(28 days)
The Over-The-Wire Expandable LeMaitre Valvulotome is indicated for cutting saphenous vein valves during in-situ bypass.
The OTW ELV is a self-centering and self-sizing catheter used for cutting valves in the saphenous vein while navigating over a guidewire.
This 510(k) summary (K111884) describes the LeMaitre Vascular OTW-Expandable LeMaitre Valvulotome (OTW-ELV), a device intended for cutting saphenous vein valves during in-situ bypass. The document focuses on demonstrating substantial equivalence to a predicate device (Expandable LeMaitre Valvulotome, K980723) through performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Parameter (Not explicitly detailed as criteria, but inferred from testing) | Reported Device Performance | Comments |
|---|---|---|---|
| Biocompatibility | ISO MEM Elution Assay | Device demonstrated as non-toxic and non-sensitizing. | Results consistent with intended use. |
| Complement Activation C3a and SC5b-9 Assay | Device demonstrated as non-toxic and non-sensitizing. | Results consistent with intended use. | |
| Platelet & Leukocyte Count | Device demonstrated as non-toxic and non-sensitizing. | Results consistent with intended use. | |
| ASTM Hemolysis Assay | Device demonstrated as non-toxic and non-sensitizing. | Results consistent with intended use. | |
| Partial Thromboplastin Time | Device demonstrated as non-toxic and non-sensitizing. | Results consistent with intended use. | |
| ISO Intracutaneous Reactivity | Device demonstrated as non-toxic and non-sensitizing. | Results consistent with intended use. | |
| Murine Local Lymph Node Assay | Device demonstrated as non-toxic and non-sensitizing. | Results consistent with intended use. | |
| ISO Acute Systemic Injection Test in the Mouse | Device demonstrated as non-toxic and non-sensitizing. | Results consistent with intended use. | |
| Mechanical Performance | Tensile testing of all bond joints | Met established specifications. | |
| Dimensional verification against product design specifications | Met established specifications. | ||
| Guidewire compatibility | Met established specifications. | ||
| Trackability through in-vitro models (simulated use) | Met established specifications. | ||
| Trackability through cadaver models (simulated use) | Met established specifications. | ||
| Efficacy cutting of in-vitro vein valves (simulated use) | Met established specifications. | Device demonstrated consistent performance. | |
| Efficacy cutting of cadaver vein valves (simulated use) | Met established specifications. | Device demonstrated consistent performance. | |
| Hemostasis | Met established specifications. | ||
| Fatigue testing | Met established specifications. |
Study Proving Device Meets Acceptance Criteria:
The document describes a series of in-vitro bench-top and in-vitro cadaver tests to demonstrate the safety and performance of the OTW-ELV. While specific quantitative acceptance criteria values are not provided in this summary, the overall conclusion states: "All test results demonstrated that the materials chosen, the manufacturing process, and the design utilized for OTW-Expandable LeMaitre Valvulotome met the established specifications necessary for consistent performance during its intended use as well as substantial equivalence to its predicate." This implies that predefined specifications for each test were met.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the specific sample sizes for each test in the test set (e.g., number of bond joints, number of cadaver veins, number of in-vitro models). It only lists the types of tests conducted.
- Data Provenance: The tests are described as "in-vitro bench-top testing" and "in-vitro cadaver testing." This indicates the data is from laboratory settings, not from human subjects. The country of origin of the data is not specified, but the submitter is based in Burlington, MA, USA. The data is retrospective in the sense that it was collected as part of the premarket notification process for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The tests performed are engineering and chemical/biological characterizations of the device's physical properties and interactions with simulated tissues/materials. They do not involve expert interpretation or subjective evaluation of medical images or clinical outcomes. Therefore, there is no "ground truth" established by medical experts in the context of this performance data.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the tests are objective measurements of physical, chemical, and biological properties, not subjective assessments requiring adjudication.
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
Not applicable. This is a medical device (valvulotome) and the described tests are for its mechanical and biological performance, not for an AI-based diagnostic or assistive system.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests would be the pre-defined engineering and safety specifications for each test. For example, for "Tensile testing of all bond joints," the ground truth would be a specific minimum tensile strength value established as acceptable. For "Efficacy cutting of in-vitro vein valves," the ground truth would be a successful and consistent cutting pattern without damage to the surrounding vessel, as defined by the test protocol.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not a machine learning model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 870.4885 External vein stripper.
(a)
Identification. An external vein stripper is an extravascular device used to remove a section of a vein.(b)
Classification. Class II (performance standards).