(30 days)
The Soft-Pass™ Embryo Mock Transfer Catheter Sets are used for mock (simulated) embryo transfer procedures to and in verifying catheter access and positioning in advance of an embryo transfer procedure.
The Soft-Pass Embryo Mock Transfer Catheter Sets are used to aid in verifying access and positioning of embryo transfer catheters prior to placing transfer catheters containing embryos into the uterine cavity. These devices consist of a polyethylene guide catheter that is 6.8 Fr in diameter and either 12 or 17.3 cm long, and a polyethylene mock transfer catheter that is 4.4 Fr in diameter and 19.7 or 24.7 cm long. The tip of the mock transfer catheter is closed. The echogenic tip versions of the device also include an echogenic stainless steel band on the distal tip of the mock transfer catheter to aid in tip visualization when using ultrasound. The echogenic tip versions also include a supporting stainless steel cannula in the proximal portion of the mock transfer catheter. Depth markers are also included on both the guide and mock transfer catheters to aid in placement of the device during a mock procedure. These devices are sterilized by ethylene oxide, single-use only, and have a three-year shelf-life.
This device submission (K191015) for the Soft-Pass™ Embryo Mock Transfer Catheter Sets does not include a new study to demonstrate acceptance criteria.
Instead, the submission states that the subject device is identical to the predicate device cleared under K173103, and the changes made in the current submission are solely to clarify the Indications for Use. Therefore, the device relies on the performance data submitted for its predicate device (K173103). The provided document does not contain the details of the study submitted for K173103.
Due to the lack of a new study in this specific document, most of the requested information cannot be extracted. However, based on the provided text, here's what can be stated:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state acceptance criteria or device performance data for this submission (K191015) because it relies on the predicate device's data. It asserts that the subject device is identical to the predicate device in terms of material specifications, physical characteristics, and manufacturing features.
| Acceptance Criteria (Not explicitly stated in this document) | Reported Device Performance (Implied from predicate equivalence for existing characteristics) |
|---|---|
| Functional equivalence to predicate device in mock embryo transfer | Identical to predicate device (K173103) in material, physical features, and manufacturing |
| Sterility | Maintained by Ethylene Oxide (ETO) process; 3-year shelf-life |
| Integrity of materials | Polyethylene, stainless steel (echogenic tip versions) |
| Dimensional accuracy (OD, Length) | Identical to predicate device: Transfer catheter (OD 4.4 Fr, Length 19.7-24.7 cm); Guide catheter (OD 6.8 Fr, Length 12-17.3 cm) |
| Visualization (for echogenic tip) | Echogenic stainless steel band aids in tip visualization with ultrasound |
2. Sample size used for the test set and the data provenance:
- Not provided in this document. This information would have been part of the K173103 submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not provided in this document. This information would have been part of the K173103 submission. The nature of the device (a physical catheter) suggests that performance testing would likely involve engineering and clinical use validation rather than expert image interpretation, but without the K173103 details, this is speculative.
4. Adjudication method for the test set:
- Not provided in this document.
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 device is a physical medical instrument (catheter), not an AI/software device that would typically undergo MRMC studies relating to human reader performance or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used:
- Not provided in this document. For a medical device like a catheter, "ground truth" would generally refer to successful mechanical function, material integrity, biocompatibility, and sterility, verified through various physical, chemical, and biological tests, rather than a clinical ground truth like pathology or outcomes data in the context of diagnostic accuracy.
8. The sample size for the training set:
- Not applicable. This device is a physical instrument, not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. This device is a physical instrument, not an AI/machine learning model.
§ 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).