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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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(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.
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