(72 days)
The Mini Embryon Intrauterine Insemination catheter allows the sperm to bypass the cervix so that an increased number can reach the Uterine cavity and subsequently the fallopian tubes. This catheter is not intended for assisted reproduction procedures.
The Mini Embryon IUI is a 5Fr Intrauterine Inseminator made of clear polyethylene, 18 cm in length, with an OD of 1.6 mm and an ID of 1.0 mm. A 5 cm distal segment with double side eyes and a rounded tip insures a very smooth entry with minimal disturbance to the endometrial bed. This is complemented with 11 cm of marked catheter shaft with 7 Fr in diameter for better and more secure handling. A proximal Luer Lock allows for connection with a syringe. It is to be supplied in two versions, Soft & Hard.
The provided text is a 510(k) summary for the "Mini-Embryon Intra Uterine Insemination Catheter." In this type of submission, the manufacturer is demonstrating that their new device is "substantially equivalent" to legally marketed predicate devices, rather than proving its safety and effectiveness through new clinical studies measuring specific performance metrics against pre-defined acceptance criteria.
Therefore, the sections of your request regarding acceptance criteria, specific study designs (like MRMC or standalone), sample sizes, and ground truth establishment are not directly applicable or explicitly detailed in this 510(k) summary. The document focuses on comparing the technological characteristics of the new device to existing predicate devices.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table of acceptance criteria or specific device performance metrics in the way a clinical study report would. Instead, it offers a "Summary comparing technological characteristics with other predicate devices." The acceptance criterion for a 510(k) submission is "substantial equivalence" to a predicate device.
The table indicates that for various technological characteristics, the Mini-Embryon Catheter is deemed "Equivalent" (E) or "Similar" (S) to the six predicate devices.
| Characteristic | Mini-Embryon vs Predicates |
|---|---|
| FDA file reference number | N/A |
| Attachments Inside Notification | E |
| Indications for use | E |
| Target population | E |
| Design | E |
| Materials | E |
| Performance | S |
| Sterility | S |
| Biocompatibility | N/A (Not Applicable) |
| Mechanical Safety | N/A (Not Applicable) |
| Chemical safety | E |
| Anatomical sites | E |
| Human factors | N/A (Not Applicable) |
| Energy used and/or delivered | S |
| Compatibility w/ environment & other devices | S |
| Where used | E |
| Standards met | E |
| Electrical safety | N/A (Not Applicable) |
| Thermal Safety | N/A (Not Applicable) |
| Radiation safety | N/A (Not Applicable) |
Reported Device Performance:
The "Performance" characteristic is deemed "Similar" (S) to the predicate devices. The document does not elaborate on what specific performance aspects were compared or what the quantitative "similarity" entails beyond the general statement that it is "safe and effective as other predicate devices cited above."
2. Sample Sizes used for the test set and the data provenance:
- Sample Size: Not applicable. This is not a study that involved a "test set" of patients or data in the traditional sense. The submission relies on a comparison of technical specifications and intended use against existing devices.
- Data Provenance: Not applicable. There is no patient data or clinical data provenance discussed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth, in the context of clinical studies, is not established for this type of submission. The "ground truth" here is the established safety and effectiveness of the predicate devices as determined by their prior FDA clearance.
4. Adjudication method for the test set:
Not applicable. There was no test set or adjudication process as typically performed in clinical trials or diagnostic accuracy studies.
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) submission, not an AI or diagnostic imaging device. No MRMC study was conducted or referenced.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device. The concept of "standalone algorithm performance" does not apply.
7. The type of ground truth used:
The "ground truth" for this 510(k) submission is the established safety and effectiveness of the legally marketed predicate devices. The manufacturer is asserting that their new device shares sufficient technological characteristics and intended use with these predicates to be considered substantially equivalent. There is no new clinical "ground truth" generated from patient outcomes or pathology for the Mini-Embryon catheter in this submission.
8. The sample size for the training set:
Not applicable. There is no concept of a "training set" for a physical medical catheter in this context.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set.
§ 884.5250 Cervical cap.
(a)
Identification. A cervical cap is a flexible cuplike receptacle that fits over the cervix to collect menstrual flow or to aid artificial insemination. This generic type of device is not for contraceptive use.(b)
Classification. Class II (performance standards).