(114 days)
HydroPICC is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to; the administration of fluids, medications, and nutrients; the sampling of blood; central venous pressure monitoring; and power injection of contrast media.
HydroPICC is rated for a Maximum Power Injection Flow Rate of 3.5mL/sec.
The HydroPICC is a peripherally inserted central catheter (PICC) intended for short or long-term use. The HydroPICC is a 4Fr, 55cm long catheter suitable for periodic access to the superior vena cava (SVC) while maintaining a reduced level of thrombus accumulation. HydroPICC is supplied in a kit with the necessary accessories to insert and maintain the catheter.
This document is a 510(k) K193015 Premarket Notification for the HydroPICC (Model 142) intravascular catheter, asserting its substantial equivalence to a previously cleared predicate device, HydroPICC (Model 141, K172885).
The submission focuses heavily on demonstrating equivalence and does NOT include a study involving AI assistance for human readers, nor a standalone AI algorithm performance study. Therefore, most of the requested information regarding AI study design, ground truth establishment for AI, expert involvement, and MRMC studies is not present in this document.
The document describes performance testing for a medical device (intravascular catheter), not an AI algorithm. The acceptance criteria and performance data described relate to physical and mechanical properties of the catheter, as distinct from the performance metrics (e.g., sensitivity, specificity, AUC) typically associated with AI/ML medical devices.
Here's the breakdown of the information that CAN be extracted, followed by a clear statement of what is NOT in the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "The subject devices met all predetermined acceptance criteria derived from the applicable guidance documents, standards and in-house protocols," but it does not provide a specific table with numerical acceptance criteria and reported performance values. Instead, it lists the types of tests performed and the standards followed.
| Test Category | Specific Tests Performed | Acceptance Criteria (Not explicitly quantified in text, stated as "met all predetermined criteria") | Reported Device Performance (Not explicitly quantified in text, stated as "met all predetermined criteria") |
|---|---|---|---|
| Mechanical & Performance Testing | Power Injection Flow Rate | Derived from standards/internal protocols | Successful/Compliant (implied) |
| Static Burst Strength | Derived from standards/internal protocols | Successful/Compliant (implied) | |
| Multiple Power Injections | Derived from standards/internal protocols | Successful/Compliant (implied) | |
| Catheter Length | Derived from standards/internal protocols | Successful/Compliant (implied) | |
| Dimensional Verification (including ID, OD, Length) | Derived from standards/internal protocols | Successful/Compliant (implied) | |
| Catheter Kink/Flex Resistance | Derived from standards/internal protocols | Successful/Compliant (implied) | |
| Tensile Testing (of Catheter and Assembly) | Derived from standards/internal protocols | Successful/Compliant (implied) | |
| Particulate testing | Derived from standards/internal protocols | Successful/Compliant (implied) | |
| Shelf life testing | Derived from standards/internal protocols | Successful/Compliant (implied) | |
| Sterility testing | Derived from standards/internal protocols | Successful/Compliant (implied) | |
| Packaging distribution testing | Derived from standards/internal protocols | Successful/Compliant (implied) | |
| MR Compatibility testing | Derived from standards/internal protocols | Successful/Compliant (implies HydroPICC-142 is labeled with MRI Safety Information, unlike predicate) | |
| Evaluation of Humectant change on Thrombus accumulation compared to predicate (internal specifications) | Derived from standards/internal protocols | Successful/Compliant (implied) | |
| Biocompatibility Testing | Risk assessment evaluation that the proposed modifications did not impact biocompatibility | Derived from standards/internal protocols | Successful/Compliant (implied) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set for each individual test. It merely states that "The subject devices met all predetermined acceptance criteria." The provenance of the data (e.g., country of origin, retrospective/prospective) is not mentioned for this engineering/performance testing.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This document describes the testing of a medical device (catheter), not the performance of an AI algorithm based on expert-labeled data.
4. Adjudication Method for the Test Set
Not applicable. This is for medical device performance (physical, mechanical, safety), not for AI algorithm evaluation requiring expert consensus/adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done because this submission is not for an AI/ML medical device and does not involve human readers interpreting images with or without AI assistance.
6. Standalone Algorithm Performance
No standalone algorithm performance study was done relevant to AI/ML, as this is not an AI/ML device.
7. Type of Ground Truth Used
The "ground truth" for this device's performance testing is established by engineering standards and specifications (e.g., ISO, ASTM standards, FDA guidance documents, and internal protocols) for physical and mechanical properties, not expert consensus on medical images, pathology, or outcomes data in the context of an AI study.
8. Sample Size for the Training Set
Not applicable. This document describes testing for a manufactured medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reason as point 8.
Summary of what is NOT in the document regarding acceptance criteria and studies for an AI/ML device:
The provided document is a 510(k) premarket notification for a physical medical device (intravascular catheter). It details the substantial equivalence to a predicate device and describes the various engineering and performance tests conducted to ensure the device meets safety and performance standards. It does not contain any information about an AI/ML device, its acceptance criteria, expert consensus, ground truth establishment, or any studies related to its performance (standalone or human-in-the-loop). Therefore, the specific requirements of the prompt regarding AI are not addressed by this document.
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”