Pentacam AXL Wave

K201724 · Oculus Optikgerate GmbH · MXK · Oct 21, 2020 · Ophthalmic

Device Facts

• Record ID: K201724
• Device Name: Pentacam AXL Wave
• Applicant: Oculus Optikgerate GmbH
• Product Code: MXK · Ophthalmic
• Decision Date: Oct 21, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1850
• Device Class: Class 2

Intended Use

The Pentacam AXL Wave is intended to image the anterior segment of the eye which includes the cornea, pupil, anterior chamber and lens. It is indicated for the evaluation of corneal shape, condition of the lens (opaque crystalline lens), the anterior chamber angle, anterior chamber depth, the volume of the anterior chamber, anterior or posterior cortical opacity, the location of cataracts using cross slit imaging with densitometry, corneal thickness, axial length, white-to-white distance, optical aberrations of the eye, and retroillumination imaging. The Pentacam AXL Wave also performs calculations to assist physicians in determining the power of the intraocular lens for implantation.

Device Story

Device images anterior eye segment (cornea, pupil, anterior chamber, lens) using rotating Scheimpflug camera; captures 100 images in <2 seconds; generates 3D model of anterior segment. Integrates Michelson interferometer for axial length measurement and Hartmann-Shack aberrometer for optical aberration assessment. Retroillumination imaging uses slit-lamp illumination method. Operated by clinicians in clinical settings. Data transmitted to connected PC for analysis and display. Physician uses 3D models and measurements to determine IOL power for cataract surgery. Benefits include comprehensive diagnostic data for surgical planning and post-op assessment.

Clinical Evidence

Bench testing only. Compliance with IEC 60601-1, IEC 60601-1-2, ISO 15004-1, ISO 15004-2, ISO 22665, and IEC 60825-1. Software verification and validation performed.

Technological Characteristics

Scheimpflug camera (CMOS), Michelson interferometer (880 nm SLD), Hartmann-Shack aberrometer, and slit-lamp retroillumination. IR LEDs (810 nm) for illumination. Connectivity via PC. Class II device. Software-based 3D modeling and densitometry analysis.

Indications for Use

Indicated for evaluation of corneal shape, lens condition (opaque crystalline lens), anterior chamber angle/depth/volume, cortical opacity, cataract location, corneal thickness, axial length, white-to-white distance, optical aberrations, and retroillumination imaging in patients requiring anterior segment assessment and IOL power calculation.

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

• Pentacam AXL (K152311)
• VX120 (K143086)

Submission Summary (Full Text)

{0}------------------------------------------------

October 21, 2020

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

OCULUS Optikgerate GmbH % Randy Prebula Partner Hogan Lovells, US LLP 555 Thirteenth Street, NW Washington, District of Columbia 20004

Re: K201724

Trade/Device Name: Pentacam AXL Wave Regulation Number: 21 CFR 886.1850 Regulation Name: AC-Powered Slitlamp Biomicroscope Regulatory Class: Class II Product Code: MXK, HJO Dated: September 18, 2020 Received: September 18, 2020

Dear Mr. Prebula:

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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for

{1}------------------------------------------------

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Elvin Ng Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K201724

Device Name Pentacam AXL Wave

#### Indications for Use (Describe)

The Pentacam AXL Wave is intended to image the anterior segment of the eye which includes the cornea, pupil, anterior chamber and lens. It is indicated for the evaluation of

- corneal shape,
- condition of the lens (opaque crystalline lens),
- the anterior chamber angle,
- anterior chamber depth,
- the volume of the anterior chamber,
- anterior or posterior cortical opacity,
- the location of cataracts using cross slit imaging with densitometry,
- corneal thickness,
- axial length,
- white-to-white distance.
- optical aberrations of the eye,
- and retroillumination imaging.

The Pentacam AXL Wave 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)

| <span style="font-family: Arial;"> <span style="font-size: 10pt;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> </span> |
|---------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial;"> <span style="font-size: 10pt;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> </span> |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

## 510(k) SUMMARY

### OCULUS Pentacam AXL Wave

#### General Information

## Applicant:

OCULUS Optikgeräte GmbH Müncholzhäuserstr. 29 35582 Wetzlar Germany Phone: [phone] [phone] Fax:

#### Contact Person:

Mr. Eckhard Loh Head of Quality and Regulatory Affairs OCULUS Optikgeräte GmbH Müncholzhäuserstr. 29 35582 Wetzlar Germany Phone: [phone] Fax: [phone]

Summary Prepared: October 20, 2020

# Device Information

| Classification Name: | Device, analysis, anterior segment<br>(AC-powered slitlamp biomicroscope,) |
|-----------------------|----------------------------------------------------------------------------|
| Trade/Propriety Name: | Pentacam AXL Wave |
| Common Name: | Ophthalmic biomicroscope |
| Regulation Number: | 21 C.F.R. § 886.1850 |
| Device class: | II |
| Product Code: | MXK, HJO |

#### Predicate Devices

| Primary Predicate: | OCULUS Optikgeräte GmbH, Pentacam AXL (K152311 |
|----------------------|------------------------------------------------|
| Secondary Predicate: | LUNEAU SAS, VX120 (K143086) |

{4}------------------------------------------------

# Intended Use / Indications for Use

The Pentacam AXL Wave is intended to image the anterior segment of the eye which includes the cornea, pupil, anterior chamber and lens. It is indicated for the evaluation of

- corneal shape,
- condition of the lens (opaque crystalline lens),
- the anterior chamber angle,
- anterior chamber depth,
- the volume of the anterior chamber,
- anterior or posterior cortical opacity,
- the location of cataracts using cross slit imaging with densitometry,
- corneal thickness,
- axial length,
- white-to-white distance,
- optical aberrations of the eve.
- and retroillumination imaging. ●

The Pentacam AXL Wave also performs calculations to assist physicians in determining the power of the intraocular lens for implantation.

# Product Description/Technological Characteristics

The Pentacam AXL Wave is intended to image the anterior segment of the eye to measure eye components, such as corneal thickness, anterior chamber depth, corneal cylinder, corneal cylinder axis and white-to-white-distance. The axial length of the eye can be measured by a built-in interferometer. An also integrated aberrometer can determine the optical aberrations of the eye. By using retroillumination imaging, the back-lit eye can be observed.

The measured parameters can be used by physicians to calculate the power of the intraocular lens (IOL) implanted during a cataract surgery.

While rotating around the eve. the Pentacam AXL Wave captures Scheimpflug images of the anterior eye segment through varying axes. The Scheimpflug images created during an examination are transmitted to a connected PC.

Scheimpflug images can be captured within maximum of two seconds. Up to 138,000 genuine height values are measured and analyzed from the Scheimpflug images.

The Scheimpflug images are the basis for the height data which are used to calculate a mathematical 3D model of the anterior eye segment.

The mathematical 3D model, corrected for eye movements, provides the basis for all subsequent analysis.

The axial length of the eye is measured by interferometry measurements are done by a common Hartmann-Shack-Aberrometer. The retroillumination works similar to the illumination method of slit-lamps.

{5}------------------------------------------------

# New features in the device

The Pentacam AXL Wave combines the functions of the cleared Oculus Pentacam AXL device (K152311) with aberrometry measurements done by a common Hartmann-Shack-Aberrometer and retroillumination which works like the respective illumination method of slit-lamps. The new capabilities (aberrometry measurement and retroillumination imaging) are "add-ons" to the functionality of the Pentacam AXL that do not modify or impact the other capabilities in any way.

The Pentacam AXL Wave has functions subject to FDA premarket review as well as exempted functions that are not subject to FDA premarket review ("optical aberration of the eye" and "retroillumination imaging"). For these applications. FDA assessed those functions only to the extent that they could adversely impact the safety and effectiveness of the functions subject to FDA premarket review.

# Performance Testing

EMC and electrical safety of the subject devices were evaluated using the following consensus standards: IEC 60601-1; IEC 60601-1-2.

Testing was also performed in accordance with ISO 15004-1, ISO 15004-2, ISO 22665 and IEC 60825-1 to demonstrate compliance with these standards.

Software verification and validation testing has also been performed.

# Substantial Equivalence Discussion

As explained in detail below, the Pentacam AXL Wave is substantially equivalent to other legally marketed Scheimpfluq imaging devices and optical aberrometers. Specifically, the Pentacam AXL Wave is substantially equivalent to the Pentacam AXL (K152311) and the Visionix VX120 (K143086).The Pentacam AXL Wave has the same general intended use and similar indications, technological characteristics, and principles of operation as the previously cleared predicates. A substantial equivalence chart comparing the similarities and differences between the Pentacam AXL Wave and its predicate devices is provided at the end of this section, below. As explained in more detail below, minor differences in the technological characteristics do not raise new questions of safety or efficacy. Bench and clinical testing demonstrate that the Pentacam AXL Wave is as safe and effective as its predicate devices.

# Intended Use/ Indications for Use

The Pentacam AXL Wave has the same intended use as the predicate Pentacam AXL device, with the only difference being the addition of the ability to evaluate optical aberration of the eye and conduct retroillumination imaging. These additional functionalities are similar to the indications identified for the other predicate device. VX120.

The cleared Pentacam AXL and VX120 are also indicated to perform measurements and calculations. The Pentacam AXL Wave is further indicated for performing all these measurements in one device. The minor differences in the way that the indications are described do not alter the intended use of the device by creating a new intended therapeutic, diagnostic, prosthetic, or surgical

{6}------------------------------------------------

use of the device compared to the predicates. These measurements are substantially equivalent to the indications for the cleared Oculus Pentacam AXL device and LUNEAU VX120.

As described below, each of the measurements for the Pentacam AXL Wave device are performed individually and are substantially equivalent in terms of technology, safety and performance to two identified predicates. The subject Pentacam AXL Wave thus meets the first requirement for establishing substantial equivalence.

# Technological Characteristics

The Pentacam AXL Wave combines the measurement capabilities of the cleared Oculus Pentacam AXL and the cleared VX120.

The combination of the two predicate devices' cleared technologies in one device does not impact the ability of either technology to operate per its separate intended use. As explained in more detail below, the Scheimpflug camera and optical interferometer of the Pentacam AXL Wave still operates in fundamentally the same manner as the Pentacam AXL and are not interfered with as a result of the additional functionalities.

Further, the Hartman-Shack aberrometer and retro-illuminator are fundamentally the same as the same features that are incorporated into the VX120. Because each technological component has already been used for the same purposes as used in the subject device, and the technological characteristics operate independently without interference from the other technological features, no new or different questions of safety or effectiveness are raised by the subject device.

The Pentacam AXL Wave and the VX120 both serve the function of wavefront aberrometer by using a Hartman-Shack aberrometer.

Both systems measure an optical wavefront using a wavefront sensor (Hartman-Shack sensor).

The Pentacam AXL Wave and the VX120 also serve the function of retroillumination by using illumination method of a slit-lamp biomicroscope.

The Pentacam AXL Wave also performs measurements of the corneal shape and cataracts, similarly to the cleared Pentacam AXL. Both the Pentacam AXL Wave and the Pentacam AXL use a digital camera with comparable resolution and the Scheimpflug principle to photograph the anterior segment of the eye and use the photographs to generate data and measurements about the eye.

Both devices also use IR LEDs for eye illumination, blue slit lamps with a slit slight of 14 mm as the light source for slit illumination, and a digital CMOS camera as the overview camera.

Minor differences, such as the spherical measurement range, which is reduces from -20D to +20D in the predicate device to -10D to +6D for the subject device, do not raise new questions of safety and effectiveness because the measurement range continues to be appropriate for the relevant patient group that is to be measured using the device.

The Pentacam AXL Wave and the Pentacam AXL use similar Pentacam software to display the measurements and three-dimensional displays. The software has been modified since the

{7}------------------------------------------------

clearance of the Pentacam AXL to display the additional measurements gained from the added wavefront aberrometer measurements and retro illumination.

Overall, the Pentacam AXL Wave has substantially equivalent technological characteristics to the predicate devices. The differences between the subject device and the cleared predicates are minor, and bench and clinical tests have confirmed the safety and effectiveness of the new device in achieving the indications for use.

| Device Type | Subject device | Predicate device<br>(Scheimpflug imaging, axial length, etc.) |
|-------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Model | Pentacam AXL Wave | Pentacam AXL |
| Manufacturer name | OCULUS Optikgeraete GmbH | OCULUS Optikgeraete GmbH |
| 510(k) Number | TBD | K152311 |
| | The Pentacam AXL Wave is intended to image the anterior segment of the eye which includes the cornea, pupil, anterior chamber and lens. It is indicated for the evaluation of corneal shape, condition of the lens (opaque crystalline lens), the anterior chamber angle, anterior chamber depth, the volume of the anterior chamber, anterior or posterior cortical opacity, the location of cataracts using cross slit imaging with densitometry, corneal thickness, axial length, white-to-white distance, optical aberrations of the eye, and retroillumination imaging. | The Pentacam AXL is designed to take photos of the anterior segment of the eye which includes the 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 imaging with densitometry, corneal thickness, axial length (by optical biometry), white-to-white distance. |
| | The Pentacam AXL Wave 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 |
| Scheimpflug Camera | Digital CMOS camera | Digital CCD camera |
| Resolution of<br>Scheimpflug camera | 1392x1040 pixel | 1392x1040 pixel |
| Slit length | 14 mm | 14 mm |
| Slit width | 35 μm | 35 μm |
| Light source for slit<br>illumination | Blue slit lamp (LED 470 nm) | Blue slit lamp (LED 470 nm) |
| Light source for eye<br>illumination | 4 IR LEDs (810 nm) | 4 IR LEDs (810 nm) |
| Device Type | Subject device | Predicate device<br>(Scheimpflug imaging, axial length, etc.) |
| Images | 100 in 2 seconds | 100 in 2 seconds |
| Rotation | 360° | 360° |
| Measuring points | up to 138,000 | up to 138,000 |
| Working distance | 80 mm | 80 mm |
| Physical principle | Scheimpflug principle / Optical<br>interferometer | Scheimpflug principle / Optical<br>interferometer |
| Calculation principle | Edge detection and 3D regression<br>polynomial functions; detection of<br>interference pattern and consideration of<br>mirror position | Edge detection and 3D regression<br>polynomial functions; detection of<br>interference pattern and consideration of<br>mirror position |
| Auto release function | Yes | Yes |
| Auto movement system | No | No |
| Fixation light | Yes, red LED (640 nm) | Yes, red LED (640 nm) |
| Overview camera | Digital CMOS camera | Digital CMOS camera |
| Resolution of overview<br>camera | 1280 x 960 | 640 x 480 |
| Measurement range -<br>Axial length | 14 – 40 mm | 14 – 40 mm |
| Light source for<br>interferometer | IR Super luminescence diode (SLD) | IR Super luminescence diode (SLD) |
| Wavelength | 880 nm | 880 nm |
| SLD-Power for<br>measurement | 0.7 mW | 0.84 mW |
| SLD-Power for<br>alignment | None | None |
| Pulse width | 520 ms | 400 ms |
| IEC 60825-1<br>classification | Class 1 laser product | Class 1 laser product |
| Embedded laser class<br>(not accessible) | 3R | 3R |
| White-to-white<br>measurement principle | Analysis of overview image | Analysis of overview image |
| Power supply | External PSU: | External PSU: |
| | HMEG49 Medical power adapter<br>Input: 90- 264 V AC: 47 – 63 Hz<br>Output: 24 V DC, 2.1 A | HMEG49 Medical power adapter<br>Input: 90- 264 V AC: 47 - 63 Hz<br>Output: 24 V DC, 2.1 A |
| Power consumption | max 35 W | max 35 W |
| Protection class | 2 | 2 |
| Protection type | IP20 | IP20 |
| Device type | B | B |
| Dimensions | 278 x 320-400 x 502-532 mm (WxDxH) | 274 mm x 316 mm x 500-530 (WxDxH) |
| Weight | 9 kg (only measuring head) | 13.2 kg |
| Technological Characteristics with the Relevant Predicate Device) | | |
| Device Type | Applicant device | Predicate device<br>(Aberrometry, retroillumination imaging) |
| Model | Pentacam AXL Wave | VX120…