Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a device for biometric measurements and visualization using OCT and other optical methods. While it mentions "Image processing," there is no mention of AI, ML, deep learning, or any related terms in the device description, intended use, or performance studies. The focus is on traditional optical measurement and image acquisition techniques.

Therapeutic

No
The device is used for biometric measurements and visualization, which assist in the determination of appropriate intraocular lens power and type, rather than directly treating a disease or condition.

Diagnostic

Yes

The device performs biometric measurements and visualization of ocular structures to assist in the determination of the appropriate power and type of intraocular lens, which is a diagnostic purpose.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "computerized biometry device consisting of an OCT system, a Keratometer system, and a camera," indicating it includes significant hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, the IOLMaster 700 is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
IOLMaster 700 Function: The IOLMaster 700 directly measures and visualizes structures within the living human eye using optical methods (OCT, keratometry, camera). It does not analyze samples taken from the body.
Intended Use: The intended use is for biometric measurements and visualization to assist in determining IOL power and type, which is a clinical assessment based on in-vivo measurements, not laboratory analysis of a specimen.

Therefore, the IOLMaster 700 falls under the category of a medical device used for in-vivo measurements and imaging, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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)

For visualization, the IOLMaster 700 employs optical coherence tomography (OCT) to obtain two-dimensional images of ocular structures of the anterior and posterior segments of the eye.

The Reference Image functionality is intended for use as a preoperative and postoperative image capture tool.

Product codes (comma separated list FDA assigned to the subject device)

HJO

Device Description

The IOLMaster 700 device is a computerized biometry device consisting of an OCT system, a Keratometer system, and a camera for the purposes of:

measuring distances within the human eye along the visual axis (e.g. axial length, lens thickness, anterior chamber depth),
measuring the corneal surface with a keratometer,
measuring distances at the front of the eye with a camera (e.g. white-to-white distance).

The IOLMaster 700 is used for visualization and measurement of ocular structures mainly required for the preparation of cataract surgeries to calculate the refractive power of the intraocular lens (IOL) to be implanted. The IOLMaster 700 device includes a swept source frequency domain optical coherence tomography (OCT) module capable of acquiring tomograms of the eye. The axial measurements are based on those tomograms.

The IOLMaster 700 device is operated via multi touch monitor and alternatively with computer mouse and keyboard. A joystick on the measuring head is used for manual alignment of the device to the patient's eye.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Optical Coherence Tomography (OCT), Keratometry, Camera

Anatomical Site

Ocular structures/eye

Indicated Patient Age Range

Adult males or females (37 to 89 years in clinical study)

Intended User / Care Setting

Physicians and eye-care professionals (under the supervision of a physician)

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

A non-significant risk clinical study was conducted at three sites to determine comparability of the measurements obtained from the IOLMaster 700 and the IOLMaster 500 and Lenstar LS 900, and to determine the repeatability and reproducibility of the measurements of the IOLMaster 700.

A total of 120 eyes were enrolled to determine the comparability of axial length (AL), anterior chamber depth (ACD), central corneal thickness (CCT), lens thickness (LT), white-to-white (WTW) and keratometry [Radii R1 and R2, Cylinder (Cyl), Spherical Equivalent (SE), Axis (A)]. Only one eye of each subject was designed as the study eye.

The subjects with cataracts enrolled in the study ranged in age from 37 to 89 years; the mean was 68 years. The severity of the cataract density was determined by the clinical investigator and included mild (Grade 1, 83%), moderate (Grade 2, 15%) and severe (Grade 3, 2%). The study population included 54 males and 66 females (45%, 55%, respectively).

Study Inclusion Criteria: Adult males or females who had been diagnosed with a cataract graded to be at least grade 1 and who were willing to participate in the study examination and measurements and give consent.

Study Exclusion Criteria:

Patients who were not capable of understanding the instructions of the investigator or to give their consent or who were unable to sit upright in front of the devices, with injuries to the forehead or chin;
Patients with an inability to keep fixation as well as those who had eccentric fixation, nervous disposition, poor patient cooperation or those with tremor, nystagmus, or shortage of breath;
Patients with insufficient corneal reflection for a keratometry or ACD measurement, i.e. due to serious tear film problems on the study eye or who had existing corneal abnormalities. e.g. corneal scars, keratoconus, degenerative diseases, active inflammation in the study eye:
Patients who did not remove their hard or soft contact lens within the required time period prior to undergoing study measurements or who had partial or complete covering of the cornea by eyelid or eyelid closure;
Patients with previous refractive or other corneal surgery on the study eyes or implantation of a phakic intraocular lens in the study eye;
Patients with morphological changes in the retinal anatomy in fovea region, e.g. vitreous hemorrhage, acute retinal detachment in the study eye.

Data Collection: The study employed three IOLMaster 700 devices, three IOLMaster 500 devices, and three Lenstar LS 900 devices; each of the three sites possessed one IOLMaster 700, one IOLMaster 500 and one Lenstar LS 900 for the duration of the study. Subjects were examined with the three study devices in one session wherein the operators attempted to take five measurements with the IOLMaster 700 and one measurement with the IOLMaster 500 as well as the Lenstar LS 900 on each study eye.

Data Analysis: Prior to data analysis, scans were reviewed using the same quality criteria as described in the User Manual, Software Description. Specifically, the reviewers used the following criteria:

Incorrect caliper placement by artifacts in B-scans (interfaces not detected correctly by the algorithm due to poor segmentation or floaters or other artifacts in the vitreous / anterior chamber)
Blurred WTW image (scleral image not visible)
Closed eyelid in any image
Distorted or missing reflections in keratometry image (incomplete number of spots reflected from cornea or blurred reflections due to shading caused by eye lashes, eye lid or poor tear film)

For the agreement comparison, only the first acceptable IOLMaster 700 measurement out of five was used to analyze the difference between the IOLMaster 700 and the comparison device.
For analyzing keratometry, the resulting parameters spherical equivalent (SE) and cylinder (CYL) were calculated based on the existing values R1 [mm] and R2 [mm].
For each of the parameters AL. ACD. R1, R2. A. SE and CYL, the difference in measurement between IOLMaster 700 and IOLMaster 500 was calculated for each eye by subtracting the value of IOLMaster 500 from the value of IOLMaster 700.
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 (Formula 1).The reproducibility SD was estimated by the square-root of sum of variance due to measurement error and variance due to study site.
The reproducibility limit (or reproducibility) was estimated by Formula 2:

1. Repeatability SD is the standard deviation under repeatability conditions. Per ISO 5725-1 and ISO 5725-6, Repeatability Limit = 2.8 × Repeatability SD. Repeated COV [%] = Coefficient of Variation = Repeatability SD = Mean. (x 100). The mean was the estimated general mean in the random ANOVA model for the R&R calculation.
1. Reproducibility SD is the standard deviation calculated for the difference between individual measurement using different operators and instruments. Per ISO 5725-1 and ISO 5725-6, Reproducibility Limit = 2.8 × Reproducibility SD.
  The Coefficient of Variability (COV) was calculated by the standard deviation from repeatability and reproducibility and the mean of all used measurements.
  As the Axis measurement in IOLMaster 700 serves only for the alignment of toric IOLs, only eyes with corneal astigmatism of 0.75 D and higher were analyzed.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Study Type: Clinical Study (Non-significant risk)
Sample Size: 120 eyes (113 for IOLMaster 500 comparison, 112 for Lenstar LS 900 comparison, 117 for repeatability/reproducibility analysis for some parameters)
AUC: Not Found
MRMC: Not Found
Standalone Performance: Not Found

Key Results:
The results of the IOLMaster 700 measurements are comparable to those of the predicate devices, IOLMaster 500 and Lenstar LS 900. In comparison with the predicate biometry devices, the IOLMaster 700 demonstrated good repeatability and reproducibility for all parameters.

Repeatability and Reproducibility (ANOVA based):

Parameter	N	Mean	Between-Replicates (SD, %CV)	Between-Site/Device (SD, %CV)	Total (Overall) (SD, %CV)
AL [mm]	117	23.605	0.009, 0.037%	0.318, 1.346%	0.318, 1.346%
ACD [mm]	117	3.053	0.010, 0.314%	0.057, 1.853%	0.057, 1.879%
CCT [µm]	117	548.598	2.271, 0.414%	2.844, 0.518%	3.640, 0.663%
LT [mm]	117	4.661	0.019, 0.410%	0.000, 0.000%	0.019, 0.410%
R1 [mm]	109	7.784	0.026, 0.334%	0.032, 0.411%	0.041, 0.530%
R2 [mm]	109	7.617	0.024, 0.316%	0.044, 0.580%	0.050, 0.661%
SE [D]	109	43.159	0.100, 0.231%	0.232, 0.537%	0.252, 0.585%
Cyl [D]	109	0.934	0.191, 20.449%	0.000, 0.000%	0.191, 20.449%
A [°]	59	81.249	5.633, 6.93%	0.000, 0.000%	5.633, 6.93%
WTW [mm]	115	11.928	0.090, 0.755%	0.018, 0.155%	0.092, 0.771%

Mean Differences Between Devices and Limits of Agreement:
(IOLMaster 700 - IOLMaster 500)

Parameter	N	Difference Mean (SD) (95% CI)	Lower Limit of Agreement	Upper Limit of Agreement
AL [mm]	113	0.004 (0.025) (0.000, 0.009)	-0.045	0.053
ACD [mm]	113	0.017 (0.121) (-0.006, 0.039)	-0.221	0.254
R1 [mm]	113	0.001 (0.044) (-0.008, 0.009)	-0.086	0.087
R2 [mm]	113	-0.002 (0.046) (-0.011, 0.006)	-0.093	0.088
SE [D]	113	-0.001 (0.190) (-0.037, 0.034)	-0.374	0.371
Cyl [D]	113	0.013 (0.318) (-0.046, 0.072)	-0.610	0.636
A [°]	59	1.407 (11.3883) (-1.561; 4.375)	-20.91	23.73
WTW [mm]	97	-0.125 (0.167) (-0.158, -0.091)	-0.452	0.203

(IOLMaster 700 - Lenstar LS 900)

Parameter	N	Difference Mean (SD) (95% CI)	Lower Limit of Agreement	Upper Limit of Agreement
LT [mm]	112	0.020 (0.120) (-0.002, 0.043)	-0.246	0.256
CCT [µm]	112	0.116 (4.492) (-0.725, 0.957)	-8.688	8.920

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found. See Summary of Performance Studies for other metrics (SD, %CV, Mean, Median, Min, Max, p-value, 95% CI, Limits of Agreement).

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K122418, K082891, K141068

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K051789

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 886.1850 AC-powered slitlamp biomicroscope.

(a)
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.(b)
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.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized representation of a human figure with three faces in profile, one behind the other. The faces are connected by a flowing line that forms the shape of a wing or a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 10, 2015

Carl Zeiss Meditec. Inc. Ms. Christine Dunbar Ophthalmic Systems Manager, Regulatory Submissions 5160 Hacienda Drive Dublin, California 94568

Re: K143275 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: June 4, 2015 Received: June 5, 2015

Dear Ms. Dunbar:

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.

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.

1

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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kesia Y. Alexander -A

for Malvina B. Eydelman 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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Section 1: Indications for Use - IOLMaster 700

510(k) Number (if known):

Device Name(s): IOLMaster 700

Indications for 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)

For visualization, the IOLMaster 700 employs optical coherence tomography (OCT) to obtain two-dimensional images of ocular structures of the anterior and posterior segments of the eye.

The Reference Image functionality is intended for use as a preoperative and postoperative image capture tool.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page ______ of________________________________________________________________________________________________________________________________________________________________

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Image /page/3/Picture/0 description: The image shows the Carl Zeiss Meditec logo and text. The logo is on the left side of the image and is blue. The text on the right side of the image says "Carl Zeiss Meditec" and "Premarket Notification 510(k)".

Section 2: 510(k) Summary

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

Submitter's name, address, telephone number, contact person, and date summary prepared:

| Submitter: | Carl Zeiss Meditec AG
Goeschwitzer Strasse 51-52
07745 Jena Germany |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Christine Dunbar, PMP
Manager, Regulatory Submissions
Carl Zeiss Meditec, Inc.
5160 Hacienda Drive
Dublin, CA 94568
christine.dunbar@zeiss.com
Tel: (925) 560-5139
Fax: (925) 557-4259 |

Date Prepared: June 29, 2015

Name of device, including trade name and classification name

1.	Trade/Proprietary Name:	a. IOLMaster 700
2.	Common/Usual Name:	a. Biometer
3.	Classification Name:	a. AC-powered, biomicroscope
4.	Product Code and Class:	a. HJO - Class II
5.	Classification Number:	a. 21 CFR 886.1850

Predicate Devices

The IOLMaster 700 is similar in function and application and is used in the preparation phase of cataract surgery as the following predicate devices:

. the IOLMaster 500 (K122418) - the primary predicate as it has the most similar intended use and characteristics,
the Lenstar LS 900 (K082891) is an additional (secondary) predicate to support the two new ● measurements featured on the IOLMaster 700,
additionally, the IOLMaster 500 as part of the ZEISS Cataract Suite markerless (K141068) ● for the Reference Imaging feature.

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Carl Zeiss Meditec Premarket Notification 510(k)

The Visante OCT (K051789) is provided as a reference device to support the OCT function of the IOLMaster 700.
The IOLMaster 700 provides similar basic measurement features as the primary predicate. IOLMaster 500 (K122418). Additionally, the IOLMaster 700 measures the corneal thickness and lens thickness which is similar to the Lenstar LS 900 (K082891) manufactured by Haag- Streit. All three devices are intended to provide measurements of the human eye and provide IOL power calculations to aid the physician prior to cataract surgery.

A comparison of the features, indications for use, and technological characteristics of the IOLMaster 700 is intended to establish substantial equivalence to the previously cleared predicate devices, the IOLMaster 500 and the Lenstar LS 900.

Device Description

The IOLMaster 700 device is a computerized biometry device consisting of an OCT system, a Keratometer system, and a camera for the purposes of:

measuring distances within the human eye along the visual axis (e.g. axial length, lens ● thickness, anterior chamber depth),
measuring the corneal surface with a keratometer, .
measuring distances at the front of the eye with a camera (e.g. white-to-white distance).

The IOLMaster 700 is used for visualization and measurement of ocular structures mainly required for the preparation of cataract surgeries to calculate the refractive power of the intraocular lens (IOL) to be implanted. The IOLMaster 700 device includes a swept source frequency domain optical coherence tomography (OCT) module capable of acquiring tomograms of the eye. The axial measurements are based on those tomograms.

The IOLMaster 700 device is operated via multi touch monitor and alternatively with computer mouse and keyboard. A joystick on the measuring head is used for manual alignment of the device to the patient's eye.

Indications for Use

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

The IOLMaster 700 measures:

Lens thickness ●
Corneal curvature and thickness
Axial length
. Anterior chamber depth

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ELECarl Zeiss Meditec Premarket Notification 510(k)

Pupil diameter ●
. White-to-white distance (WTW)

For visualization, the IOLMaster 700 employs optical coherence tomography (OCT) to obtain twodimensional images of ocular structures of the anterior and posterior segments of the eye.

The Reference Image functionality is intended for use as a preoperative and postoperative image capture tool.

Comparison of Technological Characteristics

The comparison of the technological characteristics to the predicates is as follows:

IOLMaster 700:

The IOLMaster 700 is a new biometry device providing the same basic measuring features as the IOLMaster 500 and in addition, measures central corneal thickness and lens thickness. It also includes the Reference Image functionality for use in the ZEISS Cataract Suite markerless workflow.

The IOLMaster 700 contains a swept source frequency domain optical coherence tomography (OCT) module that uses a tunable laser [1055 nm]. It is based on an interference optical method known as partial coherence interferometry (PCI). Multiple A-scans provide B-scans that are displayed as cross-sectional images of the human eye and are used to obtain axial measurements: corneal thickness, anterior chamber depth, lens thickness, and axial length. Corneal curvature and white-to-white measurements use the same technology as the IOLMaster 500.

IOLMaster 500 (K122418):

The IOLMaster 700 provides similar basic measurement features as the primary predicate, IOLMaster 500 (K122418). Both devices are combined biometry instruments used to take measurements of the human eve. It provides measurements of the following eve parameters: axial length, corneal curvature, anterior chamber depth, and white-to-white distance is similar to the measurements from the IOLMaster 700. The axial length measurement is based on partial coherence interferometry (PCI) A-scans as it is in the IOLMaster 700. The IOLMaster 500 uses a multimode laser diode [780 nm] to realize time domain interferometry (dual beam principle).

Anterior chamber depth measurements are based on a slit lamp module, whereas the IOLMaster 700 extracts anterior chamber depth from OCT scans similar to the Lenstar LS 900 (K082891) system. Corneal curvature is measured by a telecentric keratometry. White-to-white is obtained using a camera.

Lenstar LS 900 (K082891):

The IOLMaster 700 measures the corneal thickness and lens thickness which is similar to the Lenstar LS 900 (K082891) manufactured by Haag-Streit. Both devices generate A-scans. The technology used by the Lenstar LS 900 includes super luminescence diode [820 nm] as the laser source, A-scans based on Optical Low-Coherence Reflectometry (OLCR, principle of OCT) and a distance dependent

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Image /page/6/Picture/0 description: The image shows the Carl Zeiss Meditec logo and text. The logo is on the left side of the image and is a blue square with the word "ZEISS" in white letters. To the right of the logo is the text "Carl Zeiss Meditec" followed by "Premarket Notification 510(k)". The text is in black and is in a smaller font than the logo.

keratometer.

Like the IOLMaster 700, the Lenstar LS 900 is used for obtaining ocular measurements and performing calculations to assist in the determination of the appropriate power and type of IOL for implantation after cataract removal.

Visante OCT (K051789):

The reference device, Visante OCT and the IOLMaster 700 OCT both acquire and visualize crosssectional tomograms of the anterior eye segment using optical coherence tomography (OCT).

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Table 1 Summary of Comparison between IOLMaster 700 and IOLMaster 500

| Feature or Function | IOLMASTER 700
SUBJECT DEVICE | IOLMASTER 500
PRIMARY PREDICATE

K122418 |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for 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)

For visualization, the IOLMaster 700
employs optical coherence
tomography (OCT) to obtain two-
dimensional images of ocular
structures of the anterior and
posterior segments of the eye.

The Reference Image functionality is
intended for use as a preoperative and
postoperative image capture tool. | The IOLMaster is intended for the
biometric determination of ocular
measurements of axial length,
anterior chamber depth, corneal
radius, white-to-white (WTW), and
for the measurement of pupil size
and deviation of the visual axis
from the center of the pupil. For
patients who are candidates for
intraocular lens (IOL) implantation,
the device also performs
calculations to assist physicians in
determining the appropriate IOL
power and type for implantation.
This device is intended for use by
physicians and eye-care professionals
and may only be used under the
supervision of a physician

Additional IOLMaster 500
Predicate - K141068
IOLMaster 500 Indications for Use
remains unchanged from K122418. |
| Reference Image | Included feature (software license)

Green LEDs for green light
illumination for image capturing of
scleral vessels with internal camera. | Option Reference Image Feature
cleared under K141068.

K122418 |
| Cross-sectional Imaging
Technology | Swept source laser [1055 nm],
frequency domain optical coherence
interferometry (OCT principle),
acquires 2000 A-scans /second,
Two orthogonal scan units. Multiple
A-scans provide a B-scan (2D
Imaging). | Multimode laser diode [780 nm],
Time domain interferometry (dual
beam principle), |
| Fixation Light | LED [660 nm] | LED [590 nm] |
| Keratometry | Telecentric keratometry = distance
independent
Light spot projection (infrared
LEDs) | Telecentric keratometry = distance
independent
Light spot projection (infrared
LEDs) |
| AL (mm): | Swept source laser [1055 nm],
Spectral domain interferometry
(OCT principle),
Multiple A-scans provide a B-scan
(2D image). | Multimode laser diode [780 nm],
Time domain interferometry (dual
beam principle),
Measurement can be imported from
ultrasound system. |
| ACD (mm): | Swept source laser [1055 nm],
Spectral domain interferometry
(OCT principle),
Multiple A-scans provide a B-scan
(2D image). | Slit lamp principle |
| CCT, LT (mm): | Swept source laser [1055 nm],
Spectral domain interferometry
(OCT principle).
Multiple A-scans provide a B-scan
(2D image). | Not available. |
| WTW, Pupil diameter
(mm): | Infrared LEDs illumination and
image capturing of the eye with
internal camera. | Infrared LEDs illumination and
image capturing of the eye with
internal camera. |
| Computational formulas | Haigis Suite*
(*includes Haigis,
Haigis-L and Haigis-T)
Hoffer Q
Holladay 2
SRK®/T | Haigis,
Haigis-L
HofferQ
Holladay 1
Holladay 2
SRK®/T |
| Feature or Function | IOLMASTER 700
SUBJECT DEVICE | IOLMASTER 500
PRIMARY PREDICATE
K122418 |
| | | SRK® II
Phakic implants
Corneal K's correction (for eyes
after refractive surgery) |
| Ultrasound link
Option “Sonolink” | Not available | Available |

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ZEISS Carl Zeiss Meditec Premarket Notification 510(k)

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Premarket Notification 510(k)

Performance Data

Biocompatibility:

The IOLMaster 700 has two patient-contact components; the patient chin rest and the forehead rest. Biocompatibility testing was conducted according to ISO 10993-1:2009 Biological evaluation of medical devices. The material tested was compliant with the requirements in ISO10993-1:2009.

Electrical Safety and EMC:

Electrical safety and electromagnetic compatibility (EMC) for the IOLMaster 700 was evaluated. Conformance to standards for electrical safety (IEC 60601-1:2007), electromagnetic compatibility (IEC 60601-1-2:2007) and other recognized standards was demonstrated.

Optical radiation safety:

Optical radiation safety of the IOLMaster 700 was evaluated. Conformance to light hazard protection for ophthalmic instruments (ISO 15004-2:2007) and safety of laser products (IEC 60825-1:2007) was demonstrated.

Software Verification and Validation Testing:

The IOLMaster 700 was tested according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005.

Clinical Studies:

Description of Study:

A non-significant risk clinical study was conducted at three sites to determine comparability of the measurements obtained from the IOLMaster 700 and the IOLMaster 500 and Lenstar LS 900, and to

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Image /page/10/Picture/0 description: The image shows the Carl Zeiss Meditec logo and text. The logo is on the left side of the image and is a blue square with the word "ZEISS" in white letters. The text is on the right side of the image and reads "Carl Zeiss Meditec" on the first line and "Premarket Notification 510(k)" on the second line. The text is in a serif font and is black.

determine the repeatability and reproducibility of the measurements of the IOLMaster 700.

A total of 120 eyes were enrolled to determine the comparability of the following parameters: axial length (AL), anterior chamber depth (ACD), central corneal thickness (CCT), lens thickness (LT), white-to-white (WTW) and keratometry [Radii R1 and R2, Cylinder (Cyl), Spherical Equivalent (SE), Axis (A)]. Only one eye of each subject was designed as the study eye.

The subjects with cataracts enrolled in the study ranged in age from 37 to 89 years; the mean was 68 years. The severity of the cataract density was determined by the clinical investigator and included mild (Grade 1, 83%), moderate (Grade 2, 15%) and severe (Grade 3, 2%). The study population included 54 males and 66 females (45%, 55%, respectively).

The study inclusion criteria required adult males or females who had been diagnosed with a cataract graded to be at least grade 1 and who were willing to participate in the study examination and measurements and give consent.

The study exclusion criteria included:

Patients who were not capable of understanding the instructions of the investigator or to give ● their consent or who were unable to sit upright in front of the devices, with injuries to the forehead or chin;
Patients with an inability to keep fixation as well as those who had eccentric fixation, nervous ● disposition, poor patient cooperation or those with tremor, nystagmus, or shortage of breath;
Patients with insufficient corneal reflection for a keratometry or ACD measurement, i.e. due to serious tear film problems on the study eve or who had existing corneal abnormalities. e.e. corneal scars, keratoconus, degenerative diseases, active inflammation in the study eye:
Patients who did not remove their hard or soft contact lens within the required time period prior ● to undergoing study measurements or who had partial or complete covering of the cornea by eyelid or eyelid closure;
Patients with previous refractive or other corneal surgery on the study eyes or implantation of a . phakic intraocular lens in the study eye;
. Patients with morphological changes in the retinal anatomy in fovea region, e.g. vitreous hemorrhage, acute retinal detachment in the study eye.

Data Collection

The study employed three IOLMaster 700 devices, three IOLMaster 500 devices, and three Lenstar LS 900 devices; each of the three sites possessed one IOLMaster 700, one IOLMaster 500 and one Lenstar LS 900 for the duration of the study.

Subjects were examined with the three study devices in one session wherein the operators attempted to take five measurements with the IOLMaster 700 and one measurement with the IOLMaster 500 as well as the Lenstar LS 900 on each study eye.

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Image /page/11/Picture/0 description: The image contains the logo for Carl Zeiss Meditec. The logo consists of the word "ZEISS" in a bold, sans-serif font, with the letters stacked vertically and aligned to the left. To the right of the logo is the text "Carl Zeiss Meditec" followed by "Premarket Notification 510(k)". The text is in a smaller, serif font.

Data Analysis

Prior to data analysis, scans were reviewed using the same quality criteria as described in the User Manual, Software Description. Specifically, the reviewers used the following criteria:

Incorrect caliper placement by artifacts in B-scans (interfaces not detected correctly by the ● algorithm due to poor segmentation or floaters or other artifacts in the vitreous / anterior chamber)
Blurred WTW image (scleral image not visible) ●
Closed eyelid in any image ●
Distorted or missing reflections in keratometry image (incomplete number of spots reflected ● from cornea or blurred reflections due to shading caused by eye lashes, eye lid or poor tear film)

For the agreement comparison, only the first acceptable IOLMaster 700 measurement out of five was u s e d to analyze the difference between the IOLMaster 700 and the comparison device.

For analyzing keratometry, the resulting parameters spherical equivalent (SE) and cylinder (CYL) were calculated based on the existing values R1 [mm] and R2 [mm].

For each of the parameters AL. ACD. R1, R2. A. SE and CYL, the difference in measurement between IOLMaster 700 and IOLMaster 500 was calculated for each eye by subtracting the value of IOLMaster 500 from the value of IOLMaster 700.

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 (Formula 1).The reproducibility SD was estimated by the square-root of sum of variance due to measurement error and variance due to study site.

The reproducibility limit (or reproducibility) was estimated by Formula 2:

1. Repeatability SD is the standard deviation under repeatability conditions. Per ISO 5725-1 and ISO 5725-6, Repeatability Limit = 2.8 × Repeatability SD. Repeated COV [%] = Coefficient of Variation = Repeatability SD = Mean. (x 100). The mean was the estimated general mean in the random ANOVA model for the R&R calculation.
1. Reproducibility SD is the standard deviation calculated for the difference between individual measurement using different operators and instruments. Per ISO 5725-1 and ISO 5725-6, Reproducibility Limit = 2.8 × Reproducibility SD.

The Coefficient of Variability (COV) was calculated by the standard deviation from repeatability and reproducibility and the mean of all used measurements.

As the Axis measurement in IOLMaster 700 serves only for the alignment of toric IOLs, only eyes with corneal astigmatism of 0.75 D and higher were analyzed.

Table 1 summarizes the descriptive statistics for differences between the IOLMaster 700 and the comparison devices (IOLMaster 500 and Lenstar LS 900).

The values from each instrument used in the calculation of those differences are shown in Table 2

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Image /page/12/Picture/0 description: The image shows the Carl Zeiss Meditec logo and text. The logo is on the left side of the image and consists of the word "ZEISS" in a bold, sans-serif font. The text on the right side of the image reads "Carl Zeiss Meditec" followed by "Premarket Notification 510(k)". The text is in a smaller, serif font.

(Descriptive Statistics Summary for Difference), and Table 3 (Mean Difference Between Devices with Limits of Agreement).

In Tables 1-3, the first acceptable measurement for each subject was considered for comparison of the IOLMaster 700 and comparison devices (IOLMaster 500 and Lenstar LS 900).

	Table 1: Descriptive Statistics Summary - IOLMaster 700 and Comparison Devices
--	--------------------------------------------------------------------------------

	IOLMaster 700				IOLMaster 500
	n	Mean (SD)	Median	Min,
Max	n	Mean (SD)	Median	Min,
Max
Biometry mode
AL [mm]	113	23.636
(1.820)	23.260	20.49,
34.56	113	23.632
(1.811)	23.250	20.53,
34.54
ACD [mm]	113	3.061
(0.415)	3.080	2.03,
4.12	113	3.044
(0.402)	3.020	2.09,
4.08
Keratometry mode
R1, Radius in Flat
Meridian [mm]	113	7.784
(0.250)	7.780	7.10,
8.80	113	7.783
(0.252)	7.780	7.12,
8.78
R2, Radius in Steep
Meridian [mm]	113	7.610
(0.238)	7.610	6.99,
8.18	113	7.613
(0.238)	7.610	6.99,
8.15
SE [D]	113	43.175
(1.326)	43.170	39.36,
47.13	113	43.176
(1.329)	43.122	39.32,
47.06
Cyl [D]	113	0.969
(0.627)	0.870	0.00,
3.39	113	0.956
(0.663)	0.856	0.00,
3.24
A [°]	59	90.63
(68.224)	96	0,
187	59	89.22
(67.078)	89	-2,
188
WTW mode
WTW [mm]	97	11.889
(0.407)	12.00	10.9,
12.9	97	12.024
(0.429)	12.00	11.0,
13.0
	IOLMaster 700				Lenstar LS 900
	n	Mean (SD)	Median	Min,
Max	n	Mean (SD)	Median	Min,
Max
Biometry mode
LT [mm]	112	4.643
(0.411)	4.665	3.70,
5.60	112	4.623
(0.417)	4.630	3.70,
5.62
CCT [µm]	112	549.27
(36.368)	548.5	430,
655	112	549.15
(35.411)	550.0	435,
653
The value "-2" for Minimum axis of the IOLMaster 500 is due to the performed conversion for comparison.

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Biometry mode

LT [mm]

CCT [µm]

Difference between IOLMaster 700 and IOLMaster 500
	N	Mean (SD)	Median	Min, Max	p-value
T-test for paired
samples
Biometry mode
AL [mm]	113	0.004
(0.025)	0.000	-0.06, 0.09	0.074
ACD [mm]	113	0.017
(0.121)	-0.010	-0.30, 0.38	0.149
Keratometry mode
R1, Radius in Flat
Meridian [mm]	113	0.001
(0.044)	0.000	-0.14, 0.25	0.949
R2, Radius in Steep
Meridian [mm]	113	-0.002
(0.046)	0.000	-0.16, 0.13	0.598
SE [D]	113	-0.001
(0.190)	0.000	-0.92, 0.62	0.937
Cyl [D]	113	0.013
(0.318)	-0.008	-0.88, 0.87	0.659
A [°]	59	1.407
(11.388)	0	-35, 32	0.347
WTW mode
WTW [mm]	97	-0.125
(0.167)	-0.10	-0.8, 0.4	0.75 D only.

Table 4: IOLMaster 700 Variation Components

The table above shows the variance components for effect due to site/device and effect due to replicates and the corresponding repeatability and reproducibility as well as an overall SD and COV value.

Summary

The results of the IOLMaster 700 measurements are comparable to those of the predicate devices, IOLMaster 500 and Lenstar LS 900. In comparison with the predicate biometry devices, the IOLMaster 700 demonstrated good repeatability and reproducibility for all parameters.