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.

Device Description

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.

AI/ML Overview

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	< 0.25 EU/mL	Meets specification: Shelf-life testing demonstrated the product specifications were met, including Endotoxin.
Mouse Embryo Assay (MEA)	One-cell system: ≥ 80% embryos developed to expanded blastocyst at 96 hours	Meets specification: Shelf-life testing demonstrated the product specifications were met, including MEA testing.
Sterility	No microbial growth	Meets specification: Shelf-life testing demonstrated the product specifications were met, including Sterility.
Appearance	Clear, particle-free	Meets specification: Shelf-life testing demonstrated the product specifications were met, including Appearance.
Biocompatibility	Non-cytotoxic, non-sensitizing, non-irritating	Demonstrated: Testing per ISO 10993-5:2009 (Cytotoxicity), ISO 10993-10:2010 (Sensitization), and ISO 10993-10:2010 (Intracutaneous Reactivity) confirmed these properties.
Sterile Filtration and Aseptic Fill	Validated	Validated: Per ISO 13408-1:2008 and ISO 13408-2:2018.
Shelf-life	4 months (product specifications met at time 0 and after real-time aging)	Supported: Shelf-life testing conducted in accordance with ASTM F1980-16.
Transportation	N/A (Method specified as ASTM D4169-16)	Compliant: Transportation testing per ASTM D4169-16.

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

Sample Size: Not specified in terms of number of human embryo samples or patients for a clinical trial. The testing is non-clinical.
Data Provenance: The manufacturer is DonneVie Medical Technology (Shanghai) Co. Ltd. (China). The document implies testing was conducted by or for the manufacturer. The data is non-clinical performance data for the product itself, not human clinical trial data.

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

Not Applicable. This is non-clinical laboratory testing of a product's properties, not an AI or diagnostic device that requires expert human interpretation for establishing ground truth on clinical images/data.

4. Adjudication Method for the Test Set

Not Applicable. See point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is a non-clinical submission for a medical medium, not a diagnostic imaging AI device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not Applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

For the non-clinical performance tests, the "ground truth" is defined by the established scientific and regulatory standards/methods used to evaluate the physical, chemical, and biological properties of the medium.
- Biocompatibility: ISO 10993-5:2009 (Cytotoxicity), ISO 10993-10:2010 (Sensitization, Intracutaneous Reactivity).
- Sterile Filtration/Aseptic Fill: ISO 13408-1:2008 and ISO 13408-2:2018.
- Shelf-life Parameters: USP <791> (pH), USP <785> (Osmolality), USP <85> (Endotoxin), USP <71> (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.

Summary

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August 4, 2023

DonneVie Medical Technology (Shanghai) Co. Ltd. % Stuart R. Goldman Senior Regulatory Consultant, RA/QA Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, TX 78746

Re: K231370

Trade/Device Name: Dewin Blastocyst Medium (with HSA and without HSA) Regulation Number: 21 CFR§ 884.6180 Regulation Name: Reproductive Media and Supplements Regulatory Class: II Product Code: MQL Dated: May 10, 2023 Received: May 12, 2023

Dear Stuart R. Goldman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael T. Bailey -S

For Monica D. Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K231370

Device Name

Dewin Blastocyst Medium (with HSA and without HSA)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary Dewin Blastocyst Medium (with HSA and without HSA) K231370

1. Submission Sponsor

DonneVie Medical Technology (Shanghai) Co. Ltd. Suite 201, Bld. 1, 138 Xinjun Ring Minhang District, Shanghai, 201114, China Contact: Hannah Hang Yin Phone: +86 21 34781568 Title: CEO

2. Submission Correspondent

Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Office Phone: (512) 327-9997 Email: LST.AUS.ProjectManagement@ul.com Contact: Stuart R. Goldman Title: Senior Regulatory Consultant, RA/QA

3. Date Prepared

July 31, 2023

4. Device Identification

	Trade/Proprietary Name:	Dewin Blastocyst Medium (with HSA and without HSA
	Common/Usual Name:	Reproductive Media
	Regulation Name:	Reproductive media and supplements
	Regulation Number:	884.6180
	Product Code:	MQL (Media, Reproductive)
	Class:	Class II

5. Legally Marketed Predicate Device

Device name:	Sydney IVF Blastocyst Medium
510(k) number:	K153290
Manufacturer:	William A. Cook Australia Pty, Ltd

The predicate device has not been subject to a design-related recall

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6. Device Description

7. Indication for Use

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 and without HSA) is also intended for use in the transfer of blastocyst stage embryos into the uterine cavity.

1. Comparison of intended use and technological characteristics of the subject and predicate devices
  A comparison of the intended use and technological characteristics of the subject device and the predicate device is shown in the table below:

	Dewin Blastocyst Medium (withHSA and without HSA)	Cook SydneyBlastocyst Medium(Predicate –K153290)	Discussion
Manufacturer	DonneVie Medical Technology(Shanghai) Co. Ltd.	William A. CookAustralia Pty, Ltd.
Product Code	MQL	MQL
Regulation Number	884.6180	884.6180
Class	Class II	Class II
Indications for Use	Dewin Blastocyst Medium (withHSA and without HSA) isintended for culture from the 8-cell stage to the blastocyst stageof embryo development. DewinBlastocyst Medium (with HSAand without HSA) is alsointended for use in the transferof blastocyst stage embryos intothe uterine cavity.	Sydney IVF BlastocystMedium is intendedfor use during in vitrofertilizationprocedures forextended culture andtransfer of embryos.	There are differences in theindications for use statements forthe subject and predicate devices;however, the intended uses of thesubject and predicate devices arethe same (i.e., culture of embryosfrom the cleavage to blastocyststage of development and forblastocyst transfer). Therefore,they have the same intended use.
Conditions of Use	Rx Only	Rx Only	Same
Device Materials	Salts, buffer, energy substrates,antioxidant, vitamins, nutrientsupplements, amino acids, andgentamicin. It is offered withand without HSA.	Salts, energysubstrates, buffer,antioxidant, nutrientsupplements, amino	Different: The formulations of thesubject and predicate devices arenot the same. Differences indevice formulations do not raise

Table 1. Comparison of Characteristics

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		acids, gentamicin,	different questions of safety and
		and HSA.	effectiveness (S&E).
Volumes	25, 50 mL	20, 50 mL	Similar
Aseptically Filtered	Yes	Yes	Same
Single-Use	Yes	Yes	Same
Storage Condition	2 – 8°C	2 – 8°C	Same
Shelf Life	4 months	20 weeks	Different: The subject device has ashorter shelf-life than thepredicate device. Differences inshelf-life do not raise differentquestions of S&E.
pH	7.2-7.5	7.5 -7.8	Different: The subject device has alower pH range than the predicatedevice. This difference in pH rangedoes not raise different questionsof S&E.
Osmolality	260-295 mOsm/kg	280-290 mOsm/kg	Different: The subject device has awider osmolality range than thepredicate device. This difference inosmolality does not raise differentquestions of S&E.
Endotoxin	< 0.25 EU/mL	< 0.4 EU/mL	Different: The subject device has alower endotoxin specification thanthe predicate device. Thisdifference does not raise differentquestions of S&E.
MEA	One-cell system: ≥ 80% embryosdeveloped to expandedblastocyst at 96 hours	2-cell MEA: ≥ 80%expanded blastocystat 72 hours	Different: There are differences inthe type of MEA testingconducted. This difference in MEAmethod does not raise differentquestions of S&E.

As shown in the table above, there are differences in the indications for use statements and technological features of the subject and predicate devices. However, as stated in the table, the differences in indications for use do not represent a new intended use and the differences in technological features do not raise different questions of safety and effectiveness.

9. Non-Clinical Performance Data

To demonstrate safety and effectiveness of Dewin Blastocyst Medium (with HSA and without HSA) and to show substantial equivalence to the predicate device, DonneVie Medical Technology completed the following non-clinical tests. Results confirm that the design inputs and performance specifications for the device are met.

. Biocompatibility testing was conducted in support of the Dewin Blastocysts Medium that will have direct contact with the patient during embryo transfer procedures. Testing was conducted in accordance with the 2020 FDA guidance Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process. Testing included:
- -Cytotoxicity testing per ISO 10993-5:2009

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-Sensitization testing per ISO 10993-10:2010
-Intracutaneous Reactivity per ISO 10993-10:2010

The testing demonstrated the Dewin Blastocyst Medium formulation to be non-cytotoxic, nonsensitizing, and non-irritating.

. Sterile filtration and aseptic fill validation, per ISO 13408-1:2008 and ISO 13408-2:2018.
. Shelf-life testing was conducted to support the 4-month shelf-life through demonstration that the product specifications (shown below) were met at time 0 and after real-time aging in accordance with ASTM F1980-16:
- -Appearance: Clear, particle-free
- pH, per USP <791>: 7.2-7.5
- -Osmolality, per USP<785>: 260–295 mOsm/kg
- -Endotoxin, per USP <85>: < 0.25 EU/mL
- -MEA testing, in accordance with the 2021 FDA guidance Mouse Embryo Assay for Assisted Reproduction Technology Devices:
  - . Dewin Blastocyst Medium: One-cell system: ≥80% embryos developed to expanded blastocyst at 96 hours
- -Sterility, per USP <71>: No microbial growth
. Transportation testing per ASTM D4169-16

10. Statement of Substantial Equivalence

The results of the performance testing described above demonstrate that the subject medium is as safe and effective as the predicate device and supports a determination of substantial equivalence.

Regulation Number and Section

§ 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.