BARDPORT TITANIUM PORTS

K050310 · Bard Access Systems, Inc. · LJT · Apr 18, 2005 · General Hospital

Device Facts

• Record ID: K050310
• Device Name: BARDPORT TITANIUM PORTS
• Applicant: Bard Access Systems, Inc.
• Product Code: LJT · General Hospital
• Decision Date: Apr 18, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5965
• Device Class: Class 2

Intended Use

The BardPort® Implanted Ports are totally implantable vascular access devices designed to provide long term repeated access to the vascular system.

Device Story

BardPort® Implanted Ports are totally implantable vascular access devices consisting of a titanium port body and silicone intravascular catheter. The system provides long-term, repeated access to the central venous system for infusion of medications, fluids, parenteral nutrition, blood products, and blood sampling. Access is achieved percutaneously by a clinician using a non-coring needle inserted into the port reservoir. The device acts as a conduit between the external environment and the patient's vascular system. It is intended for clinical use by healthcare professionals.

Clinical Evidence

Bench testing only. Performance verification was conducted per ISO 10555-3:1997 for intravascular catheters and ISO 10993 for biocompatibility. Testing confirmed the device meets all predetermined performance acceptance criteria and is substantially equivalent to the predicate.

Technological Characteristics

Titanium port body; silicone intravascular catheters (6.6 Fr and 9.6 Fr). Design includes suture holes/slots. Connectivity: None (implanted). Sterilization: Not specified. Standards: ISO 10555-3:1997 (catheters), ISO 10993 (biocompatibility).

Indications for Use

Indicated for patients requiring repeated vascular access for infusion of medications, I.V. fluids, parenteral nutrition, blood products, and blood withdrawal.

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

• BardPort® Implanted Port (K870260)

Submission Summary (Full Text)

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# APR 1 8 2005

Single Lume Special 510

## Section 6

## 510(k) Summary

## Single Lumen Titanium Implanted Ports

## 510(k) Summary of Safety and Effectiveness Information 21CFR 807.92

### Submitter Information 6.1

| Submitter Name: | Bard Access Systems, Inc. (BAS) |
|----------------------|---------------------------------|
| | [Subsidiary of C.R. Bard, Inc.] |
| Address: | 5425 W. Amelia Earhart Drive |
| | Salt Lake City, UT 84116 |
| Telephone Number: | [phone], Ext. 5541 |
| Fax Number: | [phone] |
| Contact Person: | Michaela Rivkowich |
| Date of Preparation: | February 7, 2005 |

#### 6.2 Device Name

| Device Name: | BardPort® Implanted Port |
|----------------------|-----------------------------------------------------------------|
| Trade Name: | Titanium Port, Titanium Low-Profile Port |
| Catheter: | 6.6 Fr and 9.6 Fr Open-Ended Silicone Intravascular Catheters |
| Common/Usual Name: | Titanium Subcutaneous Port & Catheter |
| Classification Name: | 80LJT - Port & Catheter, Implanted, Subcutaneous, Intravascular |
| | 21 CFR 880.5965 -- Subcutaneous, Implanted, Intravascular |
| | Infusion Port and Catheter, Class II ' |

#### Predicate Device Name 6.3

| Device Name: | BardPort ® Implanted Port |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | Titanium Port, Titanium Low-Profile Port |
| Catheter: | 6.6 Fr and 9.6 Fr Open-Ended Silicone Intravascular Catheters |
| Common/Usual Name: | Titanium Subcutaneous Port & Catheter |
| Classification Name: | 80LJT - Port & Catheter, Implanted, Subcutaneous, Intravascular<br>21 CFR 880.5965 - Subcutaneous, Implanted, Intravascular<br>Infusion Port and Catheter, Class II |
| Premarket Notification: | K870260, concurrence date - April 15, 1987 |

#### Device Description 6.4

### Principle of Operation

I Thiciple of Operation
There are no new operating principles. The Titanium Low Profile Ports have the same basic, fundamental scientific technology as the predicate devices. Access to the port is made percutaneously with a non-coring needle that enters the port reservoir via the silicone 13 made perculaneously with a not vering might system is provided through a catheter attached to the port. The port system serves as a conduit for fluids into, and out of, the central venous system.

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### Port

- The Titanium Implanted Port is the largest of the BardPort® single lumen titanium port . family. The port body consists of titanium base and top with a round shape design. The port has four suture slots and two suture holes that are silicone encapsulated.
- The Titanium Low Profile Implanted Port is a modified, slightly smaller version of the . Titanium Implanted Port. The port body consists of titanium base and top with a round shape design. The port has six unfilled suture holes.

### Catheter

- The Titanium Implanted Port is available with attachable or pre-attached 6.6 and 9.6 Fr . open-ended silicone intravascular catheters.
- The Titanium Low Profile Port is available with attachable or pre-attached 6.6 Fr open-. ended silicone intravascular catheter

#### 6.5 Intended Use

The BardPort® Implanted Ports are totally implantable vascular access devices designed to provide long term repeated access to the vascular system.

#### હ. ર Indications for Use

The BardPort® Implanted 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.

#### 6.7 Summary of Technological Characteristics in Relation to the Predicate Device

## Does the new device have the same technological characteristics, e.g. design, material, etc.?

Yes with the exception of differences in the catheter depth marking configuration as compared to the predicate Titanium Port with 6.6 Fr and 9.6 Fr open-ended silicone catheters and Titanium Low Profile Port with 6.6 Fr open-ended silicone catheter. However, the basic fundamental scientific technology of the ports has not changed.

### Could the new characteristics affect safety or effectiveness?

Yes. The above features could affect safety or effectiveness of the device.

Do the new characteristics raise new types of safety and effectiveness questions?

No. There are no new issues of safety and effectiveness.

### Do accepted scientific methods exist for assessing effects of the new characteristics?

Yes. The following international standard was used to evaluate the device's performance:

- . ISO 10555-3:1997, Sterile, Single-Use Intravascular Catheters, Central venous catheters
Biocompatibility requirements of ISO 10993 Biological Evaluation of Medical Devices Part-1: Evaluation and Testing and the FDA Modified ISO 10993 Test Profile for a long term implanted device that exhibits tissue contact (port and catheter), indirect blood contact (port)

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and direct blood contact (catheter) were met. All materials used in the manufacture of the subject devices were previously cleared for similar applications by Bard Access Systems,

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

Yes. Verification testing was performed according to protocols based on the above referenced international standard, as well as in accordance with in-house protocols.

### Do performance data demonstrate equivalence?

Yes. Performance data gathered in design verification testing demonstrated that the Titanium and Titanium Low Profile Ports with 6.6 Fr and 9.6 Fr silicone catheters are substantially equivalent to the predicate Titanium and Titanium Low Profile Ports and met predetermined acceptance criteria, and the risks associated with use of the new device were found acceptable when evaluated by FMEA.

### Conclusion

The Titanium Port with 6.6 Fr and 9.6 Fr open-ended silicone intravascular catheters and Titanium Low Profile Port with 6.6 Fr open-ended silicone intravascular catheter meet all predetermined performance acceptance criteria of the testing performed and, based on FDA 's decision tree, are substantially equivalent to the predicate Titanium and Titanium Low Profile Ports, covered by K870260, concurrence date April 15, 1987.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized representation of a human figure, consisting of three curved lines that suggest a head, body, and legs.

APR ] & 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Michaela Rivkowich Senior Regulatory Affairs Specialist Bard Access Systems, Incorporated 5425 West Amelia Earhart Drive Salt Lake City, Utah 84116

Re: K050310

Trade/Device Name: Bardport® Single Lumen Titanium Implanted Ports Regulation Number: 880.5965 Regulation Namber Scubcutaneous Implanted Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: April 5, 2005 Received: April 6, 2005

Dear Ms. Rivkowich:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your betermined the device is substantially equivalent (for the referenced above and in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device merstate commerce prior contribute been reclassified in accordance with the provisions of Amendinents, or to de rood Cosmetic Act (Act) that do not require approval of a premarket the Federal Food, Drag, and Ooou may, therefore, market the device, subject to the general approval appreation (the Act. The general controls provisions of the Act include controls provisions of an 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 If your device is classinod (500 houlditional controls. Existing major regulations affecting (I MA), it may of subject to Bach ade of Federal Regulations, Title 21, Parts 800 to 898. In your device can be foundsh further announcements concerning your device in the Ecderal Register.

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Page 2 – Ms. Rivkowich

Please be advised that FDA's issuance of a substantial equivalence determination does not I Ticast be advised that 1 Da determination that your device complies with other requirements modi mat 1 DT mas made a works and regulations administered by other Federal agencies. Of the Act of ally I oderal backs is requirements, including, but not limited to: registration r out inust compry with art 807); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 CF Real 007), as ality systems (QS) regulation (21 CFR Part 820); and if requirements as set forth in the quality is nontrol 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) This icter will anow you to obja finding of substantial equivalence of your device to a premarket notification. The PDF 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), rryou desire specific at 110 Tompliance 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 may obtain 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 yours,

Stren Vunnes

Chiu Lin, Ph.D. Director Division of Ancsthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Section 1.2

### INDICATION(S) FOR USE STATEMENT

510(k) Number (if known): KOS 6310

Device Name: Single Lumen Titanium Implanted Ports

Indications for Use:

The BardPort® Implanted 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 X (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 NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

A
Division Sign-Off

Seneral Hospital, svices

510(K) No.: K42543/4

Orsision of Ano-

Infection Con

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