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Kitazato IUI Catheter is used for the introduction of washed spermatozoa into the uterine cavity through the cervix. Kitazato IUI Stylet is used to provide rigidity and assist in maintaining the shape of the catheter shaft.

The Kitazato IUI Catheter is a set of intrauterine insemination (IUI) catheters comprised of two different models that include either no stainless steel core (Type 4) or a stainless steel core (Type 5). Each type of catheter has a 10 cm or 18 cm catheter shaft length that incorporates an outer stiffener component and a syringe connector. The distal tip of the catheter shaft is rounded and includes two side holes 3 mm from the tip of the catheter for sperm delivery. The catheter shaft also includes depth marker bands at 5, 6, 7, and 8 cm from the distal tip to aid in delivery of the device to the targeted depth.

The catheter is composed of a polyvinyl chloride shaft and an acrylonitrile butadiene styrene (ABS) connector. The Stylet Cannula (Type 6) used with the Type 4 catheter is composed of a stainless steel cannula (SUS304) and an ABS syringe connector. The Stylet Cannula's stainless steel core provides rigidity and assists in maintaining the shape of the catheter shaft when the uterine cervix is sharply curved. The Stylet Cannula is inserted into the catheter shaft through the connector end and then the IUI Catheter is inserted into the cervix. During an IUI procedure, the catheter is introduced into the uterine cavity through the cervix, and the spermatozoa are injected into the uterine cavity by a syringe (not included) that is coupled at the connector end (6% taper connection) of the catheter shaft.

This document describes the Kitazato IUI Catheter. Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes used for each individual non-clinical performance test (e.g., number of catheters tested for tensile strength, number of samples for HSSA, etc.). It only states that the device "passed all the testing."

Data provenance is not explicitly mentioned as country of origin, however, the submission sponsor is KITAZATO Corporation in Japan, and the predicate device is from KITAZATO Medical Co., Ltd. This implies the studies were likely conducted or overseen by the Japanese manufacturer. The studies are non-clinical, implying they are laboratory-based tests rather than human studies, therefore the retrospective or prospective nature is not applicable in the same way it would be for clinical trials.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The reported studies are non-clinical performance tests for a medical device (catheter), not diagnostic studies requiring expert interpretation of results to establish ground truth.

4. Adjudication Method for the Test Set

Not applicable, as these are non-clinical performance tests with objective pass/fail criteria, not subjective human-interpreted data requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No. An MRMC comparative effectiveness study is designed for evaluating diagnostic tools where human readers are involved in interpreting results. This document describes non-clinical performance tests of a physical medical device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, standalone performance was done in the sense that the device itself was subjected to a series of tests to verify its physical, chemical, and biological properties without human intervention in the device's function during the test itself (e.g., tensile strength, sterility, biocompatibility).

7. The Type of Ground Truth Used

The ground truth for these non-clinical tests is established by recognized international standards and specifications (e.g., ANSI/AAMI, USP, ISO 10993, ISO 11607). For instance:

• Mechanical properties: Engineering specifications for tensile strength, dimensions.
• Sterility: Absence of microbial growth, as defined by USP .
• Endotoxin: Endotoxin levels below a specified threshold, as defined by ANSI/AAMI ST72.
• Biocompatibility: Absence of cytotoxicity, sensitization, and irritation as evaluated against ISO 10993 standards and FDA guidance.
• HSSA: A specific percentage of sperm motility after a defined period (≥70% at 24 hours).
• Package Integrity: Meeting requirements of ISO 11607.

8. The Sample Size for the Training Set

Not applicable. This report details acceptance criteria and performance data for a medical device based on non-clinical testing, not a machine learning or AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable for the same reason as above (no training set for a non-AI medical device).

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