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510(k) Data Aggregation
(361 days)
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).
| Test | Summary of Requirement (Acceptance Criteria) | Reported Device Performance (Result) |
|---|---|---|
| 1. Visual | Verify markings on OD with numbers at applicable increments. | Pass |
| 2. Dimensional | Verify critical dimensions. | Pass |
| 3. Clearance Parameters | Verify clearance volume. | Pass |
| 4. Port to Catheter Connection Test | Lateral and Axial (Dry): No leaks after static load. | |
| Lateral and Axial (Wet): No leaks after port exposed to wet medium and a static load. | ||
| Cycle Lateral and Axial: No leaks after cyclic load. | ||
| Creep: No leaks after minimal load. | ||
| Load to Failure, Axial and Lateral. | Pass | |
| 5. Port Leak Test | Withstand static pressure without leaking for both intermittent and continuous pressure testing. | Pass |
| 6. Power Injection Flow Rate | Verify flow rate under power injection conditions with a set viscosity and flow. | 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.
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