The Keeler Applanation Tonometer and Digital Keeler Applanation Tonometer are indicated for measuring intraocular pressure to aid in the screening and diagnosis of Glaucoma.

Device Description

The unmodified device is Keeler Applanation Tonometer and Digital Keeler Applanation Tonometer. Both are Goldman type tonometers to measure intraocular pressure to aid in the screening and diagnosis of glaucoma. 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 Keeler Tonomate is a flattening cone containing biprism that converts the circular image of the flattened cornea to two semicircles that touch and cross at the time of flattening the cornea. The force required to flatten the cornea is converted to millimeters of mercury (mmHg).

AI/ML Overview

The provided text describes a 510(k) submission for a Keeler Disposable Tonomate (also referred to as Keeler Tonomate), an accessory for the Keeler Applanation Tonometer and Digital Keeler Applanation Tonometer. The submission primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than providing a detailed study with specific acceptance criteria and performance metrics for the accessory itself.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance

The document does not explicitly state quantitative acceptance criteria or a formal study designed to measure the performance of the Keeler Tonomate against such criteria. Instead, the submission relies on the concept of substantial equivalence to predicate devices. The primary "acceptance criteria" here is that the modified device (with the disposable prism) should not raise new issues regarding the safety and effectiveness of the existing tonometers.

A table of acceptance criteria and reported device performance, as typically seen in a clinical trial or performance study, is not available in this document. The document argues that the technical characteristics of the disposable prism are identical to non-disposable prisms that have been in successful use since the 1950s.

Study Information (or lack thereof)

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria: Not explicitly defined in a quantitative manner for the disposable prism. The implicit acceptance criterion is "substantial equivalence" to the predicate non-disposable prisms, meaning no new safety or effectiveness concerns.
Reported Device Performance: No specific quantitative performance metrics (e.g., accuracy, precision) are reported for the Keeler Tonomate itself in comparison to a defined acceptance criterion. The document states that the "technical characteristics of Phakos Tonoclean and Keeler Tonomate were kept identical to those of the nondisposable prisms."

2. Sample size used for the test set and the data provenance:

Sample Size: Not applicable/not provided. No specific test set of patients or measurements with the Keeler Tonomate is described.
Data Provenance: Not applicable/not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. There was no specific test set requiring expert ground truth establishment for this 510(k) submission.

4. Adjudication method for the test set:

Not applicable. No test set requiring adjudication was performed.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC study was conducted. This device is a tonometer prism, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a manual measurement tool, not an algorithm.

7. The type of ground truth used:

Not applicable. No direct "ground truth" was established for the performance of the disposable prism through a new study. The argument is based on the long-standing clinical acceptance and identical technical characteristics of the non-disposable predicate prisms.

8. The sample size for the training set:

Not applicable. The Keeler Tonomate is a physical medical device accessory, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established:

Not applicable.

Summary of the Study and Rationale:

The document explicitly states: "No clinical investigations were required as the safety and effectiveness in clinical use of the tonometer prism has been well established for the original equipment manufacturer (OEM) version of the prism, which has been sold into the European market by the manufacturer since 2014. In addition, the technical characteristics of Phakos Tonoclean and Keeler Tonomate were kept identical to those of the nondisposable prisms which were in successful use since 1950s."

This indicates that instead of new performance studies, the submission relies on:

The established safety and effectiveness of a predicate device (the OEM version of the prism in the European market since 2014).
The historical, successful use of non-disposable prisms with identical technical characteristics since the 1950s.
Design control activities, risk management, verification/validation for the manufacturing process of the disposable prism (e.g., packaging and sterilization cycle validation), to ensure the addition of the Keeler Tonomate "does not raise new issues on the safety and effectiveness."

Therefore, the "study" demonstrating the device meets "acceptance criteria" here is a substantiation of equivalence argument based on existing data, manufacturing controls, and the identical technical characteristics of the disposable prism compared to its well-established non-disposable counterparts, rather than new clinical trials or performance assessments of the disposable prism itself.

Summary

{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 the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around a central graphic. The graphic depicts three stylized human profiles facing to the right, with flowing lines suggesting movement or connection.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 31, 2015

Keeler Instruments, Inc. Mr. Eugene R. Van Arsdale Marketing Manager 456 Parkway Broomall. PA 19008

Re: K152644

Trade/Device Name: Keeler Disposable Tonomate, Keeler Disposable Tonomate Regulation Number: 21 CFR 886.1930 Regulation Name: Tonometer and Accessories Regulatory Class: Class II, Product Code: HKY Dated: October 16, 2015 Received: October 19, 2015

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.

{1}------------------------------------------------

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.

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. Deborah L. Falls -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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K152644

Device Name Keeler Applanation Tonometer

Digital Keeler Applanation Tonometer

Indications for Use (Describe)

The Keeler Applanation Tonometer and Digital Keeler Applanation Tonometer are indicated for measuring intraocular pressure to aid in the screening and diagnosis of Glaucoma.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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}------------------------------------------------

510(k) Summary of Safety and Effectiveness

1.1 Submitter's Information

The submitter of this special pre-market notification is:

Name:	Dr. Irina Proutski (Head of Regulatory and Quality Affairs).
Address:	Keeler Limited, Clewer Hill Road, Windsor,
	Berkshire, SL4 4AA, UK
Company Phone No:	+44 (0) 1753 827125
Company Fax No:	+44 (0) 1753 827145
Contact Person:	Dr Irina Proutski
Date summary prepared:	15th July 2015

1.2 Device Identification (Unmodified)

Device Trade Name:	Keeler Applanation Tonometer and Digital KeelerApplanation Tonometer
Common Name:	Tonometer, manual
Class:	II
Classification Panel:	86
Product Code:	HKY
Regulation Number:	886.1930

1.3 Device Description

1.3.1 Unmodified Device

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.

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image displays the logo for Keeler Ophthalmic Instruments. The word "Keeler" is written in a bold, blue sans-serif font. Below the company name, the words "Ophthalmic Instruments" are written in a smaller, gray sans-serif font.

1.3.2 Modified Device

The Keeler Applanation Tonometer and Digital Keeler Applanation Tonometer with non-disposable (re-usable) applanation prism were cleared for US marketing in 2009, 2013 and 2014 under previous pre-market notifications.

The intended use and functionality of the Keeler Applanation Tonometer and Digital Keeler Applanation Tonometer are unchanged by use of this disposable accessory (Keeler Tonomate).

The Keeler Tonomate is an OBL product manufactured and privately labelled under subcontract to Keeler by Phakos (62, Rue Kleber, Montreuil 93100, France) before shipment to Keeler for distribution.

The Keeler Tonomate is pre-sterilized with ethylene dioxide by Phakos sub-contractor, SteriServices (20 Rue Des Canadiens, Bernay 27300, France). Phakos is registered with FDA for supply of sterile contact lenses and OBL-manufacturing of Keeler Disposable Cryo Probes (Establishment Registration No. 3006142778) which are sterilized by the same sub-contractor.

The Keeler Tonomate is a flattening cone containing biprism that converts the circular image of the flattened cornea to two semicircles that touch and cross at the time of flattening the cornea. The force required to flatten the cornea is converted to millimeters of mercury (mmHg).

1.4 Indications for Use

The following indications for use for the Keeler Applanation Tonometer and Digital Keeler Applanation Tonometer remain unchanged by introduction of the Keeler Tonomate:

"The Keeler Applanation Tonometer and the Digital Keeler Applanation Tonometer is indicated for measuring intraocular pressure to aid in the screening and diagnosis of Glaucoma."

1.5 Comparison with Cleared Device

The device modification submission has been prepared to obtain clearance to market a disposable version of the applanation prism used as an accessory with Keeler Applanation Tonometer and Digital Keeler Applanation Tonometer.

The Keeler Applanation Tonometer and Digital Keeler Applanation Tonometer with the Keeler Tonomate (disposable version of the Applanation Prism) are considered to be substantially equivalent to the Keeler Applanation Tonometer and Digital Keeler Applanation Tonometer with non-disposable (re-usable) Applanation Prism in the following original submissions:

Keeler Applanation Tonometer T-Type KAT; R-Type KAT (K093445) Digital Keeler Applanation Tonometer D-KAT T-Type, D-KAT R-Type (K133234)

{5}------------------------------------------------

Image /page/5/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 professional.

Digital Keeler Applanation Tonometer D-KAT Z-Type (K142179)

1.6 Summary of Design Control Activities

In accordance with FDA quidance on submission of a Special 510(k), risk management, verification/validation and other related activities were carried out to assure continuing safety and effectiveness of the device.

The original version of the Phakos Tonoclean tonometer prism was developed under their own design control system which ensured the required activities were carried out, including packaging and sterilization cycle validation.

No clinical investigations were required as the safety and effectiveness in clinical use of the tonometer prism has been well established for the original equipment manufacturer (OEM) version of the prism, which has been sold into the European market by the manufacturer since 2014. In addition, the technical characteristics of Phakos Tonoclean and Keeler Tonomate were kept identical to those of the nondisposable prisms which were in successful use since 1950s.

1.7 Conclusion

In accordance with the Federal Food, Druq and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this Premarket Notification. Keeler Limited conclude that the addition of the Keeler Tonomate (a disposable version of the Applanation prism) does not raise new issues on the safety and effectiveness of the Keeler Applanation Tonometer and Digital Keeler Applanation Tonometer.

Regulation Number and Section

§ 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.