IOLMaster 700

K170171 · Carl Zeiss Meditec, AG · HJO · Apr 6, 2017 · Ophthalmic

Device Facts

• Record ID: K170171
• Device Name: IOLMaster 700
• Applicant: Carl Zeiss Meditec, AG
• Product Code: HJO · Ophthalmic
• Decision Date: Apr 6, 2017
• 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) 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 Story

Non-invasive optical biometry instrument; uses swept-source laser and spectral domain interferometry (OCT) to measure ocular structures (axial length, lens thickness, corneal curvature/thickness, anterior chamber depth, pupil diameter, WTW distance); captures 2D images of anterior/posterior segments; includes Reference Image functionality for pre/postoperative scleral vessel imaging. Used in clinical settings by eye care professionals. Outputs biometric data and ocular images to assist clinicians in selecting intraocular lens power/type. Benefits include precise preoperative planning for cataract surgery.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-5:2009 (cytotoxicity) and ISO 10993-10:2014 (skin irritation/sensitization). Electrical safety and EMC evaluated against IEC 60601-1 (Ed 3.1), IEC 60601-1-6 (Ed 3.1), IEC 62366 (Ed 1.1), and IEC 60601-1-2 (Ed 4.0).

Technological Characteristics

Swept-source laser (1055 nm) and infrared LEDs. Spectral domain interferometry (OCT) principle. Patient interface materials: ABS. Connectivity: Internal digital camera. Electrical: 100-240V AC, 50/60Hz. Computational formulas: Haigis suite, Hoffer Q, Holladay 2, SRK/T.

Indications for Use

Indicated for biometric measurements and visualization of ocular structures to assist in determining intraocular lens power and type in patients undergoing cataract surgery or similar procedures requiring ocular biometry.

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 (K143275)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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<br>Goeschwitzer Strasse 51-52<br>D-07745 Jena<br>Germany |
| Contact: | Dr. Christian Muenster<br>Director Regulatory and Clinical Affairs<br>[phone]<br>[e-mail] |
| Prepared by: | Rahul Ram<br>Biologics Consulting Group<br>[e-mail]<br>[phone] |
| Date Prepared: | April 5, 2017 |
| Classification Regulation: | 21 CFR 886.1850, Class II, AC-powered slitlamp<br>biomicroscope |
| Panel: | Ophthalmology |
| Product Code: | HJO - AC-powered slitlamp biomicroscope. |
| Predicate Device: | Carl Zeiss Meditec AG IOLMASTER 700<br>K143275<br>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:

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- . 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<br>(CARL ZEISS MEDITEC AG)<br>K170171 | PREDICATE IOLMASTER 700<br>(CARL ZEISS MEDITEC AG)<br>K143275 |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| Indications for Use | The IOLMaster 700 is intended for<br>biometric measurements and<br>visualization of ocular structures. The<br>measurements and visualization assist in<br>the determination of the appropriate<br>power and type of intraocular lens. The<br>IOLMaster 700 measures:<br>Lens thickness<br>●<br>Corneal curvature and thickness<br>●<br>Axial length<br>●<br>Anterior chamber depth<br>●<br>Pupil diameter<br>●<br>White-to-white distance (WTW)<br>●<br>For visualization, the IOLMaster 700<br>employs optical coherence tomography<br>(OCT) to obtain two-dimensional images<br>of ocular structures of the anterior and<br>posterior segments of the eye.<br>The Reference Image functionality is<br>intended for use as a preoperative and<br>postoperative image capture tool. | Identical |
| Principles of Operation | Spectral domain interferometry (OCT<br>principle),<br>Light spot projection (infrared LEDs),<br>Image capturing | Identical |
| Feature - Corneal Curvature Measurement (KER): | | |
| Technology for obtaining<br>measurements/images | Telecentric keratometry = distance<br>independent,<br>Light spot projection (infrared LEDs) | Identical |
| Keratometry algorithm | | Similar |
| 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 |

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| DEVICE CHARACTERISTICS | PROPOSED IOLMASTER 700<br>(CARL ZEISS MEDITEC AG) | PREDICATE IOLMASTER 700<br>(CARL ZEISS MEDITEC AG)<br>K143275 | |
|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|--|
| 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 | |
| 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 | |
| Feature - Axial Length Measurement (AL): | | | |
| Technology for obtaining<br>measurement | Swept source laser 1055 nm.<br>Spectral domain interferometry (OCT<br>principle),<br>Multiple A-scans provide a B-scan | Identical | |
| Feature - Pupil Diameter Measurement (P): | | | |
| Technology for obtaining<br>measurement | Image capturing of the iris with internal<br>digital camera. | Identical | |
| Feature - White-to-White Measurement (WTW): | | | |
| Technology for obtaining<br>measurement | Image capturing of the iris with internal<br>digital camera. | Identical | |
| Feature - Reference Image Functionality: | | | |
| Technology for obtaining<br>measurement | Green LEDs for green light illumination<br>for image capturing of scleral vessels<br>with internal digital camera. | Identical | |
| Feature - Computational<br>formulas | Haigis suite (includes Haigis, Haigis-L<br>and Haigis-T);<br>Hoffer Q;<br>Holladay 2;<br>SRK®/T | 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 | |

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| Ambient conditions: | | |
|--------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| for intended use | Temperature: 10°C to +35°C,<br>Relative humidity: 30% to 80%<br>(noncondensing) | Temperature: 10°C to +35°C,<br>Relative humidity: 30% to 90%<br>(noncondensing) |
| for storage and transport | Temperature: -20°C to +60°C,<br>Relative humidity: 10% to 90%<br>(noncondensing) | for storage:<br>Temperature: -10°C to +55°C,<br>Relative humidity: 10% to 95%<br>(noncondensing)<br><br>for storage and transport:<br>Temperature: -40°C to +70°C,<br>Relative humidity: 10% to 95%<br>(noncondensing) |
| Material composition of patient<br>interface with forehead rest<br>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.