The CATS®-D Tonometer Prism is used as an optical image prism for Goldmann applanation style tonometers. It is made of PMMA, the corneal contact diameter is 6.5 mm and the total length of the prism is 30 mm.

AI/ML Overview

This document does not contain information related to AI/ML device performance or clinical studies typical for AI/ML-based medical devices. The submission (K203850) is for a CATS®-D Tonometer Prism, which is a physical accessory for Goldmann type tonometers, not an AI/ML algorithm.

The core of the submission focuses on demonstrating substantial equivalence to a predicate device (CATS® Reusable Tonometer prism K173904) through performance data related to:

Design verification: Ensuring the device meets its design specifications.
Sterilization validation and shelf-life testing: Confirming the sterility and stability of the disposable prism.
Biocompatibility testing: Cytotoxicity, sensitization, and irritation tests according to ISO 10993 standards.

There is no mention of:

Acceptance criteria for an algorithm's performance (e.g., accuracy, sensitivity, specificity).
A test set with ground truth or expert annotations.
Sample sizes for AI/ML model testing or training.
The number or qualifications of experts.
MRMC studies or human reader improvement with AI assistance.
Standalone algorithm performance.

Therefore, I cannot provide a response to the prompt's specific requirements, as they are geared towards AI/ML device evaluations, which are not relevant to this 510(k) submission.

Summary

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CATS Tonometer LLC Paul Kramsky Consultant 1517 N. Wilmot Suite 143 Tucson, Arizona 85712

Re: K203850

Trade/Device Name: CATS®-D Tonometer Prism Regulation Number: 21 CFR 886.1930 Regulation Name: Tonometer and accessories Regulatory Class: Class II Product Code: HKY Dated: May 4, 2021 Received: May 6, 2021

Dear Paul Kramsky:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrl-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Elvin Ng Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K203850

Device Name

CATS®-D Tonometer Prism

Indications for Use (Describe)

The CATS®-D Tonometer Prism is intended to be used with Goldmann type tonometers for the measurement of intraocular pressure of the human eye.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

510(k) Summary for the CATS®-D Tonometer Prism

5.1 Submission Sponsor:

CATS Tonometer, LLC 1517 N. Wilmot, Suite 143 Tucson, Arizona 85712 Telephone: 520- 975-4550

5.2 Contact:

CATS Tonometer, LLC 1517 N. Wilmot, Suite 143 Tucson, Arizona 85712 Telephone: 520- 975-4550 Contact: Nannon Roosa, President Email: nannon(@catsiop.com

5.3 Date Prepared:

June 8, 2021

5.4 Device Name:

Trade/Proprietary Name:	CATS®-D Tonometer Prism
Classification Name:	Tonometer and Accessories
Product Code:	HKY
Regulation Number:	21 CFR 886.1930

ર્સ્ટ Predicate Devices:

The CATS®-D Tonometer Prism is substantially equivalent in terms of intended use and technological characteristics to the CATS® Reusable Tonometer prism (K173904).

ર્ડ.6 Device Description:

5.7 Indications for Use:

The CATS® Tonometer Prism is intended to be used with Goldmann type tonometers for the measurement of intraocular pressure of the human eye.

5.8 Performance Data:

Design verification and sterilization validation and shelf-life testing were performed. Cytotoxicity (MEM Elution), Sensitization (Kligman Maximization Test), and Irritation (Intracutaneous irritation test) were performed per ISO 10993-5 and ISO 10993-10. The device was reported to be non-cytotoxic, non-sensitizing and non-irritating.

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5.9 Substantial Equivalence:

The CATS®-D Tonometer Prism is substantially equivalent to the 510(k) cleared CATS® reusable prism with the exception being that the disposable prism is supplied with a sterilized detachable, which snaps on to the prism housing, whereas the 510(k) cleared reusable prism was connected to the body with adhesive. This change resulted in a very slight decrease in overall length of the prism, which does not affect the safety and effectiveness of the device. In addition, the packaging was changed to a cardboard box consisting of a PETG tray with Tyvek lid, and sterilization by Ethylene Oxide. The claim of substantial equivalence to the previously cleared CATS® Reusable Tonometer Prism (K173904) is supported by the following comparison of characteristics in Table 1 and non-clinical performance data. Therefore, the CATS®-D Tonometer Prism is substantially equivalent to the predicate device.

Characteristic	CATS®-D TonometerPrism	CATS® ReusableTonometer Prism(Predicate)
Overall length	28.75 mm	30.0 mm
Base diameter	10.9 mm	10.9 mm
Contact surface diameter	6.5 mm	7.0 mm
Bi-Prism diameter	6.0 mm	6.0 mm
Bi-Prism length	10.67 mm	10.67 mm
Applanation Diameter	3.29 ± 0.02	3.29 ± 0.02
Bi-prism angle	30 degrees	30 degrees
Index of refraction	1.4906	1.4906
Prism construction material	PMMA	PMMA
Prism component adhesive	Class 9	Class 9
Prism contact surface	Concave-convexcontoured	Concave-convexcontoured
Prism surface finish	Optical polish	Optical polish
Force to IOP conversion	1.0g = 10mm Hg	1.0g = 10mm Hg
Prism tip	Detachable	Connected to body
Packaging	4 PETG trays w/Tyveklids in cardboard box	Cardboard box
Sterilization	Ethylene Oxide	Non-sterile

Table 1 - Comparison of CATS® Disposable and CATS® Reusable (Predicate) Tonometer Prisms

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.