STD MED PRIMO PORT

K070911 · Std Med, Inc. · LJT · Aug 10, 2007 · General Hospital

Device Facts

• Record ID: K070911
• Device Name: STD MED PRIMO PORT
• Applicant: Std Med, Inc.
• Product Code: LJT · General Hospital
• Decision Date: Aug 10, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.5965
• Device Class: Class 2

Intended Use

The STD Med Primo Port is a totally-implantable vascular access device designed to provide long term, repeated access to the vascular system.

Device Story

Totally-implantable vascular access device; consists of titanium port, catheter, and catheter locks. Implanted subcutaneously in subclavian fossa; catheter inserted into vascular system. Accessed percutaneously via noncoring needle through silicone rubber septum. Facilitates fluid infusion and blood withdrawal. Used by clinicians for long-term, repeated central venous access. Benefits include reliable, repeated vascular access for various therapies.

Clinical Evidence

Bench testing only. Assessments included dimensions, septum durability, port leakage, fluid dynamics, catheter-to-port connection, flow rate, obturation, priming volume, needle insertion/retention forces, and stem strength per FDA 1990 Guidance. No biocompatibility testing conducted as materials are previously cleared.

Technological Characteristics

Titanium port with silicone rubber septum. Includes catheter and catheter locks. Totally-implantable subcutaneous design. Mechanical device; no energy source or software.

Indications for Use

Indicated for patients requiring repeated vascular access for infusion of medications, IV fluids, parenteral nutrition, blood products, and blood sampling.

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

• BardPort® Implanted Port (K050310)

Submission Summary (Full Text)

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2070411
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## Section 5 - 510(k) Summary

# AUG 1 0 2007

### General Information

| Owner's Name:<br>Address: | STD Med., Inc.<br>75 Mill Street<br>Stoughton, Massachusetts 02072 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone Number: | [phone] |
| Fax Number: | [phone] |
| Contact Person: | Mark Orphanos |
| Subject Device Name: | STD Med Primo Port |
| Trade Name: | Primo Port |
| Common/Usual Name: | Titanium Subcutaneous Port & Catheter |
| Classification Name: | LJT - Port & Catheter, Implanted, Subcutaneous, Intravascular<br>21 CFR 880.5965 - Subcutaneous, Implanted, Intravascular Infusion<br>Port and Catheter, Class II |
| Predicate Device Name: | BardPort® Implanted Port |
| Trade Name: | Titanium Port, Titanium Low-Profile Port |
| Common/Usual Name: | Titanium Subcutaneous Port & Catheter |
| Classification Name: | LJT - Port & Catheter, Implanted, Subcutaneous, Intravascular<br>21 CFR 880.5965 - Subcutaneous, Implanted, Intravascular Infusion<br>Port and Catheter, Class II |
| Premarket Notification: | K050310, concurrence date - April 18, 2005 |

### Device Description

The STD Med Primo Port kit contains 1 Titanium port, 1 catheter of choice, and 2 corresponding catheter locks, The catheter is introduced into the vascular system and attached to the port stem using a catheter lock. The port is then sutured under the skin in area of the subclavian fossa. The port is accessed percutaneously using a noncoring needle that penetrates a silicone rubber septum at the top of the port. The port system is the mechanism with which fluids can pass into and out of the central venous system.

#### Intended Use

The STD Med Primo Port is a totally-implantable vascular access device designed to provide long term, repeated access to the vascular system.

#### Performance Testing

Performance data demonstrated that the STD Med Primo Port is substantially equivalent to the predicate device and/or met pre-determined acceptance criteria. The risks associated with use of the new device were found acceptable when evaluated by FMEA.

Bench tests performed in accordance with FDA's October 1990 Guidance on 510(k) Submission for Implanted Infusion Ports included assessments of overall dimensions, septum durability, port leakage, fluid dynamics clearance, catheter-to-port connection, flow rate, obturation, priming volume, needle insertion & retention forces and stem strength.

No biocompatibility testing was conducted, all materials used in the manufacture of the Primo Port device have been previously cleared for similar devices.

## Conclusion

The Primo Port meets all the pre-determined acceptance criteria of the testing performed to confirm safety and effectiveness; the Primo Port is substantially equivalent to the predicate device.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# AUG 1 0 2007

STD Med., Incorporated C/O Pamela Papineau, RAC President Delphi Medical Device Consulting, Incorporated 5 Whitcomb Avenue Ayer, Massachusetts 01432

Re: K070911

Trade/Device Name: STD Med Primo Port Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous, Implanted Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: July 20, 2007 Received: July 23, 2007

Dear Ms. Papineau:

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. Papineau

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,

Chiu Lin, Ph.D.

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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## Section 4 - Indications for Use Statement

510(k) Number (if known):
K070911

Device Name: STD Med Primo Port

Indications for Use:

The STD Med Primo 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.

Prescription Use X (Per 21 CFR 801 Subpart D)

OR

Over-the -Counter Use (Per 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Charles Brown for ADW
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: k020911