Who is the manufacturer of Dewin Blastocyst Medium (with HSA and without HSA)?

Donnevie Medical Technology (Shanghai) Co. , Ltd. filed the 510(k) submission for Dewin Blastocyst Medium (with HSA and without HSA) (K231370).

What is the FDA product code for Dewin Blastocyst Medium (with HSA and without HSA)?

MQL. It is classified under 21 CFR 884.6180 as a Class 2 device in the Obstetrics/Gynecology panel.

What is the regulatory pathway for Dewin Blastocyst Medium (with HSA and without HSA)?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Dewin Blastocyst Medium (with HSA and without HSA)?

Sydney IVF Blastocyst Medium (K153290).

Who can help prepare an FDA 510(k) submission like Dewin Blastocyst Medium (with HSA and without HSA)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Dewin Blastocyst Medium (with HSA and without HSA)

K231370 · Donnevie Medical Technology (Shanghai) Co. , Ltd. · MQL · Aug 4, 2023 · Obstetrics/Gynecology

Device Facts

Record ID	K231370
Device Name	Dewin Blastocyst Medium (with HSA and without HSA)
Applicant	Donnevie Medical Technology (Shanghai) Co. , Ltd.
Product Code	MQL · Obstetrics/Gynecology
Decision Date	Aug 4, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 884.6180
Device Class	Class 2

Intended 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) is also intended for use in transfer of blastocyst stage embryos into the uterine cavity.

Device Story

Dewin Blastocyst Medium is a liquid culture medium containing salts, buffering agents, energy substrates, antioxidants, vitamins, amino acids, and gentamicin; available with or without Human Serum Albumin (HSA). Used in clinical embryology laboratories by trained personnel for in vitro embryo development from 8-cell to blastocyst stage and subsequent transfer to the uterine cavity. The medium provides a controlled chemical environment to support embryo viability. It is supplied as an aseptically filtered, single-use solution in glass bottles. The healthcare provider uses the medium to maintain embryos during the culture period; successful development to the blastocyst stage is a prerequisite for transfer, potentially improving implantation outcomes for patients undergoing assisted reproductive technology.

Clinical Evidence

Bench testing only. Includes biocompatibility (cytotoxicity, sensitization, intracutaneous reactivity per ISO 10993), sterile filtration/aseptic fill validation, shelf-life stability (ASTM F1980-16), and Mouse Embryo Assay (MEA) performance (≥80% development to expanded blastocyst at 96 hours).

Technological Characteristics

Aqueous solution containing salts, buffer, energy substrates, antioxidant, vitamins, amino acids, and gentamicin. pH 7.2-7.5; osmolality 260-295 mOsm/kg; endotoxin < 0.25 EU/mL. Aseptically filtered; stored at 2-8°C. Packaging: glass bottles with polypropylene caps. Shelf-life: 4 months. Single-use.

Indications for Use

Indicated for embryo culture from 8-cell to blastocyst stage and transfer of blastocyst stage embryos into the uterine cavity in patients undergoing IVF procedures.

Regulatory Classification

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.).

Special Controls

*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.

Predicate Devices

Sydney IVF Blastocyst Medium (K153290)

Related Devices

K212426 — Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA]) · Donnevie Medical Technology (Shanghai) Co. , Ltd. · Jun 16, 2022
K080172 — BLASTASSIST WITHOUT PHENOL RED, MODEL REF 1215, BLASTASSIST WITH PHENOL RED, MODEL REF 1216 · Medicult A/S · Dec 18, 2008
K191063 — 1-Step Culture Medium · Shenzhen Vitavitro Biotech Co., Ltd. · Aug 23, 2019
K153290 — Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst Medium · William A. Cook Australia Pty. , Ltd. · Jan 27, 2016
K983580 — BLASTOCYST MEDIUM · Irvine Scientific Sales Co., Inc. · Feb 18, 1999

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "U.S. Food & Drug Administration" in blue. 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K231370 Device Name Dewin Blastocyst Medium (with HSA and without HSA) Indications for Use (Describe) 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. | 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) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 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 {4}------------------------------------------------ #### 6. 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. #### 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. - 8. 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 (with HSA and without HSA) | Cook Sydney Blastocyst Medium (Predicate – K153290) | Discussion | |---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | DonneVie Medical Technology (Shanghai) Co. Ltd. | William A. Cook Australia Pty, Ltd. | | | Product Code | MQL | MQL | | | Regulation Number | 884.6180 | 884.6180 | | | Class | Class II | Class II | | | Indications 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. | Sydney IVF Blastocyst Medium is intended for use during in vitro fertilization procedures for extended culture and transfer of embryos. | There are differences in the indications for use statements for the subject and predicate devices; however, the intended uses of the subject and predicate devices are the same (i.e., culture of embryos from the cleavage to blastocyst stage of development and for blastocyst transfer). Therefore, they have the same intended use. | | Conditions of Use | Rx Only | Rx Only | Same | | Device Materials | Salts, buffer, energy substrates, antioxidant, vitamins, nutrient supplements, amino acids, and gentamicin. It is offered with and without HSA. | Salts, energy substrates, buffer, antioxidant, nutrient supplements, amino | Different: The formulations of the subject and predicate devices are not the same. Differences in device formulations do not raise | #### Table 1. Comparison of Characteristics {5}------------------------------------------------ | | | 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 a shorter shelf-life than the predicate device. Differences in shelf-life do not raise different questions of S&E. | | pH | 7.2-7.5 | 7.5 -7.8 | Different: The subject device has a lower pH range than the predicate device. This difference in pH range does not raise different questions of S&E. | | Osmolality | 260-295 mOsm/kg | 280-290 mOsm/kg | Different: The subject device has a wider osmolality range than the predicate device. This difference in osmolality does not raise different questions of S&E. | | Endotoxin | < 0.25 EU/mL | < 0.4 EU/mL | Different: The subject device has a lower endotoxin specification than the predicate device. This difference does not raise different questions of S&E. | | MEA | One-cell system: ≥ 80% embryos developed to expanded blastocyst at 96 hours | 2-cell MEA: ≥ 80% expanded blastocyst at 72 hours | Different: There are differences in the type of MEA testing conducted. This difference in MEA method does not raise different questions 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 {6}------------------------------------------------ - -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.