(111 days)
Kitazato IUI Catheter consist of the following versions:
- Kitazato IUI Catheter with Outer Stiffener with Stylet Cannula, 18 cm, model number . Type 3-v1
- . Kitazato IUI Catheter with Outer Stiffener without Stylet Cannula, 18cm, model number Type 3-v2
Kitazato IUI Catheter is used for the introduction of washed spermatozoa into the uterine cavity through the cervix.
Kitazato IUI Catheter with Outer Stiffener Type with Stylet Cannula and without Stylet Cannula are recommended for uterine cervix with an anatomical curve because the catheter shaft can be easily manipulated. The Kitazato IUI Catheter is composed of an 18 cm catheter shaft 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, and a movable stopper to aid in delivery of the device to the targeted depth.
The catheter is composed of a polyvinyl chloride shaft and an ABS connector. The Stylet Cannula of the Type 3-v1 version of the device is composed of a stainless steel cannula (SUS304) and an ABS syringe connector. The Stylet Cannula 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. The spermatozoa can be introduced into the uterine cavity by the syringe that is connected to the stylet cannula with no need to remove the stylet cannula from the IUI Catheter. The syringe connector on both the catheter and stylet cannula has a 6% taper that is compatible with 6% taper connection syringe (note: syringe is not included with the catheter).
The provided text is a 510(k) summary for the Kitazato IUI Catheter. It describes the device, its intended use, and demonstrates substantial equivalence to a predicate device. However, it does not include descriptions of acceptance criteria as typically understood in a medical device study (e.g., specific performance metrics like sensitivity, specificity, or accuracy compared to a benchmark). Instead, it discusses the device's technical specifications and the results of non-clinical (laboratory) tests to demonstrate that the device meets those specifications and is comparable to a predicate device.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't provide a typical "acceptance criteria" table with performance metrics like accuracy, sensitivity, or specificity, as it's a 510(k) submission focused on substantial equivalence rather than a clinical performance study of an AI/algorithmic device. Instead, it lists the results of non-clinical tests against established specifications.
| Test Category | Acceptance Criteria (Implied / Stated) | Reported Device Performance |
|---|---|---|
| Mechanical Tensile | Established specification | Passed the established specification |
| Dimensional | Specifications for outer diameter and length | Passes outer diameter and length according to specifications |
| Endotoxin | ≤ 20 EU/device | Endotoxin values conform to the value ≤20 EU/device |
| Sterility | No microbial growth | No microbial growth from sterility testing |
| Biocompatibility | Passed all testing (cytotoxicity, intracutaneous reactivity, sensitization) | Passed all testing for cytotoxicity, intracutaneous reactivity, and sensitization |
| Phthalates (DEHP) Release | According to specifications | Passed according to specifications |
| Human Sperm Survival Assay (HSSA) | ≥ 70% motility at 24 hours | ≥70% motility at 24 hours |
| Shelf Life | Established three (3) years | Established three (3) years |
Relevant Study Information:
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Sample size used for the test set and the data provenance:
- The document describes non-clinical testing (mechanical, dimensional, endotoxin, sterility, biocompatibility, phthalates release, human sperm survival assay, and shelf life). It does not specify sample sizes for these tests, nor does it refer to a "test set" in the context of clinical data for algorithmic performance. Data provenance would be from manufacturing and laboratory testing.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This document does not describe a study involving expert-established ground truth for an algorithmic device's performance. The "ground truth" for the non-clinical tests are the objective specifications and assay results.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This document does not describe adjudication for a test set.
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If a multi-reader multicase (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:
- Not applicable. This is a medical device (catheter) and not an AI/algorithmic device. No MRMC study was conducted.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical device (catheter) and not an AI/algorithmic device. No standalone algorithm performance was assessed.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests, the "ground truth" is based on pre-defined engineering specifications, chemical/biological standards, and laboratory assay results. For example, sperm motility percentage is a direct measurement against a set threshold.
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The sample size for the training set:
- Not applicable. This is a physical medical device, not an AI/ML algorithm. There is no concept of a "training set."
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How the ground truth for the training set was established:
- Not applicable. (See #8)
§ 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).