(146 days)
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No
The provided text describes various culture media for IVF procedures and does not mention any AI or ML components.
No
The device is a culture medium used in IVF procedures for the development of embryos, not a device that directly treats a medical condition.
No
The document describes different culture media used for in vitro fertilization (IVF) and embryo development. These media facilitate the growth and maintenance of cells and embryos, rather than identifying or characterizing a disease or condition. Therefore, they are not diagnostic devices.
No
The device description and intended use clearly describe culture media, which are physical substances used in IVF procedures, not software.
Based on the provided information, these devices are IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use clearly states that these media are used during in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) procedures and for the culture of embryos. These are procedures performed outside the human body (in vitro) to aid in diagnosis or treatment related to fertility.
- Nature of the Device: Culture media used to support the development of embryos in a laboratory setting are considered reagents or substances used in an in vitro diagnostic procedure.
While the description doesn't explicitly state "diagnostic," the use in IVF/ICSI procedures and embryo culture falls squarely within the scope of IVDs, which are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease or injury. In this case, the "specimen" is the embryo and the information gained from its development in the media is crucial for the success of the fertility treatment.
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Intended Use / Indications for Use
Giftlife Fertilization Medium is intended for use during in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) procedures and culture to the two pronuclei (zygote) stage of development.
Giftlife Cleavage Medium is intended for use during in vitro fertilization (IVF) for culture of embryos from pronucleate stage to day 2 or day 3. This medium is not intended for transferring embryos to the uterine cavity.
Giftlife Blastocyst Medium is intended for use during in vitro fertilization (IVF) for culture of embryos from day 3 to the blastocyst stage. This medium is not intended for transferring embryos to the uterine cavity.
Giftlife Single Step Medium is used for culture of embryos from fertilization to the blastocyst stage.
Product codes (comma separated list FDA assigned to the subject device)
MQL
Device Description
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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 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 13, 2024
Gimbo Medical Technology Shenzhen Co., Ltd. Leo Guo General Manager 601, Building C5, No. 459 Qiaokai Road, Fenghuang Street, Guangming District Shenzhen, Guangdong 518107 China
Re: K240149
Trade/Device Name: Giftlife™ Fertilization Medium; Giftlife™ Cleavage Medium; Giftlife™ Blastocyst Medium; Giftlife™ Single Step Medium Regulation Number: 21 CFR$ 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MQL Dated: May 10, 2024 Received: May 10, 2024
Dear Leo Guo:
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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
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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
3
Indications for Use
510(k) Number (if known) K240149
Device Name
Giftlife™ Fertilization Medium; Giftlife™ Cleavage Medium; Giftlife™ Blastocyst Medium; Giftlife™ Single Step Medium
Indications for Use (Describe)
Giftlife Fertilization Medium is intended for use during in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) procedures and culture to the two pronuclei (zygote) stage of development.
Giftlife Cleavage Medium is intended for use during in vitro fertilization (IVF) for culture of embryos from pronucleate stage to day 2 or day 3. This medium is not intended for transferring embryos to the uterine cavity.
Giftlife Blastocyst Medium is intended for use during in vitro fertilization (IVF) for culture of embryos from day 3 to the blastocyst stage. This medium is not intended for transferring embryos to the uterine cavity.
Giftlife Single Step Medium is used for culture of embryos from fertilization to the blastocyst stage.
| 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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