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The Vaxcel™ w/ PASV® Port device is intended for use in patients who require long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. The device is also indicated for blood specimen withdrawal.

The Vaxcel™ w/ PASV® Port device is intended for use in patients who require long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. The device is also indicated for blood specimen withdrawal. The device is available in standard and mini port configurations made of either Titanium or Polysulfone materials.

The provided text describes a Special 510(k) submission for the Vaxcel™ with PASV® Port implantable port system, indicating that the new device is substantially equivalent to a previously cleared predicate device.

Crucially, this document does NOT contain information about acceptance criteria or a study that proves the device meets those criteria in the traditional sense of a clinical performance study with specific metrics (e.g., sensitivity, specificity, accuracy) for a diagnostic or AI-powered device.

Instead, the submission focuses on substantial equivalence to a predicate device. This means the device's safety and effectiveness are established by demonstrating that it is as safe and effective as a legally marketed device that FDA has already cleared.

Therefore, for your request, I will explain why most of the fields are not applicable in this context and what "acceptance criteria" and "study" mean in the context of a 510(k) for an implantable port system.

Summary of Device Acceptance Criteria and Performance (in the context of Substantial Equivalence):

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

Regarding the specific questions about "study" details, most are not applicable for this type of 510(k) submission, which relies on substantial equivalence rather than a de novo clinical performance study for a diagnostic AI 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 (N/A): This type of information is pertinent to a clinical performance study or an AI/diagnostic software validation. For an implantable port system seeking 510(k) clearance via substantial equivalence, the "test set" would primarily refer to data, testing, and comparisons made to demonstrate equivalence to the predicate device, not a patient cohort in a diagnostic AI study. The document mentions "All data gathered," but specifics on sample size for these comparative tests are not provided. Biocompatibility testing often uses standardized methods and laboratory samples, not human clinical test sets in this context.

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 (N/A): This is relevant for diagnostic accuracy studies, particularly in AI. Ground truth for an implantable medical device's safety and effectiveness in a 510(k) context is typically established through engineering tests, material science evaluations, biocompatibility assessments, and comparison to the predicate device's known performance, rather than expert consensus on diagnostic interpretations.

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

• Not Applicable (N/A): Adjudication methods are used in diagnostic studies (especially in AI) to resolve disagreements among multiple expert readers establishing ground truth. This is not relevant for the type of safety and effectiveness evaluation described in this 510(k) summary.

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 (N/A): This device is an implantable port system, not an AI or diagnostic tool designed to assist human readers. Therefore, an MRMC study and AI assistance effect size are irrelevant.

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

• Not Applicable (N/A): Again, this question applies to AI algorithms or diagnostic software, not to an implantable medical device like a port system.

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

• Not Applicable (N/A) in the diagnostic sense: The "ground truth" for this device's safety and effectiveness in the 510(k) context would be established by:
  • Biocompatibility testing per ISO 10993 standards: Demonstrating that the materials are safe for implantation.
  • Engineering and functional testing: Verifying the device performs its intended functions (e.g., maintain patency, permit fluid flow, withdraw blood).
  • Comparison to predicate device: Evidence that the new device performs equivalently to the already legally marketed predicate in terms of safety and effectiveness.
    The document emphasizes that "All data demonstrate this device is biocompatible for its intended use" and that "All data gathered demonstrate this device as substantially equivalent" to the predicate.

8. The sample size for the training set

• Not Applicable (N/A): This is a term used in machine learning and AI development. This document describes an implantable medical device, not an AI model.

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

• Not Applicable (N/A): As with the training set itself, the concept of establishing ground truth for a training set is specific to AI/machine learning, not a medical device seeking clearance via substantial equivalence for its physical properties and intended use.

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The Vaxcel™ w/ PASV® Port device is intended for use in patients who require long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. The device is also indicated for blood specimen withdrawal.

The Vaxcel™ w/ PASV® Port device is intended for use in patients who require long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. The device is also indicated for blood specimen withdrawal.

The provided document is a 510(k) premarket notification summary and FDA clearance letter for a medical device (Vaxcel™ with PASV® implantable port system). It describes the device's intended use and claims substantial equivalence to predicate devices.

However, this document does not contain information about acceptance criteria for device performance, nor does it detail any specific study proving the device meets such criteria.

The core of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing features, materials, general performance, and intended use against the predicate, rather than establishing new performance benchmarks through clinical trials or detailed performance studies with acceptance criteria.

The sections you requested for information about acceptance criteria and a study design are therefore not applicable or available in this document. The document explicitly states:

• "Performance Standards have not been established by FDA under Section 514 of the Food, Drug and Cosmetic Act" for this device type. This means there are no predefined regulatory performance criteria the device must meet for this specific submission.
• The "Summary of Substantial Equivalence" indicates that the device has been tested and compared to the predicate device, and that "All data gathered demonstrate this device as substantially equivalent. No new issues of safety or efficacy have been raised." This comparison forms the basis for clearance, not a study demonstrating achievement of specific performance acceptance criteria.

Therefore, I cannot provide the requested information from this document. If such studies were performed, they would be part of a more detailed 510(k) submission that is generally not made public in its entirety, or they might be internal company testing used to support the substantial equivalence claim.

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The Vaxcel™ w/ PASV® Port device is intended for use in patients who require long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. The device is also indicated for blood specimen withdrawal.

The device is available in standard and mini port configurations made of either Titanium or Polysulfone materials.

The presented text is a 510(k) summary for the Vaxcel™ with PASV® implantable port system. This document outlines the device's intended use, classification, and a summary of substantial equivalence to predicate devices, focusing on biocompatibility and performance. It does not provide details of a clinical study with acceptance criteria and device performance in the way a diagnostic or treatment efficacy study would.

Instead, the submission demonstrates substantial equivalence to already legally marketed predicate devices. This means the device is considered as safe and effective as a legally marketed device that does not require premarket approval.

Therefore, many of the specific questions about clinical study details, such as sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, and standalone performance, are not applicable in the context of this 510(k) submission.

Here's the information that can be extracted or deduced from the provided text:

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

2. Sample size used for the test set and the data provenance: Not applicable. This is a 510(k) substantial equivalence submission, not a stand-alone clinical study with a defined test set as would be for a diagnostic or treatment device. The "testing" referred to is likely in-vitro testing for biocompatibility and engineering performance comparisons to the predicate, rather than human subject testing in the traditional sense for effectiveness.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for a substantial equivalence submission of this nature. The determination of "ground truth" here is based on regulatory assessment of the device's design, materials, and intended use compared to predicate devices, supported by engineering and biocompatibility data.

4. Adjudication method for the test set: Not applicable.

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-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is an implantable port system, not a software algorithm.

7. The type of ground truth used:

• Predicate Device Performance: The primary "ground truth" for this 510(k) is the established safety and effectiveness of the legally marketed predicate devices (Vaxcel™ Implantable port system, PASV® implantable port system, Vaxcel™ with PASV® PICC).
• Biocompatibility Standards: ISO 10993 standards serve as the "ground truth" for biocompatibility assessment.

8. The sample size for the training set: Not applicable. There is no concept of a "training set" in this type of device submission.

9. How the ground truth for the training set was established: Not applicable.

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