(157 days)
The AccuCath® Midline Catheter System is a midline catheter that is inserted into a patient's vascular system for short term use (
The AccuCath® Midline Catheter System has a usable length catheter of 3.1 inches in multiple Gauge sizes. The device(s) are single use, sterile intravascular catheters designed to be inserted into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids intravenously. This longer AccuCath® Midline is substantially equivalent functional characteristics and design to the predicates [Bard Access PowerGlide™ Device (K121073) and AccuCath® BC (K140504)]. The AccuCath® Midline catheter hub is identical in design to that of the AccuCath® BC's catheter's hub. including the built-in blood control septum. Additionally, the AccuCath® Midline, like the AccuCath® BC (K140504) predicate, consists of a radiopaque catheter with a blood control valve mechanism that is delivered over a guidewire with atraumatic coiled tip design; a notched needle to enhance flashback visualization, and a body / handle that serves as an integrated safety container to mitigate the risk of sharps injuries. The AccuCath® Midline is identical to the AccuCath BC® in that it features a septum that automatically activates to stop the blood flow in the catheter hub when the needle is removed from the catheter during initial insertion by the clinician. Blood flow from the catheter hub will be restricted immediately after the needle retraction until a secure male luer connection is made. The flow path will remain opened once a secure male luer connection has been made.
This document is a 510(k) summary for the AccuCath® Midline Catheter System, seeking substantial equivalence to existing predicate devices. It focuses on the device's design, intended use, and bench testing to demonstrate its safety and effectiveness.
Based on the provided text, there is NO study described that assesses the device's clinical performance in terms of acceptance criteria, such as accuracy, sensitivity, or specificity, which would be typical for an AI/algorithm-driven device. The document primarily discusses the device's physical and functional characteristics and bench testing against established standards for medical devices.
Therefore, I cannot provide the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance metrics for an AI device.
However, I can provide information based on the "Performance Data" section of the document, which focuses on bench testing and adherence to standards for medical devices.
Here's an analysis based on the provided document, focusing on the absence of information relevant to AI-driven device performance and the presence of information related to traditional medical device testing:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria and reported device performance in the context of an AI study (e.g., sensitivity, specificity, accuracy). Instead, it lists standards against which the device was tested. The "performance" mentioned refers to the device successfully meeting the requirements of these standards.
| Acceptance Criteria (from standards) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| ISO 10993-1:2009 (Biological Evaluation) | Demonstrated substantial equivalence to predicates in terms of safety and effectiveness. (Implies meeting biocompatibility requirements) |
| Packaging & Sterilization: | |
| ASTM D4169-09 (Performance Testing of Shipping Containers) | Met (Implied by "demonstrates substantial equivalence" and listing the standard) |
| ASTM F88/F88M-09 (Seal Strength) | Met (Implied) |
| ASTM F1929 (Detecting Seal Leaks) | Met (Implied) |
| ASTM F1980-07 (2011) (Accelerated Aging) | Met (Implied) |
| ISO 11607-1:2009 (Packaging for Terminally Sterilized Medical Devices) | Met (Implied) |
| Functional/Physical Characteristics: | |
| ISO 594-1:1986 (Conical Fittings, Luer) | Met (Implied) |
| ISO 594-2:1998 (Conical Fittings, Lock) | Met (Implied) |
| ISO 7864:1993 (Sterile Hypodermic Needles) | Met (Implied) |
| ISO 9626:1991 (Stainless Steel Needle Tubing) | Met (Implied) |
| ISO 10555-1:2013 (Intravascular Catheters - General) | Met (Implied) |
| ISO 10555-5:2013 (Intravascular Catheters - Over-Needle Peripheral) | Met (Implied) |
| Guidance Document No. 934 (Sharps Injury Prevention) | Met (Implied by device description of integrated safety container) |
Note: The document states "Biocompatibility and functional bench testing performed by Vascular Pathways, Inc. demonstrates the AccuCath® Midline Cather is substantial equivalence, in terms of the safety and effectiveness, to the referenced predicate devices." This implies that the device met the requirements of the listed standards, but specific numerical results are not provided.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable/not provided as the "performance data" refers to bench testing against engineering and material standards, not a clinical study on a patient test set for an AI/algorithm.
3. 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)
This information is not applicable/not provided. Ground truth in the context of expert review for diagnostic/AI performance is not relevant to the bench testing described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided. Adjudication methods are used for resolving disagreements in expert ground truth, which is not relevant to the bench testing described.
5. 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
This information is not applicable/not provided. No MRMC study or study involving human readers with or without AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. This device is a physical medical catheter, not an algorithm, so a standalone algorithm performance study is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable/not provided for the type of "performance data" presented. The "ground truth" for the bench testing would be the specifications and requirements defined by the referenced ASTM and ISO standards.
8. The sample size for the training set
This information is not applicable/not provided. This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable/not provided. Not an AI/ML algorithm.
In summary: The provided document is a 510(k) summary for a physical medical device, the AccuCath® Midline Catheter System. The "performance data" described pertains to standard bench testing and compliance with material, manufacturing, and design standards, not to the performance of an AI/algorithm-driven device or clinical outcomes. Therefore, most of the requested points, which are highly specific to AI/ML device evaluation, are not applicable to this document.
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).