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510(k) Data Aggregation
(87 days)
VitriGuard
VitriGuard is intended for use as a cryopreservation storage device in vitrification procedures and indicated to contain and maintain human oocytes (MII), 4-8 cell embryos and blastocyst stage embryos.
VitriGuard is a sterile, single-use device that is intended for use as a cryopreservation storage device in vitrification procedures. The device consists of a two-piece polystyrene assembly that includes a hexagonal-shaped stick and cap. As part of the vitrification procedure, the oocytes or embryos are loaded on the tip of the stick is capped prior to plunging the device in liquid nitrogen and for subsequent storage. The tip has a trough area for loading, maintaining and securing oocytes or embryos. The stick and cap include a taper design that create a seal when assembled. Black markings at the end of the stick and the tip of the device provide visual aid for proper device orientation. All VitriGuard devices have a blue cap and the sticks are available in eight (8) translucent colors: clear, blue, green, yellow, lime green, purple, orange and pink.
Here's a breakdown of the acceptance criteria and the study information for the VitriGuard device, based on the provided text:
VitriGuard Acceptance Criteria and Study Information
The acceptance criteria are not explicitly stated as distinct pass/fail thresholds in a single table, but are instead derived from the "Substantial Equivalence Comparison" table and "Non-clinical performance testing" sections by comparing the subject device's performance to the predicate device and established standards. The reported device performance is also taken from these sections.
1. Table of Acceptance Criteria and Reported Device Performance
| Attribute | Acceptance Criteria (typically matching predicate or standard) | Reported Device Performance (VitriGuard) |
|---|---|---|
| Cooling Rate | Comparable to cleared oocyte and embryo vitrification devices (Predicate: 10,000°C/min) | 36,377°C/min |
| Warming Rate | Comparable to cleared oocyte and embryo vitrification devices (Predicate: -1,400°C/min) | -2,271°C/min |
| Endotoxin | ≤1.0 EU/device (Predicate) | ≤2.0 EU/device |
| MEA (1-Cell) | ≥80% embryos developed to expanded blastocyst at 96h (Predicate) | ≥80% embryos developed to expanded blastocyst at 96h |
| Sterilization SAL | 10^-6^ (Predicate) | 10^-6^ |
| Number of Uses | Single-use, disposable (Predicate) | Single-use, disposable |
| Sterilization Method | - (Predicate: Ethylene Oxide) | Radiation |
| Materials | - (Predicate: PMMA, Mediprene, Stainless steel) | Polystyrene with black marker bands |
Note on Acceptance Criteria: The document clearly states that differences in cooling/warming rates, endotoxin specifications, materials, and sterilization method "do not raise different questions of safety and effectiveness." This implies that while the values may differ from the predicate, they are still considered acceptable based on existing scientific understanding and relevant standards. For MEA, SAL, and number of uses, the criteria are explicitly met by matching the predicate.
2. Sample size used for the test set and the data provenance
The document indicates that clinical performance was primarily supported by a published literature review on closed-system vitrification devices similar to the subject device, rather than a single, dedicated clinical trial for VitriGuard with a specific test set.
- Literature 1: 33 vitrified/warmed donated oocytes.
- Literature 2: 498 vitrified/warmed donated oocytes.
- Literature 3: 190 vitrified/warmed autologous oocytes.
- Literature 4: Not explicitly stated as a single sample size for the study; reported on "clinical experience" with varying results based on maternal age.
- Literature 5: 89 vitrified/warmed donated oocytes.
- Literature 6: 33 patients, resulting in 16 embryo transfer cycles.
Data Provenance: The provenance of the data (country of origin, retrospective/prospective) is not explicitly stated for each literature reference. These are published studies by various authors (Inoue, Pujol, Perez et al, Gook et al, Pinasco et al, Goldman et al), implying they are likely a mix of prospective and retrospective observations from different clinical settings globally, based on typical scientific publication practices. The document uses this existing literature to support equivalence, rather than conducting a new, primary clinical investigation with a defined test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The "ground truth" for the literature review refers to outcomes measured in published clinical studies (survival rates, fertilization rates, cleavage rates, blastocyst development rates, implantation rates, pregnancy rates, live birth rates). The interpretation of these outcomes would have been performed by the researchers of those individual studies, but details on expert qualifications for establishing ground truth are not given here.
4. Adjudication method for the test set
This information is not provided in the document. Given that the clinical evidence relies on a review of published literature rather than a new, dedicated clinical study with a specific test set and adjudication panel for the VitriGuard device, no adjudication method specific to VitriGuard's clinical performance assessment is described.
5. 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
This is not applicable. The VitriGuard is a physical cryopreservation storage device, not an AI or imaging diagnostic tool that would involve "human readers" or AI assistance. Therefore, an MRMC study or assessment of AI effectiveness for human readers is irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The VitriGuard is a physical device, and does not involve an algorithm or human-in-the-loop performance in the context of AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance testing (e.g., cooling/warming rates, endotoxin, MEA), the ground truth is established through standardized laboratory assays and measurements (e.g., USP for endotoxin, ASTM standards for packaging, ISO standards for sterilization).
For the clinical evidence (literature review), the "ground truth" is derived from clinical outcomes data reported in the referenced published studies. This includes metrics such as:
- Oocyte survival rates
- Fertilization rates
- Cleavage rates
- Blastocyst development rates
- Implantation rates
- Clinical pregnancy rates
- Live birth rates
8. The sample size for the training set
This information is not applicable. The VitriGuard is a physical medical device, not a machine learning model that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable. As it's not an AI model, there is no training set or ground truth established for one.
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(43 days)
VitriGuard
VitriGuard 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.
VitriGuard 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. It is single-use, disposable, and provided sterile. The device consists of a two-piece polystyrene assembly that includes a hexagonalshaped stick and cap. As part of the vitrification procedure, the embryos to be stored are loaded on the tip, and capped prior to plunging the device in liquid nitrogen and for subsequent storage. The tip has a trough area for loading, maintaining, and securing the embryos. The stick and cap include a taper design that creates a seal when assembled. Markings at the end of the stick and the tip of the device provide visual aid for proper device orientation.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Cooling rate | Not explicitly stated | -2,271°C/min |
| Warming rate | Not explicitly stated | 36,377°C/min |
| Sterilization | SAL 10⁻⁶ | Radiation, SAL 10⁻⁶ |
| Endotoxin | ≤2.0 EU/device | ≤2.0 EU/device |
| Mouse Embryo Assay (MEA) | ≥80% blastocyst at 96h | Met the predetermined acceptance criteria (≥80% blastocyst at 96h) |
Note on Cooling/Warming rates: While listed as "Specifications," the document does not explicitly state them as "acceptance criteria" where a threshold needs to be met for the study. They are presented as inherent characteristics of the device. However, for the purpose of demonstrating device performance, they are included here. The MEA is the only one explicitly stated as meeting "predetermined acceptance criteria."
2. Sample size used for the test set and the data provenance
- Sample size: Not explicitly stated. The text mentions "VitriGuard devices" and "One-cell mouse embryos" without specifying a number per test.
- Data provenance: Not explicitly stated. However, given it's a pre-market submission, the study was likely conducted specifically for this submission and would be considered prospective for the device's regulatory approval. The study uses mouse embryos, which are a biological model, not human data from a specific country.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for the Mouse Embryo Assay (MEA) is established based on the biological outcome of embryo development (percent blastocyst formation), not through expert consensus or interpretation of images/data. Therefore, no "experts" were required to establish ground truth in this context.
4. Adjudication method for the test set
Not applicable. As noted above, the ground truth for the MEA is a direct biological outcome, not a subjective assessment requiring adjudication.
5. 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 not an AI-assisted diagnostic tool; it is a physical cryopreservation storage device. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm or AI system.
7. The type of ground truth used
The ground truth for the key performance test (Mouse Embryo Assay) was biological outcome data, specifically the successful development of mouse embryos to the blastocyst stage.
8. The sample size for the training set
Not applicable. This device is a physical product, not a machine learning model. There is no "training set" in this context.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth established for it.
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(128 days)
VitriGuard
VitriGuard 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.
VitriGuard 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 VitriGuard device is composed of a two-piece polystyrene assembly that includes a hexagonal shaped stick and cap. As part of the vitrification procedure, the embryos to be stored are loaded on the tip, also referred to as the leaf, and capped with a pre-cooled cap for subsequent storage following vitrification. The leaf has a trough area for loading. maintaining, and securing the embryos. The stick and cap include a taper design that creates a hermetic seal, forming a closed system. Markings at the stick and the tip of the device provide visual aid for proper device orientation. The device is provided sterile and is for single use only. The VitriGuard has been designed as a cryopreservation storage device to maintain the integrity of human 4-8 cell and blastocyst stage embryos throughout the cooling. storage, and warming processes.
Here's the information about the acceptance criteria and the study that proves the device meets them, extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Gamma Sterilization Validation | (Implicit: Meets ISO 11137-1:2006/(R)2010 and 11137-2:2013) | Passed |
| Shipping and Distribution Testing | (Implicit: Meets ISTA 3A 2008) | Passed |
| Package Integrity Testing | (Implicit: Meets ASTM F1980-07(2011), AAMI/ANSI/ISO 11607-1:2006/A1:2014, 11607-2:2006/A1:2014, ASTM F929-15, ASTM F88/F88M-15, and ASTM F1886/F1886M-09(2013)) | Passed |
| Endotoxin Evaluation | ≤2.0 EU/device (Implicit: Meets ANSI/AAMI ST72:2011/(R)2016 and USP ) | ≤2.0 EU/device (Passed) |
| Mouse Embryo Assay (MEA) | ≥80% blastocyst at 96 hours (1-cell) | ≥80% blastocyst at 96 hours (1-cell) (Passed) |
| Thermal Profile Evaluation (Cooling/Warming Rates) | Warming and cooling rates must be substantially equal to (or greater than in absolute value) to the predicate device. | Met acceptance criteria (Subject device cooling: -2,271°C/min; warming: 36,377°C/min; Predicate cooling: -1,494°C/min; warming: 21,000°C/min, indicating faster rates for the subject device) |
| Mouse Embryo Survival Evaluation | Survival rate must be ≥80% for all embryo stages. | Met acceptance criteria (≥80% survival rate for all embryo stages) |
| Mouse Embryo Development Evaluation | Blastocyst development rate must be ≥80% for all embryo stages. | Met acceptance criteria (≥80% blastocyst development rate for all embryo stages) |
| Container and Closure Integrity - Bacterial/Immersion | Negative for growth of the challenge organism. | Met acceptance criteria (Negative for growth) |
| Container and Closure Integrity Bacterial Contaminated LN2 | Test samples do not show presence or growth of the challenge organism; no leakage of LN2. | Met acceptance criteria (No presence/growth; no leakage) |
| Durability Testing | Must not exhibit any cap expulsion during the process; no leakage of LN2. | Met acceptance criteria (No cap expulsion; no leakage) |
| Product Evaluation | Device passes the predetermined design requirements. | Met acceptance criteria |
| Shelf Life Testing (Accelerated Aging) - MEA | ≥80% blastocyst at 96 hours (1-cell) | (Implicitly passed by passing overall MEA for aged samples) |
| Shelf Life Testing (Accelerated Aging) - Container and Closure Integrity Bacterial/Immersion | Negative for growth of the challenge organism. | (Implicitly passed by passing overall CCI for aged samples) |
| Shelf Life Testing (Accelerated Aging) - Container and Closure Integrity Bacterial Contaminated LN2 | Test samples do not show presence or growth of the challenge organism; no leakage of LN2. | (Implicitly passed by passing overall CCI for aged samples) |
| Shelf Life Testing (Accelerated Aging) - Durability Testing | Must not exhibit any cap expulsion during the process; no leakage of LN2. | (Implicitly passed by passing overall Durability for aged samples) |
| Shelf Life Testing (Accelerated Aging) - Product Evaluation | Device passes the predetermined design requirements. | (Implicitly passed by passing overall Product Evaluation for aged samples) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific numerical sample size (e.g., number of embryos or devices) used for each test. However, it indicates that "various mouse embryos" were used for the Mouse Embryo Survival and Development evaluations.
The data provenance is not explicitly detailed in terms of country of origin. The studies appear to be prospective in nature, as they involve conducting tests on the VitriGuard device according to specified protocols to evaluate its performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of human experts to establish ground truth for the test set. The ground truth for the performance tests (e.g., survival rates, development rates, integrity checks) is established by direct measurement against predefined criteria or by observation of biological outcomes (mouse embryo survival/development).
4. Adjudication Method for the Test Set
Not applicable, as the evaluation methods described are objective measurements or biological assays rather than subjective human assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The studies described are performance tests of the device itself, comparing its physical and biological performance characteristics to predefined criteria and to a predicate device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The VitriGuard is a cryopreservation storage device, not an AI algorithm. Its performance is evaluated through non-clinical laboratory testing.
7. The Type of Ground Truth Used
The ground truth used for the performance studies is a combination of:
- Direct Measurement/Objective Criteria: For parameters like cooling/warming rates, endotoxin levels, sterility, and physical integrity (e.g., no leakage, no cap expulsion).
- Biological Outcomes Data: Specifically for the Mouse Embryo Assay (MEA), Mouse Embryo Survival Evaluation, and Mouse Embryo Development Evaluation, where the "ground truth" is the observed biological response (e.g., percentage of blastocyst formation, survival rate). These are quantitative biological endpoints.
8. The Sample Size for the Training Set
Not applicable. The VitriGuard is a physical medical device, not an AI/machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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