(25 days)
The Poly Per-Q-Cath® Triple Lumen PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling. For blood therapy, it is recommended that a 4 French or larger catheter be used.
There are no new operating principles. The modified 6 Fr Poly Per-Q-Cath® TL PICC catheter relies on the same basic, fundamental scientific technology as the predicate 6 Fr DL Poly Per-Q Cath PICC. The devices serve as conduit for fluids and blood into. and out of the centry venous system.
The provided text is a 510(k) Summary for a medical device called the "6 Fr Poly Per-Q-Cath®3 Triple Lumen PICC". It focuses on establishing substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results in the format requested.
Therefore, many of the requested sections about acceptance criteria, study details, expert involvement, and ground truth cannot be fully extracted or are not explicitly stated in the document. The document primarily describes the process of demonstrating substantial equivalence through various tests and adherence to standards, but it doesn't provide a table of acceptance criteria with corresponding performance metrics like a standalone study report would.
Here's an attempt to answer as much as possible based on the provided text, with clear indications where information is not available:
Acceptance Criteria and Device Performance
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with specific acceptance criteria and detailed reported device performance. It states that "The 6 Fr Poly Per-Q-Cath® TL PICC meets all the predetermined performance acceptance criteria of the testing performed" and that "Performance data gathered in design verification and validation testing demonstrated that the 6 Fr Poly Per-Q-Cath® TL PICC is substantially equivalent to the predicate 6 Fr DL Poly Per-Q- Cath PICC".
The document emphasizes adherence to guidance documents and international standards for evaluation, which implicitly define the acceptance criteria for various aspects of the device. These include:
- Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, March 16, 1995: This document would outline performance requirements for catheters.
- ISO 10555-1:1997, Sterile, Single-Use Intravascular Catheters, General requirements.
- ISO 10555-1:1997, Sterile, Single-Use Intravascular Catheters, General requirements, Amendment I.
- 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.
- Design Control Guidance for Medical Device Manufacturers, dated March 11, 1997.
- Biocompatibility requirements of ISO 10993 Biological Evaluation of Medical Devices Part-J : Evaluation and Testing and the FDA Modified ISO 10993 Test Profile for externally communicating, blood contacting, long-term devices.
The device performance is generally stated as having met these requirements and demonstrating substantial equivalence to the predicate device. Specific numerical results for performance metrics are not given.
| Acceptance Criteria (Implied by Standards/Guidance) | Reported Device Performance |
|---|---|
| Catheter Performance (e.g., flow rates, material strength, durability, patency) | Met predetermined performance acceptance criteria. |
| Sterilization Effectiveness (Ethylene Oxide) | Compliant with AAMI/ANSI/ISO 11135:1994. |
| Biocompatibility | Met ISO 10993 and FDA Modified ISO 10993 Test Profile. |
| Design Controls | Adhered to Design Control Guidance for Medical Device Manufacturers. |
| Safety and Effectiveness | Risks associated with use found acceptable when evaluated by FMEA. No new types of safety and effectiveness questions. Substantially equivalent to predicate. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The text refers to "design verification and validation testing" but does not detail sample sizes, whether a "test set" in the context of an AI/ML device was used, or the provenance of any data (country, retrospective/prospective). This is a physical medical device, not an AI/ML diagnostic tool, so these types of data considerations are typically not applicable in the same way.
3. 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)
This information is not provided and is not applicable in the context of this device type and submission. Ground truth, in the AI/ML sense, is not relevant for the physical performance testing of a PICC catheter. Evaluation of risks was performed by "FMEA" (Failure Mode and Effects Analysis), which is a common engineering analysis, not typically involving "experts" in the sense of clinical ground truth establishment for diagnostic output.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is not applicable to the type of device and testing described.
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
No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly those involving AI/ML interpretation of images or data that human readers would also evaluate. This submission is for a physical medical catheter, not an AI-powered diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm only) performance study was not done. This is not an AI/ML algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The concept of "ground truth" as typically applied to AI/ML diagnostic devices is not applicable to this physical catheter device. The "ground truth" for evaluating this device's performance would be the objective measurements and observations against established engineering specifications, safety standards, and performance test protocols (e.g., measuring flow rates, material tensile strength, sterility assurance levels, biocompatibility test results against defined toxicity thresholds).
8. The sample size for the training set
This information is not provided and is not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
This information is not provided and is not applicable. This is not an AI/ML device that requires a training set or ground truth in that context.
§ 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.”