(171 days)
The Family of Wallace Malleable Stylets are a sterile single-use device intended to be used in conjunction with a Wallace Catheter for in vitro fertilization procedures where passage through the cervix is impeded.
The Wallace Malleable Stylet comprises a soft stainless steel wire, which is totally encapsulated within a Fluoroethylenepropylene (FEP) sheath. The FEP tubing is formed and closed at one end into a smooth rounded tip, and is encapsulated at the other end within an insert plastic molded luer hub. The stylet is supplied with a FEP outer sheath, which is insert molded into a plastic luer hub. The models are available in two sizes, 18 cm and 23 cm of working length and are for single use only.
The provided text describes the 510(k) summary for the Wallace Malleable Stylets, a medical device. Based on the information, here's a breakdown of the acceptance criteria and the study details:
1. Table of Acceptance Criteria and Reported Device Performance
The submission 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."
The document doesn't provide specific numerical acceptance criteria (e.g., minimum tensile strength, maximum toxicity levels) for each test. Instead, it lists the types of tests performed and implies that the device "meets" these implicitly defined criteria by virtue of the 510(k) clearance.
| Acceptance Criteria Category | Reported Device Performance (as implied by successful 510(k) clearance) |
|---|---|
| Visual Inspection | Device passed visual inspection requirements. |
| Dimensional Verification | Device met specified dimensional requirements. |
| Functional Testing | Device demonstrated appropriate functionality for its intended use. |
| One-cell Mouse Embryo Assay (MEA) | Device demonstrated non-embryotoxic properties. |
| Bacterial Endotoxin (Limulus Amoebocyte) Assay (LAL) | Device met bacterial endotoxin limits, indicating sterility. |
| Biocompatibility (ISO 10993-1:1994) | Device was biologically safe for its intended use, as per ISO 10993-1. |
| Application-Specific Tests (e.g., related to oocyte collection, embryo transfer, washed spermatozoa) | Device performance was deemed suitable for these sensitive applications. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each of the tests (Visual, Dimensional, Functional, MEA, LAL, or ISO 10993 biocompatibility).
The data provenance is not specified in terms of country of origin, nor is it explicitly stated whether the studies were retrospective or prospective. Given the nature of medical device testing for 510(k) clearance, these would typically be prospective laboratory and possibly animal (for biocompatibility) studies conducted by the manufacturer or a contract research organization.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The "ground truth" for material and functional tests would typically be defined by engineering specifications and recognized laboratory standards, not by human expert consensus in the same way clinical imaging studies might be. For biological assays like MEA and LAL, the "ground truth" is established by the assay's methodology and controls.
4. Adjudication Method for the Test Set
This information is not provided. Adjudication methods are more relevant for subjective assessments, particularly in clinical studies involving interpretation. For the objective tests described (visual, dimensional, functional, biological assays), the results are typically determined by specific measurement techniques and pass/fail criteria, rather than expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. The device is a physical malleable stylet, not an AI or imaging diagnostic tool that would typically undergo such a study.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, this question is not applicable. The Wallace Malleable Stylet is a physical medical device, not an algorithm or AI system. Its performance is inherent to its material properties and design, used by a clinician, and not a "standalone" algorithmic output.
7. The Type of Ground Truth Used
The ground truth used for performance validation appears to be a combination of:
- Engineering Specifications/Standards: For visual, dimensional, and functional characteristics.
- Biological Assay Standards: For the one-cell Mouse Embryo Assay (MEA) and Bacterial Endotoxin (Limulus Amoebocyte) Assay (LAL), where the "ground truth" is defined by the assay's ability to demonstrate lack of toxicity or presence of sterility within specified limits.
- International Standard ISO 10993, Part 1:1994: For biological safety assessment (biocompatibility). This standard defines the framework and types of tests to establish biological safety.
The "ground truth" is therefore established by adherence to established scientific and engineering principles, and recognized testing methodologies, rather than clinical outcomes or pathology reports in the traditional sense of a diagnostic device.
8. The Sample Size for the Training Set
This information is not applicable and not provided. The Wallace Malleable Stylets is a physical device, not an AI or machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided, as there is no "training set" for this type of device.
§ 884.6110 Assisted reproduction catheters.
(a)
Identification. Assisted reproduction catheters are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to introduce or remove gametes, zygote(s), preembryo(s), and/or embryo(s) into or from the body. This generic type of device may include catheters, cannulae, introducers, dilators, sheaths, stylets, and component parts.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).