(160 days)
SpermSlow™ is used to slow down the movement of sperm to allow for the selection of the most mature, viable sperm for Intracytoplasmic sperm injection (ICSI).
SpermSlow™ is a defined medium used by professionals within assisted reproduction designed to slow down the movement and to select the most mature, viable sperm as required for Intracytoplasmatic sperm injection (ICSI). SpermSlow wis principally composed of hyaluronate (HA), the main component of the extracellular matrix, which appears in large amounts between the cumulus cells of the matured oocyte-cumulus complex.
SpermSlow™ is based on a sodium bicarbonate buffered solution containing hyaluronate, HSA (US licensed source), pyruvate, glucose, amino acids, nucleotides, vitamins and antibiotics.
SpermSlow™ is supplied in polypropylene plastic vials with screw top closures in a volume of 0.5ML. Each unit is labelled and the product is presented in four pack containers which also include a package insert.
The provided 510(k) summary for K061145 (SpermSlow™) is very limited in its details regarding performance data and acceptance criteria, typical for a device of this classification and submission year. It primarily focuses on demonstrating substantial equivalence to a predicate device. Therefore, much of the requested information cannot be directly extracted from the provided text.
Here is a summary of what can be extracted and what is not available based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. It makes a general claim:
| Acceptance Criteria (Not explicitly stated in the document) | Reported Device Performance |
|---|---|
| Presumed: Effective for intended use (sperm slowing and selection for ICSI) | "SpermSlow™ has been tested in a human study. The results show that the product is effective for its intended use." |
| Presumed: Safety profile comparable to predicate / no serious adverse events | "It has been marketed in Europe since May 2004 and there has been no evidence of any serious adverse events in connection with the intended use." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not specified. The document only states "a human study."
- Data Provenance: The document mentions that the product "has been marketed in Europe since May 2004" and that safety data (absence of serious adverse events) is derived from this European marketing experience. It is not explicitly stated where the "human study" was conducted, but given the European marketing history, it is plausible it was also European data. It is not specified if the human study was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the document. The document describes a "human study" but does not detail how effectiveness (sperm slowing, selection, or ICSI outcomes) was assessed or by whom. The "ground truth" for a device that assists in sperm selection would logically be the successful use in ICSI, potentially assessed by embryologists or reproductive specialists, but the document does not elaborate.
4. Adjudication Method for the Test Set:
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This information is not applicable/not provided. The device is a medium used to assist in a biological process (sperm selection), not an AI algorithm or an imaging device that would typically undergo an MRMC study. Therefore, there is no mention of improvement with AI vs. without AI assistance or an effect size.
6. Standalone (Algorithm Only) Performance:
This information is not applicable/not provided. This is a biological medium, not an algorithm.
7. Type of Ground Truth Used:
The document vaguely implies that the "results" of the human study demonstrated the product's effectiveness for its intended use, which is "to slow down the movement of sperm to allow for the selection of the most mature, viable sperm for Intracytoplasmic sperm injection (ICSI)." The specific "ground truth" (e.g., successful fertilization rates, embryo development, live birth rates subsequent to ICSI using SpermSlow™-selected sperm) is not specified.
8. Sample Size for the Training Set:
This information is not applicable/not provided. As this is a biological medium and not an AI/machine learning device, there would not be a "training set" in the computational sense. If "training set" refers to developmental or preliminary studies, the size is not mentioned.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable/not provided for the same reasons as point 8.
§ 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.