EYESOPEN TONOMETER

K032769 · Eye-Deas, LLC · HKY · Sep 23, 2003 · Ophthalmic

Device Facts

• Record ID: K032769
• Device Name: EYESOPEN TONOMETER
• Applicant: Eye-Deas, LLC
• Product Code: HKY · Ophthalmic
• Decision Date: Sep 23, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1930
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The EYE-deas EyesOPen tonometer is used to measure the intraocular pressure (IOP) during routine eye examinations or when an increased IOP is suspected. This device is intended for use by Ophthalmologists. Optometrists, and other trained medical professionals.

Device Story

EyesOPen tonometer is a hand-held electronic device for measuring intraocular pressure (IOP). It utilizes a solid-state force transducer and a CMOS image transducer to capture signals during brief contact with the eye. A microprocessor processes these inputs to derive IOP, which is displayed on a 4-digit LCD. The device provides a visual indicator of measurement reliability via four bars representing the goodness of fit to a linear regression of pressure against applanated diameter. It is intended for use by ophthalmologists, optometrists, and trained medical professionals in clinical settings. The device benefits patients by providing a portable, rapid method for IOP assessment during routine exams or when glaucoma is suspected.

Clinical Evidence

Bench testing only. The device was tested on a simulated human eye to establish baseline performance. Results were consistent with the performance of the predicate tonometer devices on the same simulator.

Technological Characteristics

Hand-held electronic tonometer; solid-state force transducer; CMOS image transducer; 4-digit LCD display; 6mm glass coaxial contact tip; powered by 2x 3.0V lithium batteries; microprocessor-based; linear regression algorithm for IOP calculation; non-networked.

Indications for Use

Indicated for intraocular pressure (IOP) measurement in patients during routine eye exams or when elevated IOP is suspected. Intended for use by ophthalmologists, optometrists, and trained medical professionals.

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.

Predicate Devices

• Perkins tonometer
• Tono-Pen 3 tonometer

Submission Summary (Full Text)

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Eye-deas, LLC

# 510(k) Submission

## EyesOPen Manual Tonometer

### 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

The assigned 510(k) number is: K032769

Submitted by: Steven E. Feldon, M.D. President Eye-deas, LLC 39 Sandringham Road Rochester, New York 14610

Date Prepared: July 21, 2003

#### Device Name

| Proprietary Name: | EyesOPen Tonometer |
|----------------------|--------------------|
| Common Name: | Ocular Tonometer |
| Classification Name: | Tonometer, Manual |

#### Substantial Equivalence

The Eye-deas EyesOPen tonometer is similar in indications, optical design and IOP calculation methodology to the Perkins tonometer.

The Eye-deas EyesOPen tonometer is similar in indications, size, user interface, microprocessor operation and solid-state force transducer design to the Tono-Pen 3 tonometer.

#### Device Description

The Eye-deas EyesOPen tonometer is a precision electronic tonometer, which measures intraocular pressure (IOP). The body of the instrument is specially designed to fit comfortably in the user's hand, facilitating fast and accurate measurements.

The EyesOPen tonometer contains a solid-state force transducer and a CMOS image transducer that together produces electrical signals from which intraocular pressure is derived. When sufficient valid readings are obtained an IOP reading is displayed on a liquid crystal display.

Under each of the four digits are bars. The bars correspond to the goodness of fit to a linear regression of pressure against applanated diameter. The regression coefficient is 95% or better if the first bar is

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## Eye-deas, LLC

# EyesOPen Manual Tonometer

### 510(k) Submission

illuminated, 90%-95% if the second bar is illuminated, 80%-90% if the third bar is illuminated, or less than 80% if the fourth bar is illuminated.

### Intended Use

The Eye-deas EyesOPen tonometer is used to measure the intraocular pressure (IOP) during routine eye examinations or when an increased IOP is suspected.

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# EyesOPen Manual Tonometer

## Substantial Equivalence Comparison - Perkins Tonometer

| | EyesOPen tonometer | Perkins tonometer | | EyesOPen tonometer | Tono-Pen 3 |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication | Intraocular pressure (IOP)<br>measurement | Same | Indication | Intraocular pressure (IOP)<br>measurement | Same |
| Design | Hand-held microprocessor<br>based | Hand-held manual dial | Design | Hand-held microprocessor<br>based | Same |
| Force transducer | Solid state element | Spring and weight | Force Transducer | Solid-state | Same |
| Imaging transducer | Electronic imager | Operator's eye | Imaging Transducer | Electronic CMOS imager | No imaging elements |
| IOP algorithm basis | Goldmann | Same | IOP calculation basis | Goldmann | Mackay-Marg |
| Calibration | None required | External weights | Calibration | None required | None required |
| Contact tip | 6mm glass coaxial | 6 mm glass transverse | Contact tip | 6mm glass coaxial | 3 mm stainless steel<br>coaxial |
| User interface | Briefly touched against eye | Held on patient's eye while<br>dial is adjusted | Measurement technique | Briefly touched against eye | Same |
| Display | 4 digit LCD | Scribed dial | User control | Single push button | Same |
| Range of measurement | 5 - 90 mmHg | 5-50 mmHg | Single use sanitary tip<br>cover | Required | Not required |
| Statistical reliability of the<br>reading | The bars correspond to the<br>goodness of fit to a linear<br>regression of<br>pressure against<br>applanated diameter. The<br>regression coefficient is<br>95% or better if the first bar<br>is illuminated, 90%-95% if<br>the second bar is<br>illuminated, 80%-90% if the<br>third bar is illuminated, or<br>less than 80% if the fourth<br>bar is illuminated. | No indication of reading<br>reliability | Display | 4 digit LCD | Same |
| Versatility | Patient can be in any<br>position. | Same. | Range of Measurement | 5 - 90 mmHg | Same |
| Weight (with batteries) | 3 ounces | 12.4 ounces | Statistical Reliability | The bars correspond to the<br>goodness of fit to a linear<br>regression of<br>pressure against<br>applanated diameter. The<br>regression coefficient is<br>95% or better if the first bar<br>is illuminated, 90%-95% if<br>the second bar is<br>illuminated, 80%-90% if the<br>third bar is illuminated, or<br>less than 80% if the fourth<br>bar is illuminated. | The bars correspond to<br>standard deviation<br>expressed as a percentage<br>of the mean pressure. The<br>first bar is illuminated at<br><5%, the second bar is<br>illuminated at 5% to 10%,<br>the third bar is illuminated<br>at 10% to 20%, the fourth<br>bar is illuminated at >20%. |
| Dimensions | 1" H x 1¼" W x 7" L | 1 ½" H x 1 ½" W x 11" L | Versatility | Patient can be in any<br>position. | Same. |
| Power source | 2 ea 3.0 volt lithium<br>batteries | 4 ea. 1.5 volt AA batteries | Weight (with batteries) | 3 ounces | 2.3 ounces |
| Dimensions | 1" H x 1 ¼" W x 7 " L | 1" H x 1" W x 7 3/4" L | | | |
| Power Source | 2 ea 3 volt lithium batteries | 2 ea. 1/3N 3 volt lithium<br>batteries | | | |

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## EyesOPen Manual Tonometer

## Substantial Equivalence Comparison - Tono-Pen 3 Tonometer

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# Eye-deas, LLC

## EyesOPen Manual Tonometer

### Performance Testing

Although not required to establish substantial equivalence, the EyesOPen tonometer was tested to establish baseline performance. The EyesOPen tonometer was tested on a simulated human eye. The EyesOPen tonometer performance was consistent with the performance of the predicate tonometer devices on this simulator.

Stivin Foldm

Submitter's Signature

7-28-03

Date

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Image /page/5/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The eagle is facing to the left and has three lines that make up its body. The text is in all caps and is evenly spaced around the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 3 2003

Eye-deas, LLC c/o Erin Sparnon CITECH 5200 Butler Pike Plymouth Meeting, PA 19462

Re: K032769

Trade/Device Name: EyesOPen Tonometer Regulation Number: 21 CFR 886.1930 Regulation Name: Tonometer and accesories Regulatory Class: Class II Product Code: HKY Dated: September 5, 2003 Received: September 8, 2003

Dear Ms. Sparnon:

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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Page 2 - Erin Sparnon

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A. Károlyi Károly

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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Attachment I b

Page 1 of 1

510(k) Number (if known): K032769
Device Name: EyesOpen tonometer (manual tonometer)

Indications for Use:

The EYE-deas EyesOPen tonometer is used to measure the intraocular pressure (IOP) during routine eye examinations or when an increased IOP is suspected. This device is intended for use by Ophthalmologists. Optometrists, and other trained medical professionals.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

| 510(k) Number | K032769 |
|---------------|---------|
|---------------|---------|

| Prescription Use | | OR | Over-the-Counter Use |
|--------------------|--|----|----------------------|
| (Per 21CFR801.109) | | | |