(88 days)
The Zeus™ CT PICC is indicated for short or long-term (less than or greater than 30 days) peripheral access to the central venous system for intravenous therapy, power injection of contrast media, and central venous pressure monitoring. The maximum recommended infusion rate is 5 ml/sec for power injection of contrast media. The maximum pressure of the power injector utilized should not exceed 300 psi.
The r4 Vascular. Inc. Zeus™ CT PICC is a family of peripherally inserted central venous catheters designed to perform infusion, intravenous therapy, blood sampling, power injection of contrast media studies and central venous pressure monitoring. The catheters, made of radiopaque polyurethane tubing, are inserted peripherally. Each Zeus™ CT PICC has a kink resistant reverse tapered catheter design. The Zeus™ CT PICC kit includes a catheter and introduction components. The catheter is supplied sterile and non-pyrogenic in a variety of kit configurations.
The Zeus™ CT PICC product line has catheters in 4 Fr and 5 Fr single lumen and 5 Fr and 6 Fr dual lumen.
The Zeus™ CT PICC is similar to HDC's V-Cath (Polyurethane) Power PICC (Power-V), with the addition of a Biomimetic Coating that is similar in performance to the Tyco Palindrome Emerald.
The provided text is a 510(k) summary for a medical device (Zeus™ CT PICC), which focuses on demonstrating substantial equivalence to predicate devices rather than detailing specific acceptance criteria and a comprehensive study report with the requested elements. Therefore, many of the requested details are not explicitly present in the provided document.
However, based on the information that is available, here's an attempt to answer your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document broadly states that the device "met all established acceptance criteria for performance testing and design verification testing." However, specific quantitative acceptance criteria and their corresponding reported device performance values are not explicitly detailed in the provided text. The document refers to various standards (e.g., ISO 10555-1:1997, ISO 594, AAMI/ANSI/ISO 11135:1994, ISO 10993) that would contain these criteria, but doesn't list them or the specific results.
2. Sample Size Used for the Test Set and Data Provenance
The document states, "Performance testing was generated in accordance with the above referenced guidance document and standards." However, the sample size used for the test set is not specified, nor is the data provenance (e.g., country of origin, retrospective or prospective). This type of detail is typically found in a full study report, not a 510(k) summary.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the given text. The evaluations mentioned are performance testing based on established standards, likely involving engineering or lab-based assessments rather than human expert opinion for ground truth.
4. Adjudication Method
This information is not provided. Given the nature of the testing described (performance testing against standards), formal adjudication methods like 2+1 or 3+1 by human experts would not typically apply.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The document focuses on demonstrating substantial equivalence for a medical device (PICC catheter), not on evaluating the improvement of human readers with AI assistance. Therefore, no effect size of human improvement with AI is provided.
6. Standalone (Algorithm Only) Performance Study
No standalone algorithm performance study is mentioned. This device is a physical medical catheter, not an AI algorithm.
7. Type of Ground Truth Used
The "ground truth" for the performance testing of this device would be the physical and chemical specifications outlined in the referenced international and FDA standards (e.g., ISO 10555-1 for intravascular catheters, ISO 594 for Luer taper, ISO 11135 for sterilization, ISO 10993 for biocompatibility). The device's performance was measured against these established standards to ensure safety and effectiveness.
8. Sample Size for the Training Set
This information is not applicable and not provided. The Zeus™ CT PICC is a physical medical device, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided. As mentioned above, this is not an AI device.
In summary, the provided 510(k) summary focuses on regulatory compliance and demonstrating substantial equivalence through adherence to recognized standards and guidance documents for a medical device. It does not contain the detailed study information typically requested when evaluating an AI/ML algorithm or a diagnostic tool that relies on human interpretation.
§ 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.”