DIGNITY POWER INJECTABLE TITANIUM PORT

K120281 · Medical Components, Inc. · LJT · Sep 17, 2012 · General Hospital

Device Facts

• Record ID: K120281
• Device Name: DIGNITY POWER INJECTABLE TITANIUM PORT
• Applicant: Medical Components, Inc.
• Product Code: LJT · General Hospital
• Decision Date: Sep 17, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5965
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The CT 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 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

Titanium port system for subcutaneous implantation; provides repeated vascular access. Input: non-coring Huber needle inserted through skin into self-sealing septum. Operation: fluid reservoir connects to radiopaque polyurethane or silicone catheter (5F-9.6F). Physician-implanted; anchored with sutures in port pocket. Output: delivery of medications, fluids, nutrition, blood products, or contrast media; withdrawal of blood. Features anodized purple titanium housing for identification; CT/MR compatible. Benefits: enables repeated access while supporting high-pressure contrast media injection for imaging. Healthcare providers use output to manage patient therapies; contrast injection capability facilitates diagnostic imaging procedures.

Clinical Evidence

No clinical data. Safety and effectiveness demonstrated via in vitro bench testing in accordance with FDA's "Guidance on 510(k) Submissions for Implanted Infusion Ports" and ISO 10993 biocompatibility standards.

Technological Characteristics

Titanium port housing (anodized purple); polyurethane or silicone catheter (5F, 6.6F, 8F, 9.6F). Self-sealing septum for non-coring needle access. Radiopaque "CT" marking on base. Biocompatibility per ISO 10993. Mechanical device; no software or energy source.

Indications for Use

Indicated for patients requiring repeated vascular access for medication infusion, I.V. fluids, parenteral nutrition, blood products, and blood withdrawal. When used with power injectable needles, indicated for power injection of contrast media at max rates of 5 ml/s (19/20G needle) or 2 ml/s (22G needle).

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

• Power Injectable Implantable Port (K070003)
• CT Power Injectable Implantable Port (K11424)
• C-Port HP "Power Injectable" Port (K091099)

Submission Summary (Full Text)

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K170281

| Section 5 | 510(k) Summary | SEP 17 2012 |
|-------------------------------------------------------------------------------------------------------------|----------------|-------------|
| Dignity® Power Injectable Titanium Port<br>Summary of Safety and Effectiveness<br>Prepared January 30, 2012 | | |

# General Information

| Submitter: | MEDCOMP®<br>1499 Delp Drive<br>Harleysville, PA 19438<br>Phone: [phone]<br>Fax: [phone] |
|-----------------------|-------------------------------------------------------------------------------------------------------------|
| Contact: | Rosanna Severini<br>Compliance Manager |
| Device Trade Name: | Dignity® Power Injectable Titanium Port |
| Common Name: | Power Injectable, Implantable, Infusion Port |
| Classification Name: | LJT - Subcutaneous, Implanted, Intravascular Infusion Port and<br>Catheter, Long-Term, Greater than 30 Days |
| CFR Reference: | 21 CFG 880.5965, Class II |
| Classification Panel: | General Hospital |

# Predicate Devices:

| Device Trade Name: | Power Injectable Implantable Port |
|-------------------------|------------------------------------------------------------------------------------------------------------|
| Common Name: | Implanted Infusion Port & Catheter |
| Classification Name: | LJT - Subcutaneous, Implanted, Intravascular Infusion Port and<br>Catheter, Long-Term Greater than 30 Days |
| CFR Reference: | 21 CFR 880.5965, Class II |
| Classification Panel: | General Hospital |
| Premarket Notification: | K070003, Medcomp, Inc, concurrence date May 15, 2007 |
| Device Trade Name: | CT Power Injectable Implantable Port |
| Common Name: | Implanted Infusion Port & Catheter |
| Classification Name: | LJT - Subcutaneous, Implanted, Intravascular Infusion Port and<br>Catheter, Long-Term Greater than 30 Days |
| CFR Reference: | 21 CFR 880.5965, Class II |
| Classification Panel: | General Hospital |
| Premarket Notification: | K11424, Medcomp, Inc, concurrence date November 30, 2011 |
| Device Trade Name: | C-Port HP "Power Injectable" Port |
| Common Name: | Implanted Infusion Port & Catheter |
| Classification Name: | LJT - Subcutaneous, Implanted, Intravascular Infusion Port and<br>Catheter, Long-Term Greater than 30 Days |
| CFR Reference: | 21 CFR 880.5965, Class II |
| Classification Panel: | General Hospital |
| Premarket Notification: | K091099, PHS Medical GmbH |

# Intended Use:

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The totally implanted titanium port is indicated for patient therapies requiring repeated access to the vascular system.

## Indications for Use:

The CT Power Injectable 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 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 Description:

- Titanium port designed for subcutaneously implantable single fluid reservoir port . offered in a mid-size, low profile or mini version with a 5F, 6.6F, 8F or 9.6French radiopaque polyurethane or silicone 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 o anatomy and medical judgment.
- The port can be anchored with sutures in the port pocket for secure seating. o
- The catheter lock provides securement of the catheter to the port stem. o
- The port is accessed by inserting a non-coring needle through the skin into the . self sealing septum.
- Port base has radiopaque text "CT" on the underside visible by x-ray o
- Lot numbers are laser etched into the base of the port. �
- Power iniection 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/s. The maximum recommended infusion rate is 2 ml/s with a 22 gauge non-coring power injectable needle.
- The device is recognized as part of the Medcomp power injectable product line by its � anodized purple titanium housing.
- CT and MR compatible .
- The port is compatible with non-coring Huber deffected point septum penetration style . needles.

## Biocompatibility

Biocompatibility requirements of ISO 10993 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing for externally communicating, blood contacting, long-term devices were met.

## Technological Characteristics

Technological characteristics of the subject device with a polyurethane catheter are equivalent to those of the predicated devices. This equivalence extends to basic design,

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generic materials, and construction. The distinguishing difference exists in the reduced size of the subject port body.

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.

### Safety & Performance Tests

No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for this device. Design verification testing was performed according to protocols based on the recommendations and requirements of applicable FDA guidance and FDA recognized international standards. Verification testing, determined to be applicable to the safety and efficacy of the devices, was shown to meet predetermined acceptance criteria listed therein.

Risk Management of the subject device was conducted in accordance with an internal protocol based on ISO 14971: 2000, Medical Devices – Risk Management for Medical Devices. The analysis did not identify any new types or safety or efficacy questions for the proposed device.

The results of these tests, in conjunction with the substantial equivalence claims effectively demonstrate that Dignity® TI CT Rated Port is substantially equivalent to the cited predicate devices.

#### Summary of Substantial Equivalence

Based on the indications for use and safety and performance testing, the Dignity® Power Injectable Titanium Ports meets the requirements that are considered for its intended use and is substantially equivalent in design materials, sterilization, and indications for use to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

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

SEP 17 2012

Medical Components Incorporated Ms. Rosanna Severini Regulatory Specialist 1499 Delp Drive Harlevsville, Pennsylvania 19438

Re: K120281

Trade/Device Name: Dignity® Power Injectable Titanium Port Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: August 3, 2012 Received: August 6, 2012

Dear Ms. Severini:

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. 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- Ms. Severini

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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,

Anthony D. Watson, B.S., M.S., M.B.A. 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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# Indications for Use

KI202 510(k) Number (if known):

Device Name: Dignity® Power Injectable Titanium Port

indications for Use:

The CT Power Injectable Implantable Infusion Port is indicated for patient therapies in The CT Power Injectable Implantable Innusion in The port system can be used for requiring repeated access to the vasould by the persons who personal products and for the withdrawal of blood samples.

When used with a power injectable needle, the Power Injectable Implantable Infusion When used with a power injectable necade, the Forst media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s with a 19 or 20 contrast media, the maximum recommended infossimum recommended infusion rate is gauge non-coring power injecting power injectable needle.

Prescription Use
(Part 21 CFR 801

Prescription Use X_
(Part 21 CFR 801 Subpart D) AND/OR (21 CFFR 801 Subpart C (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)

Rld Chy 9/12/12

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(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices

510(k) Number: K 12028 4-1