(28 days)
Not Found
No
The description focuses on a strain gage converting pressure to an electrical signal and calculating a mean from four readings, which are standard electronic and statistical functions, not indicative of AI/ML. There is no mention of AI, ML, or related terms, nor any description of training or test data sets.
No.
The document states that the device measures intraocular pressure during routine eye examinations or when increased IOP is suspected, which is a diagnostic function, not a therapeutic one.
Yes
The device is used to measure intraocular pressure (IOP) during routine eye examinations or when an increased IOP is suspected, which aids in the detection and monitoring of eye conditions.
No
The device description explicitly states it is a "precision electronic tonometer" with a physical body, a strain gage, an LCD display, and a molded plastic tip, indicating it is a hardware device with embedded software, not a software-only medical device.
Based on the provided information, the MENTOR TONO-PEN 3 is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- MENTOR TONO-PEN 3 Function: The MENTOR TONO-PEN 3 directly measures intraocular pressure (IOP) within the eye. It does not analyze a sample taken from the body.
- Intended Use: The intended use is to measure IOP during eye examinations, which is a direct measurement on the patient, not an analysis of a biological sample.
Therefore, the MENTOR TONO-PEN 3 is a medical device used for direct measurement on a patient, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
Not Found
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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
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)
The determination of substantial equivalence is not based on an assessment of any performance data, clinical or non-clinical.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
MENTOR TONO-PEN XL
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
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: (617) 871-8184 Fax: (617) 871-7785
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.
1
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 |
| 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 |
2
The determination of substantial equivalence is not based on an assessment of any performance data, clinical or non-clinical.
DDD
Submitter's Signature
10-15-96
Date