(119 days)
For in-vitro fertilisation, handling and embryo culture. It may be used for the culturing of embryos using drop culture
The Micro well group culture dishes are injection molded and disposable. The dishes are round and supplied with a lid. The dishes holds 9 small wells respectively 16 small wells. The polymers used for the dishes are virgin crystal grade polystyrene, which has successfully passed 1- cell embryotoxicity test. The dishes are packed 1 unit in a sleeve, 10 sleeves in a case. The dishes are terminally sterilized by irradiation to achieve a SAL of 10-6. The dishes are non-pyrogenic as tested by LAL, and non-embryotoxic as tested by one cell Mouse Embryo Assay (MEA). The Dishes are single use devices.
This document describes a 510(k) premarket notification for a new medical device, not a study evaluating a device's performance against detailed acceptance criteria for an AI algorithm. Therefore, many of the requested fields are not applicable to the provided text.
The document discusses two new devices: a "Micro well group culture dish, 9-well" and a "Micro well group culture dish, 16-well," for use in in-vitro fertilization (IVF). The submission focuses on demonstrating substantial equivalence to a legally marketed predicate device (Vitrolife Micro Droplet Culture Dish, K123641) rather than presenting a performance study of a novel AI system.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are based on the characteristics of the predicate device and established standards for IVF labware. The performance is reported as meeting these standards.
| Acceptance Criteria (from Predicate Device/Standards) | Reported Device Performance (Micro well group culture dish, 9-well & 16-well) |
|---|---|
| Sterility: SAL 10⁻⁶ | Sterile (SAL 10⁻⁶) |
| Non-pyrogenic: 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.