(115 days)
The Recon™ Support Catheters are single lumen catheters intended to create a pathway for other devices in the peripheral vasculature.
The Recon™ Support Catheters are single lumen catheters with a standard luer fitting hub and separate detachable hemostatic valve to guide and provide support for the Crosser™ Ultrasonic CTO Device. The product hub identifies the BD logo and sheath profile (6F) on one side and on the opposite side, the product hub identifies the working length of catheter in centimeters (110 cm) and S for Straight and A for Angled, and T for Tapered. The Recon™ Support Catheters are available in angled and straight, tapered and non-tapered configurations in 110 cm working lengths. The Recon™ Support Catheter has a single radiopaque marker 1mm from the distal tip. The GeoAlign™ Marking System is a non-radiopague ruler on the catheter shaft referenced from the distal tip. The GeoAlign™ markings are designated on the catheter shaft by 1 cm increment bands with an accuracy within ±1 mm. The distance from the distal catheter tip is labeled in 10 cm increments. Thicker bands denote the midway point (5 cm) between the labeled distances. The GeoAlign™ Marking System is designed to be used as a tool to externally measure the intravascular advancement and/or retraction of the catheter. This can provide an intravascular reference reqarding the location of the catheter or an approximate intravascular length measurement between two points. The GeoAlign™ Marking System may also facilitate geographic alignment of an adjunctive therapy that includes the same GeoAlign™ Marking System. The GeoAlign™ Marking System provides an approximation that may not be an exact representation of the actual distance traveled intravascularly and should be confirmed under fluoroscopy. The GeoAlign™ Marking System includes non-radiopaque white markings and is designed to be utilized outside the sheath.
This document is a 510(k) summary for the Recon™ Support Catheter. It outlines the safety and effectiveness testing performed to demonstrate substantial equivalence to predicate devices (Sidekick™ & Usher™ Support Catheters).
Here's a breakdown of the requested information based on the provided text:
Important Note: The provided document is a 510(k) summary for a medical device (a support catheter), not an AI/ML powered device. Therefore, many of the questions related to AI/ML specific concepts (like multi-reader multi-case studies, expert consensus for ground truth on images, training sets, etc.) are not applicable to this type of traditional medical device submission. The performance testing is primarily in vitro (bench testing) and biocompatibility to ensure the physical and biological characteristics of the catheter are safe and effective.
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the Recon™ Support Catheter met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs. It further concludes that the device is "as safe, as effective, and performs as well as or better than the Sidekick™ and Usher™ Support Catheters."
While a specific table with numerical acceptance criteria and precise performance metrics for each test is not provided in this summary, the document lists the types of tests performed. For a traditional medical device, meeting the acceptance criteria means the device functioned within predetermined specifications, demonstrating equivalence to the predicate.
Below is a table of the types of tests performed to demonstrate that the device meets acceptance criteria. The "Reported Device Performance" column reflects the overall conclusion stated in the document regarding these tests.
| Test Category | Specific Tests Performed | Reported Device Performance |
|---|---|---|
| In Vitro Performance | Interventional Device Testing Equipment (IDTE) Track, Manual Track, Kink Diameter, Torsional Stiffness, Hemostasis Valve Leakage, Radiopacity, Hub to Shaft Tensile, Shaft Tensile, Leakage, Hub Positive Pressure Leak, Hub Stress Cracking, Hub Sub-Atmospheric Pressure Leak, Luer Resistance to Axial Separation, Luer Resistance to Unscrewing Torque, Luer Resistance to Thread Override, Particulate, Guidewire Compatibility, Sheath Compatibility, Crossing Device Trackability through Recon™ Catheter, Crossing Device Crossing Efficiency through Recon™ Catheter, Burst Strength, High Pressure Leak, Packaging Tests (pouch visual, bubble emission leak, pouch tensile). Leveraged from predicate K161986: GeoAlign™ Testing (Legibility, Durability, Compatibility, Dimensional Analysis). | "The Recon™ Support Catheter met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs." "The results from these tests demonstrate that the technological characteristics and performance criteria of the Recon™ Support Catheter is comparable to the predicate devices and that it can perform in a manner equivalent to devices currently on the market for the similar intended use." |
| Biocompatibility | Cytotoxicity, Intracutaneous Reactivity, Sensitization, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Hemolysis (Hemocompatibility), Complement Activation, Partial Thromboplastin Time (PTT), In Vivo Thromboresistance, Chemical Characterization (GC/LS/ICP). | "To demonstrate substantial equivalence of the subject device, the Recon™ Support Catheter, to the predicate device, biocompatibility tests were performed in accordance with ISO 10993-1:2018." "The Recon™ Support Catheter met all the predetermined acceptance criteria..." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the exact sample sizes used for each in vitro test. For this type of device, sample sizes are typically specified by the relevant ASTM/ISO standards or internal validation protocols for physical and mechanical tests.
- Data Provenance: The tests are in vitro (bench testing) and therefore do not involve patient data or geographical provenance in the way clinical studies for AI/ML devices would. These tests were conducted by the manufacturer, Bard Peripheral Vascular. The document implies these are prospective tests conducted specifically for this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable (N/A): This is a traditional medical device (catheter), not an AI/ML device that requires human expert review of images or data to establish 'ground truth' for algorithm performance. The ground truth for this device is established by physical measurement, chemical analysis, and adherence to engineering specifications and international standards (e.g., ISO for biocompatibility).
4. Adjudication Method for the Test Set
- N/A: As this is in vitro bench testing, there is no need for adjudication by multiple human readers. The results are typically quantitative measurements against predetermined specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- N/A: This type of study is specifically relevant to devices that assist human readers in interpreting medical images or data (e.g., AI for radiology). This device is a catheter, which is a physical tool used in a medical procedure, not an image analysis or diagnostic software.
6. Standalone (Algorithm Only) Performance
- N/A: This question pertains to AI/ML algorithms. This device is a physical catheter, not an algorithm.
7. Type of Ground Truth Used
- Ground Truth for Catheter: For the physical and mechanical tests, the ground truth is based on engineering specifications, established industry standards (e.g., ASTM, ISO), and performance of predicate devices. For biocompatibility, the ground truth is established by adherence to ISO 10993-1:2018 and the negative results from the battery of biological tests.
8. Sample Size for the Training Set
- N/A: This concept of a "training set" applies to machine learning models. The device under review is a physical medical device and does not involve machine learning.
9. How the Ground Truth for the Training Set Was Established
- N/A: As there is no training set for a machine learning model, this question is not applicable.
§ 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).