LIPIVIEW OCULAR SURFACE INTERFEROMETER

K091935 · Tearscience, Inc. · HKI · Oct 23, 2009 · Ophthalmic

Device Facts

• Record ID: K091935
• Device Name: LIPIVIEW OCULAR SURFACE INTERFEROMETER
• Applicant: Tearscience, Inc.
• Product Code: HKI · Ophthalmic
• Decision Date: Oct 23, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1120
• Device Class: Class 2

Intended Use

The LipiView® Ocular Surface Interferometer is an ophthalmic imaging device that is intended for use by a physician in adult patients to capture, archive, manipulate and store digital images of specular (interferometric) observations of the tear film, which can be visually monitored and photographically documented.

Device Story

LipiView Ocular Surface Interferometer is a bench-top ophthalmic imaging device used by physicians in clinical settings. It utilizes white light interferometry to capture real-time video of tear film dynamics via specular reflection. The device includes a chin/forehead rest, camera, zoom lens, illuminator, and touch screen. It records interference patterns as the tear film distributes across the cornea during blinking. The system processes these inputs to provide an interferometric color assessment of the tear film. Output consists of digital video images and reports displayed on a monitor or printed, allowing physicians to monitor and document ocular surface conditions. This aids in clinical decision-making regarding tear film health. The device does not contact the patient's eye.

Clinical Evidence

Bench testing only. The device underwent performance testing for optical radiation safety, electrical safety, electromagnetic compatibility, and material flammability. Software was validated in compliance with FDA guidance. No clinical trial data was required or presented for this 510(k) clearance.

Technological Characteristics

Bench-top imaging device; Class I white LED illumination with diffuser; digital camera; Microsoft Windows-based software; touchscreen interface; chin/forehead rest support. Materials near light source comply with UL 94V-1. Operates on AC power. Complies with ISO 15004-2 (Group 1) for optical radiation safety. Connectivity includes printer support and image storage drives.

Indications for Use

Indicated for adult patients requiring ophthalmic imaging of the tear film for visual monitoring and photographic documentation of specular (interferometric) observations.

Regulatory Classification

Identification

An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.

Special Controls

*Classification.* Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, 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

• OphthaVision Imaging System (K980295)
• Tearscope-Plus (K973064)

Submission Summary (Full Text)

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K691935

### 510(k) SUMMARY

| PREPARATION DATE: | September 30, 2009 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| APPLICANT: | TearScience, Inc.<br>1101G Aviation Parkway<br>Morrisville, NC 27560<br>Tel: [phone]<br>Fax: [phone] |
| | OCT 23 2009 |
| CONTACT PERSON: | Christy Stevens, OD<br>Vice President, Clinical and Regulatory Affairs |
| DEVICE TRADE NAME: | LipiView® Ocular Surface Interferometer |
| COMMON NAME: | Ophthalmic Imaging Device |
| CLASSIFICATION NAMES: | Ophthalmic Camera (21 CFR 886.1120) and<br>AC-powered Slit Lamp Biomicroscope (21 CFR 886.1850) |
| DEVICE CLASSIFICATION: | Class II |
| PRODUCT CODES: | HKI and HJO |
| PREDICATE DEVICES: | 1. OphthaVision Imaging System, MRP Group, Inc.<br>(K980295; cleared May 19, 1998;<br>Product Code HKI; 21 CFR 886.1120; Class II) |
| | 2. Tearscope-Plus, Keeler Instruments, Inc.<br>(K973064; cleared April 7, 1998;) |

#### DEVICE DESCRIPTION:

The LipiView® Ocular Surface Interferometer is a bench-top imaging device containing a computer system and electronics, chin rest and forehead rest, camera and zoom lens, illuminator and a touch screen display. The LipiView® Interferometer operates on the principle of white light interferometry and provides an interferometry color assessment of the tear film by specular reflection. The computer system captures a video image file that is recorded over time since the interference pattern changes as the tear film is distributed across the cornea during blinking. The video image of the ocular surface may be viewed on the computer screen display and in a printed report.

#### INTENDED USE

The LipiView® Ocular Surface Interferometer is an ophthalmic imaging device that is intended for use by a physician in adult patients to capture, archive, manipulate and store digital images of specular (interferometric) observations of the tear film, which can be visually monitored and photographically documented.

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#### SUBSTANTIAL EQUIVALENCE TO THE PREDICATE DEVICES

The intended use and technologic characteristics of the LiviView Interferometer are substantially equivalent to the OphthaVision Imaging System (K980295) and Tearscope-Plus (K973064). All three devices are prescription devices for imaging use by a physician during an in-office exam.

The LipiView Interferometer and the OphthaVision Imaging System are intended to capture, archive, and manipulate digital images of the imaging focal plane with the LipiView Interferometer is at the ocular surfacc and tear film, whereas the OphthaVision Imaging System can be used for intraocular imaging. Both devices provide a means to store digital images to allow a physician to monitor and photographically document conditions.

The LipiView® Ocular Surface Interferometer has similar technological characteristics to the OphthaVision Imaging System. Both devices use a digital camera. Microsoft Windows-based software, computer, monitor, graphical user interface, user controls, printer support, image storage drives, and AC power source. Both devices allow the user to select functions to process, analyze, archive and retrieve images. Analogous software features include image enhancement, alignment, comparison, animation, capture/save and print. The two devices store data in a similar Lossless file format,

Furthermore, the LipiView Interferometer and the Tearscope-Plus have the same intended use to observe the tear film by specular reflection. Both devices allow the physician to observe tear film. The LipiView® Interferometer has similar technological characteristics to the Tearscope-Plus. Both devices use a diffuser and low-level white light to illuminate the eye on an angle and view real-time tear film dynamics. Both devices show the interference patterns for evaluation of the colors observed in the tear film. The LipiView Interferometer and Tearscope-Plus are required to meet optical radiation safety standards.

The LipiView® Interferometer, OphthaVision Imaging System and Tearscope-Plus are all AC-powered devices that are required to meet electrical safety and electromagnetic compatibility standards. All three devices do not contact the patient's eye.

The LipiView Interferometer includes a chin rest support system to position the patient's head during imaging, whereas the OphthaVision Imaging System and the f earscope-Plus are used with a slit lamp biomicroscope that provides a chin rest support to position the patient's head. The chin rest support materials for the LipiView Interferometer are widely used in ophthalmic slit lamp biomicroscopy products and are known for biocompatibility. Therefore, this difference does not raise new questions of safety and effectiveness. In addition, the LipiView® Ocular Surface Interferometer conforms to disinfection of patient contact surfaces for slit lamp biomicroscopes.

Minor differences in technology between the predicate devices and the LipiView Interferometer do not raise new questions of safety and effectiveness and are supported by performance testing to applicable standards and software verification and validation. Table 5-1 compares the LipiView® Interferometer to the predicate devices.

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#### PERFORMANCE TESTING:

The LipiView® Ocular Surface Interferometer conforms to the requirements under the applicable standards for slit lamp biomicroscopes; optical radiation safety; electrical safety; and material flammability. In addition, the LipiView® Interferometer is designed and will be manufactured in compliance with voluntary consensus standards for risk management and quality management systems. The LipiVicw Interferometer software was developed and tested in compliance with FDA Guidance documents for software validation in medical devices.

#### CONCLUSIONS:

The LipiView® Ocular Surface Interferometer has comparable intended use and technologic characteristics to the predicate devices. Minor technological differences between the LipiView® Interferometer and the predicate devices do not raise new questions of safety and effectiveness and are supported by performance testing, TearScience has demonstrated through its evaluation of the LipiView Ocular Surface Interferometer that the device is substantially equivalent to the predicate devices.

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| Comparison Feature | LipiView® Ocular Surface Interferometer (K980295) | OphthaVision Imaging System (K980295) | Tearscope-Plus (K973064) |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Indications For Use | The LipiView® Ocular Surface Interferometer is an ophthalmic imaging device that is intended for use by a physician in adult patients to capture, archive, manipulate and store digital images of specular (interferometric) observations of the tear film, which can be visually monitored and photographically documented. | The OphthaVision Imaging System is intended for use to capture, archive, and manipulate digital images of the eye obtained through use of an ophthalmic camera. | Specular observation of the tear film |
| Prescription/OTC Device | Prescription diagnostic | Prescription diagnostic | Prescription diagnostic |
| Method of Operation<br>Ophthalmic Imaging | Ophthalmic camera with digital imaging system<br>Graphical User Interface<br>Touchscreen user control<br>Microsoft Windows-based software | Ophthalmic camera with digital imaging system<br>Graphical User Interface<br>Mouse, keyboard and joystick user controls<br>Microsoft Windows-based software | No software imaging capability |
| Method of Operation<br>Tear Film Observation | Real-time tear film dynamics based on interference pattern from specular reflection<br>Provides isolated tear film view and interferometric color analysis | None | Real-time tear film dynamics based on interference pattern from specular reflection |
| Illumination<br>Source | Angled Class I white LEDs with diffuser | No direct illumination source<br>Used with a slit lamp for illumination | Angled cold cathode light with diffuser<br>May be used with a slit lamp, which provides additional illumination |
| Exposure Parameters | Illuminates lower half of eye<br>Exposure and level of illumination complies with ISO 15004-2 Group 1 instrument for safety | Not applicable | Illuminates full eye including pupil<br>Exposure level not specified<br>Required to comply with safety standard |
| Brightness Control | No brightness control adjustment by user | Not applicable | High and low level brightness control |
| Material Flammability | Materials near light source comply with UL 94V-1 | Not applicable | Not specified |
| Maximum Temperature of<br>Held or Accessible Parts | Ambient temperature of parts of device held by operator or accessible to patient | Not applicable | Ambient temperature of parts of device held by operator or accessible to patient |

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol featuring a staff with two snakes entwined around it. The caduceus is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

Christy Stevens, OD VP, Clinical & Regulatory Affairs Tearscience, Inc. 1101 G Aviation Parkway Morrisville, NC 27560

Re: K091935

Trade/Device Name: LipiView Ocular Surface Interferometer Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: II Product Code: HKI, HJO Dated: October 5, 2009 Received: October 6, 2009

Dear Dr. Stevens;

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

OCT 2:3 2009

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Rulthim, m for
Melvin R. Fuhrman, M.D.

Malvina B. Eydelman, M Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE

510(k) Number:

K091935

Device Name: LipiView® Ocular Surface Interferometer

Indications for Use:

The LipiView® Ocular Surface Interferometer is an ophthalmic imaging device that is intended for use by a physician in adult patients to capture, archive, manipulate and store digital images of specular (interferometric) observations of the tear film, which can be visually monitored and photographically documented.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rostase

Page of

(Division Sign-Off) (Division Sign-DIT)
Division of Ophthalmic, Neurological and Ear,
Division of Ophthalmic, Neurological and Ear, Division.
Nose and Throat Devices

\$\qquad k07,935\$

510(k) Number