(21 days)
Not Found
No
The summary describes a mechanical vascular access system with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as "intended for the delivery of medications, intravenous fluids, parenteral nutrition solutions or blood products," which are therapeutic interventions.
No
The device is described as an implantable vascular access system for drug delivery, fluid administration, and blood withdrawal, not for diagnosing conditions.
No
The device description clearly states it is comprised of a vascular access port and a catheter, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the delivery of substances into the body and the withdrawal of blood samples. This is a direct interaction with the patient's vascular system for therapeutic and diagnostic sampling purposes.
- Device Description: The device is a physical implantable system (port and catheter) designed to facilitate access to the vascular system.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. IVDs typically involve reagents, analyzers, or test kits used to analyze biological samples.
This device falls under the category of a medical device used for vascular access, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Triumph™ VTX® Port with LifeValve® Catheter is a totally implantable vascular access system intended for the delivery of medications, intravenous fluids, parenteral nutrition solutions or blood products. The Triumph™ VTX® Port with LifeValve® Catheter is also indicated for the withdrawal of blood samples.
Product codes (comma separated list FDA assigned to the subject device)
LJT
Device Description
The Triumph™ VTX® Port with LifeValve® Catheter is a device comprised of a vascular access port and a catheter. The Triumph™ VTX® Port is available in a titanium or polysulfone configuration with a self sealing silicone rubber septum designed to maintain integrity after repeated punctures with an anti-coring needle. The LifeValve® Catheter incorporates a bidirectional valve assembly at the distal tip. The catheter is equipped with a pre-threaded stiffening stylet to facilitate passage of the catheter through the introducer. The positioned LifeValve® Catheter is secured to the Triumph™ VTX® Port reservoir with a locking mechanism. The products are packaged in a sterile tray with an introducer kit and components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
The Triumph™ VTX® Port with LifeValve® Catheter design was evaluated through Horizon Medicals risk analysis and qualified through design verification testing following established Design Control procedures. No new questions of safety or effectiveness for implantable ports or central venous catheters were raised by the risk analysis or testing of the Triumph™ VTX® Port with LifeValve® Catheter.
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.
K933986, K951814, K010189, K031718
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
SEP - 9 2003
KO 3253-7
510(K) SUMMARY [AS REQUIRED BY 21 CFR 807.92(C)] 6
Submitter's Name / Contact Person
| Manufacturer | Contact |
|---|---|
| Horizon Medical Products, Inc. | Scott Moeller |
| One Horizon Way | Director of Quality Assurance and Regulatory |
| Manchester, Georgia 31816 | Affairs |
General Information
| Trade Name | Triumph™ VTX® Port with LifeValve® Catheter |
|---|---|
| Common Name | Vascular access port with intravascular catheter |
| Classification Name | Subcutaneous, implanted, intravascular infusion port and catheter |
| Classification Number: 21 CFR §880.5965 | |
| Classification Panel: General Hospital | |
| Product Code: LJT | |
| Equivalent Devices | Product; Manufacturer; 510(k) # |
| • Triumph-1® Port Systems; Horizon Medical Products; K933986, K951814 | |
| • Vortex® Access Systems; Horizon Medical Products; K010189 | |
| • LifeValve® Central Venous Catheter; Horizon Medical Products; K031718 |
Device Description
The Triumph™ VTX® Port with LifeValve® Catheter is a device comprised of a vascular access port and a catheter. The Triumph™ VTX® Port is available in a titanium or polysulfone configuration with a self sealing silicone rubber septum designed to maintain integrity after repeated punctures with an anti-coring needle. The LifeValve® Catheter incorporates a bidirectional valve assembly at the distal tip. The catheter is equipped with a pre-threaded stiffening stylet to facilitate passage of the catheter through the introducer. The positioned LifeValve® Catheter is secured to the Triumph™ VTX® Port reservoir with a locking mechanism. The products are packaged in a sterile tray with an introducer kit and components.
Intended Use
The Triumph™ VTX® Port with LifeValve® Catheter is a totally implantable vascular access system intended for the delivery of medications, intravenous fluids, parenteral nutrition solutions or blood products. The Triumph™ VTX® Port with LifeValve® Catheter is also indicated for the withdrawal of blood samples.
1
Substantial Equivalence Comparison
The Triumph™ VTX® Port with LifeValve® Catheter is substantially equivalent to the Horizon Medical Products, Inc. (HMP) Triumph-1® Port System, Vortex® Access System and LifeValve® Central Venous Catheter.
The subject and predicate devices are substantially equivalent in intended use and fundamental scientific technology. The Triumph™ VTX® Port and the Triumph-10 and Vortex® Access System predicates are substantially similar in configuration, dimensions, and materials. The LifeValve® Catheter is essentially identical to the previously cleared LifeValve® Catheter. The Triumph™ VTX® Port with LifeValve® Catheter design was evaluated through Horizon Medicals risk analysis and qualified through design verification testing following established Design Control procedures. No new questions of safety or effectiveness for implantable ports or central venous catheters were raised by the risk analysis or testing of the Triumph™ VTX® Port with LifeValve® Catheter.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping lines forming a human figure.
Public Health Service
SEP - 9 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Scott Moeller Director of Quality Assurance and Regulatory Affairs Horizon Medical Products, Incorporated 1 Horizon Way Manchester, Georgia 31816
Re: K032557
Trade/Device Name: Triumph™ VTX® Port with life Valve® Catheter Regulation Number: 21CFR 880.5965 Regulation Name: Subcutaneous, Implanted Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: August 18, 2003 Received: August 19, 2003
Dear Mr. Moeller:
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 vour 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. Moeller
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 (301) 594-4618. 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/dsma/dsmamain.html
Sincerely yours.
Patuca Cuceritofoc
Susan Runner, DDS, MA Interim 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 STATEMENT
510(k) Number (if known):
Device Name: Triumph™ VTX® Port with LifeValve® Catheter
Indications for Use:
The Triumph™ VTX® Port with LifeValve Catheter is a totally implantable vascular access system intended for the delivery of medications, intravenous fluids, parenteral nutrition solutions or blood products. The Triumph™ VTX® Port with LifeValve® Catheter is also indicated for the withdrawal of blood samples.
Susan Runse
(Division Sign-Off) General Hospital. Division of Anesthesiolog Infection Control, Denta 510(k) Number:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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