← Product Code [LJT](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LJT) · K992697 # PORT-A-CATH II TRANS-ARTERIAL PERCUTANEOUS SYSTEM (K992697) _Sims Deltec, Inc. · LJT · Nov 18, 1999 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LJT/K992697 ## Device Facts - **Applicant:** Sims Deltec, Inc. - **Product Code:** [LJT](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LJT.md) - **Decision Date:** Nov 18, 1999 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5965 - **Device Class:** Class 2 - **Review Panel:** General Hospital - **Attributes:** Therapeutic ## Indications for Use A system is indicated when a patient requires prolonged or repeated intra-arterial infusion. ## Device Story Implantable access system for intra-arterial infusion; consists of portal with self-sealing silicone septum and single lumen polyurethane catheter. Accessories include access needle, blunt needle, introducer needle, dilator/sheath assembly, guidewire, and syringe. Used in clinical settings by healthcare professionals to provide vascular access for infusion therapy. Device allows percutaneous needle puncture to access the portal, facilitating delivery of infusates directly into the arterial system. Benefits include reliable, repeated access for patients requiring long-term arterial therapy. ## Clinical Evidence No clinical studies were performed. Substantial equivalence is based on design, material, and functional similarity to the predicate PORT-A-CATH® II Low Profile™ Venous System. Biocompatibility testing was conducted to confirm material safety. ## Technological Characteristics Portal: Polysulfone/Titanium; Septum: Silicone; Catheter: Polyurethane. Features ULTRA-LOCK® connector. Dimensions: 11.5 mm portal height, 25.0 mm base, 9.5 mm septum diameter; 1.9 mm catheter I.D., 1.0 mm O.D., 100 cm length. Implantable, non-powered, mechanical access system. ## Regulatory 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 Low Profile™ Venous Implantable Access System ([K942024](/device/K942024.md)) - PORT-A-CATH® Arterial Implantable Access System (K830730B) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ # 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS PORT-A-CATH® II Trans-Arterial Percutaneous System K 992697 August 9, 1999 # 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 | | Common/Usual Name: | Implantable Access System | | Proprietary Name: | PORT-A-CATH® II Trans-Arterial Percutaneous
System | | Equivalence Device Comparison: | PORT-A-CATH® II Low Profile™ Venous
Implantable Access System
PORT-A-CATH® Arterial Implantable Access
System | # II. DEVICE DESCRIPTION A PORT-A-CATH® II Trans-Arterial Percutaneous System consists of a portal with a self-sealing silicone septum, accessible by percutaneous needle puncture, and single lumen catheter. The following accessories are provided with the portal and catheter: PORT-A-CATH® access needle, blunt needle, extra-thin wall introducer needle, dilator/sheath assembly, guidewire and syringe. # III. INTENDED USE OF DEVICE A system is indicated when a patient requires prolonged or repeated intra-arterial infusion. {1}------------------------------------------------ # DEVICE COMPARISON IV. | | PORT-A-CATH® II
Trans-Arterial
Percutaneous System | PORT-A-CATH® II
Low Profile™ System | PORT-A-CATH®
Arterial System | |-------------------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------| | MANUFACTURER | SIMS Deltec, Inc. | SIMS Deltec, Inc. | SIMS Deltec. Inc. | | 510(K) NUMBER | Subject Device | K942024 | K830730B | | INDICATIONS FOR
USE | A system is indicated
when a patient requires
prolonged or repeated
intra-arterial infusion. | A system is indicated
when a patient requires
repeated vascular access
for injection or infusion
therapy and/or venous
blood sampling. | A system is indicated
when a patient requires
repeated vascular access
for injection or infusion
therapy and/or venous
blood sampling. | | PORTAL
DIMENSIONS
(nominal) | | | | | Height
Base
Septum Diameter | 11.5 mm
25.0 mm
9.5 mm | 11.5 mm
25.0 mm
9.5 mm | 13.5 mm
25.4 mm
11.4 mm | | CATHETER
DIMENSIONS
(nominal) | | | | | I.D.
O.D.
Length | 1.9 mm
1.0 mm
100 cm | 1.9 mm
1.0 mm
76 cm | 2.3 mm
0.8 mm
76 cm | | MATERIALS | | | | | Portal
Septum
Catheter | Polysulfone/Titanium
Silicone
Polyurethane | Polysulfone/Titanium
Silicone
Polyurethane | Titanium
Silicone
Silicone | | CATHETER
CONNECTOR | ULTRA-LOCK®
Connector | ULTRA-LOCK®
Connector | CATH-SHIELD®
Connector | {2}------------------------------------------------ ### V. SUMMARY OF STUDIES ### Functional Testing A. Functional testing was not performed because the PORT-A-CATH® II Trans-Arterial Percutaneous System is functionally the same as the PORT-A-CATH® II Low Profile™ Venous System. Biocompatibility testing was conducted on the device. ## B. Clinical Studies Clinical studies were not deemed necessary regarding the PORT-A-CATH® II Trans-Arterial Percutaneous System due to its similarity in materials, design and function to the current PORT-A-CATH® II Low Profile™ Venous System. ## C. Conclusion Drawn from the Studies As noted above, no functional testing or clinical studies were deemed necessary regarding the PORT-A-CATH® II Trans-Arterial Percutaneous System. Biocompatibility testing showed that the device materials were biocompatibile. Therefore, the device is considered acceptable for human use. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, with three curved lines representing the bird's head and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird symbol. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NOV 1 8 1999 Ms. Lisa J. Stone Manager, Requlatory Affairs Smiths Industries Medical Systems SIMS, Deltec 1265 Grey Fox Road St. Paul, Minnesota 55112 K992697 Re : > PORT-A-CATH® II Trans-Arterial Percutaneous Trade Name: System Unclassified Requlatory Class: Product Code: LJT Dated: October 18, 1999 Received: October 19, 1999 Dear Ms. Stone: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in {4}------------------------------------------------ Page 2 - Ms. Stone the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ K992697 wmo K442647 510(k) Number (if known): Device Name: PORT-A-CATH® II Trans-Arterial Percutaneous System Indications for Use: " A system is indicated when a patient requires prolonged or repeated intra-arterial infusion. " (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-The Counter Use __________ Patric Cucenti --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LJT/K992697](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LJT/K992697) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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