(22 days)
The FALCON® IVF Four Well Plate is sterile, nonpyrogenic, embryotoxicity tested, singleuse plasticware intended to prepare, store, manipulate, or transfer human gametes or embryos for in vitro fertilization (IVF) or other assisted reproduction techniques.
The FALCON® IVF Four Well Plate is sterile (SAL of 10%), non-pyrogenic by Limulus Amebocyte Lysate (LAL of
The provided text describes a 510(k) summary for the FALCON® IVF Four Well Plate, a medical device used in assisted reproduction. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the comprehensive study that proves the device meets those criteria. The provided text focuses on the device description, intended use, and substantial equivalence to a predicate device, as required for a 510(k) submission.
Based on the available information, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document mentions several characteristics that serve as performance criteria for the device. These are inherent properties of the plate that ensure its suitability for IVF procedures.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sterility | Sterile (SAL of 10%) |
| Non-pyrogenicity | Non-pyrogenic by Limulus Amebocyte Lysate (LAL of |
§ 884.6160 Assisted reproduction labware.
(a)
Identification. Assisted reproduction labware consists of laboratory equipment or supplies intended to prepare, store, manipulate, or transfer human gametes or embryos for in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures. These include syringes, IVF tissue culture dishes, IVF tissue culture plates, pipette tips, dishes, plates, and other vessels that come into physical contact with gametes, embryos or tissue culture media.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when it is a dish or plate intended for general assisted reproduction technology procedures, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.