(185 days)
No
The description focuses on the physical components and functionality of an implantable port system for vascular access and power injection, with no mention of AI or ML.
Yes
The device is indicated for infusions of medications, IV fluids, parenteral nutrition solutions, and blood products, as well as for power injection of contrast media, which are patient therapies.
No
This device is an implantable access system for therapeutic infusions and blood withdrawals, not for diagnosing conditions.
No
The device description clearly outlines a system composed of physical, implantable components (port, catheter, needles, etc.) and does not mention any software as a component or the primary function of the device.
Based on the provided information, the Jet Port Plus HP Catheter System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "patient therapies requiring repeated access to the vascular system" for infusion of various substances and withdrawal of blood samples. It is an implantable device used in vivo (within the body) for direct patient treatment and access.
- Device Description: The description details an implantable port and catheter system designed to be placed within the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The Jet Port Plus HP Catheter System does not perform any such analysis of specimens outside the body. While it can be used to withdraw blood samples, the device itself is not performing the diagnostic test on that sample.
Therefore, the Jet Port Plus HP Catheter System is a medical device used for direct patient care and treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Jet Port Plus HP Catheter System is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, IV fluids, parenteral nutrition solutions, blood products and for the withdrawal of blood samples.
When used with a power injectable needle, the Jet Port Plus HP Catheter System is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/sec with a 19G or 20G non-coring power injectable needle or 2 ml/sec with a 22G noncoring power injectable needle.
Product codes
LJT
Device Description
The Jet Port Plus HP Catheter System is an implantable device designed to provide repeated access to the vascular system without the trauma associated with multiple vena puncture. The system consists of a self-sealing injection port and a delivery catheter for the receipt and delivery of medications to the selected body site.
The Jet Port Plus HP Catheter System port is available in various profiles The Jet Port Plus HP II has a polyoxymethylene body with a silicone septum The Tita Jet Light HP has a polyoxymethylene body containing a titanium insert with a silicone septum
The base of the port has the letters "CT" to signify that it can be used for power injection on contrast agents. These letters can be visualized through a Scout CT. The serial number is laser etched into the base of the port. The port can be anchored with sutures in the port pocket for secure seating. The suture holes may contain clear silicone to prevent tissue in growth to the suture holes.
The Jet Port Plus HP Catheter System is offered with the polyurethane catheter either pre-attached by the manufacturer or attachable for application by the inserting physician. The catheter lock provides securement of the catheter to the port. I Introduction into the implanted port and catheter system is through a non-coring needle.
Power injection of contrast media, can be safely administered with a 19 or 20 gauge power injectable infusion non-corning needle at a maximum recommended infusion rate of 5 ml/sec or a 22 gauge power injectable non-coring needle at a maximum recommended infusion rate of 2 ml/sec. Maximum pressure should not exceed 300 psi.
The Jet Port Plus HP Catheter System is packaged with the necessary accessories to facilitate catheter insertion.
The port and catheter uses the same components and are manufactured and sterilized at the same manufacturing and sterilization facilities as the predicate device cleared under K000125. The addition of power injection capability is comparable to the currently marketed Power Injectable Infusion Port cleared under K070003.
Components will be assembled into standard configurations specified by the customer and packaged.
The device includes the following components:
- Implantable Port
- . Click Connector
- Guide Wire ●
- Dilator ●
- Tunneling Needle
- Vein Lifter .
- . Nurses Guide
- Companion Checklist
- Catheter .
- Huber Needle
- . Introducing Needle
- . Peel Away Sheath
- . Syringe
- Instructions for Use ●
- Patient Guide .
- Patient ID Card & Key Ring Card .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
The following section is included as required by the Safe Medical Device Act (SMDA) of 1990.
| Name: | PFM Medical, Inc |
|---|---|
| Address: | 2605 Temple Heights Drive |
| Oceanside, CA 92056 | |
| CONTACT PERSON: | SALVADORE F. PALOMARES, RAC |
510(k) Summary of Safety and Effectiveness
MAR - 7 2008
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| The assigned 510(k) number is: | |
|---|---|
| Trade Name: | Jet Port Plus HP Catheter System |
| Common Name: | Port & Catheter Implanted, Subcutaneous, Intravascular |
| Classification Name: | Same |
Equivalent Devices:
| Manufacturer: | pfm Medical, Inc | MedComp |
|---|---|---|
| Name: | Jet Port Plus Catheter System | Power Injectable, Implantable Infusion Port |
| 510(k) #: | K000125 | K070003 |
Device Description:
The Jet Port Plus HP Catheter System is an implantable device designed to provide repeated access to the vascular system without the trauma associated with multiple vena puncture. The system consists of a self-sealing injection port and a delivery catheter for the receipt and delivery of medications to the selected body site.
The Jet Port Plus HP Catheter System port is available in various profiles The Jet Port Plus HP II has a polyoxymethylene body with a silicone septum The Tita Jet Light HP has a polyoxymethylene body containing a titanium insert with a silicone septum
The base of the port has the letters "CT" to signify that it can be used for power injection on contrast agents. These letters can be visualized through a Scout CT. The serial number is laser etched into the base of the port. The port can be anchored with sutures in the port pocket for secure seating. The suture holes may contain clear silicone to prevent tissue in growth to the suture holes.
The Jet Port Plus HP Catheter System is offered with the polyurethane catheter either pre-attached by the manufacturer or attachable for application by the inserting physician. The catheter lock provides securement of the catheter to the port. I Introduction into the implanted port and catheter system is through a non-coring needle.
Power injection of contrast media, can be safely administered with a 19 or 20 gauge power injectable infusion non-corning needle at a maximum recommended infusion rate of 5 ml/sec or a 22 gauge power injectable non-coring needle at a maximum recommended infusion rate of 2 ml/sec. Maximum pressure should not exceed 300 psi.
The Jet Port Plus HP Catheter System is packaged with the necessary accessories to facilitate catheter insertion.
The port and catheter uses the same components and are manufactured and sterilized at the same manufacturing and sterilization facilities as the predicate device cleared under K000125. The addition of
1
Karate
power injection capability is comparable to the currently marketed Power Injectable Infusion Port cleared under K070003.
Components will be assembled into standard configurations specified by the customer and packaged.
The device includes the following components:
- Implantable Port
- . Click Connector
- Guide Wire ●
- Dilator ●
- � Tunneling Needle
- Vein Lifter .
- . Nurses Guide
- Companion Checklist
- Catheter .
- Huber Needle �
- . Introducing Needle
- . Peel Away Sheath
- . Syringe
- Instructions for Use ●
- Patient Guide .
- Patient ID Card & Key Ring Card .
Intended Use:
The Jet Port Plus HP Catheter System is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, IV fluids, parenteral nutrition solutions, blood products and for the withdrawal of blood samples.
When used with a power injectable needle, the Jet Port Plus HP Catheter System is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/sec with a 19G or 20G non-coring power injectable needle or 2 ml/sec with a 22G noncoring power injectable needle.
Biocompatibility:
The materials used to manufacture the Jet Port Plus HP Catheter System are used in legally marketed devices under comparable conditions of use.
2
MENT OF HEALT
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Salvadore F. Palomares, RAC Director of Regulatory Affairs PFM Medical, Incorporated 2605 Temple Heights Drive, Suite A Oceanside, California 92056
MAR - 7 2008
Re: K072481
Trade/Device Name: Jet Port Plus HP Catheter System Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: February 29, 2008 Received: March 4, 2008
Dear Mr. Palomares:
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.
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.
3
Page 2 - Mr. Palomares
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); 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 vour 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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chris Lins, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications For Use
510(k) Number (if known):
Jet Port Plus HP Catheter System Device Name:
Indications For Use:
The Jet Port Plus HP Catheter System is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, IV fluids, parenteral nutrition solutions, blood products and for the withdrawal of blood samples.
When used with a power injectable needle, the Jet Port Plus HP Catheter System is indicated for power injection of contrast media. For injection of contrast media, the maximum recommended infusion rate is 5 ml/sec with a 19G or 20G non-coring power injectable needle or 2 ml/sec with a 22G non-coring power injectable needle.
× Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
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)
Anthony D. Anater
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devicess
510(k) Number: _ )