(98 days)
The Continuous Single Culture®-NX Complete (CSCM-NXC) is intended for use as a culture medium for human gametes and embryos from fertilization through day 5/6 of development in vitro. This device can be used for transfer of embryos to the uterus.
The Continuous Single Culture®-NX Complete (CSCM-NXC) is a culture medium using a formulation modified from the predicate device. It is intended for culture of embryos from fertilization to balstulation and transfer of embryos to the uterus. This medium consists of salts, energy substrates, amino acids, buffering agents, nutrients supplements, antibiotics, and human serum albumin.
This product is a single-use device supplied in a fill volume of 20 mL. It is aseptically filled into the sterilized bottle and has a sterility assurance level (SAL) of 10-3. 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 open/close of bottle, when it is stored at 2-8°C.
This document describes the Continuous Single Culture®-NX Complete (CSCM-NXC), a culture medium for human gametes and embryos, and outlines the non-clinical performance testing conducted to demonstrate its substantial equivalence to a predicate device.
Here's an analysis of the provided text to extract the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists acceptance criteria for various tests but does not explicitly provide the reported device performance values for each test. It states that the "performance data also demonstrate that the subject device is substantially equivalent to the predicate device," implying the criteria were met. For some tests (pH, Osmolality, Endotoxin, Sterility), it states "Same as predicate" or provides a pass/fail criterion without a specific measured value from the study.
| Test / Characteristic | Acceptance Criteria | Reported Device Performance (as stated in document) |
|---|---|---|
| pH (under 5% CO2) | Same as predicate (7.25-7.54) | Met acceptance criteria (implied, no specific value) |
| Osmolality | Same as predicate (260-270 mOsm/kg) | Met acceptance criteria (implied, no specific value) |
| Mouse Embryo Assay (MEA) | ≥80% developed to the blastocyst stage at 96 hours | Met acceptance criteria (implied, no specific value) |
| Human Sperm Survival Assay (HSSA) | ≥70% of original motility at 24 hours | Met acceptance criteria (implied, no specific value) |
| Endotoxin | ≤0.25 EU/ml (LAL) | Met acceptance criteria (implied, no specific value) |
| Sterility | No microbiological growth | Met acceptance criteria (implied, no specific value) |
| Cytotoxicity | Per 10993-5:2009 (presumably pass/fail) | Met acceptance criteria (implied) |
| Guinea Pig Maximization Sensitization | Per ISO 10993-10:2010 (presumably pass/fail) | Met acceptance criteria (implied) |
| Intracutaneous Reactivity | Per ISO 10993-10:2010 (presumably pass/fail) | Met acceptance criteria (implied) |
| Shelf-life stability | Acceptance criteria for pH, Osmolality, 1-cell MEA, HSSA, Endotoxin, Sterility met at end of shelf-life | Met acceptance criteria (implied) |
| Opened bottle stability | Acceptance criteria for product characteristics met after repeated opening/closing for four weeks | Met acceptance criteria (implied) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document does not specify the sample size for the biological assays (MEA, HSSA) or the chemical/physical tests. It mentions "One-cell mouse embryos" were exposed for MEA, but not the number of embryos or replicates.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given that it's a premarket notification for a medical device in the US, it's highly likely the studies were conducted to US regulatory standards, but the geographical origin of the samples (e.g., human gametes for HSSA) is not detailed.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not applicable or not provided in the context of this device. The tests described are laboratory-based, quantitative assays (e.g., pH, osmolality, embryo development percentages, bacterial growth, endotoxin levels). These are typically assessed by trained laboratory technicians against defined quantitative acceptance criteria, rather than by human experts establishing a "ground truth" through interpretation (as would be the case for an imaging AI device).
4. Adjudication Method for the Test Set:
Not applicable. The tests are objective, quantitative measurements or established pass/fail biological assays, not subjective assessments requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. An MRMC study is relevant for diagnostic imaging devices where human readers interpret medical images with and without AI assistance to assess diagnostic performance. This document concerns an in vitro culture medium, and such a study design is not relevant here.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance):
Not applicable. This is a medical device (culture medium), not an AI algorithm. Its performance is evaluated through direct laboratory testing of its effect on biological samples (mouse embryos, human sperm) and its physical/chemical properties.
7. Type of Ground Truth Used:
The ground truth used for performance evaluation is objective laboratory measurements and established biological outcomes.
- For MEA: Percent development to expanded blastocyst stage.
- For HSSA: Percent of original motility at 24 hours.
- For chemical/physical tests: Measured values (pH, osmolality) compared to specified ranges.
- For sterility/endotoxin: Absence of growth/LAL assay results compared to limits.
These are not "expert consensus," "pathology," or "outcomes data" in the clinical sense, but rather quantifiable and verifiable laboratory results.
8. Sample Size for the Training Set:
Not applicable. This is a manufactured product (culture medium), not an AI/machine learning model that requires a training set. The "formulation modified from the predicate device" implies chemical engineering and biological optimization, not algorithm training.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for this type of device. The formulation would have been developed and optimized through R&D experiments guided by scientific principles and previous experience with culture media, evaluated against biological performance targets.
§ 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.