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510(k) Data Aggregation
(270 days)
The Kitazato OPU Needles consisting of:
- · Kitazato OPU Needle with Connection Tube (model number Type2)
- · Kitazato OPU Reduced Needle (model number Type3)
- · Kitazato OPU Two-Stage Reduced Needle (model number Type4)
are intended to obtain oocytes from ovarian follicles.
The Kitazato OPU Needles are single-use sterile devices that are used for ultrasound-guided transvaginal collection of oocytes from ovarian follicles.
All of the Kitazato OPU Needle have a similar general design and device materials. All of the Kitazato OPU Needles are composed of a 304 stainless steel needle, acrylonitrile butadiene styrene (ABS) needle hub, PVC connection tube, and a silicone stopper that is used to connect to a collection tube and vacuum pump.
Here's a breakdown of the acceptance criteria and study information for the Kitazato OPU Needles, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Criteria | Acceptance Criterion | Reported Device Performance |
|---|---|---|
| Endotoxin | < 20 EU/device (per ANSI/AAMI ST72-2011) | < 20 EU/device |
| Mouse Embryo Assay (MEA) | ≥ 80% expanded blastocysts at 96 hours (1-Cell MEA) | ≥ 80% expanded blastocysts at 96 hours (1-Cell MEA) |
| Sterilization Validation | Per ISO 11135:2014 and ISO 10993-7:2008 | Passed validation |
| Package Integrity (Dye penetration) | Per ASTM F929-15 | Passed testing |
| Package Integrity (Seal strength) | Per ASTM F88/F88M-15 | Passed testing |
| Transport Testing | Per ASTM D4169-09 | Passed testing |
| Shelf-life (MEA) | ≥ 80% expanded blastocysts at 96 hours (1-Cell MEA) | Met at 3 years |
| Shelf-life (Endotoxin) | < 20 EU/device | Met at 3 years |
| Shelf-life (Tensile testing - needle to hub) | Internal requirements met | Met at 3 years |
| Shelf-life (Tensile testing - tubing to hub) | Internal requirements met | Met at 3 years |
| Shelf-life (Bending elasticity of needle) | Return to normal position after bending 8° from straight | Met at 3 years |
| Shelf-life (Folding strength of needle) | No fracture when folded at 5 mm curvature radius to 90° | Met at 3 years |
| Shelf-life (Device appearance) | No burrs, scratches, damage | Met at 3 years |
| Shelf-life (Dimensional assessments) | Internal requirements met | Met at 3 years |
| Aspiration pressure testing | Devices operated as intended (no deformation, blockages, damage) | Operated as intended |
| Biocompatibility (Cytotoxicity) | Acceptable results per ISO 10993-5:2009 | No signs of cytotoxicity |
| Biocompatibility (Intracutaneous reactivity) | Acceptable results per ISO 10993-10:2010 | No signs of irritation reactions |
| Biocompatibility (Sensitization) | Acceptable results per ISO 10993-10:2010 | No signs of sensitization reactions |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes non-clinical performance tests. It does not specify a "test set" in the context of clinical data or human subjects. The testing involved various batches of the devices for each test. For example:
- Mouse Embryo Assay (MEA): "1-Cell mouse embryos were incubated in extracts of the subject device..." - The specific number of embryos or repetitions is not provided.
- Shelf-life studies: Performed on "real-time aged devices." The number of devices tested for each shelf-life parameter (MEA, endotoxin, tensile, bending, folding, appearance, dimensional) is not specified.
The data provenance is not explicitly stated in terms of country of origin or whether it's retrospective/prospective, as these are non-clinical lab tests performed on the manufactured devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This report details non-clinical laboratory testing (e.g., chemical, mechanical, biological assays), not clinical studies requiring expert interpretation of medical images or data. Therefore, there is no "ground truth" established by experts in the typical sense for clinical AI performance studies.
4. Adjudication Method for the Test Set:
Not applicable, as this is non-clinical laboratory testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. The document describes non-clinical performance testing of the device itself (e.g., material properties, sterility, embryotoxicity) and does not involve human readers or AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. This is a medical device (needles), not an AI algorithm. The performance is assessed based on its physical and biological characteristics, not computational output.
7. Type of Ground Truth Used:
The "ground truth" for these non-clinical tests is based on:
- Quantitative measurements: e.g., endotoxin levels (< 20 EU/device), percentage of expanded blastocysts (≥ 80%), specific dimensions.
- Qualitative observations: e.g., absence of deformation/blockages, no fracture, no burrs/scratches, no signs of cytotoxicity/sensitization/irritation.
- Adherence to established standards: e.g., ANSI/AAMI ST72-2011, ISO 11135:2014, ISO 10993-7:2008, ASTM F929-15, ASTM F88/F88M-15, ASTM D4169-09, ISO 10993-1-2009, ISO 10993-5:2009, ISO 10993-10:2010.
8. Sample Size for the Training Set:
Not applicable. This document pertains to the regulatory submission for a physical medical device, not an AI model. There is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As there is no training set, the establishment of ground truth for it is irrelevant here.
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