(84 days)
Dewin Blastocyst Medium (with HSA and without HSA) is intended for culture from the 8-cell stage to the blastocyst stage of embryo development. Dewin Blastocyst Medium (with HSA) is also intended for use in transfer of blastocyst stage embryos into the uterine cavity.
Dewin Blastocyst Medium (with HSA and without HSA) is intended for embryo culture from the cleavage to blastocyst stage of development and can also be used for transfer of blastocyst stage embryos to the uterine cavity.
Dewin Blastocyst Medium is comprised of salts, buffering agents, energy substrates, antioxidant, vitamins, nutrient supplements, amino acids, and gentamicin. Dewin Blastocyst Medium is offered with and without Human Serum Albumin (HSA).
Dewin Blastocyst Medium (with HSA and without HSA) is aseptically filtered and filled into glass bottles with polypropylene caps. The device is provided in 25 mL and 50 mL volumes. Dewin Blastocyst Medium (with HSA and without HSA) has a four-month shelf-life when stored as recommended and is for singleuse only.
The provided text describes a 510(k) premarket notification for a medical device called "Dewin Blastocyst Medium." This submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing a detailed clinical study demonstrating the device's performance against specific acceptance criteria in a human population.
Therefore, the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of human clinical performance (e.g., how human readers improve with AI, MRMC studies, standalone algorithm performance, number of experts, adjudication methods, details of ground truth establishment for clinical data sets) is not applicable to this document.
This document focuses on the non-clinical performance data used to establish substantial equivalence for a reproductive medium. The acceptance criteria described here are related to the physical, chemical, and biological properties of the medium itself, and not to its clinical effectiveness in human patients or the performance of an AI algorithm.
However, I can extract information related to the non-clinical performance acceptance criteria and the methods used to demonstrate those were met, as described in the document.
Here's a breakdown of the relevant information from the provided text, addressing the closest applicable points from your request:
Non-Clinical Acceptance Criteria and Performance Study for Dewin Blastocyst Medium
The provided document describes the non-clinical testing performed to demonstrate the safety and effectiveness of Dewin Blastocyst Medium and its substantial equivalence to a predicate device (Sydney IVF Blastocyst Medium). The "acceptance criteria" here refer to the specifications for the medium's properties and its biological compatibility.
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)
| Characteristic | Acceptance Criteria (Subject Device) | Reported Device Performance / Compliance |
|---|---|---|
| pH | 7.2-7.5 | Meets specification: Shelf-life testing demonstrated the product specifications were met, including pH. |
| Osmolality | 260-295 mOsm/kg | Meets specification: Shelf-life testing demonstrated the product specifications were met, including Osmolality. |
| Endotoxin | (pH), USP (Osmolality), USP (Endotoxin), USP (Sterility), ASTM F1980-16 (Real-time aging). |
* **Mouse Embryo Assay (MEA):** 2021 FDA guidance "Mouse Embryo Assay for Assisted Reproduction Technology Devices."
* **Transportation:** ASTM D4169-16.
8. The Sample Size for the Training Set
- Not Applicable. This refers to a manufactured product and its testing, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. See point 8.
Summary regarding the nature of the submission:
This 510(k) submission is for a reproductive medium, which is a substance used in laboratory procedures. The "acceptance criteria" and "study" described in the document pertain to the quality control and non-clinical performance of this medium itself (e.g., its chemical composition, sterility, and ability to support embryo development in a lab setting, as demonstrated by Mouse Embryo Assay). It is not a submission for an AI-powered diagnostic device, which would involve human reader studies, clinical ground truth from patient data, and AI algorithm performance metrics.
§ 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.