(51 days)
Continuous Single Culture™ Complete is intended for use as a culture medium for human gametes and embryos from fertilization through day 5/6 of development in vitro.
The Continuous Single Culture™ Complete is based upon the Single Step Medium™ (K072609) formulation that is supplemented with Human Serum Albumin, H.S.A. The Continuous Single Culture™ Complete is composed of a balanced mixture of salts, amino acids and other nutrients that have been shown to support embryo development. The Continuous Single Culture™ Complete is designed to be used as a culture media for fertilization and for development of embryos until the desired developmental stage (up to 5/6 days). Selected embryos are then moved to an embryo transfer media prior to transfer to the uterus.
The Continuous Single Culture™ Complete is supplied in liquid form, and contains gentamicin sulfate as a preservative and a therapeutic grade of Human Serum Albumin (K983584). Liquid Continuous Single Culture™ Complete is supplied in a fill volume of 20 mL.
Continuous Single Culture™ Complete has utility as a culture medium from fertilization through day 5/6 of development. The fertilized oocyte (zygote) is allowed to grow in the culture dish, supported by a culture medium and an appropriate protein supplement, in a carbon dioxide incubator at 37°C until the desired stage of development is achieved. Selected embryos are then moved to an embryo transfer media prior to transfer to the uterus.
Continuous Single Culture™ Complete is supplied as a ready to use liquid in 20 mL bottles.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study that demonstrates the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from the product specifications comparison between the proposed device (Continuous Single Culture™ Complete) and the predicate device (Single Step Medium™ K072609). The performance for the proposed device is the criteria it must meet.
| Specification | Acceptance Criteria for Continuous Single Culture™ Complete | Reported Device Performance (from "Performance Data" and "Product Specification Comparison") |
|---|---|---|
| pH | 7.25 - 7.54 | Not explicitly stated as a numerical result in the "Performance Data" or "Nonclinical Tests" sections for the new device's testing. However, "pH" is listed as a performed test under "Performance Data" and the "Product Specification Comparison" shows "7.25 - 7.54" for both the predicate and proposed device, implying the proposed device meets this. |
| Osmolality | 260 – 270 mOsm/KgH2O | Similar to pH, osmolality is listed as a performed test, and the "Product Specification Comparison" shows "260 – 270 mOsm/KgH2O" for both, implying the proposed device meets this. |
| Sterility | Pass | "Sterility" is listed as a performed test, and the "Product Specification Comparison" shows "Pass" for both, implying the proposed device meets this. |
| Endotoxin | ≤ 0.25 EU/mL | "Endotoxin" is listed as a performed test, and the "Product Specification Comparison" shows "≤ 0.25 EU/mL" for both, implying the proposed device meets this. |
| MEA (Mouse Embryo Assay) | ≥ 80% expanded blastocyst at 96 hours | The MEA "assures that the product is functional for its intended use, the support of embryonic growth, and that embryotoxic components are not present in the formulation." The "Product Specification Comparison" states "≥ 80% expanded blastocyst at 96 hours" for the proposed device. The nonclinical test section indicates one-cell MEA was performed at three facilities, and the field evaluations "demonstrate that the Continuous Single Culture™ Complete was "equal" to the proven control medium (predicate device)". |
| HSSA (Human Sperm Survival Assay) | ≥ 70% of original motility at 24 hours | The HSSA "assures that the product is both functional for its intended use with regards to sperm wash procedure and that no sperm-toxic components are present in the formulation." The "Product Specification Comparison" states "≥ 70% of original motility at 24 hours" for the proposed device. The nonclinical test section indicates HSSA was performed on donor specimens at three different test facilities, and the field evaluations "demonstrate that the Continuous Single Culture™ Complete was "equal" to the proven control medium (predicate device)". The predicate device did not have an HSSA specification (NT - Not Tested). |
| Albumin Recovery Assay | Not explicitly stated with a numerical criterion | Listed under "Additional Information" as a "condition of release," implying it's a test performed but without a specific pass/fail criterion mentioned in this document. |
| Appearance | Not explicitly stated with a numerical criterion | Listed under "Additional Information" as a "condition of release," implying it's a test performed but without a specific pass/fail criterion mentioned in this document. |
2. Sample Size Used for the Test Set and Data Provenance
- MEA (Mouse Embryo Assay): The study states that one (1)-cell MEA was performed as part of design validation. It was conducted at three (3) different test facilities. The sample size for embryos or individual tests is not specified beyond "one (1)-cell MEA." The data provenance is not explicitly stated (e.g., country of origin), but it is implied to be non-clinical laboratory testing. The study is prospective in nature, as it is part of design validation and pre-market release testing.
- HSSA (Human Sperm Survival Assay): Performed on donor specimens at three (3) different test facilities. The number of donor specimens is not specified. The donor specimens were "initially processed by gradient separation and resulting motile specimens were equally divided." Data provenance is not explicitly stated, but it is implied to be non-clinical laboratory testing using human donor samples. The study is prospective, as it is part of design validation and pre-market release testing.
- Other tests (pH, osmolality, sterility, endotoxin, albumin recovery, appearance): These are described as routine quality control tests performed "prior to release to the market" and "as a condition of release." The sample sizes for these tests (e.g., how many batches, how many units per batch) are not specified. The data provenance is internal laboratory testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This document describes non-clinical performance testing for a cell culture medium. It does not involve human interpretation of medical images or patient diagnoses that typically require expert adjudication for ground truth.
- The "ground truth" for the MEA and HSSA is an objective biological outcome (embryo development to blastocyst, sperm motility) measured by laboratory assays. The document doesn't mention expert review for establishing ground truth as it would for, say, a diagnostic imaging device. The "field evaluations" where the product was found "equal" to the control medium imply expert handling and perhaps informal assessment, but not formal "ground truth" adjudication.
4. Adjudication Method for the Test Set
- Not applicable. As noted above, this study evaluates a cell culture medium through objective laboratory assays, not a diagnostic device requiring expert adjudication of results.
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 a 510(k) summary for a cell culture medium, not an AI-assisted diagnostic device. There are no "human readers," "AI assistance," or "cases" in the context of an MRMC study.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
- Not applicable. This is a cell culture medium, not an algorithm or AI system.
7. The Type of Ground Truth Used
- For the MEA, the ground truth is biological outcome data: achievement of ≥ 80% expanded blastocyst development at 96 hours.
- For the HSSA, the ground truth is biological outcome data: ≥ 70% of original sperm motility at 24 hours.
- For pH, osmolality, sterility, and endotoxin, the ground truth is instrumental measurement data compared against defined numerical ranges or a "Pass" criterion.
8. The Sample Size for the Training Set
- Not applicable. As a non-AI/ML device, there is no "training set." The product's formulation was developed and validated, but not "trained" in the machine learning sense. The development likely involved iterative testing and refinement, but this is distinct from an AI training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this type of device.
§ 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.