VITAL-PORT(R) CT VASCULAR ACCESS SYSTEM

K140169 · Cook Incorporated · LJT · May 21, 2014 · General Hospital

Device Facts

• Record ID: K140169
• Device Name: VITAL-PORT(R) CT VASCULAR ACCESS SYSTEM
• Applicant: Cook Incorporated
• Product Code: LJT · General Hospital
• Decision Date: May 21, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5965
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Vital-Port® CT Vascular Access System is indicated for patient therapy requiring repeated vascular access for injection or infusion therapy and/or blood sampling. When used with a power injectable infusion set, Vital-Port® CT Vascular Access Systems are indicated for power injection of contrast media. The maximum pressure limit setting for power injectors used with the Vital-Port® CT may not exceed 325 psi, and the flow rate may not exceed the indicated maximum flow rate.

Device Story

Vital-Port® CT Vascular Access System is an implanted, subcutaneous, intravascular infusion port and catheter. Device facilitates repeated vascular access for infusion therapy, blood sampling, and power injection of contrast media. System comprises a plastic port body (Standard or Petite sizes) and a catheter (silicone or polyurethane). Used in clinical settings by healthcare professionals. Power injection requires compatible infusion sets; maximum pressure limit 325 psi; maximum flow rate 5 ml/sec. Clinicians access the port percutaneously to deliver fluids or withdraw blood. Device provides long-term vascular access, reducing need for repeated venipuncture, thereby improving patient comfort and clinical efficiency.

Clinical Evidence

Bench testing only. Verification testing included dynamic failure flow, instantaneous burst, static burst, puncture life, and cyclic testing. Biocompatibility testing performed per ISO 10993-1:2009 (cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, subacute toxicity, genotoxicity, implantation, and hemocompatibility). Device confirmed MR Conditional.

Technological Characteristics

Implantable infusion port and catheter. Materials: plastic port body, silicone or polyurethane catheters. Dimensions: 6.0 Fr, 7.5 Fr, or 9.5 Fr catheters, 50 cm length. Power injection rated up to 325 psi and 5 ml/sec. MR Conditional. Sterilization method not specified.

Indications for Use

Indicated for patients requiring repeated vascular access for injection, infusion therapy, or blood sampling. When used with power injectable infusion sets, indicated for power injection of contrast media at pressures up to 325 psi.

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

• Vital-Port® Vascular Access System Power Injectable Port (K081425)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Cook Medical. The word "COOK" is in large, bold, white letters on a black background. Below "COOK" is the word "MEDICAL" in smaller, white letters. There is an asterisk after the word "COOK".

750 DANIELS WAY, P.O W.COOKMEDIC.

MAY 2 1 2014

# 510(k) Summary - K140169 Vital-Port® CT Vascular Access System 21 CFR §807.92 Date Prepared: April 22, 2014

## 1. Submitter Information:

Applicant:

Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47404 Phone: [phone] Ext. 2225 Fax: [phone]

Contact:

Contact Address:

Thomas J. Kardos Email: [e-mail] Cook Incorporated 1186 Montgomery Lane Vandergrift PA. 15690 Phone: [phone] Ext. 2225 Fax: [phone]

## 2. Device Information:

| Trade name: | Vital-Port® CT Vascular Access System |
|-----------------|-------------------------------------------------------------------|
| Common name: | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Classification: | Class II |
| Regulation: | 21 CFR 880.5965 |
| | Subcutaneous, implanted, intravascular infusion port and catheter |
| Product Code: | LJT - Port & Catheter, Implanted, Subcutaneous, Intravascular |

## 3. Predicate Device:

The Vital-Port® CT Vascular Access System is substantially equivalent to the following 510(k) cleared devices manufactured by Cook Vascular Incorporated;

Vital-Port® Vascular Access System Power Injectable Port, K081425.

# 4. Device Description:

The Vital-Port® CT Vascular Access System consists of a plastic port body and catheter lock. There are two Vital-Port® CT body sizes, Standard and Petite.

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Image /page/1/Picture/0 description: The image shows the logo for Cook Medical. The word "COOK" is in large, bold, white letters on the top line, with a small trademark symbol to the right of the second "O". Below that, in smaller white letters, is the word "MEDICAL". The background is black.

The catheters offered are: 7.5 or 9.5 Fr. silicone catheters or 6.0 or 7.5 Fr. polyurethane catheters. All catheters are 50 cm in length and are supplied either pre-attached or detached.

| Device Name | Catheter Size and<br>Material | Maximum Flow<br>Rate* | Injection Pressure<br>Limit Setting |
|-----------------------|-------------------------------|-----------------------|-------------------------------------|
| Standard | 9.5 Fr silicone | 5 ml/sec | 325 psi |
| Vital-Port® CT | 7.5 Fr silicone | 5 ml/sec | 325 psi |
| Vital-Port® CT | 7.5 Fr polyurethane | 5 ml/sec | 325 psi |
| Vital-Port® CT | 6.0 Fr polyurethane | 5 ml/sec | 325 psi |
| Petite | 7.5 Fr silicone | 5 ml/sec | 325 psi |
| Petite Vital-Port® CT | 7.5 Fr polyurethane | 5 ml/sec | 325 psi |
| Petite Vital-Port® CT | 6.0 Fr polyurethane | 5 ml/sec | 325 psi |

| Configuration | Description |
|----------------------------|------------------------------------------------------------------------------------|
| Single Lumen | Single lumen catheter for contrast injection |
| Dual Lumen | Dual lumen catheter for contrast injection and saline flush |
| Power Injectable Rated | Catheter is power injectable rated to allow for high flow rates |
| Non-Power Injectable Rated | Catheter is not power injectable rated and should not be used with power injectors |

*Flow rates were achieved using a room temperature infusate equivalent to Omnipaque 300" and a Medrad Injector. Omnipaque 3000 has a viscosity of 11.8 centipoise at room temperature (20 degrees C). A change in the temperature or viscosity of the media will result in a change in achievable flow rate. Omnipaque 300% is a registered trademark of GE Healthcare.

## 5. Intended Use:

The Vital-Port® CT Vascular Access System is indicated for patient therapy requiring repeated vascular access for injection or infusion therapy and/or blood sampling. When used with a power injectable infusion set, Vital-Port® CT Vascular Access Systems are indicated for power injection of contrast media. The maximum pressure limit setting for power injectors used with the Vital-Port® CT may not exceed 325 psi, and the flow rate may not exceed the indicated maximum flow rate.

## 6. Comparison to Predicates:

It has been demonstrated that the Vital-Port® CT Vascular Access System is comparable to the predicate device in terms of intended use, duration of use, principles of operation, technological characteristics, insertion method, anatomical location, and method of sterilization.

## 7. Technological Characteristics:

The Vital-Port® CT Vascular Access System is a single lumen, long-term implantable infusion port catheter intended for in patient therapy requiring repeated vascular access, infusion therapy, power injected diagnostic techniques using contrast media and blood infusion/withdrawal.

The Vital-Port® CT Vascular Access System port body is available in two configurations, Standard and Petite, with either a pre-attached silicone or polyurethane catheter.

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Image /page/2/Picture/0 description: The image shows the logo for Cook Medical. The word "COOK" is in large, bold, white letters on a black background. Below "COOK" is the word "MEDICAL" in smaller, white letters. There is a small asterisk to the right of the word COOK.

To demonstrate reliable design and performance of the Vital-Port® CT Vascular Access System, the following verification testing was performed:

- Dynamic Failure Flow Test Testing demonstrated that the vital port did not fail during . simulated use.
- Instantaneous Burst Test Testing demonstrated that the burst test of the port system met � the acceptance criterion.
- Static Burst Test Testing demonstrated that the static failure pressure was at or above . the acceptance criterion.
- Puncture Life Test Testing demonstrated that the puncture life test met the acceptance . criterion.
- Cyclic Test - Testing demonstrated that the cyclic test met the acceptance criterion
- . MR Safety - Testing demonstrated that the Vital-Port® CT Vascular Access System is MR Conditional.
- Biocompatibility Tests of cytotoxicity, sensitization, intracutaneous reactivity, acute ◆ systemic toxicity, subacute toxicity, genotoxicity, implantation, and hemocompatibility demonstrated the Vital-Port® CT Vascular Access System to be biocompatible. In conformance with the applicable sections of ISO 10993-1:2009, the predetermined acceptance criteria were met.

The results of these tests support a conclusion that the Vital-Port® CT Vascular Access System is as safe and as effective as the predicate device.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure with three arms or extensions reaching upwards.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

### May 21, 2014

Cook. Incorporated Mr. Thomas J. Kardos Vice President, Quality Assurance and Regulatory Affairs 750 Daniels Way Bloomington, IN 47404

Re: K140169

Trade/Device Name: Vital-Port® CT Vascular Access System Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port And Catheter Regulatory Class: II Product Code: LJT Dated: April 22, 2014 Received: April 23, 2014

Dear Mr. Kardos:

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. Ilsting 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 - Mr. Brackett

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.fda.gov/MedicalDevices/Resourcesfor You/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

# Mary S. Runner -S

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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K140169

#### Device Name

Vital-Port® CT Vascular Access System

#### Indications for Use (Describe)

The Vital-Port® CT Vascular Access System is indicated for patient therapy requiring repeated vascular access for injection or infusion therapy and/or blood sampling.

When used with a power injectable infusion set, Vital-Port® CT Vascular Access Systems are indication of contrast media. The maximum pressure limit setting for power injectors used with the Vital-Port® CT may not exceed 325 psi and the indicated maximum flow rate.

Type of Use (Select one or both, as applicable)

[] Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

| FOR FDA USE ONLY | | |
|------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|----------------------------------------|
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | | |
| | Digitally signed by<br>Richard C.<br>Chapman<br>Date: 2014.05.21<br>13:55:29 -04'00' | |
| FORM FDA 3881 (1/14) | Page 1 of 2 | PSC Publishing Services [phone] |