(263 days)
Sequential Culture Media consists of Fertilization Medium, Cleavage Medium, and Blastocyst Medium that are intended to be used sequentially from fertilization to the blastocyst stage of development. The intended uses of the Fertilization Medium, Cleavage Medium, and Blastocyst Medium are as follows:
Fertilization medium is intended for use during in vitro fertilization (IVF) and intracytoplasmic sperm insertion (ICSI) procedures and culture to the two pronuclei (zygote) stage of development.
Cleavage Medium is intended for culture of embryos from the two pronuclei (zygote) stage to the 8cell stage of development. Cleavage Medium is not intended for transferring embryos to the uterine cavity.
Blastocyst Medium is intended for culture from the 8-cell stage to the blastocyst stage of development. Blastocyst Medium is not intended for transferring embryos to the uterine cavity.
Sequential Culture Media are intended for use sequentially from fertilization to late embryonic stages during assisted reproduction technology procedures for insemination and embryo culture.
The Sequential Culture Media is provided in three variants: Fertilization Medium, Cleavage Medium, and Blastocyst Medium. Each variant is provided with or without protein (human serum albumin (HSA) or recombinant HSA (rHA)). All variants contain gentamicin, an antibiotic agent that suppresses bacterial growth. Each Sequential Culture Media solution is offered in three volumes (10mL, 50mL and 100mL).
The Sequential Culture Media solution is a colorless, clear fluid, provided sterile-filtered into a container pre-sterilized by gamma irradiation. The primary container of Sequential Culture Media 10mL is a sterile non-pyrogenic PETG vial, and the primary container of the Sequential Culture Media 50mL and 100mL is a square, non-pyrogenic PETG bottle. The containers are manufactured and provided sterile (with a SAL of 10° ) by ThermoFisher Scientific, Inc. After sterilefilling, the top of the vial and bottle are sealed with tamper-evident shrink-wrap.
The provided text is a 510(k) Summary for a medical device called "Sequential Culture Media." It details the device's characteristics, comparison to a predicate device, and non-clinical performance testing.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The device is a non-AI/ML product (culture media for IVF), so the acceptance criteria are not in terms of AI model performance metrics like accuracy, sensitivity, or specificity. Instead, they are related to the physical and biological properties of the culture media.
| Criteria (Internal Requirement / Standard) | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Appearance | Clear, particulate-free | Passed (Clear, particulate-free) |
| pH (per USP ) | 7.2 – 7.6 | Passed (7.2 – 7.6) |
| Osmolarity (freezing depression method) | 270-295 mOsm/L | Passed (270-295 mOsm/L) |
| Endotoxin (per USP ) | ≤ 0.25 EU/mL | Passed (≤ 0.25 EU/mL) |
| Mouse Embryo Assay (MEA) | ≥ 80% of 1-cell mouse embryos developed to expanded blastocyst at 96 hours | Passed (≥ 80% of 1-cell mouse embryos developed to expanded blastocyst at 96 hours) |
| Sterility (per USP ) | No microbial growth | Passed (No microbial growth) |
| Stability Testing | Maintain performance specifications (Appearance, pH, Osmolarity, Endotoxin, MEA, Sterility) for 4 months | Passed (Real-time aged samples at baseline and 4 months) |
| Container Seal (per USP ) | ≤ 5.0% permeability and ≤ 1 sample exceeding 2.50% over 14 days | Passed |
| Sterile Filtration/Aseptic Fill | Validation per ISO 13408-1:2008/A1:2013 and ISO 13408-2:2018 | Passed |
| Transportation Testing | Package integrity and device performance maintained (per ASTM D4169) | Passed |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a distinct "test set" sample size in the way an AI/ML study would. Instead, performance testing applies to batches of the culture media. For the MEA, it mentions "1-cell mouse embryos," but the exact number of embryos or experimental replicates used is not provided.
- Data Provenance: The studies were non-clinical performance testing conducted by Kitazato Corporation, the device manufacturer. The data provenance is internal to the manufacturer.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Given this is a non-clinical, laboratory-based product, the concept of "experts establishing ground truth" as it applies to image interpretation or diagnostic accuracy is not directly applicable. The "ground truth" here is based on analytical chemistry, biological assays, and sterility testing, which are measured objectively using established scientific methods and standards (e.g., USP, ISO). The qualifications of those performing these tests would be standard laboratory technicians/scientists, but no specific details on their number or qualifications are provided.
4. Adjudication Method for the Test Set
Not applicable. This is not a human-reader-based test where adjudication would be necessary. The results are based on objective laboratory measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not a diagnostic device that involves human readers or AI assistance.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
Not applicable. This is not an algorithm or AI device. The device itself is the sequential culture media.
7. Type of Ground Truth Used
The "ground truth" in this context refers to the objectively measured characteristics of the culture media that are critical for its function and safety. This includes:
- Analytical Chemistry/Physical Measurements: pH, Osmolarity, Endotoxin levels.
- Biological Assay: Mouse Embryo Assay (MEA), which assesses the biological efficacy by observing embryo development.
- Microbiology: Sterility testing.
- Material Science/Engineering: Container seal integrity, package integrity.
These are established scientific and regulatory standards.
8. Sample Size for the Training Set
Not applicable. As a non-AI/ML product, there is no "training set." The product's formulation and manufacturing processes are developed based on scientific understanding of embryo culture requirements and validated against performance specifications, not through machine learning training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML model for this device. The formulation and manufacturing parameters are likely established through R&D, chemical engineering, and biological testing, informed by existing scientific knowledge and regulatory requirements for reproductive media.
§ 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.