(197 days)
The Wallace Dual Lumen Oocyte Recovery System in a sterile single-use device for ultrasonic-guided transvaginal collection of oocytes from the ovarian follicles.
The Wallace Dual Lumen Oocyte Recovery System consists of a dual lumen stainless steel needle with a plastic needle hub, and aspiration, flushing, and vacuum tubing. The needle hub acts as a handle and is designed for the user to hold between the thumb and index finger. It 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 the secondary lumen that is attached to the flushing tubing. The needle aspiration tubing connects to a silicone bung that allows connection to a sample tube. The silicone bung is also connected to the vacuum tubing that allows connection to a vacuum source.
The Wallace Dual Lumen Oocyte Recovery System consists of a 17 gauge needle that is 33 cm long, and three aspiration tubing lengths: 500, 750, and 950 mm. The system includes flushing tubing of 700 mm length and vacuum tubing of 500 mm length. The device is provided sterile and is for single-use only.
Based on the provided text, the device in question is the Wallace Dual Lumen Oocyte Recovery System, an ovulation retrieval needle. The document does not describe a study involving an AI/algorithmic device or human readers. Instead, it details the non-clinical performance testing conducted to demonstrate substantial equivalence to a predicate device.
Therefore, many of the requested sections (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set ground truth establishment) are not applicable as they pertain to the evaluation of an AI or algorithm, which is not the subject of this 510(k) summary.
Here's an analysis of the available information:
Acceptance Criteria and Device Performance for the Wallace Dual Lumen Oocyte Recovery System
The device under review is an assisted reproduction needle, not an AI or algorithm. The acceptance criteria and performance data provided relate to the physical and biological characteristics of the device to demonstrate its safety and effectiveness, primarily through comparison to a legally marketed predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The document describes various non-clinical performance tests and their acceptance criteria (implicitly met as the conclusion states the device passed all testing).
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sterilization Testing | Per ISO 11135:2014; Sterility Assurance Level (SAL) 10^-6 | Passed all testing in accordance with internal requirements and applicable standards. Implies SAL 10^-6 was met. |
| Ethylene Oxide (EtO) Residuals | Per ISO 10993-7: 2008 / (R)2012 | Passed all testing in accordance with internal requirements and applicable standards. |
| Biocompatibility: Cytotoxicity | Per ISO 10993-5: 2009 | Passed. |
| Biocompatibility: Irritation | Per ISO 10993-10: 2010 | Passed. |
| Biocompatibility: Sensitization | Per ISO 10993-10: 2010 | Passed. |
| Stability and Shelf Life (Accelerated Aging) | Two years shelf life (tested at baseline and after 2 years accelerated aging per ASTM F1980-16) | Passed. Device demonstrated stable performance over a two-year shelf life. |
| Package Integrity (Seal Tensile Strength) | Per ASTM F88/F88M-15 | Passed. |
| Package Integrity (Seal Peel) | Per ASTM F1886/F1866M-16 | Passed. |
| Mouse Embryo Assay (MEA) | ≥80% embryos expanded to blastocyst at 96 hours (for one-cell mouse embryos incubated in extracts of the device) | Passed. |
| Endotoxin | ≤20 EU/device (using Gel-Clot Limulus Amoebocyte Lysate (LAL) method per ANSI/AAMI ST72-2011 and USP ) | Passed. |
| Mechanical Performance Testing | Specific criteria not detailed, but tests included: Joint strength tensile testing; Needle point penetration force testing; Needle stiffness; Tubing flow rate; Tubing leak testing | Passed all mechanical performance tests. |
| Simulated Shipping & Distribution | Per ISTA 3A: 2008; subsequent visual inspection, bubble leak per ASTM F2096-11, and mechanical performance testing (same as above) | Passed. Device and packaging maintained integrity and performance after simulated shipping and distribution conditioning, including visual inspection, bubble leak, and mechanical performance testing. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not explicitly stated for each test (e.g., number of needles tested for mechanical performance, number of packages for integrity). However, the methods refer to standard test procedures (e.g., ISO, ASTM), which typically define sample sizes.
- Data Provenance: The document describes non-clinical laboratory testing of the device itself, not human clinical data or imaging data. Therefore, concepts like country of origin or retrospective/prospective are not applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not Applicable. This device is a physical medical instrument, not an AI/algorithmic software. "Ground truth" in this context refers to the defined scientific and engineering standards and methods for assessing the device's physical, chemical, and biological properties, which are established by standard organizations (e.g., ISO, ASTM, USP) and verified by qualified laboratory personnel.
4. Adjudication Method for the Test Set
- Not Applicable. As this is non-clinical performance testing of a physical device, there is no "adjudication" of expert opinions in the sense of image interpretation. Test results are objective measurements against defined standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. This is not an AI/algorithmic device or diagnostic tool. An MRMC study would be irrelevant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a physical medical device. "Standalone performance" in this context refers to the device's ability to meet its specifications independently, which is what the non-clinical performance testing aimed to demonstrate.
7. The Type of Ground Truth Used
- Defined Standards and Measurable Performance Metrics: The "ground truth" for this device's performance is based on established international and national standards (e.g., ISO, ASTM, ANSI/AAMI, USP) for sterility, biocompatibility, mechanical properties, and packaging integrity. Tests evaluate quantitative and qualitative measures directly against these benchmarks (e.g., specific thresholds for endotoxin, percentage of embryo development, strength limits, leak absence).
8. The Sample Size for the Training Set
- Not Applicable. This refers to an AI/algorithmic device, not a physical medical instrument. There is no concept of a "training set" for the type of evaluation described.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. Again, this is for AI/algorithmic development. The "ground truth" for evaluating this physical device is established through adherence to recognized industrial and medical device testing standards and protocols.
§ 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).