(121 days)
The TGDC - 01 PRA Tonometer is used to measure ocular pressure (IOP) in the diagnosis for use. The intended device is 0, 1101.
The TGDc-01 "PRA" is a portable tonometer that measures IOP through the eyelid in the sclera area. It has a measurement range of 5-60 mm Hg, a single measurement time of not more than 3 seconds, and uses 2 CR2032 batteries. It weighs not more than 79 g and has dimensions of 173.5 x 25.5 x 19.5 mm. It displays the IOP measurement on an LCD screen.
Here's a breakdown of the acceptance criteria and study information for the Tonometer TGDc-01 "PRA", based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state quantitative acceptance criteria or a formal study with statistical targets for performance. Instead, it relies on a qualitative comparison to predicate devices and highlights the device's technological characteristics.
However, based on the narrative, the implicit acceptance criteria are that the TGDc-01 "PRA" performs equivalently to the predicate devices (Goldmann Tonometer and Canon T-2 Non-Contact Tonometer) in terms of IOP measurement, particularly demonstrating "high coincidence degree in the whole range."
| Acceptance Criteria (Inferred from Narrative) | Reported Device Performance |
|---|---|
| IOP Measurement Equivalence to Predicate Devices | "high coincidence degree in the whole range with the compared devices." |
| Measurement Range: 5-60 mm Hg | 5-60 mm Hg |
| Single Measurement Time: = 1500 | 1500 (not less) |
| Serviceability: >= 8 years | 8 years (not less) |
| Weight: |
§ 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.