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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.

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.

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The Argyle™ Polyurethane Umbilical Vessel Catheter is intended for short-term vascular access via umbilical vessels in neonatal patients.

The Argyle™ Polyurethane Umbilical Vessel Catheter is a single-lumen catheter made of a polyurethane catheter tube which is insert molded to a polypropylene hub. The insertion tip of the catheter has been heat melted to form a smooth, rounded tip to reduce tissue trauma upon insertion. Encapsulated within the catheter walls are three barium sulfate strips spaced 120° apart, which run the length of the catheter. 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 25 cm from the tip. Catheter placement must be confirmed by x-ray. The Argyle Polyurethane Umbilical Vessel Catheter will continue to be available in three sizes: 2.5 Fr.; 3.5 Fr.; and 5 Fr. Each device will continue to be packaged in a Tyvek pouch; 10 pouches are packaged in a carton. The Argyle Polyurethane Umbilical Vessel Catheter does not contain DEHP and is Ethylene Oxide sterilized. The product and packaging is not made of natural rubber latex.

The provided document is a 510(k) summary for a medical device called the Argyle™ Polyurethane Umbilical Vessel Catheter. It describes the device, its intended use, and states that it has undergone non-clinical performance testing to demonstrate substantial equivalence to a predicate device.

Crucially, this document notes that no clinical testing was performed for the determination of substantial equivalence (Section 8. Clinical Data).

Therefore, I cannot provide information on acceptance criteria and a study that proves the device meets those criteria from this document. The device's approval was based on non-clinical performance data (laboratory testing) demonstrating that the modified device continues to meet product specifications and is substantially equivalent to an existing device.

The document states:

• "Laboratory testing was completed to support substantial equivalence between the modified device and the current device. The modified device was evaluated to show compliance to the standards requirements as well as performance characteristics related to the modification of the device. The results of the testing show that the modified device continues to meet the requirements of the product specifications and supports the determination of substantial equivalence." (Section 7. Non-Clinical Performance Data)
• "No clinical testing was performed for the determination of substantial equivalence." (Section 8. Clinical Data)

Without clinical data, the concept of "acceptance criteria" and "device performance" in the context of clinical studies, human readers, ground truth established by experts, etc., as requested in your prompt, does not apply to this specific submission. The non-clinical performance data would involve engineering tests (e.g., material strength, fluid flow, biocompatibility) against predetermined specifications, but these are not equivalent to the clinical study parameters you've asked for.

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This product is intended for use in neonatal patients to sample blood, monitor blood pressure, or administer fluids intravenously.

FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER

The provided text is an FDA 510(k) clearance letter for the FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER. This document is a regulatory approval notice and does not contain information about acceptance criteria or a study proving device performance as typically expected for imaging or AI devices. The information provided is:

• Device Name: FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER
• Regulation Number: 21 CFR 880.5200 (Intravascular Catheter)
• Regulatory Class: II
• Product Code: FOS
• Intended Use: For use in neonatal patients to sample blood, monitor blood pressure, or administer fluids intravenously.

Since this is a clearance letter for a physical medical catheter, the type of performance study details requested (e.g., number of experts, AI effect size, ground truth for training set) are not applicable in this context. These questions are typically relevant for AI/ML-based diagnostic devices or devices that involve expert interpretation of data.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or details about a study as described in your request using only the provided text, because this information is not present in the document. The FDA clearance letter confirms the device's substantial equivalence to a predicate device, which is a regulatory standard, not a detailed clinical performance study with specific metrics like sensitivity/specificity or expert adjudication.

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THIS CATHETER IS FOR USE IN NEWBORN PEDIATRIC OR NEONATAL PATIENTS TO SAMPLE BLOOD, MONITOR BLOOD PRESSURE AND ADMINISTER I.V.FLUIDS THROUGH AN UMBILICAL VESSEL.

Not Found

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) clearance letter from the FDA for a "Silicone Umbilical Catheter," confirming its substantial equivalence to a predicate device. It discusses regulatory compliance and indications for use but does not detail device performance, study methodologies, or ground truth establishment.

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THIS PRODUCT IS INTENDED FOR USE IN NEONATAL AND PEDIATRIC PATIENTS TO SAMPLE BLOOD, MONITOR BLOOD PRESSURE OR ADMINISTER FLUIDS INTRAVENOUSLY.

FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER, DUAL LUMEN.

This document is a 510(k) premarket notification approval letter from the FDA for a Silicone Umbilical Catheter, Dual Lumen. It does not contain any information about acceptance criteria or a study proving that a device meets acceptance criteria.

The letter only states that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls provisions of the Act.

Therefore, I cannot provide the requested information based on the provided text.

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The NeoMed Dual Lumen Umbilical Catheter is intended for use in neonatal and pediatric patients to sample blood, monitor blood pressure, or administer fluids intravenously.

The NeoMed Dual Lumen Umbilical Catheter is a silicone dual lumen catheter with natural white barium sulfate included for radiopacity. The device consists of the following main components: a dual lumen umbilical catheter, a hub, and two extension legs, one with a three-way stopcock and the other with an injection site.

This document describes the NeoMed Dual Lumen Umbilical Catheter and its substantial equivalence to a predicate device. It does not contain information about an AI device, therefore, the requested information about acceptance criteria, study details, ground truth establishment, or sample sizes related to AI performance cannot be provided.

The document focuses on the regulatory clearance of a medical device based on its similarity to an existing device (predicate device). The "performance data" mentioned refers to design verification tests demonstrating that the new catheter performs its intended use and is equivalent to the predicate device, not performance against specific acceptance criteria for an AI algorithm.

To explicitly address the numbered points:

1. A table of acceptance criteria and the reported device performance
   • Not applicable as this document is not about an AI device or a study with specific performance metrics against acceptance criteria. The document states, "Bench testing has demonstrated that the NeoMed Dual Lumen Umbilical Catheter is functionally equivalent to predicate NeoMed Single Lumen Umbilical Catheter and that any minor differences do not affect safety or effectiveness." and "Design verification performance test results demonstrate that the NeoMed Dual Lumen Umbilical Catheter performs its intended use and is equivalent to the predicate device."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
   • Not applicable. The document refers to "bench testing" and "design verification performance test results," which implies laboratory testing of the physical device rather than a study using a test set of data. No information on sample size or data provenance is provided.
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)
   • Not applicable. There is no mention of experts establishing ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
   • Not applicable. There is no mention of a test set or adjudication.
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 not an AI device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
   • Not applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
   • Not applicable. Ground truth for an AI algorithm is not relevant to this submission. The "ground truth" equivalent for this device would be its functional performance in laboratory tests, confirming it meets design specifications and operates as intended, similar to the predicate.
8. The sample size for the training set
   • Not applicable. This is not an AI device, so there is no training set.
9. How the ground truth for the training set was established
   • Not applicable. This is not an AI device, so there is no training set or ground truth establishment relevant to AI.

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The Neo Med Single Lumen Umbilical Catheter is intended for use in neonatal and pediatric patients to sample blood , monitor blood parties of administer Fluids intravenously

The NeoMed Single Lumen Umbilical Catheter is a silicone single lumen catheter with natural white barium sulfate included for radiopacity.

The device consists of the following main components: a single lumen umbilical catheter, a hub, and a luer lock connector, and 3 way stopcock with 2 female type connectors.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not specify a sample size for a test set. This submission relies on "bench testing" and a comparison to a predicate device, rather than a clinical study with a distinct test dataset. The data provenance is also not explicitly stated as the evaluation is based on bench testing of the new device and comparison to an established predicate.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable or provided. The evaluation is based on bench testing of the device itself and comparison to a predicate, not on human interpretation or "ground truth" derived from expert consensus on a test set of data.

4. Adjudication Method for the Test Set

This information is not applicable or provided. As there's no defined "test set" requiring expert evaluation, no adjudication method would have been used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence based on bench testing and material biocompatibility.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a sense. The "performance data" described refers to standalone testing of the device itself through "bench testing." This is a medical device, not an AI algorithm, so the concept of an "algorithm only" study doesn't directly apply here. However, the evaluation of the device's functional integrity is conducted independently.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for this device is established primarily through engineering specifications, material science standards (ISO 10993 for biocompatibility), and functional performance metrics demonstrated through bench testing. The "truth" is whether the physical device meets these established performance and safety requirements. The predicate device's established performance serves as a comparative "ground truth" for equivalence.

8. The Sample Size for the Training Set

This information is not applicable or provided. This is not an AI/machine learning device that involves training sets.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable or provided. As this is not an AI/machine learning device, there is no "training set" or corresponding ground truth establishment in that context.

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Venous/arterial umbilical access in infants for infusion through one lumen and monitoring/blood sampling through the second lumen. May also be used for the infusion of incompatable solutions, through separate lumens.

Double Lumen Umbilical Catheter

This document is a 510(k) clearance letter from the FDA for a medical device called the "Vygon Double Lumen Umbilical Catheter" (K981630). It is a regulatory approval document and not a scientific study report.

Therefore, the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies cannot be extracted from this document. This letter confirms that the device is substantially equivalent to legally marketed predicate devices, but it does not provide the specific performance data or the study design used to make that determination.

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