OIS EYESCAN PORTABLE MODULAR IMAGING SYSTEM, MODEL OIS EYESCAN

K092374 · Ophthalmic Imaging Systems · HKI · Nov 17, 2009 · Ophthalmic

Device Facts

• Record ID: K092374
• Device Name: OIS EYESCAN PORTABLE MODULAR IMAGING SYSTEM, MODEL OIS EYESCAN
• Applicant: Ophthalmic Imaging Systems
• Product Code: HKI · Ophthalmic
• Decision Date: Nov 17, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1120
• Device Class: Class 2

Intended Use

The OIS EyeScan Portable Modular Imaging System is a portable monocular camera intended for imaging of both the posterior segment (including structures of the retina, vitreous and choroid) and anterior segment (including structures of the orbit, lids, cornea, iris and lens) of the eye. The device is suitable for documentation of findings in a clinical setting.

Device Story

Portable, modular monocular camera system; captures images of eye's posterior and anterior segments. Inputs: light signals captured via LEDs, lenses, and digital camera sensors. Operation: base unit with interchangeable imaging modules; captures color, FA, FAF, red-free, ICG angiography, autofluorescence, tear film analysis, corneal fluorescences, and slit images. Used in clinical settings by healthcare providers. Output: digital images stored on industry-standard media; reviewed and analyzed via OIS WinStation software. Benefits: provides clinical documentation of ocular structures to assist provider assessment.

Clinical Evidence

Bench testing only. Performance testing and software validation conducted to ensure functional specifications were met. EMC and safety testing performed to ensure compliance with industry standards.

Technological Characteristics

Portable modular system; base unit with interchangeable imaging modules. Light source: LEDs. Imaging: digital camera sensors, functionally optimized lenses/filters. Software: OIS WinStation for capture, review, and analysis. Connectivity: industry-standard storage media.

Indications for Use

Indicated for imaging of the posterior segment (retina, vitreous, choroid) and anterior segment (orbit, lids, cornea, iris, lens) of the eye for clinical documentation.

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

• Topcon TRC-50EX and TRC-50IX (K041367)
• WinStation Digital Imaging System (K913929)
• IRI Integrated Retinal Imager (K062295)
• BX900 (K982057)
• Tearscope Plus (K973064)

Submission Summary (Full Text)

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NOV 1 7 2009

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# 510(k) Summary

# (Revision 10/14/2009)

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#### 510(K) SUMMARY

### OIS EYESCAN PORTABLE MODULAR IMAGING SYSTEM

#### 510(k) Number __K092374

| Applicant's Name: | Ophthalmic Imaging Systems<br>221 Lathrop Way<br>Suite I<br>Sacramento, CA 95864<br>USA<br>Tel: [phone]<br>Fax: [phone]<br>e-mail:[e-mail] |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Andrea Ambrose / Gil Allon<br>221 Lathrop Way<br>Suite I<br>Sacramento, CA 95864<br>USA<br>Tel: [phone]<br>Fax: [phone]<br>e-mail:[e-mail] or [e-mail] |
| Date Prepared: | August 3, 2009 (Revised 10/14/2009) |
| Trade Name: | OIS EyeScan Portable Modular Imaging System |
| Classification Name: | CFR Classification section 886.1120 (Product code HKI)<br>CFR Classification section 886.1850 (Product code HJO)<br>CFR Classification section 892.2020 (Product code NFG) |
| Classification: | Class II Medical Device |
| Predicate Device: | The OIS EyeScan Portable Modular Imaging System is<br>substantially equivalent to a combination of the following predicate<br>devices: |

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Topcon TRC-50EX and TRC-50IX (K041367), manufactured by TOPCON Corp. Topcon TRC devices are ophthalmic camera systems intended to photograph the eye's fundus, similar to the OIS EyeScan device with the Retina Module or Fluorescein Angiography Module. To the best of our understanding, the TRC-50EX received market clearance as an addition or a modification to the 510(k) clearance of the TRC-NW200 device, K041367.

WinStation Digital Imaging System (K913929) manufactured by Ophthalmic Imaging Systems is used in conjunction with ophthalmic fundus cameras to take images of the eye, similar to the OIS EyeScan device using the Retina Module or Fluorescein Angiography Module.

IRI Integrated Retinal Imager (K062295) manufactured by Medivision Medical Imaging is intended to photograph the eye's fundus similar to the OIS EyeScan device using the Retina Module or Fluorescein Angiography Module.

BX900 manufactured by Haag Streit is a slit-lamp biomicroscope with viewing and illumination optical systems, similar to the OIS EyeScan device with the Slit Module, Red Reflex Module or Topical Fluorescein Module. To the best of our understanding, the BX900 received market clearance as an addition or a modification to the 510(k) clearance of the BC900 device K982057.

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Tearscope Plus (K973064) manufactured by Keeler is a device for specular observation of the tear film, similar to the OIS EyeScan device with the Tear Film Module.

OIS EyeScan is a portable, modular imaging device, which is Device Description: designed to perform retinal imaging (including color, FA, FAF, Red-free) and corneal imaging (including tear film analysis, corneal fluorescences, slit).

> OIS EyeScan Portable Modular Imaging System, consistent with the predicate imaging devices previously listed, uses light photography to obtain clinical information. OIS EyeScan captures images using light sources (LEDs of different colors), functionally optimized lenses and filters, and digital camera sensors. OIS EyeScan uses OIS WinStation software for image capture, review The device comprises a base unit, and and analysis. interchangeable imaging modules and optional chin rest. Images may be stored on industry standard storage media.

Intended Use / Indication for Use: The OIS EyeScan Portable Modular Imaging System is a portable monocular camera intended for imaging of both the posterior segment (including structures of the retina, vitreous and choroid) and anterior segment (including structures of the orbit, lids, cornea, iris and lens) of the eye. The device is suitable for documentation of findings in a clinical setting.

Performance Standards: None. There are no mandatory performance standards for this type of device.

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The OIS EyeScan Portable Modular Imaging System has been Test Data: subjected to extensive performance testing and validation before release. Final testing of the OIS EyeScan included various performance tests and software validation tests, designed to ensure that the device met all its functional specifications. EMC and safety tests currently underway will ensure the device complies with industry and safety standards. The device does now or will comply . with these industry and safety standards prior to commencing marketing of the device. See Section 9 for statement and declaration of conformity.

The OIS EyeScan Portable Modular Imaging System is Substantial Equivalence: similar to currently legally marketed ophthalmic imaging systems intended for posterior segment and anterior segment imaging applications. Similar to other predicate devices, the operating modes of the device include color, FA, FAF, red-free, ICG angiography, autofluorescence, tear film analysis, corneal fluorescences, slit. The device uses LEDs, similar to other predicate devices, as a safe low voltage light source instead of halogen and xenon lamps. Optical specifications are similar to those of predicate devices. Image processing and storage capabilities are similar to those of predicate devices. All of the above features are similar to these features in the predicate devices.

The conclusions drawn from the above Performance Testing and Conclusions: comparison to predicate devices is that OIS EyeScan Portable i Modular Imaging System is substantially equivalent in safety and effectiveness to the predicate devices listed above.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

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

Ophthalmic Imaging Systems (OIS) c/o Ms. Andrea Ambrose Quality Manager 221 Lathrop Way, Suite I Sacramento, CA 95815

NOV 1 7 2009

Re: K092374

Trade Name: OIS EyeScan Portable Modular Imaging System Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic camera Regulatory Class: Class II Product Code: HKI, HJO, NFG Dated: October 14, 2009 Received: October 15, 2009

Dear Ms. Ambrose:

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 includions for use stated in the enclosure) to legally marketed predicate devices marked in interstate commerce prior to May 28, 1976, the enactment date of the Medical In microa in microatic 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, into receive devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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, PDA 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 aft 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/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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely vours.

Kessia Alexander for

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

K092374 510(k) Number (if known):

OIS EyeScan Portable Modular Imaging System Device Name:

Indications for Use:

The OIS EyeScan Portable Modular Imaging System is a portable monocular camera intended for imaging of both the posterior segment (including structures of the retina, vitreous and choroid) and anterior segment (including structures of the orbit, lids, cornea, iris and lens) of the eye. The device is suitable for documentation of findings in a clinical setting.

Prescription Use V (Per 21 C.F.R. 801 Subpart D) C)

OR

Over-The-Counter Use (Optional Format Subpart

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Deare 11/09/09

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

510(k) Number K092374