OCULAR RESPONSE ANALYZER

K081756 · Reichert, Inc. · HKX · Aug 7, 2008 · Ophthalmic

Device Facts

• Record ID: K081756
• Device Name: OCULAR RESPONSE ANALYZER
• Applicant: Reichert, Inc.
• Product Code: HKX · Ophthalmic
• Decision Date: Aug 7, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1930
• Device Class: Class 2

Intended Use

The Ocular Response Analyzer is intended to measure intra-ocular pressure of the eye and biomechanical response of the cornea.

Device Story

Ocular Response Analyzer (ORA) measures intra-ocular pressure (IOP) and corneal biomechanical properties. Device uses air-puff technology to deform cornea; electro-optical system monitors corneal movement during inward and outward applanation. Input: corneal deformation signals. Output: IOP and corneal hysteresis/resistance metrics. Used in clinical settings by eye care professionals. Output assists clinicians in evaluating corneal biomechanics and refining IOP measurements, potentially improving glaucoma management and diagnostic accuracy.

Technological Characteristics

Non-contact tonometer; utilizes air-puff pulse for corneal applanation; electro-optical sensing system for monitoring corneal deformation; Class II device (21 CFR 886.1930).

Indications for Use

Indicated for measuring intra-ocular pressure and corneal biomechanical response in patients requiring ophthalmic assessment.

Regulatory Classification

Identification

A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Reichert, Inc c/o Sandra Brown Quality/Regulatory Affairs Manager 3362 Walden Avenue Depew, NY 14043

Re: K081756

Trade/Device Name: Ocular Response Analyzer (ORA) Regulation Number: 21 CFR 886.1930 Regulation Name: Tonometer and accessories Regulatory Class: Class II Product Code: HKX Dated: June 13, 2008 Received: June 20, 2008

Dear Ms. Brown:

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.

AUG - 7 2008

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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,

Malvina B. Egeleda, and

Malvina B. Eydelman. M.I 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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## Indications for Use

510(k) Number (if known): K081756

Device Name: Ocular Response Analyzer

Indications for Use:

The Ocular Response Analyzer is intended to measure intra-ocular pressure of the eye and biomechanical response of the cornea.

X Prescription Use (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dexedur

hthalmic Ear

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