(151 days)
G-1TM v5/G-1TM v5 PLUS is intended for culture of embryos from the pronucleate stage to day 2 or day 3
G-1™ v5 is indicated for the culture of embryos from the pronucleate stage to day 2 or day 3
G-1™ v5 PLUS is indicated for the culture of embryos from the pronucleate stage to day 2 or day 3
The IVF Media GIII Series have been on the market for a number of years and Vitrolife Sweden AB has now made some product changes in order to further improve the robustness of these media. These improved medias are called IVF Media G5 Series. G-1TM v5/G-1TM v5 PLUS is used for culture of embryos from the pronucleate stage to day 2 or day 3
G-1™ v5/G-1™ PLUS is a device used for the culture of embryos from the pronucleate stage to day 2 or day 3.
This submission for medical device K081114, G-1™ v5 and G-1™ v5 PLUS IVF Media, is a 510(k) premarket notification. As such, the FDA determines substantial equivalence to a predicate device rather than requiring specific acceptance criteria and a detailed study proving the device meets those criteria, as would typically be seen in a de novo or PMA submission.
Therefore, the provided document does not report specific acceptance criteria or a dedicated study demonstrating the device meets those criteria in the way a clinical trial or performance study report would. Instead, it focuses on demonstrating substantial equivalence to a legally marketed predicate device (G-1™ version 3, K02244).
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable in this 510(k) submission. The document does not specify quantitative acceptance criteria or a study designed to measure and report against those criteria for the new devices (G-1™ v5 and G-1™ v5 PLUS). The regulatory pathway for this device, being a 510(k), relies on demonstrating that the new device has "technological characteristics essentially similar" to a predicate device and "none of the differences...do raise any new questions of safety or effectiveness."
2. Sample Size Used for the Test Set and Data Provenance
Not applicable/Not provided. The document does not describe a "test set" in the context of a performance study with a defined sample size for the evaluation of the new device. The evaluation of "differences" mentioned is conceptual and regulatory, not data-driven from a specific study outlined here.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable/Not provided. There is no mention of experts establishing ground truth for a test set in this 510(k) summary.
4. Adjudication Method
Not applicable/Not provided. No adjudication method is mentioned as there is no described test set or ground truth establishment process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a MRMC study was not done. This type of study is typically used for diagnostic devices where human readers interpret results, often with and without AI assistance, to assess the impact of the AI. As the device is an IVF culture medium, an MRMC study is not relevant to its intended use.
6. Standalone (Algorithm Only) Performance Study
Not applicable. The device is an IVF culture medium, not an algorithm or AI system. Therefore, a standalone algorithm performance study is not relevant.
7. Type of Ground Truth Used
Not applicable/Not provided. There is no mention of ground truth as no specific performance study is detailed.
8. Sample Size for the Training Set
Not applicable. The device is an IVF culture medium, not a machine learning model. Therefore, there is no "training set" in the context of AI or algorithm development.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set mentioned, there is no ground truth established for it.
Summary of the 510(k) Submission Approach:
The provided document details a 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance data from a new clinical study with acceptance criteria. The key arguments for substantial equivalence are:
- Identical Intended Use: The G-1™ v5/G-1™ v5 PLUS products have the same intended use as the predicate device (G-1™ version 3) – "culture of embryos from the pronucleate stage to day 2 or day 3."
- "Essentially Similar" Technological Characteristics: The submission asserts that the "technological characteristics of G-1™ v5/G-1™ v5 PLUS are essentially similar to those of the predicate device."
- No New Questions of Safety or Effectiveness: Crucially, the document states, "None of the differences between the predicate device and G-1™ v5/G-1™ v5 PLUS do raise any new questions of safety or effectiveness."
This approach means that the "study" proving the device meets acceptance criteria is essentially the regulatory comparison to the predicate device and the assertion that any modifications do not introduce new risks or alter effectiveness. The FDA's letter of substantial equivalence confirms that this demonstration was satisfactory for market clearance under the 510(k) pathway.
§ 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.