(118 days)
Implantation of a port and catheter is indicated whenever patient therapy requires repeated intravascular injection or continuous infusion of fluids, medications, antibiotics, nutitionals and the withdrawal of venous blood samples.
The device is a vascular access system consisting of an low profile port with an injectable septurn and a detached catheter. The low profile port is suitable for arm placement or for implantation in the chest wall. A non-coring, stainless steel needle is supplied with each port.
The provided text describes a 510(k) premarket notification for a medical device, specifically a "Venous Access Port Kit." This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data with detailed performance metrics and ground truth establishment, as would be expected for a novel device requiring efficacy studies.
Therefore, many of the requested categories (acceptance criteria, specific study details like sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, and ground truth methodologies) are not applicable or not available in this summary.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly defined in terms of quantitative performance metrics (e.g., sensitivity, specificity, accuracy). The acceptance criterion for a 510(k) is generally "substantial equivalence" to a predicate device.
- Reported Device Performance: No quantitative performance metrics common to diagnostic or AI device studies are reported. The text states the device "meets the minimum requirements that are considered acceptable for its intended use" and "is substantially equivalent to other currently marketed vascular access port and catheter systems."
| Metric / Criteria | Acceptance Criteria (Not Explicitly Stated for this type of device) | Reported Device Performance |
|---|---|---|
| Primary Goal: | Substantial Equivalence to predicate device | Achieved |
| Efficacy | N/A (implied by substantial equivalence) | N/A |
| Safety | N/A (implied by substantial equivalence and sterilization data) | N/A |
2. Sample size used for the test set and the data provenance
- Not Applicable / Not Available: The summary does not describe a "test set" in the context of performance evaluation for a diagnostic or AI device. The submission relies on demonstrating substantial equivalence to a predicate, not on a new performance study with a test dataset.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable / Not Available: Ground truth establishment by experts for a test set is not described as part of this 510(k) summary.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable / Not Available: No adjudication method is mentioned as there's no described test set requiring expert review.
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 / No: This device is a physical vascular access system, not an AI or diagnostic imaging device that would typically involve human readers or MRMC studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable / No: This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable / Not Available: The concept of "ground truth" as it applies to performance evaluation of diagnostic or AI devices is not relevant to this 510(k) summary for a physical medical device demonstrating substantial equivalence.
8. The sample size for the training set
- Not Applicable / Not Available: There is no "training set" described as this is not an AI or machine learning device.
9. How the ground truth for the training set was established
- Not Applicable / Not Available: As above, no training set or ground truth establishment is described.
Summary of the Study (Based on Provided Text):
The provided text is a summary of a Premarket Notification (510(k)), not a detailed clinical or performance study report. The "study" described herein is the process of demonstrating substantial equivalence to an existing legally marketed device (the "predicate device").
- Device: Venous Access Port Kit (Boston Scientific Corporation)
- Purpose of Submission: To demonstrate that the new device is as safe and effective as a legally marketed predicate device, thereby allowing it to be marketed without requiring a full Pre-Market Approval (PMA) process.
- Predicate Device: "Therex's low profile ports."
- Proof of Substantial Equivalence: The text states, "The proposed port has been shown to be substantially equivalent to Therex's low profile ports." This is based on descriptive characteristics (low profile port, injectable septum, detached catheter, suitable for arm/chest placement, non-coring needle supplied), indications for use (repeated intravascular injection, continuous infusion, withdrawal of venous blood samples), packaging, sterilization (ethylene oxide gas), and pyrogenicity (bacterial endotoxin levels monitored).
- Conclusion: "Based on the information presented, Boston Scientific Corporation believes that the proposed low profile port meets the minimum requirements that are considered acceptable for its intended use and is substantially equivalent to other currently marketed vascular access port and catheter systems."
In essence, this document serves as a regulatory submission arguing that the new device is fundamentally the same as another device already on the market, rather than a report detailing a prospective study with specific performance acceptance criteria and associated experimental data.
§ 880.5965 Subcutaneous, implanted, intravascular infusion port and catheter.
(a)
Identification. A subcutaneous, implanted, intravascular infusion port and catheter is a device that consists of a subcutaneous, implanted reservoir that connects to a long-term intravascular catheter. The device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood. The device consists of a portal body with a resealable septum and outlet made of metal, plastic, or combination of these materials and a long-term intravascular catheter is either preattached to the port or attached to the port at the time of device placement. The device is available in various profiles and sizes and can be of a single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.