(238 days)
The UNI*FUSE™ Infusion System with Cooper Wire is intended for the administration of fluids, including thrombolytic agents and contrast media, into the peripheral and pulmonary artery vasculature.
The proposed UNI*FUSE™ Infusion System with Cooper Wire devices are single-lumen, nylon catheters with longitudinal slits located at 90° intervals around the distal end of the catheter for fluid delivery. An occluding ball wire (or occlusion guidewire) provides end-hole occlusion during fluid delivery. The catheters are available in 4F and 5F diameters and overall lengths of 90cm and 135cm. Additionally, they are available in multiple infusion segment lengths, including 2cm and 5cm lengths. The active infusion area can be identified under imaging by means of radiopaque markers on the catheter shaft at the distal and proximal ends of the infusion segment.
This document is a 510(k) Summary for a medical device called the UNI*FUSE™ Infusion System with Cooper Wire. It demonstrates the substantial equivalence of the proposed device to a predicate device, which is a common pathway for FDA clearance for Class II medical devices.
The information provided does not describe an acceptance criteria table or a study that proves the device meets specific performance criteria in the way typically seen for a novel or AI-powered diagnostic device. Instead, it focuses on demonstrating substantial equivalence to a previously cleared device. This means the manufacturer is showing that their modified device is as safe and effective as a legally marketed predicate device, rather than proving performance against pre-defined quantitative acceptance criteria through a specific clinical study with human readers and ground truth, as would be the case for an AI/ML medical device.
The "studies" described here are related to proving the safety and effective use of the device when its intended use is expanded (specifically, to include the pulmonary artery vasculature). This is achieved through:
- Comparison to a Predicate Device: Showing that the modified device has substantially equivalent technological characteristics and performance to a legally marketed predicate device.
- Bench Testing and Human Factors Study: Verifying that the device can navigate, be placed, and function as intended in the newly added anatomical location (pulmonary artery).
- Clinical Literature Review: Evaluating existing literature to demonstrate that the expanded indication (use in the pulmonary artery) does not introduce new risks or increase existing risks compared to other anatomical locations or other types of catheters.
Therefore, providing a table of acceptance criteria and reported device performance in the context of an AI/ML study, as requested in the prompt, is not directly applicable to this document. The "performance" being evaluated here is related to the physical and functional aspects of a catheter and its safe deployment, not the diagnostic accuracy of an algorithm.
However, I can interpret the request in the spirit of the prompt by extracting the closest analogous information to "acceptance criteria" and "study results" as presented in this 510(k) summary:
Interpretation for a Non-AI Device Substantial Equivalence (as per the provided document):
The acceptance criteria for this device are not framed as quantitative metrics for diagnostic output (like sensitivity, specificity for an AI model) but rather as qualitative demonstrations of safety and efficacy compared to a predicate device and for the expanded indication. The "study" described is a combination of:
- Comparative Assessment: Against a predicate device (Bashir™ N-X Endovascular Catheter Model 7200, K183290) and a reference device (PULSESPRAY™ and UNIFUSE™ Infusion Catheters, K163356).
- Human Factors Study & Bench Testing: To support the expanded indication to the pulmonary artery.
- Clinical Literature Review: To support the safety profile for the expanded indication.
1. Table of "Acceptance Criteria" (interpreted as aspects needing demonstration of substantial equivalence or safety/efficacy for new indication) and "Reported Device Performance" (interpreted as the outcome of the comparative assessment or studies):
| Aspect of Evaluation (Analogous to Acceptance Criteria) | Reported Device Performance / Conclusion from Study |
|---|---|
| I. Substantial Equivalence to Predicate Device (K183290) | |
| ProCode, Regulation Number, Regulation Name, Regulatory Class | Identical to predicate device. |
| Indications for Use / Intended Use | Substantially Equivalent to predicate. Both are for administration of fluids into peripheral and pulmonary artery vasculature. (Predicate: "controlled and selective infusion of physician-specified fluids"; Proposed: "administration of fluids, including thrombolytic agents and contrast media"). |
| Operating Principle, Mechanism of Action, Patient Populations | Same as predicate device. |
| Overall Design (General features) | Both are single-lumen nylon catheters with longitudinal slits and an occluding ball wire. |
| Catheter Diameter (F) | Proposed: 4F, 5F. Predicate: 7F. Substantially Equivalent (Acknowledged difference in specific dimensions, but overall function is similar). |
| Catheter Length (cm) | Proposed: 90cm, 135cm. Predicate: 92.5cm. Substantially Equivalent. |
| Catheter Infusion Segment Length (cm) | Proposed: 2cm, 5cm. Predicate: 12.5cm. Substantially Equivalent. |
| Materials | Both use commonly used, biocompatible materials per ISO 10993-1. Substantially Equivalent. |
| Performance Testing (Functional equivalence of tests) | Batteries of testing for proposed and predicate device are not 1:1 identical but are substantially equivalent in that they fully test the functions of each device (e.g., flow rate, pressure, compatibility, durability, kink resistance). |
| II. Support for Expanded Indication (Pulmonary Artery Vasculature) | |
| Ability to Navigate and Use in Pulmonary Artery | Human Factors Study & In-House Bench Test: Demonstrated ability to navigate-to and use within the pulmonary artery vasculature. |
| Visibility under Imaging (Fluoroscopy) | Human Factors Study & In-House Bench Test: Infusion segments are clearly imaged under fluoroscopy, confirming position within pulmonary artery. |
| Adequacy of Directions for Use (DFU) | Human Factors Study: DFU provides adequately detailed instructions for accurate and reliable placement and use in pulmonary artery. |
| Risk Profile in Pulmonary Artery vs. Other Vessels | Clinical Literature Evaluation: No evidence indicating pulmonary artery is more prone to damage than other vessels for this application. Proposed Indications for Use do not increase existing risks or introduce new risks. Catheters with mechanical components may have greater risk of vessel damage compared to non-mechanical infusion catheters. The UNIFUSE™ is smaller than some other larger catheter types, suggesting a "worst-case scenario" for intrusiveness and potential damage is less with UNIFUSE™. The clinical literature supports catheter-directed therapy in the pulmonary artery vasculature as having high success rates and complications not including vessel injury/damage. |
2. Sample Size and Data Provenance:
- Test Set (for Human Factors Study): "multiple practicing physicians" (specific number not given)
- Data Provenance: The human factors study involved "simulated-use vascular model" and practicing physicians. The clinical literature review uses publicly available articles, presumably from global or diverse sources, but the document does not specify country of origin for the underlying patient data. The studies are described as both retrospective and prospective in the text (e.g., Kuo, W. et al. – 2009 for clinical literature review).
3. Number of Experts and Qualifications:
- Human Factors Study: "multiple practicing physicians experienced in the use and placement of infusion catheters." (Specific number and detailed qualifications/experience not specified beyond "practicing physicians"). These experts essentially acted as the "readers" evaluating the device's usability in the simulated environment.
- Clinical Literature Review: No specific experts were used to establish "ground truth" here; rather, the company (Angiodynamics, Inc.) performed the literature review to support their conclusions on safety.
4. Adjudication Method for Test Set:
- Human Factors Study: Not explicitly stated. The study aimed to demonstrate usability and navigability. It's implied that the observations from the "multiple practicing physicians" were collectively assessed to reach the stated conclusions about navigability, imaging clarity, and DFU adequacy. It was not a comparative diagnostic reading study.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
- No, not applicable. This is a physical medical device (catheter), not an AI/ML diagnostic algorithm. There was no MRMC study to compare human readers with and without AI assistance, as AI is not a component of this device.
6. Standalone (Algorithm Only) Performance:
- Not applicable. This is a physical medical device. No algorithm is being assessed.
7. Type of Ground Truth Used:
- Human Factors Study & Bench Testing: The "ground truth" was established by the physical and simulated performance of the device itself (e.g., was it navigable, was it visible under fluoroscopy, could fluids be administered successfully). This is a functional and usability "ground truth."
- Clinical Literature Review: The ground truth was based on the published findings and conclusions of peer-reviewed medical literature concerning catheter-directed interventions in the pulmonary artery, particularly regarding complications and safety.
8. Sample Size for Training Set:
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How Ground Truth for Training Set was Established:
- Not applicable. No training set for an AI/ML algorithm was used.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).