(115 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 Intractoplasmic 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 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 blastomere removal or 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) Premarket Notification for various micro-injection pipettes used in assisted reproduction. However, it does not contain information about specific acceptance criteria or a study proving the device meets particular performance metrics.
Instead, the submission relies on demonstrating substantial equivalence to existing predicate devices based on indications for use, design, construction, and materials. The "study" mentioned is Mouse Embryo Toxicity testing, but this is a material compatibility test and not a performance study in the context of clinical effectiveness or accuracy.
Here's a breakdown of the requested information based on the provided text, highlighting what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. The submission focuses on substantial equivalence to predicate devices rather than specific quantitative performance criteria for the new devices themselves. | Not specified in the document. No specific performance metrics (e.g., success rate of ICSI, efficiency of denuding, or precision of zona drilling) are reported. The only "performance" mentioned is that the material "meets the requirements" of Mouse Embryo Toxicity tests. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable/Not provided. There is no mention of a "test set" in the context of a performance study for the pipettes' intended use.
- Data Provenance: Not applicable/Not provided. The Mouse Embryo Toxicity testing is implicitly laboratory-based, but no details on the origin or type of data are given for any performance evaluation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable/Not provided. No performance study requiring expert ground truth is described.
- Qualifications of Experts: Not applicable/Not provided.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/Not provided. No performance study requiring adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. There is no mention of an MRMC study or any study comparing human readers (or users of the device) with or without AI assistance. The devices are tools, not AI algorithms.
- Effect Size of Human Readers with vs. without AI: Not applicable/Not provided.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
- Standalone Study Done: No. The devices are physical tools (pipettes), not algorithms. Performance is related to their physical properties and material safety, not an algorithm's standalone capability.
7. Type of Ground Truth Used
- Type of Ground Truth: For the material safety (Mouse Embryo Toxicity test), the "ground truth" would be established by the defined pass/fail criteria of the toxicity test itself, likely based on viability or developmental benchmarks of mouse embryos exposed to the material. No clinical or diagnostic "ground truth" is established for the pipettes' functional performance.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable/Not provided. The submission describes medical devices (pipettes), not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth Was Established: Not applicable/Not provided. As above, these are physical devices, not an AI algorithm with a training set.
Summary of the K983596 Submission's Approach:
The K983596 submission primarily establishes substantial equivalence by demonstrating that the Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes, Holding Pipettes, Denuding Pipettes, and Assisted Hatching/Zona Drilling Pipettes are similar in indications for use, design, construction, and materials to previously marketed predicate devices (Humagen Fertility Diagnostics Inc., SWEMED LAB International AB, and Cook Australia products available in Europe).
The only specific testing mentioned is Mouse Embryo Toxicity testing performed on the borosilicate glass material from which the pipettes are made. The submission states, "Results show the material meets the requirements of these tests," which serves as evidence of biocompatibility and material safety, rather than functional performance or clinical efficacy against specific acceptance criteria.
The FDA's successful clearance (K983596) indicates acceptance of this substantial equivalence argument, rather than a direct demonstration of meeting explicit performance criteria through a dedicated clinical or comparative study as might be expected for novel or higher-risk devices or AI algorithms.
§ 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.