5F DIGNITY CT TITANIUM PORT

K130923 · Medical Components, Inc. · LJT · Jul 31, 2013 · General Hospital

Device Facts

• Record ID: K130923
• Device Name: 5F DIGNITY CT TITANIUM PORT
• Applicant: Medical Components, Inc.
• Product Code: LJT · General Hospital
• Decision Date: Jul 31, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5965
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The 5F Dignity® Midsize CT Titanium 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 Implantable Infusion Port device 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. The maximum recommended infusion rate is 2 ml/s with a 22 gauge non-coring power injectable needle.

Device Story

The 5F Dignity® Midsize CT Titanium Port is an implantable vascular access device. It consists of a titanium port body designed for subcutaneous placement, providing a portal for repeated vascular access. The device is used by clinicians to deliver medications, IV fluids, parenteral nutrition, and blood products, or to withdraw blood samples. When utilized with compatible power-injectable non-coring needles, the port supports the power injection of contrast media for CT imaging at specified flow rates (up to 5 ml/s for 19/20G needles; 2 ml/s for 22G needles). The device facilitates long-term therapy by reducing the need for repeated venipuncture, thereby improving patient comfort and vascular preservation.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and design characteristics.

Technological Characteristics

Titanium port body; subcutaneous implantable design; non-coring needle interface; supports power injection of contrast media; flow rate limits defined by needle gauge (19-22G).

Indications for Use

Indicated for patients requiring repeated vascular access for infusion of medications, IV fluids, parenteral nutrition, blood products, and blood sampling. When used with power injectable needles, indicated for power injection of contrast media.

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.

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 10905 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

## July 31, 2013

Medical Components. Incorporated Ms. Sarah Shaffer Regulatory Specialist 1499 Delp Drive Harleysville PA 19438

Re: K130923

Trade/Device Name: 5F Dignity® Midsize CT Titanium Port Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: May 30, 2013 Received: June 4. 2013

Dear Ms. Shaffer:

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. Ilisting 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 cither 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 - Ms. Shaffer

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/ResourcesforYou/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/ReportalProblem/default.html 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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

## Mary S. Runner -S

Kwame Ulmer M.S. Acting Division 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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Indications for Use

| 510(k) Number (if known): | K130923 |
|---------------------------|--------------------------------------|
| Device Name: | 5F Dignity® Midsize CT Titanium Port |

Indications for Use:

The 5F Dignity® Midsize CT Titanium 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 Implantable
Infusion Port device 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. The maximum recommended
infusion rate is 2 ml/s with a 22 gauge non-coring power injectable needle.

| Prescription Use <u>X</u> (Part 21 CFR 801 Subpart D) AND/OR | Over-The-Counter Use (21 CFR 801 Subpart C) |
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | Richard C. Chapman |
|--------------------------------------------------------------------------------|-----------------------------------------|
| Division of Anesthesiology, General Hospital Infection Control, Dental Devices | 2013.07.30 Page 1 of 1 14:39:46 -04'00' |
| 510(k) Number: | K130923 |

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