RETCAM PORTABLE OPHTHALMIC IMAGING SYSTEM, MODEL RCP

K083771 · Clarity Medical Systems · HKI · Jan 30, 2009 · Ophthalmic

Device Facts

• Record ID: K083771
• Device Name: RETCAM PORTABLE OPHTHALMIC IMAGING SYSTEM, MODEL RCP
• Applicant: Clarity Medical Systems
• Product Code: HKI · Ophthalmic
• Decision Date: Jan 30, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.1120
• Device Class: Class 2

Intended Use

The RetCam Portable Ophthalmic Imaging System is indicated for general ophthalmic imaging including retinal, corneal and external imaging.

Device Story

RetCam Portable Ophthalmic Imaging System captures wide-field digital images and videos of eye; retinal, corneal, and external structures. Device features portable design with optional hard or soft packaging for transport within or outside hospital/clinic settings. System facilitates imaging in confined spaces. Clinicians use captured digital output for ophthalmic assessment and documentation. Portable form factor enables point-of-care imaging, assisting healthcare providers in clinical decision-making by providing visual records of ocular conditions.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use compared to the predicate device.

Technological Characteristics

Ophthalmic camera system; digital imaging and video capture; portable form factor with specialized packaging for transport; Class II device; Product Code HKI.

Indications for Use

Indicated for general ophthalmic imaging, including retinal, corneal, and external imaging, for patients requiring ophthalmic examination.

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

• RetCam Shuttle Ophthalmic Imaging System (K081858)

Submission Summary (Full Text)

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| 510k Summary | CLARITY MEDICAL SYSTEMS, INC. |
|--------------|-------------------------------|
| | DATE: JANUARY 26, 2009 |

Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92 Device Name: RetCam Portable Ophthalmic Imaging System K083771 Common Name(s): Ophthalmic Imaging System Classification Name(s): Ophthalmic Camera Manufacturer: Clarity Medical Systems, Inc.

Reg. Number: 2952489 Address: 5775 West Las Positas Boulevard Pleasanton, CA 94588-4084 [phone]

Classification(s):

Device Class: Class II Classification Panel: Ophthalmology Product Code(s): HKI

Equivalent Predicate Device: RetCam Shuttle Ophthalmic Imaging System, K081858

## Device Description:

The RetCam Portable Imaging System is designed to quickly and easily capture wide field, digital images and videos of the eye. The optional hard side or soft side packaging allows for easy transport from one location to another within or outside the hospital or clinic. The reduced packaging dimensions enhance the ease of use in confined space situations.

## Indication for Use:

The RetCam Portable Ophthalmic Imaging System is indicated for general ophthalmic imaging including retinal, corneal and external imaging.

## Company Contact:

Gary A. Seeger Vice President, Quality Assurance and Regulatory Affairs Clarity Medical Systems, Inc.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 3 0 2009

Clarity Medical Systems, Inc c/o Gary A. Seeger 5775 W. Las Positas Blvd. Pleasanton, CA 94588

Re: K083771

Trade/Device Name: RetCam Portable Ophthalmic Imaging System Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic camera Regulatory Class: Class II Product Code: HKI Dated: December 15, 2008 Received: December 18, 2008

Dear Mr. Seeger:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 yours,

Marina B. Eppler, Suid

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

Enclosure

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510(k) Number:

Device Name(s): RetCam Portable Ophthalmic Imaging System

Indications for Use Statement(s) for each and all above listed RetCam Systems:

The RetCam Portable Ophthalmic Imaging System is indicated for general ophthalmic imaging including retinal, corneal and external imaging.

Prescription Use _ X OR

Over-The-Counter Use

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY -Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)

Sem.

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

510(k) Number K083771