(303 days)
Not Found.
No
The summary describes image processing and calculations based on geometric principles and interferometry, but does not mention any AI or ML techniques.
No.
The device is designed to take images and perform calculations for diagnostic purposes, not to provide therapy.
Yes
The device is designed to "evaluate" various aspects of the anterior segment of the eye, such as corneal shape, pachymetry, anterior and posterior opacity, and the condition of the lens. It also takes images and performs calculations to assist physicians in determining the power of the intraocular lens for implantation. These functions involve identifying and assessing conditions or characteristics, which aligns with the definition of a diagnostic device.
No
The device description explicitly states that the Galilei G6 Lens Professional is comprised of both hardware and software components, including a Measurement Head, Main Monitor, PC box, Elevation Table, and an EBR Accessory with optical and mechanical components.
Based on the provided information, the Galilei G6 Lens Professional is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, prevention, or treatment of a disease or condition.
- Galilei G6 Function: The Galilei G6 Lens Professional is designed to take images of the anterior segment of the eye and perform measurements and calculations based on these images. It directly interacts with the patient's eye using light and optical principles.
- Lack of Specimen Analysis: The device does not collect or analyze any biological specimens from the patient. Its measurements are based on the physical characteristics and structures of the eye itself.
Therefore, the Galilei G6 Lens Professional falls under the category of an ophthalmic imaging and measurement device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Galilei G6 Lens Professional is designed to take images of the anterior segment of the eye, which includes cornea, iris, pupil, anterior chamber, and crystalline lens. To evaluate:
- Corneal shape
- Pachymetry (corneal thickness)
- Position of the cornea relative to iris and lens
- Anterior and posterior opacity
- Anterior chamber angle
- Anterior chamber depth
- Volume of the anterior chamber
- White-to-white distance
- Pupil size
- Condition and position of implants (e.g. IOL, phakic IOLs, intracorneal rings)
- Location of cataracts (nuclear, sub capsular and or cortical), using cross slit imaging with densitometry
- Condition of the lens (opaque crystalline lens)
- Lens shape
- Crystalline lens thickness
The Galilei G6 Lens Professional is designed to additionally evaluate:
- Axial length
The Galilei G6 Lens Professional) also performs calculations to assist physicians in determining the power of the intraocular lens for implantation.
Product codes (comma separated list FDA assigned to the subject device)
MXK, HJO
Device Description
The Galilei G6 Lens Professional is (in hardware and software) identical to the Galilei G4 Dual Scheimpflug Analyzer but features an additional biometry module (hardware and software) referred to as "EBR Accessory".
The Galilei G6 Lens Professional consists of the following functional units:
- Measurement Head Container for the cameras, light sources, monitor drivers and electronics. The Placido disk and Dual-Scheimpflug imaging is integrated into the Measurement Head, which performs a 180-degree rotation during data acquisition.
- Main Monitor Display and navigation through the software, selection of functions.
- PC box Container of the power supply and the computer. Periphery (Main monitor, mouse and keyboard) is connected directly to the computer.
- . Elevation Table - Height-adjustable instrument table with locking wheels.
- EBR Accessory Container of the EBR main printed circuit board as well as the optical and mechanical components such as a scanner and a partial coherence interferometer used for biometry measurements. Mounted inside the PC box.
The GALILE! G6 device takes images of the anterior segment of the eye, which includes the cornea, iris, pupil, limbus, anterior chamber and crystalline lens. Topography and anterior segment tomography are calculated from those images.
A pair of slit light images are recorded simultaneously with two cameras placed at opposite sides at an angle of 45°. Due to the Scheimpflug principle, an angled orientation of the camera's sensor allows a sharp focus over the entire image in spite of the 45° recording angle.
The images are then analyzed and anterior cornea, anterior lens and iris surfaces are detected. This information is then used to reconstruct a three-dimensional model of the anterior chamber.
Twenty (20) concentric rings in the Placido are reflected on the anterior surface of the cornea and recorded by a top-view camera in the center of the measurement head. The sizes and shapes of the recorded rings are used to calculate the curvature of the anterior surface of the eye.
Both the Placido and Scheimpflug information are then merged to a single model of the eye.
The EBR Accessory enables the Galilei G6 to take an optical A-scan by means of partial coherence interferometry.
A beam of partial coherence infrared light is directed along the optical axis into the eye. Whenever it passes a transition between layers with different refractive indices (e.g., corneal surfaces, crystalline lens surfaces, retinal surfaces), a portion of the light is reflected back towards the reflected light is compared to a reference beam passing through a light path of adjustable optical length. The length of the reference arm is varied by a scanner.
When the optical lengths of sample arm and reference arm match to within the coherence length of the partial coherence light source, an interference peak is detected and the corresponding layer within the eye is deduced.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found.
Input Imaging Modality
Scheimpflug photography, Placido ring imaging, Partial coherence interferometry
Anatomical Site
Anterior segment of the eye (cornea, iris, pupil, limbus, anterior chamber and crystalline lens)
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
A clinical study was conducted to support the substantial equivalence of the Galilei G6 Lens Professional to the predicate device, the Pentacam® AXL.
117 enrolled and measured subjects, 12 subjects were discontinued. A total of 105 eyes of 105 subjects were assessed.
The mean age of the subjects involved in this study was 40.7±16.3 years. 49 being right eyes and 56 being left eyes. Only one eye of each subject.
Subjects included:
- normal eyes (phakic eyes without cataracts or corneal disease),
- eyes with varying degrees of cataract,
- eyes with high myopia,
- eyes with high hyperopia,
- eyes with post-keratorefractive surgery condition.
Additional 5 analyzed eyes consisted of 2 eyes with severe keratoconus and 3 eyes with prior crosslinking treatment.
Of the 105 assessed subjects, 63 were males and 42 were females. Ethnicity was composed of 100 Non-Hispanics and 5 Hispanics. Race consisted of 98 Whites, 5 Asians, and 2 American/Alaskan Natives.
The 20 patients with cataract who completed all measurements included not only eyes with moderate cataract, but also eyes with severe cataract with grades as high as 4 in the Lens Opacification Classification System (LOCS) III, in order to ensure that cataracts of various severity grades, particularly of severe cataract, can be accurately and precisely assessed with the Galilei G6 In the LOCS III, cataract severity ranges from grade 1 (very early stage) to grade 5 (severe).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Study (Comparison Galilei G6 Lens Professional with Pentacam® AXL):
Study design: A prospective, observational, one-center study.
Sample size: 105 subjects (105 eyes).
Key results:
- In terms of agreement, the Galilei G6 demonstrates substantially equivalent performance to the predicate device, except for WtW.
- WtW is known to be different between state-of-the-art devices, and device specific offsets are commonly used in clinical practice to account for inter-device differences. Inter-device differences between the state-of-the-art devices and Galilei G6 are substantially equivalent to those between state-of-the-art devices and the PAXL.
- Repeatability and reproducibility attained with the Galilei G6 are substantially equivalent to those attained with the PAXL.
- Minor technological differences between the Galilei G6 and the Pentacam AXL raise no new issues of safety or effectiveness.
- No adverse effects and complications were observed or are to be expected.
In-house Precision Testing:
Study type: Internal clinical study.
Objectives:
- to evaluate precision in terms of repeatability (intra-device, intra-operator) and reproducibility (inter-device, inter-operator) of the GALILEI G6 Lens Professional for repeated measurements.
- to compare the precision of the Galilei G6 Lens Professional to the reported values of the Pentacam® AXL for normal eyes.
Measurements under assessment included: AL, CCT, R flat, R steep, Rm, CC, A flat, ACD, WtW.
Sample size: 12 subjects for Galilei G6 data, 40 subjects for PAXL data (as reported in K152311).
Key results: - Repeatability (intra-device, intra-operator) with the Galilei G6:
- AL [mm]: SD 0.02, CV [%] 0.08
- CCT [um]: SD 4.50, CV [%] 0.78
- R flat [mm]: SD 0.02, CV [%] 0.21
- R steep [mm]: SD 0.02, CV [%] 0.21
- Rm [mm]: SD 0.01, CV [%] 0.16
- CC [D]: SD 0.11, CV [%] 8.79
- A flat [deg]: SD 3.40, CV [%] 3.79
- ACD [mm]: SD 0.03, CV [%] 0.85
- WtW [mm]: SD 0.03, CV [%] 0.21
- Repeatability CV values are generally comparable to those with the PAXL.
- Small differences where the repeatability CV with the PAXL is smaller than that with the Galilei G6 are clinically irrelevant, because they translate to refractive differences below 0.17D.
- Repeatability SD value of 0.11D for CC corresponds to the repeatability SD values reported in literature studies with Pentacam HR and other corneal topographers and keratometers on the market.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Repeatability (SD, CV [%]), Reproducibility (SD, CV [%]) for AL, CCT, R flat, R steep, Rm, CC, A flat, ACD, WtW.
These are not sensitivity, specificity, PPV, NPV metrics.
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.
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.
Not Found.
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.
§ 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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 25, 2019
SIS AG, Surgical Instrument Systems % Kevin Walls Principal Consultant Regulatory Insight, Inc. 33 Golden Eagle Lane Littleton, CO 80127
Re: K182659
Trade/Device Name: Galilei G6 Lens Professional Regulation Number: 21 CFR 886.1850 Regulation Name: AC-Powered Slitlamp Biomicroscope Regulatory Class: Class II Product Code: MXK, HJO Dated: June 24, 2019 Received: June 25, 2019
Dear Kevin Walls:
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.
1
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 (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/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-devices/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Bradley Cunningham Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Galilei G6 Lens Professional
Indications for Use (Describe)
The Galilei G6 Lens Professional) is designed to take images of the anterior segment of the eye, which includes cornea, iris, pupil, anterior chamber, and crystalline lens. To evaluate:
- · Corneal shape
- · Pachymetry (corneal thickness)
- Position of the cornea relative to iris and lens
- · Anterior and posterior opacity
- · Anterior chamber angle
- · Anterior chamber depth
- · Volume of the anterior chamber
- · White-to-white distance
- · Pupil size
- · Condition and position of implants (e.g. IOL, phakic IOLs, intracorneal rings)
- · Location of cataracts (nuclear, sub capsular and or cortical), using cross slit imaging with densitometry
- · Condition of the lens (opaque crystalline lens)
- · Lens shape
- · Crystalline lens thickness
The Galilei G6 Lens Professional is designed to additionally evaluate:
• Axial length
The Galilei G6 Lens Professional) also performs calculations to assist physicians in determining the power of the intraocular lens for implantation.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) Summary GALILEI Lens Professional
l. SUBMITTER
SIS AG, Surgical Instrument Systems Allmendstrasse 11 CH-2502 Port Switzerland Frank Ziemer, CEO Phone: +41 32 332 70 70 +41 32 332 70 71 Fax: Email: frank.ziemer@ziemergroup.com
Contact Person: Mr. Kevin Walls Regulatory Insight, Inc. 33 Golden Eagle Lane Littleton, Colorado 80127 Phone: 720-962-5412 Fax: 720-962-5413 Email: kevin@reginsight.com
Date Prepared: July 24, 2019
DEVICE ll.
Name of Device: Galilei G6 Lens Professional Common or Usual Name: G6. Galilei Classification Name: AC-powered slit lamp biomicroscope Requlatory Class: Class II Product Code: MXK, HJO Regulation Number: 886.1850
III. PREDICATE DEVICE
The following two predicate devices were chosen:
- Galilei G4 Dual Scheimpflug Analyzer (K051940) for topography/ tomography 1. measurements only and
-
- Pentacam® AXL (K152311) for topography/tomography as well as biometry measurements
The Galilei G6 Lens Professional is (in hardware and software) identical to the Galilei G4 Dual Scheimpflug Analyzer but includes an additional biometry module (hardware and software) referred to as an "EBR Accessory" for evaluating axial length. The Galilei G4 Dual Scheimpflug Analyzer is already cleared by the FDA (K051940) and was audited by the FDA in 2017 without deviations.
The Pentacam® AXL was chosen as a predicate device because it is the only FDA approved device on the market that has substantially similar measurement principles to the Galilei G6. Both the Galilei G6 Lens Professional and the Pentacam® AXL devices use a combination of Scheimpflyg topography/tomography and axial length measurements based on partial coherence interferometry.
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Image /page/4/Picture/1 description: The image shows the logo for Ziemer Ophthalmology, which includes the word "ziemer" in a sans-serif font, with the word "OPHTHALMOLOGY" in a smaller font underneath. To the right of the word "ziemer" is a stylized red swoosh. Below the logo is the text "Page 2/13", indicating that this is page 2 of a 13-page document.
IV. DEVICE DESCRIPTION
The Galilei G6 Lens Professional is (in hardware and software) identical to the Galilei G4 Dual Scheimpflug Analyzer but features an additional biometry module (hardware and software) referred to as "EBR Accessory".
The Galilei G6 Lens Professional consists of the following functional units:
- Measurement Head Container for the cameras, light sources, monitor drivers and electron-● ics. The Placido disk and Dual-Scheimpflug imaging is integrated into the Measurement Head, which performs a 180-degree rotation during data acquisition.
- Main Monitor Display and navigation through the software, selection of functions. ●
- PC box Container of the power supply and the computer. Periphery (Main monitor, mouse ● and keyboard) is connected directly to the computer.
- . Elevation Table - Height-adjustable instrument table with locking wheels.
- EBR Accessory Container of the EBR main printed circuit board as well as the optical and ● mechanical components such as a scanner and a partial coherence interferometer used for biometry measurements. Mounted inside the PC box.
The GALILE! G6 device takes images of the anterior segment of the eye, which includes the cornea, iris, pupil, limbus, anterior chamber and crystalline lens. Topography and anterior segment tomography are calculated from those images.
A pair of slit light images are recorded simultaneously with two cameras placed at opposite sides at an angle of 45°. Due to the Scheimpflug principle, an angled orientation of the camera's sensor allows a sharp focus over the entire image in spite of the 45° recording angle.
The images are then analyzed and anterior cornea, anterior lens and iris surfaces are detected. This information is then used to reconstruct a three-dimensional model of the anterior chamber.
Twenty (20) concentric rings in the Placido are reflected on the anterior surface of the cornea and recorded by a top-view camera in the center of the measurement head. The sizes and shapes of the recorded rings are used to calculate the curvature of the anterior surface of the eye.
Both the Placido and Scheimpflug information are then merged to a single model of the eye.
The EBR Accessory enables the Galilei G6 to take an optical A-scan by means of partial coherence interferometry.
A beam of partial coherence infrared light is directed along the optical axis into the eye. Whenever it passes a transition between layers with different refractive indices (e.g., corneal surfaces, crystalline lens surfaces, retinal surfaces), a portion of the light is reflected back towards the reflected light is compared to a reference beam passing through a light path of adjustable optical length. The length of the reference arm is varied by a scanner.
When the optical lengths of sample arm and reference arm match to within the coherence length of the partial coherence light source, an interference peak is detected and the corresponding layer within the eye is deduced.
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INDICATIONS FOR USE V.
The Galilei G6 Lens Professional is designed to take images of the anterior segment of the eye, which includes cornea, iris, pupil, anterior chamber, and crystalline lens. To evaluate:
- Corneal shape ●
- Pachymetry (corneal thickness) ●
- Position of the cornea relative to iris and lens ●
- Anterior and posterior opacity
- Anterior chamber angle ●
- Anterior chamber depth
- Volume of the anterior chamber
- White-to-white distance ●
- Pupil size ●
- Condition and position of implants (e.g. IOL, phakic IOLs, intracorneal rings) ●
- Location of cataracts (nuclear, sub capsular and or cortical), using cross slit imaging with densitometry
- Condition of the lens (opaque crystalline lens)
- Lens shape
- Crystalline lens thickness
The Galilei G6 Lens Professional is designed to additionally evaluate:
- Axial length ●
The Galilei G6 Lens Professional) also performs calculations to assist physicians in determining the power of the intraocular lens for implantation.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES
The extent of equivalence to the two predicate devices (see section III) is documented in the following tables
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Table 1: Comparison Table of Galilei G6 Lens Professional and Galilei G4 Dual Scheimpflug Analyzer
| Characteristics | Galilei G6 Lens Professional | Galilei G4 Dual Scheimpflug Analyzer | Difference |
|---|---|---|---|
| 510(k) number | K182659 (pending) | K051940 | n/a |
| Intended use | The Galilei G6 Lens Professional is designed to take im- | ||
| ages of the anterior segment of the eye, which includes | |||
| cornea, iris, pupil, anterior chamber, and crystalline lens. | |||
| To evaluate: | |||
| • Corneal shape | |||
| • Pachymetry (corneal thickness) | |||
| • Position of the cornea relative to iris and lens | |||
| • Anterior and posterior opacity | |||
| • Anterior chamber angle | |||
| • Anterior chamber depth | |||
| • Volume of the anterior chamber | |||
| • White-to-white distance | |||
| • Pupil size | |||
| • Condition and position of implants (e.g. IOL, phakic | |||
| IOLs, intracorneal rings) | |||
| • Location of cataracts (nuclear, sub capsular and or | |||
| cortical), using cross slit imaging with densitometry | |||
| • Condition of the lens (opaque crystalline lens) | |||
| • Lens shape | |||
| • Crystalline lens thickness |
The GALILEI G6 Lens Professional is designed to
additionally evaluate:
• Axial length | The Galilei G4 Dual-Scheimpflug Analyzer is a device
intended to take images of the anterior segment of the
eye, which includes cornea, iris, pupil, anterior chamber,
and lens, to evaluate and analyse:
• Corneal shape
• Lens shape
• Pachymetry (thickness of the cornea)
• Pupil size
• Lens thickness
• Condition of the lens
○ Location of cataracts (nuclear, subcapsular
and or cortical), using Scheimpflug slit
imaging with densitometry
○ State of the lens (opaque crystalline lens)
• Condition and position of implants (e.g. IOLs, phakik
IOLs, intracorneal rings)
• Anterior chamber (size, volume and angle)
• Scheimpflug Image
• Position of the cornea relative to iris and lens | No difference for meas-
urements of the anterior
chamber.
The Galilei G6 Lens
Professional additionally
evaluates axial length.
Safety and effective-
ness are addressed in a
clinical study with re-
spect to the second
predicate device. |
| Measurement
principle
anterior
segment &
Topography | Scheimpflug photography for cross-sectional anterior im-
aging of the anterior chamber.
Scheimpflug photography and Placido ring imaging for
anterior corneal surface topography | Scheimpflug photography for cross-sectional anterior
imaging of the anterior chamber.
Scheimpflug photography and Placido ring imaging for
anterior corneal surface topography | No difference |
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Galilei G4 Dual Scheimpflug Analyzer Difference Characteristics Galilei G6 Lens Professional Keratometry 4.5 - 13.5 mm (25 - 75 D) 4.5 - 13.5 mm (25 - 75 D) No difference range Imaging Digital camera Digital camera No difference Technology LED LED Source: Source: Scheimpflug No difference Wavelength: 470 nm Wavelength: 470 nm Source: LED Source: LED Placido No difference Wavelength: 750 nm Wavelength: 750 nm No difference Device concept Tabletop Tabletop Operator guided by monitor and joystick Operator guided by monitor and joystick Alignment No difference Operating No difference Distance 58 mm 58 mm No difference LED LED Source: Source: Fixation Target Wavelength: 617 nm Wavelength: 617 nm Power Re-No difference 110/220 VAC, 50/60 Hz 110/220 VAC, 50/60 Hz quirement
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Table 2: Comparison Table of Galilei G6 Lens Professional and Pentacam® AXL
| Characteristics | Galilei G6 Lens Professional | Pentacam® AXL | Difference | Comment |
|---|---|---|---|---|
| 510(k) number | K182659 (pending) | K152311 | n/a | n/a |
| Intended use | The GALILEI G6 Lens Professional is designed to | |||
| take images of the anterior segment of the eye, | ||||
| which includes cornea, iris, pupil, anterior cham- | ||||
| ber, and crystalline lens. To evaluate: | ||||
| Corneal shape Pachymetry (corneal thickness) Position of the cornea relative to iris and lens Anterior and posterior opacity Anterior chamber angle Anterior chamber depth Volume of the anterior chamber White-to-white distance Pupil size Condition and position of implants (e.g. IOL, | ||||
| phakic IOLs, intracorneal rings) Location of cataracts (nuclear, sub capsular | ||||
| and or cortical), using cross slit imaging with | ||||
| densitometry Condition of the lens (opaque crystalline lens) Lens shape Crystalline lens thickness | The Pentacam® AXL is designed to take photos | |||
| of the anterior segment of the eye, which includes | ||||
| cornea, pupil, anterior chamber and lens of the | ||||
| eye. To evaluate: | ||||
| corneal shape, analyze condition of the lens (opaque | ||||
| crystalline lens), analyze the anterior chamber angle, analyze anterior chamber depth, analyze the volume of the anterior chamber, analyze anterior or posterior cortical opacity, analyze the location of cataracts (nuclear, sub | ||||
| capsular and or cortical), using cross slit im- | ||||
| aging with densitometry corneal thickness, axial length, white-to-white distance. | Minor | |||
| difference | The Pentacam® AXL | |||
| does not provide lens | ||||
| thickness, lens shape | ||||
| and pupil size. |
Lens thickness, lens
shape and pupil size
are not used for in-
traocular lens calcu-
lation. The difference
doesn't alter the two
intended uses that
are new compared to
the G4 (evaluation of
axial length, deter-
mining the power of
the intraocular lens
for implantation) and
is therefore not ex-
pected to affect safe-
ty and effectiveness. |
| | The GALILEI G6 Lens Professional is designed to
additionally evaluate:
Axial length
The Galilei G6 Lens Professional also performs
calculations to assist physicians in determining the
power of the intraocular lens for implantation. | The Pentacam® AXL also performs calculations
to assist physicians in determining the power of
the intraocular lens for implantation. | | |
| Characteristics | Galilei G6 Lens Professional | Pentacam® AXL | Difference | Comment |
| | Anterior Chamber | | | |
| Measurement
principle an-
terior seg-
ment & To-
pography | Scheimpflug photography for cross-sectional
anterior imaging of the anterior chamber.
Scheimpflug photography and Placido ring im-
aging for anterior corneal surface topography | Scheimpflug photography for cross-sectional
anterior imaging of the anterior chamber
Scheimpflug photography for anterior corneal
surface topography | Minor
difference | The Pentacam® AXL
does not feature
Placido ring imaging for
conducting topography.
Anterior corneal surface
topography may be as-
sessed with either
technology. |
| | | | | Safety and effective-
ness are addressed in
a clinical study with
respect to the second
predicate device. |
| Keratometry
range | 4.5 - 13.5 mm (25 - 75 D) | 3 - 38 mm (9 - 99 D) | Minor
difference | Keratometry range of
both devices is suffi-
ciently large to cover
any corneal shape in
any human subject.
The difference is
therefore not ex-
pected to affect safety
and effectiveness. |
| Imaging
Technology | Digital camera | Digital camera | No
difference | n/a |
| Scheimpflug | Source: LED
Wavelength: 470 nm | Source: LED
Wavelength: 475 nm | No
difference | n/a |
| Placido | Source: LED
Wavelength: 750 nm | n/a | Minor
difference | The Pentacam® AXL
does not feature
Placido ring imaging for
conducting topography.
Safety with respect to
eye safety is guaranteed
by compliance with the
respective standards, |
| Characteristics | Galilei G6 Lens Professional | Pentacam® AXL | Difference | Comment |
| Biometry | | | | |
| Measurement
principle axial
biometry | Partial coherence interferometry | Partial coherence interferometry | No
difference | n/a |
| Biometry | Source: SLED
Wavelength: 880 nm
Laser class: 1
Laser class embedded: 3B | Source: SLED
Wavelength: 880 nm
Laser class: 1
Laser class embedded: 3B | No
difference | n/a |
| Axial length
range | 14 - 40 mm | 14 - 40 mm | No
difference | n/a |
| Device | | | | |
| Device concept | Tabletop | Tabletop | No
difference | n/a |
| Alignment | Operator guided by monitor and joystick | Operator guided by monitor and joystick | No
difference | n/a |
| Operating
Distance | 58 mm | 80 mm | Minor
difference | Exact focusing distance
depends on the respec-
tive imaging optics.
Both 58mm and 80mm
represent safe distanc-
es in terms of not acci-
dentally touching the
eye.
The difference is
therefore not ex-
pected to affect safety
and effectiveness. |
| Fixation Target | Source: LED
Wavelength: 617 nm | Source: SLED
Wavelength: 880 nm | Minor
difference | Both wavelengths are
suitable for fixation as
they are visible to the
human eye under direct
fixation.
The difference is
therefore not ex-
pected to affect safety
and effectiveness. |
| Characteristics | Galilei G6 Lens Professional | Pentacam® AXL | Difference | Comment |
| Power Requirement | 110/220 VAC, 50/60 Hz | 110/220 VAC, 50/60 Hz | No difference | n/a |
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VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Non-clinical testing
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the Galilei G6 Lens Professional. The device complies with the IEC 60601-1 and IEC 60825-1 standards for safety and 60IEC 60601-2 standard for EMC.
Bench performance testing
Bench performance tests demonstrating accuracy and precision of the measured parameters of the eye were performed with our device.
Software Verification and Validation testing
As recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", Software verification and validation was performed to confirm that the software performs as intended and the corresponding documentation was provided. The software for this device is rated as "major" level of concern, as inaccurately measured or displayed ocular parameters may mislead the physician in the clinical assessment. The device complies with the IEC 62304 for Medical Device Software life-cycle processes.
Clinical Studies
Comparison Galilei G6 Lens Professional with Pentacam® AXL
Study description:
A clinical study was conducted to support the substantial equivalence of the Galilei G6 Lens Professional to the predicate device, the Pentacam® AXL. Since the Galilei G4 Dual Scheimpflug Analyzer and Galilei G6 Lens Professional are identical except that the Galilei G6 Lens Professional has an additional EBR Module for measuring axial length, only the Galilei G6 Lens Professional and the Pentacam® AXL were included in the study. The primary objectives of this clinical study were to:
- evaluate the inter-device repeatability, inter-operator repeatability and reproducibility of the 1. GALILEI G6 Lens Professional in repeated measurements of anterior segment geometry and axial intraocular distances and,
-
- demonstrate substantial equivalence through examining agreement of the GALILEI G6 Lens Professional measurements to those of the Pentacam® AXL.
Studv design:
The clinical study was a prospective, observational, one-center study. Of the total 117 enrolled and measured subjects, 12 subjects were discontinued from the study because they required repeat measurements that would have exceeded the recommended maximum number of daily measurements for patient safety and per protocol. Reasons for discontinuation included dense cataract, inability to hold gaze, see the fixation target or keep the eye open during the measurement, and excessive head or eve movements, all of which prevented extensive data collection with PAXL and Galliei G6.
The mean age of the subjects involved in this study was 40.7±16.3 years. A total of 105 eyes of 105 subjects were assessed, 49 being right eyes and 56 being left eyes. Only one eye of each subject
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-
- normal eyes (phakic eyes without cataracts or corneal disease),
-
- eyes with varying degrees of cataract,
- eves with high myopia. 3)
-
- eyes with high hyperopia,
-
- eves with post-keratorefractive surgery condition.
Additional 5 analyzed eyes consisted of 2 eyes with severe keratoconus and 3 eyes with prior crosslinking treatment. Of the 105 assessed subjects, 63 were males and 42 were females. Ethnicity was composed of 100 Non-Hispanics and 5 Hispanics. Race consisted of 98 Whites, 5 Asians, and 2 American/Alaskan Natives. The 20 patients with cataract who completed all measurements included not only eyes with moderate cataract, but also eyes with severe cataract with grades as high as 4 in the Lens Opacification Classification System (LOCS) III, in order to ensure that cataracts of various severity grades, particularly of severe cataract, can be accurately and precisely assessed with the Galilei G6 In the LOCS III, cataract severity ranges from grade 1 (very early stage) to grade 5 (severe).
Results:
- In terms of agreement, the Galilei G6 demonstrates substantially equivalent performance to the predicate device, except for WtW.
- . WtW is known to be different between state-of-the-art devices, and device specific offsets are commonly used in clinical practice to account for inter-device differences. Inter-device differences between the state-of-the-art devices and Galilei G6 are substantially equivalent to those between state-of-the-art devices and the PAXL.
- Repeatability and reproducibility attained with the Galilei G6 are substantially equivalent to ● those attained with the PAXL.
- . Minor technological differences between the Galilei G6 and the Pentacam AXL raise no new issues of safety or effectiveness.
- . No adverse effects and complications were observed or are to be expected.
Summary:
Performance data demonstrates that the Galilei G6 Lens Professional is as safe and effective as the predicate device, the Pentacam® AXL. Minor technological differences between the Galilei G6 and the predicate device raise no new issues of safety or effectiveness. No adverse effects or complications were observed or are to be expected.
In-house Precision Testing: Results
An internal clinical study was conducted
- to evaluate precision in terms of repeatability (intra-device, intra-operator) and reproducibility (inter-1) device, inter-operator) of the GALILEI G6 Lens Professional for repeated measurements and
-
- to compare the precision of the Galilei G6 Lens Professional to the reported values of the Pentacam® AXL for normal eyes.
Anterior segment geometry and axial intraocular distances under assessment included:
-
- AL
-
- ССТ
-
- R flat
-
- R steep
-
- Rm
-
- CC
-
- A flat
-
- ACD
-
- WtW
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Repeatability in this study was defined as the variation in measurements within the Galilei G6 across 3 repeated measurements for a given device and operator. The values in Table 3 illustrate that expected differences when taking another measurement by the same operator using the same device are less than 1%, except for CC (8.79%) and A flat (3.79%), which indicates high repeatability for most parameters.
Repeatability CV values are generally comparable to those with the PAXL (Table 4). Small differences where the repeatability CV with the PAXL is smaller than that with the Galilei G6 are clinically irrelevant, because they translate to refractive differences below 0.17D (=1/6 of a diopter = optical infinity = vergence from a distance of 6 meters that is perceived as coming from infinity), i.e. below the minimum defocus that is discernible to the human eye. In consideration of Gullstrand's #1 schematic eye [1], having an anterior corneal radius of curvature of 7.7mm and a corneal refractive index of 1.376, a difference of 0.01mm, for example, in anterior curvature corresponds to a difference in anterior corneal power of less than 0.07 diopters. The repeatability SD value of 0.11D for CC corresponds to the repeatability SD values reported in literature studies with Pentacam HR and other corneal topographers and keratometers on the market.
| Measure | Number of
subjects | Mean | Repeatability | | Reproducibility | |
|--------------|-----------------------|-------|---------------|--------|-----------------|--------|
| | | | SD | CV [%] | SD | CV [%] |
| AL [mm] | 12 | 23.91 | 0.02 | 0.08 | 0.02 | 0.08 |
| CCT [um] | 12 | 578 | 4.50 | 0.78 | 6.79 | 1.17 |
| R flat [mm] | 12 | 7.84 | 0.02 | 0.21 | 0.02 | 0.28 |
| R steep [mm] | 12 | 7.62 | 0.02 | 0.21 | 0.02 | 0.27 |
| Rm [mm] | 12 | 7.72 | 0.01 | 0.16 | 0.02 | 0.24 |
| CC [D] | 12 | 1.27 | 0.11 | 8.79 | 0.11 | 8.98 |
| A flat [deg] | 12 | 90 | 3.40 | 3.79 | 3.44 | 3.85 |
| ACD [mm] | 12 | 3.54 | 0.03 | 0.85 | 0.03 | 0.86 |
| WtW [mm] | 12 | 12.26 | 0.03 | 0.21 | 0.03 | 0.24 |
Table 3: Repeatability and reproducibility with the Gallei G6 in normal eyes (all three Gallei devices combined)
Table 4: Repeatability and reproducibility with the PAXL in normal eyes, as reported in K152311
| Measure | Number of
subjects | Mean | Repeatability | | Reproducibility | |
|--------------|-----------------------|-------|---------------|--------|-----------------|--------|
| | | | SD | CV [%] | SD | CV [%] |
| AL [mm] | 40 | 23.78 | 0.03 | 0.10 | 0.03 | 0.13 |
| CCT [um] | 40 | 550 | 4.00 | 0.67 | 5.00 | 0.90 |
| R flat [mm] | 40 | 7.85 | 0.02 | 0.15 | 0.017 | 0.21 |
| R steep [mm] | 40 | 7.69 | 0.02 | 0.15 | 0.018 | 0.23 |
| Rm [mm] | 40 | 7.77 | 0.01 | 0.13 | 0.015 | 0.19 |
| CC [D] | 40 | 0.92 | 0.07 | 7.68 | 0.10 | 10.84 |
| A flat [deg] | 40 | 102 | 4.90 | 4.76 | 6.35 | 6.22 |
| ACD [mm] | 40 | 3.53 | 0.02 | 0.61 | 0.026 | 0.75 |
| WtW [mm] | 40 | 11.8 | 0.04 | 0.37 | 0.08 | 0.70 |
Under the assumption of the same study design with the PAXL (3 devices, 3 measurements) repeatability CV values with the Gallei G6 as assessed with three different operators using three Galilei devices in normal eyes are consistent with those reported with the PAXL.
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VIII. CONCLUSIONS
The Galilei G6 Lens Professional, being identical to the first predicate device in all common functions, the Galilei G4 Dual Scheimpflug Analyzer, was found to be substantially equivalent to the second predicate device, the Pentacam® AXL. The non-clinical data support the safety of the device, and the hardware and software verification and validation demonstrate that the Galilei G6 Lens Professional should perform as intended in the specified use conditions. The clinical data demonstrate that the Galilei G6 Lens Professional performs substantially equivalently to the predicate devices that are currently marketed for the same intended use.