POWERPORT IMPLANTABLE PORT

K133335 · C.R. Bard, Inc. · LJT · Feb 14, 2014 · General Hospital

Device Facts

• Record ID: K133335
• Device Name: POWERPORT IMPLANTABLE PORT
• Applicant: C.R. Bard, Inc.
• Product Code: LJT · General Hospital
• Decision Date: Feb 14, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5965
• Device Class: Class 2

Intended Use

Power and Non Power-Injectable Implantable Ports are intended to be an implanted vascular access device designed to provide long-term, repeated access to the vascular system.

Device Story

Implantable vascular access system consisting of rigid housing, self-sealing septum, and distally-valved Groshong® catheter; implanted by physician. Provides repeated vascular access for infusion/withdrawal without daily external catheter care. PowerPort® models support power injection of contrast media when used with specific PowerLoc® safety infusion sets. Device remains implanted long-term; requires periodic maintenance flushing. Clinical study supported extending maintenance flushing interval from 4 weeks to 90 days using saline-only locks. Benefits include reduced frequency of maintenance procedures for patients requiring long-term therapy.

Clinical Evidence

Prospective clinical study at 5 US oncology centers involving adult patients (≥ 21 years) with implanted Bard ports. Evaluated safety of extending maintenance flushing interval to 90 days. Primary endpoint: adverse event rate. Results: 465 saline-only intervals, 28,452 patient-days, 1 adverse event recorded. Incidence rate 0.35/10,000 patient-days (95% CI: 0.01, 1.96).

Technological Characteristics

Implantable port with rigid housing and self-sealing septum; distally-valved Groshong® catheter. No changes to materials or design. Maintenance protocol extended to 90-day saline flush interval.

Indications for Use

Indicated for adult patients (≥ 21 years) requiring repeated vascular access for infusion of medications, I.V. fluids, parenteral nutrition, blood products, and blood withdrawal. PowerPort® models, when used with PowerLoc® Safety Infusion Set, are indicated for power injection of contrast media at rates up to 5 mL/s.

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

• PowerPort® Implantable Port with Groshong® Catheter (K081311)
• PowerPort® Polymeric Port with 8 F Single Lumen ChronoFlex® Catheter (K063377)
• BardPort® Titanium Ports (K050310)
• X-Port® Duo Port (K032044)
• BardPort® X-Port® isp Port (K022983)
• Plastic Low-Profile Subcutaneous Port (K924250)
• Plastic Attachable Dual Port (K912702)
• Cath-Tech Port Implantable Vascular Access System (K880571)
• Hickman Plastic Subcutaneous Port (K873213)

Submission Summary (Full Text)

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(33335

Bard Access Systems, Inc. Ports
with Groshong® Catheter – Extended Maintenance Protocol
with Groshong® Catheter – Extended Maintenance Protocol
Traditional 510(k) Premarket Notification

# ACCESS SYS

## FEB 1 4 2014

Section 5 - 510(k) Summary

### 510(k) Summary 21 CFR 807.92(a)

| | Submitter Name: | Bard Access Systems, Inc. |
|-------------------------|--------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| General<br>Provisions | Address: | 605 North 5600 West<br>Salt Lake City, UT 84116 |
| | Contact Person: | Amy Honey<br>Regulatory Affairs Specialist |
| | Telephone Number: | [phone] |
| | Fax Number: | [phone] |
| | Date of Preparation: | October 15, 2013 |
| Subject<br>Device | Trade Name: | Power and Non Power-Injectable Implantable Ports with<br>Groshong® Catheter |
| | Common Name: | Implanted Infusion Port & Catheter |
| | Classification Name: | LJT - Subcutaneous, Implanted, Intravascular Infusion Port<br>& Catheter |
| | Product Code: | LJT |
| | Regulation: | 21 CFR §880.5965 |
| Predicate<br>Devices | Trade Name: | PowerPort® Implantable Port with Groshong® Catheter |
| | Common Name: | Implanted Infusion Port & Catheter |
| | Classification Name: | LJT - Subcutaneous, Implanted, Intravascular Infusion Port<br>& Catheter |
| | Product Code: | LJT |
| | Regulation: | 21 CFR §880.5965 |
| | Premarket Notification: | K081311 |
| | Trade Name: | PowerPort® Polymeric Port with 8 F Single Lumen<br>ChronoFlex® Catheter |
| | Common Name: | Implanted Infusion Port & Catheter |
| | Classification Name: | LJT - Subcutaneous, Implanted, Intravascular Infusion Port<br>& Catheter |
| | Product Code: | LJT |
| | Regulation: | 21 CFR §880.5965 |
| | Premarket Notification: | K063377 |
| Trade Name: | BardPort® Titanium Ports | |
| Common Name: | Implanted Infusion Port & Catheter | |
| Classification Name: | LJT - Subcutaneous, Implanted, Intravascular Infusion Port & Catheter | |
| Product Code: | LJT | |
| Regulation: | 21 CFR §880.5965 | |
| Premarket Notification: | K050310 | |
| Trade Name: | X-Port® Duo Port | |
| Common Name: | Implanted Infusion Port & Catheter | |
| Classification Name: | LJT - Subcutaneous, Implanted, Intravascular Infusion Port & Catheter | |
| Product Code: | LJT | |
| Regulation: | 21 CFR §880.5965 | |
| Premarket Notification: | K032044 | |
| Trade Name: | BardPort® X-Port® isp Port | |
| Common Name: | Implanted Infusion Port & Catheter | |
| Classification Name: | LJT - Subcutaneous, Implanted, Intravascular Infusion Port & Catheter | |
| Product Code: | LJT | |
| Regulation: | 21 CFR §880.5965 | |
| Premarket Notification: | K022983 | |
| Trade Name: | Plastic Low-Profile Subcutaneous Port | |
| Common Name: | Implanted Infusion Port & Catheter | |
| Classification Name: | LJT - Subcutaneous, Implanted, Intravascular Infusion Port & Catheter | |
| Product Code: | LJT | |
| Regulation: | 21 CFR §880.5965 | |
| Premarket Notification: | K924250 | |
| Trade Name: | Plastic Attachable Dual Port | |
| Common Name: | Implanted Infusion Port & Catheter | |
| Classification Name: | LJT - Subcutaneous, Implanted, Intravascular Infusion Port & Catheter | |
| Product Code: | LJT | |
| Regulation: | 21 CFR §880.5965 | |
| Premarket Notification: | K912702 | |
| Trade Name: | Cath-Tech Port Implantable Vascular Access System | |
| Common Name: | Implanted Infusion Port & Catheter | |
| Classification Name: | LJT - Subcutaneous, Implanted, Intravascular Infusion Port<br>& Catheter | |
| Product Code: | LJT | |
| Regulation: | 21 CFR §880.5965 | |
| Premarket Notification: | K880571 | |
| Trade Name: | Hickman Plastic Subcutaneous Port | |
| Common Name: | Implanted Infusion Port & Catheter | |
| Classification Name: | LJT - Subcutaneous, Implanted, Intravascular Infusion Port<br>& Catheter | |
| Product Code: | LJT | |
| Regulation: | 21 CFR §880.5965 | |
| Premarket Notification: | K873213 | |

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Section 5 - 510(k) Summary

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#### PowerPort®

PowerPort® Implantable Ports are designed to provide repeated access to the vascular system without the need for repeated venipuncture or daily care of an external catheter. Long-Term Implantable Ports consist of a rigid housing and a self-sealing septum. The catheters used with infusion ports are essentially the same design as externalized, stand-alone intravascular catheters. Groshong® catheters are attached to the port by the physician during implantation.

PowerPort® Implantable Ports can be used for routine vascular access using a noncoring access needle. However, for power injection procedures, PowerPort® ports must be accessed with a Bard PowerLoc® Safety Infusion Set (SIS) to create a powerinjectable system.

#### Device Description

#### Non Power-Injectable Ports

Long-Term Implantable Ports are designed to provide repeated access to the vascular system without the need for repeated venipuncture or daily care of an external catheter. Long-Term Implantable Ports consist of a rigid housing and a self-sealing septum. The catheters used with infusion ports are essentially the same design as externalized, stand-alone intravascular catheters. Groshong® catheters are attached to the port by the physician during implantation.

Long-Term Implantable Ports can be used for routine vascular access using a non-coring access needle.

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| Intended Use | Power and Non Power-Injectable Implantable Ports are intended to be an implanted<br>vascular access device designed to provide long-term, repeated access to the vascular<br>system. | |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Indications For<br>Use | PowerPort®<br>The PowerPort® Implantable Port is indicated for patient therapies requiring repeated<br>access to the vascular system. The port system can be used for infusion of medications,<br>I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of<br>blood samples. | |
| | When used with a PowerLoc® Brand Safety Infusion Set, the PowerPort® device is<br>indicated for power injection of contrast media. For power injection of contrast media,<br>the maximum recommended infusion rate is 5 mL/s. | |
| | Non Power-Injectable Ports<br>The BardPort®, SlimPort®, and X-Port® implantable ports are indicated for patient<br>therapies requiring repeated access to the vascular system. The port system can be<br>used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood<br>products, and for the withdrawal of blood samples. | |
| Technological<br>Characteristics | There have been no changes to the technological characteristics or design of the Power<br>and Non Power-Injectable Implantable Ports with Groshong® Catheter; therefore, they<br>are substantially equivalent with respect to basic design and function of the of the of the<br>predicate devices. Extending the maintenance protocol from a four-week flushing<br>period to a 90-day flushing period does not impact the intended use, and has been<br>shown through clinical data not to raise any new questions regarding safety or efficacy. | |
| Safety &<br>Performance<br>Tests: Non-<br>Clinical | Verification and validation testing were not required for this submission. Safety and<br>efficacy of the change was supported through clinical data; no physical testing was<br>required. | |
| | User requirements and use-related risks have been evaluated in and mitigated through<br>a clinical study, as well as in the Instructions for Use. | |

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| Safety &<br>Performance<br>Tests: Clinical | Bard currently recommends that Power and Non Power-Injectable Implantable Ports<br>with Groshong® Catheter be filled with normal saline after each use, and if the port<br>remains unused for long periods of time, the saline lock should be changed by flushing<br>at least every four weeks. Under Institutional Review Board oversight, clinical data were<br>independently collected from patients at five major oncology centers to provide clinical<br>evidence in support of extending the maximum recommended maintenance flushing<br>interval to at least every 90 days for Bard ports with distally-valved (Groshong®)<br>catheters.<br>The study was conducted at five sites in the United States. Study subjects consisted of<br>post-infusional adult males or females ≥ 21 years of age that had a Bard port implanted.<br>The primary endpoint was to compare the rate of adverse events at three time points in<br>Group A versus extended accession intervals in Group B and Group C.<br>Considering solely the saline-only intervals, the study demonstrated that approximately<br>57% of the collected patient-day data represented flushing with saline only. Overall,<br>there were 465 saline-only intervals recorded with 28,452 patient-days of follow-up.<br>Only one adverse event was recorded in the saline-only group, yielding an incidence<br>rate of 0.35 adverse events per 10,000 patient-days, with a 95% Poisson confidence<br>interval (0.01, 1.96).<br>Maintenance flushing of Groshong® port systems has been shown to be safe for a wide<br>variety of time intervals based on the very low adverse event rates noted in the clinical<br>data. An extension of the maintenance flushing schedule from its current label of every<br>four weeks to every 90 days with saline only is recommended. |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of<br>Substantial<br>Equivalence | Based on the indications for use, technological characteristics, and safety and<br>performance testing, the subject Power and Non Power-Injectable Implantable Ports<br>with Groshong® Catheter met the minimum requirements for its intended use and is<br>substantially equivalent in design, materials, sterilization, principles of operation, and<br>indications for use to the predicate devices cited. |

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Image /page/5/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 14, 2014

Bard Access Systems, Incorporated Ms. Amy Honey Regulatory Affairs Specialist 605 North 5600 West Salt Lake City, UT 84116

Re: K133335

Trade/Device Name: PowerPort®, Non Power-Injectable Ports Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port And Catheter Regulatory Class: II Product Code: LJT Dated: October 18, 2013 Received: October 29, 2014

Dear Ms. Honey:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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Page 2 - Ms. Honey

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fdagov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Image /page/6/Picture/8 description: The image shows the name "Erin Freith-S" in a bold, sans-serif font. The name is written in black ink on a white background. The letters are evenly spaced and the name is easy to read. The text appears to be a logo or a brand name.

Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 4 - Indications for Use Statement

#### Indications for Use

510(k) Number (if known): K133335

Device Name:

PowerPort®

Indications for Use:

The PowerPort® Implantable Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, 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 Name:

Non Power-Injectable Ports

Indications for Use:

The BardPort®, SlimPort®, and X-Port® implantable ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR §801 Subpart D) AND/OR

Over-The-Counter Use (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)

Richard C. 2014.02.27 10:55:21 -05'00'

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