(92 days)
It is used for the treatment of vascular disorders, and more particularly for excising or disrupting venous valves.
The 1.5mm HYDRO Expandable LeMaitre Valvulotome is a self-centering and self-sizing valvulotome device used for cutting vein valves. The centering hoops keep the device centered in the vein. The size of the centering hoops and cutting blades adjust to the internal diameter of the vein as the valvulotome is being drawn through the vessel cutting the valves and rendering them ineffectual. The modifications to the predicate device - Expandable LeMaitre Valvulotome (ELV)- include the addition of hydrophilic coatings and co-extruded sheath to create 1.5mm HYDRO Expandable LeMaitre Valvulotome. The hydrophilic coatings provide increased lubricity and allow the device to navigating veins easier.
The provided document describes a 510(k) submission for the 1.5mm HYDRO Expandable LeMaitre Valvulotome. This is a medical device, and the submission focuses on demonstrating "substantial equivalence" to a predicate device, rather than proving performance against specific acceptance criteria in the way a new diagnostic or AI-driven device often does.
Therefore, the structure of the response will be tailored to the information provided in a 510(k) summary for a physical medical device. Many of the requested categories (like sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance of an algorithm, training set details) are not applicable to this type of submission because it's not a diagnostic or AI device.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For this device, the "acceptance criteria" are implied by meeting product performance specifications and not raising additional safety issues, as compared to its predicate device. Specific quantitative acceptance criteria with corresponding performance values are generally not provided in this type of 510(k) summary for functional device modifications. The tests performed are primarily engineering and bench tests, with a cadaver study, to show that the modified device functions similarly and safely.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Meet product performance specifications (general) | "meets the product performance specifications" |
| Modifications do not raise any additional safety issues | "modifications do not raise any additional safety issues" |
| Achieve intended use (excising/disrupting venous valves) | Demonstrated through Cadaver Study, functional testing. |
| Biocompatibility for blood contact | "is biocompatible" |
| Sterilization validated | "is validated for ethylene oxide (EO) sterilization" |
| Maintain fundamental scientific technology as predicate | "maintains the same intended use and fundamental scientific technology as the predicate device(s)" |
| Dimensional accuracy | "Dimensional Verification" completed |
| Durability/Reliability (e.g., fatigue) | "Fatigue Testing" completed |
| Fluid dynamics/Lubricity (hydrophilic coating benefit) | "Flushability" completed |
| Ease of use (insertion/removal) | "Force to insert and remove device" completed |
| Mechanism function (opening/closing) | "Force to open and close device" completed |
| Navigability in tortuous anatomy | "Tortuous Sheathing" completed |
| Functionality in a biological environment (cutting valves) | "Cadaver Study" completed |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated for specific tests (e.g., how many devices for dimensional, fatigue, force tests). For the Cadaver Study, the sample size is not specified.
- Data Provenance: Not specified. Standard practice for bench testing is typically done in a lab environment. Cadaver studies are usually conducted by the manufacturer or a contract research organization (CRO) in a controlled setting. No country of origin for the data is mentioned. The study is prospective for the device's performance given the modifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This concept is not applicable here as this is a physical device, not an AI or diagnostic device that requires expert-established ground truth on a dataset. The "ground truth" for a medical device's performance is typically established through engineering standards, functional tests, and in vivo/cadaver studies where success is defined by the device performing its intended mechanical function.
- For the cadaver study, it's implied that medical professionals (surgeons or similar) would have conducted or observed the study to assess functionality, but their number and specific qualifications are not detailed.
4. Adjudication method for the test set
- Not applicable in the context of an AI/diagnostic device's performance evaluation. For engineering tests, results are typically assessed against pre-defined engineering specifications. For the Cadaver Study, the "adjudication" would be whether the device successfully performed its function (cutting valves) and navigated the anatomy, likely assessed by the operating physician(s).
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 instrument, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical instrument, not an AI algorithm.
7. The type of ground truth used
- The "ground truth" for this device is based on functional performance metrics derived from engineering tests (e.g., force measurements, dimension checks, fatigue cycles) and observations from the cadaver study confirming the device's ability to navigate and effectively cut venous valves in a simulated biological environment. There is also biocompatibility testing against ISO 10993 guidelines.
8. The sample size for the training set
- Not applicable. This device does not use a "training set" in the context of machine learning or AI.
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).