(28 days)
Not Found
No
The device description and intended use focus on the mechanical function of an implantable infusion port and its accessories. There is no mention of software, algorithms, data processing, or any terms related to AI/ML.
Yes
The device is used for infusion of medications, IV fluids, parenteral nutrition solutions, and blood products, as well as for the withdrawal of blood samples, all of which are part of patient therapies.
No
The device is an infusion port used for repeated access to the vascular system for infusions and blood withdrawal; it does not diagnose a condition or disease.
No
The device description clearly outlines a physical, implantable medical device (infusion port and catheter) and associated hardware components. There is no mention of software as a component or function of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for providing repeated access to the vascular system for infusion of substances and withdrawal of blood samples. This is a therapeutic and procedural use, not a diagnostic use performed in vitro (outside the body).
- Device Description: The device is an implantable port and catheter system designed to facilitate access to the vascular system. It is a medical device used in vivo (within the body) for delivering and withdrawing substances.
- Lack of Diagnostic Function: The description does not mention any function related to analyzing samples in vitro to provide diagnostic information. The withdrawal of blood samples is for subsequent analysis, which would be performed by a separate IVD device or laboratory process.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) in vitro to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to provide access to the vascular system, which is a procedural and therapeutic action.
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 (comma separated list FDA assigned to the subject device)
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 port. 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 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 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 K071993. .
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): 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
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 |
DEC 1 2 2007
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: | |
|---|---|
| Manufacturer: | PFM Medical, Inc |
| Name: | T-Port HP Infusion Port |
| 510(k) #: | K071993 |
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 port. 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 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 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 K071993. .
Components will be assembled into standard configurations specified by the customer and packaged.
1
K03210 page 2 of 3
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/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
DEC 1 2 2007
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
Rc: K073210
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: November 12, 2007 Received: November 16, 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 mcan 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,
Cve
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
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Image /page/4/Picture/0 description: The image contains a series of numbers, specifically "073210". The numbers are arranged horizontally and are the primary focus of the image. The digits are somewhat faded, suggesting the image may be a scan or a photograph of a printed document.
510(k):
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 noncoring power injectable needle or 2 ml/sec with a 22G non-coring power injectable needle.
Concurrence of CDRH, Office of Device Evaluation (ODE)
ਮੇ Prescription Use Or Over the Counter Use (Per 21 CFR 801.109)
Antan v.n
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number 1473214