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510(k) Data Aggregation
(434 days)
GM501 Wash with Phenol Red and Gentamicin is intended for in vitro procedures involving handling and micromanipulation of human oocytes and embryos outside of a CO2 incubator. Include oocyte and embryo washing (e.g. after oocyte aspiration, after hyaluronidase treatment to remove cumulus cells, before and after cryopreservation, and before embryo transfer) and micromanipulation procedures (e.g. assisted hatching). GM501 Wash with Phenol Red and Gentamicin is not intended for use in transferring embryos into the uterine cavity.
GM501 Wash with Phenol Red and Gentamicin is a ready-to-use solution providing supporting conditions for human oocytes and embryos during in vitro Assisted Reproduction Technology (ART) procedures taking place outside of a CO2 incubator, including washing and micromanipulation procedures. GM501 Wash is aseptically filled into sterilized bottles (20 and 50 ml) and has a six-month shelf-life when stored as recommended. This product can also be used for up to seven days after bottle opening.
GM501 Wash with Phenol Red and Gentamicin is identical to the predicate GM501 Wash with the exception of the addition of gentamicin sulfate (10 mg/liter) and phenol red (3 mg/liter).
Here's a breakdown of the acceptance criteria and study information based on the provided text, structured to address your specific points:
1. A table of acceptance criteria and the reported device performance
| Parameter | Acceptance Criteria (Subject Device - GM501 Wash with Phenol Red and Gentamicin) | Reported Device Performance (Subject Device) | Comparison to Predicate Device |
|---|---|---|---|
| Endotoxins | < 0.25 LAL, EU/ml | < 0.25 LAL, EU/ml | Same |
| Osmolality (mOsm/Kg) | 270-290 | 270-290 | Same |
| pH | 7.2-7.5 | 7.2-7.5 | Same |
| 1-Cell MEA (Mouse Embryo Assay) | ≥ 80% blastocyst at 96h after 1h exposure to GM501 Wash with Phenol Red and Gentamicin | ≥ 80% blastocyst at 96h after 1h exposure to GM501 Wash with Phenol Red and Gentamicin | Same |
| Shelf-life | 6 months | 6 months (supported by testing of MEA, sterility, pH, osmolality, and endotoxins) | Same |
| Use-life after bottle opening | 7 days (supported by stability testing at the end of the shelf-life period with MEA, sterility, pH, osmolality, and endotoxins) | 7 days (supported by stability testing at the end of the shelf-life period with MEA, sterility, pH, osmolality, and endotoxins) | N/A (this specific testing addresses a formulation change in the subject device) |
| Sterilization | Sterilized by sterile filtration | Sterilized by sterile filtration | Same |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes used for the "test set" in terms of human subjects or embryos. The primary performance data presented is the 1-Cell MEA (Mouse Embryo Assay) which uses mouse embryos. The specific number of mouse embryos used in this assay is not provided.
The data provenance (country of origin, retrospective/prospective) is also not explicitly stated in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and not present in the document. The device is a reproductive media for in vitro procedures. Its performance is assessed through laboratory assays (like MEA) and chemical/physical property measurements, not through expert interpretation of images or clinical diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not present in the document. The device's performance is determined by objective laboratory measurements (MEA, pH, osmolality, endotoxins, sterility) rather than subjective human interpretation.
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 information is not applicable and not present in the document. The device is a reproductive media, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and "human reader improvement with AI" are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable and not present in the document. The device is a biological/chemical media, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for assessing the performance of GM501 Wash with Phenol Red and Gentamicin is based on:
- Laboratory Assay Results: Primarily the Mouse Embryo Assay (MEA), which assesses the ability of the media to support blastocyst development from 1-cell mouse embryos.
- Chemical/Physical Specifications: Adherence to defined ranges for pH, osmolality, and endotoxin levels.
- Sterility Testing: Confirmation of absence of microbial contamination.
- Stability Testing: Demonstrating that the media maintains its specifications over its shelf-life and use-life.
8. The sample size for the training set
This information is not applicable and not present in the document. The device is a reproductive media, not an AI model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable and not present in the document. The device is a reproductive media, not an AI model.
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(198 days)
GM501 Wash is intended for in vitro procedures involving handling and micromanipulation of human occytes and embryos outside of a CO> incubator. Include oocyte and embryo washing (e.g. after oocyte aspiration, after hyaluronidase treatment to remove cumulus cells, before and after cryopreservation, and before embryo transfer) and micromanipulation procedures (e.g. assisted hatching). GM501 Wash is not intended for use in transferring embryos into the uterine cavity.
GM501 Wash is a ready-to-use solution providing supporting conditions for human oocytes and embryos during in vitro Assisted Reproduction Technology (ART) procedures taking place outside of a CO2 incubator, including washing and micromanipulation procedures. GM501 Wash is aseptically filled into sterilized bottles (20, 50 and 500 ml) and has a six-month shelf-life when stored as recommended. This product can also be used for up to seven days after bottle opening.
Here's a breakdown of the acceptance criteria and study information for the GM501 Wash device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criterion | Reported Device Performance (Implied Met) |
|---|---|---|
| pH | 7.2-7.5 | Met (pH testing performed) |
| Osmolality | 270-290 mOsm/kg | Met (Osmolality testing performed) |
| Sterility | No growth (per USP <71>) | Met (Sterility testing performed) |
| Bacterial Endotoxins | <0.25 EU/ml (per USP <85>) | Met (Bacterial endotoxins testing performed) |
| Mouse Embryo Assay (MEA) | >80% blastocysts at 96h following a 1h exposure to GM501 Wash | Met (MEA performed with established protocol) |
| Aseptic Filling Validation | Per ANSI/AAMI/ISO 13408-1:2008(R)2011, ANSI/AAMI/ISO 13408-2:2003(R)2013, and FDA Guidance | Met (Performed) |
| Shelf-Life (6 months) | All above specifications (pH, osmolality, sterility, 1-cell MEA, endotoxin) maintained at 6 months | Met (Shelf-life testing performed) |
| After Bottle Opening (7 days) | All above specifications (pH, osmolality, sterility, 1-cell MEA, endotoxin) maintained 7 days after opening | Met (Stability testing after bottle opening performed) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific "test set" sample size for evaluating the device as a whole. However, it mentions the following for the Mouse Embryo Assay (MEA):
- Sample Size for MEA: "One-cell mouse embryos were exposed to GM501 Wash for one hour..." The specific number of embryos used is not provided.
- Data Provenance: The origin of the mouse embryos (e.g., country) is not specified. The study appears to be a prospective evaluation of the new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The ground truth for the MEA and other tests (pH, osmolality, etc.) is based on scientific and regulatory standards, not expert consensus on individual cases.
4. Adjudication Method for the Test Set
This information is not applicable as the evaluations are objective laboratory tests with defined criteria, not subjective interpretations 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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a reproductive media product, not an AI-powered diagnostic or assistive tool, so such a study would not be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device. The phrase "standalone" as typically used in AI/software evaluation does not apply here. The device's performance is inherently "standalone" in that its intrinsic physical and biological properties are tested.
7. The Type of Ground Truth Used
The ground truth used for each parameter is based on:
- Established scientific/regulatory standards and specifications:
- pH, Osmolality, Endotoxin: Standard laboratory measurements against defined numerical ranges.
- Sterility: Absence of microbial growth, per USP <71>.
- Aseptic Filling Validation: Compliance with international and FDA guidelines (ANSI/AAMI/ISO 13408 series, FDA Guidance).
- Mouse Embryo Assay (MEA): The biological response of mouse embryos (% developing to blastocyst stage) against a defined percentage threshold (>80%). This is an established biological assay used in reproductive media testing to assess toxicity and developmental support.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product (reproductive media), not a machine learning model, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for a machine learning model, this question does not apply.
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