(38 days)
The Vascular Pathways RIVS system is indicated for use to sample blood, monitor blood pressure, or administer fluids intravenously. This device may be used with consideration given to patient size, appropriateness of the solution being infused, and duration of therapy.
The RIVS 18, 20 and 22 Gauge devices are single use, sterile intravascular catheters designed to provide access to veins. The devices are 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 luer lock fitting, a 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.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the "Rapid Intravascular Catheter Start System," based on the user's requested format.
It's important to note that the provided text is a 510(k) summary, which generally focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive clinical study data with detailed acceptance criteria and performance metrics typically found in a full clinical trial report or a PMA submission. Therefore, some of the requested information may not be explicitly present or might be inferable only to a limited extent.
Acceptance Criteria and Study Details for the Rapid Intravascular Catheter Start System
The provided 510(k) summary for the Rapid Intravascular Catheter Start System (RIVS) focuses on demonstrating substantial equivalence to a predicate device (K073241 - Vascular Pathways, Inc., Rapid Intravascular Catheter Start System) for modified and new gauge devices. As such, the "acceptance criteria" discussed are primarily related to ensuring the modified devices maintain the same performance and safety characteristics as the predicate, rather than establishing de novo clinical performance thresholds. The "study" refers to verification and validation testing to confirm these aspects.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance results in the format requested. Instead, it makes a general statement about meeting design specifications and user needs. The core acceptance criterion for this 510(k) modification is demonstrating substantial equivalence to the predicate device in terms of design, performance, safety, and intended use.
| Acceptance Criteria Category (Inferred from 510(k) context) | Reported Device Performance (Summary Statements) |
|---|---|
| Intended Use (Maintain existing indications) | "The modified RIVS, two new gauge devices and the predicate device have the same intended use..." |
| Operating Principles (Comparable mechanism) | "The products share common features such as identical operating principles, basic design..." |
| Basic Design (Similar structure) | "The products share common features such as identical operating principles, basic design..." |
| Performance Characteristics (Maintain functional equivalence) | "Verification and validation testing provided proof the modifications met the design specifications and user needs..." |
| Safety (No new safety concerns) | "...biocompatibility testing provided evidence there were no changes to that safety aspect of the device." |
| "There are no new issues raised regarding safety or effectiveness of the modified or additional gauge devices." | |
| Physical Characteristics (Maintain physical attributes) | "...and physical characteristics." |
| Anatomical Site for Venous Access (Same application) | "...anatomical site for venous access..." |
| Sterility & Single Use (Maintain existing characteristics) | "The devices are packaged sterile and are for single patient use." |
| Biocompatibility (No adverse changes) | "...biocompatibility testing provided evidence there were no changes to that safety aspect of the device." |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "Verification and validation testing" was conducted. However, it does not specify the sample sizes used for these tests. The provenance of the data (e.g., country of origin, retrospective or prospective) is also not mentioned. Given the nature of a 510(k) for an intravascular catheter, these tests would typically be benchtop (in-vitro) and potentially simulated use tests, rather than human clinical trials.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This submission is for a medical device (intravascular catheter) and focuses on the physical and functional performance of the device itself, not on diagnostic accuracy requiring expert interpretation or "ground truth" establishment in the context of imaging or diagnostic AI. The "ground truth" here would be defined by engineering specifications and objective measurements from the verification and validation (V&V) testing.
4. Adjudication Method for the Test Set
Not applicable. As the "ground truth" is defined by engineering specifications and objective measurements, there's no need for expert adjudication in the typical sense (e.g., 2+1, 3+1 consensus). The V&V testing would involve comparing device performance against predetermined specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices (e.g., imaging AI) to assess how human reader performance is impacted by AI assistance. The RIVS is an intravascular catheter, a therapeutic/access device, and thus an MRMC study is not relevant to its regulatory submission.
6. Standalone (Algorithm Only) Performance
Not applicable. The RIVS is a physical medical device, not an algorithm or AI system. Therefore, the concept of "standalone algorithm only performance" does not apply. The performance evaluated relates to the physical and functional attributes of the catheter itself.
7. Type of Ground Truth Used
The "ground truth" for the verification and validation testing would be the established design specifications and user needs (as stated in the document). This would involve engineering standards, material specifications, functional requirements (e.g., flow rates, material strength, ease of insertion, needle shielding mechanism effectiveness), and biocompatibility standards.
8. Sample Size for the Training Set
Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI development. The device design and manufacturing processes are developed through engineering and R&D, not through training on data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. Since there is no training set, the establishment of its ground truth is irrelevant.
§ 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).