(123 days)
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No
The 510(k) summary describes a culture medium for in vitro fertilization and does not mention any software, algorithms, or AI/ML capabilities. The performance studies focus on the biological and chemical properties of the medium.
No
This device is a culture medium used for the in vitro development of human embryos; it does not directly treat or diagnose a disease or condition in a living organism.
No
The device is a culture medium used for growing human embryos, not for diagnosing a disease or condition. Its performance studies evaluate its ability to support embryo development and its chemical/biological properties.
No
The device description clearly states it is a "culture media product" and lists physical and chemical properties and performance tests related to a liquid medium, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for the in vitro culture of human embryos". "In vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
- Device Description: The description details a "culture media product" used for the "in vitro culture of embryos." Culture media are substances used to grow cells or tissues outside the body, a common application for IVDs.
- Performance Studies: The performance studies include tests like pH, Osmolality, Endotoxin, and Sterility, which are standard quality control tests for biological reagents and media used in laboratory settings, including those for in vitro procedures. The 1-cell MEA (Mouse Embryo Assay) is a specific test used to assess the suitability of media for embryo culture, directly related to its intended in vitro use.
- Predicate Device: The predicate device listed, G-TL™ IVF Media (K133568), is also an IVF media, which falls under the category of IVDs used in assisted reproductive technology.
While the device doesn't involve imaging, AI, or analyze patient samples directly, its function is to provide the necessary environment for the in vitro development of human embryos, which is a crucial step in an in vitro diagnostic or therapeutic process (in this case, assisted reproductive technology). The media itself is a reagent used in an in vitro procedure.
N/A
Intended Use / Indications for Use
This product is intended for the in vitro culture of human embryos following fertilization until Day 5/6 of development.
Product codes
MOL, MQL
Device Description
VitaVitro® 1-Step Culture Media product intended for the in vitro culture of embryos from fertilization until day 5/6 of development. It is an aseptically filtered, bicarbonate-buffered media containing physiological salt solutions, gentamicin, and human serum albumin. It is ready to use after warming to 37°C and equilibration in a CO2 environment.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The following studies have been performed to support substantial equivalence to the predicate device:
- pH testing
- Osmolality testing
- 1-cell MEA: One-cell mouse embryos were exposed to subject devices and cultured at 37°C in an atmosphere containing 5% CO2. The percent of embryos developed to the expanded blastocyst stage at 96 hours were assessed in comparison with the control group.
- Endotoxin per USP
- Sterility per USP
- Aseptic Processing Validation per ISO 13408-1:2008 and ISO 13408-2:2018
- Shelf-life testing: conducted to ensure that the specifications for the following product characteristics are met at time zero and the end of shelf-life (six months): pH testing, Osmolality testing, 1-cell MEA, Endotoxin, Sterility.
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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 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. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 23, 2019
Shenzhen VitaVitro Biotech Co., Ltd. Xiaozhen Lin, CEO R601, Building B, Hai Ke Xing Tech Park Baoshan Road No.16 Shenzhen 518118 Guangdong CHINA
Re: K191063
Trade/Device Name: 1-Step Culture Medium Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive Media and Supplements Regulatory Class: Class II Product Code: MOL Dated: July 22, 2019 Received: July 24, 2019
Dear Xiaozhen Lin:
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
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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-regulatory-information/postmarketing-safety-reportingcombination-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 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,
Sharon M. Andrews Assistant Division 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) K191063
Device Name
1-Step Culture Medium
Indications for Use (Describe)
This product is intended for the in vitro culture of human embryos following fertilization until Day 5/6 of development.
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 - K191063
1. Submission Sponsor
Shenzhen VitaVitro Biotech Co.,Ltd. R601, Building B, Hai Ke Xing Tech Park, Baoshan Road No.16 Shenzhen, Guangdong, 518118, P. R. China Contact person: Ms. Xiaozhen Lin, CEO Telephone: 86-755-84511813 Fax: 86-755-85235226 Email: jenny@vitavitro.com
3. Date Prepared
August 23, 2019
Device Identification 4.
| Device Name: | 1-Step Culture Medium |
|---|---|
| Common Name: | Embryo Culture Medium |
| Regulation Name: | Reproductive media and supplements |
| Regulation Number: | 21 CFR § 884.6180 |
| Device Classification: | Class II |
| Product Code: | MQL (Media, Reproductive) |
5. Predicate Device
G-TL™ IVF Media (K133568), manufactured by Vitrolife, Inc. The predicate device has not been subject to any design related recalls.
6. DEVICE DESCRIPTION
VitaVitro® 1-Step Culture Media product intended for the in vitro culture of embryos from fertilization until day 5/6 of development. It is an aseptically filtered, bicarbonate-buffered media containing physiological salt solutions, gentamicin, and human serum albumin. It is ready to use after warming to 37°C and equilibration in a CO2 environment.
Specifications for the 1-Step Culture Medium are listed in the table below:
| Aspect | Specification |
|---|---|
| Sterility (per USP ) | No microbial growth |
| Osmolality | 250 – 290 mOsm/kg |
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| pH | 7.2 — 7.6 | |
|---|---|---|
| Endotoxin (per USP ) |
-
- Sterility per USP
-
- Aseptic Processing Validation per ISO 13408-1:2008 and ISO 13408-2:2018;
- Shelf-life testing was conducted to ensure that the specifications for the following product characteristics are met at time zero and the end of shelf-life (six months):
- . pH testing
- . Osmolality testing
- . 1-cell MEA
- . Endotoxin
- Sterility
10. Conclusion
The subject and predicate devices have the same intended use and comparable technological characteristics. The differences in technological characteristics between the subject and predicate devices do not raise questions on safety and effectiveness. The performance data demonstrates that the subject device is substantially equivalent to the predicate device.