(87 days)
Turbo-Ject Peripherally Inserted Central Venous Catheters (PICC) are indicated 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 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 rated indicated, as shown on the following table.
| Catheter Size | Maximum Flow Rate* | Injection Pressure
Limit Setting |
|-------------------|--------------------|-------------------------------------|
| 4 Fr Single Lumen | 4 ml/sec | 325 psi |
| 4 Fr Double Lumen | 3 ml/sec | 325 psi |
| 5 Fr Single Lumen | 7 ml/sec | 325 psi |
| 5 Fr Double Lumen | 5 ml/sec | 325 psi |
*Flow rates achieved using room temperature Omnipaque 3000 contrast and veriffed using a Medrad Stellant® CT injector system. Omnipaque 300 has a viscosity of 11.8 centipoise at room temperature (20 degrees C). A change in temperature or viscosity of the contrast medium used will result in a change in achievable flow rates. Omnipaque 300® is a registered trademark of Amersham Health, New Jersey.
The Turbo-Ject PICC catheters are radiopaque polyurethane peripherally inserted central venous catheters for short or long-term use. The Turbo-Ject PICC catheters are 60 cm in length and available in 4 and 5 Fr single lumen and 4 and 5 Fr double lumen.
The set components include an introducer needle, wire guide, locking Peel-Away sheath introducer, 12cc syringe and hydrophilic-coated wire guide obturator for non-over-thewire versions. The tray components include all set items in addition to 22 and 25 gauge needles, lidocaine, antiseptic sponges, drape, gauze, 3 cc syringe, suture with needle and needle holder. The set components will be the same for the single and double lumen Turbo-Ject PICC catheter.
The provided text describes acceptance criteria and testing for the Turbo-Ject Peripherally Inserted Central Venous Catheter (PICC). However, it does not contain information about a study proving the device meets the acceptance criteria in the context of an AI/ML device, as requested in the prompt. The device described is a physical medical device, not an AI/ML algorithm. Therefore, many of the requested fields related to AI/ML studies cannot be addressed from the given document.
Here's a breakdown of what can be extracted and what cannot, based on the provided text:
Acceptance Criteria and Device Performance (as much as can be derived for a physical device):
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Maximum Flow Rate (Contrast Injection) | Maximum pressure limit setting for power injectors not to exceed 325 psi. Flow rates not to exceed indicated maximums (e.g., 4 Fr Single Lumen: 4 ml/sec, 5 Fr Single Lumen: 7 ml/sec, etc.). | The device was tested and achieved the specified flow rates using room temperature Omnipaque 300® contrast and verified with a Medrad Stellant® CT injector system. |
| Mechanical Performance | Reliable design and performance under specified testing parameters for: 1. Flow rate tests, 2. Static burst failure pressure tests, 3. Cyclic fatigue test, 4. Liquid leakage under pressure test, 5. Air leakage during aspiration test, 6. Tensile strength tests, 7. Bond strength test, 8. Shelf life testing. | "The Turbo-Ject PICC Catheter was subjected to the following tests to assure reliable design and performance under the specified testing parameters. The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a PICC catheter." Specific numerical results for each test are not detailed in this summary. |
| Biocompatibility | Biocompatibility requirements met. | Biocompatibility tests were performed. ("Biocompatibility tests"). Specific results are not detailed. |
| Sterilization | Sterilization similar to currently marketed and distributed devices. | "This device will undergo sterilization similar to the devices currently marketed and distributed." |
| Packaging | Packaging similar to currently marketed and distributed devices. | "This device will undergo packaging similar to the devices currently marketed and distributed by Cook Incorporated." |
Since the device described is a physical medical device and not an AI/ML algorithm, the following sections cannot be answered from the provided document as they pertain to AI/ML device studies:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a physical medical device. The document mentions tests but not a "test set" in the context of data for an algorithm.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. Ground truth for an AI/ML algorithm is not relevant for the physical performance tests of a catheter.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable. This relates to AI/ML performance compared to human performance, which is not relevant for a catheter's physical properties.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for a physical device's performance is adherence to engineering specifications and safety standards, validated through physical testing.
- The sample size for the training set: Not applicable. No training set for an AI model.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document details the safety and performance testing for a physical medical device (Turbo-Ject PICC Catheter) to demonstrate its substantial equivalence to predicate devices, rather than an AI/ML diagnostic or therapeutic device.
§ 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.”