PORT-A-CATH® II Venous Systems Preconnected with Polyurethane Catheter are indicated when a patient requires repeated venous access for injection or infusion therapy and/or venous blood sampling.

Device Description

PORT-A-CATH® II Venous Systems Preconnected with Polyurethane Catheter are similar in design and function to the current commercially available PORT-A-CATH® II Venous Systems with Polyurethane Catheter.

These systems differ from current commercially available systems in that the portal/catheter connection is made during the manufacturing process, by placing a polyurethane strain relief over the catheter and outlet tubes of the portal.

These systems consist of a standard or low profile portal (titanium/polysulfone) preconnected to a radiopaque catheter (polyurethane) and an access needle. Two catheter options will be available: a 2.6 mm O.D. catheter and a 1.9 mm O.D. catheter. Additionally, systems will be made available with introducer sets.

AI/ML Overview

The provided text does not contain information related to acceptance criteria, device performance, or any clinical studies involving AI or human readers.

The document is a 510(k) summary for a medical device (PORT-A-CATH® II Implantable Venous Access Systems Preconnected with Polyurethane Catheter) dating back to 1996. It details the device's design, intended use, and compares it to similar devices already on the market.

Here's why the requested information cannot be extracted from this document:

Acceptance Criteria & Device Performance: The document states that "In-vitro mechanical testing was conducted" and "results of the testing indicated that PORT-A-CATH II Venous Systems Preconnected with Polyurethane Catheter function according to specification." However, it does not provide any specific quantitative acceptance criteria or reported performance metrics (e.g., durability in cycles, flow rates, etc.). It merely states that the device met unspecified specifications.
Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth (for AI/clinical studies), Training Set Size/Ground Truth: These questions are all relevant to studies involving AI systems, diagnostic algorithms, or complex clinical trials with human interpretation. This 1996 document describes a physical medical device (an implantable port and catheter) and its pre-market clearance process. As such:
- There is no mention of a "test set" or "training set" in the context of data for an AI system.
- There are no "experts" establishing ground truth for image or data interpretation.
- No "adjudication method" for interpreting results from an AI system is mentioned.
- There is no "multi reader multi case (MRMC) comparative effectiveness study" because there is no AI component to compare with human readers.
- No "standalone" performance for an algorithm is described.
- The "ground truth" for the device's performance would be engineering specifications and biocompatibility standards, not clinical outcomes in the way an AI diagnostic tool would have.

Summary of available information:

Study Type: In-vitro mechanical testing and biocompatibility testing.
Purpose of Study: To demonstrate that the preconnected system functions according to specification and that the materials are biocompatible, establishing substantial equivalence to existing devices.
Clinical Studies: "Clinical studies were not deemed necessary" due to similarity in materials, design, and function to current commercially available systems.

Therefore, I cannot provide the requested table or answer the specific questions related to AI studies or detailed clinical trial methodology based on the provided text.

Summary

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K9626695

OCT .. 1 1996

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

PORT-A-CATH® II Implantable Venous Access Systems Preconnected with Polyurethane Catheter

July 8, 1996

GENERAL INFORMATION I.

Applicant's Name and Address:	SIMS Deltec, Inc.1265 Grey Fox RoadSt. Paul, MN 55112
Contact Person:	Lisa StoneManager, Regulatory AffairsTel. (612) 628-7224
Common/Usual Name:	Subcutaneously Implanted Intravascular InfusionPort and Catheter
Proprietary Name:	PORT-A-CATH® II Venous Implantable AccessSystems Preconnected with Polyurethane Catheter
Equivalence Device Comparison:	PORT-A-CATH® II Venous Implantable AccessSystems with Polyurethane Catheter(manufactured by SIMS Deltec, Inc.)PORT-A-CATH® II Dual Lumen VenousImplantable Access Systems Preconnected withSilicone Catheter(manufactured by SIMS Deltec Inc)

II. DEVICE DESCRIPTION

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ロ. INTENDED USE OF DEVICE

PORT-A-CATH® II Venous Systems Preconnected with Polyurethane Catheter are indicated when a patient requires repeated venous access for injection or infusion therapy and/or venous blood sampling.

IV. DEVICE COMPARISON

	PORT-A-CATH® IISystems Preconnectedwith PolyurethaneCatheter	PORT-A-CATH® II DualLumen SystemsPreconnected withSilicone CatheterK955407	PORT-A-CATH® IISystems withPolyurethane CatheterK932840 K942024
MANUFACTURER	SIMS Deltec, Inc.	SIMS Deltec, Inc.	SIMS Deltec, Inc.
INDICATIONS FOR USE	A system is indicated when apatient requires repeatedvenous access for injection(bolus) or infusion therapyand/or venous bloodsampling.	A system is indicated when apatient requires repeatedvenous access for injection(bolus) or infusion therapyand/or venous bloodsampling.	A system is indicated when apatient requires repeatedvenous access for injection(bolus) or infusion therapyand/or venous bloodsampling.
PORTAL DIMENSIONS
	STANDARD14.7 mm30.5 mm11.4 mm	LOW-PROFILE11.5 mm25.0 mm9.5 mm	DUAL-LUMEN16.0 mm50.0 (L) mm x 30.0 (W) mm11.4 mm	STANDARD14.7 mm30.5 mm11.4 mm	LOW PROFILE11.5 mm25.0 mm9.5 mm
MATERIALS
	Portal HousingSeptumCatheter	Titanium/PolysulfoneSiliconePolyurethane	Titanium/PolysulfoneSiliconeSilicone	Titanium/PolysulfoneSiliconePolyurethane
CATHETERDIMENSIONS
	I.D.O.D.Length	1.0 mm1.9 mm76 cm	1.6 mm2.6 mm76 cm	1.1 mm/1.1 mm3.4 mm76 cm	1.0 mm1.9 mm76 cm	1.6 mm2.6 mm76 cm
PORTAL/CATHETERPRECONNECTED		YES		YES	NO

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SUMMARY OF STUDIES V.

A. Functional Testing

In-vitro mechanical testing was conducted according to the "Guidance on 510(k) Submissions for Implanted Infusion Ports," October 1990. Only catheter to portal connection testing was performed, since these preconnected systems are the same as current commercially available systems, except for the connection scheme.

Biocompatibility testing was conducted on all system components.

B. Clinical Studies

Clinical studies were not deemed necessary regarding PORT-A-CATH® II Venous Systems Preconnected with Polyurethane Catheter due to their similarity in materials, design and function to current SIMS Deltec commercially available systems.

C. Conclusions Drawn from the Studies

The results of the testing indicated that PORT-A-CATH II Venous Systems Preconnected with Polyurethane Catheter function according to specification and the materials used in the system are biocompatible. Therefore, these systems are considered acceptable for human use.

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.