(256 days)
No
The document does not mention AI, ML, or related terms like deep learning or neural networks. The description focuses on optical biometry and measurement techniques.
No.
The device is intended for biometric measurements and visualization to assist in determining the appropriate power and type of intraocular lens, which is a diagnostic/measurement purpose, not a therapeutic one.
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." This involves measuring various parameters like lens thickness, corneal curvature, and axial length, which are used to assess the patient's eyes and guide treatment – a characteristic function of diagnostic devices.
No
The device description explicitly states it is a "non-invasive optical biometry instrument" and mentions various hardware components like "Spectral domain interferometry (OCT principle), Light spot projection (infrared LEDs), Image capturing, Swept source laser, Green LEDs for green light illumination for image capturing of scleral vessels with internal digital camera." This indicates it is a physical device with integrated software, not a software-only medical device.
Based on the provided information, the IOLMaster 700 is an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use explicitly states that the device is for "biometric measurements and visualization of ocular structures" and that these measurements "assist in the determination of the appropriate power and type of intraocular lens." This indicates that the device is used to obtain information from a biological sample (the eye) to aid in a clinical decision (selecting an IOL).
- Measurements: The device measures various parameters of the eye (lens thickness, corneal curvature and thickness, axial length, anterior chamber depth, pupil diameter, white-to-white distance). These are all biological measurements taken from the patient's eye.
- Non-invasive Optical Biometry: While non-invasive, the device is still interacting with and obtaining data from the biological structure of the eye.
- Clinical Studies: The description of the clinical studies further supports its use in a clinical context for evaluating the device's performance in measuring biological parameters in patients.
While the device doesn't process samples outside the body in the traditional sense of a lab test, the regulatory definition of an IVD often includes devices that examine specimens derived from the human body to provide information for diagnosis, monitoring, or treatment. In this case, the "specimen" is the eye itself, and the measurements are used to inform a treatment decision (IOL selection).
Therefore, the IOLMaster 700 fits the criteria of an IVD device.
N/A
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)
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 K170171.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Spectral domain interferometry (OCT principle), Light spot projection (infrared LEDs), Image capturing, Swept source laser
Anatomical Site
Ocular structures/Eye, Cornea, Lens, Anterior chamber, Pupil, Sclera
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
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.
Clinical Data:
Clinical studies were conducted to obtain raw image data of normal eyes (cataract and non-cataract) 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.
Objectives:
- 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
- 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.
- Included datasets consisted of 142 normal eyes (i.e., without previous surgery or any known pathologies except for cataract) and 738 measurements.
Results:
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. 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 eyes
- the axis with PAD ≥ 0.1 D of PCS and keratometry in normal eyes.
b) Clinical study IOLMaster 2017-01909
- 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:
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.
Key Results for Normal Eyes:
- The spherical equivalent of Total Keratometry (TK) and of the conventional keratometry are interchangeable for normal eyes – non-cataract and cataract eyes.
- TK astigmatism measurements systematically differ from keratometry, and TK overcomes the systematic weakness of keratometry in accounting for the contribution of the posterior cornea surface to the corneal astigmatism.
- TK is suitable for IOL power calculation of toric IOLs using existing keratometry-based formulas.
- The repeatability and reproducibility of TK and PCS are comparable to conventional keratometry.
7.6.2. Post-LVC eyes
a) Clinical study HamburgLVC
- 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 consisted 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.
Results:
Comparison of TK measurements to K values modified according to the clinical history method (CHM). 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. Figures 1 and 2 present distributions of disagreement and vector differences.
b) Clinical study IOLMaster 2017-01909
- 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:
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.
Key Results for Post-LVC Eyes:
- TK measurements systematically differ from keratometry measurements in this patient group, and TK overcomes the systematic weakness of keratometry in accounting for changes in the back-ratio due to LVC treatment.
- TK yields results much closer to CHM results than the Haigis-L results are to CHM results.
- TK analysis can be used for IOL power calculation of both toric and non-toric IOLs in post-LVC eyes as an alternative to conventional keratometry.
- The repeatability and reproducibility of TK and PCS are comparable to that of conventional keratometry.
Key Metrics
For Clinical study IOLM71 (Normal Eyes), Bland-Altman testing was conducted to assess agreement, with p-values indicating statistical significance for differences.
For Clinical study IOLMaster 2017-01909 (Normal and Post-LVC Eyes), Repeatability standard deviation (SD), Repeatability limit (95% confidence limit), Reproducibility SD, and Coefficient of Variation (CV%) were reported for various measurements (SE_TK, CYL_TK, A_TK, SE_PCS, CYL_PCS, A_PCS). Specific values are provided in Table 2 and Table 3.
Example metrics from Table 2 (Non-cataract Subjects):
- SE_TK: Repeatability SD = 0.090, Limit = 0.251, CV% = 0.21%; Reproducibility SD = 0.093, Limit = 0.261, CV% = 0.21%
- CYL_TK: Repeatability SD = 0.159, Limit = 0.446, CV% = 11.55%; Reproducibility SD = 0.173, Limit = 0.485, CV% = 12.55%
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
1
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 (DICE@fda.hhs.gov) 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
2
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
Goeschwizer Strasse 51-52
D-07745 Jena
Germany |
|------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Lisa Graney
Consultant
Biologics Consulting Group, Inc.
1555 King Street, Suite 300
Alexandria, VA 22314
(571) 777-9518
lgraney@biologicsconsulting.com |
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 |
| 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
4
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
(CARL ZEISS MEDITEC AG) | PREDICATE IOLMASTER 700
(CARL ZEISS MEDITEC AG)
K170171 |
|------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Principles of Operation | Spectral domain interferometry (OCT
principle),
Light spot projection (infrared LEDs),
Image capturing | Identical |
| Feature - Corneal Curvature Measurement: | | |
| Keratometry (considering
anterior corneal surface) | Available | Available |
| Technology for obtaining
measurements/images | Telecentric keratometry = distance
independent,
Light spot projection (infrared LEDs) | Identical |
| Measurement range /
Resolution of display | 5 mm to 11 mm / 0.01 mm | Identical |
| Total Keratometry (considering
anterior and posterior corneal
surface) calculated by SW
algorithm | Available (with additional algorithm) | Not available |
| Total Keratometry measurement
values: | | |
| Spherical Equivalent (TSE) [D] | Available | Not available |
| Corneal cylinder (TAD) [D] | Available | Not available |
| Axis (Tα) [°] | Available | Not available |
| Posterior corneal surface
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
measurements/images | Swept source laser,
Spectral domain interferometry (OCT
principle),
Multiple A-scans provide a B-scan | Identical |
| Measurement range /
Resolution of display | Phakic eye range
1.0 mm to 10 mm / 0.01 mm
Pseudophakic eye range
0.13 mm to 2.5 mm / 0.01mm | Identical |
| 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 |
| Measurement range /
Resolution of display | 0.2 mm to 1.2 mm / 1 μm | 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 |
| Measurement range /
Resolution of display | 0.7 mm to 8 mm / 0.01 mm | Identical |
| Feature - Axial Length Measurement (AL): | | |
| Technology for obtaining
measurement | Swept source laser,
Spectral domain interferometry (OCT
principle),
Multiple A-scans provide a B-scan | Identical |
| Measurement range /
Resolution of display | 14 mm to 38 mm / 0.01 mm | Identical |
| Feature - Pupil Diameter Measurement (P): | | |
| Technology for obtaining
measurement | Image capturing of the iris with internal
digital camera. | Identical |
| Measurement range /
Resolution of display | 1 mm to 12 mm / 0.1 mm | Identical |
| Feature - White-to-White Measurement (WTW): | | |
| Technology for obtaining
measurement | Image capturing of the iris with internal
digital camera. | Identical |
| Measurement range /
Resolution of display | 8 mm to 16 mm / 0.1 mm | 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;
Barrett Suite (includes Barrett Universal
II, Barrett Toric and Barrett True K);
Holladay 1 | Haigis Suite (includes Haigis,
Haigis-L and Haigis-T);
Hoffer Q;
Holladay 2;
SRK®/T |
| Optical radiation: | | |
| Illumination for OCT | Light source: Tunable laser
Wavelength range: 1035 nm to 1080 nm
Maximum power output: 1.67 mW
Max. exposure time per eye and day: 8 h | Identical |
| Illumination for keratometer
(corneal curvature) measurement | Light source: LED
Wavelength: 950 nm
Delivered power: 1 Normal eyes = without prior Laser Vision Correction
9
- 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 | |||
| 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 |