(129 days)
MicroFrance® Wormald Vascular Clamps are indicated for use for temporary or partial occlusion of blood vessels during surgical procedures.
MicroFrance® Wormald Vascular Clamps enable a surgeon to suture the vessel defect, allowing the clamps to be released and therefore flow to be maintained. The stainless steel clamps are rotatable, allowing for proper orientation of the jaw tip as well as the handle. The device functions by clamping the jaw around the vessel to isolate the operative area. The degree of closure is adjusted by a ratcheting handle.
The provided document is a 510(k) summary for the MicroFrance® Wormald Vascular Clamp and describes a device that is substantially equivalent to a predicate device, not an AI/ML powered medical device. Therefore, much of the requested information (e.g., sample size, ground truth, expert qualifications, MRMC studies, standalone performance, training set details) is not applicable or cannot be extracted from this type of regulatory submission. This document focuses on demonstrating equivalence to an existing device through comparison of features and non-clinical bench testing.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria in the typical sense of performance metrics (e.g., sensitivity, specificity, accuracy). Instead, the demonstration of equivalence relies on showing that the new device has similar characteristics and performs according to specifications.
| Feature / Criterion | Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (MicroFrance® Wormald Vascular Clamps) |
|---|---|---|
| Indications for Use | Similar to predicate device (Wexler Vascular Clamp Series) | "MicroFrance® Wormald Vascular Clamps are indicated for use for temporary or partial occlusion of blood vessels during surgical procedures." (Identical to predicate) |
| Principles of Operation | Similar to predicate device | "Clamp jaw applied around the vessel to isolate the operative area. The degree of closure is adjusted by a ratcheting handle." (Identical to predicate) |
| Materials | Similar to predicate device | "Stainless Steel" (Predicate also uses Stainless Steel, but also Titanium) |
| Device Design (Jaw tips, orientations, handle) | Similar to predicate device | "Variety of jaw tips and orientations, ratchet lock on handle, ring handle, integrated flush port, rotatable shaft" (Similar to predicate's "Variety of jaw tips and orientations, ratchet lock on handle, ring handle," with additional features of "integrated flush port, rotatable shaft" which are considered minor differences not affecting substantial equivalence.) |
| Sterility | Similar to predicate device | "Non-sterile" (Identical to predicate) |
| Reusable | Similar to predicate device | "Yes" (Identical to predicate) |
| Functionality (Ratchet Mechanism, Jaw Movement) | Perform according to specifications and allow varying degrees of pressure; rotation, opening, and closure of jaws consistently; ensure clamp and jaw plating consistency | "Bench testing provided evidence that the proposed MicroFrance® Wormald Vascular Clamps performs according to specifications. The ratchet mechanism on each device allows the surgeon to apply varying degrees of pressure on the vessel. The nature of the tests comprised of three sections for each instrument type. It tested rotation, opening and closure of the jaws as well as testing of the clamps and jaw plating to ensure consistency." (Meets implied functional requirements) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a number of devices or clinical cases. The "bench testing" refers to mechanical tests on the instruments themselves. The document states "three sections for each instrument type," implying a set of tests performed on each specific clamp design.
- Data Provenance: Bench testing, likely conducted internally by the manufacturer (Medtronic Xomed, Inc.). The document does not mention data from other countries or a retrospective/prospective study design in the context of device performance testing.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- This information is not applicable as the study is bench testing of a mechanical device, not an AI/ML algorithm or a study requiring expert clinical interpretation to establish ground truth.
4. Adjudication Method for the Test Set
- This information is not applicable as the study is bench testing of a mechanical device.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI/ML devices where human readers' performance with and without AI assistance is evaluated. This document describes a surgical instrument.
6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done
- No, a standalone performance study in the context of an AI algorithm was not done. The "bench testing" refers to mechanical performance evaluation of the clamp itself.
7. The Type of Ground Truth Used
- Engineering specifications and functional requirements. For mechanical devices, the "ground truth" is typically defined by engineering design specifications, material properties, and functional performance criteria (e.g., maximum force, consistency of movement, integrity of components). The testing confirmed the device "performs according to specifications."
8. The Sample Size for the Training Set
- This information is not applicable as there is no AI/ML algorithm being trained in this context.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable as there is no AI/ML algorithm or training set.
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).