PORT-A-CATH POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS

K093414 · Smiths Medical Asd, Inc. · LJT · Mar 1, 2010 · General Hospital

Device Facts

• Record ID: K093414
• Device Name: PORT-A-CATH POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS
• Applicant: Smiths Medical Asd, Inc.
• Product Code: LJT · General Hospital
• Decision Date: Mar 1, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5965
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PORT-A-CATH® and PORT-A-CATH® II POWER P.A.C. Implantable Venous Access Systems are indicated when patient therapy requires repeated vascular access for injection or infusion therapy and/or venous blood sampling. When used with a GRIPPER PLUS® POWER P.A.C. Safety Huber Needle or other power injectable Huber needle, the PORT-A-CATH® POWER P.A.C. implantable venous access systems are indicated for power injection of contrast media.

Device Story

Implantable venous access system; consists of portal with self-sealing septa and catheter connector; placed in chest or arm. Facilitates repeated venous access for parenteral delivery of medications, fluids, nutritional solutions, and blood sampling. When paired with power-indicated Huber needle, enables power injection of contrast media. Used in clinical settings by healthcare professionals. System provides long-term vascular access, reducing need for repeated venipuncture; benefits patient through reliable, repeated delivery of therapy.

Clinical Evidence

No clinical data. Bench testing only. Biocompatibility established via material similarity to predicates. MR safety testing performed per ASTM F2503-05 at 3 Tesla, confirming MR Conditional status.

Technological Characteristics

Implantable venous access port with self-sealing septa and catheter connector. Materials biocompatible per predicate similarity. MR Conditional per ASTM F2503-05. Sterile, non-pyrogenic, single-patient use.

Indications for Use

Indicated for patients requiring repeated vascular access for injection/infusion therapy or venous blood sampling. When used with power-injectable Huber needles, indicated for power injection of contrast media at a maximum rate of 5 ml/sec.

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

• PORT-A-CATH® POWER P.A.C. Implantable Venous Access Systems (K070116)
• PORT-A-CATH® II POWER P.A.C. Implantable Venous Access Systems (K072657)

Submission Summary (Full Text)

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# smiths medical

bringing technology to life

# 510(k) Number: Ko 934/ 4

Page 1 of 3

Date Prepared October 29, 2009

## Submitter Information

MAR - 1 2010

| Submitter's Name: | Smiths Medical ASD, Inc. |
|-------------------|------------------------------------------|
| Address: | 1265 Grey Fox Road<br>St. Paul, MN 55112 |

Establishment Registration: 2183502

| Contact Person: | Rachelle Parsons, RAC<br>Sr. Regulatory Affairs Associate | |
|-----------------|-----------------------------------------------------------|--|
| | Phone: [phone]<br>Fax: [phone] | |

## Device Information

| Trade Name: | PORT-A-CATH® POWER P.A.C. Implantable Venous<br>Access Systems |
|----------------------|----------------------------------------------------------------------|
| Common Name: | Subcutaneously Implanted Intravascular Infusion Port and<br>Catheter |
| Classification Name: | Port and Catheter, Implanted, Subcutaneous, Intravascular |
| Product Code: | LJT |
| Regulation: | 21 CFR §880.5965 |
| | |
| Trade Name: | PORT-A-CATH® II POWER P.A.C. Implantable Venous<br>Access Systems |
| Common Name: | Subcutaneously Implanted Intravascular Infusion Port and<br>Catheter |
| Classification Name: | Port and Catheter, Implanted, Subcutaneous, Intravascular |
| Product Code: | LJT |
| Regulation: | 21 CFR §880.5965 |

Submission Page 19

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## 510(k) Summary

#### Page 2 of 3

#### Predicate Device(s)

The predicate devices are the above currently marketed devices. The reference 510(k) numbers for these devices are as follows:

| Device | 510(k) |
|----------------------------------------------------------------|----------------|
| PORT-A-CATH® POWER P.A.C. Implantable Venous Access Systems | K070116 |
| PORT-A-CATH® II POWER P.A.C. Implantable Venous Access Systems | and<br>K072657 |

#### Device Descriptions

## PORT-A-CATH®, PORT-A-CATH® II POWER P.A.C. line of Access Ports

The PORT-A-CATH® POWER P.A.C and PORT-A-CATH® II POWER P.A.C. Implantable Venous Access Systems are totally implantable venous access systems designed to permit repeated access to the venous system for the parenteral delivery of medications, fluids, nutritional solutions, and for the sampling of venous blood. When used with a power indicated Huber needle, the PORT-A-CATH® POWER P.A.C. and PORT-A-CATH® II POWER P.A.C. Implantable Venous Access Systems are indicated for power injection of contrast media.

The PORT-A-CATH® POWER P.A.C. and PORT-A-CATH® II POWER P.A.C. Implantable Venous Access Systems can be placed in the chest or arm, are supplied sterile, are non-pyrogenic and intended for single patient use only. The PORT-A-CATH® POWER P.A.C and PORT-A-CATH® II POWER P.A.C. Implantable Venous Access Systems consists of a portal with one or two self-sealing septa, and catheter connector that are assembled during implantation. The systems are offered in either a kit or a tray configuration.

#### Intended Use/Indications for Use

The PORT-A-CATH® and PORT-A-CATH® II POWER P.A.C. Implantable Venous Access Systems are indicated when patient therapy requires repeated vascular access for injection or infusion therapy and/or venous blood sampling.

When used with a GRIPPER PLUS® POWER P.A.C. Safety Huber Needle or other power injectable Huber needle, the PORT-A-CATH® POWER P.A.C. implantable venous access systems are indicated for power injection of contrast media.

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## 510(k) Summary

#### Page 3 of 3

#### Summary of Non-Clinical Testing

The non-clinical testing included assessment of the physical properties of the PORT-A-CATH® POWER P.A.C. Implantable Venous Access System and its ability to achieve its intended use. Bench testing of the device confirmed the suitability of the device for its intended use.

Biocompatibility assessment of the device was performed. The purpose of the biocompatibility assessment was to ensure that biocompatibility had been established for the device. The device is biocompatible based on the similarity of the materials of construction to the predicate devices commercially marketed by Smiths Medical ASD, Inc.

MR safety testing was performed on selected ports in accordance with established American Society for Testing and Materials (ASTM) standards. This testing was performed to establish the safety of the listed medical devices in the MR environment. The devices selected represent the entire product line of the devices listed. Testing was performed in the presence of a 3 Tesla MR imaging device.

The devices listed were determined to be MR Conditional according to the terminology specified in the ASTM Designation F2503-05 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment.

#### Summary of Clinical Testing

Human clinical studies were deemed not necessary to evaluate the safety or effectiveness of the PORT-A-CATH® POWER P.A.C. Implantable Venous Access Systems.

#### Statement of Equivalence

The PORT-A-CATH® POWER P.A.C. Implantable Venous Access System is substantially equivalent to the currently marketed Power PAC Implantable Venous Access System based on a comparison of the indications for use and the technological characteristics of the device.

#### Conclusion

The PORT-A-CATH® POWER P.A.C. Implantable Venous Access System is substantially equivalent to the currently marketed Power PAC Implantable Venous Access System based on the technological characteristics of the device. Bench tests confirmed the suitability of the device for its intended use.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized eagle with three stripes forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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

Ms. Rachelle Parsons Senior, Regulatory Affairs Specialist Smiths Medical ASD, Incorporated 1265 Grev Fox Road Saint Paul, Minnesota 55112

# MAR - 1 2010

Re: K093414

Trade/Device Name: PORT-A-CACH® II POWER P.A.C. Implantable Venous Access Systems, PORT-A-CATH® POWER P.A.C. Implantable Venous Access Systems, P.A.S. Port® T2 POWDER PAC Implantable Venous Access Systems Regulation Number: 21CFR 880.5965

Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT

Dated: February 17, 2010 Received: February 18, 2010

Dear Ms. Parsons:

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 practive, 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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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,

h for

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

510(k) Number:

Device Name: PORT-A-CATH® II POWER P.A.C. Implantable Venous Access Systems

Indications for Use:

"The PORT-A-CATH" II POWER P.A.C. Implantable Venous Access Systems are indicated when patient therapy requires repeated vascular access for injection or infusion therapy and/or venous blood sampling.

When used with a GRIPPER PLUS® POWER P.A.C. Safety Huber Needle or other power injectable Huber needle, the PORT-A-CATH® II POWER P.A.C. implantable venous access systems are indicated for power injection of contrast media. For power injections of contrast media, the maximum recommended infusion rate is 5 ml/sec."

Prescription Use X (Per 21 CFR 801.109)

AND/OR

Over-The Counter Use (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)

---

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

510(k) Number: K093414

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# Indications for Use

510(k) Number:

Device Name: PORT-A-CATH® POWER P.A.C. Implantable Venous Access Systems

#### Indications for Use:

"The PORT-A-CATH" POWER P.A.C. Implantable Venous Access Systems are indicated when patient therapy requires repeated vascular access for infusion therapy and/or venous blood sampling.

When used with a GRIPPER PLUS® POWER P.A.C. Safety Huber Needle or other power injectable Huber needle, the PORT-A-CATH® POWER P.A.C. implantable venous access systems are indicated for power injection of contrast media. For power injections of contrast media, the maximum recommended infusion rate is 5 ml/sec."

Prescription Use X (Per 21 CFR 801.109)

AND/OR

Over-The Counter Use (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)

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

510(k) Number: K093414

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# Indications for Use

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name: P.A.S. Port® T2 POWER.P.A.C. Implantable Venous Access Systems

#### Indications for Use:

"The P.A.S Port® T2 POWER P.A.C. Implantable Venous Access Systems are indicated when patient therapy requires repeated vascular access for injection or infusion therapy and/or venous blood sampling.

When used with a GRIPPER PLUS® POWER P.A.C. Safety Huber Needle or other power injectable Huber needle, the P.A.S. Port® POWER P.A.C. implantable venous access systems are indicated for power injection of contrast media. For power injections of contrast media, the maximum recommended infusion rate is 5 ml/sec."

Prescription Use >< (Per 21 CFR 801.109)

AND/OR

Over-The Counter Use (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)

Clas

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

510(k) Number: k093414