(23 days)
The disposable Vascular Probe is intended to be used during coronary and peripheral vascular surgery to probe blood vessels distally and proximally for blockages, to measure the internal diameter of vessels, and to act as an intravascular retractor.
The Vascular Probe is a sterile, single use, disposable device with a polyurethane coated streamline bulb on each end of a flexible polycarbonate or polycarbonate-polyurethane shaft. The bulbs are of different size on each end of the Vascular Probe. An appropriately-sized bulb is inserted either proximally or distally through the arteriotomy to probe the interior of the vessel and may be used by the surgeon to retract the vascular wall.
The Vascular Probe is packaged in a double sterile barrier. The contents of the unopened, undamaged container are sterile.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: Synovis Vascular Probe / Vascular Probe ES
Predicate Device: Synovis Life Technologies Inc. (previously doing business as Bio-Vascular, Inc.), Robicsek Probe/Retractor; 510(k) K910682
This submission focuses on a change in a component (new vinyl resin in the colorant of the polyurethane coating) of an already marketed device, rather than a completely new device. Therefore, the "study" described is primarily a series of verification and validation tests to ensure the new component does not negatively impact the pre-established safety and performance of the device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Biocompatibility | Device continues to be biocompatible for its intended use. | "The testing performed on the Vascular Probes demonstrated the devices continue to be biocompatible and safe for their intended use." |
| Mechanical Strength | Probes continue to meet the current Vascular Probe finished device specifications for tensile strength. | "Tensile strength testing was conducted on the Vascular Probes manufactured with the new vinyl resin and concluded that the Probes continue to meet the current Vascular Probe finished device specifications." |
| Material Safety | Remain safe for its intended use with the new vinyl resin. | Implicitly covered by biocompatibility and tensile strength testing. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The text does not specify the exact number of units or samples used for biocompatibility and tensile strength testing. It states "Testing conducted" and "Tensile strength testing was conducted on the Vascular Probes manufactured with the new vinyl resin."
- Data Provenance: Not explicitly stated, but assumed to be internal testing conducted by the manufacturer, Synovis Surgical Innovations. Given it's a 510(k) submission for a component change, the data would be prospective for the specific tests, as they were conducted to evaluate the impact of the new resin.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable (N/A). This submission is not a clinical study involving human assessment or interpretation for diagnostic accuracy. The "ground truth" for the tests performed (biocompatibility, tensile strength) is based on established scientific protocols and engineering standards, not expert clinical consensus on individual cases.
4. Adjudication Method for the Test Set
- Not applicable (N/A). As mentioned above, this is laboratory and bench testing, not a study requiring adjudication of clinical data or expert opinions. The results are objective measurements against predefined specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC study was NOT done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The Vascular Probe is an surgical instrument, not a diagnostic device of that nature.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
- No, a standalone algorithm performance study was NOT done. This is relevant for AI/ML-driven diagnostic devices. The Vascular Probe is a physical surgical tool.
7. The Type of Ground Truth Used
- Laboratory Standard / Engineering Specification:
- For Biocompatibility: Conformance to ISO 10993-1 (Biological Evaluation of medical devices – Part 1: Evaluation and testing within a risk management process).
- For Tensile Strength: Conformance to "current Vascular Probe finished device specifications."
8. The Sample Size for the Training Set
- Not applicable (N/A). This device does not involve algorithms or machine learning that would require a "training set." The tests are designed to verify material properties and biological compatibility.
9. How the Ground Truth for the Training Set Was Established
- Not applicable (N/A). See the answer to point 8.
§ 870.4475 Surgical vessel dilator.
(a)
Identification. A surgical vessel dilator is a device used to enlarge or calibrate a vessel.(b)
Classification. Class II (performance standards).