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Dewin Gamete Buffer is intended for human gamete and embryo short-term handling procedures outside the incubator, including washing and intracytoplasmic sperm injection (ICSI).

Dewin Follicle Flushing Solution is intended for use during ovarian follicle flushing and oocyte collection procedures for use in in vitro fertilization procedures.

Dewin One Step Medium 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.

The DonneVie Dewin Reproductive Media are solutions used in assisted reproductive procedures. The family of Reproductive Media include the following 3 types and their variants:

• Dewin Gamete Buffer [with and without Human Serum Albumin (HSA)];
• Dewin Follicle Flushing Solution;
• Dewin One Step Medium [with and without HSA].

All variants contain gentamicin, an antibiotic agent that suppresses bacterial growth. The Gamete Buffer and Follicle Flushing media are offered in 100mL volume, while the One Step Medium is offered in volumes of 25mL and 50mL. The three Dewin Reproductive Media are used together during an assisted reproductive procedure. The Follicle Flushing Solution is used to first flush/wash the Cumulus-Oocyte Complex after it's removed from the ovary; it is then transferred to the Gamete Buffer for cleaning. After the prepared oocyte has been fertilized, it is transferred to the One Step Medium to culture the embryo from fertilization to blastocyst stage.

The primary glass bottle containers are washed, then sterilized and depyrogenated via dry heat. The bottle caps are supplied sterile by electron beam irradiation. The media are sterile filtered through a 0.2µm filter in an aseptic isolator at DonneVie Medical Technology Co., Ltd.

The provided FDA 510(k) clearance letter describes a medical device called "Dewin Reproductive Media" and presents non-clinical performance testing to demonstrate its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Dewin Reproductive Media are primarily derived from the specifications compared to the predicate device and the results expected from specific non-clinical tests.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not specify the exact sample sizes for most of the non-clinical tests conducted. For example, it doesn't state how many batches were tested for sterility, pH, osmolality, or endotoxin, nor does it specify the number of mouse embryos used in the MEA tests.

• Provenance: The studies were conducted by DonneVie Medical Technology (Shanghai) Co. Ltd. This implies the data provenance is likely from China, as that is the submitter's location. The studies are non-clinical, meaning they are laboratory tests, not human trials. They are implicitly prospective in the sense that they were designed and executed to test the device's performance against predefined criteria.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This section is not applicable as the studies described are non-clinical laboratory tests, not studies requiring expert interpretation of medical images or patient outcomes. The "ground truth" for these tests (e.g., pH value, osmolality, microorganism presence, blastocyst development) is established through established laboratory methods and validated instrumentation, not by expert consensus in a clinical diagnostic context.

4. Adjudication Method for the Test Set

This section is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies, particularly in cases where human readers or diagnosticians are involved and their interpretations need to be reconciled to establish a ground truth. For laboratory tests, the results are typically quantitative or qualitative outcomes determined by a predefined method, eliminating the need for expert adjudication in this typical sense.

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

This section is not applicable. The device is a "Reproductive Media," which are solutions used in assisted reproductive procedures (e.g., for washing gametes, culturing embryos). It is not an AI-powered diagnostic device or an imaging system. Therefore, no MRMC study involving human readers or AI assistance would be relevant or conducted for this type of product.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

This section is not applicable. The device is a reproductive media solution, not an algorithm or an AI system. Its performance is evaluated through physical, chemical, and biological laboratory tests, not through algorithmic output.

7. The Type of Ground Truth Used

The ground truth for the non-clinical tests is established through:

• Physicochemical Measurements: For parameters like pH, osmolality, and endotoxin, the ground truth is the numerical value obtained using validated analytical instruments and methods (e.g., pH meter, osmometer, LAL assay).
• Biological Endpoints: For the Mouse Embryo Assay (MEA), the ground truth is the observed development of mouse embryos to the expanded blastocyst stage within a specified timeframe, as assessed under a microscope by trained personnel following a standardized protocol.
• Microbiological Endpoints: For sterility testing, the ground truth is the absence of microbial growth in culture, determined by standard microbiological techniques.
• Regulatory Standards: Compliance with ISO standards for sterilization, biocompatibility, and transportation testing.

8. The Sample Size for the Training Set

This section is not applicable. The Dewin Reproductive Media is a chemical/biological product, not a machine learning model or AI system that requires a "training set." The product's formulation and manufacturing processes are developed through research and development, not by training an algorithm on a dataset.

9. How the Ground Truth for the Training Set was Established

This section is not applicable as there is no "training set" for this type of device.

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Dewin Vitrification Kit is intended for use in the vitrification of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

Dewin Thawing Kit is intended for use in the thawing of vitrified oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

Dewin Vitrification Kit and Dewin Thawing Kit include a set of five media intended for use in the vitrification and thawing of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embryos as part of InVitro Fertilization (IVF) procedures.

The Vitrification Kit and Thawing Kit media are offered in 2mL and 5mL volumes. Dewin Vitrification Kit includes two media components, Equilibration Solution (ES) and Vitrification Solution (VS), containing the cryoprotectants ethylene glycol, trehalose (only in VS), and dimethyl sulfoxide. During the vitrification process, embryos are first exposed to ES and then to VS. Using this methodology, the permeating cryoprotectants can replace water in the oocyte or PN through blastocyst stage embryos prior to vitrification and storage in liquid nitrogen.

Dewin Thawing Kit is composed of three media used stepwise for thawing and removing cryoprotectants from vitrified oocytes and PN through blastocyst stage embryos. It is composed of Thawing Solution (TS), Dilution Solution (DS) and Washing Solution (WS).

The primary ingredients of the vitrification and thawing media are water, sodium chloride, potassium chloride, sodium dihydrogen phosphate dihydrate, magnesium sulphate heptahydrate, calcium chloride, sodium bicarbonate, gentamicin sulfate, glucose, sodium-s-lactate, sodium pyruvate, alanyl glutamine, taurine, EDTA, phenol red, HEPES, HSA, trehalose, ethylene glycol, DMSO, non-essential amino acids. Cryoprotectants in the media include ethylene glycol (7.5% in ES, 15% in VS), DMSO (7.5% in ES, 15% in VS), and trehalose in VS, TS and DS.

The five solutions in the Dewin Vitrification Kit and Dewin Thawing Kit are aseptically filtered (storage vials sterilized by dry heat and radiation) and provided in glass bottles capped with a polypropylene screw-top cap. They are single-use only and have a shelf-life of 7 months when stored at 2-8°C.

The provided FDA clearance letter and 510(k) summary pertain to the Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit). This document does not describe an AI/ML-enabled device or a study involving human readers or comparative effectiveness with AI. Therefore, most of the requested information (such as effect size of human readers with AI assistance, expert qualifications, and adjudication methods) is not applicable or cannot be extracted from the given text.

The information below focuses solely on the device and its testing as described in the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Dewin Reproductive Media are primarily based on physical, chemical, and biological performance measures. The reported device performance matches these criteria for the supported shelf-life.

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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)

*   **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.

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Dewin Reproductive Media consists of Dewin Fertilization Medium (with HSA and without HSA) and Dewin Cleavage Medium (with HSA and without HSA). The indications for use for the Dewin Fertilization Medium and Dewin Cleavage Medium are as follows:

Dewin Fertilization Medium is intended for use during in vitro fertilization (IVF) procedures and culture to the two pronuclei (zygote) stage of development. Dewin Fertilization Medium is also intended for washing sperm and collected oocytes after aspiration prior to IVF procedures. Dewin Fertilization Medium is not intended for use in intrauterine insemination procedures.

Dewin Cleavage Medium is intended for culture of embryos from the two pronuclei (zygote) stage of embryo development. Dewin Cleavage Medium is also intended for use in the transfer of cleavage stage embryos into the uterine cavity.

Dewin Reproductive Media includes two products (Dewin Fertilization and Dewin Cleavage Medium). Dewin Fertilization Medium is intended for use in washing sperm and oocytes for use in in IVF procedures. Dewin Cleavage Medium, is intended for use in culturing embryos from the zygote stage to the 8-cell stage of development and can also be used for embryo transfer procedures.

Dewin Reproductive Media are comprised of salts, energy substrates, anti-oxidant, nutrient supplements, amino acids, EDTA, gentamicin, and phenol red. Dewin Reproductive Media are offered with and without Human Serum Albumin (HSA).

The Dewin Reproductive Media are aseptically filtered and filled into glass bottles with polypropylene caps. The devices are provided in 25 mL and 50 mL volumes. Dewin Reproductive Media have a fourmonth shelf-life when stored as recommended and are for single-use only.

The medical device in question is Dewin Reproductive Media, which includes Dewin Fertilization Medium and Dewin Cleavage Medium. This document is a 510(k) Summary, which typically compares a new device to a legally marketed predicate device to demonstrate substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The provided text lists acceptance criteria and performance for several non-clinical tests. It doesn't explicitly present a comparative table of acceptance criteria vs. specific reported device performance values for all criteria, but it states that "Results confirm that the design inputs and performance specifications for the device are met." and for specific tests, it states the acceptance criteria (e.g., pH target, MEA success rate).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "non-clinical performance testing" and describes the types of tests (biocompatibility, shelf-life, MEA, etc.). However, it does not specify the sample sizes used for these tests nor does it provide information on the data provenance (country of origin, retrospective/prospective). For MEA (Mouse Embryo Assay), a specific number of embryos would be used, but this is not detailed.

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)

This section is not applicable as the device is a reproductive medium (solution), not an AI/imaging device requiring expert interpretation for ground truth establishment. The performance is assessed through laboratory assays (e.g., cell development, chemical properties, sterility).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable for the same reasons as point 3. The performance evaluation is based on objective laboratory measurements and biological assays, not subjective expert reviews requiring adjudication.

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

This section is not applicable as the device is a reproductive medium and not an AI-assisted diagnostic or imaging tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This section is not applicable as the device is a reproductive medium and does not involve an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For this device, the "ground truth" or reference standard is based on:

• Established scientific and regulatory standards: e.g., ISO standards for biocompatibility and aseptic filling, USP standards for pH, osmolality, endotoxin, and sterility, ASTM standards for transportation.
• Biological assay endpoints: For the Mouse Embryo Assay (MEA), the endpoint is the percentage of embryos developed to the expanded blastocyst stage within a specified timeframe (e.g., ≥80% development). This is an objective, measurable biological outcome.
• Chemical and physical properties: Measured parameters like pH, osmolality, and endotoxin levels are compared against predefined numerical specifications.

8. The sample size for the training set

This is not applicable as the device is a reproductive medium and does not involve a training set for an algorithm.

9. How the ground truth for the training set was established

This is not applicable as the device is a reproductive medium and does not involve a training set.

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