← Product Code [HKX](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKX) · K032799

# NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER (K032799)

_Reichert, Inc. · HKX · Jan 20, 2004 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKX/K032799

## Device Facts

- **Applicant:** Reichert, Inc.
- **Product Code:** [HKX](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKX.md)
- **Decision Date:** Jan 20, 2004
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.1930
- **Device Class:** Class 2
- **Review Panel:** Ophthalmic

## Indications for Use

The ORA is intended to measure intra-ocular pressure of the eye and the biomechanical response of the cornea for the purpose of aiding in the diagnosis and monitoring of glaucoma.

## 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 response to air pulse. Output: IOP measurements and corneal biomechanical metrics. Used in clinical settings by eye care professionals. Data aids clinicians in glaucoma diagnosis and monitoring by providing corneal-compensated IOP values, potentially improving accuracy over standard tonometry.

## Clinical Evidence

No clinical data provided in the summary document; substantial equivalence based on technological characteristics and bench testing.

## Technological Characteristics

Non-contact tonometer; utilizes air-puff delivery system and electro-optical sensing to measure corneal applanation. Class II device (21 CFR 886.1930). Product code HKX. Standalone desktop unit.

## Regulatory 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.

## Predicate Devices

- Reichert Non-Contact Tonometer ([K980656](/device/K980656.md))

## Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the HHS logo, which is a stylized human figure with three arms reaching upwards. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the logo.

Public Health Service

JAN 2 0 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Reichert, Inc. C/O Frank Drexelius Regulatory Affairs Manager 3374 Walden Avenue Depew, NY 14043

Re: K032799

Trade/Device Name: Ocular Response Analyzer Regulation Number: 21 CFR 886.1930 Regulation Name: Tonometer and Accessories Regulatory Class: Class II Product Code: HKX Dated: July 31, 2003 Received: September 9, 2003

Dear Mr. Drexelius:

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 cnclosure) 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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Page 2 - Mr. Frank Drexelius

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 Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

A Ralph Rosenthal

A. Ralph Rosenthal, 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 (if known): K032799

Device Name: __ Ocular Response Analyzer - ORA __

Revised 12/15/2002.

Indications for Use:

The ORA is intended to measure intra-ocular pressure of the eye and the biomechanical response of the cornea for the purpose of aiding in the diagnosis and monitoring of glaucoma.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)

Hay R. Butteny DOED / DSDB

Division Sign-Off sion of Ophthalmic Ear, Nose and Throat Devises

**Prescription Use**
(Per 21 CFR 801.109)

**510(k) Number**

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