(90 days)
Not Found
No
The device description explicitly states it is a non-active, completely mechanical device without electrical components, and the operation principle is based on the Goldmann applanation method, which is a traditional, non-AI/ML technique. There are no mentions of AI, ML, image processing, or data sets for training/testing.
No.
The device is indicated for measuring intraocular pressure to aid in the screening and diagnosis of glaucoma, not for treating or curing a condition.
Yes
The "Intended Use / Indications for Use" section states that the device is "indicated for measuring intraocular pressure to aid in the screening and diagnosis of Glaucoma," which clearly points to a diagnostic purpose. The "Device Description" further clarifies it as a "screening device used to measure intraocular pressure which is one of the factors considered in diagnosing glaucoma."
No
The device description explicitly states it is a "non-active medical device and is completely mechanical, therefore without electrical components." This indicates it is a hardware-based device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Keeler Applanation Tonometer directly measures intraocular pressure within the eye. It does not analyze a specimen taken from the body.
- Anatomical Site: The device interacts directly with the eye (intraocular), not with a sample taken from the body.
Therefore, based on the provided information, the Keeler Applanation Tonometer is a medical device, but it falls under a different classification than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Keeler Applanation Tonometer is indicated for measuring intraccular pressure to aid in the screening and diagnosis of Glaucoma.
Product codes
HKY
Device Description
The 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 a non-active medical device and is completely mechanical, therefore without electrical components. The operation principal is based on Goldmann applanation method. The product is installed on a special support on the slit lamp and is used in conjunction with commercially available slit lamps.
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)
The performance of Keeler Applanation Tonometer has been evaluated in bench testing, comparative study with its predicative devices and field trial.
Bench testing was carried out using arrangement as per Tonometer Standard BSENISO 8612: 2001. Keeler Applanation Tonometer units under test are verified against the nominal requirements of Tonometer standard.
Bench testing arrangement was also used to carry out comparative study, i.e. comparing Keeler Applanation Tonometer with its predicate devices. Keeler Applanation Tonometer and its predicate devices were subject to the same nominal requirements as set by the Tonometer standard and the results demonstrate that they are substantially equivalent.
Field test was conducted by ophthalmic professional to compare Keeler Applanation Tonometer with its predicate device and the findings are comparable.
Based on the results of the performance testing, the Keeler Applanation Tonometer is iudged to be as safe, as effective and performs as well as the predicate devices.
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
Abbreviated 510(k) Summary
Manufacturer's information
Company Name: Keeler Ltd
.
Company Address: Clewer Hill Road
Windsor
SL4 4AA
UK
Contact Person: Neil Atkins
Telephone: +44 (0)1753 857177 +44 (0)1753 827145 · Fax:
Submitter's information
The submitter of this pre-market notification is:
Mr. Eugene VanArsdale (Marketing Manager). Keeler Instruments Inc 456. Parkway, Broomall, PA 19008 Company Phone No: (610) 353 4350 Company Fax No: (610) 353 7814
Date summary prepared: January 04, 2010
Proposed Device Identification
| Device Trade Name: | Keeler Applanation Tonometer |
|---|---|
| Common Name: | Goldmann Tonometer |
| Class: | 2 |
| Classification Panel: | 86 |
| Product Code: | HKY |
| Regulation Number: | 886.1930 |
Indications for Use
The Keeler Applanation Tonometer is indicated for measuring intraccular pressure to aid in the screening and diagnosis of Glaucoma.
Device Description and intended use
The 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 a non-active medical device and is completely mechanical, therefore without electrical components,
JAN 1 9 2010
1
The operation principal is based on Goldmann applanation method.
The product is installed on a special support on the slit lamp and is used in conjunction with commercially available slit lamps.
Predicated Devices
Keeler Applanation Tonometer is judged to be substantially equivalent in safety, effectiveness and intended use to the following legally marketed devices:
Substantial Equivalence 1:
| Predicate Device: | F900 and A900, CSO |
|---|---|
| 510(k) No: | K022054 |
| Manufacturer: | CSO S.R.L |
| Substantial Equivalence 2: | |
|---|---|
| Predicate Device: | Haag Streit AT 900 |
| 510(k) No: | K981432 |
| Manufacturer: | Haag-Streit |
Substantial Equivalence Comparison
Table below shows the comparison of Keeler Applanation Tonometer to predicate devices. The comparison of intended use and technological features of KAT indicate that the device is substantially equivalent to legally marketed predicate devices.
| Comparison of Goldmann Tonometer Technological Characteristics
| Keeler Applanation Tonometer vs. CSO Tonometer | ||
|---|---|---|
| Criteria | Predicate Device | |
| F900 and A900, | ||
| CSO Tonometers | ||
| (Re:510(k) | ||
| K022054) | Keeler Applanation Tonometer (KAT) | |
| Type | Manual contact | |
| Tonometer | Manual contact Tonometer | |
| Indication | Intraocular Pressure | |
| (IOP) measurement | Intraocular Pressure (IOP) | |
| measurement | ||
| Design | Slit lamp mounted | |
| manual dial | Slit lamp mounted manual dial | |
| Prism Material | Acrylic (PMMA) | Acrylic (PMMA) |
| Measurement Range | 0-80mmHg | 0-80mmHg |
| Measurement | ||
| technique | Applanation | Applanation |
| Measurement Method | Direct reading of | |
| IOP in mmHg (each | ||
| division on dial of | ||
| measuring drum is | ||
| equal to 0.2gmf | ||
| (1.96mN)) | Direct reading of IOP in mmHg (each | |
| division on dial of measuring drum is | ||
| equal to 0.2gmf (1.96mN)) | ||
| Calibration | Maintenance and | Maintenance and calibration required |
2
| calibration required | ||
|---|---|---|
| Intended use | Instrument is | |
| intended to measure | ||
| pressure by | ||
| applanation | ||
| (applying a small flat | ||
| disc to cornea) | Instrument is intended to measure | |
| pressure by applanation (applying a | ||
| small flat disc to cornea) |
| Comparison of Goldmann Tonometer Technological Characteristics
| Keeler Applanation Tonometer vs. Haag-Streit AT 900 | ||
|---|---|---|
| Criteria | Predicate Device | |
| Haag-Streit AT 900 | ||
| (Re:510(k) | ||
| K0981432) | Keeler Applanation Tonometer (KAT) | |
| Type | Manual contact | |
| Tonometer | Manual contact Tonometer | |
| Indication | Intraocular Pressure | |
| (IOP) measurement | Intraocular Pressure (IOP) | |
| measurement | ||
| Design | Slit lamp mounted | |
| manual dial | Slit lamp mounted manual dial | |
| Measurement Range | 0-80mmHg | 0-80mmHg |
| Measurement | ||
| technique | Applanation | Applanation |
| Measurement Method | Direct reading of | |
| IOP in mmHg (each | ||
| division on dial of | ||
| measuring drum is | ||
| equal to 0.2gmf | ||
| (1.96mN)) | Direct reading of IOP in mmHg (each | |
| division on dial of measuring drum is | ||
| equal to 0.2gmf (1.96mN)) | ||
| Calibration | Maintenance and | |
| Calibration required | Maintenance and calibration required | |
| Intended use | Instrument is | |
| intended to measure | ||
| pressure by | ||
| applanation | ||
| (applying a small flat | ||
| disc to cornea) | Instrument is intended to measure | |
| pressure by applanation (applying a | ||
| small flat disc to cornea) |
Note: There is no difference between Predicate devices and Keeler Applanation
Tonometer.
.
3
Summary of Performance Testing
The performance of Keeler Applanation Tonometer has been evaluated in bench testing, comparative study with its predicative devices and field trial.
Bench testing was carried out using arrangement as per Tonometer Standard BSENISO 8612: 2001. Keeler Applanation Tonometer units under test are verified against the nominal requirements of Tonometer standard.
Bench testing arrangement was also used to carry out comparative study, i.e. comparing Keeler Applanation Tonometer with its predicate devices. Keeler Applanation Tonometer and its predicate devices were subject to the same nominal requirements as set by the Tonometer standard and the results demonstrate that they are substantially equivalent.
Field test was conducted by ophthalmic professional to compare Keeler Applanation Tonometer with its predicate device and the findings are comparable.
Based on the results of the performance testing, the Keeler Applanation Tonometer is iudged to be as safe, as effective and performs as well as the predicate devices.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Keeler Instruments, Inc. c/o Mr. Eugene R. VanArsdale Marketing Director 456 Parkway Broomall, PA 19008
JAN 1 9 2010
Re: K093445
Trade/Device Name: Keeler Applanation Tonometer, T-Type KAT, K-Type KAT; (KAT) Regulation Number: 21 CFR 886.1930 Regulation Name: Tonometer and Accessories Regulatory Class: II Product Code: HKY Dated: October 19, 2009 Received: October 21, 2009
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, 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 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 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.
5
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrl/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Kesia Alexander for
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known):
Device Name: Keeler Applanation Tonometer (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 V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Danl Kauk
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K093445