(300 days)
Media for Embryo Preparation products that are used for assisted reproduction procedures. These media come in direct physical contact with human gametes or embryos for the purposes of preparation, maintenance, transfer or storage.
Quinn's® HTF Medium was developed for in vitro fertilization and procedures involving the culture of early cleavage stage mammalian embryos.
Quinn's® HTF Medium with HEPES was developed for in vitro procedures involving manipulations of gametes and embryos not requiring the use of a CO2 incubator. Such procedures include oocyte recovery, gamete washing, micromanipulation, embryo transfer and cryopreservation.
Quinn's® Basal XI HTF Medium was developed for in vitro procedures involving the culture of early cleavage stage mammalian embryos. This is the medium for culture of embryos from Day 1 through to Day 3.
Quinn's® D3+ Medium was developed for in vitro procedures involving the culture of early cleavage stage mammalian embryos. This is the medium for culture of embryos after Day 3 of development.
Media for Embryo Preparation products that are used for assisted reproduction procedures. These media come in direct physical contact with human gametes or embryos for the purposes of preparation, maintenance, transfer or storage.
This is a 510(k) premarket notification for a medical device called "Media for Embryo Preparation." The provided documents are NOT a study or a report detailing acceptance criteria and device performance. They are regulatory documents from the FDA, specifically:
- Document 0: An FDA letter granting substantial equivalence (510(k) clearance) for the device. This letter indicates that the FDA has reviewed the submission and determined that the device is as safe and effective as a legally marketed predicate device.
- Document 1: The "Indications For Use" statement from the 510(k) submission, outlining the intended purpose of the embryo preparation media.
Therefore, I cannot extract the requested information (acceptance criteria, device performance, study details, sample sizes, ground truth information, MRMC study results, etc.) from these documents because they do not contain that type of technical performance data or study report.
To answer your prompt, I would need a different type of document, such as:
- A clinical study report
- A performance testing report
- A validation study report
- The summary of safety and effectiveness (SSE) part of the 510(k) submission, which often includes details on performance data.
Without such a document, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for the test set and data provenance.
- Number and qualifications of experts.
- Adjudication method.
- MRMC comparative effectiveness study details.
- Standalone performance details.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
§ 884.6180 Reproductive media and supplements.
(a)
Identification. Reproductive media and supplement are products that are used for assisted reproduction procedures. Media include liquid and powder versions of various substances that come in direct physical contact with human gametes or embryos (including water, acid solutions used to treat gametes or embryos, rinsing solutions, sperm separation media, supplements, or oil used to cover the media) for the purposes of preparation, maintenance, transfer or storage. Supplements are specific reagents added to media to enhance specific properties of the media (e.g., proteins, sera, antibiotics, etc.).(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing). The device, when it is phosphate-buffered saline used for washing, and short-term handling and manipulation of gametes and embryos; culture oil used as an overlay for culture media containing gametes and embryos; and water for assisted reproduction applications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.