(441 days)
Kitazato IUI Catheters are used for the introduction of washed spermatozoa into the uterine cavity through the cervix.
Kitazato IUI Catheters are sterile, single-use catheters for use in infusion of washed spermatozoa into the uterine cavity. Catheters are composed of a catheter shaft and a connector. The connector is connected to a syringe (not included with the catheter), and washed spermatozoa are aspirated through the tip of the catheter shaft connected to the syringe. During the insemination procedure, the shaft of catheter is introduced into the uterine cavity through the cervix, and then spermatozoa are injected into the uterine cavity. The Kitazato IUI Catheter has the following types; IUI Catheter with Stainless Steel Center Core Type and IUI Catheter without Stainless Steel Center Core Type.
The provided 510(k) summary for the Kitazato IUI Catheters outlines non-clinical testing to demonstrate substantial equivalence to a predicate device, rather than a study proving performance against medical acceptance criteria. This type of filing (510(k)) aims to show that a new device is as safe and effective as a legally marketed predicate device, not necessarily to establish de novo medical performance standards through clinical trials or direct comparative effectiveness.
Therefore, the information requested for AI device studies (e.g., sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth for training) is not applicable to this 510(k) submission, as it focuses on demonstrating equivalence through non-clinical bench testing.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Tensile Testing | Tensile strength to withstand 4.9N | Withstood 4.9N (Implied by "all the specifications have met the acceptance criteria for the device" and "passed all testing") |
| Dimensional Testing | Outer diameter and length according to specifications | Passed outer diameter and length according to specifications (Implied by "all the specifications have met the acceptance criteria for the device" and "passed all testing") |
| Endotoxin Testing | Endotoxin values conform to the value ≤20 EU/device | Endotoxin values conform to ≤20 EU/device (Implied by "all the specifications have met the acceptance criteria for the device" and "passed all testing") |
| Sterility Testing | No microbial growth | No microbial growth (Implied by "all the specifications have met the acceptance criteria for the device" and "passed all testing") |
| Human Sperm Survival Assay (HSSA) | ≥70% motility at 24 hours | ≥70% motility at 24 hours (Implied by "all the specifications have met the acceptance criteria for the device" and "passed all testing") |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified for each test. The summary indicates that "all the specifications have met the acceptance criteria," suggesting sufficient samples were tested for each non-clinical evaluation.
- Data Provenance: Not specified, but the tests are non-clinical, likely conducted in a laboratory setting by the manufacturer (KITAZATO Medical Co., Ltd., Japan) or a contracted testing facility.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This submission relies on objective non-clinical test results against defined physical, chemical, and biological specifications, not expert-derived ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically associated with human interpretation of data (e.g., medical images) to establish ground truth for performance evaluation, which is not the case here.
5. If a multi reader multi case (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), not an AI-powered diagnostic or assistive technology. No MRMC study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. 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 technical specifications and industry standards for mechanical properties, dimensions, biocompatibility (endotoxin, HSSA), and sterility. For example, for endotoxin, the ground truth is a value of "≤20 EU/device."
8. The sample size for the training set
- Not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set was used.
§ 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).