Who can help prepare an FDA 510(k) submission like PORT-A-CATH II VENOUS IMPLANTABLE ACCESS SYSTEMS PRECONNECTED WITH POLYURETHANE CATHETER?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

PORT-A-CATH II VENOUS IMPLANTABLE ACCESS SYSTEMS PRECONNECTED WITH POLYURETHANE CATHETER

Q: Who is the manufacturer of PORT-A-CATH II VENOUS IMPLANTABLE ACCESS SYSTEMS PRECONNECTED WITH POLYURETHANE CATHETER?

Sims Deltec, Inc. filed the 510(k) submission for PORT-A-CATH II VENOUS IMPLANTABLE ACCESS SYSTEMS PRECONNECTED WITH POLYURETHANE CATHETER (K962695).

Q: What is the FDA product code for PORT-A-CATH II VENOUS IMPLANTABLE ACCESS SYSTEMS PRECONNECTED WITH POLYURETHANE CATHETER?

LJT. It is classified under 21 CFR 880.5965 as a Class 2 device in the General Hospital panel.

Q: What is the regulatory pathway for PORT-A-CATH II VENOUS IMPLANTABLE ACCESS SYSTEMS PRECONNECTED WITH POLYURETHANE CATHETER?

510(k) clearance (submission type: Traditional).

K962695 · Sims Deltec, Inc. · LJT · Oct 1, 1996 · General Hospital

Device Facts

Record ID	K962695
Device Name	PORT-A-CATH II VENOUS IMPLANTABLE ACCESS SYSTEMS PRECONNECTED WITH POLYURETHANE CATHETER
Applicant	Sims Deltec, Inc.
Product Code	LJT · General Hospital
Decision Date	Oct 1, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5965
Device Class	Class 2
Attributes	Therapeutic

Intended Use

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 Story

Implantable venous access system consisting of titanium/polysulfone portal and radiopaque polyurethane catheter. Device provides subcutaneous access to venous system for repeated infusion, injection, or blood sampling. Portal/catheter connection is pre-assembled during manufacturing using polyurethane strain relief. System includes access needle and optional introducer sets. Used by clinicians in hospital or clinical settings to facilitate long-term vascular access; reduces need for repeated venipuncture; improves patient comfort and safety during therapy administration.

Clinical Evidence

No clinical data. Bench testing only. In-vitro mechanical testing performed on the catheter-to-portal connection per FDA guidance. Biocompatibility testing conducted on all system components.

Technological Characteristics

Portal housing: titanium/polysulfone. Septum: silicone. Catheter: radiopaque polyurethane. Dimensions: 1.9 mm or 2.6 mm O.D. catheters. Pre-connected portal/catheter assembly with polyurethane strain relief. Mechanical device; no software or energy source.

Indications for Use

Indicated for patients requiring repeated venous access for injection (bolus) or infusion therapy and/or venous blood sampling.

Regulatory Classification

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.

Special Controls

*Classification.* Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.

Predicate Devices

PORT-A-CATH® II Dual Lumen Venous Implantable Access Systems Preconnected with Silicone Catheter (K955407)
PORT-A-CATH® II Venous Implantable Access Systems with Polyurethane Catheter (K932840)
PORT-A-CATH® II Venous Implantable Access Systems with Polyurethane Catheter (K942024)

Related Devices

K994216 — PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM · Sims Deltec, Inc. · Jan 27, 2000
K974471 — PORT-A-CATH- II DUAL-LUMEN LOW PROFILE SYSTEM, PORT-A-CATH II DUAL LUMEN LOW PROFILE SYSTEM WITH INTRODUCER SET, PORT-A · Sims Deltec, Inc. · Jan 22, 1998
K962230 — CELSITE PORT WITH PRECONNECTED CATHETER · B.Braun Medical, Inc. · Dec 16, 1996
K031844 — VAXCEL WITH PASV PORT (LOW PROFILE), MODELS 45-236 AND 45-238 · Boston Scientific Corp · Jul 15, 2003
K961580 — PORT-A-CATH P.A.S. PORT II IMPLANTABLE VENOUS ACCESS SYTEMS · Sims Deltec, Inc. · Sep 20, 1996

Submission Summary (Full Text)

{0} K962695 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 ## I. GENERAL INFORMATION Applicant's Name and Address: SIMS Deltec, Inc. 1265 Grey Fox Road St. Paul, MN 55112 Contact Person: Lisa Stone Manager, Regulatory Affairs Tel. (612) 628-7224 Common/Usual Name: Subcutaneously Implanted Intravascular Infusion Port and Catheter Proprietary Name: PORT-A-CATH® II Venous Implantable Access Systems Preconnected with Polyurethane Catheter Equivalence Device Comparison: PORT-A-CATH® II Venous Implantable Access Systems with Polyurethane Catheter (manufactured by SIMS Deltec, Inc.) PORT-A-CATH® II Dual Lumen Venous Implantable Access Systems Preconnected with Silicone Catheter (manufactured by SIMS Deltec, Inc.) ## II. 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. {1} 510(k) Summary of Safety and Effectiveness Page 2 of 3 ## III. 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® II Systems Preconnected with Polyurethane Catheter | PORT-A-CATH® II Dual Lumen Systems Preconnected with Silicone Catheter K955407 | PORT-A-CATH® II Systems with Polyurethane Catheter K932840 K942024 | | --- | --- | --- | --- | | MANUFACTURER | SIMS Deltec, Inc. | SIMS Deltec, Inc. | SIMS Deltec, Inc. | | INDICATIONS FOR USE | A system is indicated when a patient requires repeated venous access for injection (bolus) or infusion therapy and/or venous blood sampling. | A system is indicated when a patient requires repeated venous access for injection (bolus) or infusion therapy and/or venous blood sampling. | A system is indicated when a patient requires repeated venous access for injection (bolus) or infusion therapy and/or venous blood sampling. | | PORTAL DIMENSIONS | | | | | Height | STANDARD LOW-PROFILE 14.7 mm 11.5 mm | DUAL-LUMEN 16.0 mm | STANDARD LOW-PROFILE 14.7 mm 11.5 mm | | Base | 30.5 mm 25.0 mm | 50.0 (L) mm x 30.0 (W) mm | 30.5 mm 25.0 mm | | Septum Diameter | 11.4 mm 9.5 mm | 11.4 mm | 11.4 mm 9.5 mm | | MATERIALS | | | | | Portal Housing Septum Catheter | Titanium/Polysulfone Silicone Polyurethane | Titanium/Polysulfone Silicone Silicone | Titanium/Polysulfone Silicone Polyurethane | | CATHETER DIMENSIONS | | | | | I.D. | 1.0 mm 1.6 mm | 1.1 mm/1.1 mm | 1.0 mm 1.6 mm | | O.D. | 1.9 mm 2.6 mm | 3.4 mm | 1.9 mm 2.6 mm | | Length | 76 cm 76 cm | 76 cm | 76 cm 76 cm | | PORTAL/CATHETER PRECONNECTED | YES | YES | NO | {2} 510(k) Summary of Safety and Effectiveness Page 3 of 3 # V. SUMMARY OF STUDIES ## 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.