(30 days)
The Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes are used for the intracytoplasmic single sperm injection of oocytes. The Holding Pipettes are used to hold the oocyte in position with the application of vacuum. The Denuding Pipettes are used to remove the cumulus cell layers. The Assisted Hatching/Zona Drilling Pipettes are used to make a hole in the zona pellucida to enable blastomere removal or embryo assisted hatching.
The Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes are used for the intracytoplasmic single sperm injection of oocytes, the Holding Pipettes are used to hold the occyte in position with the application of vacuum during single sperm injection with the micro-injection pipette, the Denuding Pipettes are used to remove cumulus cell layers, and the Assisted Hatching/Zona Drilling Pipettes are used to make a hole in the zona pellucida to enable embryo assisted hatching. These devices are manufactured entirely from borosilicate glass. Mouse Embryo Toxicity testing has been performed on the borosilicate glass. Results show the material meets the requirements of these tests.
The provided text describes a 510(k) summary for Cook OB/GYN's Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes, Holding Pipettes, Denuding Pipettes, and Assisted Hatching/Zona Drilling Pipettes. However, it does not include detailed information about specific acceptance criteria or a study that clearly defines and proves the device meets those criteria in a format typically seen for medical device performance studies involving AI or complex algorithm evaluations.
The document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific quantitative acceptance criteria through a dedicated study.
Here's an analysis based on the provided text, addressing the requested points where information is available, and indicating when it is not:
-
1. A table of acceptance criteria and the reported device performance
This information is not explicitly stated in the provided document in the context of quantitative performance metrics for the pipettes' function (e.g., success rate of ICSI, embryo viability, etc.). The 510(k) submission relies on demonstrating substantial equivalence.
The "acceptance criteria" for this type of device, as per the submission, appear to be met by:
- Equivalence in indications for use, design, construction, and materials to predicate devices.
- Satisfactory Mouse Embryo Toxicity testing for the borosilicate glass material.
- Adherence to specified process controls and a Quality Assurance Program.
Acceptance Criterion (Inferred from Substantial Equivalence) Reported Device Performance (Inferred from Submission) Equivalence in indications for use "similar to the ... predicate devices" Equivalence in design "similar to the ... predicate devices" Equivalence in construction "similar to the ... predicate devices" Equivalence in materials "similar to the ... predicate devices" Satisfactory Mouse Embryo Toxicity (MET) testing of material "Results show the material meets the requirements of these tests." Adherence to process controls and Quality Assurance "This device will be manufactured according to specified process controls and a Quality Assurance Program." -
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 describe a clinical "test set" in the sense of a dataset for evaluating device performance in human or animal subjects. The "test" mentioned is Mouse Embryo Toxicity testing.
- Sample Size: Not specified for MET testing (e.g., number of embryos, batches tested).
- Data Provenance: Not specified for MET testing.
- Retrospective or Prospective: Not applicable, as it's a materials test, not a clinical study.
-
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)
Not applicable. The evaluation is for substantial equivalence and material safety (Mouse Embryo Toxicity), not for diagnostic or clinical performance requiring "ground truth" established by human experts in the context of complex image or data interpretation.
-
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set requiring expert adjudication 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
Not applicable. This device is a micro-tool (pipette), not an AI/software-as-a-medical-device (SaMD) or diagnostic imaging system. No human reading or AI assistance is involved in its direct function.
-
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
-
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the Mouse Embryo Toxicity testing, the "ground truth" would be the observed viability/health of mouse embryos after exposure to the device material, assessed against established biological safety standards for such materials. For substantial equivalence, the "ground truth" is the established regulatory compliance and performance of the predicate devices.
-
8. The sample size for the training set
Not applicable. No training set for an algorithm is mentioned as this is a physical device.
-
9. How the ground truth for the training set was established
Not applicable. No training set for an algorithm.
Summary of the Regulatory Strategy:
The manufacturer, Cook OB/GYN, pursued a 510(k) pathway by demonstrating substantial equivalence of their Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes, Holding Pipettes, Denuding Pipettes, and Assisted Hatching/Zona Drilling Pipettes to legally marketed predicate devices. This approach meant they did not need to conduct in-depth clinical performance studies as would be required for novel devices or AI solutions. Instead, they focused on showing that their devices are "similar with respect to indications for use, materials and physical construction" to existing devices and that the materials used are biologically safe (via Mouse Embryo Toxicity testing). The FDA agreed with this assessment, granting 510(k) clearance.
§ 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.