(197 days)
The Double Lumen Ovum Aspiration Need for laparoscopic or ultrasound guided transvaginal aspiration and flushing of oocytes from ovarian follicles for patients undergoing Assisted Reproductive procedures.
Double Lumen Ovum Pick-up Needles consist of a double lumen stainless steel needle with a manipulating handle. The manipulating handle has two ports: the central port through which oocytes are aspirated via the central lumen, and a secondary side port to allow flushing of follicles via a secondary lumen. The needle is intended to be used to aspirate oocytes from follicles of human ovaries via a laparoscopic or ultrasound guided transvaginal path.
The Double Lumen Ovum Aspiration Needles are sterile and single-use devices.
The Double Lumen Ovum Aspiration Needles are available in 16 or 17 gauge sizes and three lengths: 30, 33 and 35 cm. The needles are provided with an aspiration tube of 75 cm length and a vacuum tube with a length of 70 or 100 cm.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Performance Metric | Acceptance Criteria (Threshold/Standard) | Reported Device Performance (Result) |
|---|---|---|---|
| Biocompatibility | Cytotoxicity | Conformance to ISO 10993-5:2009 | Conformed |
| Sensitization | Conformance to ISO 10993-10:2010 | Conformed | |
| Irritation | Conformance to ISO 10993-10:2010 | Conformed | |
| Embryo Compatibility | Mouse Embryo Assay (MEA) | Not explicitly stated, but implied to show comparable development to control group | Percent of embryos developed to expanded blastocyst stage within 72 hours, assessed in comparison with the control group (implied positive result) |
| Sterility/Purity | Endotoxin Testing | Conformance to USP | Conformed |
| Mechanical Performance | Negative Pressure Leak Test | Not explicitly stated, but implied to meet functional requirements | Performed and implied to meet requirements |
| Tensile Strength (Tubing to Cannula) | Not explicitly stated, but implied to meet functional requirements | Performed and implied to meet requirements | |
| Tensile Strength (Tubing to Bung) | Not explicitly stated, but implied to meet functional requirements | Performed and implied to meet requirements | |
| Durability/Shelf Life | Negative Pressure Leak Test (after aging) | Not explicitly stated, but implied to maintain functional requirements after 3 years | Performed after three years of real time aging and implied to maintain requirements |
2. Sample Size Used for the Test Set and Data Provenance
The document describes design verification and validation activities for a medical device (Double Lumen Ovum Aspiration Needles), not a study involving human data, algorithms, or test sets in the context of medical imaging or AI.
Therefore, the concepts of "sample size used for the test set," "data provenance," "country of origin of the data," and "retrospective or prospective" are not applicable to this type of device submission. The tests were performed on the device itself or its materials.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This information is not applicable as the document describes physical/material testing of a medical device, not a diagnostic or AI-driven system requiring expert ground truth establishment.
4. Adjudication Method for the Test Set
This information is not applicable for the reasons stated above.
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
This information is not applicable. This submission is for a physical medical device, not an AI-based diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. This submission is for a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device is based on established industry standards (e.g., ISO, USP) and internal functional requirements for biocompatibility, mechanical performance, and sterility. For the Mouse Embryo Assay (MEA), the "ground truth" would be the development of a control group of embryos.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" as this is not an algorithm or AI model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. There is no "training set" or associated ground truth establishment for an AI model.
§ 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).