TRIMPORT IMPLANTABLE ACCESS SYSTEM (MODIFICATION) by GERARD MEDICAL ENTERPRISES, INC.

The Gerard Medical, Inc. TrimPort Implantable Access System is precision engineered to provide repeated access to the vascular system for both parenteral delivery of fluids and the withdrawal of venous blood.

Device Description

The implantable segments of the TrimPort System and comparable devices are the portal, the radiopaque catheter, and a locking catheter connector.

AI/ML Overview

The provided text describes a medical device called TrimPort (K954258), an implanted vascular access system. However, it does not contain information about acceptance criteria, device performance metrics, or a study that proves the device meets specific acceptance criteria in the manner requested by the prompt (e.g., sample size, expert qualifications, adjudication methods).

The text focuses on:

Device Description and Intended Usage: Explains what the TrimPort is and how it's used.
Device Design, Testing, and Potential Adverse Occurrences: Discusses design considerations and instructions to mitigate potential issues like catheter disconnection, system leaks, and system occlusions. It mentions internal testing ("standard usage and extreme misuse tests") but provides no specific data or methodology.

Therefore, I cannot generate the requested table and study details. The information required (acceptance criteria, specific performance metrics, sample sizes for testing/training, ground truth establishment, expert details, study design like MRMC or standalone performance) is not present in the provided text.

Summary

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K954258

Summary of Safety and Effectiveness Information 4 .

Gerard Medical, Inc. Company Name and Address: 6 City Depot Rd. P.O. Box 940 Charlton City, MA 01508

Company Telephone No.: (508) 248-1562

Richard Cayer, Jr. Company Contact Name:

Summary Date: May 8, 1996

Proprietary Name: TrimPort

Implanted Vascular Access System Common or Usual Name:

Implanted Subcutaneous IV Catheter Classification Name:

Class: Unclassified

Legally Marketed Substantially Equivalent Devices:

Manufactured by Ideas for Medicine Inc. Ideas' Port.

Manufactured by Strato LifePort with PolyCath Catheter. Medical Corp.

Device Description and Intended Usage:

The implantable segments of the TrimPort System and comparable devices are the portal, the radiopaque catheter, and a locking catheter connector.

The small veins in one's arms and hands can become severely damaged when subjected to frequent needle punctures and/or Usage of a TrimPort device, which is irritating fluids. implanted beneath the skin, frees patients from the discomfort and potential damage to veins from repeated injections into them.

The TrimPort catheter is implanted into a large blood vessel so that fluids can be introduced or blood withdrawn without the necessity for repeated injections into the patient's vein.

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Once the implanted TrimPort is ready for use, the physician or nurse will cleanse the skin at the implantation site and will of narso will orcation by simply feeling the unobtrusive but clear outline of its top rim. A needle specific to this purpose will be inserted gently through the skin into the portal of the TrimPort, where it will remain throughout the fluid delivery-withdrawal process.

Device Design, Testing, and Potential Adverse Occurrences:

We have reviewed a great quantity of information regarding our own and many competitive implantable vascular access systems. Based on our analysis, we feel that there are specific occurrences that would negatively affect the safety and effectiveness The following is a list of these potential of these devices. adverse occurrences and a summary of what we have done to minimize the risks.

1. Catheter Disconnection:
  We designed an excellent catheter locking mechanism that remains intact, even under extreme conditions. To ensure that the surgeon implanting our TrimPort assembles the locking device properly, we provide clear and complete instructions and diagrams in our "Instructions for Use".
1. System Leak:
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We precisely engineered our TrimPort vascular access systems so that they perform properly (Re: two-way flow, leak tight), even under extreme misuse conditions. To ensure this, we mandate that all new designs must be able to pass each of our standard usage and extreme misuse tests. To minimize the possibility of misuse, we instruct those who access the device to use syringes that are 10cc or larger. This helps to prevent the emission of damaging pressure into Our recommendations to use 10cc or larger the system. syringes and not to exceed 40 psi when using the system is stated several times in our "Instructions for Use". Note that this is also a standard warning in the competitive instruction manuals we have reviewed.

1. System Occlusions: We make numerous references, and provide much direction, in our "Instructions for Use" relative to flushing our device and clearing system occlusions.
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Regulation Number and Section

§ 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.