(47 days)
The ADROIT™ Guiding Catheter is intended for use for intravascular introduction of interventional / diagnostic devices into the coronary or peripheral vascular systems.
The 5F ADROIT™ Guiding Catheter features a 5F outer diameter, with a single through lumen of 0.058". The catheter body is reinforced with tightly wound stainless steel braid wire. The catheter body transitions to progressively lower durometers from the body to the distal tip, providing a gradual decrease in stiffness. The lumen is accessed via a polycarbonate luer hub. The 5F ADROIT™ Catheter is offered in an overall length of 100cm. A broad range of tip shapes are offered for specific procedures.
This document is a 510(k) premarket notification for the ADROIT™ Guiding Catheter. The purpose of this notification is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device. This type of submission does not typically include a full clinical study with acceptance criteria and device performance in the way machine learning or diagnostic devices might. Instead, the focus is on engineering and performance testing to show equivalence to a predicate.
Based on the provided document, here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a quantitative format for each test. Instead, it states that "Bench testing confirms that the 5F ADROIT™ Guiding Catheter can be used according to its intended use and in an equivalent manner to the predicate device." This implies that the performance of the ADROIT™ Guiding Catheter met or was comparable to the predicate device for each test.
| Test Performed | Reported Device Performance |
|---|---|
| Catheter ID | Confirmed to be usable according to intended use and equivalent to predicate. |
| Body and Tip Seal Strength | Confirmed to be usable according to intended use and equivalent to predicate. |
| Hydrostatic Pressure | Confirmed to be usable according to intended use and equivalent to predicate. |
| Hub Aspiration | Confirmed to be usable according to intended use and equivalent to predicate. |
| CSI Compatibility | Confirmed to be usable according to intended use and equivalent to predicate. |
| Kink Radius | Confirmed to be usable according to intended use and equivalent to predicate. |
| I-Torque | Confirmed to be usable according to intended use and equivalent to predicate. |
| Flexibility/3-Point Bend | Confirmed to be usable according to intended use and equivalent to predicate. |
| U-Torque | Confirmed to be usable according to intended use and equivalent to predicate. |
| Backup Support | Confirmed to be usable according to intended use and equivalent to predicate. |
2. Sample Size Used for the Test Set and Data Provenance
This document describes bench testing, meaning the tests were performed on the device itself (hardware) rather than clinical data from patients. Therefore, terms like "test set" or "data provenance" related to patient data are not applicable in this context. The sample size would refer to the number of physical catheters tested for each performance characteristic. This specific number is not provided in the document.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
This type of information is not applicable as the evaluation is based on objective physical and mechanical properties of the device, not on expert interpretation of data or images.
4. Adjudication Method for the Test Set
This is not applicable as the testing involves objective measurements of device performance, not subjective assessment requiring adjudication.
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 or AI-assisted devices where human reader performance is being evaluated. This submission is for a physical medical device (guiding catheter).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done
No, a standalone algorithm study was not done. This is not an algorithm-based device.
7. The Type of Ground Truth Used
The "ground truth" for this type of device is established by engineering and performance specifications and standards for medical catheters. These include physical dimensions, material properties, and mechanical performance characteristics (e.g., strength, flexibility, torque). The predicate device's established performance serves as a benchmark for substantial equivalence.
8. The Sample Size for the Training Set
This is not applicable as this is not a machine learning device. The "training set" concept is irrelevant here.
9. How the Ground Truth for the Training Set was Established
This is not applicable as this is not a machine learning device.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).