(142 days)
Follicle Aspiration Set, Reduced Single Lumen is intended for flushing and/or aspiration of oocytes from ovarian follicles
The Follicle Aspiration Set, Reduced Single Lumen device is a modification of the current Vitrolife Follicle Aspiration Set (K991273). The Follicle Aspiration Set, Reduced Single has the same intended use as the predicate device technological characteristics related to safety and effectiveness. A thinner type of needle end is being introduced, and the last 40-60 mm close to the tip of a standard needle is reduced from an inner diameter of 1.2 mm to an inner diameter of 0.6 mm.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Vitrolife Follicle Aspiration Set, Reduced Single Lumen.
Important Note: The provided document is a 510(k) Premarket Notification Summary, which focuses on demonstrating substantial equivalence to a predicate device. It primarily details the safety and effectiveness testing required to prove this equivalence, rather than setting and meeting formal "acceptance criteria" in the way a clinical trial for a novel device would. Therefore, the "acceptance criteria" here are inferred from the safety tests performed.
Acceptance Criteria and Device Performance
| Acceptance Criteria (Inferred from Safety Concerns) | Reported Device Performance |
|---|---|
| Resistance to breakage of the reduced needle part during procedure. (Main safety concern due to thinner diameter) | The needle has undergone testing according to ISO 9626 with respect to resistance of tubing to breakage and passed. The needle also passed an extended angle test. It's noted that the wall of the reduced part is at least 50% thicker than the wall of the standard part, contributing to its strength. |
| Maintenance of intended use and technological characteristics related to safety and effectiveness (compared to predicate) | The device has the same intended use and technological characteristics related to safety and effectiveness as the predicate device (Vitrolife Follicle Aspiration Set - K991273). The change is a thinner needle end. |
Study Details
Given the nature of the 510(k) submission and the device (a modification of an existing medical instrument), the "study" is primarily focused on bench testing to demonstrate the safety of the design change. It's not a clinical study with human participants or a traditional AI/software efficacy study.
1. Sample sizes used for the test set and data provenance:
* Test Set Sample Size: Not explicitly stated as a number of individual needles. The testing is described as occurring "according to ISO 9626" and also an "extended angle test." ISO standards typically define sample sizes for such tests, but the specific number used by Vitrolife is not reported here.
* Data Provenance: Not applicable in the context of a clinical study. This is a report on internal bench testing conducted by the manufacturer, Vitrolife Sweden AB.
2. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
* This is not applicable as the "ground truth" for mechanical component testing is defined by engineering standards (e.g., ISO 9626) and passing specific physical tests, not by expert consensus on clinical data.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
* Not applicable. Adjudication methods like 2+1 are used for interpreting clinical data, not for bench testing. The passing or failing of these mechanical tests is objective.
4. 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:
* No. This is a physical medical device (a needle), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study is irrelevant.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* No. This is a physical medical device, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* The "ground truth" for the safety tests is based on engineering standards and specifications (specifically ISO 9626 for resistance to breakage and an "extended angle test"). The device passing these prescribed mechanical tests constitutes the "ground truth" for demonstrating its structural integrity.
7. The sample size for the training set:
* Not applicable. This device is a modified physical instrument, not an AI model, so there is no "training set."
8. How the ground truth for the training set was established:
* Not applicable, as there is no training set for this type of device.
§ 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).