(227 days)
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
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Tensile Testing | Passed established specifications | Passed |
| Dimensional Testing | Conforms to outer diameter and length specifications | Passed |
| Appearance Testing | Passes visual inspection for scratches, burrs, and foreign objects | Passed |
| Endotoxin Testing (per ANSI/AAMI ST72:2002/(R)2010) | ≤ 20 EU/device | Conforms to specification |
| Sterility Testing (per USP ) | No microbial growth | No microbial growth |
| Biocompatibility Testing (per ISO 10993-1:2009 and 2016 FDA guidance) | Cytotoxicity: Passed | |
| Sensitization: Passed | ||
| Irritation: Passed | Passed cytotoxicity, intracutaneous reactivity (irritation), and sensitization | |
| Human Sperm Survival Assay (HSSA) | ≥ 70% motility at 24 hours | ≥ 70% motility at 24 hours |
| Color fastness of the depth marker bands | No change in appearance after conditioning | No change in appearance |
| Shelf Life Testing | Established three (3) year shelf life | Established three (3) year shelf life |
| Package Integrity Testing (per ISO 11607-1:2006(R)2014, ISO 11607-2:2006) | Passed dye penetration, seal strength, and visual inspection | Passed dye penetration, seal strength, and visual inspection |
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).
§ 884.6110 Assisted reproduction catheters.
(a)
Identification. Assisted reproduction catheters are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to introduce or remove gametes, zygote(s), preembryo(s), and/or embryo(s) into or from the body. This generic type of device may include catheters, cannulae, introducers, dilators, sheaths, stylets, and component parts.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).