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The AngioDynamics, Inc. Morpheus® CT PICC and Procedure Kit is indicated for short or long term peripheral access to the central venous system for intravenous therapy, power injections of contrast media, and allows for central venous pressure monitoring. For blood sampling, infusion, . or therapy use a 4 French or larger catheter. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used.

The AngioDynamics, Inc. Morpheus® PICC and Procedure Kits are currently available in sizes ranging from 3F - 5F Single Lumen and 5F - 7F Dual Lumen Catheters. The catheter shaft has ink markings spaced 1 cm apart. These markings start at the hub and proceed distally to the catheters' tip. The markings provide the physician a guide to use when trimming the catheter to the desired length. The Morpheus® CT PIC Catheter is to be labeled at the following CT Injection Flow Rates:

This 510(k) summary describes a special 510(k) premarket notification for a device modification to the AngioDynamics Morpheus® CT PICC and Procedure Kit. This submission focuses on non-clinical performance data (bench testing) to demonstrate substantial equivalence to predicate devices, particularly regarding the ability to withstand specified CT injection flow rates.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly defined by the reported performance metrics of the various catheter sizes, which are then compared to a predicate device or internal standards to ensure reliability and safety for their intended use, particularly for power injections of contrast media. The device must demonstrate sufficient static and dynamic burst pressure resistance for its labeled CT flow rates.

Note: The acceptance criteria are implicitly met if the device demonstrates these burst pressures at the indicated flow rates, ensuring safe operation within the specified parameters. The "Acceptance Criteria (Implied)" column indicates the functional requirement that the device is intended to meet.

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

The document does not explicitly state the numerical sample size used for each specific test (e.g., number of catheters tested for burst pressure). However, the tests are described as "non-clinical tests" and "bench testing." Therefore, the data provenance is from laboratory tests, not human or patient data. The country of origin for the data is implicitly the United States, given the manufacturer's location and FDA submission. The nature of the data is prospective, as these tests are conducted specifically to evaluate the modified device's performance.

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

Not applicable. This submission relies on non-clinical (bench) testing, not on expert evaluation of clinical data or images. The "ground truth" is established through physical measurements and engineering standards.

4. Adjudication Method for the Test Set

Not applicable. As this involves bench testing, there is no adjudication method in the sense of expert review of discrepancies. The results are physical measurements. Quality control procedures and adherence to test protocols would ensure the reliability of the 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

Not applicable. This is a 510(k) submission for a non-AI medical device (a catheter) and involves non-clinical performance data. Therefore, an MRMC study or AI assistance is irrelevant to this submission.

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

Not applicable. This is a 510(k) submission for a non-AI medical device (a catheter). There is no algorithm or standalone performance in the context of AI.

7. The Type of Ground Truth Used

The "ground truth" in this context is the physical performance characteristics of the catheter, specifically its resistance to burst pressure under various flow conditions. This is established through direct, quantifiable physical measurements in a laboratory setting, such as:

• Pressure readings (psi): Measured by specialized equipment during static and dynamic burst tests.
• Flow rates (mL/sec): Precisely controlled by infusion pumps during testing.
• Observation of catheter integrity: Visual confirmation of whether a burst occurs.

This is a form of engineering/performance data ground truth.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is a physical medical device and not an AI/machine learning model. The modification is evaluated through direct performance testing.

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

Not applicable, as there is no training set for an AI/machine learning model. The product's intended performance is established through engineering design, material selection, and rigorous physical testing.

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The AngioDynamics, Inc. Morpheus™ CT PICC and Procedure Kit is indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections term penpherar aboob to the ocharing, infusion, or therapy use a 4 French or larger catheter.

Not Found

I am sorry, but based on the provided document, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them.

The document is a 510(k) clearance letter from the FDA for a medical device (AngioDynamics, Incorporated Morpheus™ CT PICC and Procedure Kit). This type of document primarily confirms that the FDA has determined the device is substantially equivalent to a legally marketed predicate device.

It does not contain:

1. A table of acceptance criteria or reported device performance.
2. Details about sample sizes, data provenance, number or qualifications of experts, or adjudication methods for any test set.
3. Information about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
4. Information about the type of ground truth used, or the sample size and ground truth establishment for a training set.

The letter focuses on regulatory compliance and the determination of substantial equivalence, not on the specific performance study details that would be found in a clinical study report or a more detailed technical submission.

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The ANGIODYNAMICS, Inc. Morpheus™ PICC and Procedure Kit is indicated for short or long term peripheral access to the central venous system for intravenous therapy, parenteral nutrition, and blood sampling.

Not Found

I apologize, but this document is a 510(k) clearance letter from the FDA to AngioDynamics, Inc. for their Morpheus PICC and Procedure Kit.

It is a regulatory document granting market clearance and does not contain any information about a clinical study, acceptance criteria, or device performance metrics as they relate to a study's results.

Therefore, I cannot extract the requested information regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document indicates that the device is "substantially equivalent" to legally marketed predicate devices, meaning its safety and effectiveness are considered to be at the same level as devices already on the market, but it does not detail the specific performance metrics or studies used to demonstrate this equivalence, other than the general statement of "special 510(k) device modification" which implies some changes were made and reviewed.

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The AngioDynamics, Inc. Morpheus™ PICC and Procedure Kit is indicated for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling,

Not Found

The provided text is a 510(k) clearance letter from the FDA for a medical device: the AngioDynamics, Inc. Morpheus™ PICC and Procedure Kit.

This type of document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as it pertains to AI/ML device testing. It is a regulatory approval document confirming substantial equivalence to a predicate device.

Therefore, I cannot provide the requested information based on the given input. The document confirms:

• Device Name: AngioDynamics, Inc. Morpheus™ PICC and Procedure Kit
• Intended Use: Short or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.
• Regulatory Clearance: 510(k) clearance, indicating substantial equivalence to a legally marketed predicate device.

To answer your questions, one would typically need access to the full 510(k) submission, which would include performance data if it were a novel device requiring such studies, or if it were an AI/ML powered device, which this clearly is not.

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The AngioDynamics, Inc. Morpheus™ PICC and Procedure Kit is indicated for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.

Not Found

This document is not a study report but rather an FDA 510(k) clearance letter for the AngioDynamics, Inc. Morpheus™ PICC and Procedure Kit.

The purpose of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove specific performance criteria through a detailed clinical or technical study as described in the prompt. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics will not be found in this type of document.

Here's what can be extracted from the provided text, and where information is inherently missing:

1. A table of acceptance criteria and the reported device performance

   • Not Applicable. This document does not describe specific performance acceptance criteria or report on device performance based on a study against such criteria. The FDA clearance is based on substantial equivalence to a 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. This document does not mention any specific test set, sample size, or data provenance from a device performance study.

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. This document does not describe a study involving expert truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not Applicable. This document does not describe a study involving 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 a medical device (PICC and Procedure Kit), not an AI diagnostic medical device. No MRMC study is mentioned or relevant here.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

   • Not Applicable. This is not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • Not Applicable. No ground truth is mentioned as this is a device clearance based on substantial equivalence.

8. The sample size for the training set

   • Not Applicable. No training set for an algorithm is mentioned as this is a medical device and not an AI/machine learning product.

9. How the ground truth for the training set was established

   • Not Applicable. No training set information is available or relevant.

Summary based on the provided document:

The provided document is an FDA 510(k) clearance letter for the AngioDynamics, Inc. Morpheus™ PICC and Procedure Kit. This type of clearance indicates that the device has been determined to be substantially equivalent to a legally marketed predicate device.

The clearance letter does not contain information about specific performance acceptance criteria or a study designed to prove the device meets such criteria in the way requested for an AI/diagnostic device. Instead, the basis for clearance is the demonstration of substantial equivalence, which typically involves comparing the new device's technological characteristics, materials, and intended use to an existing predicate device, often through bench testing and sometimes limited clinical data, but not typically a formal study with detailed acceptance criteria and ground truth as outlined in the prompt.

The "Indications for Use" section (Page 3) states: "The AngioDynamics, Inc. Morpheus™ PICC and Procedure Kit is indicated for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling." These are the clinical statements of what the device is intended for, not performance criteria.

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