(90 days)
The Culture Dish is intended to be used when culturing tissues and cells. It may be used for the use with sperm and for the culturing of embryos.
"To culture tissues and cells"
May be used to hold sperm and culture embryos
The Culture Dish is intended to be used when culturing tissues and cells. It may be used for the use with sperm and for the culturing of embryos. The catalog number is GDEC-100. The basic design is that of a traditional culture dish. Approx 60mm round with 1½ inch sidewalls. This dish does have defined areas for the cell to be confined within. These areas are squares of picket-fenced walls, which will allow fluids, nutrients and byproducts to freely flow among the culturing cell, embryos.
This document is a 510(k) Premarket Notification for the genX Culture Dish. It mainly focuses on demonstrating substantial equivalence to existing devices rather than providing detailed performance studies with hard acceptance criteria or specific metrics of accuracy, sensitivity, or specificity commonly found for diagnostic devices.
Therefore, many of the requested sections (1, 2, 3, 4, 5, 6, 7, 8, 9) cannot be fully answered with the provided information as the document does not contain data from such studies.
Here's an analysis of what can be extracted based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use | "To culture tissues and cells". "May be used to hold sperm and culture embryos." (Matches predicate devices) |
| Design | Traditional culture dish, approx. 60mm round with 1.5 inch sidewalls, defined square areas ("picket-fenced walls") for cell confinement. (Stated as "Same design" as predicate, implying it meets their design criteria). |
| Materials | Configured the same for use as predicate devices. (Stated as "Same materials configured the same for use"). |
| Procedures/Method | Performs similar procedures by method as predicate devices. (Stated as "Perform similar procedures, by method"). |
| Performance Criteria | Same performance criteria as predicate devices. (Stated as "Same performance criteria"). |
| Sterility Methods | Gamma Irradiated by contractor; Dosage: 2.5 Mrad; Sterility Assurance Level (SAL): 10^-6. Validation in accordance with ANSI / AAMI / ISO 11137-1994 Standards. |
| Sterility Release | Contractor issues a "Certificate of Sterilization". |
| Intended Population | Same as predicate devices. (Stated as "Same intended population"). |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The document does not describe a performance study with a test set. The submission focuses on demonstrating substantial equivalence based on design, materials, and intended use, rather than presenting clinical or laboratory performance data from a specific test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. No ground truth establishment for a test set is described.
4. Adjudication Method for the Test Set
Not applicable. No adjudicated test set is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This type of study is not mentioned as the device is not an AI-powered diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is a culture dish, not a digital algorithm or AI.
7. Type of Ground Truth Used
Not applicable. The submission for this type of device (culture dish) relies on demonstrating equivalency to already marketed devices, not on proving diagnostic accuracy against a specific ground truth. The "ground truth" in this context would be the successful and safe use of existing, predicate culture dishes.
8. Sample Size for the Training Set
Not applicable. As a physical medical device (culture dish), there is no 'training set' in the context of machine learning or algorithms. The design and manufacturing process would involve validation and verification, but not in the same way as an AI system.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
§ 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.