(153 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 Power PICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media. For blood sampling, infusion or therapy, use a 4 French or larger catheter. The maximum recommended infusion rate is 5ml/sec for power injection of contrast media. The maximum pressure of power injectors used with the Power PICC catheter may not exceed 300 psi.
The PowerPICC " Catheters are open-ended radiopaque polyurethane catheters. .
. Catheter size is 5 Fr DI, with 55 cm usable length.
. 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 radiology and nursing PICC configurations.
. Purple colorants were added to the catheter materials to provide the catheter with an appearance that allows the end user to differentiate the PowerPICC from other PICC 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 describes a 510(k) submission for the 5 Fr DL PowerPICC® Catheter, comparing it to a predicate device, the 6 Fr DL PowerPICC® Catheter. This is a medical device submission, primarily focused on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a clinical study or specific acceptance criteria with performance data in the typical sense of an AI/software as a medical device (SaMD) study.
Therefore, many of the requested points, especially those related to AI/SaMD specific studies (like MRMC studies, standalone algorithm performance, training set details), are not applicable to this 510(k) submission for a physical medical catheter.
However, I can extract information related to the performance data and the conclusion of substantial equivalence.
Here's a breakdown of the relevant information:
Acceptance Criteria and Device Performance
The document states that the new device (5 Fr DL PowerPICC® Catheter) underwent "Verification and validation testing...according to protocols based on the above referenced guidance document recommendations and standards, as well as in accordance with in-house protocols." It then concludes, "Performance data gathered in design verification testing demonstrated that the 5 Fr DL PowerPICC® catheter is substantially equivalent to the predicate 6 Fr DL PowerPICC catheter, and the risks associated with use of the new device were found acceptable when evaluated by FMEA."
And, "The 5 Fr DL PowerPICC® catheter meets all the predetermined performance acceptance criteria of the testing performed..."
Since this is a 510(k) for a physical medical device, the "acceptance criteria" are related to mechanical, material, and biocompatibility performance as outlined in the cited standards and guidance documents. The document does not list specific quantitative acceptance criteria values in a table, nor does it provide a table of reported device performance values. Instead, it provides a qualitative statement of meeting these criteria and substantial equivalence.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Predetermined Acceptance Criteria (Implicit from Standards/Guidance) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Meet requirements of ISO 10555-1:1997, ISO 10555-3:1997 and internal protocols for catheter integrity, flow rates, pressure limits, etc. | "Performance data gathered in design verification testing demonstrated that the 5 Fr DL PowerPICC® catheter is substantially equivalent to the predicate 6 Fr DL PowerPICC catheter." |
| "meets all the predetermined performance acceptance criteria of the testing performed" | ||
| Material/Design equivalence | Be substantially equivalent to the predicate device (6 Fr DL PowerPICC® Catheter) in design, material, etc., or demonstrate safety/effectiveness of minor differences. | Minor differences identified, but "the basic fundamental scientific technology of the catheter has not changed." "The risks associated with use of the new device were found acceptable when evaluated by FMEA." |
| Biocompatibility | Meet requirements of ISO 10993 Biological Evaluation of Medical Devices Part-1 and FDA Modified ISO 10993 Test Profile for externally communicating, blood contacting, long-term devices. | "Biocompatibility requirements...were met. All materials used in the manufacture of the subject device were previously cleared for similar applications by Bard Access Systems." |
| Sterilization | Meet requirements of AAMI/ANSI ISO 11135:1994 Medical Devices -- Validation and Routine Control of Ethylene Oxide Sterilization. | Implied by the statement that the device "meets all the predetermined performance acceptance criteria of the testing performed." (Though not explicitly detailed for sterilization in performance section, it's listed as a standard used). |
Study Details:
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Sample size used for the test set and the data provenance:
- The document does not specify sample sizes for individual tests (e.g., how many catheters were tested for flow rate, burst pressure, etc.).
- Data provenance is not explicitly mentioned (e.g., country of origin). The testing was done at Bard Access Systems, Inc.
- The testing appears to be retrospective in the sense that it evaluates a manufactured device against established standards, rather than a prospective clinical trial.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in the context of this 510(k) for a physical medical device. "Ground truth" established by experts is typically for diagnostic devices or AI, where a human expert provides the definitive diagnosis or assessment. For a catheter, the "ground truth" is defined by the physical and material specifications and performance against industry standards.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials, especially for evaluating diagnostic accuracy where multiple reviewers assess a case and consensus or a tie-breaker is needed. For product verification, performance is measured objectively against defined physical parameters.
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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:
- No. This is not applicable. An MRMC study is relevant for diagnostic devices, particularly those involving human interpretation of images or other data, often with AI assistance. This submission is for a physical intravascular catheter.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is not applicable. This refers to AI algorithm performance.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this medical device submission is the engineering specifications, material properties, and performance requirements outlined in international standards (ISO, AAMI/ANSI) and FDA guidance documents, along with the demonstrated performance of the predicate device. Compliance is tested against these objective benchmarks.
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The sample size for the training set:
- This is not applicable. There is no "training set" in the context of a physical medical device 510(k) submission. This term relates to machine learning models.
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How the ground truth for the training set was established:
- This is not applicable, as there is no training set for this type of device submission.
§ 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.”