Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a non-invasive optical biometry instrument for measurement and visualization. It mentions OCT and other imaging techniques but does not mention AI, ML, or any related terms in the device description, intended use, or performance studies summary. The changes described are limited to labeling and material changes, explicitly stating they do not affect the principle of operation.

Therapeutic

No.
The device is used for biometric measurements and visualization of ocular structures to assist in determining the appropriate power and type of intraocular lens, not for direct treatment or therapy.

Diagnostic

No

The device collects biometric measurements and visualizes ocular structures to assist in determining the appropriate power and type of intraocular lens, which is a measurement or preparation for treatment, not a diagnosis of a disease state.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "non-invasive optical biometry instrument" and mentions hardware components like a forehead rest, chin rest, infrared LEDs, and an internal digital camera, indicating it is a physical device with integrated software, not software only.

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 (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
IOLMaster 700 Function: The IOLMaster 700 is a non-invasive optical biometry instrument that directly measures and visualizes structures within the eye. It does not analyze specimens taken from the body.
Intended Use: The intended use clearly states it's for "biometric measurements and visualization of ocular structures" to assist in determining intraocular lens power and type. This is a direct measurement and imaging process, not an analysis of a biological sample.

Therefore, the IOLMaster 700 falls under the category of a medical device used for direct measurement and imaging of the body, 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 image capture tool.

Product codes

HJO

Device Description

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 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 K143275.

The differences between the subject IOLMaster 700 and the predicate IOLMaster 700 that are the subject of this 510(k) submission are:

Labeling changes, including inclusion of additional clinical data and minor updates;
Materials changes to the forehead rest and chin rest

The changes described in this submission do not affect how the hardware is used to acquire images, nor do these changes affect the principle of operation of the device.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Optical Coherence Tomography (OCT), Light spot projection (infrared LEDs), Image capturing, Telecentric keratometry, Swept source laser, Internal digital camera

Anatomical Site

ocular structures / eye

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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

Not Found

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

Electrical Safety & Electromagnetic Compatibility:
The IOLMaster 700 was evaluated against the requirements of Edition 3.1 of IEC 60601-1 (IEC 60601-1:2005 + Amendment 1 (2012)), Edition 3.1 of IEC 60601-1-6 (IEC 60601-1-6:2010 + Amendment 1 (2013)) and Edition 1.1 of IEC 62366 (IEC 62366:2007 + Amendment 1 (2014)), and found to comply.

The IOLMaster 700 was evaluated against the requirements of Edition 4.0 of IEC 60601-1-2 (IEC 60601-1-2:2014) and found to comply.

Biocompatibility:
Testing was conducted as per the following biocompatibility standards:

ISO 10993-10:2014 (skin irritation and sensitization)
ISO 10993-5:2009 (cytotoxicity)

Testing demonstrated that the new materials are biocompatible for the proposed use.

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

Not Found

Predicate Device(s)

K143275

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

April 6, 2017

Carl Zeiss Meditec Ag % Mr. Rahul Ram Consultant Biologics Consulting Group, Inc. 400 N. Washington Street, Suite 100 Alexandria, VA 22314

Re: K170171

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: January 18, 2017 Received: January 19, 2017

Dear Mr. Ram:

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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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

You must comply with all the Act's requirements, including, but not limited to: registration and listing

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 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,

Denise L. Hampton -S

for 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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Indications for Use

510(k) Number (if known) K170171

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)

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 image capture tool.

Type of Use (Select one or both, as applicable)
区 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.

Device Common Name:	Biometer
Device Trade Name:	IOLMASTER 700
Applicant:	Carl Zeiss Meditec AG
Goeschwitzer Strasse 51-52
D-07745 Jena
Germany
Contact:	Dr. Christian Muenster
Director Regulatory and Clinical Affairs
+49 7364 206985
christian.muenster@zeiss.com
Prepared by:	Rahul Ram
Biologics Consulting Group
rram@biologicsconsulting.com
(571) 777-9518
Date Prepared:	April 5, 2017
Classification Regulation:	21 CFR 886.1850, Class II, AC-powered slitlamp
biomicroscope
Panel:	Ophthalmology
Product Code:	HJO - AC-powered slitlamp biomicroscope.
Predicate Device:	Carl Zeiss Meditec AG IOLMASTER 700
K143275
Product Code: HJO - AC-powered slitlamp biomicroscope.

Indications for Use:

The indications for use are identical between the subject and predicate IOLMaster 700 devices.

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:

4

. 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.

Device Description:

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 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 K143275.

The differences between the subject IOLMaster 700 and the predicate IOLMaster 700 that are the subject of this 510(k) submission are:

. Labeling changes, including inclusion of additional clinical data and minor updates;
Materials changes to the forehead rest and chin rest ●

The changes described in this submission do not affect how the hardware is used to acquire images, nor do these changes affect the principle of operation of the device.

Electrical Safety & Electromagnetic Compatibility:

The IOLMaster 700 was evaluated against the requirements of Edition 3.1 of IEC 60601-1 (IEC 60601-1:2005 + Amendment 1 (2012)), Edition 3.1 of IEC 60601-1-6 (IEC 60601-1-6:2010 + Amendment 1 (2013)) and Edition 1.1 of IEC 62366 (IEC 62366:2007 + Amendment 1 (2014)), and found to comply.

The IOLMaster 700 was evaluated against the requirements of Edition 4.0 of IEC 60601-1-2 (IEC 60601-1-2:2014) and found to comply.

Biocompatibility:

Testing was conducted as per the following biocompatibility standards:

ISO 10993-10:2014 (skin irritation and sensitization) ●
. ISO 10993-5:2009 (cytotoxicity)

Testing demonstrated that the new materials are biocompatible for the proposed use.

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Device Comparison Table:

| DEVICE CHARACTERISTICS | PROPOSED IOLMASTER 700
(CARL ZEISS MEDITEC AG)
K170171 | PREDICATE IOLMASTER 700
(CARL ZEISS MEDITEC AG)
K143275 |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| 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. | Identical |
| Principles of Operation | Spectral domain interferometry (OCT
principle),
Light spot projection (infrared LEDs),
Image capturing | Identical |
| Feature - Corneal Curvature Measurement (KER): | | |
| Technology for obtaining
measurements/images | Telecentric keratometry = distance
independent,
Light spot projection (infrared LEDs) | Identical |
| Keratometry algorithm | | Similar |
| Feature - Lens Thickness Measurement (LT): | | |
| Technology for obtaining
measurements/images | Swept source laser
Spectral domain interferometry (OCT
principle),
Multiple A-scans provide a B-scan | Identical |

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| DEVICE CHARACTERISTICS | PROPOSED IOLMASTER 700
(CARL ZEISS MEDITEC AG) | PREDICATE IOLMASTER 700
(CARL ZEISS MEDITEC AG)
K143275 | |
|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|--|
| Feature - Central Corneal Thickness Measurement (CCT): | | | |
| Technology for obtaining
measurement | Swept source laser
Spectral domain interferometry (OCT
principle),
Multiple A-scans provide a B-scan | Identical | |
| Feature - Anterior Chamber Depth Measurement (ACD): | | | |
| Technology for obtaining
measurement | Swept source laser
Spectral domain interferometry (OCT
principle),
Multiple A-scans provide a B-scan | Identical | |
| Feature - Axial Length Measurement (AL): | | | |
| Technology for obtaining
measurement | Swept source laser 1055 nm.
Spectral domain interferometry (OCT
principle),
Multiple A-scans provide a B-scan | Identical | |
| Feature - Pupil Diameter Measurement (P): | | | |
| Technology for obtaining
measurement | Image capturing of the iris with internal
digital camera. | Identical | |
| Feature - White-to-White Measurement (WTW): | | | |
| Technology for obtaining
measurement | Image capturing of the iris with internal
digital camera. | Identical | |
| Feature - Reference Image Functionality: | | | |
| Technology for obtaining
measurement | Green LEDs for green light illumination
for image capturing of scleral vessels
with internal digital camera. | Identical | |
| Feature - Computational
formulas | Haigis suite (includes Haigis, Haigis-L
and Haigis-T);
Hoffer Q;
Holladay 2;
SRK®/T | Identical | |
| Electrical Data: | | | |
| Rated voltage / frequency | 100 V to 240 V AC (± 10 %) / 50/60 Hz | Identical | |
| Power consumption:
Basic unit
In standby mode | 150 W
1 W | Identical | |

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Ambient conditions:
for intended use	Temperature: 10°C to +35°C,
Relative humidity: 30% to 80%
(noncondensing)	Temperature: 10°C to +35°C,
Relative humidity: 30% to 90%
(noncondensing)
for storage and transport	Temperature: -20°C to +60°C,
Relative humidity: 10% to 90%
(noncondensing)	for storage:
Temperature: -10°C to +55°C,
Relative humidity: 10% to 95%
(noncondensing)

for storage and transport:
Temperature: -40°C to +70°C,
Relative humidity: 10% to 95%
(noncondensing) |
| Material composition of patient
interface with forehead rest
and chin rest cap | ABS | PC/ABS Blend |

Substantial Equivalence Summary:

Given the acceptable results of performance testing for the significant device modifications, we believe that the subject IOLMaster 700 is substantially equivalent to the predicate IOLMaster 700, cleared under K143275.