NON-CONTACT TEAR FILM THERMOGRAGH

K111771 · United Integrated Services Co., Ltd. · HKI · Nov 30, 2011 · Ophthalmic

Device Facts

• Record ID: K111771
• Device Name: NON-CONTACT TEAR FILM THERMOGRAGH
• Applicant: United Integrated Services Co., Ltd.
• Product Code: HKI · Ophthalmic
• Decision Date: Nov 30, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1120
• Device Class: Class 2

Intended Use

The UIS Non-Contact Thermograph System is an ophthalmic imaging device that stores, archives, and manipulates digital images of ocular surface temperature measurements taken by a physician in adult patients.

Device Story

The UIS Non-Contact Thermograph System (IT-85) is an ophthalmic imaging device used by physicians to measure and record ocular surface temperature. The patient positions their chin and forehead on a bracket and fixates on the camera; the system captures thermal radiation from the ocular surface without an illumination source. The device stores, archives, and manipulates these digital thermal images. Operation is controlled via keypad, keyboard, or mouse. The system provides thermal pattern data to assist the physician in clinical assessment. It is intended for use in a clinical setting.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Ophthalmic imaging system; thermal sensor for temperature measurement; passive thermal radiation detection (no illumination source); keypad/keyboard/mouse interface; AC-powered; Class II device.

Indications for Use

Indicated for adult patients requiring ocular surface temperature measurement and imaging by a physician.

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

• LipView Ocular Surface Interferometer (K091935)

Submission Summary (Full Text)

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K111771

NOV 3 0 2011

# II. 510(K) Summary of Safety and Effectiveness (Per 21 CFR 807.92)

### 2.1. General Information Establishment

- . Manufacturer: United Integrated Service Co., Ltd.
- Address: 5F, No. 3, Lane 7, PaoKao Road, Hsintein, New Taipei City, 23144, Taiwan
- Owner Number: 9049882
- 1 Contact Person: Dr. Jen, Ke-Min E-mail: [e-mail] 886-3-5208829 (Tel); 886-3-5209783 (Fax) Address: No.58, Fu Chiun Street, Hsin Chu City, 30067, Taiwan, ROC
- . Date Prepared: June 18, 2011

### Device

ﺎ

- . Proprietary Name: United Integrated Non-Contact Thermograph System Model: IT-85
- Common Name: Opthalmic Camera
- . Classification Name: Camera, Ophthalmic, Ac-Powered, Class II
- . Product Code: HKI

## 2.2. Safety and Effectiveness Information

#### . Predicate Device:

Claim of Substantial Equivalence (SE) is made to LipView Ocular Surface Interferometer (K091935)

- . Device Description: The ocular surface temperature is measured by the thermal sensor of the thermograph system. The subject places his/her chin and forehead to the measuring bracket. Keep both eyes on the camera of the thermograph system. Listen to the voice instruction to close and open his/her eyes for recording the temperature variation of his/her ocular surface.
#### ● Intended Use:

The UIS Non-Contact Thermograph System is an ophthalmic imaging device that stores, archives, and manipulates digital images of ocular surface temperature measurements taken by a physician in adult patients.

#### ● Substantial Equivalence (SE)

A claim of substantial equivalence is made to LipView Ocular Surface Interferometer (K091935). Both of them have the similar working principle and technologies. The major differences for the two devices are the subject device is controlled by the keypad buttons or keyboard, and mouse user control; and the predicate device is touch screen user control. Especially, the real-time dynamics of the subject device is based on thermal pattern from the direct radiation of

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ocular surface, thus it has no illumination source; but the predicate device is based on interference pattern from specular reflection which has the angled class I white LEDs with diffuser to illuminate lower half of eye. The differences are due to the feature design aspects, not relating to the safety or effectiveness aspects. They are substantially equivalent.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes forming its body and wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

United Integrated Service Co., Ltd. c/o Dr. Ke-Min Jen Official Correspondent No. 58, Fu Chiun Street Hsin Chu City, TW-HSO China (Taiwan) 30067

NOV 3 0 2011

Re: K111771

Trade/Device Name: Non-Contact Thermograph System. IT-85 Regulation Number: 21 CFR 886.1120 Regulation Name: Camera, ophthalmic, AC-powered Regulatory Class: Class II Product Code: HKI Dated: November 2, 2011 Received: November 16, 2011

Dear Dr. Jen:

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

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Dr. Ke-Min Jen

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.

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/CDRH/CDRHOffices/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 vours.

Kesia Alexander

for

Malvina B. Eydelman, M.D. 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 ( If Known ):__K111771 Device Name: _Non-Contact Thermograph System, IT-85

Indications for Use:

The UIS Non-Contact Thermograph System is an ophthalmic imaging device that stores, archives, and manipulates digital images of ocular surface temperature measurements taken by a physician in adult patients.

Prescription Use __ V (21 CFR Part 801 Subpart D)

AND/OR

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dor Callaway

Pixsion Sign-Off Division of Ophthalmic, Neurological and ear, Nose and Throat Devices

510(k) K111771

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