POWERPORT POLYMETRIC PORT WITH 8 FR S/L CHRONOFLEX CATHETER

K063377 · C.R. Bard, Inc. · LJT · Jan 25, 2007 · General Hospital

Device Facts

• Record ID: K063377
• Device Name: POWERPORT POLYMETRIC PORT WITH 8 FR S/L CHRONOFLEX CATHETER
• Applicant: C.R. Bard, Inc.
• Product Code: LJT · General Hospital
• Decision Date: Jan 25, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5965
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PowerPort" Polymeric Port is a totally implantable vascular access device designed to provide long-term. repeated access to the vascular system long-term, repeated access to the vascular system.

Device Story

Totally implantable vascular access device; consists of plastic port and 8 Fr open-ended single lumen ChronoFlex® catheter. Triangular port design features three palpation bumps for identification; purple colorants added to port and catheter materials to signify power injectability. Used in clinical settings by physicians for long-term vascular access. Device facilitates infusion of medications, fluids, nutrition, blood products, and blood sampling. When paired with PowerLoc Safety Infusion Set, enables power injection of contrast media. Provides patient benefit through reliable, repeated vascular access while minimizing trauma associated with frequent venipuncture.

Clinical Evidence

Bench testing only. Verification testing performed according to protocols based on FDA guidance for implanted infusion ports and intravascular catheters. Standards utilized include BS/EN/ISO 10555-1, BS/EN/ISO 10555-3, AAMI/ANSI/ISO 11135, and AAMI/ANSI/ISO 10993-1. Performance data demonstrated equivalence to the predicate device.

Technological Characteristics

Totally implantable vascular access port made of polymer; 8 Fr open-ended single lumen ChronoFlex® catheter. Triangular form factor with palpation bumps. Sterilization via ethylene oxide (AAMI/ANSI/ISO 11135). Complies with ISO 10555-1/3 and NF S 94-370 standards. Biocompatibility evaluated per ISO 10993-1.

Indications for Use

Indicated for patients requiring repeated vascular access for infusion of medications, I.V. 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

• PowerPort™ Implanted Titanium Port with 8 Fr ChronoFlex® Catheter (K060812)

Submission Summary (Full Text)

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K06-337

Carpe 1 of 3

PowerPort™ Polymeric Port Traditional 510(k)

## Section 5

## PowerPort™ Implanted Polymeric Port with 8 Fr ChronoFlex® Catheter 510(k) Summary of Safety and Effectiveness 21 CFR 807.92(a)

JAN 2 5 2007

### 5.1 General Information

| Submitter Name: | Bard Access Systems, Inc. (BAS)<br>[Wholly owned Subsidiary of C.R. Bard, Inc.] |
|-----------------------------------------------|---------------------------------------------------------------------------------|
| Address: | 5425 W. Amelia Earhart Drive<br>Salt Lake City, UT 84116 |
| Telephone Number: | [phone] ext. 5541 |
| Fax Number: | [phone] |
| Contact Person: | Michaela Rivkowich |
| Date of Preparation: | November 6, 2006 |
| Registration Number: | 1720496 |
| Additional Registration Numbers:<br>C.R. Bard | 2212754 |

### 5.2 Subject Device Information

| Device Name: | PowerPort ^TM Implanted Polymeric Port with 8 Fr ChronoFlex ^® Catheter |
|-----------------------|---------------------------------------------------------------------------------------------|
| Trade Name: | PowerPort ^TM , ChronoFlex ^® |
| Common/Usual Name: | Implanted Infusion Port and Catheter |
| Classification Name: | Class II, 80 LJT |
| Classification Panel: | Subcutaneous, Implanted, Intravascular Infusion Port and Catheter<br>General Hospital |

### 5.3 Predicate Device Information

| Device Name: | PowerPort™ Implanted Titanium Port with 8 Fr ChronoFlex® Catheter |
|-----------------------|---------------------------------------------------------------------------------------|
| Trade Name: | PowerPort™, ChronoFlex® |
| Common/Usual Name: | Implanted Infusion Port and Catheter |
| Classification Name: | Class II, 80 LJT |
| Classification Panel: | Subcutaneous, Implanted, Intravascular Infusion Port and Catheter<br>General Hospital |

### 5.4 Intended Use

The intended use is the same as for the predicate device.

The PowerPort" Polymeric Port is a totally implantable vascular access device designed to provide
long-term. repeated access to the vascular system long-term, repeated access to the vascular system.

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### Indications for Use ર્ડ

The indications for use are the same as those for the predicate device.

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 medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.

When used with the 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 m}/s.

### Device Description ર્સ્ડર્

The PowerPort™ device consists of a plastic port and an 8 Fr open-ended single lumen ChronoFlex® The rower of - device ocables of a pith a cathlock. The port is triangular in shape and has three palpation bumps to distinguish it as power injectable. Purple colorants have been added to the port and parpater materials to provide the device with an appearance that allows the placing physician to identify the PowerPort device as power injectable.

### Technological Comparison to Predicate Device 5.7

The technological characteristics of the PowerPort™ Polymeric Port and 8 Fr ChronoFlex® Catheter are The teoliners of the se of the predicate PowerPort™ Titanium Port and 8 Fr ChronoFlex® Catheter in terms of intended use, indications for use, application, user population, basic design, performance and labeling.

### 510(k) Substantial Equivalence Decision Tree 5.8

## New device is compared to Marketed Device?

- Pres. PowerPort™ Polymeric Port device is compared to the predicate PowerPort™ Titanium A Port device.
## Does the new device have the same indication statement and the same intended use as the predicate device?

- Yes. The intended use and the indications for use are the same as those for the predicate A device.
- Does the new device have the same technological characteristics, e.g. design, material, etc?
predicate PowerPort™ Titanium Port; however, the fundamental scientific technology of the device has not changed.
### Could the new characteristics affect safety or effectiveness?

- Yes. The design changes may affect safety or effectiveness of the device. A
## Do the new characteristics raise new types of safety and effectiveness questions?

- > No. There are no new types of safety and effectiveness questions.
## Do accepted scientific methods exist for assessing effects of the new characteristics?

- Yes. Testing was based on FDA guidance documents and recognized standards to evaluate A the device's performance:
- Guidance on 510(k) Submissions for Implanted Infusion Ports, dated October 1990 "
- Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term I Intravascular Catheters, dated 3/16/95

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- BS/EN/ISO 10555-1: 1997, Sterile, single-use intravascular catheters, Part 1. General . requirements.
- ISO 10555-1: 1995, Sterile, single-use intravascular catheters, Part 1. General ' requirements, Amendment 1: 1999
- BS/EN/ISO 10555-3: 1997, Sterile, single-use intravascular catheters, Part 3. Central 트 venous catheters
- AAMI/ANSI/ISO 11135: 1994, Medical Devices -- Validation and Routine Control of 1 Ethylene Oxide Sterilization
- AAMI/ANSI/ISO 10993-1: 2003, Biological Evaluation of medical Devices Part 1: l Evaluation and Testing, and the FDA Modified ISO 10993 Test Profile
- NF S 94-370, French Standard, Surgical Implants, implantable catheter chambers, . intravenous, intraarterial, intraperitoneal, intrathecal and epidural use (April 1999)

### Are performance data available to assess effects of new characteristics?

- Yes. Verification testing was performed according to protocols based on the above-A referenced guidance documents recommendations and additional standards.
### Do performance data demonstrate equivalence?

- Yes. Performance data gathered in design verification testing demonstrated that the subject A PowerPort" Polymeric Port device is substantially equivalent to the predicate device, the PowerPort™ Titanium Port, K060812, concurrence date July 14, 2006.

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Image /page/3/Picture/1 description: The image shows a logo with a stylized eagle or bird symbol on the right side. To the left of the bird symbol, there is text arranged vertically, which reads 'DEPARTMENT OF HEALTH AND HUMAN SERVICES'. The logo appears to be a representation of a government agency or organization related to health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

C.R. Bard, Incorporated Mr. Michaela Rivkowich Associate Regulatory Affairs Manager Bard Access Systems, Incorporated 5425 West Amelia Earhart Drive Salt Lake City, Utah 84116

JAN 2 5 2007

Re: K063377

Trade/Device Name: PowerPort™ Implanted Polymeric Port Regulation Number: 880.5965 Regulation Name: Subcutaneous Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: November 6, 2006 Received: November 8, 2006

Dear Mr. Rivkowich:

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 offecting 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 - Mr. Rivkowich

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 proctice 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

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

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2/11-1-77-4 PowerPort™ Polymeric Port Traditional 510(k)

### Section 4

## Indications for Use

510(k) Number (if known): ______________

Device Name: PowerPort™ Implanted Polymeric Port

## 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 medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples,

When used with the PowerLoc " Safety Infusion Set, the PowerPort" device is indicated for power injection of contrast media. For power injection of contrast infusion rate is 5 ml/s.

Prescription Use ਮ (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 OF
NEED OF AND AFFERED AFF AFFEDED) NEEDED)

# Concurrence of CDRH, Office of Device Evaluation (ODE)

::

Anthony D. Avistar

长463377

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