SMARTPORT CT VORTEX; LP TITANIUM, SINGLE PLASTIC, SINGLE TITANIUM, TRIUMPH LOW PROFILE TITANIUM PORTS

K081472 · AngioDynamics, Inc. · LJT · Sep 23, 2008 · General Hospital

Device Facts

• Record ID: K081472
• Device Name: SMARTPORT CT VORTEX; LP TITANIUM, SINGLE PLASTIC, SINGLE TITANIUM, TRIUMPH LOW PROFILE TITANIUM PORTS
• Applicant: AngioDynamics, Inc.
• Product Code: LJT · General Hospital
• Decision Date: Sep 23, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5965
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SmartPort CT Port Access System is indicated for any adult patient requiring repeated access of the vascular system or other selected body site, for the delivery of medications, nutritional supplementation, fluids, blood, blood products, and sampling of blood. The SmartPort CT Series ports are also indicated for power injection of CT contrast media.

Device Story

SmartPort CT Series Port Access System; subcutaneous implanted vascular access port with attachable catheter. Titanium or plastic reservoir; self-sealing silicone rubber septum; toroidal reservoir design with tangential outlet stem. Catheters (6.6FR to 12FR) include radiopacifiers and depth markings. Used by clinicians for repeated vascular access; delivery of medications, fluids, blood products, nutritional supplementation; blood sampling. Supports power injection of CT contrast media up to 300 PSI. Implanted surgically; accessed percutaneously via noncoring needle. Benefits patient by providing reliable, repeated vascular access while enabling high-pressure contrast media delivery for CT imaging.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing confirmed device integrity at 300 PSI dynamic pressure for power injection of contrast media.

Technological Characteristics

Titanium or plastic port; silicone rubber septum; polyurethane or silicone catheter (6.6-12 FR). Toroidal reservoir design with tangential outlet. Implantable. Sterile, single-use. No software or electronic components.

Indications for Use

Indicated for adult patients requiring repeated vascular access for delivery of medications, nutrition, fluids, blood products, or blood sampling. Also indicated for power injection of CT contrast media at max rates of 3 ml/sec or 5 ml/sec using 20 Ga or 19 Ga power injectable infusion sets.

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

• AngioDynamics SmartPort CT MP (K072375)
• AngioDynamics SmartPort CT (K062414)
• Horizon Medical Vortex Ports (K905841, K953529, K010189, K032557)

Submission Summary (Full Text)

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SEP 2 3 2008

4081472

### 4.0 510(k) Summary

Date: May 19, 2008

### Sponsor of the 510(k)

AngiodDynamics, Inc. 603 Queensbury Ave Queensbury, NY 12801 Establishment Registration number 1319211 Contact: Brian Kunst, Vice President, Regulatory Affairs and Quality Assurance 518-798-1215, x1123

### Device Identification:

| Proprietary Name: | SmartPort CT Series Port Access Systems |
|------------------------|--------------------------------------------------------------------|
| Common Name: | Vascular access port |
| Classification Name: | Subcutaneous, implanted, intravascular infusion port &<br>catheter |
| Classification Number: | 21 CFR §880.5965 |
| Classification Panel: | General Hospital |
| Product Code: | LJT |
| Regulatory Class: | II |

## Legally marketed device to which equivalence is claimed:

| AngioDynamics SmartPort CT MP | 510(k) K072375 |
|-------------------------------|-------------------------------------------|
| AngioDynamics SmartPort CT | 510(k) K062414 |
| Horizon Medical Vortex Ports | 510(k) K905841, K953529, K010189, K032557 |

### Intended Use / Indications

The SmartPort CT Port Access System is indicated for any adult patient requiring repeated access of the vascular system or other selected body site, for the delivery of medications, nutritional supplementation, fluids, blood, blood products, and sampling of blood.

The SmartPort CT Series ports are also indicated for power injection of CT contrast media.

| Vortex CT 510(k) | Confidential | Page 11 of 39 |
|------------------|--------------|---------------|
| May 19, 2008 | | |

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### Device Description

The SmartPort CT Series ports are Titanium or plastic, single or dual ports with a self sealing silicone rubber septum designed to maintain integrity after punctures with a noncoring needle. The port has a hollow area, or reservoir, under the septum through which fluid passes during infusion or aspiration.

The Vortex design features a proprietary reservoir with rounded walls giving it a toroidal shape. The outlet stem is located tangential to the reservoir wall allows fluid to pass between the reservoir and the catheter.

The SmartPort CT Series port systems offers models with catheters from 6.6FR to 12FR. The catheters contain radiopacifiers and have depth markings.

| Question | YES | NO |
|---------------------------------------------------------------------------------------|-----|----|
| Is the device intended for prescription use (21 CFR 801 Subpart D)?A | X | |
| Does the device contain components derived from a tissue or other biologic<br>source? | | X |
| Is the device provided sterile? | X | |
| Is the device intended for single use? | X | |
| Is the device a reprocessed single use device? | | X |
| Does the device contain a drug? | | X |
| Does the device contain a biologic? | | X |
| Does the device use software? | | X |
| Does the submission include clinical information? | | X |
| Is the device implanted? | X | |

| Vortex CT 510(k) | Confidential | Page 12 of 39 |
|------------------|--------------|---------------|
| May 19, 2008 | | |

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# Device comparison table

| | AngioDynamics<br>SmartPort CT Series<br>Vortex Ports | AngioDynamics SmartPort<br>CT MP | AngioDynamics SmartPort<br>CT | RITA Medical Systems<br>(formerly Horizon Medical<br>Products) |
|----------------------------------|---------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|----------------------------------------------------------------|
| | | K072375 | K062414 | K905841, K953529,<br>K010189, K032557 |
| Intended use, power<br>injection | Maximum 3 ml/sec or 5 ml/sec<br>injection rate of contrast dye<br>injected at up to 300 psi | Maximum 3 ml/sec injection rate<br>of contrast dye injected at up to<br>300 psi. | Maximum 5 ml/sec injection rate<br>of contrast dye injected at up to<br>300 psi. | Not indicated for power<br>injection |
| Design | Port system with attachable<br>catheter | Port system with attachable<br>catheter, single. | Port system with attachable<br>catheter, single. | Port system with attachable<br>catheter, single or dual. |
| Port Material | Titanium or Plastic | Titanium | Titanium | Titanium or Plastic |
| Catheter Material | Polyurethane or Silicone | Polyurethane | Polyurethane or Silicone | Polyurethane or Silicone |
| Catheter Size | 6.6-12 FR | 5 FR | 7.5-9.6 FR | 6.6-12 FR |
| Shape | Round port system with<br>tangential outlet | Round port system with tangential<br>outlet | Round port system with tangential<br>outlet | Round port system with<br>tangential outlet |
| Septum Material | Silicone | Silicone | Silicone | Silicone |
| Pressure withstand,<br>dynamic | 300 PSI | 300 PSI | 300 PSI | Not Rated |
| Needles used for<br>Access | 19 or 20 Ga power injectable<br>infusion set | 19 or 20 Ga power injectable<br>infusion set | 19 or 20 Ga power injectable<br>infusion set | 19 or 20 Ga infusion set |

Confidential

Vortex CT 510(k)
May 19, 2008

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 3 2008

Mr. Brian Kunst ANGIODYNAMICS, Incorporated 603 Queensbury Avenue Queensbury, New York 12804

Re: K081472

Trade/Device Name: SmartPort CT Series Port Access System Regulation Number: 880.5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: Il Product Code: LJT Dated: August 27, 2008 Received: August 29, 2008

Dear Mr. Kunst:

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 deviccs 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. Kunst

Please be advised that FDA's issuance of a substantial equivalence determination docs 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 Center for Devices and Radiological Health's (CDRHI's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

QRS

Chiu S. Lin. Ph. D Division 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

510(k) Number (if known):

| Device Name: | SmartPort CT Series Port Access System | | ----- |
|--------------|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|
| | | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |

Indications for Use:

The SmartPort CT Series Port Access System is indicated for any pationt requiring repeated access of the vascular system for the delivery of medications, nutritional supplementation, fluids, blood, blood products, and the sampling of blood.

The SmartPort CT Series Port Access System is also indicated for power injection of contrast media at a maximum infusion rate of 3 ml/sec or 5 ml/sec when used with 20 Ga or 19 Ga power injectable infusion sets.

X ____________________________________________________________________________________________________________________________________________________________________________ Prescription Use AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807

Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Amithen

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

510(k) Number: __ < 415/4 22