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(272 days)
The Kitazato ET Catheters are intended for ultrasound guided introduction of embryos into the uterine in vitro fertilisation.
Kitazato ET Catheters are sterile, single-use catheters for embryo transfer. The ET Catheters consist of a transfer catheter, guide catheter, and a stylet sheath. The Transfer catheter (hereafter referred to as 'catheter' or 'ET Catheter') is composed of a catheter shaft, a connector and a shaft protective sleeve (protector). The catheter types include a normal catheter (Type1, EC-PRO Normal), a catheter with a stainless outer stiffener (Type2, EC-PRO Supported), a catheter with Echo Line (Type3, EC-PRO Master), and a catheter that has both the stainless outer stiffener and the echo line (Type4, EC-PRO Master Supported), all of which are offered in lengths of 18cm and 23cm, and various versions (v1-v8). A corresponding Trial catheter of the same length is provided for all four Types of the Kitazato ET Catheters. The Guide catheter is offered both with a straight shaft and a 30° pre-curved distal shaft. The Stylet Cannula (Type5) is an optional accessory used when additional rigidity is needed during insertion of the cannula through the cervix, and is offered in two lengths, 13.5 cm and 18.5 cm.
During the implantation procedure of the embryo into the uterus, the catheter is introduced into the uterine cavity through the cervix, then the embryo is delivered into the uterine cavity by plunging the syringe that is coupled at the connector end of the catheter via a 6% taper luer lock. A syringe is not included with the Kitazato ET Catheters.
The provided text describes the Kitazato ET Catheters, an embryo transfer catheter, and its substantial equivalence to a predicate device. It includes non-clinical performance data to support its safety and effectiveness.
Here's the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | ||
| Cytotoxicity | Pass (ISO 10993-5:2009) | Passed |
| Sensitization | Pass (ISO 10993-10:2010) | Passed |
| Irritation | Pass (ISO 10993-10:2010) | Passed |
| Mouse Embryo Assay (MEA) | ≥ 80% expanded to blastocyst at 96 hours (1-Cell MEA) | Passed (1-cell mouse embryos, ≥ 80% expanded blastocysts at 96 hrs) |
| Endotoxin | < 20 EU/device | < 20 EU/device (conforms to specification) |
| Sterilization Validation | Conformance to ISO 11135:2014 & ISO 10993-7:2008 | Passed |
| Dimensional Verification | Final sterile devices conform to dimensional specifications; luer connectors conform to ISO 594-1 and ISO 594-2 | Passed |
| Appearance Testing | Pass visual inspection for scratches, burrs, and foreign objects | Passed |
| Mechanical Tensile Testing | Met established specifications | Tensile strength met the established specifications |
| Depth Mark Color-fastness | Clearly legible after soaking in saline for 24 hours and 100 cycles of rubbing | Remained clearly legible |
| Package Integrity | Pass dye penetration, seal strength, and visual inspection per ASTM 1929-15, ASTM 1866/F 1886M-09, and ASTM F88/F88M-15 | Passed |
| Transport Testing | Packaging maintained device integrity | Packaging maintained device integrity |
| Shelf Life Testing | Maintained performance for 3 years (tensile strength, dimension, appearance, sterility, endotoxin, MEA, and color fastness) | Established three (3) year shelf life following real time aging; parameters assessed (tensile strength, dimension, appearance, sterility, endotoxin, MEA, and color fastness) |
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical performance testing of the device itself and does not involve human subjects or clinical data for a "test set" in the context of AI/diagnostic algorithm evaluation. Therefore, details regarding sample size for a test set and data provenance (country of origin, retrospective/prospective) are not applicable here. The testing was performed on the device prototypes and manufactured units.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the study is a non-clinical device performance test and does not involve establishing ground truth from human expert interpretations of data (e.g., medical images).
4. Adjudication Method for the Test Set
This information is not applicable as the study is a non-clinical device performance test and does not involve adjudication of expert interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document describes non-clinical performance testing of a medical device (catheter), not an AI algorithm intended to assist human readers. Therefore, an effect size of human readers' improvement with vs. without AI assistance is not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone performance study in the context of an AI algorithm was not done. This document pertains to the physical performance characteristics of a medical catheter, not an AI or diagnostic algorithm.
7. Type of Ground Truth Used
For the non-clinical performance tests, the "ground truth" used are the defined specifications and standards for the device's physical, chemical, and biological properties. This includes:
- ISO standards (e.g., ISO 10993 for biocompatibility, ISO 11135 for sterilization, ISO 11607 for packaging)
- ANSI/AAMI standards (e.g., ANSI/AAMI ST72 for endotoxin)
- ASTM standards (e.g., ASTM D4169 for transport, ASTM F88/F88M-15 for seal strength)
- JIS standards (e.g., JIS L 0849 / JIS L 0803 for color-fastness)
- Internal established specifications for tensile strength, dimensions, and appearance.
- Biological assays (Mouse Embryo Assay) with specific biological endpoints (blastocyst development rate).
8. Sample Size for the Training Set
This information is not applicable. The document does not describe the development or testing of an AI algorithm, so there is no training set in that context. The "training" for the device would be its design and manufacturing process, and performance is tested against established specifications.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As there is no AI algorithm training set, there is no ground truth established for it in this context.
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