(240 days)
ARTSMedia Semen Wash Medium (AM Semen Wash) is intended for washing of sperm and for sperm swim-up procedures. The medium can also be used for IUI (Intra Uterine Insemination).
ARTSMedia Semen Wash Medium (AM Semen Wash) is intended for washing of sperm and for sperm swim-up procedures. The medium can also be used for IUI (Intra Uterine Insemination).
ARTSMedia Semen Wash Medium consists of physiological salts, energy substrates, buffering agents, Gentamicin Sulphate, and water.
Furthermore, ARTSMedia Semen Wash Medium is aseptically filtered and provided in a volume of 20 mL. 50 mL. and 100 mL in pre-sterilized glass bottles closed with Fluorotec-coated stoppers and aluminum caps. The ARTSMedia Semen Wash Medium is tested for pH, osmolality, endotoxin, sterility, and sperm toxicity before lot release. The device has a shelf-life of 18 months when stored at 2-8°C and is for single-use only.
The provided text describes a 510(k) premarket notification for a medical device called "ARTSMedia Semen Wash Medium." It compares the new device to a predicate device and presents non-clinical performance testing. However, the document does NOT contain information about a study involving an AI/Machine Learning enabled device, human readers, or the establishment of ground truth for such a study. Therefore, I cannot extract the requested information regarding acceptance criteria and study proving device performance for an AI/ML device.
The document is solely about a reproductive media and supplements device and its substantial equivalence based on physical and chemical properties and biocompatibility, not an AI/ML diagnostic or assistive device.
Therefore, for all the requested information, the answer will be "Not applicable / No information provided in the given text."
Here's a breakdown of why based on the input text:
- A table of acceptance criteria and the reported device performance: The document provides a table comparing characteristics like pH, Osmolality, Human Sperm Survival Assay, and Endotoxin for the subject and predicate devices. These are "performance" metrics for a biological solution, but not for an AI/ML device's diagnostic accuracy or similar.
| Parameter | Acceptance Criteria (from predicate/comparison) | Reported Device Performance (ARTSMedia Semen Wash Medium) |
|---|---|---|
| Human Sperm Survival Assay (% motility compared with control after 24 hours) | ≥ 80% | ≥ 80% |
| Endotoxin (EU/ml) |
§ 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.