(90 days)
The PowerPICC™ catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, power injection of contrast media, and allows for central venous pressure monitoring. For blood sampling, infusion or therapy, use a 4 French or larger catheter. The maximum recommended infusion rate is 5mL/sec. The maximum pressure of power injectors used with the PowerPICC catheter may not exceed 300 psi. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used.
The Poly Per-Q-Cath PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling and allows for central venous pressure monitoring. For blood therapy, it is recommended that a 4 French or larger catheter be used. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used.
The Poly Per-O-Cath® Triple Lumen PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling and allows for central venous pressure monitoring. For blood therapy, it is recommended that a 4 French or larger catheter be used. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used.
PowerHohn and PowerLine Catheters are indicated for short or long term access to the central venous system. They are designed for administering I.V. fluids, blood products, drugs and parenteral nutrition solutions, as well as blood withdrawal, power injection of contrast media and allow for central venous pressure monitoring. The maximum recommended infusion rate is 5mL/sec. The maximum pressure of power injectors used with the PowerHohn and PowerLine catheters may not exceed 300 psi. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used.
Subject devices:
- Catheters range in French size from 3-5 Fr SL; 4-6 Fr DL and 6 Fr TL .
- Catheter usable length ranges from 40 -60 cm. .
- Catheters are open-ended catheters extruded from polyurethane material containing barium ● sulfate for radiopacity.
- The catheter extension legs are polyurethane extrusions. Extension legs are minimum 2.2 in. . in length to promote easy application of occlusive dressings. Each extension leg has a thumb clamp.
- The luer hub base material is Isoplast polyurethane. .
- The catheter has a reverse taper design .
- The user is informed of the gage size in product labeling and it is printed on the luer hub. .
- The catheter shaft tubing is marked with depth indicators, with "0" indicated to serve as a . reference for the catheter insertion point
- Catheters are provided sterile and are packaged with legally marketed kit components that are . preferred by clinicians
The provided document describes a 510(k) premarket notification for Central Venous Pressure Monitoring (CVPM) capability in various catheter devices, rather than a standalone device with extensive acceptance criteria and a study demonstrating its performance in a clinical setting against a ground truth.
The document focuses on demonstrating substantial equivalence to existing predicate devices for an expanded indication for use: "allows for central venous pressure monitoring." The key point is that the catheters themselves are not new, but their indicated use now includes CVPM. Therefore, the "acceptance criteria" and "study" are geared towards proving that the existing or slightly modified catheters are suitable for this additional function, specifically focusing on the catheter lumen size for effective CVPM.
Here's the breakdown of the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| CVPM Functionality | Catheter lumen of 20 gauge or larger for central venous pressure monitoring | Subject devices, except for 21 gauge catheter lumens, met the performance criteria of design verification. As a result, the recommendation of catheter lumen of 20 gauge or larger was added to the indications for use. |
| Safety and Effectiveness | No change in design affecting safety or effectiveness compared to predicate devices | No change in design that could affect the safety or effectiveness of the device. |
| No new types of safety and effectiveness questions raised by new characteristics | No new types of safety and effectiveness questions. | |
| Applicable Standards | - IEC 60601-2-34:2000(E) Ed.2 (Medical electrical equipment - Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment) | Testing was based on recognized and un-recognized standards. (Implied: device met these standards for the relevant aspects) |
| - AAMI TIR: 1992 (Evaluation of Clinical Systems for Invasive Blood Pressure Monitoring) | Testing was based on recognized and un-recognized standards. (Implied: device met these standards for the relevant aspects) | |
| - ANSI/AAMI BP22:1994 (Blood Pressure Transducers) | Testing was based on recognized and un-recognized standards. (Implied: device met these standards for the relevant aspects) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a test set in the traditional sense of a clinical trial with a specific number of patients or samples. The "testing" mentioned is bench testing (laboratory studies). Therefore, there is no information on:
- Sample size used for a clinical test set.
- Country of origin of data for a clinical test set.
- Retrospective or prospective nature of a clinical test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the document describes bench testing and design verification, not a clinical study involving human readers or expert consensus to establish a clinical "ground truth."
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as #3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. The document focuses on the device's capability for CVPM, not on human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No, a standalone algorithm performance study was not done. This submission is for physical catheter devices, not AI algorithms.
7. The Type of Ground Truth Used
The "ground truth" used for evaluating the central venous pressure monitoring capability was based on recognized and un-recognized standards for invasive blood pressure monitoring equipment and transducers, likely involving physical measurements and comparisons in a controlled bench setting. This is best described as bench test performance against established engineering or medical device performance standards. It is not clinical pathology, expert consensus on images, or patient outcomes data.
8. The Sample Size for the Training Set
This information is not applicable. The document describes physical medical devices (catheters) and their expanded indications, not a machine learning model that would require a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as #8.
§ 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.”