Search Results
Found 1 results
510(k) Data Aggregation
(238 days)
Medium for culture of embryos from fertilization to blastocyst stage
G-TL™ is an aseptically filtered and manufactured bicarbonate-buffered physiological medium ready to use after warming to 37°C and equilibration in a CO2 environment. It is designed to be used by professionals within assisted reproduction. G-TL™ is intended for the culture of human embryos from fertilization to the time of embryo transfer. G-TL™ is contained within a 30ml transparent polyethyleneterephthalate glycol (PETG) bottle with high density polyethylene (HDPE) closures. Both the bottle and box are individually labeled and each box contains a package insert.
The G-TL™ device is a medium for the culture of human embryos. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a traditional clinical study with acceptance criteria for device performance in human subjects.
Here's an analysis based on the provided text, addressing your points:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Set by Device Manufacturer for Comparison) | Reported Device Performance (G-TL™) | Predicate Device Performance (CSC™ Complete) |
|---|---|---|
| pH: Within physiological range | 7.30 ±0.1 | 7.25-7.54 |
| Osmolality (mOsm/Kg): Within physiological range | 270 ±5 | 265 ±5 |
| Sterility Assurance Level (SAL): | 10^-3 | 10^-3 |
| Bacterial Endotoxin (EU/ml): |
Ask a specific question about this device
Page 1 of 1