(71 days)
The Insemination Catheters are used for transferring sperms into the uterine cavity.
The catheter is used for intrauterine insemination.
The Insemination Catheters are used for transferring sperms into the uterine cavity. They have a well rounded tip and two distal side ports. The insemination fluid is introduced using a syringe attached to the proximal luer. The material used in these devices is Polypropylene. Biocompatibility is assured according to ISO 10993.
Here's an analysis of the provided text regarding the Labotect Insemination Catheter 320301.
It's important to note that this document describes a traditional medical device (catheter) and not an AI/ML-driven device. Therefore, many of the questions related to AI performance, ground truth, training sets, and expert consensus for AI will not be directly applicable. The details provided are for a medical device seeking 510(k) clearance based on substantial equivalence to predicate devices, which focuses on design, material, and manufacturing standards, not algorithmic performance.
Acceptance Criteria and Device Performance
Since this is not an AI/ML device, the "acceptance criteria" are related to manufacturing standards, biocompatibility, and functional aspects for an insemination catheter. The device performance is tied to meeting these specific criteria for safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Tested according to ISO 10993 (cytotoxicity, sensitization, irritation/intracutaneous reactivity) | "Biocompatibility is assured according to ISO 10993." (implicitly passed all tests as per Blue Book memorandum #G95-1) |
| Sterilization Validation | Gamma sterilization validated according to ANSI/AAMI/ISO 11137 and EN 556, SAL 10⁻⁶ | Fully validated. |
| Mouse Embryo Assay (MEA) | Two-Cell-MEA, blastocyst hatching >80% | "Mouse Embryo Assay batch tested: Two-Cell-MEA, blastocyst hatching >80%" (Indicates routine batch testing to meet this spec.) |
| Endotoxin (Bacterial) | Bacterial Endotoxin Assay, Endotoxin Value 80% blastocyst hatching), and Endotoxin levels ( |
§ 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).