational study conducted at a single clinical U.S. site. Eligible participants aged 22 or older were enrolled to two study group: 1) Normal – individuals with no corneal pathology, active ocular infection in either eye, no history of ocular surgery. 2) Corneal – individuals with corneal pathologies including but not limited to: Post status Laser-Assisted In Situ Keratomileusis (LASIK) surgery, Keratoconus, or other corneal dystrophies or degenerations in the study eye(s) as confirmed within the past six (6) months.
Repeatability analysis was based on the variability of repeated scans of the same eye with the same device/operator pair, while the reproducibility analysis was based on repeatability and the combined device/operator effect for multiple devices. The repeatability and reproducibility (R&R) were estimated for each study group using a random-effects analysis of variance (ANOVA) model. CV% was calculated as $100 \times \mathrm{SD} / \mathrm{Mean}$; precision limits were calculated as $2.77 \times \mathrm{SD}$ (ISO 5725-6).
Precision and agreement of the ETM between the Pentacam® Cornea OCT and the Optovue Solix were tested for 25 sections over a 7 mm diameter. The sections included a central 2mm diameter zone (C) surrounded by three annular rings (2 to 5 mm, 5 to 7 mm and 7 to 9mm), with each ring comprised of eight sections (nasal - N, superior nasal - SN, superior - S, superior temporal - ST, temporal - T, inferior temporal - IT, inferior - I, and inferior nasal - IN). The mean epithelial thickness of each section was analysed, and only measurements with sufficient quality (Quality Score OCT = "OK") were accepted for analysis.
Scan accountability (OCT-derived epithelium thickness map): In the Normal cohort, 433 Pentacam® Cornea OCT scans were acquired to obtain 360 acceptable scans (40 eyes × 9
{7}
Pentacam® Cornea OCT 510(k) Summary OCULUS
scans), requiring 73 repeat scans (16.9%) due to Quality Score (QS) warnings (QS = Yellow/Red). In comparison, 371 Optovue Solix scans were acquired to obtain 360 acceptable scans, requiring 11 repeat scans (3.0%) due to signal strength warnings. In the Corneal cohort, 443 Pentacam® Cornea OCT scans were acquired to obtain 360 acceptable scans, requiring 83 repeat scans (18.7%) due to QS warnings; in comparison, 376 Optovue Solix scans were acquired to obtain 360 acceptable scans, requiring 16 repeat scans (5.0%) due to signal strength warnings. All repeat scans were performed by the operator per protocol to obtain an acceptable-quality scan; no Pentacam® Cornea OCT scans were removed after investigator review. The higher repeat-scan rate observed with Pentacam® Cornea OCT is attributable to its more stringent QS criteria (including cornea centering, epithelium margin distance, analyzed area, and lost segments) and sensitivity to eyelid coverage in the superior 7–9 mm sectors, which promotes inclusion of only valid epithelial thickness data in the final analysis.
## Results
For normal group: the mean age of the 40 subjects was 44.1±11.0 years, ranging from 22 years to 70 years. 19 (47.5%) right eyes and 21 (52.5%) left eyes were measured. 28 female and 12 male patients were included in the normal group.
For corneal group: The mean age of the 40 subjects (19 males – 37.5%) was 48.3 ±12.1 years, ranging from 23 to 74 years. 22 (55%) right eyes and 18 (45%) left eyes were measured. 21 female and 19 male patients were included in the corneal group.
Notes: Mean (μm) is the average epithelial thickness for the sector. Repeatability reflects within-eye repeated scans under the same configuration; Reproducibility reflects variability across configurations (different device/operator pairs).
CV% = 100×SD/Mean.
Limits were calculated as 2.77×SD per ISO 5725-6.
Pentacam® Cornea OCT precision analysis for epithelial thickness measurements in normal eyes:
| Sections | Number of Subjects | Mean (μm) | Repeatability | | | | Reproducibility | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | SD | Limit | CV (%) | 95% CI | SD | Limit | CV (%) | 95% CI |
| Zone 0 to 2 mm | | | | | | | | | | |
| C | 40 | 55.6 | 1.0 | 2.6 | 1.8 | [1.6;2.0] | 1.3 | 3.7 | 2.5 | [2.2;2.7] |
| Ring 2 to 5 mm | | | | | | | | | | |
| T | 40 | 52.9 | 0.9 | 2.5 | 1.7 | [1.5;1.9] | 1.1 | 3.1 | 2.1 | [1.9;2.3] |
| ST | 40 | 50.0 | 1.0 | 2.9 | 2.0 | [1.7;2.2] | 1.2 | 3.4 | 2.4 | [2.1;2.6] |
| S | 40 | 50.0 | 1.0 | 2.9 | 2.0 | [1.7;2.2] | 1.3 | 3.5 | 2.4 | [2.1;2.6] |
| SN | 40 | 52.6 | 1.0 | 2.8 | 1.9 | [1.6;2.1] | 1.2 | 3.4 | 2.3 | [2.0;2.5] |
| N | 40 | 55.0 | 1.1 | 3.0 | 2.0 | [1.5;2.3] | 1.4 | 3.9 | 2.6 | [2.0;3.0] |
| IN | 40 | 55.6 | 1.0 | 2.7 | 1.8 | [1.5;2.0] | 1.2 | 3.2 | 2.1 | [1.8;2.4] |
| I | 40 | 53.3 | 0.8 | 2.3 | 1.5 | [1.2;1.7] | 1.1 | 3.0 | 1.9 | [1.7;2.1] |
| IT | 40 | 55.6 | 1.0 | 2.7 | 1.8 | [1.5;2.0] | 1.1 | 3.1 | 2.0 | [1.8;2.2] |
| Ring 5 to 7 mm | | | | | | | | | | |
| T | 40 | 55.6 | 1.0 | 2.7 | 1.8 | [1.5;2.1] | 1.1 | 3.1 | 2.1 | [1.9;2.3] |
{8}
Pentacam® Cornea OCT 510(k) Summary OCULUS
Pentacam® Cornea OCT precision analysis for epithelial thickness measurements in normal eyes:
| Sections | Number of Subjects | Mean (μm) | Repeatability | | | | Reproducibility | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | SD | Limit | CV (%) | 95% CI | SD | Limit | CV (%) | 95% CI |
| ST | 40 | 52.6 | 1.0 | 2.8 | 1.9 | [1.7;2.1] | 1.3 | 3.5 | 2.5 | [2.2;2.7] |
| S | 40 | 50.0 | 1.1 | 3.2 | 2.2 | [2.0;2.4] | 1.5 | 4.2 | 2.9 | [2.6;3.2] |
| SN | 40 | 47.6 | 1.0 | 3.2 | 2.1 | [1.8;2.4] | 1.4 | 3.9 | 2.6 | [2.3;2.9] |
| N | 40 | 47.1 | 0.8 | 2.6 | 1.7 | [1.3;2.0] | 1.2 | 3.4 | 2.3 | [1.8;2.6] |
| IN | 40 | 53.3 | 0.8 | 2.2 | 1.5 | [1.2;1.6] | 1.1 | 3.0 | 1.9 | [1.7;2.2] |
| I | 40 | 66.7 | 1.0 | 2.3 | 1.5 | [1.3;1.7] | 1.1 | 3.1 | 2.0 | [1.7;2.2] |
| IT | 40 | 58.8 | 1.0 | 2.6 | 1.7 | [1.5;1.9] | 1.1 | 3.2 | 2.1 | [1.8;2.3] |
| Ring 7 to 9 mm | | | | | | | | | | |
| T | 40 | 50.0 | 1.0 | 2.9 | 2.0 | [1.7;2.2] | 1.2 | 3.3 | 2.3 | [2.1;2.5] |
| ST | 40 | 52.4 | 1.1 | 2.9 | 2.1 | [1.9;2.3] | 1.4 | 3.9 | 2.8 | [2.5;3.0] |
| S | 35 | 50.0 | 1.7 | 4.6 | 3.4 | [2.8;3.8] | 1.9 | 5.4 | 4.0 | [3.4;4.4] |
| SN | 40 | 53.8 | 1.4 | 3.8 | 2.6 | [2.3;2.8] | 1.7 | 4.6 | 3.2 | [2.9;3.4] |
| N | 40 | 57.9 | 1.1 | 3.0 | 1.9 | [1.5;2.2] | 1.3 | 3.6 | 2.3 | [1.9;2.5] |
| IN | 40 | 56.2 | 0.9 | 2.5 | 1.6 | [1.3;1.8] | 1.2 | 3.3 | 2.2 | [1.8;2.5] |
| I | 40 | 52.9 | 0.9 | 2.5 | 1.7 | [1.3;1.9] | 1.3 | 3.6 | 2.4 | [2.0;2.6] |
| IT | 40 | 58.8 | 1.0 | 2.7 | 1.7 | [1.5;1.9] | 1.2 | 3.3 | 2.1 | [1.9;2.3] |
Optovue Solix precision analysis for epithelial thickness measurements in normal eyes:
| Sections | Number of Subjects | Mean (μm) | Repeatability | | | | Reproducibility | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | SD | Limit | CV (%) | 95% CI | SD | Limit | CV (%) | 95% CI |
| Zone 0 to 2 mm | | | | | | | | | | |
| C | 40 | 54.2 | 1.3 | 3.4 | 2.4 | [1.2; 3.1] | 1.6 | 4.3 | 2.9 | [1.5; 3.8] |
| Ring 2 to 5 mm | | | | | | | | | | |
| T | 40 | 52.6 | 1.0 | 3.4 | 1.9 | [1.4; 2.3] | 1.1 | 3.2 | 2.2 | [1.6; 2.6] |
| ST | 40 | 54.2 | 1.3 | 4.4 | 2.4 | [1.8; 2.9] | 1.4 | 4.0 | 2.8 | [2.1; 3.2] |
| S | 40 | 52.0 | 1.3 | 3.3 | 2.5 | [1.8; 3.0] | 1.5 | 4.1 | 2.8 | [2.2; 3.3] |
| SN | 40 | 53.8 | 1.4 | 3.6 | 2.6 | [1.7; 3.1] | 1.5 | 4.2 | 2.9 | [2.0; 3.4] |
| N | 40 | 54.5 | 1.2 | 3.9 | 2.2 | [1.4; 2.7] | 1.4 | 3.8 | 2.6 | [1.8; 3.1] |
| IN | 40 | 55.0 | 1.1 | 4.0 | 2.0 | [1.3; 2.4] | 1.3 | 3.6 | 2.4 | [1.7; 2.9] |
| I | 40 | 55.6 | 1.0 | 4.1 | 1.8 | [1.3; 2.2] | 1.2 | 3.2 | 2.2 | [1.6; 2.5] |
| IT | 40 | 52.9 | 0.9 | 3.3 | 1.7 | [1.2; 2.0] | 1.1 | 3.0 | 2.0 | [1.6; 2.3] |
| Ring 5 to 7 mm | | | | | | | | | | |
| T | 40 | 52.0 | 1.3 | 5.3 | 2.5 | [2.0; 3.0] | 1.5 | 4.1 | 2.9 | [2.3; 3.4] |
| ST | 40 | 50.0 | 1.5 | 4.9 | 3.0 | [2.6; 3.2] | 1.7 | 4.8 | 3.4 | [3.0; 3.8] |
| S | 40 | 50.0 | 1.2 | 5.8 | 2.4 | [1.9; 2.7] | 1.4 | 4.0 | 2.8 | [2.2; 3.2] |
| SN | 40 | 52.4 | 1.1 | 6.6 | 2.1 | [1.6; 2.4] | 1.3 | 3.7 | 2.5 | [2.0; 2.9] |
| N | 40 | 52.9 | 0.9 | 5.9 | 1.7 | [1.3; 2.0] | 1.3 | 3.7 | 2.5 | [1.7; 2.9] |
| IN | 40 | 55.6 | 1.0 | 3.7 | 1.8 | [1.1; 2.3] | 1.3 | 3.5 | 2.3 | [1.8; 2.7] |
{9}
Pentacam® Cornea OCT
510(k) Summary
OCULUS
Optovue Solix precision analysis for epithelial thickness measurements in normal eyes:
| Sections | Number of Subjects | Mean (μm) | Repeatability | | | | Reproducibility | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | SD | Limit | CV (%) | 95% CI | SD | Limit | CV (%) | 95% CI |
| I | 40 | 55.6 | 1.0 | 4.4 | 1.8 | [1.2; 2.2] | 1.2 | 3.4 | 2.3 | [1.6; 2.7] |
| IT | 40 | 54.2 | 1.3 | 3.7 | 2.4 | [1.4; 3.0] | 1.4 | 3.9 | 2.7 | [1.8; 3.3] |
| Ring 7 to 9 mm | | | | | | | | | | |
| T | 40 | 51.5 | 1.7 | 4.6 | 3.3 | [1.9; 4.0] | 1.9 | 5.2 | 3.6 | [2.2; 4.4] |
| ST | 40 | 50.0 | 1.7 | 5.5 | 3.4 | [2.5; 4.0] | 2.2 | 6.0 | 4.4 | [3.4; 5.1] |
| S | 40 | 48.8 | 2.1 | 6.1 | 4.3 | [3.8; 4.6] | 2.8 | 7.7 | 5.7 | [4.8; 6.4] |
| SN | 40 | 51.5 | 1.7 | 5.9 | 3.3 | [2.5; 3.8] | 2.0 | 5.5 | 3.8 | [3.0; 4.4] |
| N | 40 | 53.8 | 1.4 | 7.6 | 2.6 | [2.2; 2.9] | 1.7 | 4.8 | 3.1 | [2.6; 3.5] |
| IN | 40 | 57.1 | 1.2 | 6.1 | 2.1 | [1.7; 2.4] | 1.8 | 4.9 | 3.2 | [2.5; 3.7] |
| I | 40 | 52.6 | 1.0 | 4.3 | 1.9 | [1.4; 2.3] | 1.4 | 4.0 | 2.7 | [2.1; 3.1] |
| IT | 40 | 54.5 | 1.2 | 5.2 | 2.2 | [1.4; 2.7] | 1.5 | 4.1 | 2.7 | [1.7; 3.3] |
Pentacam® Cornea OCT precision analysis for ETM measurements in eyes with corneal disease
| Sections | Number of Subjects | Mean (μm) | Repeatability | | | | Reproducibility | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | SD | Limit | CV (%) | 95% CI | SD | Limit | CV (%) | 95% CI |
| Zone 0 to 2 mm | | | | | | | | | | |
| C | 40 | 55.6 | 1.0 | 2.8 | 1.8 | [1.6;2.0] | 1.4 | 3.8 | 2.5 | [2.2;2.7] |
| Ring 2 to 5 mm | | | | | | | | | | |
| T | 40 | 54.2 | 1.3 | 3.7 | 2.4 | [1.8;2.8] | 1.6 | 4.4 | 2.8 | [2.2;3.3] |
| ST | 40 | 55.6 | 1.0 | 2.8 | 1.8 | [1.5;2.1] | 1.3 | 3.5 | 2.3 | [1.9;2.6] |
| S | 40 | 52.6 | 1.0 | 2.9 | 1.9 | [1.6;2.1] | 1.4 | 3.9 | 2.5 | [2.0;2.8] |
| SN | 40 | 56.2 | 0.9 | 2.6 | 1.6 | [1.4;1.8] | 1.2 | 3.3 | 2.1 | [1.9;2.4] |
| N | 40 | 58.8 | 1.0 | 2.7 | 1.7 | [1.5;1.9] | 1.3 | 3.5 | 2.3 | [2.0;2.5] |
| IN | 40 | 58.8 | 1.0 | 2.7 | 1.7 | [1.4;1.9] | 1.2 | 3.3 | 2.1 | [1.8;2.3] |
| I | 40 | 58.8 | 1.0 | 2.7 | 1.7 | [1.5;1.9] | 1.2 | 3.5 | 2.2 | [1.9;2.4] |
| IT | 40 | 58.8 | 1.0 | 2.7 | 1.7 | [1.5;1.9] | 1.3 | 3.6 | 2.3 | [2.1;2.5] |
| Ring 5 to 7 mm | | | | | | | | | | |
| T | 40 | 52.6 | 1.0 | 2.8 | 1.9 | [1.7;2.0] | 1.4 | 3.9 | 2.6 | [2.2;2.8] |
| ST | 40 | 52.6 | 1.0 | 2.8 | 1.9 | [1.7;2.1] | 1.4 | 3.8 | 2.6 | [2.2;2.8] |
| S | 40 | 54.2 | 1.3 | 3.5 | 2.4 | [2.0;2.7] | 1.6 | 4.4 | 3.0 | [2.6;3.3] |
| SN | 40 | 52.2 | 1.2 | 3.4 | 2.3 | [1.9;2.6] | 1.5 | 4.0 | 2.7 | [2.0;3;3] |
| N | 40 | 55.6 | 1.0 | 2.7 | 1.8 | [1.6;2.0] | 1.2 | 3.4 | 2.3 | [2.0;2.5] |
| IN | 40 | 52.9 | 0.9 | 2.5 | 1.7 | [1.4;1.9] | 1.2 | 3.4 | 2.2 | [1.9;2.4] |
| I | 40 | 52.9 | 0.9 | 2.5 | 1.7 | [1.4;1.9] | 1.3 | 3.7 | 2.4 | [2.0;2.7] |
| IT | 40 | 52.9 | 0.9 | 2.6 | 1.7 | [1.5;1.9] | 1.3 | 3.5 | 2.3 | [2.0;2.5] |
| Ring 7 to 9 mm | | | | | | | | | | |
| T | 40 | 52.2 | 1.2 | 3.3 | 2.3 | [1.8;2.6] | 1.5 | 4.1 | 2.8 | [2.3;3.2] |
{10}
Pentacam® Cornea OCT 510(k) Summary OCULUS
Pentacam® Cornea OCT precision analysis for ETM measurements in eyes with corneal disease
| Sections | Number of Subjects | Mean (μm) | Repeatability | | | | Reproducibility | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | SD | Limit | CV (%) | 95% CI | SD | Limit | CV (%) | 95% CI |
| ST | 40 | 48.0 | 1.2 | 3.5 | 2.5 | [1.9;2.9] | 1.6 | 4.4 | 3.1 | [2.5;3.6] |
| S | 38 | 50.0 | 1.6 | 4.4 | 3.2 | [2.6;3.6] | 2.1 | 5.7 | 4.1 | [3.3;4.7] |
| SN | 39 | 53.8 | 1.4 | 3.8 | 2.6 | [2.2;3.0] | 1.7 | 4.6 | 3.2 | [2.8;3.6] |
| N | 40 | 53.8 | 1.4 | 3.9 | 2.6 | [1.9;3.0] | 1.7 | 4.8 | 3.2 | [2.3;3.7] |
| IN | 40 | 52.4 | 1.1 | 3.1 | 2.1 | [1.8;2.4] | 1.3 | 3.7 | 2.5 | [2.1;2.9] |
| I | 40 | 52.0 | 1.3 | 3.7 | 2.5 | [1.9;2.9] | 1.4 | 4.0 | 2.7 | [2.2;3.1] |
| IT | 40 | 52.4 | 1.1 | 3.1 | 2.1 | [1.7;2.3] | 1.3 | 3.7 | 2.5 | [2.2;2.7] |
Optovue Solix precision analysis for ETM measurements in eyes with corneal disease:
| Sections | Number of Subjects | Mean (μm) | Repeatability | | | | Reproducibility | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | SD | Limit | CV (%) | 95% CI | SD | Limit | CV (%) | 95% CI |
| Zone 0 to 2 mm | | | | | | | | | | |
| C | 40 | 54.5 | 1.2 | 3.4 | 2.2 | [1.3; 2.7] | 1.4 | 3.9 | 2.5 | [1.7; 3.0] |
| Ring 2 to 5 mm | | | | | | | | | | |
| T | 40 | 54.5 | 1.2 | 3.4 | 2.2 | [1.7; 2.6] | 1.4 | 4.0 | 2.6 [2.2; 2.9] | |
| ST | 40 | 55.2 | 1.6 | 4.4 | 2.9 | [1.8; 3.6] | 1.8 | 5.1 | 3.4 | [2.3; 4.0] |
| S | 40 | 54.5 | 1.2 | 3.3 | 2.2 | [1.8; 2.5] | 1.5 | 4.0 | 2.7 | [2.2; 3.1] |
| SN | 40 | 54.2 | 1.3 | 3.6 | 2.4 | [1.6; 2.9] | 1.6 | 4.6 | 3.0 | [1.9; 3.7] |
| N | 40 | 56.0 | 1.4 | 3.9 | 2.5 | [1.7; 3.1] | 1.8 | 4.9 | 3.2 | [2.0; 3.9] |
| IN | 40 | 57.7 | 1.5 | 4.0 | 2.6 | [1.5; 3.2] | 1.7 | 4.8 | 3.1 | [2.0; 3.7] |
| I | 40 | 57.7 | 1.5 | 4.1 | 2.6 | [1.6; 3.2] | 1.7 | 4.6 | 3.0 | [2.1; 3.5] |
| IT | 40 | 57.1 | 1.2 | 3.3 | 2.1 | [1.6; 2.5] | 1.5 | 4.1 | 2.6 | [2.0; 3.1] |
| Ring 5 to 7 mm | | | | | | | | | | |
| T | 40 | 52.0 | 1.3 | 3.7 | 2.5 | [1.9; 3.0] | 2.0 | 5.5 | 3.8 | [2.7; 4.5] |
| ST | 40 | 51.4 | 1.9 | 5.3 | 3.7 | [2.3; 4.5] | 2.2 | 6.2 | 4.3 | [3.2; 5.1] |
| S | 40 | 51.4 | 1.8 | 4.9 | 3.5 | [2.8; 3.9] | 2.1 | 5.9 | 4.2 | [3.5; 4.7] |
| SN | 40 | 52.5 | 2.1 | 5.8 | 4.0 | [2.7; 4.8] | 2.5 | 7.0 | 4.9 | [3.0; 6.0] |
| N | 40 | 54.5 | 2.4 | 6.6 | 4.4 | [2.2; 5.6] | 2.8 | 7.8 | 5.3 | [2.8; 6.6] |
| IN | 40 | 53.8 | 2.1 | 5.9 | 3.9 | [1.8; 5.0] | 2.4 | 6.6 | 4.4 | [2.7; 5.5] |
| I | 40 | 54.2 | 1.3 | 3.7 | 2.4 | [1.9; 2.8] | 1.8 | 4.9 | 3.3 | [2.8; 3.7] |
| IT | 40 | 53.3 | 1.6 | 4.4 | 3.0 | [2.1; 3.5] | 1.9 | 5.2 | 3.5 | [2.6; 4.1] |
| Ring 7 to 9 mm | | | | | | | | | | |
| T | 40 | 51.5 | 1.7 | 4.6 | 3.3 | [2.1; 4.0] | 2.4 | 6.8 | 4.8 | [3.0; 5.8] |
| ST | 40 | 48.8 | 2.0 | 5.5 | 4.1 | [2.7; 4.9] | 2.3 | 6.4 | 4.7 | [3.5; 5.6] |
| S | 38 | 47.8 | 2.2 | 6.1 | 4.6 | [3.8; 5.2] | 2.8 | 7.7 | 5.8 | [4.8; 6.5] |
| SN | 39 | 50.0 | 2.1 | 5.9 | 4.2 | [2.9; 5.0] | 2.7 | 7.5 | 5.3 | [3.5; 6.4] |
{11}
Pentacam® Cornea OCT
510(k) Summary
OCULUS
| Optovue Solix precision analysis for ETM measurements in eyes with corneal disease: | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Sections | Number of Subjects | Mean (μm) | Repeatability | | | | Reproducibility | | | |
| | | | SD | Limit | CV (%) | 95% CI | SD | Limit | CV (%) | 95% CI |
| N | 40 | 52.9 | 2.7 | 7.6 | 5.1 | [3.2; 6.3] | 3.3 | 9.1 | 6.1 | [3.9; 7.5] |
| IN | 40 | 53.7 | 2.2 | 6.1 | 4.1 | [2.2; 5.1] | 2.5 | 7.0 | 4.8 | [3.5; 5.8] |
| I | 40 | 50.0 | 1.5 | 4.3 | 3.0 | [2.4; 3.5] | 1.9 | 5.4 | 3.8 | [3.0; 4.3] |
| IT | 40 | 54.3 | 1.9 | 5.2 | 3.5 | [2.4; 4.2] | 2.2 | 6.0 | 4.0 | [2.8; 4.8] |
The study demonstrated high repeatability and reproducibility of epithelial thickness measurements across corneal zones in both normal and corneal pathology groups, supporting the clinical utility of the device.
Repeatability and reproducibility CV (%) values remained below the predefined performance goals.
Agreement analysis was done based on the same 40 healthy patients of the precision part of the study (normal group). The mean age of the 40 subjects (12 males and 28 females) was $44.1 \pm 11.0$ years, ranging from 22 to 70 years. 19 (47.5%) right eyes and 21 (52.5%) left eyes were measured.
The agreement of the Pentacam® Cornea OCT and the Optovue Solix was analyzed using the first paired acceptable scans-- defined as the earliest configuration in which both the test and predicate device have acceptable scans in the same configuration.
Results of the Bland-Altman analysis for the agreement between Pentacam® Cornea OCT and Optovue Solix for normal group. Mean difference was calculated by subtracting the corneal epithelium thickness of the Optovue Solix from the Pentacam® Cornea OCT (Pentacam® Cornea OCT minus Optovue Solix). All values are given in $\mu$ m. Confidence intervals are calculated based on bootstrapping method
| Sections | Difference (Mean ±SD) | 95% CI for Mean Difference | 95% LoA (Lower; Upper) | 95% CI for Lower LOA | 95% CI for Upper LoA |
| --- | --- | --- | --- | --- | --- |
| Zone 0 to 2mm | | | | | |
| C | 0.2 ±2.2 | -0.5; 0.8 | -4.1; 4.4 | -5.8; -2.5 | 3.1; 5.6 |
| Ring 2 to 5mm | | | | | |
| T | 1.1 ±1.6 | 0.6; 1.6 | -2.0; 4.1 | -2.6; -1.3 | 3.3; 4.8 |
| ST | 1.0 ±2.0 | 0.4; 1.6 | -2.9; 4.8 | -3.9; -1.7 | 3.6; 6.0 |
| S | 1.0±2.0 | 0.4; 1.6 | -2.8; 4.9 | -3.8; -1.8 | 4.0; 5.6 |
| SN | 0.9 ±1.6 | 0.5; 1.4 | -2.2; 4.0 | -3.0; -1.2 | 3.3; 4.6 |
| N | 1.0 ±1.3 | 0.6; 1.4 | -1.7; 3.6 | -2.3; -1.0 | 2.8; 4.3 |
| IN | 1.3 ±1.4 | 0.8; 1.7 | -1.5; 4.0 | -2.2; -0.6 | 3.3; 4.6 |
| I | 1.4 ±1.2 | 1.1; 1.8 | -0.9; 3.8 | -1.5; -0.3 | 3.2; 4.3 |
| IT | 1.3 ±1.5 | 0.9; 1.8 | -1.6; 4.2 | -2.1; -0.9 | 3.4; 4.7 |
| Ring 5 to 7mm | | | | | |
| T | 1.0 ±1.8 | 0.4; 1.5 | -2.6; 4.6 | -3.3; -1.7 | 3.6; 5.4 |
| ST | 1.3 ±2.3 | 0.6; 2.0 | -3.2; 5.7 | -4.2; -2.1 | 4.6; 6.6 |
| S | 0.6 ±2.4 | -0.2; 1.3 | -4.2; 5.3 | -5.6; -2.7 | 3.9; 6.6 |
{12}
Pentacam® Cornea OCT
510(k) Summary
OCULUS
Results of the Bland-Altman analysis for the agreement between Pentacam® Cornea OCT and Optovue Solix for normal group. Mean difference was calculated by subtracting the corneal epithelium thickness of the Optovue Solix from the Pentacam® Cornea OCT (Pentacam® Cornea OCT minus Optovue Solix). All values are given in μm. Confidence intervals are calculated based on bootstrapping method
| Sections | Difference (Mean ±SD) | 95% CI for Mean Difference | 95% LoA (Lower; Upper) | 95% CI for Lower LOA | 95% CI for Upper LoA |
| --- | --- | --- | --- | --- | --- |
| SN | 0.9 ±1.7 | 0.4 ; 1.5 | -2.4 ; 4.2 | -3.1 ; -1.5 | 3.5 ; 4.9 |
| N | 0.9 ±1.6 | 0.4 ; 1.4 | -2.3 ; 4.1 | -3.1 ; -1.3 | 3.0 ; 5.2 |
| IN | 1.1 ±1.6 | 0.7 ; 1.7 | -2.1 ; 4.3 | -2.9 ; -1.1 | 3.3 ; 5.5 |
| I | 1.4 ±1.7 | 0.9 ; 1.9 | -1.9 ; 4.7 | -2.7 ; -0.9 | 3.9 ; 5.5 |
| IT | 1.3 ±1.8 | 0.7 ; 1.8 | -2.2 ; 4.8 | -3.1 ; -1.2 | 3.9 ; 5.4 |
| Ring 7 to 9mm | | | | | |
| T | 0.8 ±2.2 | 0.1 ; 1.5 | -3.5 ; 5.1 | -4.3 ; -2.5 | 3.6 ; 6.4 |
| ST | 1.5 ±2.4 | 0.8 ; 2.2 | -3.3 ; 6.2 | -4.3 ; -2.2 | 4.9 ; 7.4 |
| S | 0.7 ±4.0 | -0.6 ; 1.9 | -7.1 ; 8.4 | -8.8 ; -4.9 | 6.1 ; 10.4 |
| SN | 0.7 ±2.6 | -0.1 ; 1.5 | -4.4 ; 5.8 | -5.5 ; -2.8 | 4.6 ; 6.8 |
| N | 0.0 ±3.2 | -1.0 ; 0.9 | -6.2 ; 6.1 | -7.9 ; -4.2 | 4.0 ; 8.3 |
| IN | 0.5 ±2.2 | -0.2 ; 1.2 | -3.8 ; 4.8 | -5.4 ; -2.5 | 3.3 ; 6.0 |
| I | 1.0 ±2.1 | 0.4 ; 1.6 | -3.2 ; 5.1 | -4.2 ; -2.0 | 3.5 ; 6.5 |
| IT | 0.7 ±1.9 | 0.1 ; 1.2 | -3.1 ; 4.4 | -4.0 ; -2.1 | 3.4 ; 5.2 |
Independent of the statistical method, the upper CI of the upper LOA as well as the lower CI of the lower LOA were within the predefined performance goals for all sectors. Furthermore, the test device showed a very high agreement with very small mean deviations in all sectors. The mean differences between the devices were consistently below 2μm across all sections.
Agreement analysis was done based on the same 40 cornea patients of the precision part of the study (cornea group). The mean age of the 40 subjects (19 males - 47,5%, 21 females - 52,5%) was 48.3 ±12.1 years, ranging from 23 to 74 years. 22 (55%) right eyes and 18 (45%) left eyes were measured.
Similar to the normal group, the agreement of the Pentacam® Cornea OCT and the Optovue Solix was analyzed using the first paired acceptable scans—defined as the earliest configuration in which both the test and predicate device have acceptable scans in the same configuration.
Results of the Bland-Altman analysis for the agreement between Pentacam® Cornea OCT and Optovue Solix for cornea group. Mean difference was calculated by subtracting the corneal epithelium thickness of the Optovue Solix from the Pentacam® Cornea OCT (Pentacam® Cornea OCT minus Optovue Solix). All values are given in μm. Confidence intervals are calculated based on bootstrapping method.
| Sections | Difference (Mean ±SD) | 95% CI for Mean Difference | 95% LoA (Lower; Upper) | 95% CI for Lower LOA | 95% CI for Upper LoA |
| --- | --- | --- | --- | --- | --- |
| Zone 0 to 2mm | | | | | |
| C | 0.2 ± 2 | -0.4 ; 0.8 | -3.7 ; 4.0 | -4.5 ; -2.7 | 2.7 ; 5.0 |
| Ring 2 to 5mm | | | | | |
{13}
Pentacam® Cornea OCT
510(k) Summary
OCULUS
Results of the Bland-Altman analysis for the agreement between Pentacam® Cornea OCT and Optovue Solix for cornea group. Mean difference was calculated by subtracting the corneal epithelium thickness of the Optovue Solix from the Pentacam® Cornea OCT (Pentacam® Cornea OCT minus Optovue Solix). All values are given in $\mu$ m. Confidence intervals are calculated based on bootstrapping method.
| Sections | Difference (Mean ±SD) | 95% CI for Mean Difference | 95% LoA (Lower; Upper) | 95% CI for Lower LOA | 95% CI for Upper LoA |
| --- | --- | --- | --- | --- | --- |
| T | 0.5 ± 2.9 | -0.5 ; 1.3 | -5.2 ; 6.1 | -8.1 ; -2.4 | 4.2 ; 7.9 |
| ST | 1.6 ± 2.5 | 0.8 ; 2.4 | -3.3 ; 6.5 | -4.7 ; -1.7 | 4.6 ; 8.3 |
| S | 1.9 ± 2.2 | 1.2 ; 2.6 | -2.5 ; 6.3 | -3.6 ; -1.3 | 4.5 ; 7.8 |
| SN | 1.6 ± 1.9 | 1.0 ; 2.2 | -2.1 ; 5.2 | -2.7 ; -1.3 | 4.0 ; 6.2 |
| N | 1.0 ± 1.8 | 0.4 ; 1.6 | -2.5 ; 4.4 | -3.3 ; -1.6 | 3.4 ; 5.3 |
| IN | 1.0 ± 2.1 | 0.4 ; 1.6 | -3.0 ; 5.1 | -4.3 ; -1.7 | 4.0 ; 6.0 |
| I | 0.8 ± 2.4 | 0.0 ; 1.5 | -4.0 ; 5.5 | -5.8 ; -2.4 | 4.0 ; 6.8 |
| IT | 0.7 ± 2.2 | 0.0 ; 1.4 | -3.7 ; 5.1 | -5.5 ; -1.9 | 3.4 ; 6.5 |
| Ring 5 to 7mm | | | | | |
| T | 1.7 ± 2.4 | 0.9 ; 2.4 | -3.0 ; 6.4 | -4.5 ; -1.5 | 4.6 ; 7.9 |
| ST | 2.1 ± 2.8 | 1.4 ; 3.1 | -3.4 ; 7.7 | -4.9 ; -1.6 | 5.2 ; 10.1 |
| S | 2.6 ± 3.4 | 1.6 ; 3.7 | -4.1 ; 9.2 | -6.0 ; -1.9 | 6.7 ; 12.0 |
| SN | 2.1 ± 2.3 | 1.4 ; 2.8 | -2.4 ; 6.7 | -3.8 ; -1.0 | 5.2 ; 7.9 |
| N | 1.2 ± 2.5 | 0.3 ; 1.9 | -3.7 ; 6.1 | -5.3 ; -1.9 | 4.4 ; 7.5 |
| IN | 1.0 ± 2.1 | 0.4 ; 1.6 | -3.1 ; 5.1 | -3.8 ; -2.2 | 3.8 ; 6.2 |
| I | 0.9 ± 2.9 | -0.1 ; 1.7 | -4.8 ; 6.5 | -6.8 ; -2.7 | 4.8 ; 8.1 |
| IT | 1.7 ± 2.6 | 0.9 ; 2.6 | -3.4 ; 6.8 | -4.3 ; -2.2 | 4.8 ; 8.5 |
| Ring 7 to 9mm | | | | | |
| T | 1.1 ± 2.6 | 0.4 ; 2.0 | -3.9 ; 6.2 | -5.5 ; -1.9 | 3.8 ; 8.6 |
| ST | 1.7 ± 3.1 | 0.9 ; 2.7 | -4.3 ; 7.8 | -5.9 ; -2.3 | 4.9 ; 10.6 |
| S | 1.8 ± 4.1 | 0.5 ; 3.2 | -6.4 ; 9.9 | -8.3 ; -4.1 | 6.3 ; 12.8 |
| SN | 1.0 ± 2.3 | 0.3 ; 1.8 | -3.4 ; 5.5 | -4.5 ; -2.1 | 3.7 ; 7.2 |
| N | 1.6 ± 3.6 | 0.6 ; 2.7 | -5.5 ; 8.7 | -7.9 ; -2.4 | 5.3 ; 12.6 |
| IN | 0.5 ± 2.8 | -0.4 ; 1.3 | -5.1 ; 6.0 | -7.6 ; -2.5 | 4.1 ; 7.6 |
| I | -0.1 ± 3.6 | -1.3 ; 0.9 | -7.2 ; 6.9 | -10.8 ; -3.4 | 4.3 ; 9.0 |
| IT | 0.8 ± 3.0 | -0.1 ; 1.7 | -5.0 ; 6.6 | -6.2 ; -3.4 | 5.0 ; 8.0 |
Similar to the normal group, the upper CI of the upper LOA as well as the lower CI of the lower LOA in the cornea cohort remained within the predefined performance goals for all sectors.
Furthermore, the test device showed consistently high agreement with the predicate device, with minimal deviations. The mean differences between the devices were uniformly small – remaining below $2\mu \mathrm{m}$ across all sections—indicating negligible measurement bias and strong concordance throughout the corneal regions.
Substantial Equivalence
{14}
Pentacam® Cornea OCT 510(k) Summary OCULUS
As explained below, the Pentacam® Cornea OCT is substantially equivalent to other legally marketed ophthalmic devices. Specifically, the Pentacam® Cornea OCT is substantially equivalent to the predicate device-Optovue Solix OCT (K222166). The Pentacam® Cornea OCT has the same intended use and similar indications, technological characteristics, and principles of operation related to optical coherence tomography (OCT) imaging and measurement of corneal as the legally marketed Solix OCT device.
The Pentacam® Cornea OCT also incorporates Scheimpflug-based imaging and biometry functions that are consistent with those of the previously cleared Pentacam® AXL Wave (K201724), which is identified as a reference device. These secondary functions support anterior segment analysis and do not alter the primary OCT-based imaging function.
Minor differences in technological characteristics between the Pentacam® Cornea OCT and the identified predicate devices do not raise new or different questions of safety or effectiveness. Bench and clinical testing demonstrate that the Pentacam® Cornea OCT is as safe and effective as the predicate devices for its intended use.
A substantial equivalence chart comparing the similarities and differences between the Pentacam® Cornea OCT and its predicate and reference devices is provided below.
## Comparison of OCT Technological Characteristics
| | Subject Device | Predicate Device (Optovue Solix) | Substantial Equivalence Comparison |
| --- | --- | --- | --- |
| | Pentacam® Cornea OCT | Optovue Solix | |
| Regulation | 21 CFR 886.1570 | 21 CFR 886.1570 | Same |
| Product Code | OBO, MXK | OBO, HKI | Same |
| 510(k) Number | TBD | K222166 | NA |
| Classification | II | II | Same |
| Classification Name | Ophthalmoscope, Ophthalmic camera | Ophthalmoscope, Ophthalmic camera | Same |
| Intended Use | The OCT system is intended for the in vivo imaging, cross-sectional, and the three-dimensional imaging and measurement of corneal epithelium. It is indicated for use as a diagnostic device to aid in the detection and management of ocular diseases. | SOLIX is an optical coherence tomography system intended for the in vivo imaging, cross-sectional, and the three-dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, corneal epithelium, corneal stroma, pachymetry, and anterior chamber of the eye | Different
The same for the claimed subset of corneal structures. |
| Indications for Use | The Pentacam® Cornea OCT is a multifunction ophthalmic imaging device designed to acquire images of the anterior segment using Scheimpflug imaging (digital CMOS camera with slit-lamp illumination) and OCT. | SOLIX is an optical coherence tomography system intended for the in vivo imaging, cross-sectional, and the three-dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex | Different
The Pentacam Cornea OCT is only for the corneal structure of an eye, a subset of the kinds of images and uses included in the cleared reference device. |
{15}
Pentacam® Cornea OCT 510(k) Summary OCULUS
| | Subject Device | Predicate Device (Optovue Solix) | Substantial Equivalence Comparison |
| --- | --- | --- | --- |
| | Pentacam® Cornea OCT | Optovue Solix | |
| | Scheimpflug imaging provides anterior segment visualization and quantitative anterior segment measurements.
The OCT component of the system uses broadband Multi-SLD and is intended for the in vivo imaging, cross-sectional, and the three-dimensional imaging and measurement of corneal epithelium.
The Pentacam® Cornea OCT is indicated for use as a diagnostic device to aid in the detection and management of ocular diseases affecting the anterior segment of the eye. | (GCC), optic disc, cornea, corneal epithelium, corneal stroma, pachymetry, and anterior chamber of the eye. With the integrated reference database, SOLIX is also a quantitative tool for the comparison of the retina, retinal nerve fiber layer, and optic disc measurements in the human eye to a database of known normal subjects.
It is indicated for use as a diagnostic device to aid in the detection and management of ocular diseases.
The SOLIX with the AngioVue software feature is indicated as an aid in the visualization of vascular structures of the retina and choroid in normal subjects, and in subjects with glaucoma and retinal diseases.
The AngioAnalytics software feature of AngioVue is indicated for the measurement of vascular density, the foveal avascular zone, the thickness of retinal layers, and nerve fiber layer, and measurement of optic disc parameters in normal subjects, and in subjects with glaucoma and retinal diseases. | |
| Technological Characteristics | Spectral-Domain Optical Coherence Tomography (SD-OCT) | Spectral-Domain Optical Coherence Tomography (SD-OCT) | Same |
| System Components | - Forehead rest
- Measuring window
- Scheimpflug camera
- Chin rest
- Twist grip
- Cross slide
- Base unit (measuring box)
- Power supply
- Sliding plate with circle marks
- Joystick
- Computer with Windows operating system | - Scanner
- Control Unit
- Chin and Head rest
- Joystick and base assembly
- Computer with Windows operating system
- Monitor
- Keyboard and Mouse
- System Table
- CAM Lens FullRange
- CAM Lens | Different due external design of the device |
| Signal Type | Optical scattering from tissue for OCT | Optical scattering from tissue for OCT | Same |
| OCT Light Source | Superluminescent diode (SLD) 780-1000 nm | Superluminescent diode (SLD) 840nm | Same |
{16}
Pentacam® Cornea OCT
510(k) Summary
OCULUS
| | Subject Device | Predicate Device (Optovue Solix) | Substantial Equivalence Comparison |
| --- | --- | --- | --- |
| | Pentacam® Cornea OCT | Optovue Solix | |
| OCT Optical Power | Max. 1.2mW | 1.45mW (at cornea) | Different
Pentacam has an optical set up including detector which reduces the required power output. This does not raise different questions of safety or effectiveness, safety was proved by compliance with respective standards IEC 60825-1 and ANSI Z.80.36 |
| Fixation Light Source | Red LED | Blue LED | Different
Red fixation light is a standard for Pentacam models. It does not affect scanning. |
| IR Fundus Imaging Light Source | Not Applicable | NIR LED | Not Applicable
The Pentacam® Cornea OCT is intended for cornea only. |
| Iris Viewer Illumination | IR LED | IR LED | Same |
| Working Distance | 45 mm | Retina imaging: 35 mm
With CAM (Cornea Anterior Module) attached: 20mm | Different
Distance of the front of the device and patient's eye and due to optical set up.
The working distance depends on the respective imaging optics.
Both 45mm and 80mm represent safe distances in terms of not accidentally touching the eye.
This does not raise different questions of safety or effectiveness. |
| Ergonomic | Forehead rest
Joystick | Chin and forehead rest
Joystick for alignment on the eye | Same |
| Electrical | Medical-grade power supply (IEC 60601 compliant) | Medical-grade power supply (IEC 60601 compliant) | Same |
| Cleaning and Disinfection | Chin and forehead rest can be cleaned with a disinfecting agent, such as isopropyl alcohol wipes or a germicide with a lint-free cloth. | Chin and forehead rest can be cleaned with a disinfecting agent, such as isopropyl alcohol wipes or a germicide with a lint-free cloth. | Same |
| Axial Resolution (in tissue) | ≤2 μm | 5μm | Different
Imaging resolutions in Pentacam® Cornea OCT is higher but the differences do not raise different questions of safety or effectiveness. |
| Scan Rate | 50,000 A-Scan/second | 120,000 A-Scan/second | Different
For the application of the Pentacam® Cornea OCT (cornea) and the different scanning patterns (including their geometries), a lower A-scan rate |
{17}
Pentacam® Cornea OCT
510(k) Summary
OCULUS
| | Subject Device | Predicate Device (Optovue Solix) | Substantial Equivalence Comparison |
| --- | --- | --- | --- |
| | Pentacam® Cornea OCT | Optovue Solix | |
| | | | is sufficient/appropriate. A higher scan rate would reduce the signal-to-noise ratio.
The difference does not raise different questions of safety or effectiveness. |
| Scan Depth | 3.6 mm | ~up to 3 mm except full-range scans up to 6.25 mm such as FullRangeTM Retina and FullRangeTM AC scans | Different
Scan only cornea of an eye so the scan depth is smaller.
The difference does not raise different questions of safety or effectiveness. |
| AngioVue (wider FOV) | Not Applicable | AngioVue 12mm | Not Applicable
The Pentacam® Cornea OCT is intended for cornea only. |
| AngioVue (wider FOV) | Not Applicable | AngioVue 9mm | Not Applicable
The Pentacam® Cornea OCT is intended for cornea only. |
| AngioVue | Not Applicable | AngioVue Retina | Not Applicable
The Pentacam® Cornea OCT is intended for cornea only. |
| AngioVue | Not Applicable | AngioVue 3mm | Not Applicable
The Pentacam® Cornea OCT is intended for cornea only. |
| AngioVue | Not Applicable | AngioVue Disc | Not Applicable
The Pentacam® Cornea OCT is intended for cornea only. |
| Retina | Not Applicable | Line | Not Applicable
The Pentacam® Cornea OCT is intended for cornea only. |
| Retina | Not Applicable | Full Range Retina | Not Applicable
The Pentacam® Cornea OCT is intended for cornea only. |
| Retina | Not Applicable | Retina Cube | Not Applicable
The Pentacam® Cornea OCT is intended for cornea only. |
| Retina | Not Applicable | Raster | Not Applicable
The Pentacam® Cornea OCT is intended for cornea only. |
| Retina | Not Applicable | Radial Lines | Not Applicable
The Pentacam® Cornea OCT is intended for cornea only. |
| Nerve Fiber | Not Applicable | Disc Cube | Not Applicable
The Pentacam® Cornea OCT is intended for cornea only. |
| Retina | Not Applicable | Wellness | Not Applicable
The Pentacam® Cornea OCT is intended for cornea only. |
| Cornea | Epithelium Map | Corneal Map | Same
Different naming |
| Cornea | 3D scan | Anterior Radial | Same |
{18}
Pentacam® Cornea OCT
510(k) Summary
OCULUS
| | Subject Device | Predicate Device (Optovue Solix) | Substantial Equivalence Comparison |
| --- | --- | --- | --- |
| | Pentacam® Cornea OCT | Optovue Solix | |
| | | | Different naming |
| Cornea | Averaging mode | Cornea Line | Same
Different naming |
| Cornea | Not Applicable | Cornea Angle | Not Applicable
The Pentacam® Cornea OCT has not this scanning mode of cornea. |
| Cornea | Sector scan | Cornea Cube | Same
Different naming |
| Cornea | Not Applicable | Full Range AC | Not Applicable
The Pentacam® Cornea OCT has not this scanning mode of cornea. |
| Motion Artifacts Reduction | Image registration | Tracking based on IR fundus image + MCT | Different
The difference is based on software.
The difference does not raise different questions of safety or effectiveness. |
| Post- Processing for OCT Scans | Segmentation and analysis of OCT Scans for Cornea Epithelium thickness map | • Segmentation and analysis of OCT Scans for Retina and Nerve Fiber
• Segmentation and analysis of OCT Scans for Cornea
• Scan Quality
• Manual editing of segmentation error and propagation of manual correction to neighboring B-scans
• Projection artifacts removal (PAR)
• Visualization and qualitative analysis of retinal and vascular structures based on en face images | Same for applicable cornea scans
The Pentacam® Cornea OCT is intended for cornea only.
NA for posterior scans |
| Post-Processing for OCT Scans | Not Applicable
OCT scans only for anterior segment of the eyes | Feature under AngioAnalytics license:
• Quantitative analysis of vascular structures based on en face images
• Quantitative analysis of retinal, nerve fiber, and optic disc structure
• Fovea detection
• Optic disc margin detection | Not Applicable
The Pentacam® Cornea OCT is intended for cornea only. |
| Reference Database (RDB) | Not Applicable | OCT structural RDB Collected for the following scans: AngioVue Retina, AngioVue Disc, Retina Cube Disc Cube and Wellness scans
• No OCT Angiography RDB available | Not Applicable
The Pentacam® Cornea OCT is intended for cornea only. |
{19}
Pentacam® Cornea OCT
510(k) Summary
OCULUS
| Subject Device | Predicate Device (Optovue Solix) | Substantial Equivalence Comparison |
| --- | --- | --- |
| Pentacam® Cornea OCT | Optovue Solix | |
| Device Packaging and Sterilization | The device is not sterile, does not require sterilization, and does not include shelf-life claims on product labeling. Shipping packaging has been designed to safely transport the device to the end user facility. | The device is not sterile, does not require sterilization, and does not include shelf-life claims on product labeling. Shipping packaging has been designed to safely transport the device to the end user facility. |
Comparison of Scheimpflug Imaging (Tomographic) Technological Characteristics
| | Applicant Device | Reference Device (Scheimpflug Imaging, Etc.) | Substantial Equivalence Comparison |
| --- | --- | --- | --- |
| Model | Pentacam® Cornea OCT | Pentacam® AXL Wave | NA |
| Manufacturer name | OCULUS Optikgeraete GmbH | OCULUS Optikgeraete GmbH | Same |
| 510(k) Number | TBD | K201724 | NA |
| Product code | OBO, MXK | MXK, HJO | |
| Classification | II | II | Same |
| Classification Name | AC-Powered Slitlamp Biomicroscope | AC-Powered Slitlamp Biomicroscope | Same |
| | The Pentacam® Cornea OCT is a multifunction ophthalmic imaging device designed to acquire images of the anterior segment using Scheimpflug imaging (digital CMOS camera with slit-lamp illumination) and OCT. Scheimpflug imaging provides anterior segment visualization and quantitative anterior segment measurements. The OCT component of the system uses broadband Multi-SLD and is intended for the in vivo imaging, cross-sectional, and the three-dimensional imaging and measurement of corneal epithelium.. The Pentacam® Cornea OCT is indicated for use as a diagnostic device to aid in the detection and management of ocular diseases affecting the anterior segment of the eye. | The Pentacam® AXL Wave is designed to take photos of the anterior segment of the eye which includes the cornea, pupil, anterior chamber and lens of the eye. To evaluate:
- corneal shape,
- analyze condition of the lens (opaque crystalline lens),
- analyze the anterior chamber angle,
- analyze anterior chamber depth,
- analyze the volume of the anterior chamber,
- analyze anterior or posterior cortical opacity,
- analyze the location of cataracts (nuclear, sub capsular and or cortical), using cross slit imaging with densitometry,
- corneal thickness,
- axial length (by optical biometry),
- white-to-white distance
- optical aberrations of the eye,
- retroillumination imaging. | Different
For Scheimpflug imaging the additional information was added to Intended Use of Applicant Device. The information is about how the image is captured (camera type). Both predicate and applicant devices use identical camera and image capture method. This additional information does not raise new or different questions of safety and effectiveness.
Pentacam® Cornea OCT does not have retroillumination imaging, optical aberrations and optical biometry. The absence of these functions does not raise new or different questions of safety and effectiveness.
Pentacam® Cornea OCT has an additional indication related with OCT imaging, which has previously been cleared by FDA and which does not raise new or different questions of safety and effectiveness, as supported by the Solix reference device. |
{20}
Pentacam® Cornea OCT
510(k) Summary
OCULUS
| | Applicant Device | Reference Device (Scheimpflug Imaging, Etc.) | Substantial Equivalence Comparison |
| --- | --- | --- | --- |
| | | The Pentacam® AXL Wave also performs calculations to assist physicians in determining the power of the intraocular lens for implantation | |
| Scheimpflug Camera | Digital CMOS camera | Digital CMOS camera | Same |
| Resolution of Scheimpflug camera | 1360x1024 pixel (active) | 1392x1040 pixel (effective)
1360x1024 pixel (active) | Same |
| Slit length | 28 mm | 14 mm | Different
Minor difference
Different illumination opening widths and optical structures.
This does not raise different questions of safety or effectiveness, safety was proved by compliance with respective standards IEC 60825-1 and ANSI Z.80.36 |
| Slit width | 35 μm | 35 μm | Same |
| Light source for slit illumination | Blue slit lamp (LED 470 nm) | Blue slit lamp (LED 470 nm) | Same |
| Light source for eye illumination | 4 IR LEDs (840 nm) | 4 IR LEDs (810 nm) | Different
Adapted for the optical beam path with tailored coatings and filters to enable multiple measurement or imaging modalities within the same optical path.
This does not raise different questions of safety or effectiveness, safety was proved by compliance with respective standard ANSI Z.80.36 |
| Images | Up to 100 in 2 seconds (Standard mode 25 in 1 seconds; cornea fine mode 50/100 in 2 seconds) | Up to 100 in 2 seconds (Standard mode 25 in 1 seconds; cornea fine mode 50/100 in 2 seconds) | Same |
| Rotation | Up to 180° | Up to 180° | Same
Within half a turn, 360° of the patient's eye can be captured |
| Measuring points | up to 138,000 (optional 276,000) | up to 138,000 | Same |
| Working distance | 45 mm | 80 mm | Different
Distance of the front of the device and patient's eye and due to optical set up.
The working distance depends on the respective imaging optics. Both 45mm and 80mm represent safe distances in terms of not accidentally |
{21}
Pentacam® Cornea OCT
510(k) Summary
OCULUS
| | Applicant Device | Reference Device (Scheimpflug Imaging, Etc.) | Substantial Equivalence Comparison |
| --- | --- | --- | --- |
| | | | touching the eye. This does not raise different questions of safety or effectiveness. |
| Physical principle | Scheimpflug principle / Spectrometer | Scheimpflug principle / Optical interferometer | Different Pentacam® Cornea OCT has an additional measuring modality related with OCT imaging, which has previously been cleared by FDA and which does not raise new or different questions of safety and effectiveness, as supported by the Solix reference device. |
| Calculation principle | Edge detection and 3D regression polynomial functions; detection of interference pattern and consideration of mirror position | Edge detection and 3D regression polynomial functions; detection of interference pattern and consideration of mirror position | Same |
| Auto release function | Yes | Yes | Same |
| Auto movement system | No | No | Same |
| Fixation light | Yes, red LED (640 nm) | Yes, red LED (640 nm) | Same |
| Overview camera | Digital CMOS camera | Digital CMOS camera | Same |
| Resolution of overview camera | 1280 x 960 | 1280 x 960 | Same |
| Measurement range - Axial length | NA | 14 – 40 mm | NA The Pentacam® Cornea OCT does not have functionality to measure the axial length. Absence of this function does not raise new or different questions of safety and effectiveness. |
| Light source for interferometer | NA | IR Super luminescence diode (SLD) | NA The Pentacam® Cornea OCT does not have an interferometer. Absence of interferometer does not raise new or different questions of safety and effectiveness. |
| Wavelength | NA | 880 nm | NA The Pentacam® Cornea OCT does not have an interferometer. Absence of interferometer does not raise new or different questions of safety and effectiveness. |
| SLD-Power for measurement | NA | 0.7 mW | NA The Pentacam® Cornea OCT does not have an interferometer. |
{22}
Pentacam® Cornea OCT 510(k) Summary OCULUS
| | Applicant Device | Reference Device (Scheimpflug Imaging, Etc.) | Substantial Equivalence Comparison |
| --- | --- | --- | --- |
| | | | Absence of interferometer does not raise new or different questions of safety and effectiveness. |
| Pulse width | NA | 520 ms | NA
The Pentacam® Cornea OCT does not have an interferometer.
Absence of interferometer does not raise new or different questions of safety and effectiveness. |
| IEC 60825-1 classification | Class 1 laser product | Class 1 laser product | Same |
| Embedded laser class (not accessible) | 3B | 3R | Different
Usage of a light source capable of emitting higher light energy if not embedded, while operating within the limits of a Class I laser product under normal conditions (like the predicate)
This does not raise different questions of safety or effectiveness, safety was proved by compliance with respective standard IEC 60825-1. |
| White-to-white measurement principle | Analysis of overview image | Analysis of overview image | Same |
| Power supply | Externa PSU:
GSM90B24-P1M (10029038)
Input: 100 - 240 V AC, 50/60 Hz
Output: 24 V DC, 3.75 A | External PSU:
HMEG49 Medical power adapter
Input: 90- 264 V AC; 47 – 63 Hz
Output: 24 V DC, 2.1 A | Different
The increased power consumption of the applicant device is attributable to a greater rotating mass and more advanced electronics.
This does not raise different questions of safety or effectiveness, safety was proved by compliance with respective standards AAMI/ANSI 60601-1 and IEC 60601-1-2. |
| Power consumption | max 75 W | max 35 W | Different
The increased power consumption is attributable to a greater rotating mass and more advanced electronic components.
This does not raise different questions of safety or effectiveness, safety was proved by compliance with respective standards AAMI/ANSI 60601-1 and IEC 60601-1-2. |
| Protection class | 2 | 2 | Same |
{23}
Pentacam® Cornea OCT 510(k) Summary OCULUS
| | Applicant Device | Reference Device (Scheimpflug Imaging, Etc.) | Substantial Equivalence Comparison |
| --- | --- | --- | --- |
| Protection type | IP00 | IP20 | Different
Under worst-case conditions (with the base unit set to maximum height). IP20 under normal conditions.
For Pentacam OCT test was conducted in for the maximum height,
This does not raise different questions of safety or effectiveness. |
| Device type | B | B | Same |
| Dimensions | 305 x 259 - 404 x 512 - 542 mm (WxDxH) | 278 x 320-400 x 502-532 mm (WxDxH) | Different
Space for a larger number of components
This does not raise different questions of safety or effectiveness. |
| Weight | 27.8 kg | 9 kg (only measuring head) | Different
Weight of larger number of components.
This does not raise different questions of safety or effectiveness |
The Pentacam® Cornea OCT is as safe and effective as the predicate device Optovue SoliX OCT. The Pentacam® Cornea OCT has the same intended use and similar indications, technological characteristics, and principles of operation related to spectral-domain optical coherence tomography (OCT) imaging and measurement of corneal structures as the SoliX OCT.
Minor technological differences between the Pentacam® Cornea OCT and the predicate device do not raise new or different questions of safety or effectiveness. The Pentacam® Cornea OCT also incorporates Scheimpflug-based imaging and biometry functionalities that are consistent with those of the previously cleared Pentacam® AXL Wave, which is identified as a reference device. These functions do not alter the primary OCT-based imaging function.
Scientific information provided by the reference device Optovue SoliX, including the Clinical Agreement and Precision Study of the Pentacam® Cornea OCT Compared to the Optovue SoliX, supports the safety and effectiveness of the new technological characteristic of the Pentacam® Cornea OCT, namely the spectral-domain OCT scanning technology.
Bench and clinical testing demonstrate that the Pentacam® Cornea OCT is as safe and effective as its predicate device. Therefore, the Pentacam® Cornea OCT is substantially equivalent to the legally marketed predicate device.
This summary of safety and effectiveness is submitted in accordance with the requirements of 21 CFR 807.92. I certify that this summary is accurate and that it reflects the data in the premarket notification.
