(77 days)
The 2.6F Vascu-PICC® catheters are indicated for short or long term access to the central venous system via peripheral insertion in neonates, infants, and children. It may be used for administration of fluids, medication, and nutritional therapy.
- Designed for peripheral vein catherization .
- Comprised of a polyurethane material o
- The lumen is connected to the extensions by a hub with a suture wing for ◆ placement.
- Clamps are provided on the extension tube to prevent air/fluid communication. 0
- Female luer connectors provide the connection for intravenous administration. 0
The provided text describes a medical device, the 2.6F Vascu-PICC®, and its 510(k) submission for substantial equivalence to a predicate device. The document primarily focuses on the regulatory approval process and includes information about the device's design, intended use, and the performance testing conducted to support its safety and effectiveness.
However, the text does not contain information related to an AI/ML device or a study that would involve acceptance criteria for an AI model's performance in terms of metrics like sensitivity, specificity, or accuracy, which is what your request is about.
In this context, the entire section related to "Acceptance Criteria and Study for AI/ML Device" cannot be fulfilled as the input document is for a physical medical catheter, not an AI/ML diagnostic or prognostic tool.
Therefore, many of the requested categories in your prompt are not applicable to this document. I will fill in the applicable information about the device performance and acceptance criteria from this specific document.
Acceptance Criteria and Study for the 2.6F Vascu-PICC® (Physical Medical Device)
This document details the 510(k) submission for a physical medical device, the 2.6F Vascu-PICC®, not an AI/ML device. Therefore, the acceptance criteria and supporting studies are focused on the physical characteristics, biocompatibility, and performance of the catheter itself, rather than AI model metrics.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Standard Met) | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing for externally communicating, blood contacting, long-term devices. | Met (Subject product testing yielded acceptable safety and performance outcomes). |
| General Catheter Requirements | ISO 10555-1: 1997, Sterile Single Use-Intravascular Catheters, General Requirements. | Met (Subject product testing yielded acceptable safety and performance outcomes). |
| Central Venous Catheter Requirements | ISO 10555-3: 1997, Sterile Single Use-Intravascular Catheters, Central Venous Catheters. | Met (Subject product testing yielded acceptable safety and performance outcomes). |
| Luer Lock Fittings | ISO 594-2: Conical Fittings with a 6% (Luer) Taper for Syringes, Needles, and a Certain Other Medical Equipment - Part 2: Lock Fittings. | Met (Subject product testing yielded acceptable safety and performance outcomes). |
| Risk Management | Internal protocol based on ISO 14971: 2000, Medical Devices – Risk Management for Medical Devices. | Analysis did not identify any new types of safety or efficacy questions for the proposed device. |
| Substantial Equivalence | Demonstrates equivalence in design, materials, sterilization, and indications for use to the predicate device (1.9F Vascu-PICC®, K091466). | Based on indications for use and safety/performance testing, the device meets the requirements and is substantially equivalent. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each test. The document refers to "subject product testing" which implies tests were performed on a sample of the 2.6F Vascu-PICC® devices, but the exact number of units tested for each standard is not provided.
- Data Provenance: The tests were conducted by Medcomp, the manufacturer ("internal protocol based on ISO 14971: 2000"). The document does not specify the country of origin of the data beyond the manufacturer's location (Harleysville, PA, USA). The studies appear to be prospective testing of the manufactured device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a physical device submission. Ground truth in the context of expert consensus on diagnostic images or clinical outcomes is not relevant here. The "ground truth" for these tests would be the established international standards (ISO standards) themselves, which define the acceptable parameters for device performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. This concept pertains to resolving discrepancies among expert readers in AI/ML validation studies. For direct performance testing against international standards, the results are typically objectively measured and compared to the standard's defined acceptance limits.
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:
- Not Applicable. This type of study involves AI assistance for human interpretation, which is not relevant for this physical medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. There is no algorithm being evaluated in this submission.
7. The type of ground truth used:
- The ground truth for this device's performance is objective measurements against established international standards such as ISO 10993, ISO 10555-1, ISO 10555-3, and ISO 594-2. For risk management, the "ground truth" is adherence to ISO 14971.
8. The sample size for the training set:
- Not Applicable. No AI model is being trained.
9. How the ground truth for the training set was established:
- Not Applicable. No AI model is being trained.
§ 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.”