(450 days)
Not Found
No
The summary describes a standard implantable infusion port and its physical characteristics and performance testing, with no mention of AI or ML capabilities.
No.
A therapeutic device is one that treats a disease or condition. This device is a port used to administer substances like chemotherapy, antibiotics, and parenteral nutrition, and for blood collection, but it does not directly treat a condition itself.
No
The device is an implantable infusion port used for administering various substances and drawing blood, primarily for therapeutic purposes. While it can be used for injecting contrast media during diagnostic studies, the device itself does not perform diagnosis; it facilitates diagnostic procedures performed by other equipment.
No
The device description clearly states it is composed of physical components (radiopaque dome/housing, septum, catheter, connecting ring) and is accessed percutaneously with a needle, indicating it is a hardware medical device.
Based on the provided information, the POLYSITE implantable infusion port is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "long term access to the central venous system" for administering various substances (chemotherapy, antibiotics, etc.), collecting blood samples, and transfusing blood products. It is a device for delivering or collecting substances from within the body.
- Device Description: The description details a physical implantable device with a port and catheter, designed for percutaneous access.
- Lack of IVD Characteristics: An IVD device is used to examine specimens from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The POLYSITE port is used in vivo (within the body) to interact directly with the patient's circulatory system.
Therefore, the POLYSITE implantable infusion port is a medical device, specifically an implantable access device, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LJT, OKE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
central venous system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data included with this submission
- Biocompatibility according to ISO 10993-1: 2009
- Safety and functionality testing
o in accordance with the FDA's "Guidance on 510(k) Submissions for Implanted Infusion Ports" dated October 1990:- Catheter to port connection (dry and wet conditions)
- Septum puncture (with 19, 20 and 22 Gauge needles)
- 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS As required by section 807.92(c)
DEC 1 1 2013
| Submitter | PEROUSE MEDICAL
Route du Manoir
60173 IVRY LE TEMPLE
FRANCE
Phone +33(0)3 44 08 17 00
Fax +33(0)3 44 08 17 01
Website: www.perousemedical.com |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contacts | Isabelle JEANTY
Deputy Managing Director - Quality & Regulatory Affairs Director
e-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 marketed
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) |
| 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.
Image: Diagram of the port |
| Technological
characteristics | Technological characteristics of the subject devices are equivalent to
predicated devices. This equivalence extends to basic design generic
materials 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 visible
under X-ray. The symbol used is also different.
These differences do not impact the intended use and do not raise
any new questions regarding safety or effectiveness. |
| Intended 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. |
| Performance data | Performance data included with this submission - Biocompatibility according to ISO 10993-1: 2009
- Safety and functionality testing
o in accordance with the FDA's "Guidance on 510(k)
Submissions for Implanted Infusion Ports" dated
October 1990: - Catheter to port connection (dry and wet
conditions) - Septum puncture (with 19, 20 and 22 Gauge
needles) - 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 |
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Tel... 33 (0)4 72 39 74 14 Fax 33 (0)4 78 51 89 67
ww.perousemedical.com
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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.
4
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
5
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
Date: 2013.12.09 15:51:14 -05'00' |
| ------------------------------------------------------------------------------ | ----------------------------------------------------------------------------- |
|---|
FORM FDA 3881 (9/13)
Page 1 of 2
6
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