(40 days)
No
The description focuses on the Goldmann applanation method and does not mention any AI/ML components or image processing.
No.
The device is a diagnostic tool used for measuring intraocular pressure to aid in the screening and diagnosis of Glaucoma, rather than directly providing therapy.
Yes
The "Intended Use / Indications for Use" states that the device is indicated "to aid in the screening and diagnosis of Glaucoma," which is a diagnostic purpose.
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 includes hardware components.
Based on the provided information, this device 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.
- Device Function: The Z-type Digital Keeler Applanation Tonometer measures intraocular pressure by directly contacting the cornea of the eye. This is a measurement taken in vivo (within the living body), not in vitro (in a test tube or laboratory setting).
- Intended Use: The intended use is to measure intraocular pressure to aid in the screening and diagnosis of Glaucoma. This is a clinical measurement taken directly from the patient.
Therefore, the device's function and intended use clearly place it outside the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Z-type Digital Keeler Applanation Tonometer is indicated for measuring intraocular pressure to aid in the screening and diagnosis of Glaucoma.
Product codes
HKY
Device Description
The Z-type 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cornea
Indicated Patient Age Range
Not Found
Intended User / Care Setting
In a professional healthcare facility environment
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
Verification tests have been carried out in accordance to the FDA quidelines "Tonometers - Premarket Notification [510(k)] Submissions" to confirm that the performance and safety aspects of the modified applanation tonometer are comparable with the Digital Keeler Applanation Tonometer cleared for marketing under 510(k) K133234. The modified Z-type D-KAT has also been evaluated against the requirements of BS EN 60601-1 for electrical safety and to BS EN 60601-1-2 for electromagnetic compatibility. In all tests the modified device was in compliance with these FDA recognized standards.
Key Metrics
Measurement deviation: 0.49 mN or 1.5% of measurement value, whichever is the greater
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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by a flowing line that forms the hair and neck of each figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 17, 2014
Keeler Instruments Inc. % Mr. Eugene R. Van Arsdale Marketing Manager 459 Parkway Broomall, PA 19008
Re: K142179
Trade/Device Name: Z-type Digital Keeler Applanation Tonometer Regulation Number: 21 CFR 886.1930 Regulation Name: Tonometer and Accessories Regulatory Class: Class II Product Code: HKY Dated: August 7, 2014 Received: August 8, 2014
Dear Mr. Van Arsdale:
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. 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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
2
Indications for Use
510(k) Number (if known) K142179
Device Name
Z-type Digital Keeler Applanation Tonometer
Indications for Use (Describe)
The Z-type Digital Keeler Applanation Tonometer is indicated for measuring intraocular pressure to aid in the screening and diagnosis of Glaucoma.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Digital Keeler Applanation
Image /page/3/Picture/1 description: The image shows the logo for Keeler Ophthalmic Instruments. The word "Keeler" is written in a large, bold, blue font. Below the word "Keeler" is the phrase "Ophthalmic Instruments" written in a smaller, gray font. The logo is simple and professional.
10. 510 (K) Summarv of safety and Effectiveness
1. Submitter Name and Address
Keeler Instruments Inc. 459 Parkwav Broomall PA 19008
Contact: Eugene R Van Arsdale (Marketing Manager) Phone: 1 610 353 4350 Fax: 1 610 353 7814 Email: erv@keelerusa.com
Date Prepared: June 2014
2. Device Name (Unmodified)
Trade Name:
Tonometer (D-KAT) T-Type D-KAT, R-Type D-KAT Common/Usual Name: Classification Name: Tonometer and Accessories Regulation No: 886.1930 Device Requlatory Class: ll Review Panel: Ophthalmic Product Code: HKY Premarket Notification (510(k)) Number: K093445
3. Proposed Modification
The proposed modification described in this Special 510(k) covers the dimensional changes to the current Digital Keeler Applanation Tonometer (D-KAT) to allow mounting of the device on the bottom-illuminating slit lamp (Zeisstype illumination system).
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 variant of the D-KAT uses the same operating principle found in all Goldmann type tonometers.
The internal mechanism of the new version of D-KAT (Z-type D-KAT) functions in the same way as the previously cleared model (T-type D-KAT, R-type D-KAT) and permits the measured IOP to be read on an LED display. The LED display allows for easy reading by the user. The dimensional modifications introduced in the current model allow the model to be fitted on Zeiss-type slit lamp.
4
Image /page/4/Picture/0 description: The image shows the logo for Keeler Ophthalmic Instruments. The word "Keeler" is written in a large, blue, sans-serif font. Below the word "Keeler" is the phrase "Ophthalmic Instruments" written in a smaller, gray, sans-serif font. The logo is simple and clean, and it is likely used to represent the company's brand.
The intended use of the Z-tvpe Digital Keeler Applanation Tonometer (Ztype D-KAT) as well as the method used by the clinician to obtain a reading remains unchanged by this modification.
4. Device Description
The Z-type 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 Zeiss-type Slit lamps.
The Z-type D-KAT uses the same Applanation Prisms as the predicate 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 gold standard test and is the most widely accepted method in current practice.
The Z-tvpe Digital Keeler Applanation Tonometer functions in accordance with the 'Goldmann method' i.e. the measuring of pressure to maintain a uniform applanation of the surface of the eye.
The Z-type D-KAT is used in conjunction with commercially available Zeiss-type Slit Lamps.
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.
5
Image /page/5/Picture/0 description: The image shows the logo for Keeler Ophthalmic Instruments. The word "Keeler" is written in a large, bold, blue font. Below the word "Keeler" is the phrase "Ophthalmic Instruments" written in a smaller, gray font. The logo is simple and professional.
Calibration Procedure
During factory setup / calibration procedure known pressures covering the measurement range are applied to the measurement arm using a calibration arm verified using the calibration procedure outlined in the Tonometer standard ISO 8612:2009.
Calibration procedure 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.
Software
The software uses information stored / programmed during the factory setup / calibration procedure 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 change in shape of the device.
The intended use of the Z-type 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 Digital Keeler Applanation Tonometer is indicated for measuring intraocular pressure to aid in the screening and diagnosis of Glaucoma."
6. Materials Biocompatibility
With respect to material that comes into direct contact intentionally with the eye, there are no changes.
7. Cleaning and Disinfection
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.
6
Image /page/6/Picture/0 description: The image contains the logo for Keeler Ophthalmic Instruments. The word "Keeler" is in a large, bold, blue font. Below that, the words "Ophthalmic Instruments" are in a smaller, gray font. The logo is simple and clean.
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.
| Characteristic
Features | Predicate Device -
Digital Keeler
Applanation
Tonometer
(T-type and R-type
D-KAT) | Modified Device -
Z-type Digital
Keeler applanation
Tonometer
(Z
type D-KAT) | Notes |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Type | Manual contact
Tonometer | Manual contact
Tonometer | No change |
| Indicated 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 |
| Intended Use | Intraocular Pressure
(IOP) measurement | Intraocular Pressure
(IOP) measurement | No change |
| Target
Population | Patients with high
IOP | Patients with high
IOP | No change |
| Anatomical
Sites | Cornea | Cornea | No change |
| Where Used | In a professional
healthcare facility
environment | In a professional
healthcare facility
environment | No change |
| Units of
measure | mmHg - millimetre
of mercury | mmHg - millimetre
of mercury | No change |
| Design | Mounted on top
illuminating (Haag-
Streit-style) Slit
lamp, manual dial | Mounted on bottom-
illuminating (Zeiss-
style) Slit lamp,
manual dial | Change in shape
of the device to
allow mounting
on bottom-
illuminating slit
lamp( Zeiss-type
illumination |
| | | | system). |
| | | | The change
does not affect
the intended
use, safety and
effectiveness or
the fundamental
scientific
technology. |
| Display | Numerical display -
Direct reading of
IOP in mmHg from
display | Numerical display -
Direct reading of
IOP in mmHg from
display | No change |
| Measurement
Range | 5-65mmHg | 5-65mmHg | No change |
| 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 |
| 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 | AA Battery to power
digital display | AA Battery to power
digital display | No change |
| Software | Contains software | Contains software | No change |
| Mounting
method on slit
lamp | Fixed (R-Type) and
Take-away (T-Type) | Fixed | No change |
| Maintenance
and Calibration | Maintenance and
calibration required | Maintenance and
calibration required | No change |
| | Factory set | Factory set | No change |
| | Calibration arm
assembly is
supplied with each
device to check | Calibration arm
assembly is
supplied with each
device to check | No change |
| | | | |
| | calibration | calibration | |
| Materials | Tonometer body -
anodized aluminium; | Tonometer body -
anodized aluminium; | No change |
| | Tonometer prism -
Medical grade
acrylic | Tonometer prism -
Medical grade
acrylic | |
| Biocompatibility | All materials are
tested for
biocompatibility | All materials are
tested for
biocompatibility | No change |
| 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 |
| Intended Use | Intraocular Pressure
(IOP) measurement | Intraocular Pressure
(IOP) measurement | No change |
| Units of
measure | mmHg - millimetre
of mercury | mmHg - millimetre
of mercury | No change |
| Design | Mounted on top-
illuminating (Haag-
Streit-style) Slit
lamp, manual dial | Mounted on bottom-
illuminating (Zeiss-
style) Slit lamp,
manual dial | Change in shape
of the device to
mount on Zeiss-
type illumination
system.
The change
does not affect
the intended use,
safety and
effectiveness or
the fundamental
scientific
technology. |
| Measurement
Range | 5-65mmHg | 5-65mmHg | No change |
| 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 |
| Maintenance | Maintenance and | Maintenance and | No change |
| and Calibration | calibration required | calibration required | |
| | Factory set | Factory set | |
| | Calibration arm
assembly is
supplied with each
device to check
calibration | Calibration arm
assembly is
supplied with each
device to check
calibration | |
| Indicated 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 | 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 | AA Battery to power
digital display | AA Battery to power
digital display | No change |
| Software | Contains software | Contains software | No change |
| Display | Numerical display -
Direct reading of
IOP in mmHg from
display | Numerical display -
Direct reading of
IOP in mmHg from
display | No change |
7
Image /page/7/Picture/0 description: The image contains the logo for Keeler Ophthalmic Instruments. The word "Keeler" is written in a large, bold, blue font. Below the word "Keeler" is the phrase "Ophthalmic Instruments" written in a smaller, gray font. The logo is simple and professional.
8
Image /page/8/Picture/0 description: The image contains the logo for Keeler Ophthalmic Instruments. The word "Keeler" is written in a large, bold, blue font. Below the word "Keeler" is the phrase "Ophthalmic Instruments" written in a smaller, gray font. The logo is simple and professional.
Special 510(K)
9
Image /page/9/Picture/0 description: The image contains the logo for Keeler Ophthalmic Instruments. The word "Keeler" is in a bold, blue sans-serif font. Below it, the words "Ophthalmic Instruments" are in a smaller, gray sans-serif font. The logo is simple and professional.
10
Image /page/10/Picture/0 description: The image shows the logo for Keeler Ophthalmic Instruments. The word "Keeler" is written in a large, blue, sans-serif font. Below the word "Keeler" is the phrase "Ophthalmic Instruments" written in a smaller, gray, sans-serif font. The logo is simple and clean, and it is likely used to represent the company on its website, marketing materials, and products.
9. Performance and Safety
Verification tests have been carried out in accordance to the FDA quidelines "Tonometers - Premarket Notification [510(k)] Submissions" to confirm that the performance and safety aspects of the modified applanation tonometer are comparable with the Digital Keeler Applanation Tonometer cleared for marketing under 510(k) K133234.
The software used in the modified Z-type D-KAT has been verified against the requirements ISO 62304 Medical device software - Software life cycle processes.
The modified Z-type D-KAT has also been evaluated against the requirements of BS EN 60601-1 for electrical safety and to BS EN 60601-1-2 for electromagnetic compatibility.
In all tests the modified device was in compliance with these FDA recognized standards.
10. Substantial Equivalence
The modified Z-type Digital Keeler Applanation Tonometer is considered to be substantially equivalent to the Digital Keeler Applanation Tonometer described in the original 510(k) submissions (K133234).