(177 days)
Indicated for short-or long-term peripheral access to the central venous 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.
Rated for maximum power injection flow rate of 3.5ml/s
The HydroPICC peripherally inserted central catheter (PICC) is a 5 French, dual lumen catheter comprised of a radiopaque hydrophilic catheter material with a suture wing, Luer lock hubs, and extension tubes made from materials commonly used in the manufacture of catheters are provided packaged in kit configurations with the appropriate accessories for placement in the appropriate clinical environments. The maximum power injection flow rate for each lumen is indicated on each extension tube clamp.
HydroPICC has been shown to be effective in reducing thrombus accumulation. Reduction of thrombus accumulation was evaluated using in vivo models. Pre-clinical in vitro and in vivo evaluations do not necessarily predict clinical performance with respect to thrombus formation.
This document is a 510(k) summary for the HydroPICC 5F Dual Lumen Catheter. It indicates that the device has undergone performance testing to demonstrate substantial equivalence to a predicate device. However, the document does not contain details about acceptance criteria, reported device performance, sample sizes for test or training sets, data provenance, number or qualifications of experts, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance.
The provided text focuses on the physical and technological characteristics of the medical device and its predicate, along with the regulatory and biocompatibility testing performed to establish substantial equivalence. It does not describe an AI/ML device or its performance study in the way the request specifies.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's the breakdown of what can be extracted:
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A table of acceptance criteria and the reported device performance: Not available in the provided text. The document refers to conformance with recognized standards but does not list specific acceptance criteria or performance metrics for the device in a study context.
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Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not available in the provided text.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not available in the provided text.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not available in the provided text.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not available in the provided text. This device is not an AI/ML product.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not available in the provided text. This device is not an AI/ML product.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not available in the provided text. For the type of device (intravascular catheter), "ground truth" would typically refer to physical and mechanical properties, not diagnostic categories.
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The sample size for the training set: Not available in the provided text. This device is not an AI/ML product.
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How the ground truth for the training set was established: Not available in the provided text. This device is not an AI/ML product.
What can be extracted from the document regarding "performance testing" related to the device:
The document lists various performance tests conducted to demonstrate conformance with FDA-recognized standards for intravascular catheters. These tests are primarily focused on the physical, mechanical, and safety aspects of the catheter, rather than diagnostic or AI-driven performance.
| Acceptance Criteria (Implied by Standard Conformance) | Reported Device Performance (Implied by "Conformance") |
|---|---|
| Conformance to General Requirements for Intravascular Catheters (EN ISO 10555-1:2013) | "tested and demonstrated to be in conformance" with this standard, indicating it meets general safety and performance requirements for intravascular catheters (e.g., freedom from defects, integrity of fluid pathways, connection security, etc.). |
| Conformance for Central Venous Catheters (EN ISO 10555-3:2013) | "tested and demonstrated to be in conformance" with this standard, indicating it meets specific requirements for central venous catheters. |
| Kinking resistance for Single Lumen Catheters and Medical Tubing (EN ISO 13868:2014) | "tested and demonstrated to be in conformance" with this standard, indicating it resists kinking to an acceptable degree. |
| MRI Safety: Magnetically Induced Displacement Force (ASTM F2052:2015) | "tested and demonstrated to be in conformance", confirming acceptable displacement force in an MRI environment. The device is stated to be "MRI Conditional." |
| MRI Safety: Radio Frequency Induced Heating (ASTM F2182: 2011) | "tested and demonstrated to be in conformance", confirming acceptable RF-induced heating in an MRI environment. The device is stated to be "MRI Conditional." |
| MRI Safety: Magnetically Induced Torque (ASTM F2213: 2017) | "tested and demonstrated to be in conformance", confirming acceptable magnetically induced torque in an MRI environment. The device is stated to be "MRI Conditional." |
| MRI Safety: Evaluation of MR Image Artifacts (ASTM F2119: 2013) | "tested and demonstrated to be in conformance", confirming acceptable levels of image artifacts from the device in an MRI environment. The device is stated to be "MRI Conditional." |
| Biocompatibility (ISO 10993-1, FDA Guidance "Use of International Standard ISO 10993-1") | "evaluation of the HydroPICC in accordance with ISO 10993-1 and FDA Guidance," covering direct blood path (catheter body) for >30 days and external contact (Luer lock hub, polyurethane extension tubing, suture wing) for >30 days, implying acceptable biocompatibility. The text also states, "HydroPICC has been shown to be effective in reducing thrombus accumulation. Reduction of thrombus accumulation was evaluated using in vivo models." (Pre-clinical, in vitro, and in vivo evaluations do not necessarily predict clinical performance with respect to thrombus formation - this is an important caveat). |
| Sterility Assurance Level (ISO 11135-1, AAMI TIR28:2016) | "Sterility Assurance Level (SAL) of 10-6 via a validated overkill Ethylene Oxide (EO) method." This meets requirements of ISO 11135-1 as determined through AAMI TIR28:2016. |
| Package Integrity (ISTA 3A:2016, ASTM D4169) | Package integrity testing, after environmental conditioning and simulated transportation, "complies to ISTA 3A:2016... and ASTM D4169," demonstrating protection of product and sterility maintenance. |
| Labeling Conformance (ISO 15223-1:2016) | "All labeling was evaluated according to ISO 15223-1:2016... and the subject device was determined to have the appropriate labeling." |
| Sterile Barrier Packaging Testing (ASTM F88/F88-15, ASTM F20965) | "complies to Seal strength ASTM F88/F88-15 and Detecting Gross Leaks ASTM F20965." |
| Shelf Life Validation (ASTM F1980-16) | "Shelf life 13 months is validated using the FDA recognized standard ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices." |
Study Details (as much as can be inferred/is stated):
- Sample Size, Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth (for diagnostic AI/ML): Not applicable or not provided. The study mentioned for "reducing thrombus accumulation" used "in vivo models," but specific details like sample size, provenance, control groups, or exact endpoints are not given.
- Training Set Sample Size/Ground Truth: Not applicable for this type of medical device submission.
§ 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.”