POWER INJECTABLE IMPLANTABLE INFUSION PORT WITH SILICONE LUMEN (ATTACHABLE AND PRE-ATTACHED)

K070003 · Medcomp · LJT · May 15, 2007 · General Hospital

Device Facts

• Record ID: K070003
• Device Name: POWER INJECTABLE IMPLANTABLE INFUSION PORT WITH SILICONE LUMEN (ATTACHABLE AND PRE-ATTACHED)
• Applicant: Medcomp
• Product Code: LJT · General Hospital
• Decision Date: May 15, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5965
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Power Iniectable Implantable Infusion 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 power injectable needle, the power injectable infusion port is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s with a 19 or 20 gauge non-coring power injectable needle.

Device Story

Subcutaneously implantable single fluid reservoir port; used for repeated vascular access. System includes port and choice of silicone (9.6F) or polyurethane (8F) catheter. Physician implants port in pocket, securing with sutures. Access achieved by inserting non-coring needle through skin into self-sealing septum. Base features radiopaque 'CT' marking for identification under X-ray. Enables power injection of contrast media at max 5 ml/s using 19/20G power injectable needles. Benefits include reliable, repeated vascular access for various therapies and contrast administration. Used in clinical settings by physicians.

Clinical Evidence

No clinical data. Safety and effectiveness demonstrated via in vitro bench testing and biocompatibility testing per ISO 10993 standards.

Technological Characteristics

Polysulfone housing; silicone septum; silicone or polyurethane catheter. Radiopaque 'CT' marking. Biocompatible materials per ISO 10993. Permanent implantable device. Non-powered mechanical device.

Indications for Use

Indicated for patients requiring repeated vascular access for medication infusion, IV fluids, parenteral nutrition, blood products, or blood withdrawal. When used with a 19 or 20 gauge power injectable needle, 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

• Mediport II Single Lum/Port Vascular Access Port (M.R.I) (K864349)
• PowerPort Implanted Titanium Port with 8Fr. ChronoFlex® Catheter (K060812)

Submission Summary (Full Text)

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Kologis

1083

# 510(k) SUMMARY

#### A. Submitter Information:

### MAY 1 5 2007

| | Submitter: | MEDCOMP®<br>1499 Delp Drive<br>Harleysville, PA 19438<br>[phone] Telephone |
|----|------------------------------------|-------------------------------------------------------------------------------------------|
| | | [phone] Fax |
| | Contact:<br>Date Prepared: | Jean Callow, Regulatory Specialist<br>December 29, 2006 |
| B. | Trade Names: | Not assigned at time of submission |
| | Common Name: | Power Injectable, Implantable,<br>Infusion Port |
| | Classification Name: | Subcutaneous, Implanted, Intravascular<br>Infusion Port and Catheter<br>Long Term |
| | Classification: | LJT |
| | Classification Advisory Committee: | General Hospital |
| | C.F.R. Section: | 880.5965 |
| | Device Classification: | II |
| C. | Predicate Devices: | K864349 Mediport II Single Lum/Port<br>Vascular Access Port (M.R.I)., Bard Acc<br>Systems |

કર્ડ K060812, PowerPort Implanted Titanium Port with 8Fr. ChronoFlex® Catheter., Bard Access Systems

#### Device Description: D.

(

The Power Injectable, Infusion Port is a subcutaneously implantable single fluid reservoir port offered with a choice of a silicone (9.6F) or polyurethane (8F) catheter either pre-attached by the manufacturer or attachable for application by the inserting physician. Placement of the port is determined by the inserting physician based on patient anatomy and medical judgment. The port can be anchored with sutures in the port pocket for secure seating. The catheter lock provides securement of the catheter to the port stem. The port is accessed by inserting a non-coring needle through the skin into the self-sealing septum.

The base of the port is printed with the letters "CT" in reverse with radiopaque ink to signify that it can be used for power injection on contrast agents (orientation will appear correct under x-ray). Lot numbers are laser etched into the base of the port. The assembly is over molded with an optically clear silicone to prevent tissue in growth to the sufure holes that are easily accessed through the silicone. The rigid top half of the port centers the silicone septum and aids in locating the implanted device under the skin.

Power Injectable, Implantable Infusion Port Page 1 of 3

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Power injection of contrast media, can be safely administered with a 19 or 20 gauge power iniectable infusion non-corning needle at a maximum recommended infusion rate of 5 ml/s.

The implantable infusion port is packaged with the necessary accessories to facilitate catheter insertion.

The body of the port is manufactured with a polysulfone housing as the predicate device cleared under K864349. The addition of power injection capability is comparable to the currently marketed PowerPort cleared under K060812.

#### E. Intended Use:

The Power Iniectable Implantable Infusion 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 power injectable needle, the power injectable infusion port is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s with a 19 or 20 gauge non-coring power injectable needle.

#### ແມ່ Comparison to Predicate Devices:

The Power Injectable, Implantable Infusion Port is substantially equivalent to the predicate devices in terms of intended use, insertion method, anatomical location, design, performance, materials, labeling and method of sterilization.

#### G. Safety and Effectiveness / Performance Data:

In vitro testing was performed on the Power Injectable, Implantable Infusion Port to assure reliable design and performance in accordance with the FDA's "Guidance on 510(k) Submissions for Implanted Infusion Ports" dated October 1990. Verification testing and performance testing performed according to the referenced standards as well as in accordance with in-house protocols.

Clinical studies were not deemed necessary since in vitro testing was sufficient to demonstrate safety and effectiveness by way of comparison to legally marketed predicate devices. This device presents no known additional risks to the patient that are not well documented and for which there is already a prescribed therapy.

Biocompatibility testing on the Power Injectable. Infusion Port demonstrates that the materials used meet the requirements of ISO 10993 for a permanent implantable tissue and blood contact device. All materials used in this product are the same or similar to other vascular access products and present no unusual or unacceptable risk to the patient.

#### H. Conclusion:

Performance data indicated the performance and materials of the Power Injectable Implanted Infusion Port is equivalent to the claims of the currently marketed Mediport II

Power Injectable, Implantable Infusion Port Page 2 of 3

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6070003
Single Lum/Port Vascular Access Port (M.R.I) and PowerPort Implanted Titanium Port 3of?
with 8Fr. ChronoFlex® Catheter.

:

Power Injectable, Implantable Infusion Port Page 3 of 3

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized graphic of three human figures, represented by flowing lines, facing to the right. The figures are stacked on top of each other, creating a sense of unity and support.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 15 2007

Ms. Jean Callow Regulatory Specialist MedComp 1499 Delp Drive Harleysville, Pennsylvanian 19438

Re: K070003

Trade/Device Name: The Power Injectable Implantable Infusion Port Regulation Number: 880.5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: May 8, 2007 Received: May 9, 2007

Dear Ms. Callow:

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 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. Callow

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 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.

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 yours,

Clurs

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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KC070003
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## Indications for Use

510(k) Number (if known):

Device Name:

Indications for Use:

THE POWER INJECTABLE IMPLANTABLE INFUSION 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 POWER INJECTABLE NEEDLE, THE POWER INJECTABLE INFUSION PORT IS INDICATED FOR POWER INJECTION OF CONTRAST MEDIA. FOR POWER INJECTION OF CONTRAST MEDIA, THE MAXIMUM RECOMMENDED INFUSION RATE IS 5 ML/S WITH A 19 OR 20 GAUGE NON-CORDIG POWER INJECTABLE NEEDLE.

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)

Susan Gunser

sion of Anesthesiology, General Hospital caon Control, Dental Devices

2(k) Number: K070603

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