VORTEX MP

K032754 · Horizon Medical Products, Inc. · LJT · Sep 12, 2003 · General Hospital

Device Facts

• Record ID: K032754
• Device Name: VORTEX MP
• Applicant: Horizon Medical Products, Inc.
• Product Code: LJT · General Hospital
• Decision Date: Sep 12, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5965
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Vortex® MP Peripheral Access System is indicated for peripheral placement in the mid-arm, above the antecubital space and well below the subaxillary area, when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.

Device Story

Vortex® MP Peripheral Access System is a vascular access port system for peripheral venous access. Device consists of a titanium port with a self-sealing silicone septum, a catheter (polyurethane or silicone), a locking mechanism, and introduction components. Used in clinical settings for patients requiring repeated venous access for infusion or blood sampling. The port is implanted in the mid-arm; healthcare providers access the system using a non-coring needle through the septum. The system facilitates repeated access while maintaining integrity after multiple punctures. Benefits include reliable venous access for therapy delivery and blood collection.

Clinical Evidence

No clinical data; device evaluated through design verification testing.

Technological Characteristics

Titanium port housing; self-sealing silicone septum; polyurethane or silicone catheter. Peripheral vascular access port system. Sterile packaging. No software or electronic components.

Indications for Use

Indicated for patients requiring repeated venous access for injection, infusion therapy, or venous blood sampling via peripheral placement in the mid-arm (above antecubital space, below subaxillary area).

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

• Horizon Medical Products MicroPort 2 Peripheral Access System (K994196)

Submission Summary (Full Text)

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K 032754

510(k) Summary

# SEP 1 2 2003

## 510(K) SUMMARY [AS REQUIRED BY 21 CFR 807.92(C)]

#### Submitter's Name / Contact Person

Manufacturer Horizon Medical Products, Inc. One Horizon Way Manchester, Georgia 31816

Contact Scott Moeller Director of Quality Assurance and Regulatory Affairs

#### General Information

| Trade Name | Vortex® MP Peripheral Access System | |
|---------------------|-------------------------------------------------------------------------|------------------|
| Common Name | Vascular access port | |
| Classification Name | Subcutaneous, implanted, intravascular infusion port and catheter | |
| | Classification Number: | 21 CFR §880.5965 |
| | Classification Panel: | General Hospital |
| | Product Code: | LJT |
| Equivalent Device | Horizon Medical Products MicroPort 2 Peripheral Access System (K994196) | |

### Device Description

The Vortex® MP Peripheral Access System is a device comprised of a vascular access port, a catheter, locking mechanism and introduction components. The Vortex MP® Port is available in a titanium configuration with a self sealing silicone septum designed to maintain integrity after repeated punctures with an non-coring needle. The catheter is offered in polyurethance and silicone models. The products are packaged in sterile trays with introduction components.

### Intended Use / Indications

The Vortex® MP Peripheral Access System is indicated for peripheral placement in the mid-arm, above the antecubital space and well below the subaxillary area, when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.

### Substantial Equivalence Comparison

The Vortex® MP Peripheral Access System and the predicate MicroPort 2 Peripheral Access System share an identical intended use and fundamental scientific technology. The subject and predicate devices are substantially similar in configuration, dimensions, and materials. The Vortex® MP Peripheral Access System design was evaluated through HMP risk and qualified through design verification testing following established Design Control procedures. No new questions of safety or effectiveness were raised for the Vortex® MP Peripheral Access System.

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Image /page/1/Picture/1 description: The image is a black and white circular logo. The logo contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle. Inside the circle is a symbol that looks like a stylized bird with three curved lines representing its body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# SEP 1 2 2003

Mr. Scott Moeller Director of Quality Assurance and Regulatory Affairs Horizon Medical Products, Incorporated One Horizon Way Manchester. Georgia 31816

Re: K032754

Trade/Device Name: Vortex MP Peripheral Assess System Regulation Number: 880.5965 Regulation Name: Subcutaneous Implant Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: September 4, 2003 Received: September 5, 2003

Dear Mr. Moeller:

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. Moeller

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/dsma/dsmamain.html

Sincerely yours,

Susan Runner

Susan Runner, DDS, MA Interim 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 STATEMENT

510(k) Number (if known): _ レクタブ54

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#### Device Name: Vortex MP Peripheral Access System

#### Indications for Use:

The Vortex® MP Peripheral Access System is indicated for peripheral placement in the mid-arm, above the antecubital space and well below the subaxillary area, when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.

Patricia Cuscentz

esthesiology. General Hospital. ontrol Dental D

510(k) Number: K032754

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)