POWERPORT CLEARVUE SLIM IMPLANTABLE PORT

K122899 · C.R. Bard, Inc. · LJT · Nov 15, 2012 · General Hospital

Device Facts

• Record ID: K122899
• Device Name: POWERPORT CLEARVUE SLIM IMPLANTABLE PORT
• Applicant: C.R. Bard, Inc.
• Product Code: LJT · General Hospital
• Decision Date: Nov 15, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5965
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PowerPort® ClearVUE® Slim Implantable Port with 8F Polyurethane Catheter is intended to be an implanted vascular access device designed to provide long-term, repeated access to the vascular system.

Device Story

Implantable vascular access port; consists of hard plastic port body and 8F polyurethane catheter; attached via catheter lock compression fitting. Triangular body shape; three palpation bumps on septum. Used for long-term, repeated vascular access; infusion of medications, fluids, nutrition, blood products; blood withdrawal. Operated by clinicians in clinical settings. For power injection of contrast media, must be accessed with Bard PowerLoc® Safety Infusion Set (SIS). Output is delivery of fluids/medications or withdrawal of blood samples. Benefits include reliable, repeated vascular access for patients requiring frequent therapy.

Clinical Evidence

Bench testing only. Verification testing performed per 21 CFR 820.30, including MR safety (ASTM F2503, F2052, F2119, F2182, F2213), catheter requirements (ISO 10555-1, ISO 10555-3), sterilization (ISO 11135-1), biocompatibility (ISO 10993-1, ISO 10993-7), and bacterial endotoxins (AAMI ST72). Risk management conducted per ISO 14971.

Technological Characteristics

Hard plastic port body; 8F polyurethane catheter; catheter lock compression fitting. Triangular shape with three palpation bumps. Sterilized via ethylene oxide. Complies with ISO 10555-1/3, ISO 10993-1/7, and ASTM standards for MR safety.

Indications for Use

Indicated for patients requiring repeated vascular access for infusion of medications, IV fluids, parenteral nutrition, blood products, and blood withdrawal. When used with PowerLoc® Safety Infusion Set, indicated for power injection of contrast media at max rate 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

• Titanium PowerPort® isp with 8F Polyurethane Catheter

Submission Summary (Full Text)

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K122899

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Section 5 – 510(k) Summary

Bard Access Systems, Inc.
PowerPort® ClearVUE® Slim Implantable Port
with 8F Polyurethane Catheter
Traditional 510(k) Premarket Notification

Image /page/0/Picture/3 description: The image shows the logo for BARD ACCESS SYSTEMS. The word "BARD" is in large, bold, sans-serif font. Below it, in a smaller font, are the words "ACCESS SYSTEMS."

NOV 15 2012

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

| General<br>Provisions | Submitter Name: | Bard Access Systems, Inc. |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| | Address: | 605 North 5600 West<br>Salt Lake City, UT 84116 |
| | Contact Person: | Amy J. Honey<br>Regulatory Affairs Specialist |
| | Telephone Number: | [phone] |
| | Fax Number: | [phone] |
| | Date of Preparation: | September 19, 2012 |
| Subject<br>Device | Trade Name: | PowerPort® ClearVUE® Slim Implantable Port with 8F |
| | Common Name: | Polyurethane Catheter |
| | Classification Name: | Implanted Infusion Port & Catheter |
| | Product Code/<br>Regulation: | LIT/21 CFR §880.5965 |
| Predicate Device | Trade Name: | Titanium PowerPort® isp with 8F Polyurethane Catheter |
| | Common Name: | Implanted Infusion Port & Catheter |
| | Classification Name: | LIT - Subcutaneous, Implanted, Intravascular Infusion<br>Port & Catheter |
| | Product Code/<br>Regulation: | LIT/21 CFR §880.5965 |
| Device<br>Description | The PowerPort® ClearVUE® Slim with 8F Polyurethane Catheter is a member of<br>the PowerPort® series of power-injectable implanted ports. The subject device<br>consists of a hard plastic port and 8F polyurethane catheter that is attached to<br>the port with a catheter lock compression fitting. The subject device is<br>distinguishable as a member of BAS's power-injectable port series by the<br>triangular body shape and three palpation bumps on the septum. | |
| | PowerPort® implanted ports can be used for routine vascular access using a non-<br>coring access needle. However, for power injection procedures, PowerPort® ports<br>must be accessed with a Bard PowerLoc® Safety Infusion Set (SIS) to create a<br>power-injectable system. | |
| Intended Use | The PowerPort® ClearVUE® Slim Implantable Port with 8F Polyurethane Catheter<br>is intended to be an implanted vascular access device designed to provide long-<br>term, repeated access to the vascular system. | |
| Indications For<br>Use | The PowerPort® ClearVUE® Slim Implantable Port with 8F Polyurethane Catheter<br>is indicated for patient therapies requiring repeated access to the vascular<br>system. The port system can be used for infusion of medications, I.V. fluids,<br>parenteral nutrition solutions, blood products, and for the withdrawal of blood<br>samples. When used with a PowerLoc® Safety Infusion Set (SIS), the PowerPort®<br>device is indicated for power injection of contrast media. For power injection of<br>contrast media, the maximum recommended infusion rate is 5 mL/s. | |
| Technological<br>Characteristics | Technological characteristics of the PowerPort® ClearVUE® Slim Implantable Port<br>with 8F Polyurethane Catheter are substantially equivalent with respect to basic<br>design and function of the Titanium PowerPort® isp with 8F Polyurethane<br>Catheter. The differences between the two devices do not impact the intended<br>use, and do not raise any new questions regarding safety or efficacy. | |
| Safety &<br>Performance<br>Tests | Verification testing has been performed in accordance with Design Controls per<br>21 CFR §820.30. The following guidance documents and standards in conjunction<br>with in-house protocols were used to determine appropriate methods for<br>evaluating the performance of the device:<br>Guidance on 510(k) Submissions for Implanted Infusion Ports;<br>October, 1990 Guidance – Establishing Safety and Compatibility of Passive Implants<br>in the Magnetic Resonance (MR) Environment; August 21, 2008 ASTM F2503: 2008, Standard Practice for Marking Medical Devices<br>and Other Items for Safety in the Magnetic Resonance (MR)<br>Environment ASTM F 2052: 2006, Standard Test Methods for Measurement of<br>Magnetically Induced Displacement Force on Medical Devices in the<br>Magnetic Resonance Environment ASTM F2119: 2007, Standard Test Method for Evaluation of MR<br>Image Artifacts from Passive Implants ASTM F2182 Rev A: 2011, Standard Test Method for Measurement of<br>Radio Frequency Induced Heating On or Near Passive Implants During<br>Magnetic Resonance Imaging ASTM F2213: 2006 (R2011),Standard Test Method for Measurement<br>of Magnetically Induced Torque on Medical Devices in the Magnetic<br>Resonance Environment ISO 10555-1/Amd 1/ Amd 2: 1195/1999/2009, Sterile, Single-Use<br>Intravascular Catheters, Part 1: General Requirements BS/EN/ISO 10555-3: 1996 Cor 1:2002, Sterile, Single-Use Intravascular | |

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Catheters, Part 3: Central Venous Catheters AAMI/ANSI/ISO 11135-1: 2007, Sterilization of Healthcare Products – . Ethylene Oxide – Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices AAMI/ANSI/ISO 10993-1/Cor 1: 2009/2010, Biological Evaluation of . Medical Devices Part 1: Evaluation and Testing, and the FDA Modified ISO 10993 Test Profile AAMI/ANSI/ISO 10993-7:2008, Biological Evaluation for Medical . Devices; Part 7 - Ethylene Oxide Sterilization Residuals USP<161>: Sept. 8, 2009, Transfusion and Infusion Assemblies and ● Similar Medical Devices AAMI ST72, Jan. 1, 2001 (R 2010): Bacterial Endotoxins—Test . Methodologies, Routine Monitoring, and Alternatives to Batch Testing The subject device met all predetermined acceptance criteria derived from the above listed references and demonstrated substantially equivalent performance as compared to the cited predicate device. Risk management, including a failure modes and effects analysis (FMEA) of the subject device, was conducted in accordance with ISO 14971: 2009, Medical Devices - Risk Management for Medical Devices. Based on the indications for use, technological characteristics, and safety and performance testing, the subject PowerPort ClearVUE® Slim Implantable Port Summary of with 8F Polyurethane Catheter meets the minimum requirements that are Substantial considered adequate for its intended use and is substantially equivalent in design, Equivalence materials, sterilization, principles of operation, and indications for use to the predicate device cited.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

## November 15, 2012 .

C.R. Bard, Incorporated Ms. Amy Honey Regulatory Affairs Specialist 605 North 5600 West Salt Lake City, Utah 84116

Re: K122899

Trade/Device Name: PowerPort® ClearVUE® Slim Implantable Port with 8F Polyurethane Catheter Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter

Regulatory Class: II Product Code: LJT Dated: September 19, 2012 Received: September 21, 2012

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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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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industrv/default.htm.

Sincerely vours.

DN: c=US, o=U.S. Government, ou=HHS, DA. ou=People. cn=Anthony D. Watson 342.19200300.100.1.1=1300092402 Date: 2012.11.15 14:01:44 -05'00

Anthony D. Watson, B.S., M.S., M.B.A 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

Bard Access Systems, Inc.
PowerPort® ClearVUE® Slim Implantable Port with 8F Polyurethane Catheter Traditional 510(k) Premarket Notification

### Indications for Use

# K122899

510(k) Number (if known):

PowerPort® ClearVUE® Slim Implantable Port with 8F Polyurethane Catheter

Device Name:

Indications for Use:

The PowerPort® ClearVUE® Slim Implantable Port with 8F Polyurethane Catheter is indicated for The PowerPort" Clear VDE "Sim Insplantable Per The vascular system. The port system can be
patient therapies requiring repeated access to the vascular system. Incoducts a patient therapies requiring repeated access to the rate to nutions, blood products, and used for infusion of medications, I.V. halas; perchers a PowerLoce" Safety infusion Set (SS), the
for the withdrawal of blood samples. When used with a Power interion of for the withdrawal of blood samples. When ease in edia. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s.

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) Digitally signed by Sajjad H. Syed
DN: c=US, o=U.S. Government, ou=HHS, Sajjad H. Syed ou=FDA, ou=People, cn=Sajjad H. Syed, 0.9 2342.19200300.100.1.1=2000601742 Date: 2012.11.15 16:07:57 -05'00' (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

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