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Blastomere Biopsy Pipettes: The intended use of the Blastomere Biopsy Pipettes is for removal of blastomere(s) from embryos, which may be done in order to perform preimplantation genetic diagnosis on the genetic material in the biopsied cell(s).

Polar Body Biopsy Pipettes: The intended use of the Polar Body Biopsy Pipettes is for removal of polar bodies from oocytes, which may be done in order to perform preimplantation genetic diagnosis on the genetic material in the biopsied cell(s).

The Blastomere Biopsy Pipettes are very fine glass pipettes used in IVF/Assisted Reproduction Technology (ART) laboratories for the aspiration of blastomere(s) from embryos for the purpose of preimplantation genetic diagnosis. These pipettes have an inner diameters varying from 18-42 um based customer's preferences and the stage of the embryos being biopsied. The tip may be flat or beveled at 45 degrees, then fire polished, and bended to 10 - 45 degrees or straight.

The Polar Body Biopsy Pipettes are very fine glass pipettes tools used in IVF/Assisted Reproduction Technology (ART) laboratories for the aspiration of polar bodies from oocytes and embryos for the purpose of preimplantation genetic diagnosis. These pipettes have an inner diameters varying from 13-15 um. The tip may be flat or beveled at 45 degrees, then fire polished, and bended to 10-45 degrees or straight. Some of the tip may be pulled to form a sharp spike after polishing based customer's preferences.

These devices are intended for one-time use and will be marked sterile.

These devices are manufactured entirely from borosilicate glass. They are manufactured to specific sizes or the size may be modified to meet customer specifications, following procedures of the Sunlight Quality System. The final products are batch tested as part of a quality assurance program using Mouse Embryo Toxicity testing and endotoxin testing. The acceptance specifications of these tests are ≥80% of 2-cell mouse embryos to blastocysts and endotoxin ≤ 0.5 EU/device.

The Sunlight Medical, Inc. Biopsy Pipettes (Blastomere Biopsy Pipettes and Polar Body Biopsy Pipettes) underwent a 510(k) submission (K092554) to demonstrate substantial equivalence to predicate devices rather than a direct clinical performance study with acceptance criteria in the traditional sense. The equivalence was established based on similarities in indications for use, materials, physical construction, manufacturing processes, and quality controls.

Here's an analysis based on the provided document:

1. A table of acceptance criteria and the reported device performance

The submission does not specify "acceptance criteria" for clinical performance as would be seen in a diagnostic accuracy study. Instead, the "acceptance specifications" refer to quality control tests performed on the manufactured devices. The primary "performance" reported is related to the equivalence to the predicate device and the results of these quality control tests.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

There is no test set of clinical images or cases described for evaluating device performance in a clinical setting. The "test set" for the quality control criteria would be a sample of manufactured pipettes, but the number of devices tested is not specified. The provenance of the data for these quality control tests (Mouse Embryo Toxicity and Endotoxin) is from the manufacturer's internal "Quality Assurance Program".

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 is not applicable as there was no test set requiring expert ground truth for clinical performance evaluation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as there was no test set requiring adjudication for clinical performance evaluation.

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 device is a surgical tool (pipette) and not an AI-assisted diagnostic device. Therefore, no MRMC study or AI assistance evaluation was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a physical tool, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for the quality control tests is based on established biological and chemical assays:

• Mouse Embryo Toxicity: The ability of 2-cell mouse embryos to develop to the blastocyst stage in the presence of the device's leachables. This is an accepted biological indicator for cytotoxicity in reproductive medical devices.
• Endotoxin Test: Quantification of bacterial endotoxins, which is a standard safety measure for medical devices that may come into contact with biological systems.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of device performance in a clinical scenario or AI training, as this is a physical medical device. The "training" for the device would pertain to the manufacturing process and quality system setup, for which sample sizes are not specified in the document.

9. How the ground truth for the training set was established

This is not applicable as there is no training set of clinical data. The "ground truth" for manufacturing consistency and quality is established through standard operating procedures, material specifications, and quality control methodologies (like the mouse embryo and endotoxin tests).

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