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.

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

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.

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 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 help 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.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes several non-clinical tests and their outcomes, which can be interpreted as the device meeting specific acceptance criteria. However, explicit numerical acceptance criteria values are not provided for all tests, nor are numerical performance results always given.

Test Category	Acceptance Criteria (Implicit from text)	Reported Device Performance
Biocompatibility	Considered biocompatible for use as a surface device with mucosal membrane contact of less than 24 hours (according to ISO 10993-1:2003 and FDA G95-1).	"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" (Implies successful completion)
Shelf Life Aging (Tip Cover)	Met acceptance criteria in initial shelf life functional testing for tonometer accuracy.	"The tip covers met the acceptance criteria in the initial shelf life functional testing for tonometer accuracy." (Implies successful completion)
Operating Life (Tonometer)	Provide a 2500 nominal operating life for the tonometer.	"The battery pack met the acceptance criteria for providing the tonometer with a 2500 nominal operating life." (Implies successful completion)
Bench Testing	Met acceptance criteria for operating range, accuracy, repeatability, sensitivity, angle of incidence, and battery life.	"The units under test met the acceptance criteria of the operating range, accuracy, repeatability, sensitivity, angle of incidence and battery life." (Implies successful completion)
Electromagnetic Compatibility (EMC) & Electrical Safety	Compliance with BS EN 60601-1 and BS EN 60601-1-2 requirements for RF emission, immunity, magnetic immunity, and ESD 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." (Implies successful completion)

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for any of the non-clinical tests (biocompatibility, shelf life, operating life, bench testing, EMC/electrical safety). It only mentions "units under test" for bench testing and the "battery pack" for operating life.

The data provenance is not specified. It is likely that these were internal company tests conducted by Medtronic Xomed, Inc. There is no indication of country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The tests described are primarily engineering and material science tests, not clinical studies requiring expert ground truth for diagnostic accuracy.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of the non-clinical tests, an adjudication method like 2+1 or 3+1 typically used for clinical diagnostic studies would not be applicable. The tests likely had predefined pass/fail criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a MRMC comparative effectiveness study was not conducted or reported in this document. The submission focuses on non-clinical performance and substantial equivalence to a predicate device, not on human reader performance with or without AI assistance.

6. Standalone Performance Study

The studies described (biocompatibility, shelf life, operating life, bench testing, EMC/electrical safety) are essentially standalone performance studies for the device itself or its components. They evaluate the device's technical specifications and compliance with safety and performance standards without involving a human operator in a diagnostic capacity (beyond potentially operating the device for the bench tests). These are algorithmic/device-only performance evaluations in a non-clinical context.

7. Type of Ground Truth Used

The ground truth for these non-clinical tests is based on:

Established standards and regulations: ISO 10993-1:2003, FDA G95-1 for biocompatibility, BS EN 60601-1 and BS EN 60601-1-2 for EMC/electrical safety.
Engineering specifications and design requirements: For operating life, accuracy, repeatability, sensitivity, angle of incidence, and battery life, the "acceptance criteria" themselves serve as the ground truth against which performance is measured. These would be derived from the device's intended performance specifications.
Functional performance criteria: For shelf life, the "tonometer accuracy" serves as the ground truth.

8. Sample Size for the Training Set

This information is not applicable as the document does not describe the development or testing of an AI algorithm or a machine learning model that would require a "training set." The device described is a physical instrument for measuring intraocular pressure.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as above; there is no AI algorithm or machine learning model with an associated training set.

Summary

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

MAR 3 -7006

510(k) Summary

510(k) Owner	Medtronic Xomed, Inc6743 Southpoint Drive NorthJacksonville, FL 32216-0980 USA904-296-9600904-296-2386 (FAX)
Contact Name	Penny M. LaymanRegulatory Manager, Sustaining BusinessMedtronic 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, ProductCode 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

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.

	MentorTono-Pen 3K964312	Medtronic XomedTono-Pen AVIA
Indications forUse	The Mentor TONO-Pen 3 is used to measurethe intraocular pressure (IOP) during routineeye examination or when an increased IOP issuspected.	The Medtronic Xomed Tono-Pen AVIA isused to measure the intraocular pressure(IOP) during routine eye examination orwhen an increased IOP is suspected.
Transducer type	Elemental silicon, diaphragm type strain-gagetransducer	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)Display on one side	Two Liquid Crystal Displays (LCD).Display on both sides for left or righthanded user.
Power Source	Two 3.0 volt lithium manganese dioxidebatteries	Two 3.0 volt lithium manganese dioxidebatteries
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,with the index finger on the activation switch.Once activated, the user touches the cornealightly and briefly and withdraws the device.A reading will be displayed on the LCD. Afterfour readings an average IOP will appear aswell as the reliability of the average numbershown.	The Tono-Pen AVIA is a curved,ergonomically shaped device with the indexfinger used for the activation switch. Onceactivated, the user touches the cornea lightlyand briefly. A reading will be displayed onboth LCDs for ease of use by either a rightor left handed person. After 10 readings anaverage IOP will appear as well as thenumber of data points collected.
Range ofmeasurement	5-80 mmHg	5-55 mmHg
Calibration /Verification	Recommended once daily	Recommended once daily.

Summary of Tonometer Technological Characteristics

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

	Oculab, Inc.Ocu-filmK882750	Medtronic XomedOcu-Shield
Intended Use	Protective membrane to prevent transmissionof infection between patients as well asprovide protection to the transducer tip.	The Ocu-Shield tip cover is used to helpprotect the patient from cross contaminationand protect the Tono-Pen AVIA sensorfrom eye fluids during use or debris duringstorage.
Material	Natural Rubber Latex	Polyethylene
Shape	Finger Cover design	Molded to AVIA transducer shape
Tip Thickness	.003''	.0008"
PackagingConfiguration	Individually placed on a tubular cardboardinsert and packed in a box of 90	Multi-Pack dispensers, box of 180Single Pack, Individual plastic cups, sealedwith a Tyvek cover
Provided	Non-sterile, sanitized	Multi pack: Non-sterile, sanitizedSingle pack: Sterile
Sterilization /SanitizationMethod	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 (301) 827-8910. 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/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

Regulation Number and Section

§ 886.1930 Tonometer and accessories.

(a)
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.(b)
Classification. Class II.