(127 days)
Arctic™ Sperm Cryopreservation Medium is intended for use in assisted reproductive procedures involving the cryopreservation and storage of human sperm.
The Arctic™ Sperm Cryopreservation Medium is a modified version of the predicate device (K991337). It is a defined medium consisting of salts, buffering materials, cryoprotectants, vitamins, amino acids, minerals, carbohydrates, surfactant, energy source, and human serum albumin. The Arctic™ Sperm Cryopreservation Medium is a single-use device that is aseptically filled into sterilized vials and has a sterility assurance level (SAL) of 10-3. This medium is supplied in a fill volume of 5 mL. and twelve (12) 5mL vials are included in a package, The product is tested for pH, osmolality, sperm cyrosurvival, endotoxin and sterility before lot release, and has a shelf-life of 18 months.
This document describes the Arctic™ Sperm Cryopreservation Medium, a device intended for use in assisted reproductive procedures involving the cryopreservation and storage of human sperm. The regulatory submission (K171224) demonstrates its substantial equivalence to a predicate device (Sperm Maintenance Medium with Glycerol, K991337).
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Characteristic | Acceptance Criteria (Arctic™ Sperm Cryopreservation Medium) | Reported Performance/Results (Arctic™ Sperm Cryopreservation Medium) |
|---|---|---|
| pH | 7.25 - 7.54 | Met (same as predicate) |
| Osmolality | 2300 - 2600 mOsm/kg | 2300 - 2600 mOsm/kg (within range, comparable to predicate's 2362-2532 mOsm/kg) |
| Appearance | Clear, free of particulate | Clear, free of particulate (comparable to predicate's clear, light yellow, free of particulate) |
| Formulation | 21 Ingredients | 21 Ingredients (modified from predicate's 20 ingredients) |
| Aseptic Processing Validation | Per ISO 13408-1:2008 and ISO 13408-2:2003 | Performed |
| Sterility | No microbiological growth (per USP ) | Met |
| Endotoxin | ≤1.0 EU/ml (per USP ) | ≤1.0 EU/ml (more stringent than predicate's ≤3.0 EU/ml) |
| Sperm Cryosurvival Assay (Post-thaw motility relative to control) | ≥80% of control motility | Met |
| Shelf-life (accelerated study for pH, osmolality, sperm cryosurvival, endotoxin, sterility) | pH: 7.25-7.54; Osmolality: 2300-2600 mOsm/kg; Sperm Cryosurvival: ≥80% of control motility; Endotoxin: ≤1.00 EU/ml; Sterility: No microbiological growth | Met for all criteria at time zero and end of shelf-life |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the specific number of samples for each test (e.g., pH, osmolality, endotoxin, sterility). For the Sperm Cryosurvival Assay, it states "Donor semen was mixed with the test medium and control (predicate device)". This suggests a comparative test using an unspecified number of donor semen samples. The data provenance is not specified regarding country of origin or whether it's retrospective or prospective; however, it is part of a regulatory submission for a medical device, implying prospective testing for the purpose of demonstrating substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a cryopreservation medium, and its performance is assessed through laboratory tests (e.g., pH, osmolality, microbiological growth, sperm motility), not through expert interpretation of images or clinical outcomes that require human ground-truthing in the typical sense of diagnostic AI.
4. Adjudication method for the test set
Not applicable. The tests are laboratory-based and yield objective measurements (e.g., pH values, osmolality values, presence/absence of growth, percentage motility) which do not require an adjudication method.
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
Not applicable. This is not an AI-assisted diagnostic device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone medical product (a cryopreservation medium). The performance tests described (e.g., pH, osmolality, sperm cryosurvival) are standalone evaluations of the product's physical, chemical, and biological properties, not an algorithm's performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The 'ground truth' for this device's performance is established by objective, quantitative laboratory measurements and established scientific standards/methods (e.g., USP for sterility, USP for endotoxin, specified pH and osmolality ranges, and a minimum percentage of control motility for cryosurvival).
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that involves a "training set." The product is a chemical formulation.
9. How the ground truth for the training set was established
Not applicable. As noted above, this device does not involve a training set.
§ 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.