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510(k) Data Aggregation
(150 days)
The iVitri®Straw is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell and blastocyst stage embryos.
The iVitri® Straw device is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell and blastocyst stage embryos. The iVitri® Straw device consists of a square-shaped polystyrene stick and acrylonitrile butadiene styrene (ABS) cap. As part of the vitrification procedure, the embryos are loaded on the tip of the stick, and capped for subsequent storage following vitrification. The tip of the storage device is curved to aid in maintaining and securing the embryos during handling procedures. The stick and cap include a tapered design that creates a hermetic seal, forming a closed storage system. Markings on the stick and tip of the device are used to aid in the proper orientation during embryo loading procedures. The device is provided sterile and is for single use only.
Here's an analysis of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided FDA 510(k) summary for the iVitri® Straw.
Acceptance Criteria and Device Performance for iVitri® Straw
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Cooling Rate | Not explicitly stated as a separate acceptance criterion, but implicitly comparable to predicate. | -3,022°C/min (Predicate: -3,020°C/min - considered comparable) |
| Warming Rate | Not explicitly stated as a separate acceptance criterion, but implicitly comparable to predicate. | +40,976°C/min (Predicate: +40,694°C/min - considered comparable) |
| Sterility Assurance Level (SAL) | 10⁻⁶ (as per ISO 11137-1:2006(R)2011 and ISO 11137-2:2013) | 10⁻⁶ |
| Endotoxin | ≤0.5 EU/device (per USP <85>) | < 0.5 EU/device |
| Mouse Embryo Assay (MEA) | 1-Cell MEA ≥80% expanded blastocyst formation at 96 hours | ≥80% expanded blastocyst formation at 96 hours (Tested in comparison with control group) |
| Durability and Closure Integrity | No leakage, damage (breaks, etc.), deformation, or discoloration after exposure to liquid nitrogen and 37°C temperatures. | Met the acceptance criteria (No leakage, damage, deformation, or discoloration observed). |
| Package Integrity (Dye Penetration) | Passed (as per ASTM F929-15) | Passed |
| Package Integrity (Seal Strength) | Passed (as per ASTM F88/F88M-15) | Passed |
| Shelf-life | MEA, Durability and closure integrity, Device appearance (discoloration, deformation, damage), and Dimensional assessments met. | Studies ensured these product specifications were met (Real-time and accelerated). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific number of devices or embryos used for each non-clinical test (e.g., durability, MEA). However, it implies multiple samples were tested for each criterion (e.g., "The samples were assembled...", "Test samples, "1-Cell mouse embryos were incubated...").
- Provenance: The tests are non-clinical (laboratory-based performance tests) conducted by the manufacturer (Reprobiotech Corp.). There is no mention of country of origin of data or whether it's retrospective or prospective in the context of human subjects, as no human data is presented. It's prospective testing on the manufactured device models.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The ground truth for this device's performance is established through objective, standardized laboratory tests and measurements against predefined specifications (e.g., temperature rates, endotoxin levels, sterility SAL, MEA blastocyst formation rate, physical integrity). There is no "ground truth" established by human experts in the context of diagnostic interpretation or clinical outcomes.
4. Adjudication Method for the Test Set
Not applicable. As the tests are objective non-clinical performance evaluations, there is no need for expert adjudication. Results are based on direct measurement and observation against quantitative and qualitative criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a cryopreservation storage straw and does not involve human interpretation or diagnostic capabilities where an MRMC study would be relevant. It's a labware device, not an imaging or diagnostic AI tool.
6. Standalone (Algorithm Only Without Human-in-the-loop Performance)
Not applicable. This device is not an algorithm or AI. It is a physical medical device (labware). The performance described is inherent to the device itself.
7. Type of Ground Truth Used
The ground truth is established through:
- Objective Measurements: E.g., temperature readings for cooling/warming rates, spectrophotometric analysis for endotoxin, biological assays for MEA.
- International Standards: Adherence to ISO for sterilization, ASTM for package integrity, USP for endotoxin.
- Predefined Specifications: Quantitative thresholds (e.g., SAL 10⁻⁶, Endotoxin ≤0.5 EU/device, MEA ≥80%) and qualitative criteria (e.g., absence of damage for durability).
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set. The performance data presented are for validation of the manufactured device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As it's not an AI/ML device, there is no training set or ground truth establishment for a training algorithm.
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