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K Number
K203850
Device Name
CATS®-D Tonometer Prism
Manufacturer
CATS Tonometer LLC
Date Cleared
2021-06-14

(165 days)

Product Code
HKY
Regulation Number
886.1930
Type
Traditional
Panel
OP
Reference & Predicate Devices
K173904
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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

Device Description

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.

§ 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.