(175 days)
The SureStrip Virification Straw is cryopreservation storage device. It is intended for use in vitrification procedures to contain and maintain human oocytes (MII), 4-8 cell stage embryos, or blastocyst stage embryos.
The SureLock Vitrification Straw is a cryopreservation storage device. It is intended for use in vitrification procedures to contain and maintain human oocytes (MII) or 1-cell stage embryos.
Not Found
The provided text includes a 510(k) clearance letter for the SureStrip Vitrification Straw and SureLock Vitrification Straw. However, this document does not contain information regarding acceptance criteria or a study proving the device meets said criteria.
The document states that the devices are substantially equivalent to legally marketed predicate devices, which means they do not require new performance studies to demonstrate safety and effectiveness for a 510(k) clearance.
Therefore, I cannot provide the requested information from the given text.
The information I would have looked for, but is absent, includes:
- A table of acceptance criteria and reported device performance.
- Sample size and data provenance for a test set.
- Details on experts used for ground truth.
- Adjudication method.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
- If standalone performance was evaluated.
- Type of ground truth used.
- Sample size and ground truth establishment for a training set.
§ 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.