(30 days)
The NovaCath™ Secure IV Catheter System 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 intravascularly. The needle-shielding feature aids in the prevention of needlestick injuries. Upon catheter insertion, blood is contained within the device to aid in the prevention of blood exposure. The NovaCath™ device may be utilized in any patient population with consideration given to vascular anatomy and appropriateness of procedure. The 18, 20, and 22 gauge NovaCath™ devices are suitable for use with power injectors for a maximum of 300psi.
The NovaCath™ Secure IV Catheter System is a short-term, therapeutic, IV catheter. The NovaCath™ currently has four commercially available models. This special 510(k) adds two additional models of different catheter lengths to the existing gauge size portfolio. Two (2) additional models: 20G with 1.25" Catheter Length and 24G with 0.56" Catheter Length are being added to the existing four (4) models cleared in K120839: 18G with 1.25" Catheter Length, 20G with 1.00" Catheter Length, 22G with 1.00" Catheter Length, and 24G with 0.75" Catheter Length.
The NovaCath™ Secure IV Catheter System is comprised of an over-the-needle, radiopaque intravascular catheter, integrated extension tubing with a secondary stabilization hub, a female luer lock and clamp, and a passive safety needle shielding mechanism. The design of the NovaCath™ Secure IV Catheter System is considered a closed system since it protects users from blood exposure during the catheter insertion procedure. Blood is contained within the device after needle withdrawl by a self-sealing septum and luer lock, which is provided with a one-time use vent plug. The clamp on the extension tubing is provided to eliminate blood exposure when the vent plug is replaced with an infusion set connection or other end cap.
The document describes the NovaCath™ Secure IV Catheter System, and this submission is a "Special 510(k): Device Modification" to add two new models (20G x 1.25" and 24G x 0.56" catheters) to an existing cleared device (K120839). Therefore, the study focuses on demonstrating that these new models perform substantially equivalently to the predicate device and meet relevant performance standards.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" against "reported device performance" in the typical format of a clinical study or performance goals. Instead, it details specific tests performed for the modified devices and the consensus standards they adhere to. The "reported device performance" is implied by the successful completion of these tests.
| Acceptance Criteria (Proxy) / Test Performed | Reported Device Performance (Implied) | Relevant Standard |
|---|---|---|
| 20G x 1.25" Catheter (New Model) | ||
| Power Injection Test for Flow Rate and Device Pressure (up to 300 psi) | Device performs acceptably under power injection conditions and meets flow rate/pressure requirements. | ISO 10555-1:2013 |
| Flow Rate Test | Achieved a flow rate of 40 ml/min. (Note: Predicate 20G flow rate was 46 ml/min, showing a slight decrease but still deemed substantially equivalent). | ISO 10555-1:2013 |
| 24G x 0.56" Catheter (New Model) | ||
| Flow Rate Test | Achieved a flow rate of 14 ml/min. (Matches predicate 24G flow rate of 14 ml/min). | ISO 10555-1:2013 |
| Test Access to the Sharp in Safe Mode (for Modified Housing/“Slider” Component) | The device's needle-shielding feature functions correctly, preventing access to the sharp in safe mode. | ISO 23908:2011 |
Note on "Acceptance Criteria": The document refers to compliance with ISO standards. For example, "Power Injection Test for Flow Rate and Device Pressure" would have specific acceptance criteria defined within ISO 10555-1:2013 regarding maximum pressure tolerance and flow rate. The document states these tests were "completed," implying successful adherence to these criteria. The flow rates are explicitly mentioned for specific gauges.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the sample size used for each specific test (e.g., number of catheters tested for flow rate or power injection).
- Data Provenance: The data comes from design verification tests conducted by Tangent Medical Technologies, Inc. This is a retrospective analysis of the device's performance based on internal testing protocols as part of a 510(k) submission for device modification. The country of origin of the data is implicitly the USA, where the company is based.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- The document describes engineering and design verification tests against established ISO standards. This type of testing typically relies on standard measurement techniques and equipment rather than expert consensus on a "ground truth" derived from patient data. Therefore, the concept of "experts establishing ground truth" in the clinical sense is not applicable to these specific performance tests. The "ground truth" here is the adherence to the technical specifications outlined in the ISO standards.
4. Adjudication Method for the Test Set
- As the tests are engineering/design verification, an adjudication method (like 2+1 or 3+1) is not applicable. The results are typically objectively measured against pre-defined engineering specifications and ISO standard requirements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was not done and is not relevant for this type of device modification submission. This study focuses on the physical and functional performance of an intravascular catheter, not on interpretative diagnostic accuracy requiring human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Not applicable. This device is a physical medical device (catheter system), not an algorithm or AI system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the device's performance is adherence to recognized international consensus standards for intravascular catheters (ISO 10555-1:2013 and ISO 23908:2011) and pre-defined engineering specifications established by the manufacturer. These standards dictate acceptable parameters for flow rates, pressure resistance, and sharps protection.
8. The Sample Size for the Training Set
- Not applicable. This is a physical medical device, not an AI/machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
- Not applicable, as there is no training set for this device.
§ 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).