(15 days)
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No
The description focuses on traditional electronic measurement and linear regression for data processing, with no mention of AI/ML terms or concepts.
No
Explanation: A tonometer is a diagnostic device used to measure intraocular pressure, which helps in detecting conditions like glaucoma. It does not treat or cure any medical condition.
Yes
Explanation: The device measures intraocular pressure (IOP) to assist in routine eye examinations or when increased IOP is suspected, which falls under the definition of diagnosing or aiding in the diagnosis of a medical condition.
No
The device description explicitly mentions hardware components like a solid-state force transducer, a CMOS image transducer, and a liquid crystal display, indicating it is a physical device with integrated software, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Function: The EYE-deas EyesOPen tonometer measures intraocular pressure (IOP) by directly interacting with the eye (in vivo). It does not analyze specimens 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.
Therefore, based on the provided information, the EYE-deas EyesOPen tonometer is a medical device used for in vivo measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The EYE-deas EyesOPen tonometer is used to measure the intraocular pressure (IOP) during routine eye examinations or when an increased IOP is suspected. This device is intended for use by Ophthalmologists. Optometrists, and other trained medical professionals.
Product codes
HKY
Device Description
The Eye-deas EyesOPen tonometer 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.
The EyesOPen tonometer contains a solid-state force transducer and a CMOS image transducer that together produces electrical signals from which intraocular pressure is derived. When sufficient valid readings are obtained an IOP reading is displayed on a liquid crystal display.
Under each of the four digits are bars. The bars correspond to the goodness of fit to a linear regression of pressure against applanated diameter. The regression coefficient is 95% or better if the first bar is illuminated, 90%-95% if the second bar is illuminated, 80%-90% if the third bar is illuminated, or less than 80% if the fourth bar is illuminated.
Mentions image processing
The EyesOPen tonometer contains a solid-state force transducer and a CMOS image transducer that together produces electrical signals from which intraocular pressure is derived.
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Ophthalmologists. Optometrists, and other trained medical professionals.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Although not required to establish substantial equivalence, the EyesOPen tonometer was tested to establish baseline performance. The EyesOPen tonometer was tested on a simulated human eye. The EyesOPen tonometer performance was consistent with the performance of the predicate tonometer devices on this simulator.
Key Metrics
The bars correspond to the goodness of fit to a linear regression of pressure against applanated diameter. The regression coefficient is 95% or better if the first bar is illuminated, 90%-95% if the second bar is illuminated, 80%-90% if the third bar is illuminated, or less than 80% if the fourth bar is illuminated.
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Eye-deas, LLC
510(k) Submission
EyesOPen Manual Tonometer
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
The assigned 510(k) number is: K032769
Submitted by: Steven E. Feldon, M.D. President Eye-deas, LLC 39 Sandringham Road Rochester, New York 14610
Date Prepared: July 21, 2003
Device Name
| Proprietary Name: | EyesOPen Tonometer |
|---|---|
| Common Name: | Ocular Tonometer |
| Classification Name: | Tonometer, Manual |
Substantial Equivalence
The Eye-deas EyesOPen tonometer is similar in indications, optical design and IOP calculation methodology to the Perkins tonometer.
The Eye-deas EyesOPen tonometer is similar in indications, size, user interface, microprocessor operation and solid-state force transducer design to the Tono-Pen 3 tonometer.
Device Description
The Eye-deas EyesOPen tonometer 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.
The EyesOPen tonometer contains a solid-state force transducer and a CMOS image transducer that together produces electrical signals from which intraocular pressure is derived. When sufficient valid readings are obtained an IOP reading is displayed on a liquid crystal display.
Under each of the four digits are bars. The bars correspond to the goodness of fit to a linear regression of pressure against applanated diameter. The regression coefficient is 95% or better if the first bar is
1
Eye-deas, LLC
EyesOPen Manual Tonometer
510(k) Submission
illuminated, 90%-95% if the second bar is illuminated, 80%-90% if the third bar is illuminated, or less than 80% if the fourth bar is illuminated.
Intended Use
The Eye-deas EyesOPen tonometer is used to measure the intraocular pressure (IOP) during routine eye examinations or when an increased IOP is suspected.
2
EyesOPen Manual Tonometer
Substantial Equivalence Comparison - Perkins Tonometer
| EyesOPen tonometer | Perkins tonometer | EyesOPen tonometer | Tono-Pen 3 | ||
|---|---|---|---|---|---|
| Indication | Intraocular pressure (IOP) | ||||
| measurement | Same | Indication | Intraocular pressure (IOP) | ||
| measurement | Same | ||||
| Design | Hand-held microprocessor | ||||
| based | Hand-held manual dial | Design | Hand-held microprocessor | ||
| based | Same | ||||
| Force transducer | Solid state element | Spring and weight | Force Transducer | Solid-state | Same |
| Imaging transducer | Electronic imager | Operator's eye | Imaging Transducer | Electronic CMOS imager | No imaging elements |
| IOP algorithm basis | Goldmann | Same | IOP calculation basis | Goldmann | Mackay-Marg |
| Calibration | None required | External weights | Calibration | None required | None required |
| Contact tip | 6mm glass coaxial | 6 mm glass transverse | Contact tip | 6mm glass coaxial | 3 mm stainless steel |
| coaxial | |||||
| User interface | Briefly touched against eye | Held on patient's eye while | |||
| dial is adjusted | Measurement technique | Briefly touched against eye | Same | ||
| Display | 4 digit LCD | Scribed dial | User control | Single push button | Same |
| Range of measurement | 5 - 90 mmHg | 5-50 mmHg | Single use sanitary tip | ||
| cover | Required | Not required | |||
| Statistical reliability of the | |||||
| reading | The bars correspond to the | ||||
| goodness of fit to a linear | |||||
| regression of | |||||
| pressure against | |||||
| applanated diameter. The | |||||
| regression coefficient is | |||||
| 95% or better if the first bar | |||||
| is illuminated, 90%-95% if | |||||
| the second bar is | |||||
| illuminated, 80%-90% if the | |||||
| third bar is illuminated, or | |||||
| less than 80% if the fourth | |||||
| bar is illuminated. | No indication of reading | ||||
| reliability | Display | 4 digit LCD | Same | ||
| Versatility | Patient can be in any | ||||
| position. | Same. | Range of Measurement | 5 - 90 mmHg | Same | |
| Weight (with batteries) | 3 ounces | 12.4 ounces | Statistical Reliability | The bars correspond to the | |
| goodness of fit to a linear | |||||
| regression of | |||||
| pressure against | |||||
| applanated diameter. The | |||||
| regression coefficient is | |||||
| 95% or better if the first bar | |||||
| is illuminated, 90%-95% if | |||||
| the second bar is | |||||
| illuminated, 80%-90% if the | |||||
| third bar is illuminated, or | |||||
| less than 80% if the fourth | |||||
| bar is illuminated. | The bars correspond to | ||||
| standard deviation | |||||
| expressed as a percentage | |||||
| of the mean pressure. The | |||||
| first bar is illuminated at | |||||
| 20%. | |||||
| Dimensions | 1" H x 1¼" W x 7" L | 1 ½" H x 1 ½" W x 11" L | Versatility | Patient can be in any | |
| position. | Same. | ||||
| Power source | 2 ea 3.0 volt lithium | ||||
| batteries | 4 ea. 1.5 volt AA batteries | Weight (with batteries) | 3 ounces | 2.3 ounces | |
| Dimensions | 1" H x 1 ¼" W x 7 " L | 1" H x 1" W x 7 3/4" L | |||
| Power Source | 2 ea 3 volt lithium batteries | 2 ea. 1/3N 3 volt lithium | |||
| batteries |
3
EyesOPen Manual Tonometer
Substantial Equivalence Comparison - Tono-Pen 3 Tonometer
4
Eye-deas, LLC
EyesOPen Manual Tonometer
Performance Testing
Although not required to establish substantial equivalence, the EyesOPen tonometer was tested to establish baseline performance. The EyesOPen tonometer was tested on a simulated human eye. The EyesOPen tonometer performance was consistent with the performance of the predicate tonometer devices on this simulator.
Stivin Foldm
Submitter's Signature
7-28-03
Date
5
Image /page/5/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The eagle is facing to the left and has three lines that make up its body. The text is in all caps and is evenly spaced around the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 3 2003
Eye-deas, LLC c/o Erin Sparnon CITECH 5200 Butler Pike Plymouth Meeting, PA 19462
Re: K032769
Trade/Device Name: EyesOPen Tonometer Regulation Number: 21 CFR 886.1930 Regulation Name: Tonometer and accesories Regulatory Class: Class II Product Code: HKY Dated: September 5, 2003 Received: September 8, 2003
Dear Ms. Sparnon:
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.
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Page 2 - Erin Sparnon
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA 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) 594-4613. 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/dsma/dsmamain.html
Sincerely yours,
A. Károlyi Károly
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Attachment I b
Page 1 of 1
510(k) Number (if known): K032769
Device Name: EyesOpen tonometer (manual tonometer)
Indications for Use:
The EYE-deas EyesOPen tonometer is used to measure the intraocular pressure (IOP) during routine eye examinations or when an increased IOP is suspected. This device is intended for use by Ophthalmologists. Optometrists, and other trained medical professionals.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
| 510(k) Number | K032769 |
|---|---|
| --------------- | --------- |
| Prescription Use | OR | Over-the-Counter Use | |
|---|---|---|---|
| (Per 21CFR801.109) |