(234 days)
SepaSperm Washing Solution is used for preparation and washing of sperm for use in assisted reprocedures. SepaSperm Washing Solution is not intended for use in intrauterine insemination procedures.
SepaSperm Solution is used for separation of motile sperm from seminal fluid for use in assisted reproduction procedures.
SepaSperm is used for preparation and washing of sperm and for separation of motile sperm from semen in assisted reproductive techniques.
The device includes two types of solutions used for density-gradient centrifugation:
- . SepaSperm Solution for sperm preparation and separation from semen, and
- . SepaSperm Washing Solution for sperm washing and preparation
Both solutions are provided in two sizes (100mL and 50mL bottles). This product is single-use only and includes no accessories. The provided sterile-filtered into a container that is sterilized by gamma irradiation.
SepaSperm Solution is offered in four different densities, determined by the amount of silica present:
- SepaSperm Solution 100% -
- -Lower laver solution 80%
- Middle layer solution 60% -
- -Upper layer solution 40%
SepaSperm Solution is composed of silica particles diluted with modified human tubal fluid (m-HTF) medium, with dextran and polyvinylpyrrolidone added. The m-HTF medium is a HEPES-buffered solution which is suitable for use in ambient conditions. All SepaSperm Solutions are provided with and without gentamicin. SepaSperm Solution has a shelf-life of six or 12 months for media without or with gentamicin, respectively.
The SepaSperm Washing Solution consists of m-HTF medium supplemented with dextran and polyvinylpyrrolidone. It contains no silica. SepaSperm Washing Solution is used to wash the prepared sperm and suspend the final pellet. SepaSperm Washing Solutions are provided with and without gentamicin. SepaSperm Washing Solution has a shelf-life of six or 12 months for media without or with gentamicin, respectively.
The provided text describes the acceptance criteria and a "Summary of Non-Clinical Performance Testing" for the SepaSperm Washing Solution and SepaSperm Solution, which are reproductive media. This document is a 510(k) summary for a medical device submitted to the FDA, indicating a comparison to a predicate device.
Here's the breakdown of the information requested:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Specification) | Reported Device Performance (Summary of Non-Clinical Performance Testing) |
|---|---|
| Appearance | Met (implicitly, as it's part of "Shelf Life Performance Testing" and results confirm specifications are met) |
| Specific gravity: 1.0600-1.1200 | Met (implicitly, as results confirm specifications are met) |
| pH, per USP : 7.2 - 7.6 | Met (implicitly, as results confirm specifications are met) |
| Osmolality, per USP : 270-300 mOsm/Kg | Met (implicitly, as results confirm specifications are met) |
| Endotoxin, per USP : : No microbial growth | Met (implicitly, as results confirm specifications are met) |
| Sterile filtration and Aseptic fill validation, per ISO 13408-1:2008(R2013) and ISO 13408-2:2003(R)2013) | Met (implicitly, as results confirm specifications are met) |
| Transportation testing per ASTM D4169-16 | Met (implicitly, as results confirm specifications are met) |
| Bottle seal strength testing and containers performance testing per | Met (implicitly, as results confirm specifications are met) |
| Effectiveness of device in three separation modes (sperm assessment for motility, morphology, viability, purity, and integrity before and after separation) | Met (implicitly, as results confirm specifications are met) |
2. Sample size used for the test set and the data provenance:
The document does not specify the sample size for individual tests (e.g., how many batches for shelf-life, how many sperm samples for HSSA or separation effectiveness) or the provenance (country of origin, retrospective/prospective nature) of the non-clinical performance test data. It only states that "The following studies have been performed to support substantial equivalence to the predicate devices."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The studies listed are laboratory performance tests for the media itself, not clinical studies involving expert interpretation of medical images or patient data.
4. Adjudication method for the test set:
This information is not applicable and therefore not provided, as the studies are described as non-clinical performance testing of a medical device (media), not human-read clinical data requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable and therefore not provided. This is a 510(k) submission for reproductive media, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable and therefore not provided. This is a medical device (culture media), not an algorithm.
7. The type of ground truth used:
The "ground truth" for the performance testing of these media solutions is based on established laboratory standards and specifications (e.g., USP for pH, USP for osmolality, USP for endotoxin, USP for sterility, ISO 13408 standards for sterile filtration, ASTM D4169 for transportation, USP for container performance). For sperm assessment, the "ground truth" would be the initial characteristics of the sperm samples and their characteristics after processing, compared against expected physiological ranges and performance standards.
8. The sample size for the training set:
This information is not applicable and therefore not provided. This is not a machine learning or AI-based device, so there is no concept of a "training set."
9. How the ground truth for the training set was established:
This information is not applicable and therefore not provided for the reason stated in 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.