(112 days)
The Icare HOME tonometer is a prescription device intended as an adjunct to the routine clinical monitoring of intraocular pressure (IOP) of adult patients.
The Icare HOME Tonometer is a home-use handheld, battery operated device. The Icare HOME tonometer technology is based on the previously cleared Icare tonometer model TA011 (K063873), which has been commercially distributed in the United States, Europe and many other countries worldwide. The measurement method, the measurement algorithm and technology of the two models are identical and both models use the same disposable probe tip. The Icare HOME tonometer utilizes the rebound method to measure intraocular pressure. A small (1.8 mm diameter), light (26.5 mg), sterile, single-use probe tip makes brief and gentle contact with the eye. The device measures the deceleration of the magnetized probe and the rebound time during contact with the eye and calculates the IOP from these parameters. Deceleration of the probe is slower at low IOP compared to high IOP. A single measurement sequence includes six measurements for both measurement modes. The probe moves to the cornea and returns to the neutral position during each of the six measurements. After the six measurements the tonometer calculates the final IOP and stores it with other information in the tonometer's memory, including date, time, eye identification (right or left) and measurement quality i.e., the standard deviation of the six individual measurements. The Icare HOME Tonometer can record over one thousand measurement results. The physician can transfer this recorded measurement information to a computer through a USB cable.
Here's an analysis of the provided text, extracting information related to acceptance criteria and the study proving the device meets them:
Device: Icare HOME Tonometer (K163343/S001)
Intended Use: Prescription device intended as an adjunct to the routine clinical monitoring of intraocular pressure (IOP) of adult patients.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly state "acceptance criteria" in a tabulated format with pass/fail. Instead, it describes various tests and their "acceptable" outcomes. I've extrapolated these into a table based on the success statements. Note that some criteria are qualitative (e.g., "acceptable", "meets standards"), reflecting the regulatory language.
| Aspect Tested | Acceptance Criteria (Implicitly Stated) | Reported Device Performance |
|---|---|---|
| Bench Performance - Accuracy (vs. Manometer) | Differences between Icare HOME tonometer and manometer values at each pressure should be less than +/- 3 mmHg. | Differences were less than +/- 3 mmHg across the range. |
| Bench Performance - Precision (Standard Deviation) | Standard deviations and coefficients of variation should be consistently low. | Standard deviations and coefficients of variation for each Icare Home tonometer were consistently low (0-8%) across the measurement range, specifically 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.