(138 days)
Intended for flushing and/or aspiration of oocytes from ovarian follicles.
The Follicle Aspiration Set. Reduced Single Lumen proposed in this submission is intended for ultrasound-guided transvaginal aspiration and flushing of oocytes from ovarian follicles. This product is comprised of the following components:
- A stainless steel needle .
- A silicone cork to be pushed into the opening of a sampling tube .
- A length of TPE-O tubing for aspiration and flushing ●
- An adapter for flushing .
The subject device is provided sterile and is for single use only. It comes in four versions with the same design but different dimensions, as described below.
The provided text is a 510(k) summary for the Vitrolife Sweden AB Follicle Aspiration Set, Reduced Single Lumen. This document demonstrates the device's substantial equivalence to a predicate device, rather than providing a detailed study report for meeting specific performance criteria typically associated with AI/ML-enabled devices.
Therefore, many of the requested categories (such as sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set sample size, and ground truth establishment for training set) are not applicable to this type of device and submission. This is a medical device clearance based on engineering performance and material compatibility, not on diagnostic accuracy derived from AI analysis of data.
However, I can extract the acceptance criteria and reported performance for the engineering and biological tests conducted.
Acceptance Criteria and Device Performance for Vitrolife Sweden AB Follicle Aspiration Set, Reduced Single Lumen
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sterilization Validation | Met ISO 11137-2:2013 standards. (Specific performance metric not detailed, but implied compliance). |
| Endotoxin Testing | ≤ 1.2 EU/device (determined by LAL method per USP ). |
| Breakage and Elasticity Testing | Met requirements in ISO 9626:2016 for stainless steel needle. (Specific performance metric not detailed, but implied compliance). |
| Accelerated Shelf-Life Testing (3-year shelf-life): | |
| - Mouse Embryo Assay (MEA): ≥ 80% embryos expanded to blastocysts within 96 hours. | One-cell mouse embryos exposed to device extracts. Percent of embryos developed to expanded blastocyst stage within 96 hours were assessed in comparison with the control group. (Specific percentage not detailed, but implied compliance indicating ≥ 80% was achieved or demonstrated equivalence to control). |
| - Visual Inspection | Performed per ASTM F1886/F1886M-09. (Specific results not detailed, but implied compliance). |
| - Dye Penetration Testing | Performed per ASTM F1929-12. (Specific results not detailed, but implied compliance). |
| - Seal Strength Testing | Performed per ASTM F88/F88M-09. (Specific results not detailed, but implied compliance). |
| - Vacuum Testing: Operate as intended without damage under -500 mmHg vacuum pressure. | Demonstrated operation as intended without signs of damage. |
| - Flow Testing: Flow rates within anticipated ranges under intended use conditions. | Demonstrated flow rates within anticipated ranges. |
| - Tensile Strength Testing: Tensile strength at joints within anticipated ranges. | Demonstrated tensile strength at joints within anticipated ranges. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each test set (e.g., number of devices for endotoxin testing, number of embryos for MEA). The tests are typically laboratory-based engineering and biological assessments compliant with recognized standards. Data provenance is not described in terms of geographical origin or retrospective/prospective study design as would be relevant for clinical data. These are intrinsic performance tests of the device itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The "ground truth" for these types of tests is generally defined by the specific test method, instrument calibration, and adherence to international standards (e.g., ISO, ASTM, USP). There are no human "experts" establishing ground truth in the context of diagnostic interpretation for these performance evaluations. Qualified laboratory personnel perform and interpret the results according to the established protocols.
4. Adjudication Method for the Test Set
Not applicable. These are quantitative and qualitative laboratory tests with defined pass/fail criteria from international standards. There is no ambiguous "case" interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This device is an aspiration set, primarily a mechanical and sterile instrument, not an imaging or diagnostic device that involves human interpretation of results.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm or AI-enabled system. Its performance is entirely mechanical, material-based, and biological compatibility.
7. The Type of Ground Truth Used
The ground truth is based on established international and national standards and methodologies for medical device performance, sterility, material safety, and biocompatibility. Examples include:
- Sterilization: ISO 11137-2:2013
- Endotoxin: USP
- Needle Properties: ISO 9626:2016
- Embryo Toxicity: Mouse Embryo Assay (MEA), a recognized biological test.
- Packaging Integrity: ASTM F1886/F1886M-09, ASTM F1929-12, ASTM F88/F88M-09
8. The Sample Size for the Training Set
Not applicable. This device does not use machine learning, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, this question is irrelevant to the device submission.
§ 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).