(15 days)
Not Found
No
The summary describes a physical vascular access system with no mention of software, algorithms, or any technology related to AI or ML.
No.
The device facilitates the delivery of therapy (injection/infusion) but is not a therapy itself. Its function is to provide repeated venous access, which is a method of administering treatment, not performing it.
No
Explanation: The device is indicated for repeated venous access for injection or infusion therapy and/or venous blood sampling, which are therapeutic and collection functions, not diagnostic.
No
The device description explicitly lists hardware components such as a vascular access port, catheter, locking mechanism, and introduction components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "central venous placement... when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling." This describes a device used in vivo (within the body) for delivering substances or collecting samples directly from the bloodstream.
- Device Description: The description details components like a vascular access port, catheter, and introduction components, all designed for insertion into 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 other components used to test biological samples like blood, urine, or tissue.
Therefore, the Vortex® MP Vascular Access System is a medical device used for direct patient care and access to the vascular system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Vortex® MP Vascular Access System is indicated for central venous placement (either peripheral or chest placement) when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.
Product codes (comma separated list FDA assigned to the subject device)
LJT
Device Description
The Vortex® MP Vascular Access System is a device comprised of a vascular access port, a catheter, locking mechanism and introduction components. The Vortex MP® Port is available in a titanium configuration with a self sealing silicone septum designed to maintain integrity after repeated punctures with a non-coring needle. The catheter is offered in polyurethane and silicone models. The products are packaged in sterile trays with introduction components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
central venous placement (either peripheral or chest placement)
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 Vortex MP Vascular Access System was evaluated through HMP risk analysis and qualified through design verification testing following established Design Control procedures. No new questions of safety or effectiveness were raised for the Vortex MP Vascular Access System.
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
Premarket Notification – Special 510(k): Device Modification
Horizon Medical Products, I Horizon Medical Products, Inc. Vortex® MP Vascular Access System
Image /page/0/Picture/2 description: The image shows a handwritten sequence of characters and numbers. The sequence starts with a character that resembles a stylized 'K', followed by the numbers '033473'. The handwriting is somewhat rough, giving the sequence a casual and informal appearance.
510(k) Summary
510(K) SUMMARY [AS REQUIRED BY 21 CFR 807,92(C){
Submitter's Name / Contact Person
| Manufacturer | Contact |
|---|---|
| Horizon Medical Products, Inc. | Scott Moeller |
| One Horizon Way | Director of Quality Assurance and Regulatory Affairs |
| Manchester, Georgia 31816 |
General Information
| Trade Name | Vortex® MP Vascular Access System | |
|---|---|---|
| Common Name | Vascular access port | |
| Classification Name | Classification Number: | |
| Classification Panel: | ||
| Product Code: | Subcutaneous, implanted, intravascular infusion port and catheter | |
| 21 CFR §880.5965 | ||
| General Hospital | ||
| LJT | ||
| Equivalent Device | Horizon Medical Products Vortex® MP Peripheral Access System | |
| (K032754) |
Device Description
The Vortex® MP Vascular Access System is a device comprised of a vascular access port, a catheter, locking mechanism and introduction components. The Vortex MP® Port is available in a titanium configuration with a self sealing silicone septum designed to maintain integrity after repeated punctures with a non-coring needle. The catheter is offered in polyurethane and silicone models. The products are packaged in sterile trays with introduction components.
Intended Use / Indications
The Vortex® MP Vascular Access System is indicated for central venous placement (either peripheral or chest placement) when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.
Substantial Equivalence Comparison
The subject and predicate devices utilize the identical fundamental scientific technology and are identical in configuration and dimensions. The subject and predicate devices are substantially similar in materials of construction. The Vortex MP Vascular Access System was evaluated through HMP risk analysis and qualified through design verification testing following established Design Control procedures. No new questions of safety or effectiveness were raised for the Vortex MP Vascular Access System.
1
Image /page/1/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three stylized human profiles facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 8 2003
Mr. Scott Moeller Director of Quality Assurance and Regulatory Affairs Horizon Medical Products, Incorporated One Horizon Way Manchester, Georgia 31816
Re: K033473
Trade/Device Name: Modification to Vortex MP Vascular Access Port Regulation Number: 880.5965 Regulation Name: Subcutaneous Implanted Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: October 31, 2003 Received: November 3, 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 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.
2
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 (OS) 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 (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,
Clupis
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
3
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): _ LO33413
Page 1 of 1
Vortex MP Vascular Access System Device Name:
Indications for Use:
The Vortex® MP Vascular Access System is indicated for central venous placement (either peripheral or chest placement) when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Latica Cuscante
510(k) Number: K053475