(89 days)
No
The document describes a purely mechanical implantable infusion port and its accessories. There is no mention of any software, data processing, or intelligent capabilities.
No
The device is an infusion port system designed for repeated vascular access for administering medications, fluids, nutrition, blood products, and contrast media, as well as for withdrawing blood samples. It facilitates these therapies but does not directly deliver a therapeutic effect itself.
No
The T-Port HP Infusion Port is an implantable device designed for repeated access to the vascular system for infusion of medications, fluids, nutrition solutions, blood products, and for the withdrawal of blood samples. It is not used for diagnosing conditions or diseases.
No
The device description clearly states it is an "implantable device" consisting of physical components like a port, catheter, and various accessories for insertion. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for accessing the vascular system for infusion of substances and withdrawal of blood samples from the patient. This is a direct interaction with the patient's body for therapeutic and diagnostic purposes, not for testing samples in vitro (outside the body).
- Device Description: The description details an implantable port and catheter system designed to be placed within the patient's body. This is characteristic of an in vivo device.
- Lack of IVD Characteristics: There is no mention of reagents, assays, or any process for analyzing biological samples in vitro. The device facilitates the collection of samples, but the analysis itself would be performed separately, likely using IVD devices.
Therefore, the T-Port HP Infusion Port is an in vivo medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The T-Port HP Infusion Port 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 T-Port HP Infusion Port 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 non-coring power injectable needle.
Product codes
LJT
Device Description
The T-Port HP Infusion Port 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 T-Port HP Infusion Port is offered with the polyurethane catheter either preattached by the manufacturer or attachable for application by the inserting physician. The port can be anchored with sutures in the port pocket for secure seating. The catheter lock provides securement of the catheter to the port. Introduction of solution into the implanted port and catheter system is through a non-coring needle.
The base of the port has the letters "CT" to signify that it can be used for power injection on contrast agents. The serial number is laser etched into the base of the suture holes may contain clear silicone to prevent tissue in growth to the suture holes.
Power injection of contrast media, can be safely administered with a 19 or 20 qauqe 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 T-Port HP Infusion Port is packaged with the necessary accessories to facilitate catheter insertion.
The port and catheter 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 Implantable 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 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
ge 1 of 2
510(k) Summary of Safety and Effectiveness
UCT 1 7 2007
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
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: | T-Port HP Infusion Port |
| Common Name: | Port & Catheter Implanted, Subcutaneous, Intravascular |
| Classification Name: | Same |
Equivalent Devices:
pfm Medical, Inc Manufacturer: MedComp Name: Jet Port Plus Catheter System Power Injectable, Implantable Infusion Port 510(k) #: K000125 K070003
Device Description:
The T-Port HP Infusion Port 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 T-Port HP Infusion Port is offered with the polyurethane catheter either preattached by the manufacturer or attachable for application by the inserting physician. The port can be anchored with sutures in the port pocket for secure seating. The catheter lock provides securement of the catheter to the port. Introduction of solution into the implanted port and catheter system is through a non-coring needle.
The base of the port has the letters "CT" to signify that it can be used for power injection on contrast agents. The serial number is laser etched into the base of the suture holes may contain clear silicone to prevent tissue in growth to the suture holes.
Power injection of contrast media, can be safely administered with a 19 or 20 qauqe 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 T-Port HP Infusion Port is packaged with the necessary accessories to facilitate catheter insertion.
The port and catheter 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 Implantable Infusion Port cleared under K070003.
Components will be assembled into standard configurations specified by the customer and packaged.
1
K071993 page 2 of 2
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 T-Port HP Infusion Port 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 T-Port HP Infusion Port 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 non-coring power injectable needle.
Biocompatibility:
The materials used to manufacture the T-Port HP Infusion Port are used in legally marketed devices under comparable conditions of use.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the department's name encircling a stylized symbol. The symbol resembles a human figure in profile, with three flowing lines representing the body and head. The overall design is simple and conveys a sense of health and well-being.
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
OCT 1 7 2007
Re: K071993
Trade/Device Name: T-Port HP Infusion Port Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: July 17, 2007 Received: July 20, 2007
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 your 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) 276-0120. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Cure
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):
Device Name: T-Port HP Infusion Port
Indications For Use:
The T-Port HP Infusion Port 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 T-Port HP Infusion Port 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 non-coring power injectable needle.
X 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)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K417993