Search Results

For the introduction of embryo(s) or washed spermatozoa into the uterine cavity during assisted reproductive procedures.

The Family of Wallace Catheters are designed for use in Assisted Reproduction Techniques (ART) and In-Vitro Fertilization (IVF) procedures.

MODELS 1816, 1816N and 2316: These devices consist of a two (2) piece assembly comprised of a detachable outer sheath through which a flexible open-ended Catheter has been inserted and held firm by means of a pressure fitting at the Luer hubs, which are supplied as secure syringe connections. The overall length for this assembly ranges from 18cm (model 1816) to 23cm (models 1816N and 2316) with a consistent outer diameter of approximately 0.060 inches, which is equal to a Stubs Needle Gauge of 16. At the distal tip of the catheter is a single, smooth, rounded opening to aide in atraumatic uterine insertion with centimeter markings at the proximal end to assist in visualization of the degree of penetration into the uterus. The sheath also carries centimeter markings; these however are at the distal tip to assist in visualization of penetration through the external cervical Os. Each catheter is packed inside of the outer sheath, covered by the tip protector. This serves to protect the catheter from distortion or damage during shipment.

NOTE: MODEL 2316 catheter is manufactured of a slightly higher durometer material resulting in a slightly stiffer device. This stiffness may be preferred when greater control is desired.

The provided text is a 510(k) summary for the Wallace Catheters. It describes the device, its intended use, and the types of tests performed to ensure its efficacy and safety. However, this document does not contain the specific acceptance criteria or the detailed results of a study that directly compares the device's performance against those criteria.

Here's an breakdown based on the information available and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not specified in the provided text. The document mentions tests like "one-cell Mouse Embryo Assay" and "Bacterial Endotoxin (Limulus Amoebocyte Lysate) Assay," but the number of samples used for these tests is not indicated.
• Data Provenance: Not specified. The document does not mention the country of origin of the data or whether the studies were retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• Not applicable. The "ground truth" concept is usually relevant for studies involving human interpretation (e.g., medical imaging) where there's a need for expert consensus on a diagnosis or finding. The tests mentioned here (one-cell Mouse Embryo Assay, Bacterial Endotoxin Assay) are laboratory assays that typically have objective, measurable endpoints rather than requiring expert judgment for ground truth establishment.

4. Adjudication Method for the Test Set

• Not applicable for the types of tests described. The tests mentioned are objective laboratory assays.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a MRMC comparative effectiveness study was not done. The device described is a medical catheter used for embryo/spermatozoa transfer, not an AI or imaging diagnostic device that would typically involve human readers interpreting cases. Therefore, there is no mention of human readers or AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• No, a standalone algorithm study was not done. This device is a physical medical instrument, not a software algorithm.

7. Type of Ground Truth Used

• The ground truth for the safety and efficacy of the device's materials and function would be established through objective laboratory measurements and biological assays. For example:
  • Mouse Embryo Assay: The "ground truth" would be the observed viability and development of mouse embryos when exposed to the device's materials, demonstrating non-toxicity.
  • Bacterial Endotoxin Assay: The "ground truth" would be the measured levels of endotoxin, required to be below a certain threshold.
  • Dimensional/Visual/Functional Tests: The "ground truth" would be adherence to specified physical dimensions, visual integrity, and proper mechanical function.

8. Sample Size for the Training Set

• Not applicable. This device is not an AI model, 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 for an AI model.

In summary: The provided 510(k) summary focuses on the device description, intended use, classification, and the types of tests performed to demonstrate safety and efficacy. It explicitly states, "There are no published standards for these particular types of products, and as such tests have been developed which are considered sufficient to ensure the efficacy and safety of the device(s) for its intended use." However, it does not provide the specific numerical acceptance criteria or the quantitative results from the studies to show how the device met those criteria.

Ask a specific question about this device