POLYSITE IMPLANTABLE INFUSION PORTS

K122834 · Perouse Medical · LJT · Dec 11, 2013 · General Hospital

Device Facts

• Record ID: K122834
• Device Name: POLYSITE IMPLANTABLE INFUSION PORTS
• Applicant: Perouse Medical
• Product Code: LJT · General Hospital
• Decision Date: Dec 11, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5965
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The POLYSITE implantable infusion Port is indicated for long term access to the central venous system and allows for repeated vascular access. POLYSITE Implantable Infusion venous access ports are used to administer chemotherapy, antibiotics and antiviral drugs. They can also be used for parenteral nutrition, collection of blood samples and transfusion of blood or blood products. A non-coring needle must be used to access POLYSITE Implantable Infusion Ports. Some references of POLYSITE (POLYSITE Pressure Injectable Implantable Infusion Port-Pl references) can be used for high pressure injection of contrast media during diagnostic studies. The maximum flow rate of power injector equipment used with the pressure injectable port may not exceed 5 mL/s. For high pressure injection of contrast media, a high pressure needle must be used to access the POLYSITE Pressure Injectable implantable Infusion port. The manufacturer recommends the use of PPS PI Pressure Injectable Safety Huber needle.

Device Story

POLYSITE is an implantable infusion port system consisting of a radiopaque housing, self-sealing septum, and radiopaque catheter. Used for long-term central venous access; allows repeated administration of medications, nutrition, and blood products. Accessed percutaneously by clinicians using non-coring needles. Pressure-injectable variants support high-pressure contrast media delivery for diagnostic imaging (max 5 mL/s flow rate). Device provides reliable venous access, reducing need for repeated venipuncture; benefits patients undergoing chronic therapies like chemotherapy. System is purely mechanical; no electronic or software components.

Clinical Evidence

No clinical data provided. Safety and effectiveness demonstrated through bench testing, including biocompatibility (ISO 10993-1:2009), septum puncture testing, port leak testing, fluid dynamic clearance, radioopacity determination, magnetic field interaction/heating/artifact evaluation at 3 Tesla, static burst testing, and catheter tensile strength testing.

Technological Characteristics

Implantable infusion port with radiopaque dome/housing, self-sealing septum, and radiopaque catheter. Materials: Plastic portal body (vs. titanium in predicates). Connectivity: None. Energy source: None. Sterilization: Not specified. Design features include markers visible under X-ray and visible light for pressure-injectable models.

Indications for Use

Indicated for patients requiring long-term, repeated central venous access for chemotherapy, antibiotics, antivirals, parenteral nutrition, blood sampling, or blood product transfusion. Pressure-injectable models are indicated for high-pressure contrast media injection (max 5 mL/s) during diagnostic studies. Requires use of non-coring needles; high-pressure needles required for contrast injection.

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

• PowerPort isp Implantable Port with attachable 8Fr. Chronoflex Polyurethane Catheter (K072215)
• Slimport Titanium implantable port with attachable 6F Chronoflex Open-ended single-lumen venous catheter (K870260)

Submission Summary (Full Text)

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K122834

### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS As required by section 807.92(c)

DEC 1 1 2013

| Submitter | PEROUSE MEDICAL<br>Route du Manoir<br>60173 IVRY LE TEMPLE<br>FRANCE<br>Phone [phone]<br>Fax [phone]<br>Website: www.perousemedical.com |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contacts | Isabelle JEANTY<br>Deputy Managing Director - Quality & Regulatory Affairs Director<br>e-mail : [e-mail] |
| Preparation date | April 12th 2013 |
| K number | K122834 |
| Trade Name | POLYSITE® Implantable Infusion Port (CATALOG REFERENCES: 2016PI -<br>3017PI- 4018PI - 2016SPI - 3017SPI - 4018SPI- 2016C -3017C -<br>4018C-2016SC-3017SC-4018SC) |
| Common Name | Implantable Infusion Port |
| Classification Name | PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR |
| Legally marketed<br>predicate devices | - PowerPort isp Implantable Port with attachable 8Fr. Chronoflex<br>Polyurethane Catheter (K072215)<br>- Slimport Titanium implantable port with attachable 6F<br>Chronoflex Open-ended single-lumen venous catheter<br>(K870260) |
| Description | POLYSITE Implantable Infusion Port is composed of a radiopaque<br>dome or housing and a self sealing septum, connected to a<br>radiopaque catheter by a connecting ring (supplied unassembled).<br>The port is accessed percutaneously by using a non-coring needle.<br>Image: Diagram of the port |
| Technological<br>characteristics | Technological characteristics of the subject devices are equivalent to<br>predicated devices. This equivalence extends to basic design generic<br>materials and construction. The distinguishing differences exists in:<br>- the external portal body material: titanium for the predicates,<br>and plastic for the subject devices<br>- the markers of POLYSITE Pressure Injectable are visible under X-<br>ray and visible light, the marking of the predicate is only visible<br>under X-ray. The symbol used is also different.<br>These differences do not impact the intended use and do not raise<br>any new questions regarding safety or effectiveness. |
| Intended Use | The POLYSITE implantable infusion Port is indicated for long term<br>access to the central venous system and allows for repeated vascular<br>access.<br>POLYSITE Implantable Infusion venous access ports are used to<br>administer chemotherapy, antibiotics and antiviral drugs. They can<br>also be used for parenteral nutrition, collection of blood samples and<br>transfusion of blood or blood products.<br>A non-coring needle must be used to access POLYSITE Implantable<br>Infusion Ports.<br>Some references of POLYSITE (POLYSITE Pressure Injectable<br>Implantable Infusion Port-Pl references) can be used for high pressure<br>injection of contrast media during diagnostic studies. The maximum<br>flow rate of power injector equipment used with the pressure<br>injectable port may not exceed 5 mL/s.<br>For high pressure injection of contrast media, a high pressure needle<br>must be used to access the POLYSITE Pressure Injectable implantable<br>Infusion port. The manufacturer recommends the use of PPS PI<br>Pressure Injectable Safety Huber needle. |
| Performance data | Performance data included with this submission<br>- Biocompatibility according to ISO 10993-1: 2009<br>- Safety and functionality testing<br>o in accordance with the FDA's "Guidance on 510(k)<br>Submissions for Implanted Infusion Ports" dated<br>October 1990:<br>- Catheter to port connection (dry and wet<br>conditions)<br>- Septum puncture (with 19, 20 and 22 Gauge<br>needles)<br>- Port leak testing (air method)<br>- Clearance (fluids dynamic test) |
| | Other: Radioopacity determination Evaluation of magnetic field interactions, heating and artifacts at 3 Tesla High pressure injection simulation Static burst test Contrast media injection limits Catheter tensile strength Maximum flow rate Absence of septum leak after 19 Gauge needle punctures Coring absence |
| Clinical data | Clinical studies were not deemed necessary since the intended use and the technological characteristics are substantially equivalent to others marketed ports.<br>Satisfactory in vitro testing and adequate instructions for use are sufficient to demonstrate safety and effectiveness by way of comparison to legally marketed predicate devices. |
| Substantial equivalence | POLYSITE Implantable Infusion Ports are substantially equivalent to their predicate devices in term of intended use and technological characteristics (materials, design and functionality). |
| Conclusion | Performance data demonstrate safety, effectiveness and substantial equivalence |

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Division Oncologio & Cardiovasculaire Route du Manost 60173 Ivry le Temple. France Tel. [phone] Fax [phone]

Division Imagerie Interventionnelle & BtoB 135. Route Neuve 69540 Irigny, France
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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the circle is a stylized symbol that resembles a person embracing another person. The symbol is composed of three curved lines that form the shape of two figures.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

December 11, 2013

Perouse Medical Ms. Isabelle Jeanty Deputy Managing Director - Quality & Regulatory Affairs Director Route du Manoir 60173 Ivry Le Temple FRANCE

Re: K122834

Trade/Device Name: POLYSITE Implantable Infusion Port Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT, OKE Dated: December 3, 2013 Received: December 4, 2013

Dear Ms. Jeanty:

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. 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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Page 2 - Ms. Jeanty

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/MedicalDevjces/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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Kwame O. Ulmer -S

for

Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

#### 510(k) Number (if known) K 122834

#### Device Name

#### Polysite Implantable Infusion Port

#### Indications for Use (Describe)

The POLYSITE implanable infusion Port is indicated for long term access to the central venous system and allows for repeated vascular access.

POLYSITE Implantable Infusion venous access ports are used to administer chemotherapy, antibiotics and antiviral drugs. They can also be used for parenteral nutrition, collection of blood samples and transfusion of blood products.

A non-coring needle must be used to access POLYSITE Implantable Infusion Ports.

Some references of POLYSITE Pressure Injectable Implantable Infusion Port-PI references) can be used for high pressure injection of contrast media during diagnosic studies. The maximum flow rate of power injector equipment used with the pressure injectable port may not exceed 5 ml/s.

For high pressure injection of contrast media, a high pressure needle must be used to access the POLYSITE Pressure Injectable implantable Infusion port. The manufacturer recommends the use of PPS PI Pressure Injectable Safety Huber needle.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | Digitally signed by Richard C. Chapman<br>Date: 2013.12.09 15:51:14 -05'00' |
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FORM FDA 3881 (9/13)
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