(94 days)
The Continuous Single Culture®-NX (CSCM-NX) is intended for use as a culture medium for human gametes and embryos from fertilization through day 5/6 of development in vitro.
The Continuous Single Culture®-NX (CSCM-NX) is a culture medium using a formulation modified from the predicate device. It is intended for culture of embryos from fertilization to blastulation. This medium consists of salts, energy substrates, amino acids, buffering agents, nutrients supplements, and antibiotics. This product is a single-use device supplied in a fill volume of 20 mL and 60 mL. It is aseptically filled into sterilized bottles and has a sterility assurance level (SAL) of 10⁻⁶. The product is tested for pH, osmolality, embryotoxicity, spermtoxicity, endotoxin, and sterility before lot release. The product has a four-month shelf-life and remains stable for four weeks after opening/closing of the bottle when it is stored at 2-8°C.
This document describes the Continuous Single Culture®-NX (CSCM-NX), a culture medium for human gametes and embryos. The information provided is from a 510(k) premarket notification.
Acceptance Criteria and Reported Device Performance
The acceptance criteria and reported device performance are primarily focused on ensuring the new device (CSCM-NX) performs comparably to its predicate device (Continuous Single Culture Complete) and meets safety and quality standards for reproductive media.
Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (from predicate device) | Reported Device Performance (CSCM-NX) |
|---|---|---|
| pH (under 5% CO2) | 7.25-7.54 | "Same as predicate device" (Implies within 7.25-7.54 range) |
| Osmolality | 260-270 mOsm/kg | "Same as predicate device" (Implies within 260-270 mOsm/kg range) |
| Formulation | 39 ingredients (predicate device) | "Comparable to predicate device" (Modified; no HSA, adjusted concentrations) |
| 1-cell Mouse Embryo Assay (MEA) | ≥80% developed to the blastocyst stage at 96 hours | Met acceptance criteria (Implied by conclusion of substantial equivalence based on testing) |
| Human Sperm Survival Assay (HSSA) | ≥70% of original motility at 24 hours | Met acceptance criteria (Implied by conclusion of substantial equivalence based on testing) |
| Endotoxin | ≤0.25 EU/ml (LAL) | Met acceptance criteria (Implied by conclusion of substantial equivalence based on testing) |
| Sterility | No microbiological growth | Met acceptance criteria (Implied by conclusion of substantial equivalence based on testing) |
| Shelf-life | 4 months (product stability meeting all listed criteria) | Confirmed over 4 months (real-time and accelerated studies) |
| In-use stability | 4 weeks after opening/closing (storage at 2-8°C, meeting all listed criteria) | Confirmed over 4 weeks (stability testing) |
The study supporting these claims are a series of non-clinical performance tests designed to demonstrate the substantial equivalence of the CSCM-NX to its predicate device.
Additional Information on the Study:
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify exact sample sizes for the individual tests (MEA, HSSA, endotoxin, sterility, pH, osmolality). For the Mouse Embryo Assay, it mentions "One-cell mouse embryos were exposed to subject devices," indicating a biological sample rather than a human data set. For other tests, specific batch or replicate numbers are not provided.
- Data Provenance: The studies were internal non-clinical performance tests conducted by Irvine Scientific. The data is prospective as it was generated specifically for the 510(k) submission. No country of origin for external data is mentioned, as the studies appear to be proprietary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is a product performance study for a culture medium, not a diagnostic device relying on expert interpretation of results. Therefore, no experts were used to establish ground truth in the sense of clinical decision-making. The "ground truth" for these tests are objective, measurable laboratory parameters (e.g., pH, osmolality, blastocyst development rates, sperm motility percentages, endotoxin levels, sterility absence).
4. Adjudication method for the test set:
- Not applicable. As described above, there is no expert interpretation or adjudication involved in determining the outcome of these objective laboratory tests. The results are quantitative measurements or observation of biological phenomena against predefined criteria.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The CSCM-NX is a culture medium, and its effectiveness is determined by objective laboratory assays, not by human interpretation of its "output" in a clinical setting. Therefore, there is no effect size presented for human readers improving with or without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is not an algorithm or an AI system. It is a biological culture medium. Performance is assessed through specific biological and chemical assays.
7. The type of ground truth used:
- The ground truth for this device's performance relies on objective, verifiable laboratory measurements and biological outcomes established through standardized assays. This includes:
- Chemical properties (pH, osmolality).
- Biological response (mouse embryo development to blastocyst, human sperm motility).
- Contaminant levels (endotoxin).
- Absence of microbial growth (sterility).
- These measurements are compared against pre-established acceptance criteria, which were likely derived from industry standards, historical performance of the predicate device, or biological necessity for successful embryo culture.
8. The sample size for the training set:
- Not applicable. This device is a culture medium, not a machine learning model. Therefore, there is no "training set" in the context of algorithm development.
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set for an algorithm, there is no ground truth established for such a 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.