(312 days)
Covering of medium during IVF and micro-manipulation procedures.
Double-washed, medium-equilibrated light paraffin oil packaged with a visual pH indicator. Ready to use after equilibration at +37°C and 5% CO2.
Here's an analysis of the provided text regarding the OVOIL™-150 device, focusing on acceptance criteria and supporting studies:
This submission is for a Class II medical device, OVOIL™-150, which is an assisted reproduction medium. The premarket notification (510(k)) focuses on demonstrating substantial equivalence to other legally marketed reproductive media, rather than proving novel effectiveness. Therefore, the "acceptance criteria" discussed here relate to lot-release testing to ensure product quality and safety, rather than clinical performance metrics typically associated with AI/software devices. The "study that proves the device meets the acceptance criteria" refers to these routine lot-release assays and general clinical experience.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test) | Purpose/Method | Reported Device Performance (Assurance) |
|---|---|---|
| Mouse Embryo Assay (MEA) | Assure suitability for intended use, absence of toxins. | Performed prior to market release for each lot. Test medium droplets under OVOIL are used. Assures the media is suitable and non-toxic. |
| Limulus Amebocyte Lysate (LAL) Assay | Assure suitability for intended use, absence of toxins. | Performed prior to market release for each lot. Assures the media is suitable and non-toxic. |
| pH Testing | Ensure chemical stability/suitability. | Tested for each lot prior to release, according to USP and EP guidelines. |
| Osmolality Testing | Ensure physiological compatibility. | Tested for each lot prior to release, according to USP and EP guidelines. |
| Clinical Experience | Establish safety and effectiveness over time. | "OVOIL™-150 has been used for IVF and micromanipulation procedures for many years at many different assisted reproduction facilities. Clinical experience during that time has established its safety and effectiveness for such use." |
2. Sample Size Used for the Test Set and Data Provenance
- MEA and LAL Assays for each lot: The sample size is not explicitly stated in terms of number of "units" or "batches" tested, but the implication is that each manufactured lot undergoes these tests. The provenance is internal quality control data from the manufacturer.
- pH and Osmolality Testing: Similar to MEA and LAL, these are performed for each lot. The provenance is internal quality control data from the manufacturer.
- Clinical Experience: This refers to an accumulation of usage over "many years at many different assisted reproduction facilities." This is a retrospective summary of real-world usage, rather than a specific prospective study with a defined sample size. The geographical provenance (countries) is not specified beyond "many different facilities."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- For MEA, LAL, pH, and Osmolality: These are analytical laboratory tests with defined protocols (e.g., USP, EP guidelines). The interpretation is typically objective based on quantitative results meeting predefined specifications. There is no mention of "experts" establish ground truth in the sense of consensus interpretation for these tests. Quality control personnel with appropriate laboratory qualifications would perform and interpret these tests.
- For Clinical Experience: "Clinical experience" implies interpretation by a broad range of clinicians (e.g., embryologists, reproductive endocrinologists) in their routine practice. There is no formally established number of experts or adjudication process described; it's a general statement about observed safety and effectiveness through widespread use.
4. Adjudication Method for the Test Set
- For MEA, LAL, pH, and Osmolality: No adjudication method is described. These are standardized quantitative tests where results are compared against predetermined specifications.
- For Clinical Experience: No formal adjudication method is mentioned. The statement relies on the cumulative, informal observation of satisfactory performance in clinical practice over time.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This device is a culture medium, not an imaging or diagnostic AI device that would typically involve human readers. The evaluation here is based on chemical/biological properties and general clinical use, not comparative reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. OVOIL™-150 is a physical product (culture medium), not an algorithm or software device. Therefore, a "standalone algorithm performance" assessment is irrelevant.
7. The Type of Ground Truth Used
- For MEA and LAL: The "ground truth" is defined by the objective pass/fail criteria of the standardized assays for toxicity and suitability for supporting embryo development.
- For pH and Osmolality: The "ground truth" is adherence to specified numerical ranges as defined by pharmacopoeial guidelines (USP, EP).
- For Clinical Experience: The "ground truth" is derived from real-world outcomes and observations in IVF and micromanipulation procedures, indicating safety and effectiveness through consistent, long-term use. This is a form of outcomes data and expert consensus (informal, through broad clinical acceptance).
8. The Sample Size for the Training Set
This question is not applicable as this is not an AI/ML device that requires a training set. The device is a physical product.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as this is not an AI/ML device that requires a training set.
§ 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.