(246 days)
CaseMONO™ Culture is intended for use for culture of embryos from fertilization to the blastocyst stage. This device can be used for transfer of embryos to the uterus.
CaseBioscience® HTF is intended for use for the culture of embryos to the cleavage stage (Day 3). This device can be used for transfer of embryos to the uterus.
CaseMONO w/HEPES™ is intended for use in short-term handling and manipulating gametes and embryos, including washing and intracytoplasmic sperm injection (ICSI). This medium is not intended for transfering to the uterine cavity.
CaseBioscience® HTF w/HEPES is intended for use in short-term handling gametes embryos, including washing and intracytoplasmic sperm injection (ICSI). This medium is not intended for transferring embryos to the uterine cavitv.
CaseMONO Culture, CaseMONO w/HEPES, CaseBioscience HTF, and CaseBioscience HTF w/HEPES are intended for use during in vitro procedures for gamete/embryo culture and one step media.
CaseMONO Culture is intended for use for culture of embryos from fertilization to the blastocyst stage. This device is a one-step media and can be used for transfer of embryos to the uterus.
CaseMONO w/HEPES is intended for use in short-term handling and manipulating gametes and embryos, including washing and intracytoplasmic sperm injection (ICSI).
CaseBioscience HTF is intended for use for the culture of embryos to the cleavage stage (Day 3). This device is not a one-step medium but can be used for transfer of embryos to the uterus.
CaseBioscience HTF w/HEPES is intended for use in short-term handling and manipulating gametes and embryos, including washing and intracytoplasmic sperm injection (ICSI).
CaseMONO Culture and CaseMONO w/HEPES have almost identical composition with differences in amount of NaHCO3 and Phenol red and presence of HEPES in CaseMONO w/HEPES. Similarly, CaseBioscience HTF and CaseBioscience HTF w/HEPES have an almost identical composition with the exception of HEPES present in CaseBioscience HTF w/HEPES and minor difference in composition for NaCl, Sodium L-lactate and Phenol red. CaseMONO Culture and CaseMONO w/HEPES contain EDTA. All media formulations contain antibiotic gentamicin.
The four solutions are aseptically filtered (storage vials sterilized by radiation) and provided in PETG square media bottles with HDPE screw-style caps. They have a shelf-life of 90 days when stored at 2-8°C. Media in the vials can be used for up to seven days after vial opening.
Acceptance Criteria and Device Performance Study for CaseBioscience Assisted Reproduction Media
This document outlines the acceptance criteria and the study conducted to prove that the CaseBioscience® Assisted Reproduction Media (CaseMONO™ Culture, CaseMONO™ w/HEPES, CaseBioscience® HTF, and CaseBioscience® HTF w/HEPES) meet these criteria, as detailed in the K242107 510(k) Summary.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for each variant of the CaseBioscience Assisted Reproduction Media are based on various non-clinical performance tests. The reported device performance met these acceptance criteria.
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Shelf-Life Testing | Product specifications (Appearance, pH, Osmolality, Sterility, Bacterial Endotoxin, MEA) met at time 0 and after aging at 2-8°C for 90 days. | All specified product parameters (Appearance, pH, Osmolality, Sterility, Bacterial Endotoxin, MEA) were met at time 0 and after 90 days of storage at 2-8°C, supporting a 90-day shelf-life. |
| Appearance | All solutions without precipitates. | Solutions were observed to be clear and free of precipitates. |
| pH (USP ) | CaseMONO™ Culture & CaseBioscience® HTF: 7.2-7.4 | |
| CaseMONO™ w/HEPES & CaseBioscience® HTF w/HEPES: 7.2-7.6 | CaseMONO™ Culture & CaseBioscience® HTF: Measured pH values were within 7.2-7.4. | |
| CaseMONO™ w/HEPES & CaseBioscience® HTF w/HEPES: Measured pH values were within 7.2-7.6. | ||
| Osmolality (USP ) | CaseMONO™ Culture: 260-270 mOsm/kg | |
| CaseBioscience® HTF: 285-295 mOsm/kg | ||
| CaseMONO™ w/HEPES: 260-270 mOsm/kg | ||
| CaseBioscience® HTF w/HEPES: 285-295 mOsm/kg | CaseMONO™ Culture: Measured osmolality was within 260-270 mOsm/kg. | |
| CaseBioscience® HTF: Measured osmolality was within 285-295 mOsm/kg. | ||
| CaseMONO™ w/HEPES: Measured osmolality was within 260-270 mOsm/kg. | ||
| CaseBioscience® HTF w/HEPES: Measured osmolality was within 285-295 mOsm/kg. | ||
| Sterility (USP ) | No microbial growth. | No microbial growth was detected. |
| Bacterial Endotoxin (USP ) | . | The devices passed transportation testing per ASTM D4169-22 and subsequent cap/seal leak testing. |
2. Sample Size and Data Provenance
The provided document details non-clinical performance testing for assisted reproduction media. The sample sizes for each specific test (e.g., number of embryos in MEA, number of samples for pH/Osmolality) are not explicitly stated in this summary.
The data provenance is from non-clinical laboratory testing and is retrospective in nature, as it was conducted to support a 510(k) submission for an existing product. The country of origin of the data is not specified, but the testing would have been conducted by or for CaseBioscience, Inc., which is based in Canada.
3. Number of Experts and Qualifications for Ground Truth
This submission pertains to in vitro reproductive media. The ground truth for performance (e.g., embryo development, chemical properties, sterility) is established through standardized laboratory assays and specifications, rather than expert human interpretation of images or patient data. Therefore, the concept of "experts establishing ground truth for a test set" in the context of image interpretation or clinical diagnosis by multiple medical professionals is not applicable here. The "experts" would be the scientists and quality control personnel in the laboratory performing the assays, adhering to validated methods.
4. Adjudication Method for the Test Set
As the evaluation is based on objective laboratory measurements and standardized assays (e.g., pH meters, osmometers, bacterial growth cultures, embryo development rates), an "adjudication method" in the sense of a consensus process among human readers (e.g., 2+1, 3+1) is not applicable. The results are quantitative and binary (pass/fail against a threshold).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study is typically performed for AI/CADe systems where human readers interpret medical images. Since this submission is for in vitro assisted reproduction media, which do not involve human interpretation of images or AI assistance in the diagnostic process, an MRMC comparative effectiveness study was not performed. Therefore, effect size of human improvement with AI assistance is not relevant or measurable in this context.
6. Standalone (Algorithm Only) Performance Study
This submission is for a medical device that is a consumable media, not a software algorithm. Therefore, a "standalone algorithm only" performance study is not applicable. The performance is assessed based on the physical, chemical, and biological properties of the media itself.
7. Type of Ground Truth Used
The ground truth used for proving the device meets the acceptance criteria is based on:
- Laboratory-established specifications and thresholds: For parameters like pH, osmolality, bacterial endotoxin, and appearance.
- Standardized biological assays: Specifically, the Mouse Embryo Assay (MEA), where the "ground truth" for success is a predefined percentage of embryos reaching a certain developmental stage (expanded blastocyst) within a specified timeframe.
- Compliance with international standards: For sterilization, aseptic processing, and biocompatibility testing (e.g., ISO, USP, ASTM).
8. Sample Size for the Training Set
This product is an in vitro medical device, not an AI/ML software. Therefore, there is no "training set" in the context of machine learning model development. The product is manufactured and tested according to established quality control procedures and specifications.
9. How the Ground Truth for the Training Set Was Established
Since there is no training set for an AI/ML model, this question is not applicable. The "ground truth" for the performance of the media is established by validated laboratory methods and industry/regulatory standards.
§ 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.