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The Low Profile Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, IV fluids, parenteral nutrition solutions, blood products and for the withdrawal of blood samples.

When used with a power injectable needle, the Low Profile Port is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 3 ml/sec with a 19G or 20G non-coring power injectable needle or 2 ml/sec with a 22G non-coring power injectable needle.

The Low Profile Port is an implantable device designed to provide repeated access to the vascular system without the trauma associated with multiple vena puncture. The system consists of a self-sealing injection port and a delivery catheter for the receipt and delivery of medications to the selected body site.

The Low Profile Port has a polyoxymethylene body, with or without a titanium insert and a silicone septum.

The base of the port has the letters "CT" to signify that it can be used for power injection on contrast agents. These letters can be visualized through a Scout CT. The lot number is laser etched into the base of the port. The port can be anchored with sutures in the port pocket for secure seating. The suture holes may contain clear silicone to prevent tissue in growth to the suture holes.

The Low Profile Port is offered with the polyurethane catheter either pre-attached by the manufacturer or attachable for application by the inserting physician. The catheter lock provides securement of the catheter to the port. Introduction of solution into the implanted port and catheter system is through a non-coring needle.

Power injection of contrast media, can be safely administered with a 19 or 20 gauge power injectable infusion non-corning needle at a maximum recommended infusion rate of 3ml/sec or a 22 gauge power injectable non-coring needle at a maximum recommended infusion rate of 2 ml/sec. Maximum pressure should not exceed 300 psi.

The Low Profile Port is packaged with the necessary accessories to facilitate catheter insertion.

The port and catheter uses the same components and are manufactured and sterilized at the same manufacturing and sterilization facilities as the predicate device cleared under K072481. The power injection capability is comparable to the currently marketed Jet Port Plus HP Catheter cleared under K072481.

Components will be assembled into standard configurations or configurations specified by the customer and packaged.

• Implantable Port
• Click Connector
• Guide Wire
• Dilator
• Tunneling Needle
• Vein Lifter
• Introducing Needle
• Peel Away Sheath
• Syringe
• Catheter
• Huber Needle
• Instructions for Use
• Nurses' Guide
• Companion Checklist
• Patient Guide
• Patient Chart Sheet
• Patient ID Card and Key Ring Card

The provided text describes the Low Profile Port, an implantable device designed for vascular access. The device's acceptance criteria and the study proving its compliance are detailed in the 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance:

The document indicates that the Low Profile Port "met all established acceptance criteria for performance testing and design verification testing." While specific numerical acceptance criteria values are not explicitly stated in this document, the performance data demonstrated equivalence to the predicate device, the Jet Port Plus HP Catheter System (K072481). The key performance aspect highlighted is the power injection capability.

• Max 2 ml/sec with 22G non-coring power injectable needle.
• Maximum pressure should not exceed 300 psi. |
  | Sterilization | Met requirements of ISO 11135:2007 (Ethylene Oxide Sterilization). |
  | Biocompatibility | Met requirements of ISO-10993, Part 1: Evaluation and Testing for externally communicating, blood-contacting, long-term devices. |
  | Overall Safety & Effectiveness | Demonstrated to be safe and effective for its intended use through performance testing and design verification, substantiating equivalence to the predicate device. |

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

The document states that "Verification testing was performed according to protocols." However, it does not specify the sample size used for the test set or the data provenance (e.g., country of origin of the data, retrospective or prospective).

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

This document does not mention the use of experts to establish a ground truth for a test set. The evaluation relies on design verification and performance testing against established standards and comparison to a predicate device.

4. Adjudication Method for the Test Set:

Not applicable as there is no mention of expert consensus or a specific adjudication method for a test set in this document.

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 device is an implantable medical device (port and catheter), not an artificial intelligence (AI) or imaging analysis device that would typically involve a multi-reader multi-case comparative effectiveness study with human readers.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" in this context is established through compliance with recognized standards and direct comparison of physical and performance characteristics to a legally marketed predicate device.

• Performance data: Direct measurements and tests to ensure the device meets specified functional requirements (e.g., flow rates, pressure limits, material properties).
• Compliance with International Standards: ISO 11135:2007 for sterilization and ISO 10993-1 for biocompatibility.
• Guidance Documents: FDA's Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, dated 3/16/95.
• Equivalence to Predicate Device: The Jet Port Plus HP Catheter System (K072481) serves as the primary "ground truth" for demonstrating substantial equivalence in terms of technology, safety, and effectiveness.

8. The Sample Size for the Training Set:

Not applicable. This document describes a physical medical device, not an AI or machine learning model that would require a training set.

9. How the Ground Truth for the Training Set was Established:

Not applicable. As above, there is no training set for this type of device.

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