Search Results

PORT-A-CATH® and PORT-A-CATH® II POWER P.A.C. Implantable Venous Access Systems: "The PORT-A-CATH® POWER P.A.C. implantable venous access systems are indicated when patient therapy requires repeated vascular access for injection or infusion therapy and/or venous blood sampling. When used with a GRIPPER PLUS® POWER P.A.C. needle, the PORT-A-CATH® POWER P.A.C. implantable venous access system is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/sec." "The PORT-A-CATH® II POWER P.A.C. implantable venous access system is indicated when patient therapy requires repeated vascular access for injection or infusion therapy and/or venous blood sampling. When used with a GRIPPER PLUS® POWER P.A.C. needle, the PORT-A-A-CATH® II POWER P.A.C. implantable venous access system is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/sec."

GRIPPER PLUS® POWER P.A.C. Needle: "The GRIPPER PLUS® POWER P.A.C. needle is indicated for the administration into or withdrawal of fluids from implanted ports. It is designed to help protect against exposure to bloodborne pathogens caused by accidental needlestick injuries. When used with the PORT-A-CATH® POWER P.A.C. and POWER PORT-A-CATH® II POWER P.A.C. implantable venous access systems, the GRIPPER PLUS® POWER P.A.C. needle is also indicated for power injection of contrast media into the central venous system. The maximum recommended infusion rate is 5 ml/sec. for 19 and 20 gauge needles and 3ml/sec. for 22 gauge needles."

The PORT-A-CATH® and PORT-A-CATH® II POWER P.A.C. implantable venous access systems are similar to the current PORT-A-CATH® and PORT-A-CATH® II implantable venous access systems. They both are totally implantable venous access systems designed to permit repeated access to the venous system for the parenteral delivery of medications, fluids, nutritional solutions, and for the sampling of venous blood. However, when used with a GRIPPER PLUS® POWER P.A.C. needle, the PORT-A-CATH® and PORT-A-CATH® II POWER P.A.C. implantable venous access systems are indicated for power injection of contrast media. The PORT-A-CATH® and PORT-A-CATH® II POWER P.A.C. implantable venous access systems can be placed in the chest or arm. The PORT-A-CATH® and PORT-A-CATH® II POWER P.A.C. implantable venous access systems are supplied sterile and non-pyrogenic. All PORT-A-CATH® and PORT-A-CATH® II POWER P.A.C. implantable venous access systems are designed and intended for single patient use only. A system consists of a portal with one or two self-sealing septa and a single or dual lumen catheter and is accessible by percutaneous puncture with a non-coring needle.

The GRIPPER PLUS® POWER P.A.C. needle is similar to the current GRIPPER PLUS® needle, with the addition of an added indication. Both are supplied sterile and non-pyrogenic and are intended for the administration into or withdrawal of fluids from implanted ports. In addition, they both have a passive needle stick protection feature that is designed to help protect against exposure to bloodborne pathogens caused by accidental needlestick injuries. It does not protect against other routes of bloodborne pathogen transmission. The difference between the two however, is when used with a PORT-A-CATH® and/or PORT-A-CATH® II POWER P.A.C. implantable venous access system; the GRIPPER PLUS® POWER P.A.C. needle is indicated for power injection of contrast media.

The provided text describes functional testing for the PORT-A-CATH® POWER P.A.C. Implantable Venous Access System, PORT-A-CATH® II POWER P.A.C. Implantable Venous Access System, and GRIPPER PLUS® POWER P.A.C. Needle, but it does not include information about an AI/ML device or its studies. The document is a 510(k) summary for medical devices, not an AI/ML product.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI device. The document states:

• "Functional testing" was performed, and the devices "met all established acceptance criteria for performance testing and design verification testing." (Page 3)
• "Clinical studies... were deemed not necessary" due to similarity to existing devices. (Page 3)

The document does not elaborate on what these specific acceptance criteria were, nor does it detail the results of the "functional testing" beyond stating that the criteria were met. There is no mention of a "test set" or "ground truth" as would be relevant for an AI study.

Ask a specific question about this device