Search Results

The Invisiport is indicated for any patient requiring repeated access of the vascular system for delivery of medications, nutritional supplementation, fluids, blood products, or the sampling of blood, or for power injection of contrast media when used with a power-injectable Huber needle or infusion set.

The predicate device and subject device are injection ports. An open ended radiopaque catheter is preattached to the predicate and subject devices.

This 510(k) pre-market notification supports the addition of a catheter size variation to the predicate device. The modification to the predicate device to create the subject device is a change in the attached catheter. The predicate device attached catheter is substantially a 6 Fr catheter. The subject device attached catheter is a 4.4 Fr catheter. This change affects the attached catheter.

The provided text is a 510(k) summary for a medical device called Invisiport™, specifically addressing a modification to an existing predicate device. The primary modification is a change in the attached catheter from 6 Fr to 4.4 Fr.

Here's an analysis based on your request, using the information available in the document:

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

The document provides a Table 1: Subject Device Performance Testing Summary which lists tests, a summary of requirements (acceptance criteria surrogates), and the result (Pass).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes used for each of the performance tests. It also does not explicitly state the country of origin of the data or whether the tests were retrospective or prospective. Given that these are bench tests for a 510(k) submission, they are inherently prospective, conducted specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable (N/A). The document describes bench performance tests, not studies involving expert evaluation of clinical data or images to establish ground truth. The "ground truth" for these tests is the physical performance against defined engineering requirements, verified by laboratory measurements.

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

This section is not applicable (N/A). Adjudication methods like 2+1 or 3+1 typically refer to the process of resolving discrepancies among multiple human readers in clinical studies or image interpretations. The tests described are bench tests with objective pass/fail criteria.

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 section is not applicable (N/A). This document describes a 510(k) submission for a physical medical device (an infusion port and catheter), not an AI-powered diagnostic tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study involving human readers and AI assistance was not performed.

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

This section is not applicable (N/A). As mentioned above, this is a physical medical device, not an algorithm or AI system.

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

The ground truth for these performance tests is based on engineering specifications and established test methods. For example, for "Port Leak Test," the ground truth is "Withstand static pressure without leaking." This is verified through direct physical measurement against a predetermined threshold or standard.

8. The sample size for the training set

This section is not applicable (N/A). There is no "training set" mentioned in the context of this device's performance evaluation. Training sets are relevant for machine learning or AI models.

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

This section is not applicable (N/A). As there is no training set for an AI model, the method for establishing its ground truth is irrelevant here.

Ask a specific question about this device

The Invisiport™ is indicated for any patient requiring repeated access of the vascular system for delivery of medications, nutritional supplementation, fluids, blood, blood products, or the sampling of blood, or for power injection of contrast media when used with a power-injectable Huber needle or infusion set.

The Invisiport™ consists of an injection port made from material evaluated for hiocompatibility. The Invisiport has a self-sealing silicone septum. An open ended radiopaque catheter is pre-attached to the port. The silicone septum covers a reservoir that can be accessed with a non-coring Huber type needle. Power injection of contrast for imaging examinations can be performed when the port is accessed with a power-injectable Huber needle or infusion set.

This submission describes the Invisiport™, an implantable infusion port. The acceptance criteria and the study proving it meets these criteria are outlined primarily through a comparison to predicate devices and a statement of compliance with relevant FDA guidance.

1. Table of Acceptance Criteria and Reported Device Performance

The device does not have explicit "acceptance criteria" presented as quantitative thresholds in the provided text for performance outcomes. Instead, substantial equivalence is established by demonstrating that its technical characteristics and performance are comparable to legally marketed predicate devices and that it meets a general standard of efficacy and safety as outlined by FDA guidelines. The table below summarizes the comparison:

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

The document does not explicitly state the sample size used for performance testing (e.g., number of devices tested for catheter length, ID, OD, or other performance characteristics). The tests are described as being conducted "according to methods presented in FDA Guidance," suggesting laboratory-based performance testing rather than human clinical trials. Thus, the concept of "data provenance" (country of origin, retrospective/prospective) as it applies to clinical data is not relevant here.

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

This information is not provided. The study appears to be a technical, laboratory-based performance evaluation against established engineering and material standards, rather than one requiring clinical expert consensus for ground truth.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable to the type of performance testing described. Adjudication methods are typically employed in studies where expert review is needed to establish ground truth for subjective interpretations (e.g., image analysis, clinical diagnoses).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No MRMC comparative effectiveness study was done. The submission is a 510(k) premarket notification for a medical device (implantable infusion port), which typically relies on demonstrating substantial equivalence to predicate devices through technical and laboratory performance testing, rather than comparative clinical efficacy studies with human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable. The Invisiport™ is a physical medical device, not an algorithm or AI system. Therefore, the concept of "standalone" or "algorithm only" performance does not apply.

7. The Type of Ground Truth Used

The "ground truth" for the performance criteria appears to be derived from:

• Predicate Device Specifications: The technical characteristics (e.g., catheter length, ID, OD) are compared directly to ranges or values of legally marketed predicate devices.
• FDA Guidance Documents: Performance tests were conducted "according to methods presented in FDA Guidance," implying a benchmark against established regulatory standards and test methodologies for implanted infusion ports. These guidances establish the "truth" for safety and performance metrics (e.g., biocompatibility testing, sterility, mechanical integrity).

8. The Sample Size for the Training Set

This question is not applicable. The Invisiport™ is a physical medical device, not an AI system. Therefore, there is no "training set" in the context of machine learning.

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

This question is not applicable. As stated above, there is no training set.

Ask a specific question about this device