(29 days)
The PowerPICC® Catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.
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. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used.
The 4 Fr SL PowerPICC® Catheters are open-ended radiopaque polyurethane. Catheter usable length is 55 cm. The catheter has a reverse taper design 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 in basic and full PICC configurations with legally marketed kit components. Purple colorants were added to the catheter materials to provide the catheter with an appearance that allows the end user to differentiate Bard's power injectable catheters from other manufacturers' power injectable catheters. The catheter extension leg, junction and clamp ID tag were printed with markings to identify the catheter as PowerPICC® and to include information to facilitate proper use of the device.
The provided text is for a 510(k) premarket notification for a medical device called the "4 Fr SL PowerPICC® Catheter." This is a regulatory submission for a medical device and not a study proving device performance against acceptance criteria in the way a clinical or AI performance study would.
Therefore, the requested information elements such as a table of acceptance criteria and reported device performance, sample sizes for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI models are not applicable to this document.
Instead, this document details the substantial equivalence of the 4 Fr SL PowerPICC® Catheter to predicate devices. Substantial equivalence means the device is as safe and effective as a legally marketed device (predicate device) and does not raise new questions of safety or effectiveness.
Here's a breakdown of what is contained in the document, which can be interpreted in relation to "acceptance criteria" for a regulatory submission of this type:
1. "Acceptance Criteria" (Regulatory Context) and "Reported Device Performance" (Substantial Equivalence Claims):
In the context of a 510(k), "acceptance criteria" are not reported as specific performance metrics against a threshold for a new study, but rather that the new device meets established standards and is substantially equivalent to predicates.
| Criteria (Regulatory Focus) | Reported "Performance" (Substantial Equivalence) |
|---|---|
| Intended Use (Same as predicate) | The PowerPICC® Catheters are intended for short or long-term peripheral access to the central venous system for intravenous therapy and blood sampling. This is explicitly stated to be identical to predicate devices. |
| Indications for Use (Same as predicate) | 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. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used. Stated to be substantially equivalent to predicates. |
| Technological Characteristics (Same as predicate) | Technological similarities between the subject 4 Fr SL PowerPICC® catheter and the predicate devices remain identical. "There are no new questions raised regarding safety or efficacy of the 4 Fr SL PowerPICC®." |
| Biocompatibility (Meets standards) | Met requirements of ISO 10993 Biological Evaluation of Medical Devices Part-1: Evaluation and Testing and the FDA Modified ISO 10993 Test Profile. All materials were previously cleared for similar applications. |
| Performance Testing (Meets standards) | Conducted in accordance with FDA guidance documents and international standards: |
- Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, March 16, 1995
- ISO 10555-1:1997, Sterile, Single-Use Intravascular Catheters, General requirements and Amendment 1
- ISO 10555-3:1997, Sterile, Single-Use Intravascular Catheters, Central venous catheters
- AAMI/ANSI/ISO 11135:1994, Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization
- AAMI/ANSI/ISO 10993-1:2003, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, and the FDA Modified ISO 10993 Test Profile
- IEC 60601-2-34: 2000-10, Medical electrical equipment Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment
- AAMI TIR9: 1992, Evaluation of Clinical Systems for Invasive Blood Pressure Monitoring
- ANSI/AAMI BP22: 1994, Blood Pressure Transducers
Subject product testing yielded acceptable safety & performance outcomes. |
| Sterilization (Meets standards) | EO sterilization adoption tests yielded acceptable results. |
| Overall Substantial Equivalence (Regulatory Outcome) | The device "meets the minimum requirements that are considered adequate for its intended use and is substantially equivalent in design, materials, sterilization, principles of operation and indications for use to current commercially available catheters/cited predicates." |
2. Sample size used for the test set and the data provenance:
- N/A. This is not a study reporting on a "test set" in the context of an AI/algorithm. Performance testing was done against established standards for medical devices, but specific sample sizes for these tests (e.g., how many catheters were mechanically tested) are not provided in this summary. The data provenance would be from laboratory and engineering testing, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This refers to expert consensus for ground truth, which is not relevant for this type of medical device submission. The "ground truth" here is compliance with recognized engineering, biocompatibility, and sterilization standards, which are evaluated by technical experts and regulatory bodies.
4. Adjudication method for the test set:
- N/A. Not applicable, as there is no "test set" in the context of human expert review as in an AI study.
5. 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:
- N/A. This device is a catheter, not an AI or imaging diagnostic tool. An MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This device does not have an "algorithm-only" performance to assess.
7. The type of ground truth used:
- For the performance claims made:
- Engineering/Laboratory Test Standards: Compliance with international and national standards (ISO, AAMI, IEC) for physical performance (e.g., flow rates, pressure resistance), biocompatibility, and sterilization.
- Predicate Device Compliance: The "ground truth" for substantial equivalence is that the new device shares fundamental characteristics and performance with previously cleared, legally marketed predicate devices.
8. The sample size for the training set:
- N/A. This is not a machine learning or AI device, so there is no training set.
9. How the ground truth for the training set was established:
- N/A. Not applicable, as there is no training set.
In summary, the provided document is a 510(k) summary demonstrating substantial equivalence for a physical medical device. It relies on compliance with established regulatory standards and comparison to predicate devices, rather than the types of clinical or AI performance studies described in the prompt's questions.
§ 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.”