(197 days)
The iCare IC200 tonometer is intended to be used for the measurement of intraocular pressure of the human eye.
The iCare IC200 tonometer (model TA031) is a hand-held, battery-operated device which measures intraocular pressure (IOP) without the need for topical anaesthesia by rebound tonometry. The tonometer is to be used by a healthcare professional. The tonometer uses the rebound method. A small and light, sterile, single-use probe makes brief contact with the eye. The device measures the deceleration of the probe and the rebound time and calculates the IOP from these parameters. Deceleration of the probe is slower at low IOP compared to high IOP. The measurement method, the IOP measurement algorithm and rebound technology (including disposable probe) are identical with the predicate device. iCare IC200 tonometer can obtain IOP measurements in all angles between horizontal and supine directions. External design has not been modified. The user interface menu has been updated to contain a Quick Measure mode. The new Quick Measure feature is used to measure patient's IOP with fewer rebound measurements and faster measurement cycle. Quick Measure takes two or three rebound measurements; two if both results are within 2 mmHg and third if the difference between the first two measurements is greater than 2 mmHg.
The provided document, a 510(k) Premarket Notification review for the iCare IC200 tonometer, outlines the acceptance criteria and the study performed to demonstrate substantial equivalence to a predicate device. This submission focuses on a new feature of the device, the "Quick Measure" mode, rather than the entire device itself, as the underlying technology remains the same as the predicate.
Here's a breakdown of the requested information based on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criterion for the Quick Measure mode's performance is its ability to meet the performance goals of the ANSI Z80.10:2014 standard for ophthalmic tonometers, specifically regarding agreement with reference tonometers (GAT and Perkins) within ±5 mmHg. This is presented across different Intraocular Pressure (IOP) subgroups.
Table 1: Acceptance Criteria and Reported Device Performance for iCare IC200 Quick Measure Mode
| Group (IOP Range) | Acceptance Criteria (Max % Outside ±5 mmHg vs. Reference) | Reported Performance (N Eyes: % Outside ±5 mmHg vs. GAT Reference - Sitting) | Reported Performance (N Eyes: % Outside ±5 mmHg vs. Perkins Reference - Supine) |
|---|---|---|---|
| Low (≤ 16 mmHg) | Not explicitly stated as a percentage, but implied to be low, as 0% achieved. | 44: 0.0 % | 44: 0.0 % |
| Medium (> 16 to |
§ 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.