The Corvis ST is intended to measure the intra-ocular pressure of the eye in patients with less than 3 diopters of corneal astigmatism. In addition, the Corvis ST is designed to photograph the eye and take Scheimpflug images of the anterior segment of the eye to evaluate the thickness of the cornea.

Device Description

The Corvis ST performs the following two functions: Tonometry and Pachymetry. The Corvis ST measures intraocular pressure without contact with the eye by applying an air puff to the eye. The eye is illuminated and during the air puff, a high-speed camera records the movement of the eye with more than 4000 images per second. The high-speed camera analyzes a sequence of 140 Scheimpflug images of the cornea to determine intra-ocular pressure. The Corvis ST measure corneal thickness and shape based on sectional images when the cornea is not influenced by the air puff. The pachymetry measurements of the Corvis ST and the cleared Oculus predicate use the same image processing routine for analysis to obtain corneal thickness measurements. Tonometry and pachymetry functions can be performed during the same evaluation or separately.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the Corvis ST, based on the provided document:

Acceptance Criteria and Device Performance:

Performance Metric	Acceptance Criteria (Bench/Clinical)	Reported Device Performance
Pachymetry (Clinical)	- Correlation coefficient with predicate device (Pachycam) for representative apical thickness value: Not explicitly stated, but implied to be high for substantial equivalence.	> 0.98 (correlation coefficient)
	- Overall mean difference to predicate device (Pachycam): Not explicitly stated, but implied to be small for substantial equivalence.	-0.10 ± 4.48 µm (mean difference to Pachycam)
	- Within-eye repeatability (standard deviation): Not explicitly stated, but implied to be low.	3.03 µm (within-eye repeatability)
Tonometry (Clinical)	- Conformance to ANSI Z80.10-2009 and EN ISO 8612:2009.	Meets all requirements of EN ISO 8612:2009 and ANSI Z80.10-2009 (excluding astigmatism >3D).
	- Mean deviation between Corvis ST and reference tonometer (GAT): Not explicitly stated, but implied to be small.	0.2 ± 2.4 mmHg
	- Percentage of eyes within ± 5 mmHg deviation from reference tonometer for each IOP group (<16 mmHg, >16 - <23 mmHg, >=23 mmHg).	Group 1 (7-16 mmHg): 97.5% (39/40)
		Group 2 (>16 - <23 mmHg): 95% (38/40)
		Group 3 (≥23 mmHg): 97.5% (39/40)
	- Overall percentage of eyes within ± 5 mmHg deviation from reference tonometer.	96.7% (116/120)
	- No eye had a deviation to the reference tonometer of more than 7.5 mmHg.	Confirmed. No eye had a deviation > 7.5 mmHg.
Tonometry (Bench)	- Conformance to ANSI Z80.10-2009, section 4.2.3 "Bench Assessments of Bias and Precision".	Conforms.
	- Correlation coefficient of representative IOP value: Not explicitly stated, but implied to be very high.	> 0.99
	- Overall difference of Corvis ST measurements to manometric adjusted pressure values: Not explicitly stated, but implied to be small.	-0.26 ± 1.1 mmHg
	- None of the paired differences between reference tonometer and test tonometer readings for each manometric adjusted pressure value are greater than +/- 5 mmHg.	Confirmed by results.
	- None of the paired differences between reference tonometer and test tonometer readings for each pressure range are greater than +/- 7.5 mmHg.	Confirmed by results.
Pachymetry (Bench)	- Correlation coefficient of representative pachymetry value: Not explicitly stated, but implied to be very high.	> 0.99
	- Overall difference of Corvis ST measurements to reference thickness values: Not explicitly stated, but implied to be small, and accurate/reproducible over the 300 µm range.	-0.43 ± 3.85 µm

Study Details:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Pachymetry (Clinical):
  - Test Set Size: 51 subjects (102 eyes).
  - Data Provenance: Internal study (implies data was collected by the manufacturer, likely prospective). No specific country of origin is mentioned, but the manufacturer is based in Germany.
- Tonometry (Clinical):
  - Test Set Size: 120 eyes (40 eyes per IOP group).
  - Data Provenance: Not explicitly stated if internal, but likely collected prospectively for the purpose of the study. No specific country of origin is mentioned.
- Pachymetry (Bench):
  - Test Set Size: "Several glass plates with several known thicknesses." Not a human sample size.
  - Data Provenance: Internal study.
- Tonometry (Bench):
  - Test Set Size: Manometric controlled test eye (phantom). Not a human sample size.
  - Data Provenance: Internal study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Pachymetry (Clinical): Ground truth was established by comparing to measurements from the FDA-cleared predicate device, Pachycam (K041841). No human experts were explicitly mentioned for ground truth.
- Tonometry (Clinical): Ground truth was established using the Goldmann applanation tonometer (Haag-Streit), which is considered a clinical standard. No human experts were explicitly mentioned for ground truth.
- Bench Testing (Pachymetry & Tonometry): Ground truth was established by known physical standards (calibrated glass plates for pachymetry, manometrically controlled pressure chamber for tonometry).
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- No adjudication method involving human readers for the test set was mentioned or implied for either pachymetry or tonometry. The comparison was directly against established reference devices or physical standards.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC comparative effectiveness study was mentioned.
- The Corvis ST is a diagnostic measurement device (tonometer/pachymeter), not an AI-assisted diagnostic aid for human readers. Its performance is evaluated on the accuracy of its direct measurements against a reference, not on how it assists human interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, the performance studies described are for the standalone device. The device takes measurements directly, and its output (IOP, corneal thickness) is compared to a reference standard. There is no human-in-the-loop component for the measurement process itself in these evaluations.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Pachymetry (Clinical): Ground truth based on measurements from an FDA-cleared predicate device (Pachycam).
- Tonometry (Clinical): Ground truth based on measurements from a widely accepted clinical standard device (Goldmann applanation tonometer).
- Bench Testing (Both): Ground truth based on known physical standards (calibrated glass plates, manometrically adjusted pressure chamber).
The sample size for the training set
- The document describes performance studies, which are typically test sets. It does not provide information about a training set for the device's algorithms. The device's image processing routines are mentioned, and for pachymetry, it states they use the "same image processing routine" as the cleared predicate, implying established algorithms rather than ones newly trained for this submission.
How the ground truth for the training set was established
- Not applicable as no training set information is provided in the document. The device's underlying technology seems to rely on established image processing techniques and comparison against predicate devices rather than a de novo AI model that requires a distinct training phase.

Summary

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K113066 510(k) SUMMARY Oculus Optikgeraete GmbH Corvis ST

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

NOV

........

Oculus Optikgeraete GmbH Muenchholzhaeuser Strasse 29 35582 Wetzlar Germany

Phone:	+49(0)641 2005-0
Facsimile:	+49(0)641 2005-255
Contact Person:	Eckhard Loh
Date Prepared:	November 7, 2012

Name of Device and Name/Address of Sponsor

Corvis ST

Oculus Optikgeraete GmbH Muenchholzhaeuser Strasse 29 35582 Wetzlar Germany

Common or Usual Name

Non-Contact-Tonometer (Product Code HKX), Pachymeter (Product Code MXK)

Classification Name

21 C.F.R. §886.1930, Tonometer (AC Powered), Analysis, Anterior Segment

Predicate Devices

Nidek Incorporated, Non-Contact-Tonometer NT 1000 (K913189) Oculus Optikgeraete GmbH, Pachycam (K041841)

Intended Use / Indications for Use

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Technological Characteristics

The Corvis ST performs the following two functions:

Tonometry

The Corvis ST measures intraocular pressure without contact with the eye by applying an air f your to the eye. The eye is illuminated and during the air puff, a high-speed camera records the movement of the eye with more than 4000 images per second. The high-speed camera analyzes a sequence of 140 Scheimpflug images of the cornea to determine intra-ocular pressure.

Pachymetry

The Corvis ST measure corneal thickness and shape based on sectional images when the cornea is not influenced by the air puff. The pachymetry measurements of the Corvis ST and the cleared Oculus predicate use the same image processing routine for analysis to obtain corneal thickness measurements.

Tonometry and pachymetry functions can be performed during the same evaluation or separately.

Performance Data

Clinical Data - Pachymetry

The "Side-by-side testing of Central Corneal thickness (Apex): Corvis ST vs. Pachycam" was an internal study to evaluate the correlation between the measurement data of the FDA cleared device Pachycam (K041841) and the Corvis ST.

The study evaluated the apical thickness of the center (Pachymetry). Both eyes of each subject were measured and every eye was measured three times on the same device.

The number of subjects was 51, so 102 eyes were examined. In the study, subjects were chosen with corneal thicknesses from 463 um to 635 um.

Results:

The correlation coefficient of the representative apical thickness value was > 0.98. The overall mean (+/- standard deviation) difference of the Corvis ST apical thickness measurements to the Pachycam was -0.10 ± 4.48 µm. The within-eye repeatability (standard deviation) of the Corvis ST for each set of triplicate results per eye per subject was calculated to be 3.03 µm.

Clinical Data - Tonometry

Testing was performed in conformance with ANSI Z80.10-2009 (in accordance with FDA's extent of recognition) and EN ISO 8612:2009.

The aim of this evaluation was to compare the intraccular pressure (IOP) results measured by the Corvis ST tonometer with those obtained by the Goldmann applanation tonometer (Haag-Streit) over three IOP-groups.

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Results:

	Difference IOP (Corvis ST) - IOP (GAT)
Group	Number of eyes	IOP(mmHg)	Difference Corvis ST to referencetonometer (GAT)	Within limits(5mmHg)
1	40	7 - 16	0.8 ± 2.3 mmHg	39 (97.5 %)
2	40	> 16 - < 23	-0.5 ± 2.2 mmHg	38 (95 %)
3	40	≥ 23	0.3 ± 2.5 mmHg	39 (97.5 %)
total	120	7-48	0.2 ± 2.4 mmHg	116 (96.7 %)

The mean deviation between the test tonometer and the reference tonometer was 0.2 ± 2.4 mmHg. 96.7 % of the investigated eves were within the limits of ± 5 mmHo, no eve had a deviation to the reference tonometer of more than 7.5 mmHq.

The Corvis ST meets all the requirements EN ISO 8612:2009 and to ANSI Z80.10-2009 (in accordance with FDA´s extent of recognition) if eyes with astigmatism >3 D are excluded in accordance with EN ISO 8612:2009. The agreement between the Corvis ST and the Goldmann applanation tonometer (GAT) is satisfactory, with a standard deviation of the difference between the Corvis measurement and the Goldmann measurement of 2.4 mmHq.

Bench Testing - Tonometry

The company performed tonometric testing to evaluate the accuracy and reproducibility of the Corvis ST in its intended measuring range in accordance with FDA's extent of recognition section 4.2.3 "Bench Assessments of Bias and Precision" of ANSI Z80.10-2009, Ophthalmic Instruments -Tonometers (Ophthalmic). The testing was performed by measuring a manometric controlled test eye, which consisted of a membrane enclosed with a water filled pressure chamber. The pressure in the test chamber was adjusted by a hydrostatic head and controlled manometrically by an attached calibrated pressure sensor as reference. The measurements were taken using the Corvis ST device and additionally verified by a reference tonometer.

Results:

In the tonometry bench test, the correlation coefficient of the representative IOP value was > 0.99. The overall difference of the Corvis ST measurements to the manometric adjusted pressure values was -0.26 ± 1.1 mmHg. The test bench results show that none of the paired differences between the reference tonometer reading and the test tonometer reading for each manometric adjusted pressure value are greater than +/- 5 mmHg and also that none of the paired differences between the reference tonometer reading and the test tonometer reading for each pressure range are greater than +/- 7.5 mmHg.

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Bench Testing - Pachymetry

The focus of this internal study was to demonstrate that the performance data of the Corvis ST is accurate and reproducible over the complete stated measurement range of 300 um. The testing was performed by measuring several glass plates with several known thicknesses, known scattering, and known refraction indices.

Results:

In the pachymetry bench test, the correlation coefficient of the representative pachymetry value was > 0.99. The overall difference of the Corvis ST measurements to the reference thickness values was -0.43 ± 3.85 µm.

Substantial Equivalence

The Corvis ST is substantially equivalent to the predicate devices. The Corvis ST has the same intended use, technological characteristics, and principles of operation as its predicate devices. Bench and clinical testing demonstrate substantially equivalent performance to the predicates. The minor technological differences between the Corvis ST and its predicate raise no new issues of safety and effectiveness. Performance data demonstrate that the Corvis ST is as safe and effective as the predicate devices. Thus, the Corvis ST is substantially equivalent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

OCULUS Optikgeraete GmbH % Mr. Eckhard Loh Regulatory Affairs Manager Munchholzhauser Str. 29 Wetzlar Germany D-35582

Re: K113066

Trade/Device Name: OCULUS Corvis® ST model 72210 Regulation Number: 21 CFR 886.1930 Regulation Name: Tonometer, AC-powered Regulatory Class: Class II Product Code: HKX, MXK Dated: October 24, 2012 Received: October 24, 2012

Dear Mr. Loh:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 -- Mr. Eckhard Loh

Please be advised that FDA's issuance of a substantial equivalence determination docs 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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Kesia Y. Alexander

Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Corvis ST	Indications for UseStatement	Image: OCULUS logo
-----------	----------------------------------	--------------------

Indications for Use Statement

510(k) Number (if known): K113066

Device Name: Corvis ST

Indications for Use:

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 IF NEEDED)

fice of Device Evaluation (ODE) Concurrence of CDRH,

(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear,

Nose and Throat Devices

510(k) Number K113066

Page 1 of 1

\DC - 027529/00001 - 3710581 v1

Regulation Number and Section

§ 886.1930 Tonometer and accessories.

(a)
Identification. A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.(b)
Classification. Class II.