(30 days)
The Pre-Implantation Genetic Diagnosis Pipettes are used for the aspiration of Blastomeres for pre-implantation genetic diagnosis.
The Pre-Implantation Genetic Diagnosis Pipettes (Biopsy Pipettes) are used for the aspiration of The Tre Implantation genetic diagnosis. These devices are intended for one-time use and will be marketed sterile. These devices are manufactured entirely from borosilicate glass. Mouse Embryo Toxicity testing and Endotoxin testing have been performed on the borosilicate glass. Results show the material meets the requirements of these tests.
The provided text is a 510(k) Summary of Safety and Effectiveness for the Pre-Implantation Genetic Diagnosis Pipettes (Biopsy Pipettes), along with the FDA's clearance letter. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed studies with specific acceptance criteria, performance metrics, and human reader studies as would be seen for complex AI/ML-driven or diagnostic devices.
Therefore, the information requested in your prompt related to specific performance criteria, statistical study details (sample sizes for test/training sets, ground truth establishment, expert adjudication), and AI-specific elements (MRMC studies, standalone performance with AI) is not present in this document. This is because the device is a simple medical tool (pipettes) and the 510(k) pathway primarily requires demonstrating equivalence, not extensive clinical performance studies in the same vein as more complex devices.
However, I can extract the information that is available:
Acceptance Criteria and Device Performance (Limited Information)
The document states equivalence to predicate devices based on materials, design, and function, rather than specific numerical performance metrics.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material Safety: Non-toxic and endotoxin-free materials for patient contact. | Mouse Embryo Toxicity Testing: Material meets requirements. |
| Endotoxin Testing: Material free from harmful levels of endotoxins. | Endotoxin Testing: Material meets requirements. |
| Substantial Equivalence: Similar indications for use, design, construction, and materials to predicate devices. | The device is substantially equivalent to Cook Australia devices, specifically those manufactured by Cook Docencialia in Europe. |
Study Details (Limited; focus on material safety)
Given the nature of the device (borosilicate glass pipettes), the "studies" performed were primarily material testing.
- Sample size used for the test set and the data provenance: Not specified for "Mouse Embryo Toxicity testing" and "Endotoxin testing." The provenance would be Cook OB/GYN labs or a contracted testing facility. This would be a prospective test of newly manufactured materials.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Material testing typically follows standardized protocols, and results are interpreted according to pre-defined thresholds, not through expert consensus on a "ground truth" derived from cases.
- Adjudication method for the test set: Not applicable for material testing.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This type of study is relevant for diagnostic imaging or AI devices, not for basic medical tools like pipettes.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No. This is not an AI/algorithm-driven device.
- The type of ground truth used: For the material testing, the "ground truth" is adherence to established biological safety standards, as determined by the results of the Mouse Embryo Toxicity and Endotoxin tests against their respective benchmarks.
- The sample size for the training set: Not applicable. This device is not an AI/ML model that requires a training set.
- How the ground truth for the training set was established: Not applicable.
Summary of Device and Regulatory Context:
The Pre-Implantation Genetic Diagnosis Pipettes (Biopsy Pipettes) by Cook OB/GYN are simple borosilicate glass tools intended for aspirating blastomeres for pre-implantation genetic diagnosis. The 510(k) submission focused on demonstrating substantial equivalence to existing pipettes, specifically noting Cook Australia devices as predicates. The key evidence provided for safety and effectiveness related to the materials used: Mouse Embryo Toxicity testing and Endotoxin testing were performed on the borosilicate glass, and the results indicated the material met the required standards. No clinical performance data, AI algorithm performance, or human reader studies were presented or required for this type of device and regulatory pathway.
§ 884.6130 Assisted reproduction microtools.
(a)
Identification. Assisted reproduction microtools are pipettes or other devices used in the laboratory to denude, micromanipulate, hold, or transfer human gametes or embryos for assisted hatching, intracytoplasmic sperm injection (ICSI), or other assisted reproduction methods.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when the assisted reproduction microtools (pipettes) are manufactured from glass, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.