(166 days)
The Central Venous Catheters including:
14 G, 16 G, 18 G, and 20 G in single-lumen catheters;
4 F. 5 F, 7 F and 8 F in double-lumen catheter;
5.5 F and 7 F in triple-lumen catheter;
are intended for vascular access infusion and withdrawal of blood, blood products, and fluids, plasma pheresis, hyperalimentation, central venous blood sampling and continuous and intermittent drug infusion.
Able® Central Venous Catheter is a polyurethane central venous catheter which is intended to insert into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously.
All the variants of applicant devices: single-lumen, and triple-lumen, and triple-lumen. There are outer diameter dimensions of 14 G, 16 G, 18 G, and 20 G in single-lumen catheters, 4 F, 5 F, 7 F and 8 F in double-lumen catheter, and 5.5 F and 7 F in triple-lumen catheter.
The applicant device mainly consists of 5 parts: distal end, catheter body of effective length, catheter junction, extension cannula, and catheter hub. Distal end is soft and flexible, which is intended to be located within the patient's vena cava. Catheter body of effective length is tubular and with no-communication single or multiple lumens. Catheter junction attaches catheter body of effective length and extension cannula. At the end of the extension cannula, there is female catheter hub for the connection.
The provided text is a 510(k) summary for a Central Venous Catheter, which is a medical device. The information requested in your prompt (Acceptance Criteria, Sample Sizes, Ground Truth, MRMC studies, etc.) is typically associated with AI/software-as-a-medical-device (SaMD) submissions, especially for diagnostic or predictive algorithms.
The document you provided does not contain information related to AI/SaMD performance studies. It describes a physical medical device (catheter) and its testing against established physical and biological standards. Therefore, most of your specific questions cannot be answered from the given text.
However, I can extract the relevant information regarding the device's testing and acceptance criteria as described:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the physical device testing was done in compliance with various ISO standards and internal tests. The acceptance criteria for these tests are generally that the device "conforms" or "is in compliance" with these standards, meaning it met the specifications outlined within them. The document does not provide specific numerical ranges for acceptance or detailed performance data for each test beyond stating compliance.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biological Evaluation | In compliance with ISO 10993 |
| Compatibility of Component Material | Provided (implies satisfactory) |
| Physical & Mechanical Standards | Conforms to ISO 10555-1 and ISO 10555-3 |
| Specific Tests (e.g., Surface, Size, Flow Rate, Tensile Strength, Leakage, Radiodetectability etc.) | Testing to Support Substantial Equivalence included; Assumed to have met acceptance criteria for substantial equivalence, though specific numerical results or criteria are not detailed. |
2. Sample Size used for the test set and the data provenance
The document does not specify sample sizes used for each of the physical and biological tests conducted (e.g., how many catheters were tested for flow rate or tensile strength). The data provenance is implied to be from Foshan Nanhai Bai He Medical Technology Co., Ltd. in China, as they are the manufacturer and submitter. The tests described are "testing to support substantial equivalence," which suggests prospective testing performed on manufactured devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. The device is a physical medical device (catheter), not an AI/SaMD that requires expert ground truth for diagnostic or predictive accuracy. The "ground truth" for this device is based on established engineering and materials science standards (e.g., ISO 10993, ISO 10555-1, ISO 10555-3).
4. Adjudication method for the test set
This question is not applicable. Adjudication methods like "2+1" or "3+1" are relevant for expert review of images or data in AI/SaMD studies. For a physical device, testing follows standardized methods, and results are typically objective measurements.
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
This question is not applicable. MRMC studies are used for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This document describes a physical medical device (catheter), not an AI application.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This document describes a physical medical device, not an algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance is based on predefined engineering specifications, material properties, and compliance with international standards (e.g., ISO 10993 for biocompatibility, ISO 10555-1 and ISO 10555-3 for intravascular catheters). These standards effectively serve as the "ground truth" against which the device's performance is measured.
8. The sample size for the training set
This question is not applicable. There is no AI algorithm described in this submission, so there is no "training set."
9. How the ground truth for the training set was established
This question is not applicable, as there is no AI algorithm or training set.
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).