(27 days)
Spectrum Turbo-Ject® Peripherally Inserted Central Venous Catheter (PICC) Sets and Trays are intended for short- or long-term use for venous pressure monitoring, blood sampling, administration of drugs and fluids, and for use with power injectors for delivery of contrast in CT studies. The catheter is impregnated with the antimicrobials minocycline and rifampin to help provide protection against catheter-related bloodstream infections (CRBSIs). The Spectrum Turbo-Ject® PICC is indicated for multiple injections of contrast media through a power injector. The maximum pressure limit setting for Power Injectors used with the Turbo-Ject PICC may not exceed 325 psi and the flow rate may not exceed the maximum flow rate indicated.
The proposed Spectrum Turbo-Ject® PICCs are radiopaque polyurethane peripherally inserted central venous catheters for short- or long-term use, and can be inserted through a Peel-Away® introducer, or over-the-wire. The proposed devices are minimally tapered 4.0 Fr and 5.0 Fr single and double lumen catheters. The set components may include the PICC, obturator, Peel-Away® introducer, entry needles, wire guide, and other convenience components. The set is supplied sterile and is intended for one-time use.
The provided text describes a 510(k) summary for the Cook Medical Spectrum Turbo-Ject® Peripherally Inserted Central Venous Catheter Set. It outlines the device's intended use, comparison to predicate devices, and the testing conducted to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Tensile Testing | Peak load value > 10 N | Peak load value was greater than 10 N |
| Dynamic Pressure Testing | Catheters do not fail during simulated use | Catheters did not fail during simulated use |
| Static Failure Pressure Testing | Static failure pressure at or above the acceptance criterion | Static failure pressure was at or above the acceptance criterion |
| Liquid Leakage Testing | Catheters do not leak liquid | Catheters did not leak liquid |
| Air Leakage Testing | Catheters do not exhibit air leakage | Catheters did not exhibit air leakage |
| Antimicrobial Testing | Minimum zone of inhibition of 15 mm | Catheters met the predetermined acceptance criteria |
Note: For "Static Failure Pressure Testing" and "Antimicrobial Testing", the specific numerical acceptance criteria (other than >15mm for antimicrobial, which is also stated as "predetermined") are not explicitly defined in the document, but the document states the device met them.
2. Sample Size and Data Provenance
The document does not explicitly state the sample sizes used for each specific test (e.g., number of catheters tested for tensile strength or leakage).
The data provenance is retrospective, as the submission is for modifications to previously cleared devices (K081690, K072625, K132334, K132885). The testing was conducted to demonstrate substantial equivalence to these predicate devices. The country of origin of the data is not specified, but the applicant address is in Bloomington, IN, USA.
3. Number of Experts and Qualifications
The document does not mention the involvement of experts to establish ground truth for a test set. The tests describe physical and performance characteristics of the device, which are typically evaluated through laboratory testing against predefined engineering specifications.
4. Adjudication Method
Not applicable. This type of submission (510k for a medical device) typically relies on laboratory testing and engineering specifications rather than expert adjudication of a test set, which is more common in diagnostic device or AI algorithm evaluations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. The device is a "Peripherally Inserted Central Venous Catheter Set," a physical medical device, not a diagnostic imaging or AI-assisted system that would typically involve human readers.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is a physical medical device, not an algorithm or AI system.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is based on engineering specifications and established criteria for medical device safety and effectiveness. For example:
- Tensile strength: Measured against a force (10 N).
- Leakage: Absence of liquid/air leakage.
- Pressure: Ability to withstand specified pressure (325 psi).
- Antimicrobial activity: Measured zone of inhibition (15 mm).
These are objective, quantitative measurements against predefined 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. The design and manufacturing process would involve internal validation and verification activities, but these are not referred to as training sets.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device. The specifications and acceptable performance limits are derived from industry standards (e.g., ISO 10555-1:1995), regulatory requirements, and the performance characteristics of predicate devices.
§ 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.”