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510(k) Data Aggregation
(458 days)
The Kitazato OPU Needles consisting of:
- Kitazato OPU Needle with Connection Tube, model number Type 2
- . Kitazato OPU Reduced Needle, model number Type 3
are intended to obtain oocytes from ovarian follicles.
The Kitazato OPU Needles are intended to puncture into the vaginal wall and obtain oocytes from ovarian follicles. The OPU Needle with Connection Tube, model number Type 2, product consists of Aspiration Needle with Connection Tube and Silicone Stopper Connector. The OPU Reduced Needle, model number Type 3, product consists of Reduced Aspiration Needle with Connection Tube and Silicone Stopper Connector.
Here's a breakdown of the acceptance criteria and study information for the Kitazato OPU Needle based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Tensile Testing: Withstand 22N for needle tube O.D. <0.55 mm | Passed (supports claims of substantial equivalence) |
| Bending Elasticity Testing: Return to normal position after bending 8° from straight for needle tube O.D. ≤1.0 mm | Passed (supports claims of substantial equivalence) |
| Folding Strength Testing: No fracture of needle tube detected when O.D. ≤1.0 mm and length ≥12mm is folded to 90° | Passed (supports claims of substantial equivalence) |
| Dimensional Testing: Passes outer diameter and length according to specifications | Passed (supports claims of substantial equivalence) |
| Endotoxin Testing: Endotoxin values conform to ≤20 EU/device | Passed (supports claims of substantial equivalence) |
| Sterility Testing: No microbial growth | Passed (supports claims of substantial equivalence) |
| Mouse Embryo Assay: ≥80% expanded to blastocyst stage within 96 hours | ≥80% expanded to blastocyst stage within 96 hours (specifically reported, implying passing) |
| Biocompatibility: Complies with applicable voluntary standards | Passed (supports claims of substantial equivalence) |
| Sterilization: Complies with applicable voluntary standards | Passed (supports claims of substantial equivalence) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each individual test (e.g., number of needles for tensile testing, number of samples for endotoxin testing). It broadly states that "The Kitazato OPU Needles were tested."
- Sample Size: Not explicitly stated for each test, but implied to be sufficient for demonstrating compliance with specifications.
- Data Provenance: Not explicitly stated, but the submission is from KITAZATO Medical Co., Ltd. in Tokyo, Japan. It is reasonable to infer the testing was conducted in Japan or at a facility accredited by the manufacturer. The studies are retrospective as they were conducted to demonstrate the device meets criteria before market approval.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is generally not applicable for the non-clinical performance studies described in this 510(k) summary. These tests are laboratory-based and measure physical, chemical, and biological properties, not human interpretation of medical data. Therefore, there is no "ground truth" established by human experts in the clinical sense for these specific tests.
4. Adjudication Method for the Test Set
This is not applicable because the tests are laboratory-based and yield objective measurements or observations (e.g., pass/fail, numerical values, presence/absence of microbial growth). There is no "adjudication" required in the context of expert review or consensus for these non-clinical tests.
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, an MRMC comparative effectiveness study was not done. This device is a physical medical instrument (OPU Needle), not an AI-powered diagnostic or assistive tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This device is a physical medical instrument and does not involve any algorithms or AI.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests are the pre-defined acceptance criteria and specifications themselves. For example:
- For Mechanical Tensile Testing, the ground truth is "withstanding 22N."
- For Endotoxin Testing, the ground truth is "≤20 EU/device."
- For the Mouse Embryo Assay, the ground truth is "≥80% expanded to blastocyst stage within 96 hours."
- For Biocompatibility and Sterilization, the ground truth is compliance with "applicable voluntary standards."
These are objective, measurable performance standards.
8. The Sample Size for the Training Set
This is not applicable. As a physical medical device, there is no "training set" like there would be for an AI algorithm. The manufacturing process is controlled, and products are testedbatch-wise or according to a sampling plan defined by a quality management system.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as point 8.
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