TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER

K053430 · Medtronic Xomed, Inc. · HKY · Mar 3, 2006 · Ophthalmic

Device Facts

• Record ID: K053430
• Device Name: TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER
• Applicant: Medtronic Xomed, Inc.
• Product Code: HKY · Ophthalmic
• Decision Date: Mar 3, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1930
• Device Class: Class 2

Intended Use

The Tono-Pen AVIA tonometer is used to measure the IntraOcular Pressure (IOP) during routine eye examination or when an increased IOP is suspected. The Ocu-Shield tip cover is used to help protect the patient from cross contamination and protect the Tono-Pen AVIA sensor from eye fluids during use or debris during storage.

Device Story

Tono-Pen AVIA is a handheld electronic tonometer for measuring intraocular pressure (IOP). Device utilizes an elemental silicon, diaphragm-type strain-gage transducer to convert corneal pressure into electrical signals. Integrated 10-bit microprocessor processes and analyzes waveforms from corneal touches; calculates and displays averaged IOP and number of data points on dual LCDs. Operated by clinicians during routine eye exams or glaucoma screenings. Ergonomic design supports left or right-handed use. Ocu-Shield polyethylene tip covers protect the sensor from fluids/debris and prevent cross-contamination. Powered by lithium manganese dioxide batteries. Provides rapid, precise IOP measurements to assist clinical decision-making regarding glaucoma management.

Clinical Evidence

Bench testing only. Performance validated against operating range, accuracy, repeatability, sensitivity, angle of incidence, and battery life requirements. Biocompatibility testing performed per ISO 10993-1:2003 and FDA G95-1. Electromagnetic compatibility and electrical safety testing conducted per BS EN 60601-1 and BS EN 60601-1-2.

Technological Characteristics

Handheld electronic tonometer; molded ABS plastic body; elemental silicon diaphragm strain-gage transducer. Dual LCDs. Powered by two 3.0V lithium manganese dioxide batteries. Ocu-Shield tip cover: polyethylene, 0.0008" thickness, gamma-sterilized. Connectivity: standalone. Software: C++ based processing. Standards: BS EN 60601-1, BS EN 60601-1-2, ISO 10993-1:2003.

Indications for Use

Indicated for measuring intraocular pressure in patients where glaucoma or increased intraocular pressure is suspected.

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 3 (K964312)
• Oculab Ocu-Film tip cover (K882750)

Reference Devices

• Tono-Pen XL

Submission Summary (Full Text)

{0}------------------------------------------------

MAR 3 -7006

# 510(k) Summary

| 510(k) Owner | Medtronic Xomed, Inc<br>6743 Southpoint Drive North<br>Jacksonville, FL 32216-0980 USA<br>904-296-9600<br>904-296-2386 (FAX) |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------|
| Contact Name | Penny M. Layman<br>Regulatory Manager, Sustaining Business<br>Medtronic Xomed, Inc. |
| Date Summary Prepared | November 30, 2005 |
| Proprietary Name | Tono-Pen AVIATM tonometer with Ocu-ShieldTM tip cover |
| Common Name | Tonometer, Manual |
| Classification Name | Tonometer and accessories (21 CFR 886.1930, Product<br>Code HKY) |

#### Marketed device claiming equivalence to

The Tono-Pen AVIA with Ocu-Shield is equivalent to the Mentor Tono-Pen 3, K964312. The accessory tip cover is similar to the Oculab Ocu-Film tip cover, K882750. The current Medtronic Xomed tonometer is named the Tono-Pen XL.

#### Device Description

The Tono-Pen AVIA is a precision electronic manual tonometer which measures intraocular pressure. The body of the instrument is ergonomically designed to fit comfortably in the user's hand to facilitate a technique that helps to ensure fast, precise measurements. The sensor must be covered with an Ocu-Shield tip cover to help protect the patient from cross contamination as well as provide protection of the sensor.

#### Intended Use

The Tono-Pen AVIA tonometer is used to measure the IntraOcular Pressure (IOP) during routine eye examination or when an increased IOP is suspected.

The Ocu-Shield tip cover is used to help protect the patient from cross contamination and protect the Tono-Pen AVIA sensor from eye fluids during use or debris during storage.

### Indications for Use

The indications for use include measuring intraocular pressure for suspected glaucoma or when an increased intraocular pressure is suspected.

## Performance Characteristics

The Tono-Pen AVIA is an ergonomic hand held tonometer that measures intraocular pressure. The tip of the tonometer contains a sensor that houses a transducer assembly

{1}------------------------------------------------

that converts applied pressure into an electrical signal. The electronics housed in the ergonomic Tono-Pen AVIA body, process and analyze the waveforms produced by each touch of the corneal surface of the eye, to produce an averaged IOP measurement. The measurement along with the number of data points collected is displayed on the Liquid Crystal Displays (LCD). The Ocu-Shield is a protective membrane shaped to cover the tip and is used to protect the patient from cross contamination, and when used during storage, protects the sensor from damage. A replaceable battery compartment houses the Tono-Pen AVIA POWERCEL lithium manganese dioxide batteries.

| | Mentor<br>Tono-Pen 3<br>K964312 | Medtronic Xomed<br>Tono-Pen AVIA |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | The Mentor TONO-Pen 3 is used to measure<br>the intraocular pressure (IOP) during routine<br>eye examination or when an increased IOP is<br>suspected. | The Medtronic Xomed Tono-Pen AVIA is<br>used to measure the intraocular pressure<br>(IOP) during routine eye examination or<br>when an increased IOP is suspected. |
| Transducer type | Elemental silicon, diaphragm type strain-gage<br>transducer | Elemental silicon, diaphragm type strain-gage transducer |
| Microprocessor | 8 Bit Processor | 10 Bit Processor |
| Software | Assembly | C++ |
| Body material | Molded ABS plastics | Molded ABS plastics |
| Display | One Liquid Crystal Display (LCD)<br>Display on one side | Two Liquid Crystal Displays (LCD).<br>Display on both sides for left or right<br>handed user. |
| Power Source | Two 3.0 volt lithium manganese dioxide<br>batteries | Two 3.0 volt lithium manganese dioxide<br>batteries |
| Operating Life | Five years of average use (2500 uses/year) | Five years of average use (2500 uses/year) |
| User interface | The Tono Pen 3 is held as you would a pencil,<br>with the index finger on the activation switch.<br>Once activated, the user touches the cornea<br>lightly and briefly and withdraws the device.<br>A reading will be displayed on the LCD. After<br>four readings an average IOP will appear as<br>well as the reliability of the average number<br>shown. | The Tono-Pen AVIA is a curved,<br>ergonomically shaped device with the index<br>finger used for the activation switch. Once<br>activated, the user touches the cornea lightly<br>and briefly. A reading will be displayed on<br>both LCDs for ease of use by either a right<br>or left handed person. After 10 readings an<br>average IOP will appear as well as the<br>number of data points collected. |
| Range of<br>measurement | 5-80 mmHg | 5-55 mmHg |
| Calibration /<br>Verification | Recommended once daily | Recommended once daily. |

# Summary of Tonometer Technological Characteristics

{2}------------------------------------------------

| | Oculab, Inc.<br>Ocu-film<br>K882750 | Medtronic Xomed<br>Ocu-Shield |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Protective membrane to prevent transmission<br>of infection between patients as well as<br>provide protection to the transducer tip. | The Ocu-Shield tip cover is used to help<br>protect the patient from cross contamination<br>and protect the Tono-Pen AVIA sensor<br>from eye fluids during use or debris during<br>storage. |
| Material | Natural Rubber Latex | Polyethylene |
| Shape | Finger Cover design | Molded to AVIA transducer shape |
| Tip Thickness | .003'' | .0008" |
| Packaging<br>Configuration | Individually placed on a tubular cardboard<br>insert and packed in a box of 90 | Multi-Pack dispensers, box of 180<br>Single Pack, Individual plastic cups, sealed<br>with a Tyvek cover |
| Provided | Non-sterile, sanitized | Multi pack: Non-sterile, sanitized<br>Single pack: Sterile |
| Sterilization /<br>Sanitization<br>Method | Gamma Irradiation | Gamma Irradiation |
| Shelf Life | 3 Years | 3 Years |

### Summary of Tip Cover Technological Characteristics

#### Summary of Non-Clinical Testing

#### Biocompatability

The Ocu-Shield tip cover is considered biocompatible for use as a surface device with mucosal membrane contact of less than 24 hours. The appropriate tests were performed according to:

- ISO 10993-1:2003, Biological evaluation of medical devices Part 1 Evaluation . and Testing
- FDA G95-1, Required Biocompatibility Training and Toxicology Profiles for . Evaluation of Medical Devices, May 1, 1995

#### Shelf Life Aging, Tip Cover

The tip covers met the acceptance criteria in the initial shelf life functional testing for tonometer accuracy.

#### Operating Life, Tonometer

The battery pack met the acceptance criteria for providing the tonometer with a 2500 nominal operating life.

#### Bench testing

The units under test met the acceptance criteria of the operating range, accuracy, repeatability, sensitivity, angle of incidence and battery life.

### Electromagnetic Compatibility and Electrical Safety Testing

The RF emission and immunity testing, magnetic immunity and ESD testing passed for the Tonometer testing performed to BS EN 60601-1 and BS EN 60601-1-2 requirements.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three wavy lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 3 2006

Medtronic Xomed, Inc. % Penny Layman 6743 Southpoint Dr. N Jacksonville, FL 32216

Re: K053430

Trade/Device Name: Tono-Pen AVIA Regulation Number: 21 CFR 886.1930 Regulation Name: Tonometer and accessories Regulatory Class: Class II Product Code: HK Y Dated: February 1, 2006 Received: February 2, 2006

Dear Ms. Layman:

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.

{4}------------------------------------------------

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FI)A 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/industry/support/index.html.

Sincerely yours.

M.B. Eckles - M.D.

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

Enclosure

{5}------------------------------------------------

## Indications for Use

510(k) Number (if known): Unknown KOS3430

Device Name: Tono-Pen AVIA™ tonometer and Ocu-Shield™ tip cover

Indications for Use:

The indications for use include measuring intraocular pressure for suspected glaucoma or when an increased intraocular pressure is suspected.

Prescription Use _ X (Per 21 CFR 801 Subpart D) Or

Over-the-Counter Use (Per 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)

Clary R. Buttery

Onhthalmic F Throat [

510(k) Number K053430