← Product Code [LJT](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LJT) · K081311 # POWERPORT IMPLANTED PORT WITH GROSHONG CATHETER (K081311) _C.R. Bard, Inc. · LJT · Jun 4, 2008 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LJT/K081311 ## Device Facts - **Applicant:** C.R. Bard, Inc. - **Product Code:** [LJT](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LJT.md) - **Decision Date:** Jun 4, 2008 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 880.5965 - **Device Class:** Class 2 - **Review Panel:** General Hospital - **Attributes:** Therapeutic ## Indications for Use PowerPort™ devices are totally implanted vascular access devices designed to provide long-term, repeated access to the vascular system. The PowerPort™ implanted port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medication, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. When used with a PowerLoc™ safety infusion set, the PowerPort™ device is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s. ## Device Story PowerPort™ with Groshong® catheter is a totally implanted vascular access device; consists of titanium port and silicone valved catheter connected via cathlock compression fitting. Port features triangular body, purple coloring, and three palpation bumps on septum for identification. Used by clinicians for long-term, repeated vascular access; enables infusion of medications, fluids, nutrition, blood products, and blood sampling. For power injection of contrast media, device must be accessed with Bard PowerLoc™ safety infusion set. System facilitates power injection up to 5 ml/s. Benefits include reliable, repeated vascular access for patients requiring frequent therapy. ## Clinical Evidence Bench testing only. Design verification testing performed per FDA guidance and recognized international standards. Risk management conducted via FMEA per ISO 14971:2007. No clinical data presented. ## Technological Characteristics Titanium port body; silicone Groshong® tipped and valved catheter; cathlock compression fitting. Triangular port shape with three palpation bumps on septum. Power injectable when used with specific safety infusion set. Sterilization method not specified. ## 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 - PowerPort™ Implanted Titanium Port ([K060812](/device/K060812.md)) ## Reference Devices - PowerLoc™ safety infusion set ## 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}------------------------------------------------ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Page 23 of 60 | 510(k) Summary | | | JUN - 4 2008 | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|---------------------------------------------------------------------------------|--------------| | General
Provisions | Submitter Name: | Bard Access Systems, Inc. (BAS)
[Wholly owned subsidiary of C.R. Bard, Inc.] | | | | Address: | 605 N 5600 W
Salt Lake City, UT 84116 | | | | Telephone Number: | (801) 595-0700 ext. 7105 | | | | Fax Number: | (801) 595-5425 | | | | Contact Person: | Ji Hyun Kim | | | | Date of Preparation: | May 30, 2008 | | | | Registration Number: | 3006260740 BAS | | | | | 2212754 C. R. Bard | | | Subject
Device | Trade Name: | PowerPort™ Implanted Port
with Groshong® Catheter | | | | Common/Usual Name: | Implanted Infusion Port & Catheter | | | | Classification Name: | 80 LJT – Subcutaneous, Implanted, Intravascular
Infusion Port & Catheter | | | Predicate
Devices | Trade Name: | PowerPort™ Implanted Titanium Port | | | | Common/Usual Name: | Implanted Infusion Port & Catheter | | | | Classification Name: | 80 LJT – Subcutaneous, Implanted, Intravascular
Infusion Port & Catheter | | | | Premarket Notification: | K060812, clearance date July 14, 2006 | | | Classification | | Class II
21 CFR §880.5965
General Hospital | | | Performance
Standards | | | | | Performance standards have not been established by FDA under section 51-
of the Federal Food, Drug and Cosmetic Act. | | | | | Intended Use | | | | | PowerPort™ devices are totally implanted vascular access devices designed
to provide long-term, repeated access to the vascular system. | | | | | Indications
for Use | | | | | The PowerPort™ implanted port is indicated for patient therapies requiring
repeated access to the vascular system. The port system can be used for
infusion of medication, I.V. fluids, parenteral nutrition solutions, blood
products, and for the withdrawal of blood samples. | | | | | When used with a PowerLoc™ safety infusion set, the PowerPort™ device is
indicated for power injection of contrast media. For power injection of
contrast media, the maximum recommended infusion rate is 5 ml/s. | | | | ## 510(k) Summary K081311 pg 1 of 2 {1}------------------------------------------------ Page 24 of 60 | Device
Description | The subject PowerPort™ implanted port with Groshong™ catheter is a
member of the PowerPort™ series of power injectable implanted ports. The
subject device consists of a titanium port and silicone Groshong® tipped and
valved catheter that is attached to the port with a cathlock compression fitting.
The subject port is distinguishable as a member of BAS's power injectable
port series by the triangular body shape, unique purple coloring, and three
palpation bumps on the septum.
PowerPort™ implanted ports can be used for routine vascular access using a
non-coring access needle. However, for power injection procedures,
PowerPort™ ports must be accessed with a Bard PowerLoc™ safety infusion
set to create a power injectable system. | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Technological
Characteristics | Technological characteristics of the subject PowerPort™ implanted port with
Groshong™ catheter are equivalent to those of the Bard Access Systems
predicate PowerPort™ Implanted Titanium Port [K060812]. | | Safety &
Performance
Tests | No performance standards have been established under Section 514 of the
Food, Drug and Cosmetic Act for this device. However, design verification
testing was performed according to protocols based on the
recommendations/requirements of applicable FDA guidance and FDA
recognized international standards. Verification testing, determined to be
applicable to the safety and efficacy of the device, was shown to meet
predetermined acceptance criteria listed therein. | | Risk management, including a failure modes and effects analysis (FMEA), of
the subject device was conducted in accordance with an internal protocol
based on ISO 14971:2007, Medical Devices - Application of Risk
Management to Medical Devices (General). The analysis did not identify any
new types of safety or efficacy questions for the subject PowerPort™
implanted port with Groshong™ catheter. | | | Summary of
Substantial
Equivalence | Based on the indications for use, technological characteristics, and safety and
performance testing, the subject PowerPort™ implanted port with Groshong™
catheter meets-the-minimum requirements that are considered adequate for
its intended use and is substantially equivalent in design, materials,
sterilization, principles of operation and indications for use to current
commercially available implanted ports cited as predicates. | {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. Public Health Service JUN - 4 2008 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Ji-Hyun Kim Regulatory Affairs Manager C.R. Bard, Incorporated Bard Access Systems, Incorporated 605 North 5600 West Salt Lake City, Utah 84116 Rc: K081311 Trade/Device Name: PowerPort™ Implanted Port with Groshong™ Catheter Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: May 8, 2008 Received: May 9, 2008 Dear Ms. Kim: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register. {3}------------------------------------------------ Page 2 - Ms. Kim Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Clive Chiu Lin, Ph.D. Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Indications for Use Statement 510(k) Number (if known): Ko81311 Device Name: PowerPort™ Implanted Port with Groshong™ Catheter Indications for Use: The PowerPort™ implanted port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medication, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. When used with a PowerLoc™ safety infusion set, the PowerPort™ device is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s. Prescription Use V Over-The-Counter Use AND/OR (Part 21 CFR §801 Subpart D) (21 CFR §801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Antony Lo huaton (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: 5981311 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LJT/K081311](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LJT/K081311) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com