(28 days)
The Spectrum Turbo-JeCT PICC is indicated for short- or long-term use for yenous pressure monitoring, blood sampling, administration of drugs 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 Spectrum Turbo-JeCT PICC may not exceed 325 psi and the flow rate may not exceed the maximum flow rate indicated.
The Spectrum Turbo-JeCT PICC catheters are radiopaque polyurethane peripherally inserted central venous catheters impregnated with the antimicrobials minocycline and rifampin for short- or long-term use. The devices are currently available in the following configurations: 4 Fr single lumen, 5 Fr single lumen, 5 Fr double lumen. The proposed devices add two additional configurations, more specifically, a 3 Fr single lumen catheter and a 6 Fr triple lumen catheter.
The provided 510(k) summary describes a medical device modification (Spectrum® Turbo-JeCT™ PICC Set) and the testing performed to demonstrate its substantial equivalence to a predicate device. However, it does not detail a study involving AI or machine learning. Therefore, many of the requested categories related to AI performance, ground truth, and expert involvement are not applicable to this document.
Here's the information that can be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present acceptance criteria in a quantitative table for all tests. It lists the maximum flow rates for different catheter sizes and the maximum pressure limit setting, which can be interpreted as performance targets. The study, in essence, aimed to verify these stated flow rates and pressure limits.
| Acceptance Criteria (Target) | Reported Device Performance (Achieved) |
|---|---|
| For all catheter sizes: | |
| Injection Pressure Limit Setting: | 325 psi (Stated as a maximum limit setting, implying the device can withstand this pressure without failure, and the flow rates are achieved at or below this pressure. The tests would confirm performance within this limit.) |
| Specific to Catheter Sizes (for Omnipaque 300® at 20°C with Medrad Stellant® CT injector): | |
| 3 Fr Single Lumen Maximum Flow Rate: | 2 mL/sec (Flow rates were achieved for this configuration, implying it met or exceeded this target under the specified conditions. Implied acceptance: The device should achieve at least 2 mL/sec.) |
| 4 Fr Single Lumen Maximum Flow Rate: | 4 mL/sec (Flow rates were achieved for this configuration. Implied acceptance: The device should achieve at least 4 mL/sec.) |
| 5 Fr Single Lumen Maximum Flow Rate: | 7 mL/sec (Flow rates were achieved for this configuration. Implied acceptance: The device should achieve at least 7 mL/sec.) |
| 5 Fr Double Lumen Maximum Flow Rate: | 5 mL/sec (Flow rates were achieved for this configuration. Implied acceptance: The device should achieve at least 5 mL/sec.) |
| 6 Fr Triple Lumen Maximum Flow Rate (Lumen #1 only): | 7 mL/sec (Flow rates were achieved for this configuration. Implied acceptance: The device should achieve at least 7 mL/sec.) |
| Other Performance Requirements (Implicit Acceptance) | The device meets applicable design and performance requirements for:- Tensile Testing - Cyclic Bending - Zone of Inhibition - Elution Profile - Air and Liquid Leakage - Burst Pressure - Cyclic Pinch Clamping - HPLC Analysis - Stability Testing |
2. Sample Size Used for the Test Set and Data Provenance
The document lists "Test Data" but does not specify the sample sizes used for each test (Tensile Testing, Flow Rate, Cyclic Bending, etc.). It does mention "Flow rates achieved using room temperature Omnipaque 300® contrast and verified using a Medrad Stellant® CT injector system," indicating a laboratory-based, prospective testing methodology. There is no information regarding the country of origin of the data beyond the implied US-based manufacturing and testing by Cook Incorporated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This is a medical device performance and safety study involving physical and chemical tests, not a diagnostic or AI-based study requiring expert ground truth for interpretation of complex data like images or patient records. The "ground truth" for these tests would be established by objective measurements against predefined specifications.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this is not a study requiring human adjudication of results in the traditional sense. Test results would be generated by instruments and procedures, and then compared against engineering specifications or regulatory requirements.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not done. This type of study is specifically for evaluating the performance of diagnostic systems or AI in clinical settings with human readers, which is not relevant to the physical and chemical performance tests described for this PICC line.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. There is no algorithm or AI component discussed in this 510(k) summary. The "device" being tested is a physical medical catheter.
7. The Type of Ground Truth Used
The "ground truth" for this device modification study is based on engineering specifications, material science principles, and predefined performance targets for physical and chemical properties. For example, flow rates must meet specific mL/sec values, burst pressure must exceed a certain psi, and antimicrobial activity must be demonstrated (zone of inhibition). These are objective, measurable criteria, not subjective expert interpretations.
8. The Sample Size for the Training Set
Not applicable. There is no mention of a training set as this is not an AI or machine learning study.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth for it to be established.
§ 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).