(182 days)
The SunIVF Universal™ Dish is intended to be used to hold human sperm, oocytes, and embryos during their manipulation and culture in in-vitro procedures of assisted human reproduction, including washing, handling, conventional invitro fertilization, fertilization by intracytoplasmic sperm injection, assisted hatching, biopsy, and cryopreservation.
The SunIVF Micromanipulation™ Dish is intended to be used to hold human sperm, oocytes and embryos during their manipulation in in vitro procedures of assisted human reproduction, including fertilization by intracytoplasmic sperm injection, assisted hatching, and biopsy.
The SunIVF ICSI™ Dish is intended to be used to hold human oocytes and sperm during the procedure of fertilization by intracytoplasmic sperm injection.
The SunIVF Freezing Dish 1 is intended to be used to hold human oocytes and embryos during the procedures of cryopreservation.
The SunIVF Freezing Dish 2 is intended to be used to hold human oocytes and embryos during the procedures of cryopreservation.
The SunIVF Vitrification Dish is intended to be used to hold human oocytes and embryos during the procedures of vitrification.
The SunIVF Rotational Dish is intended to be used to hold human oocytes and embryos during handling and culture.
The SunIVF General Flat Dish – 35 X 10 mm is intended to be used for washing and handling of human oocytes and embryos.
The SunIVF General Flat Dish – 60 X 15 mm is intended to be used for washing and handling of human oocytes and embryos.
The SunIVF General Flat Dish – 90 X 17 mm is intended to be used for washing and handling of human oocytes and embryos.
Not Found
This FDA 510(k) clearance letter for the SunIVF line of assisted reproduction labware (K080395) does not contain the detailed information requested regarding acceptance criteria and a study to prove device performance.
The document is a clearance letter, which states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. It does not include:
- A table of acceptance criteria and reported device performance: This type of information would typically be found in the manufacturer's 510(k) submission, not in the FDA's clearance letter.
- Sample size used for the test set and data provenance: Again, this data is part of the submission, not the clearance letter.
- Number of experts and their qualifications for ground truth: This information is not provided.
- Adjudication method: Not mentioned.
- MRMC comparative effectiveness study results: This type of study is more common for diagnostic imaging AI devices, not for labware. It is not mentioned here.
- Standalone (algorithm only) performance: Not applicable as this is labware, not an algorithm.
- Type of ground truth used: Not applicable as this is labware, not a diagnostic device relying on ground truth.
- Sample size for the training set: Not applicable as this is labware, not an AI/ML algorithm.
- How ground truth for the training set was established: Not applicable.
Explanation Based on Document Content:
The document primarily focuses on:
- Device Identification: Listing the various SunIVF dishes (Universal, Micromanipulation, ICSI, Freezing 1 & 2, Vitrification, Rotational, General Flat dishes) and their product code (MQL, Class II).
- Intended Use: For each dish, it describes its purpose in assisted human reproduction procedures (e.g., holding sperm, oocytes, and embryos during manipulation, culture, IVF, ICSI, cryopreservation).
- Substantial Equivalence: The core of the 510(k) clearance, indicating that the FDA found the device to be as safe and effective as a predicate device already on the market. This often means the new device shares similar technological characteristics and intended uses with existing devices, and as such, does not require new clinical studies to prove performance in the same way a novel device might.
- Regulatory Compliance: Advising the manufacturer of their ongoing responsibilities under the Act (e.g., registration, listing, good manufacturing practices).
Conclusion:
To obtain the detailed information requested about acceptance criteria and performance studies, one would need to access the full 510(k) submission (K080395) made by GenX International, Inc. to the FDA, which is a much more comprehensive document than this clearance letter. The clearance letter itself merely confirms that the FDA concluded the device is substantially equivalent based on the information provided in that submission.
§ 884.6160 Assisted reproduction labware.
(a)
Identification. Assisted reproduction labware consists of laboratory equipment or supplies intended to prepare, store, manipulate, or transfer human gametes or embryos for in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures. These include syringes, IVF tissue culture dishes, IVF tissue culture plates, pipette tips, dishes, plates, and other vessels that come into physical contact with gametes, embryos or tissue culture media.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when it is a dish or plate intended for general assisted reproduction technology procedures, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.