(281 days)
The iVitri® EZ 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®EZ 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® EZ device is composed of a twopiece polystyrene assembly with a square-shaped stick (body) and cap. As part of the vitrification procedure, the embryos are loaded on the tip, and capped for subsequent storage following vitrification. The tip of the storage device is curved to aid in maintaining and securing the embryos during 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.
The provided document describes the iVitri® EZ, a cryopreservation storage device intended for use in vitrification procedures to contain and maintain human 4-8 cell and blastocyst stage embryos. The document is a 510(k) summary filed with the FDA, demonstrating substantial equivalence to a predicate device.
Here's the breakdown of the acceptance criteria and the study information based on the provided text:
Based on the information provided, the "study" is a collection of non-clinical performance tests conducted to demonstrate substantial equivalence to a predicate device. This is not a comparative effectiveness study in the typical sense of comparing human readers with and without AI assistance or a standalone diagnostic performance study with a large test set.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Cooling Rate | (Implied to be sufficient for vitrification, compared to predicate: -1,494°C/min) | -3,020°C/min |
| Warming Rate | (Implied to be sufficient for vitrification, compared to predicate: +21,000°C/min) | +40,694°C/min |
| Sterilization | SAL 10-6 | Radiation, SAL 10-6 |
| Endotoxin | ≤ 0.5 EU/device | ≤ 0.5 EU/device |
| Mouse Embryo Assay (MEA) | 1-Cell MEA ≥ 80% expanded blastocyst formation at 96 hours | 1-Cell MEA ≥ 80% expanded blastocyst formation at 96 hours |
| Durability & Closure Integrity | No leakage, damage (breaks, etc.), deformation, or discoloration after liquid nitrogen exposure and warming | Met acceptance criteria (no failure modes) |
| Package Integrity | Met ASTM F1980-16, F929-15, F88/F88M-15 standards | Met standards |
| Shelf-life | MEA, Durability & Closure Integrity, Device appearance, Dimensional assessments are met throughout shelf-life | Met specifications |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" in the context of clinical or diagnostic performance. The tests performed are non-clinical, related to the device's physical properties and biological compatibility.
- Cooling/Warming Rate Testing: The sample size for devices tested is not explicitly stated.
- Durability and Closure Integrity Testing: The sample size for devices tested is not explicitly stated, but it mentions "The samples were assembled..."
- Endotoxin Testing: Not explicitly stated, but typically involves a batch or a representative number of devices.
- Mouse Embryo Assay (MEA): "1-Cell mouse embryos were incubated in extracts of the subject device." The number of embryos or devices tested is not specified.
- Sterilization Validation: Not explicitly stated, typically involves a statistically relevant sample size of devices/batches to confirm SAL.
- Package Integrity Testing: Not explicitly stated, involves samples of packaged devices.
- Shelf-life Studies: Not explicitly stated, involves samples of the device over time.
Data Provenance: The data is generated from in vitro (MEA) and laboratory/engineering tests conducted by the manufacturer, Reprobitech Corp. The country of origin for the data is not specified, but the applicant (Reprobitech Corp.) is based in Flushing, New York, USA. The studies are prospective in the sense that they were conducted for the purpose of this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for these non-clinical performance tests is based on objective measurements (e.g., temperature, physical integrity, biological response of mouse embryos) against predefined criteria, not expert interpretation of human data.
4. Adjudication Method for the Test Set
Not applicable. There is no human interpretation or adjudication involved in establishing the "ground truth" for the non-clinical tests described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. There is no mention of an MRMC comparative effectiveness study. The device is a labware product, not a diagnostic imaging or AI-assisted diagnostic device, so this type of study is not relevant to its regulatory submission as described.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithmic or AI device. The tests performed are for the physical and biological compatibility characteristics of a medical device intended for embryo cryopreservation.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests outlined includes:
- Objective Measurements: Temperatures, physical integrity assessments (absence of leakage, damage, deformation, discoloration), and adherence to specified engineering standards (e.g., ASTM standards for package integrity).
- Biological Response: Defined as the percentage of 1-cell mouse embryos developing to the expanded blastocyst stage (≥ 80% at 96 hours). This is a biological endpoint widely accepted in the field for assessing embryo toxicity/compatibility.
- Chemical Analysis: Endotoxin levels measured against a specified limit (≤ 0.5 EU/device).
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a "training set." The performance tests are for the manufactured physical device itself.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 884.6160 Assisted reproduction labware.
(a)
Identification. Assisted reproduction labware consists of laboratory equipment or supplies intended to prepare, store, manipulate, or transfer human gametes or embryos for in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures. These include syringes, IVF tissue culture dishes, IVF tissue culture plates, pipette tips, dishes, plates, and other vessels that come into physical contact with gametes, embryos or tissue culture media.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when it is a dish or plate intended for general assisted reproduction technology procedures, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.