(316 days)
Not Found
No
The 510(k) summary describes a culture medium for IVF procedures, listing its chemical components and intended uses. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
This device is designed for use in in vitro fertilization (IVF) procedures for culturing sperm, oocytes, and embryos, rather than for directly treating a disease or medical condition in a patient.
No
This device, Dewin Reproductive Media, is intended for use in in vitro fertilization (IVF) procedures, specifically for culturing and handling gametes and embryos. It is a culture medium used in the process of creating and developing embryos outside the body, not for diagnosing any condition in a patient.
No
The device description clearly states that the device is comprised of chemical components (salts, energy substrates, etc.) and is provided in glass bottles, indicating it is a physical product, not software.
Based on the provided text, the Dewin Reproductive Media is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly describes the media's role in in vitro fertilization (IVF) procedures, specifically for washing sperm and oocytes, and culturing embryos. This is a process of creating and developing embryos outside the body, not a diagnostic test performed on a sample taken from the body to diagnose a condition or disease.
- Device Description: The description details the composition of the media and its use in the IVF process (washing and culturing). It doesn't mention any analytical or diagnostic function.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze a sample, detect a marker, or provide information for diagnosis.
- Predicate Device: The predicate device (K153290) is also described as "Fertilization Medium" and "Cleavage Medium," which are consistent with media used in IVF procedures, not IVDs.
In summary, the Dewin Reproductive Media is a culture medium used in the process of IVF, not a diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MQL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Testing:
- Biocompatibility testing per ISO 10993-1, ISO 10993-5:2009, ISO 10993-10:2010. Results: Dewin Cleavage Medium formulations were 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 to support 4-month shelf-life, with product specifications met at time 0 and after accelerated aging per ASTM F1980-16. Specifications tested: Appearance (Clear, particle-free), pH (7.2–7.5), Osmolality (260–295 mOsm/kg), Endotoxin (
§ 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.
0
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.
1
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
2
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:
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.
| 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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3
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 and
without 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.
4
6. 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.
7. Indications for Use
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 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.
-
- 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 IVF
Media
- K153290
(Predicate Device) | 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 Reproductive Media consists of
Dewin Fertilization Medium (with HSA
and without HSA) and Dewin Cleavage
Medium (with HSA and without HSA). | Sydney IVF
Fertilization Medium
is intended for use
during in vitro | There are differences in thefor the subject and predicate
devices; however, the |
| | The indications for use for the Dewin
Fertilization Medium and Dewin
Cleavage Medium are as follows:
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 | procedures for
insemination and
incubation of oocytes.
Sydney IVF Cleavage
Medium is intended
for use during in vitro
fertilization
procedures for culture
and transfer of
cleavage stage
embryos. | intended uses of the subject
and predicate devices are the
same. Therefore, they have
the same intended use. |
| | Cleavage Medium is also intended for
use in the transfer of cleavage stage
embryos into the uterine cavity. | | |
| Conditions of
Use | Rx Only | Rx Only | Same |
| Device
Materials | Salts, energy substrates, anti-oxidant,
nutrient supplements, amino acids,
EDTA, gentamicin, and phenol red. It is
offered with and without HSA. | Salts, energy
substrates, buffer,
anti-oxidant, nutrient
supplements, amino
acids, antibiotic,
protein | Different: The formulations of
the subject and predicate
devices include the same
types of chemical
constituents; however, the
formulations are not the
same. Differences in device
formulations do not raise
different questions of safety
and effectiveness (S&E). |
| Volume | 25, 50 mL | 20, 50, 100 mL | Different: The subject and
predicate devices are provided
in different volumes.
Differences in volumes do not |
| | | | raise different questions of
S&E. |
| 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 | 285-295 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. |
| Sterility | No microbial growth | No microbial growth | Same |
| Endotoxin | : 7.2–7.5- -Osmolality, per USP: 260–295 mOsm/kg
- -Endotoxin, per USP : : 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.