(318 days)
UMBILICAL VESSELS CATHETER is intended for short-term vascular access via umbilical vessels in neonatal patients:
Via the umbilical artery:
--- sampling of blood,
---measurement of intravascular arterial pressure.
Via the umbilical vein:
--- infusion (simultaneous infusion of several medicinal products for the dual lumen catheter).
The UMBILICAL VESSELS CATHETER has catheters in single lumen and dual lumen. The catheters tube is made of radiopaque polyurethane which is insert molded to a polyurethane hub. The insertion tip of the catheter has been heat melted to form a smooth, rounded tip to reduce tissue trauma upon insertion.
Placement of the device is facilitated by depth markings, which are printed on the catheter at 1 cm intervals, beginning at 5 cm from the insertion tip and continuing to 40 cm from the tip. Catheter placement must be confirmed by x-ray.
The UMBILICAL VESSELS CATHETER has 17 primary configurations: Catheters in 2 Fr., 2.5 Fr., 2.8 Fr., 3 Fr., 3.5 Fr., 4 Fr., 5 Fr., 6 Fr., 6.5 Fr. and 7 Fr. for Single lumen; 2.8 Fr., 3 Fr., 3.5 Fr., 4 Fr., 5 Fr., 6 Fr. and 6.5 Fr. for dual lumen. Each device will continue to be packaged in a Tyvek pouches are packaged in a carton. The UMBILICAL VESSELS CATHETER does not contain DEHP and is Ethylene Oxide sterilized. The product and packaging are not made of natural rubber latex.
The provided text describes a 510(k) premarket notification for an Umbilical Vessels Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance criteria through extensive clinical studies involving AI. Therefore, most of the requested information regarding AI performance metrics, sample sizes for training/test sets, ground truth establishment, expert adjudication, and MRMC studies is not applicable to this document.
However, I can extract information related to the device's functional performance and equivalence.
Here's a breakdown of what can be extracted based on your request:
1. Table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative sense for the device's functional performance beyond complying with established standards. Instead, it demonstrates compliance with recognized industry standards. The "reported device performance" is a statement of "Pass" for each test, indicating that the device met the requirements of the specified standards.
| Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|
| Sterilization (ISO 11135:2014) | Pass |
| Seal Strength (ASTM F88/F88M-09) | Pass |
| Seal Integrity (ASTM F1886-98, Visual) | Pass |
| Seal Leaks (ASTM F1929-98, Dye P) | Pass |
| Internal Pressurization (ASTM F1140-00) | Pass |
| Performance Testing (ASTMD4169-05) | Pass |
| Leak Determination (ASTM D3078-02) | Pass |
| Repeat Seal Integrity (ASTM F1886-98) | Pass |
| Genotoxicity (ISO 10993-3:2014) | Pass |
| Hemocompatibility (ISO 10993-4:2006; ASTM F756) | Pass |
| Cytotoxicity (ISO 10993-5:2009) | Pass |
| Implantation (ISO 10993-6:2016) | Pass |
| EO, ECH Residual (ISO 10993-7:2008) | Pass |
| Sensitization (ISO 10993-10:2010) | Pass |
| Irritation/Intracutaneous Reactivity (ISO 10993-10:2010) | Pass |
| Acute Systemic Toxicity (ISO 10993-11:2006) | Pass |
| Subacute/Subchronic Toxicity (ISO 10993-11:2006) | Pass |
| Material-Mediated Pyrogenicity (ISO 10993-11:2006) | Pass |
| Limulus Amebocyte Lysate (USP) | Pass |
| Intravascular Catheters (ISO 10555-1:2013) | Pass |
| Conical Fittings (ISO 594-1:1986) | Pass |
| Conical Fittings (ISO 594-2:1998) | Pass |
| Sterile Hypodermic Syringes (ISO7886-1:2017) | Pass |
| Flow rate: The flowrate for each lumen is not less than 80% of the Nominal value for catheters of nominal outside diameter less than 1.0; and the flowrate for each lumen is not less than 90% of the Nominal value for catheters of nominal outside diameter equal to 1.0 or greater. (Comply with ISO 10555-1) | Reported as "Comply with ISO 10555-1" |
| Peak tensile force: More than 5N, 10N, or 15N (Comply with ISO 10555-1) | Reported as "SE (Comply with ISO 10555-1)" |
| Freedom from leakage: No leakage for liquid and air (Comply with ISO 10555-1) | Reported as "SE (Comply with ISO 10555-1)" |
| Material: Polyurethane POM M370 44 (Comply with ISO 10993 series) | Reported as "SE (Comply with ISO 10993 series)" |
2. Sample size used for the test set and the data provenance:
The document refers to "nonclinical testing" performed according to applicable standards. It does not specify the sample size for these tests. Data provenance is implied to be laboratory testing as part of the manufacturing and submission process, likely conducted in China where the correspondent is located. This is not retrospective clinical data from a specific country, but rather prospective bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. For this type of device and submission, "ground truth" related to expert consensus or clinical judgment on a test set (as would be relevant for an AI device) is not established. The ground truth here is adherence to engineering and biocompatibility standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are relevant for subjective assessments, particularly in clinical image interpretations or similar AI-assisted diagnoses. Here, the tests are objective measurements against established standards.
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 is a medical catheter, not an AI-powered diagnostic or assistive tool. There are no "human readers" interpreting data with or without AI assistance in the context of this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used:
For the non-clinical testing, the "ground truth" is defined by the requirements and specifications within the referenced international and national standards (e.g., ISO 11135, ASTM F88, ISO 10993 series for biocompatibility, ISO 10555-1 for intravascular catheters). The tests determine if the device meets these objective, pre-defined standards.
8. The sample size for the training set:
Not applicable. There is no AI model or "training set" for this device.
9. How the ground truth for the training set was established:
Not applicable, as there is no 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).