(67 days)
For the removal of the cumulus complex and corona radiata surrounding the oocyte in preparation for ICSI.
SynVitro® Hyadase is a ready-to-use hyaluronidase product designed for denudation of the oocyte and is based on raw material from a non-bovine source. SynVitro®Hyadase does not contain human serum albumin (HSA) or antibiotics.
Here's an analysis of the provided text regarding the SynVitro® Hyadase device, focusing on acceptance criteria and supporting studies:
This document describes a 510(k) submission for a medical device, SynVitro® Hyadase, which is a hyaluronidase product used for denuding oocytes (removing surrounding cells) prior to Intracytoplasmic Sperm Injection (ICSI). The submission focuses on demonstrating substantial equivalence to a predicate device.
Key takeaway: The provided text describes a comparative effectiveness study to demonstrate substantial equivalence to a predicate device, rather than a study defining and meeting de novo acceptance criteria for a novel device. The acceptance criteria are implicitly based on the predicate device's performance regarding morphological quality of embryos, fertilization rate, and cleavage rate.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit from Predicate Equivalence) | Reported SynVitro® Hyadase Performance |
|---|---|
| Morphological quality of embryos (equivalent to predicate) | No significant difference |
| Fertilization rate (equivalent to predicate) | No significant difference |
| Cleavage rate (equivalent to predicate) | No significant difference |
Study Details
1. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The text mentions "Two comparable groups of oocytes were inseminated." and "a randomised clinical study has been performed comparing SynVitro® Hyadase... to Medi-Cult's Hyaluronidase product." Without specific numbers, the exact sample size cannot be determined from this document.
- Data Provenance: Not explicitly stated (e.g., country of origin). Both studies are described as "clinical studies." It is implied to be prospective since it's a comparative study.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not mentioned.
- Qualifications of Experts: Not mentioned. Given the nature of assessing embryo morphology, fertilization, and cleavage rates, it would typically involve embryologists or fertility specialists, but this is not specified.
3. Adjudication method for the test set:
- Adjudication Method: Not mentioned.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: No, this does not appear to be an MRMC study. This device is a biochemical product (hyaluronidase), not an AI algorithm or an imaging device requiring human reader interpretation in the context of an MRMC study.
- Effect Size: Not applicable.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This is not an algorithm.
6. The type of ground truth used:
- The "ground truth" for the comparative studies was based on clinical outcomes relevant to assisted reproductive technology:
- Morphological quality of the embryos
- Fertilization rate
- Cleavage rate
7. The sample size for the training set:
- Training Set Sample Size: Not applicable. This submission describes a clinical study to compare a new product to a predicate, not a machine learning model that requires a training set.
8. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable.
Summary of Device Performance and Equivalence:
The provided clinical documentation indicates that two comparative studies were conducted:
- Comparison of Hyaluronidase Sources: This study compared hyaluronidase from two different sources (one being SynVitro® Hyadase's non-bovine source) and found no significant difference in morphological quality of embryos, fertilization rate, and cleavage rate.
- Comparison to Predicate Device (Medi-Cult's Hyaluronidase): This randomized clinical study compared SynVitro® Hyadase (without HSA) to the predicate Medi-Cult Hyaluronidase (with HSA). The results indicated that both products were "equally effective" regarding morphological quality of the embryos, fertilization rate, and cleavage rate.
Based on these studies, the manufacturer concluded that SynVitro® Hyadase is substantially equivalent to the predicate device K991334 (Medi-Cult Hyaluronidase) and effective for its intended use. The FDA concurred with this determination.
§ 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.