STD MED PRIMO PORT POLY

K080645 · Std Med, Inc. · LJT · May 2, 2008 · General Hospital

Device Facts

• Record ID: K080645
• Device Name: STD MED PRIMO PORT POLY
• Applicant: Std Med, Inc.
• Product Code: LJT · General Hospital
• Decision Date: May 2, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5965
• Device Class: Class 2
• Attributes: Therapeutic

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 port, catheter, and catheter locks. Port sutured under skin in subclavian fossa; accessed percutaneously via non-coring needle through silicone rubber septum. Facilitates fluid infusion into and withdrawal from central venous system. Used in clinical settings by healthcare professionals for long-term, repeated vascular access. Benefits patient by providing reliable, repeated access for therapies without repeated venipuncture.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence supported by design control documentation, risk analysis, and verification/validation testing results.

Technological Characteristics

Totally-implantable vascular access port; silicone rubber septum; catheter and catheter locks. Single-use, sterile. Class II device (21 CFR 880.5965).

Indications for Use

Indicated for patient therapies requiring repeated access to the vascular system, including infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and withdrawal of blood samples.

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

• STD Med Primo Port (K057091)

Submission Summary (Full Text)

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K080645

# 510(k) Summary

| Trade Name: | Primo Port |
|-------------|------------|
|-------------|------------|

| | MAY - 2 2008 |
|--|--------------|
|--|--------------|

| Sponsor: | STD Med, Inc. |
|---------------------|--------------------------------------------------------------------------------------------------------------|
| | 75 Mill Street |
| | Stoughton, MA 02072 |
| | FDA Registration No. 1222928 |
| Device Common Name: | Subcutaneous Port & Catheter |
| Classification: | According to Section 513 of the Federal Food, Drug, and Cosmetic Act, the device classification is Class II. |
| Predicate Device: | K0570911 – STD Med Primo Port |

## Product Description:

The device described in this 510(k) consists of a a modified sterile, single use, implantable port, with catheter and catheter locks. The port 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 the area of the subclavian fossa. The port is accessed percutancously usina a non-coring 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.

## Indications for Use:

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

## Safety and Performance:

This submission is a Special 510(k): Device Modification as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), STD Med has provided certification of compliance to 21 CFR 820.30 Design Control requirements, and a description of the internal Risk Analysis procedure. A description and summary of the verificaion and validation testing methods and results utilized to qualify the device modifications is included in this submission.

## Conclusion:

Based on the indications for use, technological characteristics, performance testing and comparison to predicate device, the proposed modified STD Med, Inc. Primo Port has been shown to be safe and effective for its intended use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

STD Med, Incorporated MAY - 2 2008 C/O Ms. Pamela Papineau, RAC Delphi Medical Device Consulting, Incorporated 5 Whitcomb Avenue Ayer, Massachusetts 01432

Re: K080645

Trade/Device Name: STD Med Primo Port Poly Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous, Implanted Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: April 18, 2008 Received: April 21, 2008

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.

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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**STD Med, Inc.**
March 3, 2008

Special 510(k) Premarket Notification: Device Modification Modified Primo Port

Page

510(k) Number (if known): 1380645

Device Name: STD Med Primo Port Poly

Indications for Use:

The STD Med Primo Port Poly 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 (Per 21 CFR 801 Subpart D)

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

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

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

St. Rul for ADW

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

'0(k) Number: KD80045

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