(140 days)
The AccuCath BC Intravascular Catheter System is inserted into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids intravenously. This device may be used with consideration given to adequacy of vascular anatomy, appropriateness of the solution being infused, and duration of therapy. The AccuCath BC is suitable for use with low pressure power injectors having a maximum pressure setting of 300 psi and maximum flow rate of 6mL/second.
The AccuCath BC Intravascular Catheter System has a usable length catheter of 2.25 inches in 18, 20 and 22 Gauge sizes. The devices 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 BC catheter is identical to the AccuCath with the addition of needle echogenicity and a septum with plunger integrated into the catheter hub. The AccuCath BC catheter's hub has a built in blood control septum. The blood control feature is a single-use 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 luer connection is made. The flow path is permanently opened once a secure luer connection has been made. Similar to the original AccuCath system, the device is provided with a safety mechanism which allows the needle to be shielded following placement of the catheter. All devices have the basic structure of a protective cover, a catheter with a bier lock fitting, an echogenic needle connected to a flashback chamber, a safety container, a guide wire within the lumen of the needle which is connected to a slider and a spring and release button.
The provided text is a 510(k) summary for a medical device called the "AccuCath BC Intravascular Catheter System." This type of document focuses on demonstrating substantial equivalence to a predicate device through performance testing, rather than establishing acceptance criteria and conducting a study to prove the device meets them in the way clinical trials for new drugs or de novo medical devices would.
Therefore, the information requested in your prompt regarding acceptance criteria, specific study design, sample sizes for training/test sets, expert qualifications, and ground truth establishment is not directly available in the provided text. The document describes a performance testing approach against recognized standards and predicate devices rather than a standalone clinical study to meet specific performance metrics.
However, I can extract the relevant information about the performance testing conducted and present it in a modified format that aligns with your request where possible.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical performance metrics for the device itself (e.g., accuracy, sensitivity). Instead, the device is deemed to meet acceptance criteria by demonstrating compliance with a series of international and ASTM standards and showing substantial equivalence to predicate devices. The "reported device performance" in this context refers to the successful demonstration of compliance with these standards and the assertion of substantial equivalence.
| Acceptance Criteria (Implied by Standards Compliance and Equivalence) | Reported Device Performance |
|---|---|
| Biocompatibility: Device materials are safe for biological contact. | Complies with ISO 10993-1:2009 (Biological Evaluation of Medical Devices- Part I: Evaluation and Testing). |
| General Catheter Requirements: Meets fundamental design and safety requirements for intravascular catheters. | Complies with ISO 10555-1:1995 (Sterile, Single Use intravascular Catheters - Part 1: General Requirements). |
| Over-Needle Peripheral Catheter Requirements: Specific standards for this type of catheter. | Complies with ISO 10555-5:2012 (Sterile, Single Use Intravascular Catheters - Part 5: Over-Needle Peripheral Catheters). |
| Luer Fittings: Ensures proper connection with standard medical equipment. | Complies with ISO 594-1:1986 and ISO 594-2:1998 (Conical Fittings with a 6% (Luer) Taper for Syringes, Needles and Certain Other Equipment). |
| Radiopacity: Ability to be visualized under X-ray. | Complies with ASTM F640:2012 (Std Test Methods for Determining Radiopacity for Medical Use). |
| Packaging Integrity and Sterilization: Maintains sterility and device integrity during storage and transport. | Complies with ISO 11607-1:2006, ISO 11607-2:2006, ASTM D4169-09, ASTM F2096-11, ASTM F88/F88M-09, ASTM F1980-07 (2011), and AAMI TIR16:2000. |
| Sharps Injury Prevention: Incorporates features to prevent needle-stick injuries. | Complies with Guidance Document No. 934 - Medical Devices with sharps injury prevention features (August 9, 2005). |
| Substantial Equivalence: Similar in safety and effectiveness to legally marketed predicate devices. | "Biocompatibility and functional bench testing performed by Vascular Pathways, Inc. demonstrate the substantial equivalence, in terms of the safety and effectiveness, of the AccuCath BC Intravascular Catheter System to the predicate devices cited." |
| Power Injection Compatibility: Safe for use with specified power injectors. | Demonstrated capability for "use with low pressure power injectors having a maximum pressure setting of 300 psi and maximum flow rate of 6mL/second." This was based on adding power injection to the previously cleared Rapid Intravascular Catheter Start System indication, consistent with the Ethicon PROTECTIV* ACUVANCE IV Catheter System (K012128). |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document refers to "functional bench testing" and "in vitro bench testing," but does not provide numbers of devices or test repetitions for these experimental setups.
- Data Provenance: The testing was "performed by Vascular Pathways, Inc." The data is likely from retrospective bench testing against established standards, specifically designed to demonstrate compliance for regulatory submission. It is not clinical data from a specific country of origin in the way a clinical trial would generate.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
This type of information is not applicable to the presented study. The document describes engineering and materials testing against defined standards (e.g., ISO, ASTM) and comparison to predicate devices, not a study requiring expert consensus on a clinical test set or ground truth in the context of diagnostic interpretation.
4. Adjudication Method for the Test Set
This is not applicable. There was no "test set" requiring adjudication in the sense of expert review for diagnostic accuracy or clinical outcomes. The performance was assessed against predefined standard specifications and functional requirements.
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 is not applicable. The device is an intravascular catheter, not an AI-powered diagnostic system. No MRMC study was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical medical instrument, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation is based on:
- International and National Standards: Compliance with ISO and ASTM standards (e.g., for sterility, biocompatibility, material properties, Luer taper, radiopacity, packaging).
- Predicate Device Performance: The functional performance, safety, and effectiveness of the AccuCath BC are demonstrated to be "substantially equivalent" to already legally marketed predicate devices. This implicitly means the predicate devices' accepted performance serves as a benchmark or "ground truth."
- Design Input Requirements: The testing confirmed that "the output of the design process met all design input requirements." These requirements serve as an internal "ground truth" for the device's intended function.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" in the context of this device's evaluation, as it's not an AI/ML product.
9. How the Ground Truth for the Training Set was Established
This is not applicable. As there is no training set, there is no ground truth established for one.
§ 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).