IOLMaster 700

K173771 · Carl Zeiss Meditec, AG · HJO · Aug 24, 2018 · Ophthalmic

Device Facts

• Record ID: K173771
• Device Name: IOLMaster 700
• Applicant: Carl Zeiss Meditec, AG
• Product Code: HJO · Ophthalmic
• Decision Date: Aug 24, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1850
• Device Class: Class 2

Intended Use

The IOLMaster 700 is intended for biometric measurements and visualization of ocular structures. The measurements and visualization assist in the determination of the appropriate power and type of intraocular lens. The IOLMaster 700 measures: - Lens thickness - Corneal curvature and thickness - Axial length - Anterior chamber depth - Pupil diameter - White-to-white distance (WTW)

Device Story

IOLMaster 700 is a non-invasive optical biometry instrument used in clinical settings by eye care professionals. It utilizes spectral domain interferometry (OCT principle) via a swept-source laser, infrared LED light spot projection, and internal digital camera image capturing to measure ocular structures: axial length, anterior chamber depth, lens thickness, corneal curvature/thickness, pupil diameter, and white-to-white distance. The device processes these inputs to provide biometric data and visualization, assisting clinicians in selecting appropriate intraocular lens (IOL) power and type. A key feature is the Total Keratometry (TK) algorithm, which calculates corneal power by accounting for both anterior and posterior corneal surfaces. Output is displayed to the clinician for IOL power calculation, facilitating surgical planning. The device benefits patients by providing accurate biometric data for IOL selection, including in challenging cases like post-LVC eyes where historical data may be unavailable.

Clinical Evidence

Clinical studies (prospective, non-significant risk) evaluated TK and PCS measurements in normal (cataract/non-cataract) and post-LVC eyes. Data from 142 normal eyes and 30 post-LVC eyes were analyzed. Primary endpoints included repeatability, reproducibility, and agreement with conventional keratometry and the Clinical History Method (CHM). Results demonstrated TK is interchangeable with conventional keratometry for spherical equivalent in normal eyes and provides results closer to the CHM gold standard than Haigis-L in post-LVC eyes. Repeatability/reproducibility SDs were comparable to conventional keratometry.

Technological Characteristics

Non-invasive optical biometer. Sensing: Spectral domain interferometry (OCT principle) using a 1035-1080 nm tunable swept-source laser; telecentric keratometry using 950 nm infrared LEDs; image capturing via internal digital camera. Connectivity: Standalone. Electrical: Class I, IP 20, Type B (IEC 60601-1). Laser: Class 1 (IEC 60825-1:2007). Software: Includes Haigis Suite and Barrett Suite for IOL power calculations. Algorithm: Rule-based/computational for TK/PCS.

Indications for Use

Indicated for biometric measurements and visualization of ocular structures to assist in determining intraocular lens power and type in patients, including those with cataracts and those who have undergone prior laser vision correction (LVC).

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

• IOLMaster 700 (K170171)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Carl Zeiss Meditec AG % Lisa Graney Consultant Biologics Consulting Group, Inc. 1555 King Street, Suite 300 Alexandria, Virginia 22314

### Re: K173771

Trade/Device Name: IOLMaster 700 Regulation Number: 21 CFR 886.1850 Regulation Name: AC-Powered Slitlamp Biomicroscope Regulatory Class: Class II Product Code: HJO Dated: December 11, 2017 Received: July 18, 2018

### Dear Lisa Graney:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone

(1-800-638-2041 or 301-796-7100).

Sincerely,

Alexander Beylin -S 2018.08.24 14:15:53 -04'00'

for Malvina 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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# Indications for Use

510(k) Number (if known) K173771

Device Name IOLMaster 700

Indications for Use (Describe)

The IOLMaster 700 is intended for biometric measurements and visualization of ocular structures. The measurements and visualization assist in the determination of the appropriate power and type of intraocular lens. The IOLMaster 700 measures:

- · Lens thickness
- · Corneal curvature and thickness
- · Axial length
- · Anterior chamber depth
- · Pupil diameter
- · White-to-white distance (WTW)

| 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

In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the IOLMaster 700 is provided below:

#### 1. SUBMITTER:

| Applicant: | Carl Zeiss Meditec AG<br>Goeschwizer Strasse 51-52<br>D-07745 Jena<br>Germany |
|------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Lisa Graney<br>Consultant<br>Biologics Consulting Group, Inc.<br>1555 King Street, Suite 300<br>Alexandria, VA 22314<br>[phone]<br>[e-mail] |

Date Prepared: July 18, 2018

#### 2. DEVICE:

| Device Trade Name: | IOLMaster 700 |
|----------------------|--------------------------------------------------------|
| Device Common Name: | Biometer |
| Classification Name: | 21 CFR 886.1850, AC-powered slit lamp<br>biomicroscope |
| Regulatory Class: | Class II |
| Product Code: | HJO |

#### PREDICATE DEVICE: 3.

The predicate device is the previous version of the IOLMaster 700, cleared under K170171.

#### DEVICE DESCRIPTION: 4.

The IOLMaster 700 is a non-invasive optical biometry instrument for visualization and measurement of ocular structures. The IOLMaster 700 is the latest generation device in the

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IOLMaster series. The version of the IOLMaster 700 that is the subject of this submission is a modified version of the IOLMaster 700 cleared under K170171.

#### INDICATIONS FOR USE: 5.

"The IOLMaster 700 is intended for biometric measurements and visualization of ocular structures. The measurements and visualization assist in the determination of the appropriate power and type of intraocular lens. The IOLMaster 700 measures:

- Lens thickness .
- Corneal curvature and thickness
- . Axial length
- Anterior chamber depth .
- Pupil diameter
- White-to-white distance (WTW) •

#### TECHNOLOGICAL COMPARISON: 6.

| DEVICE CHARACTERISTICS | PROPOSED IOLMASTER 700<br>(CARL ZEISS MEDITEC AG) | PREDICATE IOLMASTER 700<br>(CARL ZEISS MEDITEC AG)<br>K170171 |
|------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Principles of Operation | Spectral domain interferometry (OCT<br>principle),<br>Light spot projection (infrared LEDs),<br>Image capturing | Identical |
| Feature - Corneal Curvature Measurement: | | |
| Keratometry (considering<br>anterior corneal surface) | Available | Available |
| Technology for obtaining<br>measurements/images | Telecentric keratometry = distance<br>independent,<br>Light spot projection (infrared LEDs) | Identical |
| Measurement range /<br>Resolution of display | 5 mm to 11 mm / 0.01 mm | Identical |
| Total Keratometry (considering<br>anterior and posterior corneal<br>surface) calculated by SW<br>algorithm | Available (with additional algorithm) | Not available |
| Total Keratometry measurement<br>values: | | |
| Spherical Equivalent (TSE) [D] | Available | Not available |
| Corneal cylinder (TAD) [D] | Available | Not available |
| Axis (Tα) [°] | Available | Not available |
| Posterior corneal surface<br>measurement values: | | |
| Spherical Equivalent (PSE) [D] | Available | Not available |
| Corneal cylinder (PAD) [D] | Available | Not available |
| Axis (Pα) [°] | Available | Not available |
| Feature - Lens Thickness Measurement (LT): | | |
| Technology for obtaining<br>measurements/images | Swept source laser,<br>Spectral domain interferometry (OCT<br>principle),<br>Multiple A-scans provide a B-scan | Identical |
| Measurement range /<br>Resolution of display | Phakic eye range<br>1.0 mm to 10 mm / 0.01 mm<br>Pseudophakic eye range<br>0.13 mm to 2.5 mm / 0.01mm | Identical |
| Feature - Central Corneal Thickness Measurement (CCT): | | |
| Technology for obtaining<br>measurement | Swept source laser,<br>Spectral domain interferometry (OCT<br>principle),<br>Multiple A-scans provide a B-scan | Identical |
| Measurement range /<br>Resolution of display | 0.2 mm to 1.2 mm / 1 μm | Identical |
| Feature - Anterior Chamber Depth Measurement (ACD): | | |
| Technology for obtaining<br>measurement | Swept source laser,<br>Spectral domain interferometry (OCT<br>principle),<br>Multiple A-scans provide a B-scan | Identical |
| Measurement range /<br>Resolution of display | 0.7 mm to 8 mm / 0.01 mm | Identical |
| Feature - Axial Length Measurement (AL): | | |
| Technology for obtaining<br>measurement | Swept source laser,<br>Spectral domain interferometry (OCT<br>principle),<br>Multiple A-scans provide a B-scan | Identical |
| Measurement range /<br>Resolution of display | 14 mm to 38 mm / 0.01 mm | Identical |
| Feature - Pupil Diameter Measurement (P): | | |
| Technology for obtaining<br>measurement | Image capturing of the iris with internal<br>digital camera. | Identical |
| Measurement range /<br>Resolution of display | 1 mm to 12 mm / 0.1 mm | Identical |
| Feature - White-to-White Measurement (WTW): | | |
| Technology for obtaining<br>measurement | Image capturing of the iris with internal<br>digital camera. | Identical |
| Measurement range /<br>Resolution of display | 8 mm to 16 mm / 0.1 mm | Identical |
| Feature - Reference Image Functionality: | | |
| Technology for obtaining<br>measurement | Green LEDs for green light illumination<br>for image capturing of scleral vessels with<br>internal digital camera. | Identical |
| Feature - Computational<br>formulas | Haigis Suite (includes Haigis, Haigis-L<br>and Haigis-T);Hoffer Q;<br>Holladay 2;<br>SRK®/T;<br>Barrett Suite (includes Barrett Universal<br>II, Barrett Toric and Barrett True K);<br>Holladay 1 | Haigis Suite (includes Haigis,<br>Haigis-L and Haigis-T);<br>Hoffer Q;<br>Holladay 2;<br>SRK®/T |
| Optical radiation: | | |
| Illumination for OCT | Light source: Tunable laser<br>Wavelength range: 1035 nm to 1080 nm<br>Maximum power output: 1.67 mW<br>Max. exposure time per eye and day: 8 h | Identical |
| Illumination for keratometer<br>(corneal curvature) measurement | Light source: LED<br>Wavelength: 950 nm<br>Delivered power: < 500 µW | Identical |
| Illumination for WTW<br>measurement | Light source: LED<br>Wavelength: 860 nm/880 nm<br>Delivered power: < 500 µW | Identical |
| Green illumination for sclera<br>images | Source: LED<br>Wavelength: 520 nm<br>Delivered power: < 100 µW<br>Max. exposure time per eye and day:<br>27 min (corresponding to approx. 3000<br>measurements ) | Identical |
| Fixation light | Source: LED<br>Wavelength: 660 nm<br>Delivered power: < 1 µW | Identical |
| Electrical Data: | | |
| Rated voltage / frequency | 100 V to 240 V AC (± 10 %) / 50/60 Hz | Identical |
| Power consumption:<br>Basic unit<br>In standby mode | 150 W<br>1 W | Identical |
| Electrical Safety Parameters: | | |
| Protection class | I | Identical |
| Protection mode | IP 20 | Identical |
| Device type | B (IEC 60601-1) | Identical |
| Laser class | Class 1 (IEC 60825-1:2007)<br>In device (not accessible): 3B | Identical |
| Ambient conditions: | | |
| for intended use | Temperature: 10°C to +35°C,<br>Relative humidity: 30% to 80%<br>(noncondensing) | Identical |
| for storage and transport | Temperature: -20°C to +60°C,<br>Relative humidity: 10% to 90%<br>(noncondensing) | Identical |

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#### 7. PERFORMANCE DATA:

#### 7.1. Biocompatibility Testing:

The device materials are identical to the predicate device. Therefore, patient contact information is not needed for this device.

### 7.2. Electromagnetic Compatibility, Electrical, Thermal, Mechanical, Laser and Optical Radiation Safety Testing:

No hardware changes have been made from the predicate IOLMaster 700 (K170171); therefore, no EMC, electrical, thermal, mechanical, laser, or optical radiation safety testing is provided in this submission.

#### 7.3. Software Verification and Validation Testing:

Software verification and validation testing was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of

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Premarket Submissions for Software Contained in Medical Devices." Verification and validation of the IOLMaster 700 was conducted to ensure that the product works as designed.

#### 7.4. Bench Testing:

To verify the accuracy and repeatability of the IOLMaster 700 when making posterior corneal surface (PCS) and Total Keratometry (TK) measurements, bench testing was conducted in which the device acquired images of test targets of known curvatures. The results are then compared to the expected values and differences from the expected values must be within the tolerance range identified. This testing showed that the modified IOLMaster 700 is able to acquire posterior corneal surface (PCS) and Total Keratometry (TK) measurements which are accurate and repeatable.

#### Animal Testing: 7.5.

Not applicable. Animal studies are not necessary to establish the substantial equivalence of this device.

#### 7.6. Clinical Data:

Clinical studies were conducted to obtain raw image data of normal eyes1 (cataract and noncataract) as well as post LVC eyes. The image data were analyzed using the Total Keratometry (TK) / posterior corneal surface (PCS) measurement algorithm in the modified IOLMaster 700 (subject device) and compared to conventional keratometry in the predicate device IOLMaster 700.

The objectives of this testing were as follows:

- . To characterize the relationship between TK and conventional keratometry measurements.
- To characterize the relationships between PCS measurements and the respective Gullstrand model eye-derived assumptions.
- To characterize the repeatability and reproducibility of TK and PCS measurements. ●

#### 7.6.1. Normal eyes (Cataract and non-cataract eyes)

- a) Clinical study IOLM71
The following raw data was used for testing the stated objectives:

- Raw data collected within a prospective, non-significant risk clinical study conducted at three sites.
- Collection of the data using the same measurement and image acquisition method as the ● current IOLMaster 700.
- Eyes with low to high cylinder were enrolled in the study. ●

¹ Normal eyes = without prior Laser Vision Correction

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- Included datasets consisted of 142 normal eyes (i.e. without previous surgery or any ● known pathologies except for cataract) and 738 measurements in the normal (i.e. without previous surgery or any known pathologies except for cataract).
# b) Clinical study IOLMaster 2017-01909

The following data were used for repeatability and reproducibility analysis:

- Prospective, monocentric, non-significant risk clinical R&R study. ●
- Collection of the data at study site employed three IOLMaster 700 devices.
- Included datasets consisted of 32 non-cataract eyes and 281 measurements as well as 31 cataract eyes and 278 measurements. Only one eye of each patient was included.

## Results

- a) Clinical study IOLM71
For each of the normal eye PCS measurements and TK values (spherical equivalent, cylinder, axis) were compared to conventional keratometry and Gullstrand model derived posterior corneal surfaces.

Additionally, to address variability, Bland-Altman testing was conducted to assess the agreement of:

- the spherical equivalents of TK and keratometry in normal eyes, ●
- the cylinders of TK and keratometry in normal eyes,
- the cylinders of TK and keratometry in normal eyes with with-the-rule (WTR) and against-the-rule (ATR) astigmatism,
- the axis with AD ≥ 0.75 D of TK and keratometry in normal eyes, ●
- the spherical equivalents of PCS and keratometry-Gullstrand ratio-derived PCS in normal eyes
- the cylinders of PCS and keratometry-Gullstrand ratio-derived PCS in normal eves
- the axis with PAD ≥ 0.1 D of PCS and keratometry in normal eyes.

Results are summarized in Table 1.

Abbreviations used in Table 1:

- SE Spherical equivalent of corneal power according to keratometry [D]
- AD Cylinder of corneal power according to keratometry [D]
- Axis of the steep meridian according to keratometry [°] ರ
- TSE Spherical equivalent of corneal power according to TK [D]
- TAD Corneal cylinder of corneal power according to TK [D]
- Ta Axis of the steep meridian according to TK [°]
- PSE Spherical equivalent of posterior corneal power [D]
- PAD Cylinder of posterior corneal power [D]

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- Axis of the steep meridian of posterior corneal power [°] Pa
- WTR With-the-rule astigmatism, where the steep meridian is roughly vertical.
- Against-the-rule astigmatism, where the steep meridian is roughly horizontal. ATR

| | | Difference | | | | | | | | |
|-----------------------------|-----|------------|--------|---------|--------|--------|--------------------|---------|-----------------|--|
| Parameter | N | Mean | SD | Min | Med | Max | 95% CI for<br>Mean | p-value | 95% LOA | |
| Keratometry | | | | | | | | | | |
| PSE vs. PSEKera [D] | 141 | 0.027 | 0.114 | -0.301 | 0.031 | 0.414 | 0.019, 0.036 | < 0.001 | 0.255, -0.200 | |
| PΔD vs. PΔDKera [D] | 129 | -0.150 | 0.132 | -0.511 | -0.158 | 0.225 | -0.160, -0.140 | < 0.001 | 0.114, -0.414 | |
| Pα vs. α [°]<br>PΔD ≥ 0.1 D | 117 | -3.409 | 31.152 | -88.187 | -2.326 | 87.786 | -5.879, -0.939 | 0.007 | 58.896, -65.713 | |
| TSE vs. SE [D] | 141 | 0.013 | 0.110 | -0.303 | 0.016 | 0.383 | 0.005, 0.022 | 0.002 | 0.233, -0.206 | |
| TΔD vs. ΔD [D] | 129 | -0.032 | 0.183 | -0.444 | -0.038 | 0.441 | -0.046, -0.018 | < 0.001 | 0.334, -0.398 | |
| WTR | 76 | -0.147 | 0.110 | -0.444 | -0.155 | 0.138 | -0.158, -0.136 | < 0.001 | 0.074, -0.367 | |
| ATR | 33 | 0.185 | 0.120 | -0.081 | 0.193 | 0.441 | 0.167, 0.204 | < 0.001 | 0.424, -0.054 | |
| Tα vs.α [°]<br>ΔD ≥ 0.75 D | 84 | 0.603 | 3.416 | -14.828 | 0.579 | 10.725 | 0.278, 0.927 | < 0.001 | 7.434, -6.228 | |

### Table 1: Mean Difference Summary Statistics

### b) Clinical study IOLMaster 2017-01909

Repeatability standard deviation (SD) was estimated by the square-root of the estimated variance due to measurement error based on the random effect ANOVA model. The repeatability limit (or repeatability) was estimated with a 95% confidence limit of the difference between two repeated measurements. The reproducibility SD was estimated by the square-root of sum of the variances due to device/operator configuration, interaction between subject, and measurement error. Additionally, the coefficient of variation in percentage (CV) for repeatability were provided.

Results are summarized in Table 2.

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| Table 2: Repeatability and Reproducibility, normal patients (n = 32 non-cataract subjects and n =<br>31 cataract subjects), IOLMaster 700 version 1.70 / Repeatability Analysis |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Population |

| | N<br>Scans | Mean | Repeatability | | | Reproducibility | | |
|-----------------------------|------------|--------|---------------|--------|--------|-----------------|--------|--------|
| | Scans | Mean | SD | Limit | CV% | SD | Limit | CV% |
| Non-cataract Subjects | | | | | | | | |
| SE_TK [D] | 281 | 43.59 | 0.090 | 0.251 | 0.21% | 0.093 | 0.261 | 0.21% |
| CYL_TK [D] | 281 | -1.38 | 0.159 | 0.446 | 11.55% | 0.173 | 0.485 | 12.55% |
| A_TK [°]<br>(CYL K ≥ 0.75D) | 219 | 136.46 | 2.998 | 8.393 | 2.20% | 3.393 | 9.499 | 2.49% |
| SE_PCS [D] | 281 | -5.88 | 0.030 | 0.085 | 0.52% | 0.033 | 0.091 | 0.55% |
| CYL_PCS [D] | 281 | -0.36 | 0.047 | 0.132 | 13.06% | 0.052 | 0.145 | 14.31% |
| A_PCS [°] | 281 | 139.19 | 4.319 | 12.093 | 3.10% | 5.424 | 15.188 | 3.90% |
| Cataract Subjects | | | | | | | | |
| SE_TK [D] | 278 | 44.16 | 0.088 | 0.246 | 0.20% | 0.103 | 0.288 | 0.23% |
| CYL_TK [D] | 278 | -1.01 | 0.148 | 0.416 | 14.69% | 0.159 | 0.446 | 15.77% |
| A_TK [°]<br>(CYL K ≥ 0.75D) | 171 | 133.79 | 3.459 | 9.685 | 2.59% | 3.854 | 10.791 | 2.88% |
| SE_PCS [D] | 278 | -5.92 | 0.029 | 0.080 | 0.48% | 0.035 | 0.097 | 0.58% |
| CYL_PCS [D] | 278 | -0.27 | 0.048 | 0.133 | 17.43% | 0.048 | 0.136 | 17.75% |
| A_PCS [°] | 278 | 145.12 | 7.371 | 20.640 | 5.08% | 8.949 | 25.058 | 6.17% |

(SE_TK, CYL_TK, A_TK) = Spherical equivalent, Cylinder, Axis IOLMaster 700 v1.70 Total Keratometry, (SE_PCS, CYL_PCS, A_PCS) = Spherical equivalent, Cylinder, Axis IOLMaster 700 v1.70 Posterior Corneal Surface Reproducibility Limit = 2.8*SD.

Note: poststratification of IOLMaster 700 v 1.70 axis (A_TK) is based on the per-patient median of the IOLMaster v1.50 Cylinder (CYL_K) measurement, cut at 0.75D.

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#### 7.6.2. Post-LVC eyes

### a) Clinical study HamburgLVC

For the quantitative comparison analyses, the data from the "HamburgLVC" study were examined

- Raw data collected within a prospective, single-site clinical study.
- Collection of the data using the same measurement and image acquisition method as the current IOLMaster 700.
- Eyes with low to high cylinder were enrolled in the study. Included datasets consists of 30 eyes and 60 measurements (one pre- and one postoperative measurement for each eye). From the 30 eyes, 29 eyes have undergone a myopic and one eye has undergone a hyperopic LASIK treatment. Only one eye of each patient was included.

### b) Clinical study IOLMaster 2017-01909

The following data are used for repeatability and reproducibility analysis:

- Prospective, monocentric, non-significant risk clinical R&R study.
- Collection of the data at study site employed three IOLMaster 700 devices. ●
- . Included datasets consisted of 30 post-LVC eyes and 267 measurements. Only one eye of each patient was included.

### Results

In post-LVC eyes, IOL calculation typically consists of two steps: correcting keratometry K values and using a standard formula. When the required historic data is available, the clinical history method is considered the gold standard for correcting K values. Otherwise, a history-free approximation, like Haigis-L, is typically used in clinical practice.

The dataset HamburgLVC includes post-LVC measurements and pre-LVC and post-LVC refraction data. This allows comparison of TK measurements to K values modified according to the clinical history method. As a benchmark, comparison of Haigis-L modified K values to the clinical history method was also conducted. The analysis was performed for non-toric lenses as well as for toric lenses.

Abbreviations in Figure 1 and Figure 2:

- SE Spherical equivalent of keratometry [D]
- TSE Spherical Equivalent for TK [D]
- CHM Clinical History Method
- CSE Spherical equivalent of postoperative corneal power derived from CHM

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Image /page/13/Figure/2 description: The image contains two scatter plots side by side, both titled "post-LASIK (HamburgLVC)". The left plot shows "TSE vs. CSE" with the y-axis labeled "Differences of devices [D]" and the x-axis labeled "subjective refraction change [D]". A dashed line indicates "Mean + 2SD = 0.78685" and another indicates "Mean - 2SD = -0.60124". The right plot shows "SE (Haigis-L) vs. CSE" with the same axis labels as the left plot. A dashed line indicates "Mean + 2SD = 1.4485" and another indicates "Mean - 2SD = -0.12801".

Figure 1: Distribution of disagreement of the spherical equivalents of TK and CHM (left), and of Haigis-L and CHM (right) by subjective refraction change in case of post LASIK eyes. The teal dot marks the hyperopic post-LVC measurement.

Image /page/13/Figure/4 description: The image contains two polar plots comparing power vector differences between different methods for LASIK surgery. The plot on the left compares 'HH-LVC TK' versus 'CHM', with a mean difference of 0.049D at 41.03 degrees. The plot on the right compares 'HH-LVC Haigis-TL' versus 'CHM', with a mean difference of 0.172D at 173.59 degrees. Both plots display data points distributed around the center, with radial lines indicating diopter values and angular lines indicating degrees.

- Figure 2: Double-angle plots of vector differences between corneal cylinder of TK and toric CHM (left), and as a baseline of Haigis-T corrected keratometry and toric CHM (right), respectively. The mean vector differences are 0.049 D @ 41. 03° (left) and 0.172 D @ 173.59° (right).

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# c) Clinical study IOLMaster 2017-01909

Repeatability standard deviation (SD) was estimated by the square-root of the estimated variance due to measurement error based on the random effect ANOVA model. The repeatability limit (or repeatability) was estimated by the 95 % confidence limit of the difference between two repeated measurements. The reproducibility SD was estimated by the square-root of sum of the variances due to device/operator configuration, interaction between subject, and measurement error. Additionally, the coefficient of variation in percentage (CV) for repeatability were provided.

Results are summarized in Table 3.

| | N<br>Scans | Mean | SD | Repeatability<br>Limit | CV% | SD | Reproducibility<br>Limit | CV% |
|-----------------------------|------------|--------|--------|------------------------|-------|--------|--------------------------|-------|
| SE_TK [D] | 267 | 40.64 | 0.083 | 0.233 | 0.21 | 0.092 | 0.257 | 0.23 |
| CYL_TK [D] | 267 | -0.91 | 0.135 | 0.379 | 14.82 | 0.148 | 0.414 | 16.19 |
| A_TK [°]<br>(CYL_K ≥ 0.75D) | 231 | 150.85 | 5.416 | 15.165 | 3.59 | 5.510 | 15.428 | 3.65 |
| SE_PCS [D] | 267 | -5.91 | 0.027 | 0.076 | 0.46 | 0.034 | 0.094 | 0.57 |
| CYL_PCS [D] | 267 | -0.31 | 0.044 | 0.124 | 14.45 | 0.048 | 0.135 | 15.77 |
| A_PCS [°] | 267 | 153.01 | 11.236 | 31.462 | 7.34 | 11.345 | 31.767 | 7.41 |

### Table 3: Repeatability and Reproducibility, post LVC patients (n = 30), IOLMaster 700 version 1.70 / Repeatability Analysis Population

(SE TK, CYL TK, A TK) = Spherical equivalent, Cylinder, Axis IOLMaster 700 v 1.70 Total Keratometry, (SE PCS, CYL PCS, A PCS) = Spherical equivalent, Cylinder, Axis IOLMaster 700 v1.70 Posterior Corneal Surface

Reproducibility Limit = 2.8*SD.

Note: poststratification of IOLMaster 700 v 1.70 axis (A_TK) is based on the per-patient median of the IOLMaster v1.50 Cylinder (CYL K) measurement, cut at 0.75D.

#### 7.6.3. Conclusion

## Normal eyes

The analysis of the data shows that the spherical equivalent of Total Keratometry (TK) and of the conventional keratometry are interchangeable for normal eyes - non-cataract and cataract eyes based on analysis of the mean difference and limits of agreement.

Hence, TK analysis in the modified IOLMaster 700 can be used for IOL power calculation of non-toric IOLs in normal (spherical) eyes as an alternative to conventional keratometry in the predicate IOLMaster 700.

The verification shows that TK astigmatism measurements systematically differ from keratometry as expected and in agreement with scientific literature. The results show that TK overcomes the systematic weakness of keratometry in accounting for the contribution of the posterior cornea surface to the corneal astigmatism.

Combined with the interchangeability in spherical equivalent, TK is thus suitable for IOL power calculation of toric IOLs using existing keratometry-based formulas, but not for formulas including a model of the posterior corneal astigmatism that differs from the keratometer model as a workaround of the weakness of keratometry.

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The repeatability and reproducibility of TK and PCS is comparable to conventional keratometry.

## Post-LVC eyes

The analysis for post-LVC eyes shows that TK measurements systematically differ from keratometry measurements in this patient group as expected. Analysis also shows that TK overcomes the systematic weakness of keratometry in accounting for changes in the back-ratio due to LVC treatment.

Individual differences between TK and the clinical history method (CHM), which is considered the established gold standard, are above the noise level and above the limit of clinical significance. However, analysis of the relative performance of the Haigis-L formula, which is an established history-free alternative to CHM, showed that TK yields results much closer to CHM results than the Haigis-L results are to CHM results.

Combined with the interchangeability in spherical equivalent in normal eyes, TK combined with a regular IOL calculation formula (e.g. Haigis) is a valid tool for IOL calculation in post-LVC eyes, particularly in cases after myopic LASIK without availability of the historic data required for CHM.

Therefore, TK analysis in the modified IOLMaster 700 can be used for IOL power calculation of both toric and non-toric IOLs in post-LVC eyes as an alternative to conventional keratometry in the predicate IOLMaster 700.

It is further concluded that the repeatability and reproducibility of TK and PCS is comparable to the that of conventional keratometry.

#### CONCLUSION: 8.

All testing deemed necessary was conducted on the modified IOLMaster 700 to ensure that the device is as safe and effective when used in accordance with its Instructions for Use as the predicate device.

The differences in technological characteristics do not raise different questions of safety and effectiveness and the results of performance testing demonstrate that the subject device performs in accordance with specifications and meets user needs and intended uses.

Clinical data demonstrated that TK can be used as an alternative to conventional keratometry for IOL power calculation in both normal eyes and post LASIK Vision Correction eyes for both spherical and astigmatic eyes.

Based on the detailed comparison of specifications for each of the modifications to the previously cleared IOLMaster 700, the results of performance testing and clinical testing the modified IOLMaster 700 is substantially equivalent to the predicate device IOLMaster 700, as cleared in K170171.