(123 days)
No
The description focuses on the Goldmann applanation method and standard performance testing, with no mention of AI or ML terms or methodologies.
No
The device is used for measuring intraocular pressure to aid in screening and diagnosis of Glaucoma, not for treating or preventing a disease.
Yes
The device is indicated for measuring intraocular pressure "to aid in the screening and diagnosis of Glaucoma," which clearly states its role in diagnosis.
No
The device description explicitly states it is an "active medical device, powered by a single AA battery" and its operation is based on the Goldmann applanation method, indicating it is a hardware device.
Based on the provided information, the Keeler Applanation Tonometer is not an IVD (In Vitro Diagnostic) 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.
- Device Function: The Keeler Applanation Tonometer directly measures intraocular pressure on the surface of the eye (cornea). It does not analyze any biological specimens taken from the patient.
- Intended Use: The intended use is to measure intraocular pressure to aid in the screening and diagnosis of Glaucoma, which is a direct measurement on the patient, not an analysis of a sample.
Therefore, this device falls under the category of a medical device used for direct measurement on the patient, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Keeler Applanation Tonometer is indicated for measuring intraocular pressure to aid in the screening and diagnosis of Glaucoma.
Product codes
HKY
Device Description
The Digital Keeler Applanation Tonometer is a screening device used to measure intraocular pressure which is one of the factors considered in diagnosing glaucoma. The product is an active medical device, powered by a single AA battery. The operation principal is based on Goldmann applanation method.
The Indications for Use, Operating principles, measurement accuracy and repeatability are the same as the predicate device. The device is used in conjunction with commercially available Slit lamps and can be used with the same mounting options as predicate device.
The D-KAT uses the same Applanation Prisms as the predicate Keeler Applanation Tonometer.
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
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)
Verification tests have been carried out to confirm that the performance and safety aspects of the modified Digital Keeler Applanation Tonometer (D-KAT) are comparable with the Keeler Applanation Tonometer cleared for marketing under 510(k) K093445. The results demonstrated that the modified D-KAT was substantially equivalent in relation to performance, usability and safety to the aforementioned predicate device.
With respect to performance of the modified tonometer, bench testing using a balance system was carried to verify the measuring force was in accordance with Section A2 of ISO 8612:2009, Ophthalmic Instruments - Tonometers.
Usability tests have also been conducted by healthcare professionals, where comparisons were made against the predicate device (K093445).
In accordance with the Keeler Software Quality Plan, the software used in the modified D-KAT has been verified against design requirements and finally released, as required by IEC 62304 Medical device software - Software life cvcle processes.
In addition to the above testing activities, Keeler has conducted assessment and/or testing to the following standards to further reinforce the safety and effectiveness of the modified D-KAT:
- AAMI ANSI 60601-1:2005 Medical Electrical Equipment-General requirements for safety and essential performance
- IEC 60601-1-2:2007 Medical Electrical Equipment-Electromagnetic compatibility-Requirements and tests
- ISO 15004-1:2006 Ophthalmic Instruments- Fundamental requirements and test methods Part 1: General requirements applicable to all ophthalmic instruments
- ISO 15223-1:2012 Medical Devices: Symbols to be used with medical devices labels, labelling and information to be supplied-general requirements
- Biological evaluation of medical devices: - ISO10993-1 Evaluation and testing within a risk management process
- ISO14971:2007 Medical Devices-Application of risk management to medical devices
In all tests the modified device was in compliance with these FDA recognized standards.
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
K 133234
Ophthalmir Instruments
FEB 2 1 2014
510(k) Summary of Safety and Effectiveness
Submitter Name and Address 1.
Keeler Instruments Inc. 459 Parkway Broomall PA 19008
Eugene R Van Arsdale (Marketing Manager) Contact: Phone: 1 610 353 4350 Fax: 1 610 353 7814 erv@keelerusa.com Email:
Date Prepared: 20 February 2014
2. Device Name (Unmodified)
Trade Name:
Common/Usual Name: T-Type KAT, R-Type KAT Classification Name: Tonometer and Accessories 886.1930 Regulation No: Device Requlatory Class: ============================================================================================================================================================================== Review Panel: Ophthalmic Product Code: HKY Premarket Notification (510(k)) Number: K093445
- Proposed Modification
The proposed modification described in this Traditional 510(k) covers the introduction of a digital variant to the current Keeler Applanation Tonometer (KAT) range. This modification is intended to provide an addition to the Keeler Applanation Tonometers product range.
(KAT)
Keeler Applanation Tonometer
In applanation tonometry the intraocular pressure (IOP) is calculated from the force required to flatten a constant area of the cornea. Goldmann tonometry is considered to be the gold standard test and is the most widely accepted method in current practice.
The new digital variant of the KAT uses the same operating principle found in all Goldmann type tonometers.
The internal mechanism of the KAT has been modified to permit the measured IOP to be read on an LED display. The LED display allows for easy reading by the user rather than reading from the dial as is currently the case with standard Goldmann tonometers.
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The intended use of the Digital Keeler Applanation Tonometer (D-KAT) as well as the method used by the clinician to obtain a reading remains unchanged by this modification.
4. Device Description
The Digital Keeler Applanation Tonometer is a screening device used to measure intraocular pressure which is one of the factors considered in diagnosing glaucoma. The product is an active medical device, powered by a single AA battery. The operation principal is based on Goldmann applanation method.
The Indications for Use, Operating principles, measurement accuracy and repeatability are the same as the predicate device. The device is used in conjunction with commercially available Slit lamps and can be used with the same mounting options as predicate device.
The D-KAT uses the same Applanation Prisms as the predicate Keeler Applanation Tonometer.
Method of Operation
In applanation tonometry the intraocular pressure is calculated from the force required to flatten a constant area of the cornea. Goldmann tonometry is considered to be the qold standard test and is the most widely accepted method in current practice.
The Digital Keeler Applanation Tonometer functions in accordance with the 'Goldmann method' i.e. the measuring of pressure to maintain a uniform i applanation of the surface of the eye.
A disinfected or sterile disposable applanation prism is mounted on the Tonometer head at the end of the measurement arm and then placed against the cornea. The examiner then uses a cobalt blue filter to view two green semi circles, known as mires. The force applied to the Tonometer head is then adjusted using the rotating measurement drum connected to a variable tension spring until the inner edges of the green mires in the viewfinder meet. When an area of 3.06mm has been flattened, the opposing forces of corneal rigidity and the tear film are roughly approximate and cancel each other out allowing the pressure in the eye to be determined from the force applied.
The intraocular pressure is presented on the digital display.
The D-KAT is used in coniunction with commercially available Slit Lamos and can be used with the same mounting options as the predicate devices.
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Calibration
During factory setup / calibration known pressures covering the measurement range are applied to the measurement arm using calibration bars verified using the calibration procedure outlined in the Tonometer standard ISO 8612:2009.
Calibration provides a relationship between the pressure applied to the measurement arm and the position of the rotating measuring drum. Linear interpolation is used between the calibration points.
It should be noted that whilst the D-KAT has a Digital read-out that can indicate decimal point measurement, it is not intended to imply higher accuracy. The D-KAT instrument has been validated to a measurement deviation of ±0.49mN (~0.5mmHg) or 1.5%, whichever is greater, in accordance with the above standard.
Software
The software uses information stored / programmed during the factory setup / calibration to monitor the position of the measurement arm against the position of the rotating measuring drum to determine the patients IOP, which is displayed to the user on the LED display.
5. Labelling and Intended Use
Instructions for use (IFU) for the applanation tonometer have been updated to incorporate the use of the digital interface.
The intended use of the Digital Keeler Applanation Tonometer (D-KAT) as well as the method used by the clinician to obtain a reading remains unchanged by this modification.
"The Keeler Applanation Tonometer is indicated for measuring intraocular pressure to aid in the screening and diagnosis of Glaucoma."
Materials Biocompatibility 6.
With respect to material that comes into direct contact intentionally with the eve, there are no changes.
Cleaning and Disinfection 7.
Cleaning instructions for the tonometer body and the recommended method for disinfecting applanation prisms remains unchanged.
Instructions have been provided in the Instructions for use.
8. Comparison of the device with the Predicate
The comparison table below summarizes the similarities and differences between both systems, with respect to safety and effectiveness, which are discussed in more detail in the following sections.
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Ophthalmic Instruments
| Characteristic
Features | Predicate Device -
Keeler Applanation
Tonometer
(KAT) | Modified Device -
Digital Keeler
Applanation
Tonometer
(D-KAT) | Notes |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Type | Manual contact
Tonometer | Manual contact
Tonometer | No change |
| Indication | Intraocular Pressure
(IOP) measurement | Intraocular Pressure
(IOP) measurement | No change |
| Units of
measure | mmHg - millimetre
of mercury | mmHg - millimetre
of mercury | No change |
| Design | Slit lamp mounted
manual dial | Slit lamp mounted
manual dial | No change |
| Measurement
Range | 0-80mmHg | 5-65mmHg | A measurement
range of 0 -
80mmHg is not a
requirement for this
device
Device meets the
requirements
specified in the
Tonometer
standard ISO
8612:2009
The modification
does not affect the
safety or
effectiveness of the
device |
| Measurement
technique | Applanation | Applanation | No change |
| Measurement
Method | Goldmann method -
the measuring of
pressure to maintain
a uniform
applanation of the
surface of the eye. | Goldmann method -
the measuring of
pressure to maintain
a uniform
applanation of the
surface of the eye. | No change |
| Calibration | Maintenance and
calibration required
Factory set
Calibration arm
assembly is | Maintenance and
calibration required
Factory set
Calibration arm
assembly is | No change |
| | supplied with each
device to check
calibration | supplied with each
device to check
calibration | |
| Intended use | The Keeler
Applanation
Tonometer is
indicated for
measuring
intraocular pressure
to aid in the
screening and
diagnosis of
Glaucoma. | The Keeler
Applanation
Tonometer is
indicated for
measuring
intraocular pressure
to aid in the
screening and
diagnosis of
Glaucoma. | No change |
| Mounting
method on slit
lamp | Fixed (R-Type) and
Take-away (T-Type) | Fixed (R-Type) and
Take-away (T-Type) | No change |
| Measurement
deviation | 0.49 mN or 1.5% of
measurement value,
whichever is the
greater | 0.49 mN or 1.5% of
measurement value,
whichever is the
greater | No change |
| Power
requirements | None required –
device is
mechanical | AA Battery to power
digital display | Device has been
tested to meet IEC
60601-1 Electrical
Safety and IEC
60601-1-2 EMC
requirements
The modification
does not affect the
safety or
effectiveness of the
device |
| Software | None | Contains software | The software has
been designed and
developed in
accordance with
ISO 62304 Medical
device software -
Software life-cycle
processes
A Calibration
(verification) Arm
Assembly is
supplied with each |
| | | | the user to check
the tonometer is in
calibration. |
| | | | The modification
does not affect the
safety or
effectiveness of the
device |
| Display | Analogue scale -
Direct reading from
the dial (each
division on dial of
rotating measuring
knob is equal to
0.2gmf (1.96mN))
which is multiplied
by 10 by the user to
calculate the
pressure in mmHg | Numerical display -
Direct reading of
IOP in mmHg from
display | Both devices
generate a IOP in
mmHg |
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Ophthalmic Instruments
9. Performance and Safety
Verification tests have been carried out to confirm that the performance and safety aspects of the modified Digital Keeler Applanation Tonometer (D-KAT) are comparable with the Keeler Applanation Tonometer cleared for marketing under 510(k) K093445. The results demonstrated that the modified D-KAT was substantially equivalent in relation to performance, usability and safety to the aforementioned predicate device.
With respect to performance of the modified tonometer, bench testing using a balance system was carried to verify the measuring force was in accordance with Section A2 of ISO 8612:2009, Ophthalmic Instruments - Tonometers.
Usability tests have also been conducted by healthcare professionals, where comparisons were made against the predicate device (K093445).
In accordance with the Keeler Software Quality Plan, the software used in the modified D-KAT has been verified against design requirements and finally released, as required by IEC 62304 Medical device software - Software life cvcle processes.
In addition to the above testing activities, Keeler has conducted assessment and/or testing to the following standards to further reinforce the safety and effectiveness of the modified D-KAT:
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Ophthalmic Instruments
| | ~ AAMI ANSI 60601-1:2005 Medical Electrical Equipment-General
requirements for safety and essential
performance |
|--|--------------------------------------------------------------------------------------------------------------------------|
| | |
- IEC 60601-1-2:2007 Medical Electrical Equipment-Electromagnetic compatibility-Requirements and tests
- ISO 15004-1:2006 Ophthalmic Instruments- Fundamental requirements and test methods Part 1: General requirements applicable to all ophthalmic instruments
- ISO 15223-1:2012 Medical Devices: Symbols to be used with medical devices labels, labelling and information to be supplied-general requirements
- Biological evaluation of medical devices: - ISO10993-1 Evaluation and testing within a risk management process
- ISO14971:2007 Medical Devices-Application of risk management to medical devices
In all tests the modified device was in compliance with these FDA recognized standards.
10. Substantial Equivalence
The modified Digital Keeler Applanation Tonometer is considered to be substantially equivalent to the Keeler Applanation Tonometer described in the original 510(k) submission (K093445).
Digital Keeler Applanation Tonometer Traditional 510(k)
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The text is in all caps and is oriented to follow the curve of the circle.
February 21, 2014
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002
Keeler Instruments, Inc. % Mr. Eugene R. VanArsdale Marketing Manager 456 Parkway Broomall, PA 19008-4295
Re: K133234
Trade/Device Name: Digital Keeler Applanation Tonometer (D-KAT) Regulation Number: 21 CFR 886.1930 Regulation Name: Tonometer and Accessories Regulatory Class: Class II Product Code: HKY Dated: January 6, 2014 Received: January 7, 2014
Dear Mr. VanArsdale:
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. Drye. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 conceming 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.
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Page 2 - Mr. Eugene VanArsdale ﺑﻪ ﻣﺮﮐﺰ ﺩﺭ ﻣﯿ
.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.goy/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kesia Y. Alexander -S
for Malvina B. Eydelman, 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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Image /page/9/Picture/0 description: The image shows the word "Keeler" in a bold, sans-serif font. Below the word "Keeler" is the phrase "Ophthalmic Instruments" in a smaller font size. The text is black against a white background.
Ophthelmic Instruments
Indications for Use Statement
510(k) Number (if known): K133234
Device Name: Digital Keeler Applanation Tonometer. (D-KAT)
Indications for Use:
The Keeler Applanation Tonometer is indicated for measuring intraocular pressure to aid in the screening and diagnosis of Glaucoma.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jan C. Callaway -S 2014.02.04 14:41:26 -05'00'