MODIFICATION TO: T-PORT HP INFUSION PORT

K073210 · Pfm Medical, Inc. · LJT · Dec 12, 2007 · General Hospital

Device Facts

• Record ID: K073210
• Device Name: MODIFICATION TO: T-PORT HP INFUSION PORT
• Applicant: Pfm Medical, Inc.
• Product Code: LJT · General Hospital
• Decision Date: Dec 12, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5965
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The T-Port HP Infusion Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, IV fluids, parenteral nutrition solutions, blood products and for the withdrawal of blood samples. When used with a power injectable needle, the T-Port HP Infusion Port is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/sec with a 19G or 20G non-coring power injectable needle or 2 ml/sec with a 22G non-coring power injectable needle.

Device Story

Implantable subcutaneous vascular access port; consists of self-sealing injection port and polyurethane catheter. Used for repeated vascular access; enables infusion of medications, fluids, nutrition, blood products, and blood sampling. Physician-implanted in port pocket; secured via sutures. Features 'CT' marking on base for power injection identification; laser-etched serial number. Introduction of solutions via non-coring needle. Power injection parameters: max 5 ml/sec (19G/20G needle) or 2 ml/sec (22G needle); max pressure 300 psi. Benefits patient by providing reliable, long-term vascular access, reducing trauma from repeated venipuncture.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and comparison to predicate device.

Technological Characteristics

Implantable port with polyurethane catheter; self-sealing septum. Base marked 'CT' for power injection identification. Suture holes may contain clear silicone. Sterilized using same validated processes as predicate. No electronic components or software.

Indications for Use

Indicated for patients requiring repeated vascular access for medication infusion, IV fluids, parenteral nutrition, blood product administration, or blood sampling. Compatible with power injection of contrast media when used with specified non-coring power injectable needles.

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

• T-Port HP Infusion Port (K071993)

Submission Summary (Full Text)

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## 510(k) Summary of Safety and Effectiveness

The following section is included as required by the Safe Medical Device Act (SMDA) of 1990.

| Name: | PFM Medical, Inc |
|-----------------|--------------------------------------------------|
| Address: | 2605 Temple Heights Drive<br>Oceanside, CA 92056 |
| CONTACT PERSON: | SALVADORE F. PALOMARES, RAC |

DEC 1 2 2007

## 510(k) Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| The assigned 510(k) number is: | |
|--------------------------------|--------------------------------------------------------|
| Trade Name: | T-Port HP Infusion Port |
| Common Name: | Port & Catheter Implanted, Subcutaneous, Intravascular |
| Classification Name: | Same |

| Equivalent Devices: | |
|---------------------|-------------------------|
| Manufacturer: | PFM Medical, Inc |
| Name: | T-Port HP Infusion Port |
| 510(k) #: | K071993 |

Device Description:

The T-Port HP Infusion Port is an implantable device designed to provide repeated access to the vascular system without the trauma associated with multiple vena puncture. The system consists of a self-sealing injection port and a delivery catheter for the receipt and delivery of medications to the selected body site. The T-Port HP Infusion Port is offered with the polyurethane catheter either preattached by the manufacturer or attachable for application by the inserting physician. 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. Introduction of solution into the implanted port and catheter system is through a non-coring needle.

The base of the port has the letters "CT" to signify that it can be used for power injection on contrast agents. The serial number is laser etched into the base of the port. The suture holes may contain clear silicone to prevent tissue in growth to the suture holes.

Power injection of contrast media, can be safely administered with a 19 or 20 gauge power injectable infusion non-corning needle at a maximum recommended infusion rate of 5 ml/sec or a 22 gauge power injectable non-coring needle at a maximum recommended infusion rate of 2 ml/sec. Maximum pressure should not exceed 300 psi.

The T-Port HP Infusion Port is packaged with the necessary accessories to facilitate catheter insertion.

The port and catheter are manufactured and sterilized at the same manufacturing and sterilization facilities as the predicate device cleared under K071993. .

Components will be assembled into standard configurations specified by the customer and packaged.

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K03210 page 2 of 3

The device includes the following components:

- Implantable Port .
- . Click Connector
- Guide Wire
- Dilator .
- Tunneling Needle ●
- . Vein Lifter
- . Nurses Guide
- Companion Checklist .
- Catheter ●
- Huber Needle .
- Introducing Needle ●
- Peel Away Sheath .
- Syringe .
- Instructions for Use ●
- . Patient Guide
- Patient ID Card & Key Ring Card ●

## Intended Use:

The T-Port HP Infusion Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, IV fluids, parenteral nutrition solutions, blood products and for the withdrawal of blood samples.

When used with a power injectable needle, the T-Port HP Infusion Port is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/sec with a 19G or 20G non-coring power injectable needle or 2 ml/sec with a 22G non-coring power injectable needle.

## Biocompatibility:

The materials used to manufacture the T-Port HP Infusion Port are used in legally marketed devices under comparable conditions of use.

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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

DEC 1 2 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Salvadore F. Palomares, RAC Director of Regulatory Affairs PFM Medical, Incorporated 2605 Temple Heights Drive, Suite A Oceanside, California 92056

Rc: K073210

Trade/Device Name: T-Port HP Infusion Port Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: November 12, 2007 Received: November 16, 2007

Dear Mr. Palomares:

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 - Mr. Palomares

Please be advised that FDA's issuance of a substantial equivalence determination does not mcan 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,

Cve

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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Image /page/4/Picture/0 description: The image contains a series of numbers, specifically "073210". The numbers are arranged horizontally and are the primary focus of the image. The digits are somewhat faded, suggesting the image may be a scan or a photograph of a printed document.

510(k):

Device Name: T-Port HP Infusion Port

- Indications for Use: The T-Port HP Infusion Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, IV fluids, parenteral nutrition solutions, blood products and for the withdrawal of blood samples.
When used with a power injectable needle, the T-Port HP Infusion Port is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/sec with a 19G or 20G noncoring power injectable needle or 2 ml/sec with a 22G non-coring power injectable needle.

Concurrence of CDRH, Office of Device Evaluation (ODE)

ਮੇ Prescription Use Or Over the Counter Use (Per 21 CFR 801.109)

Antan v.n
(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital Devices

510(k) Number 1473214