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.

Device Description

POLYSITE Implantable Infusion Port is composed of a radiopaque dome or housing and a self sealing septum, connected to a radiopaque catheter by a connecting ring (supplied unassembled). The port is accessed percutaneously by using a non-coring needle.

AI/ML Overview

The POLYSITE® Implantable Infusion Port is indicated for long-term access to the central venous system and for repeated vascular access. It can be used to administer chemotherapy, antibiotics, and antiviral drugs, for parenteral nutrition, and for collecting blood samples and transfusions. Some references of the POLYSITE Pressure Injectable Implantable Infusion Port-PI can also be used for high-pressure injection of contrast media during diagnostic studies, with the maximum flow rate of power injector equipment not exceeding 5 mL/s.

The device's acceptance criteria and performance data are based on safety and functionality testing and biocompatibility assessments, rather than a clinical study. The device did not require a clinical trial to demonstrate safety and effectiveness because it was found to be substantially equivalent to previously marketed predicate devices (PowerPort isp Implantable Port with attachable 8Fr. Chronoflex Polyurethane Catheter (K072215) and Slimport Titanium implantable port with attachable 6F Chronoflex Open-ended single-lumen venous catheter (K870260)).

Here are the details regarding the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Attribute	Acceptance Criteria	Reported Device Performance (Summary)
Biocompatibility	Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Material-Mediated Pyrogenicity, Hemocompatibility, Implantation (26-week), Genotoxicity, Carcinogenicity, Chronic Toxicity	All tests defined by ISO 10993-1: 2009 for permanent implantable devices with limited blood contact.	The device met all biocompatibility requirements according to ISO 10993-1: 2009.
Safety and Functionality	Catheter to port connection (dry and wet conditions)	Secure connection without leakage or disconnection under specified conditions.	Testing demonstrated secure and leak-free catheter to port connection under both dry and wet conditions, in accordance with FDA guidance.
	Septum puncture (with 19, 20, and 22 Gauge needles)	Ability to withstand multiple punctures with specified needle gauges without leakage or damage compromising integrity.	The septum demonstrated satisfactory performance after repeated punctures with 19, 20, and 22 Gauge needles, maintaining integrity and preventing leakage, in accordance with FDA guidance.
	Port leak testing (air method)	No air leakage when tested with the specified air method.	No air leakage was detected during port leak testing using the air method, in accordance with FDA guidance.
	Clearance (fluids dynamic test)	Adequate internal fluid flow characteristics.	The device demonstrated satisfactory fluid dynamic clearance, in accordance with FDA guidance.
	Radioopacity determination	Sufficient radioopacity for clear visualization under X-ray.	The device exhibited sufficient radioopacity, allowing for clear visualization under X-ray. The markers of POLYSITE Pressure Injectable are visible under X-ray and visible light.
	Evaluation of magnetic field interactions, heating and artifacts at 3 Tesla	Minimal magnetic field interaction, heating, and artifacts at 3 Tesla MRI.	The device demonstrated acceptable performance with minimal magnetic field interactions, heating, and artifacts when evaluated at 3 Tesla.
	High pressure injection simulation	Ability to withstand specified high-pressure injections without failure (for PI references).	The POLYSITE Pressure Injectable references successfully withstood high-pressure injection simulations without failure.
	Static burst test	Withstand a specified amount of internal pressure without bursting.	The device passed the static burst test, demonstrating its ability to withstand the specified internal pressure.
	Contrast media injection limits	Maintain integrity and functionality within specified contrast media injection limits (for PI references).	The POLYSITE Pressure Injectable references performed effectively within the specified contrast media injection limits, with the maximum flow rate not exceeding 5 mL/s.
	Catheter tensile strength	Exhibit sufficient tensile strength to prevent breakage under physiological and clinical forces.	The catheter demonstrated adequate tensile strength.
	Maximum flow rate	Achieve and maintain specified maximum flow rates (for PI references during high-pressure injection). The maximum flow rate of power injector equipment used with the pressure injectable port may not exceed 5 mL/s.	The POLYSITE Pressure Injectable references achieved and maintained the specified maximum flow rates, within the 5 mL/s limit for power injector equipment.
	Absence of septum leak after 19 Gauge needle punctures	No leakage after a specified number of punctures with a 19 Gauge needle.	The septum showed no leakage after repeated punctures with a 19 Gauge needle.
	Coring absence	No evidence of coring (material shearing) upon needle insertion.	No coring was observed during needle insertion tests.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The information provided specifies that "Performance data included with this submission" consisted of Biocompatibility testing according to ISO 10993-1: 2009 and Safety and functionality testing "in accordance with the FDA's 'Guidance on 510(k) Submissions for Implanted Infusion Ports' dated October 1990." These are laboratory/bench tests, not studies with human subjects. Therefore, the concept of a "test set" in the context of clinical data, or data provenance (country of origin, retrospective/prospective clinical data) and human sample size, is not applicable here. The data provenance would be the testing laboratories in France where Perouse Medical performed these in vitro and bench tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable since no clinical studies involving expert interpretation of data or ground truth establishment from patient cases were conducted or required. The "ground truth" for the performance data comes from the objective results of the specified physical and biological tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as there was no clinical test set requiring expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No such study was done. The device is a physical medical device (implantable infusion port), not an AI-powered diagnostic or assistive technology.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable as the device is a physical medical device and does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the device's performance was established through:

Standardized laboratory protocols and measurements for physical and mechanical properties (e.g., leak testing, tensile strength, flow rate).
Internationally recognized biocompatibility standards (ISO 10993-1: 2009) for biological safety.
FDA guidance documents for specific performance testing related to implanted infusion ports.

8. The sample size for the training set

This is not applicable as there was no "training set" in the context of an algorithm or machine learning. The device design and testing are based on engineering principles and regulatory standards.

9. How the ground truth for the training set was established

This is not applicable for the same reason as above.

Summary

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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 MEDICALRoute du Manoir60173 IVRY LE TEMPLEFRANCEPhone +33(0)3 44 08 17 00Fax +33(0)3 44 08 17 01Website: www.perousemedical.com
Contacts	Isabelle JEANTYDeputy Managing Director - Quality & Regulatory Affairs Directore-mail : i.jeanty@perousemedical.com
Preparation date	April 12th 2013
K number	K122834
Trade Name	POLYSITE® Implantable Infusion Port (CATALOG REFERENCES: 2016PI -3017PI- 4018PI - 2016SPI - 3017SPI - 4018SPI- 2016C -3017C -4018C-2016SC-3017SC-4018SC)
Common Name	Implantable Infusion Port
Classification Name	PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
Legally marketedpredicate devices	- PowerPort isp Implantable Port with attachable 8Fr. ChronoflexPolyurethane Catheter (K072215)- Slimport Titanium implantable port with attachable 6FChronoflex Open-ended single-lumen venous catheter(K870260)
Description	POLYSITE Implantable Infusion Port is composed of a radiopaquedome or housing and a self sealing septum, connected to aradiopaque catheter by a connecting ring (supplied unassembled).The port is accessed percutaneously by using a non-coring needle.Image: Diagram of the port
Technologicalcharacteristics	Technological characteristics of the subject devices are equivalent topredicated devices. This equivalence extends to basic design genericmaterials and construction. The distinguishing differences exists in:- the external portal body material: titanium for the predicates,and plastic for the subject devices- the markers of POLYSITE Pressure Injectable are visible under X-ray and visible light, the marking of the predicate is only visibleunder X-ray. The symbol used is also different.These differences do not impact the intended use and do not raiseany new questions regarding safety or effectiveness.
Intended Use	The POLYSITE implantable infusion Port is indicated for long termaccess to the central venous system and allows for repeated vascularaccess.POLYSITE Implantable Infusion venous access ports are used toadminister chemotherapy, antibiotics and antiviral drugs. They canalso be used for parenteral nutrition, collection of blood samples andtransfusion of blood or blood products.A non-coring needle must be used to access POLYSITE ImplantableInfusion Ports.Some references of POLYSITE (POLYSITE Pressure InjectableImplantable Infusion Port-Pl references) can be used for high pressureinjection of contrast media during diagnostic studies. The maximumflow rate of power injector equipment used with the pressureinjectable port may not exceed 5 mL/s.For high pressure injection of contrast media, a high pressure needlemust be used to access the POLYSITE Pressure Injectable implantableInfusion port. The manufacturer recommends the use of PPS PIPressure Injectable Safety Huber needle.
Performance data	Performance data included with this submission- Biocompatibility according to ISO 10993-1: 2009- Safety and functionality testingo in accordance with the FDA's "Guidance on 510(k)Submissions for Implanted Infusion Ports" datedOctober 1990:- Catheter to port connection (dry and wetconditions)- Septum puncture (with 19, 20 and 22 Gaugeneedles)- Port leak testing (air method)- 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.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

Siège sodal Route du Manoli 60173 lyry le Temple, France 00 11 80 Ft Eigh E C P1 Fax : 33 (0)3 44 08 17 01

Division Oncologio & Cardiovasculaire Route du Manost 60173 Ivry le Temple. France Tel. 33 (013 44 08 17 00 Fax 33 (0)3 44 08 17 01

Division Imagerie Interventionnelle & BtoB 135. Route Neuve 69540 Irigny, France
Tel... 33 (0)4 72 39 74 14 Fax 33 (0)4 78 51 89 67

ww.perousemedical.com

SAS as capital de 131e 702 eur SIPEN 717 883 995 RC 5 Bear Nº TVA mbacomma FR 01 3 17 883 999

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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.

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

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. ChapmanDate: 2013.12.09 15:51:14 -05'00'
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FORM FDA 3881 (9/13)
Page 1 of 2

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-DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete unle to review that collection. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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Regulation Number and Section

§ 880.5965 Subcutaneous, implanted, intravascular infusion port and catheter.

(a)
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.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.