(142 days)
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No
The summary describes media and buffers used in IVF procedures, with no mention of AI, ML, image processing, or any computational analysis of data.
No
The devices, Oocyte Flushing & Retrieval Medium and Gamete Buffer, are intended for use in in vitro fertilization procedures for handling oocytes, gametes, and embryos. They are not therapeutic devices that treat or prevent a disease or condition.
No
The devices (Oocyte Flushing & Retrieval Medium and Gamete Buffer) are described as being used during and for various procedures related to in vitro fertilization, such as oocyte collection, handling gametes and embryos, and ICSI. These are interventional or handling roles, not diagnostic roles that involve identifying or classifying a disease or condition. They are mediums or buffers used in the process, not tools for diagnosis.
No
The 510(k) summary describes "Oocyte Flushing & Retrieval Medium" and "Gamete Buffer," which are biological or chemical substances used in IVF procedures, not software.
Based on the provided information, it is highly likely that these devices are IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended uses clearly describe the use of these products in procedures involving biological samples (oocytes, gametes, embryos) outside of the body ("in vitro fertilization procedures," "short-term handling gametes and embryos"). This is a key characteristic of IVDs.
- Specific Procedures: The mention of "oocyte collection procedures," "washing," and "intracytoplasmic sperm injection (ICSI)" further reinforces their use in laboratory or clinical settings for handling and manipulating biological materials.
While the "Device Description" is not found, the intended use alone strongly suggests that these are reagents or media used in laboratory procedures to analyze or manipulate biological samples for medical purposes (in this case, related to fertility treatment).
Therefore, based on the provided text, these devices fit the definition of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Oocyte Flushing & Retrieval Medium is intended for use during and oocyte collection procedures for use in in vitro fertilization procedures.
Gamete Buffer is indicated for use in short-term handling gametes and embryos, including washing and intracytoplasmic sperm injection (ICSI).
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.
0
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May 10, 2024
Gimbo Medical Technology Shenzhen Co., Ltd. Leo Guo General Manager 601, Building C5, No. 459 Qiaokai Road, Fenghuang Street, Guangming District Shenzhen. Guangdong Province 518107 China
Re: K234023
Trade/Device Name: Oocyte Flushing & Retrieval Medium; Gamete Buffer Regulation Number: 21 CFR$ 884.6180 Regulation Name: Reproductive Media and Supplements Regulatory Class: II Product Code: MQL Dated: December 20, 2023 Received: April 9, 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.
2
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) K234023
Device Name
Oocyte Flushing & Retrieval Medium; Gamete Buffer
Indications for Use (Describe)
Oocyte Flushing & Retrieval Medium is intended for use during and oocyte collection procedures for use in in vitro fertilization procedures.
Gamete Buffer is indicated for use in short-term handling gametes and embryos, including washing and intracytoplasmic sperm injection (ICSI).
Type of Use (Select one or both, as applicable) | |
---|---|
X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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