MENTOR TONO-PEN 3

K964312 · Mentor Ophthalmics, Inc. · HKY · Nov 26, 1996 · Ophthalmic

Device Facts

• Record ID: K964312
• Device Name: MENTOR TONO-PEN 3
• Applicant: Mentor Ophthalmics, Inc.
• Product Code: HKY · Ophthalmic
• Decision Date: Nov 26, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1930
• Device Class: Class 2

Intended Use

The MENTOR TONO-PEN 3 is used to measure the intraocular pressure (IOP) during routine eye examination or when an increased IOP is suspected.

Device Story

Hand-held electronic tonometer; measures intraocular pressure (IOP). Input: physical contact with cornea via silicon strain gage transducer. Operation: microprocessor-based; converts pressure to electrical signal. Output: LCD displays individual readings, mean IOP, and statistical reliability (via horizontal bars). Used by clinicians in office, surgical, bedside, or remote settings. Patient benefit: rapid, accurate IOP assessment regardless of patient position or corneal irregularities. Device includes computer interface jack for data output.

Clinical Evidence

No clinical data provided. The 510(k) summary explicitly states that the determination of substantial equivalence is not based on an assessment of any performance data, clinical or non-clinical.

Technological Characteristics

Hand-held electronic tonometer. Transducer: elemental silicon strain gage. Power: 2x 3.0V lithium manganese dioxide batteries. Interface: LCD display, computer interface jack. Form factor: 7.25" x 1" x 0.875", 2.0 oz. Tip: molded plastic with latex protective membrane (Ocu-Film). Microprocessor-based control.

Indications for Use

Indicated for patients requiring intraocular pressure (IOP) measurement during routine eye exams or when elevated IOP is suspected. Suitable for use in cases of irregular or high corneal astigmatism.

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

• MENTOR TONO-PEN XL

Submission Summary (Full Text)

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NOV 26 1996

# 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K964312

## Submitted By: David Downey
Director, Quality Assurance and Regulatory Affairs
Mentor O&O, Inc.
3000 Longwater Drive
Norwell, MA 02061
Tel: [phone]
Fax: [phone]

Date Prepared: October 15, 1996

## Device Name

Proprietary Name: MENTOR® TONO-PEN 3

Common Name: Ocular Tonometer

Classification Name: Tonometer, Manual

## Substantial Equivalence

MENTOR TONO-PEN 3 is similar in indications, design and features to MENTOR TONO-PEN XL

## Device Description

The MENTOR TONO-PEN 3 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.

TONO-PEN 3 contains an elemental silicon strain gage which converts intraocular pressure to an electrical signal. The pen displays each valid reading on a liquid crystal display [LCD]. When four valid readings are obtained, a mean IOP reading and an indication of reliability are shown on the LCD. The TONO-PEN 3 has a molded plastic tip which must be covered by a latex protective membrane. MENTOR Ocu-Film Tip covers are recommended.

## Intended Use

The MENTOR TONO-PEN 3 is used to measure the intraocular pressure (IOP) during routine eye examination or when an increased IOP is suspected.

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510(k) Summary: Mentor O&O TONO-PEN 3

# Substantial Equivalence Comparison

| | MENTOR TONO-PEN 3 | MENTOR TONO-PEN XL |
| --- | --- | --- |
| | | |
| Indication | Intraocular pressure (IOP) measurement. | Same |
| Design | Hand-held, microprocessor based. | Same |
| Transducer | Elemental silicon, diaphragm type strain gage transducer. | Precision stainless steel plunger on a strain gage force transducer. |
| Calibration | Not necessary | Needed |
| Distal tip | Si diaphragm | Stainless steel |
| Tip cover | Latex protective membrane | Same |
| User interface | The TONO-PEN III is held as you would a pencil, with the index finger on the activation switch. Once activated, the user touches the cornea lightly and briefly and withdraws the TONO-PEN III. A reading will be displayed on the LCD. After four readings an average will appear as well as the reliability of the average number shown. | Same |
| Computer interface | There is a computer interface jack located on the underside of the unit. | Same |
| Display | Liquid Crystal Display | Same |
| Range of measurement | 5-80 mm Hg | Same |
| Statistical reliability | The display of four horizontal bars across the lower border of the LCD block indicate the statistical reliability of the averaged measurement. For example, if the 5% bar is displayed, the standard deviation of the valid measurements is 5% or less of the average number shown. | Same |
| Versatility | Can be used in cases of irregular or high corneal astigmatism. It may be used with the patient in any position, making it suitable for the office, during surgery, in clinics, at the bedside or in remote locations. | Same |

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| | MENTOR TONO-PEN 3 | MENTOR TONO-PEN XL |
| --- | --- | --- |
| | | |
| Weight | 2.0 ounces | 2.6 ounces |
| Dimensions | 7 1/4” x 1” x 7/8” | Same |
| Power source | 2 ea. 3.0 volt lithium manganese dioxide batteries | Same |

The determination of substantial equivalence is not based on an assessment of any performance data, clinical or non-clinical.



510(k) Summary: Mentor O&O TONO-PEN 3