(84 days)
Not Found
No
The device description and performance studies focus on the chemical composition and biological function of a culture medium, with no mention of AI or ML technologies.
No.
The device is a culture medium for embryo development and transfer, not a device directly used for therapy or treatment of a disease or condition.
No
The device is an embryo culture medium used from the 8-cell stage to the blastocyst stage and for transfer of blastocyst stage embryos, not to diagnose a condition.
No
The device description clearly states it is a liquid medium comprised of various chemical components, provided in glass bottles, and intended for embryo culture and transfer. This is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the culture of embryos and transfer of embryos into the uterine cavity. This is a direct interaction with biological material outside of the body for the purpose of facilitating a biological process (embryo development and implantation), not for the diagnosis of a condition based on in vitro examination of specimens.
- Device Description: The description details a culture medium comprised of various components to support embryo growth. This aligns with a reagent used in a biological process, not a diagnostic test.
- Lack of Diagnostic Purpose: There is no mention of analyzing a specimen to provide information about a patient's health status, disease, or condition. The purpose is to support embryo development and transfer.
IVD devices are typically used to examine specimens (like blood, urine, tissue) in vitro to provide diagnostic information. This device is used to facilitate a biological process in vitro (embryo culture) and then for direct use in vivo (embryo transfer).
N/A
Intended Use / 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) is also intended for use in transfer of blastocyst stage embryos into the uterine cavity.
Product codes
MQL
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 single-use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
uterine cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Biocompatibility testing was conducted: 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 Blastocyst Medium formulation to be non-cytotoxic, non-sensitizing, and non-irritating.
Sterile filtration and aseptic fill validation per ISO 13408-1:2008 and ISO 13408-2:2018.
Shelf-life testing: The product specifications (Appearance: Clear, particle-free; pH, per USP : 7.2-7.5; Osmolality, per USP: 260–295 mOsm/kg; Endotoxin, per USP : : No microbial growth) were met at time 0 and after real-time aging in accordance with ASTM F1980-16 for a 4-month shelf-life.
Transportation testing per ASTM D4169-16.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
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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)
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) |
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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
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.
-
- 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:
- Comparison of intended use and technological characteristics of the subject and predicate devices
| | 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
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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 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 | : 7.2-7.5 |
- -Osmolality, per USP: 260–295 mOsm/kg
- -Endotoxin, per USP : : 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.