(224 days)
The Single Lumen Ovum Aspiration Needles are used for laparoscopic or ultrasound guided transvaginal aspiration and flushing of oocytes from ovarian follicles for patients undergoing Assisted Reproductive procedures.
Single Lumen Ovum Aspiration Needles consist of a stainless-steel needle with a manipulating handle which may be connected to a fluorinated ethylene-propylene (FEP) or polytetrafluorethylene (PTFE) tube, which in turn is connected to a Silicone stopper (bung). The stopper has a Luer lock fitting directly to the stopper or connected to a length of tube to allow connection to a vacuum pump which provides aspiration suction. The stopper is placed in a 14mL test tube which acts as a collection reservoir. Needles are available in 16 to 21 gauge sizes and lengths from 25 to 35 cm. Needles have an echogenic tip that enhances the visualization of the needle tip under ultrasound. The Single Lumen Ovum Aspiration Needles are sterile and single-use devices.
Here's an analysis of the provided FDA 510(k) summary, specifically addressing the acceptance criteria and the study that proves the device meets them:
The document is a 510(k) premarket notification for the "Single Lumen Ovum Aspiration Needles." This is a medical device, and the focus of the regulatory claim is substantial equivalence to a predicate device, not necessarily a demonstration of clinical superiority or a deep dive into AI performance. Therefore, many of the typical AI/ML acceptance criteria and study details you'd expect are not present.
The "acceptance criteria" here largely refer to the performance standards and modifications made to demonstrate that the new device is as safe and effective as the predicate device.
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Test Performed) | Reported Device Performance |
|---|---|
| Biocompatibility (ISO 10993-1:2009) | Passed for Cytotoxicity, Sensitization, and Irritation. |
| - Cytotoxicity (ISO 10993-5:2009) | Passed |
| - Sensitization (ISO 10993-10:2010) | Passed |
| - Irritation (ISO 10993-10:2010) | Passed |
| Mouse Embryo Assay | ≥80% development to blastocyst at 72 hours (compared to control group). |
| Endotoxin testing (USP ) | limits. |
- Mechanical testing: Measurements against predefined engineering specifications for strength, leak resistance, and stiffness.
8. The sample size for the training set
This information is not applicable. The device is not an AI/ML system and therefore does not have a "training set" in the computational sense. The design verification and validation tests are performed on representative samples of the manufactured device.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for an AI/ML algorithm.
§ 884.6100 Assisted reproduction needles.
(a)
Identification. Assisted reproduction needles are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to obtain gametes from the body or introduce gametes, zygote(s), preembryo(s) and/or embryo(s) into the body. This generic type of device may include a single or double lumen needle and component parts, including needle guides, such as those used with ultrasound.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).