(228 days)
Gx-IVF™ medium is intended for preparation and handling of gametes, for in vitro fertilisation and intrauterine insemination.
Gx-TL™ medium is intended for culture of embryos from fertilisation to the blastocyst stage and for embryo transfer.
Gx-MOPS™ PLUS medium is intended for handling and manipulating oocytes and embryos in ambient atmosphere.
The subject devices are culture and handling media consisting of physiological salts, energy substrates, amino acids, buffering agents, nutrients supplements, antioxidants, gentamicin and human serum albumin. These devices have different applications in Assisted Reproduction Technology (ART) procedures handled by IVF professionals. The media are aseptically filtered into gamma sterilised PETG bottles with HDPE closure and a tamper evident seal and tested for pH, osmolality, embryo toxicity, endotoxins, and sterility.
This document describes the acceptance criteria and the study that proves the device meets those criteria for the Gx-IVF™, Gx-TL™, and Gx-MOPS™ PLUS media used in Assisted Reproduction Technology (ART).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the subject devices (Gx-IVF™, Gx-TL™, Gx-MOPS™ PLUS) are primarily defined by comparison to their predicate devices and specific performance tests. The tables below summarize the key criteria and reported performance for each device.
Gx-IVF™
| Characteristic | Acceptance Criteria (Predicate: G-IVF™ PLUS K081116) | Reported Device Performance (Gx-IVF™) |
|---|---|---|
| Composition | ||
| Antibiotics | Gentamicin | Gentamicin |
| Protein | Human Serum Albumin | Human Serum Albumin |
| Amino acids | YES | YES |
| Glucose | YES | YES |
| Physiological salts | YES | YES |
| Buffer | Sodium bicarbonate | Sodium bicarbonate |
| Product & Performance Specifications | ||
| pH | 7.30 ± 0.10 | 7.30 ± 0.10 |
| Osmolality (mOsm/kg) | 262 ± 5 | 265 ± 5 |
| Bacterial endotoxin | 80% expanded blastocyst within 96 hours | ≥ 80% embryos developed to expanded blastocyst at 96 hours |
| Sterilization Method | Aseptic filtration | Aseptic filtration |
| Storage Conditions | Store dark at +2 to +8°C | Store dark at +2 to +8°C |
| Bottle | Nalgene PETG bottle with HDPE closure and tamper evident seal | Nalgene PETG bottle with HDPE closure and tamper evident seal |
Gx-MOPS™ PLUS
| Characteristic | Acceptance Criteria (Predicate: G-MOPS™ PLUS K081115) | Reported Device Performance (Gx-MOPS™ PLUS) |
|---|---|---|
| Composition | ||
| Antibiotics | Gentamicin | Gentamicin |
| Protein | Human Serum Albumin | Human Serum Albumin |
| Amino acids | Yes | Yes |
| Glucose | Yes | Yes |
| Physiological salts | Yes | Yes |
| Buffer | MOPS | MOPS |
| Product & Performance Specifications | ||
| pH | 7.27 ± 0.07 | 7.27 ± 0.07 |
| Osmolality (mOsm/kg) | 261 ± 5 | 265 ± 5 |
| Bacterial endotoxin |
- Bacterial endotoxins testing per USP
- pH measurements per USP
- Osmolality per USP
- Mouse Embryo Assay (MEA)
- Shelf-life testing
- Open/close stability testing
- Transportation testing (ASTM D4169-16)
- Biocompatibility studies:
- Cytotoxicity testing (ISO 10993-5:2009)
- Tests for Irritation and Skin Sensitization (ISO 10993-10:2010, Guinea Pig Maximization Sensitization Test)
- Tests for Irritation and Skin Sensitization (ISO 10993-10:2010, Vaginal Mucosal Irritation Study in Rabbits)
3. Number of Experts Used to Establish Ground Truth and Qualifications
This document describes technical performance and biocompatibility studies for medical devices (reproductive media and supplements). It does not involve human subject data or image analysis that would typically require expert consensus for ground truth establishment. Therefore, information regarding "number of experts" or their qualifications is not applicable in this context. The "ground truth" here is defined by established scientific and regulatory standards (e.g., USP for sterility, ISO 10993 for biocompatibility).
4. Adjudication Method for the Test Set
Not applicable for this type of non-clinical, in-vitro performance testing where results are based on objective laboratory measurements against defined standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This document describes the testing of in-vitro fertilization media, not an AI-assisted diagnostic device. Therefore, an MRMC comparative effectiveness study to assess human reader improvement with AI assistance is not relevant or applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. The devices are media for ART, not algorithms requiring standalone performance analysis.
7. The Type of Ground Truth Used
The ground truth for these devices is based on established scientific and regulatory standards and objective laboratory methods for determining chemical, physical, and biological properties. This includes:
- Regulatory Standards: USP , USP , USP , USP , ISO 13408-1:2008, ISO 13408-2:2018, ISO 10993-5:2009, ISO 10993-10:2010.
- Defined Acceptance Specifications: pH ranges, osmolality ranges, endotoxin limits, percentage of embryo development in MEA, absence of microbial growth, non-cytotoxic, non-sensitizing, non-irritating outcomes.
- Comparison to Predicate Devices: The performance of the subject devices is demonstrated to be substantially equivalent to that of the legally marketed predicate devices, implying the predicate devices' established safety and effectiveness serve as a benchmark.
8. The Sample Size for the Training Set
Not applicable. There is no machine learning or AI algorithm involved that would require a training set. The "training" in this context refers to manufacturing validation and quality control processes.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set for an algorithm is involved.
§ 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.