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.

Device Description

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.

AI/ML Overview

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).

Test/Parameter	Acceptance Criteria (Design Input/Performance Spec)	Reported Device Performance (as stated in sections 9 & 10)
Biocompatibility	Non-cytotoxic, non-sensitizing, non-irritating	"The testing demonstrated the Dewin Cleavage Medium formulations to be non-cytotoxic, non-sensitizing, and non-irritating."
Sterile filtration & Aseptic fill	Conformance to ISO 13408-1:2008 and ISO 13408-2:2018	(Stated as conforming, no specific numerical results given)
Shelf-Life (4 months)	Product specifications met at time 0 and after accelerated aging	"demonstration that the product specifications (shown below) were met at time 0 and after accelerated aging"
Appearance	Clear, particle-free	(Stated as conforming, no specific numerical results given)
pH	7.2–7.5 (per USP <791>)	(Stated as conforming, no specific numerical results given)
Osmolality	260–295 mOsm/kg (per USP <785>)	(Stated as conforming, no specific numerical results given)
Endotoxin	< 0.25 EU/mL (per USP <85>)	(Stated as conforming, no specific numerical results given)
MEA (Fertilization Medium)	One-cell system: ≥80% embryos developed to expanded blastocyst at 96 hours after 24-hour exposure	(Stated as conforming, no specific numerical results given beyond meeting the ≥80% criterion)
MEA (Cleavage Medium)	One-cell system: ≥80% embryos developed to expanded blastocyst at 96 hours after 48-hour exposure	(Stated as conforming, no specific numerical results given beyond meeting the ≥80% criterion)
Sterility	No microbial growth (per USP <71>)	(Stated as conforming, no specific numerical results given)
Transportation Testing	Conformance to ASTM D4169-16	(Stated as conforming, no specific numerical results given)

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.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 16, 2022

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

Re: K212426

Trade/Device Name: Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA]) Regulation Number: 21 CFR§ 884.6180 Regulation Name: Reproductive Media and Supplements Regulatory Class: II Product Code: MOL Dated: May 10, 2022 Received: May 17, 2022

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.

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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.

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 (OS) 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 medical devices and radiation-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,

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) K212426

Device Name

Dewin Reproductive Media (Dewin Fertilization [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA])

Indications for Use (Describe)

Dewin Reproductive Media consists of Dewin Fertilization (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:

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 Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA], Dewin Cleavage Medium [with HSA and without HSA]) K212426

1. Sponsor Information

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. Correspondent Information

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

June 15, 2022

4. Device Identification

Trade/Proprietary Name:	Dewin Reproductive Media (Dewin Fertilization Medium [with HSA andwithout HSA], and Dewin Cleavage 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(s)

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

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

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6. Device Description

7. Indications for Use

Dewin Fertilization Medium is intended for use during vitro fertilization (IVF) procedures and culture to the two pronuclei (zygote) stage of development. Dewin Fertilization Medium is also intended for washing and handling 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 to the 8-cell stage of embryo development. Dewin Cleavage Medium is also intended for use in the transfer of cleavage 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 Reproductive Media – K212426(Subject Device)	Cook Sydney IVFMedia- K153290(Predicate Device)	Discussion
Manufacturer	DonneVie Medical Technology(Shanghai) Co. Ltd.	William A. CookAustralia Pty, Ltd.
Product Code	MQL	MQL
RegulationNumber	884.6180	884.6180
Class	Class II	Class II
Indicationsfor Use	Dewin Reproductive Media consists ofDewin Fertilization Medium (with HSAand without HSA) and Dewin CleavageMedium (with HSA and without HSA).	Sydney IVFFertilization Mediumis intended for useduring in vitro	There are differences in thefor the subject and predicatedevices; however, the
	The indications for use for the DewinFertilization Medium and DewinCleavage Medium are as follows:Dewin Fertilization Medium is intendedfor use during vitro fertilization (IVF)procedures and culture to the twopronuclei (zygote) stage ofdevelopment. Dewin FertilizationMedium is also intended for washingand handling sperm and collectedoocytes after aspiration prior to IVFprocedures. Dewin Fertilization Mediumis not intended for use in intrauterineinsemination procedures.Dewin Cleavage Medium is intended forculture of embryos from the twopronuclei (zygote) stage to the 8-cellstage of embryo development. Dewin	procedures forinsemination andincubation of oocytes.Sydney IVF CleavageMedium is intendedfor use during in vitrofertilizationprocedures for cultureand transfer ofcleavage stageembryos.	intended uses of the subjectand predicate devices are thesame. Therefore, they havethe same intended use.
	Cleavage Medium is also intended foruse in the transfer of cleavage stageembryos into the uterine cavity.
Conditions ofUse	Rx Only	Rx Only	Same
DeviceMaterials	Salts, energy substrates, anti-oxidant,nutrient supplements, amino acids,EDTA, gentamicin, and phenol red. It isoffered with and without HSA.	Salts, energysubstrates, buffer,anti-oxidant, nutrientsupplements, aminoacids, antibiotic,protein	Different: The formulations ofthe subject and predicatedevices include the sametypes of chemicalconstituents; however, theformulations are not thesame. Differences in deviceformulations do not raisedifferent questions of safetyand effectiveness (S&E).
Volume	25, 50 mL	20, 50, 100 mL	Different: The subject andpredicate devices are providedin different volumes.Differences in volumes do not
			raise different questions ofS&E.
AsepticallyFiltered	Yes	Yes	Same
Single-Use	Yes	Yes	Same
StorageCondition	2 – 8°C	2 – 8°C	Same
Shelf-Life	4 months	20 weeks	Different: The subject devicehas a shorter shelf-life thanthe predicate device.Differences in shelf-life do notraise different questions ofS&E.
pH	7.2-7.5	7.5 - 7.8	Different: The subject devicehas a lower pH range than thepredicate device. Thisdifference in pH range doesnot raise different questions ofS&E.
Osmolality	260-295 mOsm/kg	285-295 mOsm/kg	Different: The subject devicehas a wider osmolality rangethan the predicate device. Thisdifference in osmolality doesnot raise different questions ofS&E.
Sterility	No microbial growth	No microbial growth	Same
Endotoxin	< 0.25 EU/mL	< 0.4 EU/mL	Different: The subject devicehas a lower endotoxinspecification than thepredicate device. Thisdifference does not raisedifferent questions of S&E.
MEA	One-cell system: ≥80% embryosdeveloped to expanded blastocyst at 96hours after 24-hour exposure to DewinFertilization MediumOne-cell system: ≥80% embryosdeveloped to expanded blastocyst at 96	2-Cell MEA: ≥ 80%expanded blastocystat 72 hours	Different: There aredifferences in the type of MEAtesting conducted. Thisdifference in MEA methoddoes not raise differentquestions of S&E, as bothmethods are acceptable to
	hours after 48-hour exposure to DewinCleavage Medium	support an assistedreproduction media device.

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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 Testing

To demonstrate safety and effectiveness of Dewin Reproductive Media 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 Cleavage 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:
- l Cytotoxicity testing per ISO 10993-5:2009
- । Sensitization testing per ISO 10993-10:2010
- -Intracutaneous Reactivity per ISO 10993-10:2010

The testing demonstrated the Dewin Cleavage Medium formulations 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 for both products through demonstration that the product specifications (shown below) were met at time 0 and after accelerated 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 Fertilization Medium: One-cell system: ≥80% embryos developed to expanded blastocyst at 96 hours after 24-hour exposure to Dewin Fertilization Medium
  - . Dewin Cleavage Medium: One-cell system: ≥80% embryos developed to expanded blastocyst at 96 hours after 48-hour exposure to Dewin Cleavage Medium
- -Sterility, per USP <71>: No microbial growth
Transportation testing per ASTM D4169-16 ●

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10. Statement of Substantial Equivalence

The results of the performance testing described above demonstrate that the subject media products are as safe and effective as the predicate devices and support 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.