(212 days)
Cumulase™ is indicated for use in removing the cumulus matrix surrounding oocytes in preparation for assisted reproduction technology (ART) procedures.
Recombinant Human Hyaluronidase Solution
Cumulase™ is a hyaluronidase enzyme in a HEPES buffered salt solution. The hyaluronidase enzyme raw material is a highly characterized biotechnology developed recombinant human hyaluronidase (rHuPH20). Cumulase™ is not preserved.
The provided document describes the Cumulase™ device, a recombinant human hyaluronidase solution intended for use in assisted reproduction technology (ART) procedures. The document focuses on the device's technical specifications and regulatory clearance, rather than a clinical study evaluating its performance against specific acceptance criteria.
Therefore, I cannot directly extract details about a study demonstrating the device meets acceptance criteria in the format requested, as the information is not present in the provided text. The document is a 510(k) premarket notification summary, which primarily establishes substantial equivalence to a predicate device and outlines manufacturing and characterization rather than a clinical performance study with predefined acceptance criteria.
However, I can infer some aspects based on the available information:
1. A table of acceptance criteria and the reported device performance:
The document lists "Product Control Testing" which can be interpreted as internal quality control acceptance criteria. However, it does not provide performance results against these criteria in a comparative table for a specific study.
| Acceptance Criteria (Product Control Testing) | Reported Device Performance (Not explicitly stated in this document as performance results from a study) |
|---|---|
| Enzymatic Activity (USP Assay) | Expected to pass, but specific results not available. |
| pH (USP ) | Expected to fall within an acceptable range, but specific results not available. |
| Endotoxin (USP ) | Expected to be within limits, but specific results not available. |
| Osmolality (USP ) | Expected to be within limits, but specific results not available. |
| Sterility (USP ) | Expected to be sterile, but specific results not available. |
| Mouse Embryo Assay (One Cell) | Expected to demonstrate non-toxicity/suitability, but specific results not available. |
The document states: "rHuPH20 Hyaluronidase has been extensively characterized to International Committee on Harmonization regulatory requirements." and "Cumulase™ has been qualified to ISO 10993 standards for biocompatibility." This indicates that these criteria were met, but specific data is not provided.
The "study that proves the device meets the acceptance criteria" is not described in detail as a standalone clinical performance study with statistical results. The 510(k) process primarily relies on demonstrating substantial equivalence to a predicate device (Medi-Cult Hyaluronidase, 510(k) # K991334) through characterization and quality control, rather than a prospective clinical trial.
Based on the provided information, the following questions cannot be answered as the relevant data is not present:
- Sample sized used for the test set and the data provenance: Not applicable as a clinical "test set" for performance evaluation is not described in this document.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method: Not applicable.
- 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: Not applicable. This device is a biological solution, not an AI or imaging device requiring human reader interpretation.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: For the quality control tests listed, the ground truth would be the established USP standards and ISO 10993 requirements for each parameter.
- The sample size for the training set: Not applicable as this is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable.
Summary of available information related to the device's characteristics and "demonstration of meeting criteria":
- Technological Characteristics: Cumulase™ uses a recombinant human biotechnology-developed source of hyaluronidase enzymatic activity, distinguishing it from the bovine testicular derived source of the predicate device.
- Product Formulation: Hyaluronidase enzyme in a HEPES buffered salt solution, unpreserved. The raw material is rHuPH20, extensively characterized to ICH regulatory requirements.
- Manufacturing Process: Chemically defined and free of animal-derived components or materials.
- Biocompatibility: Qualified to ISO 10993 standards.
- Product Control Testing (Acceptance Criteria): Enzymatic Activity (USP Assay), pH (USP ), Endotoxin (USP ), Osmolality (USP ), Sterility (USP ), Mouse Embryo Assay (One Cell). The implication is that the product consistently meets these internal specifications.
- Predicated Device: Medi-Cult Hyaluronidase (510(k) # K991334). The 510(k) process for Cumulase™ is based on demonstrating substantial equivalence to this device.
The provided text serves as a regulatory submission document for market clearance, highlighting the safety and effectiveness of the device through characterization and comparison to a legally marketed predicate, rather than a detailed report of a clinical performance study against quantified acceptance criteria.
§ 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.