(84 days)
Not Found
No
The description details standard electronic signal processing and analysis of waveforms, which is not indicative of AI/ML. There are no mentions of AI, ML, or related concepts like training or test sets.
No.
The device is used to measure IntraOcular Pressure (IOP), which is a diagnostic function, not a therapeutic one. It provides information for diagnosis but does not treat any condition.
Yes
The device is used to measure IntraOcular Pressure (IOP) to detect suspected glaucoma or increased IOP, which are diagnostic purposes.
No
The device description clearly outlines a physical instrument with a sensor, transducer, electronics, LCD display, and a battery compartment, indicating it is a hardware device with embedded software, not a software-only medical device.
Based on the provided information, the Tono-Pen AVIA tonometer is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Tono-Pen AVIA Function: The Tono-Pen AVIA directly measures intraocular pressure by touching the corneal surface of the eye. It does not analyze a specimen taken from the body.
- Intended Use: The intended use is to measure IOP during routine eye examinations or when increased IOP is suspected, which is a direct measurement on the patient, not an analysis of a sample.
Therefore, the Tono-Pen AVIA is a medical device used for direct measurement on a patient, not an IVD.
N/A
Intended Use / Indications for 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.
The indications for use include measuring intraocular pressure for suspected glaucoma or when an increased intraocular pressure is suspected.
Product codes
HKY
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Corneal surface of the eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
MAR 3 -7006
510(k) Summary
| 510(k) Owner | Medtronic Xomed, Inc
6743 Southpoint Drive North
Jacksonville, FL 32216-0980 USA
904-296-9600
904-296-2386 (FAX) |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------|
| Contact Name | Penny M. Layman
Regulatory Manager, Sustaining Business
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
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
Tono-Pen 3
K964312 | Medtronic Xomed
Tono-Pen AVIA |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
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. | The Medtronic Xomed Tono-Pen AVIA is
used to measure the intraocular pressure
(IOP) during routine eye examination or
when an increased IOP is suspected. |
| Transducer type | Elemental silicon, diaphragm type strain-gage
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)
Display on one side | Two Liquid Crystal Displays (LCD).
Display on both sides for left or right
handed user. |
| Power Source | Two 3.0 volt lithium manganese dioxide
batteries | Two 3.0 volt lithium manganese dioxide
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,
with the index finger on the activation switch.
Once activated, the user touches the cornea
lightly and briefly and withdraws the device.
A reading will be displayed on the LCD. After
four readings an average IOP will appear as
well as the reliability of the average number
shown. | The Tono-Pen AVIA is a curved,
ergonomically shaped device with the index
finger used for the activation switch. Once
activated, the user touches the cornea lightly
and briefly. A reading will be displayed on
both LCDs for ease of use by either a right
or left handed person. After 10 readings an
average IOP will appear as well as the
number of data points collected. |
| Range of
measurement | 5-80 mmHg | 5-55 mmHg |
| Calibration /
Verification | Recommended once daily | Recommended once daily. |
Summary of Tonometer Technological Characteristics
2
| | Oculab, Inc.
Ocu-film
K882750 | Medtronic Xomed
Ocu-Shield |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Protective membrane to prevent transmission
of infection between patients as well as
provide protection to the transducer tip. | 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. |
| Material | Natural Rubber Latex | Polyethylene |
| Shape | Finger Cover design | Molded to AVIA transducer shape |
| Tip Thickness | .003'' | .0008" |
| Packaging
Configuration | Individually placed on a tubular cardboard
insert and packed in a box of 90 | Multi-Pack dispensers, box of 180
Single Pack, Individual plastic cups, sealed
with a Tyvek cover |
| Provided | Non-sterile, sanitized | Multi pack: Non-sterile, sanitized
Single pack: Sterile |
| Sterilization /
Sanitization
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 (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