(394 days)
For in vitro assisted reproductive procedures involving the manipulation of gametes and embryos, including fertilization, embryo culture and embryo transfer.
IVF™-50, IVF™-500 and IVF™-500 Antibiotic-Free are bicarbonatebuffered culture media composed of a mixture of balanced salts, Human Serum Albumin and other nutrient substances. IVF™-50 includes Penicillin-G. IVF™-500 is manufactured and sold antibiotic-free or with Pc-G. The media is designed for use during assisted reproduction procedures, including fertilization, embryo culture and embryo transfer.
The provided text describes a premarket notification for IVF media, outlining its intended use, technological characteristics, and testing performed. However, it does not contain explicit acceptance criteria and a study demonstrating that the device meets those criteria, as one would typically find for a new AI/software device. This is a medical device from 1999, which is a key factor.
Here's an analysis based on the information provided, highlighting the limitations due to the nature of the submission:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly define quantitative acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for the IVF media as one would for an AI/software device. Instead, the "performance" is demonstrated through various biological assays and the establishment of safety and effectiveness through clinical experience.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Not cytotoxic and non-irritating | Biocompatibility testing included cytotoxicity and rabbit vaginal irritation assays. (Results are not detailed but the FDA approval implies satisfactory outcomes). |
| Suitability for intended use & absence of unacceptable toxins | Each lot of IVF media is assayed by: |
- Two-cell Mouse Embryo Assay (MEA)
- Human Sperm Survival Assay (HSSA)
- Limulus Amebocyte Lysate (LAL) Assay
These assays are stated to "insure that the media is suitable for its intended use and does not contain unacceptable levels of toxins." (Specific results or thresholds for these assays are not provided, but the statement implies successful performance). |
| Safety and Effectiveness for Assisted Reproduction Procedures | "IVF™-50, IVF™-500 and IVF™-500 Antibiotic Free has been used for fertilization, embryo culture and embryo transfer for many years at many different assisted reproduction facilities. Clinical experience during that time has established its safety and effectiveness for such use." (This is a historical claim, not a prospective study with defined metrics). |
| Material Safety (regarding human serum albumin) | Donors of the source material for the human serum albumin are screened for CJD. The source material is also tested for HIV and hepatitis. (This is a process control, not a performance metric for the final product in the same way as the above). |
| Substantial Equivalence to Predicate Device | The FDA determined the device is substantially equivalent to legally marketed predicate devices in the category of Reproductive Media (21 C.F.R. § 884.6180). This is the overarching "acceptance criteria" for 510(k) clearance, based on the testing and existing clinical experience, rather than specific performance numbers against a clinical endpoint for a novel AI device. Substantial equivalence means the device is as safe and effective as a legally marketed predicate device. This is satisfied by demonstrating similar technological characteristics and performance (as implied by the biological assays and historical use). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set: There is no "test set" in the context of an AI/software device. The testing described involves biocompatibility testing (cytotoxicity and rabbit vaginal irritation assays) and lot-release assays (Mouse Embryo Assay, Human Sperm Survival Assay, LAL Assay).
- Sample Size: Not specified for biocompatibility or lot-release assays. For the "clinical experience," it refers to "many years at many different assisted reproduction facilities," implying a large, but unquantified, real-world usage.
- Data Provenance: Not explicitly stated for specific tests. The manufacturer is Scandinavian IVF Sciences AB, located in Sweden, so it's reasonable to infer some testing was conducted in Europe, but this is not confirmed.
- Retrospective or Prospective: The "clinical experience" is inherently retrospective, relying on historical use. The biocompatibility and lot-release assays would be prospective for each batch.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is not an AI/software device requiring expert interpretation or ground truth labeling of data for performance evaluation. The "ground truth" for media performance is established by biological assays and observed clinical outcomes over time.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/software device requiring human adjudication for data labeling.
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/software device involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/software algorithm. The device itself is "standalone" in the sense that it's a biochemical medium used in a clinical procedure.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance relies on:
- Biological assay results: Measured outcomes from the Two-cell Mouse Embryo Assay, Human Sperm Survival Assay, and Limulus Amebocyte Lysate (LAL) Assay.
- Biocompatibility results: Outcomes from cytotoxicity and rabbit vaginal irritation assays.
- Clinical outcomes/experience: The observed safety and effectiveness from "many years at many different assisted reproduction facilities" through procedures like fertilization, embryo culture, and embryo transfer. This implicitly refers to successful pregnancies, live births, and lack of adverse events, though detailed outcome data is not provided in this summary.
8. The sample size for the training set
Not applicable. This is not an AI/software device that uses a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/software device that uses a training set.
Summary for K991348/52:
This submission concerns IVF culture media, a biochemical product, not an AI or software device. Therefore, many of the questions regarding AI/software performance metrics, ground truth establishment, training/test sets, and human reader studies are not applicable. The "study" proving the device meets criteria primarily consisted of biocompatibility testing, lot-release biological assays, and a historical review of clinical experience to demonstrate safety and effectiveness and establish substantial equivalence to predicate devices under the 510(k) pathway.
§ 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.