(100 days)
ICSI Cumulase® is for the removal of the cumulus complex and corona radiata surrounding the oocyte in preparation for ICSI.
ICSI Cumulase is a defined sterile, ready to use media used by professionals within assisted reproduction and intended for the removal of the cumulus complex and corona radiata surrounding the oocyte in preparation for ICSI. ICSI Cumulase is a modified version of SynVitro® Cumulase ( K060699) and is based on a salt solution containing a recombinant hyaluronidase and HSA (US license No 1716). ICSI Cumulase is supplied in transparent polypropylene plastic vials with screw top closures in a volume of 0.5 ml.
Here's a breakdown of the acceptance criteria and the study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly based on predicate device equivalence) | Reported Device Performance (ICSI Cumulase®) |
|---|---|---|
| Safety | Equivalent to predicate devices (SynVitro® Cumulase® & Cumulase®) | Product is effective and safe. |
| Effectiveness/Functionality | Equivalent to predicate devices for intended use | Product is effective and safe. Performs the intended use. |
| Technological Characteristics | Similar to predicate devices: same intended use, contains recombinant human hyaluronidase enzyme (Cumulase®). | Essentially similar to predicate devices. |
| Product Testing Controls | Sterility (Ph. Eur. & USP) | Each batch tested to Ph. Eur. & USP. |
| Osmolarity (Ph. Eur. & USP) | Each batch tested to Ph. Eur. & USP. | |
| pH (Ph. Eur. & USP) | Each batch tested to Ph. Eur. & USP. | |
| Endotoxin (Ph. Eur. & USP) | Each batch tested to Ph. Eur. & USP. | |
| Enzyme Activity (Ph. Eur. & USP) | Each batch tested to Ph. Eur. & USP. | |
| Mouse Embryo Assay (MEA) | Each batch tested. | |
| Stability | Demonstrated stability | Stability studies performed. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a distinct "test set" sample size in the traditional sense of a clinical trial. Instead, the evaluation relies on a literature review of existing data for the Cumulase® enzyme.
- Data Provenance: The data provenance is described as "an evaluation of all relevant preclinical and clinical literature regarding the use of the Cumulase® enzyme." This indicates the data is retrospective, drawn from already published or available studies concerning the active enzyme. The country of origin for this literature is not specified, but the device manufacturer is Danish.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the document. The evaluation was based on a literature review, not a new study with expert-labeled ground truth.
4. Adjudication Method for the Test Set
- This information is not applicable/not provided. There was no new test set requiring expert adjudication in the context of this 510(k) submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- No, an MRMC comparative effectiveness study was not done. This device is a medical media intended for laboratory use, not an AI-assisted diagnostic tool that would typically involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a biochemical solution (enzyme) used in a laboratory procedure, not an algorithm. The assessment focused on the safety and effectiveness of the media itself.
7. The Type of Ground Truth Used
- The "ground truth" for the safety and effectiveness determination was established through a review of existing preclinical and clinical literature on the Cumulase® enzyme. This literature would contain outcomes data from previous studies where the enzyme was used. The claim of "effective and safe" is based on the findings within this body of literature.
8. The Sample Size for the Training Set
- This information is not applicable/not provided. There is no "training set" in the context of this device, as it is not an AI/machine learning product. The evaluation relies on existing scientific literature, not a newly trained model.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, there is no training set for this type of device. The ground truth for the overall safety and effectiveness claim was established via a literature review of existing studies on the Cumulase® enzyme.
§ 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.