(30 days)
Not Found
No
The device description and intended use focus on a physical vascular access system and its components, with no mention of software, algorithms, or data processing that would suggest AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is used for the "delivery of medications, nutritional supplementation, fluids, blood, blood products" and "sampling of blood," which are functionalities indicative of a therapeutic device designed to manage or treat a patient's condition.
No
The device is described as an access system for delivering substances and sampling blood, not for diagnosing conditions.
No
The device description explicitly states it is comprised of physical components like a vascular access port, catheter, locking mechanism, and introduction components, which are hardware.
Based on the provided information, the Vortex® EZ Port Access System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for accessing the vascular system or other body sites for delivering substances and sampling blood from the patient. This is a direct interaction with the patient's body for therapeutic or diagnostic sampling purposes, not for testing samples outside the body to diagnose a condition.
- Device Description: The description details a port and catheter system designed for implantation and access to the body. This aligns with a medical device used for patient care, not a device used to analyze biological samples in a lab setting.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any processes typically associated with in vitro diagnostics.
Therefore, the Vortex® EZ Port Access System is a medical device used for patient access, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Vortex® EZ Port Access System is indicated for any patient requiring repeated access of the vascular system or other selected body site, for the delivery of medications, nutritional supplementation, fluids, blood, blood products, and sampling of blood.
Product codes
LJT
Device Description
The Vortex® EZ Port Access System is a device comprised of a vascular access port, a catheter, locking mechanism and introduction components. The Vortex® EZ Port is available in a Delrin port body configuration with a self sealing silicone septum designed to maintain integrity after repeated punctures with a non-coring needle. The port base is crafted of silicone so that the port can be sutured to the underlying tissue anywhere around this base. A pre-attached or a detached/attachable catheter is offered in either polyurethane or silicone models with or without a highly radiopaque tip molded on. 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
vascular system or other selected body site
Indicated Patient Age Range
any patient
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® EZ Port Access System design was evaluated through 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® EZ Port Access System.
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
Premarket Notification - Special 510(k): Device Modification 510(k) Summary RITA Medical Systems, Inc. Vortex® EZ Port Access System
January 2005
Page 17 of 23
510(k) Summary [as required by 21 CFR 807.92(c)]
FEB 2 5 2005
Submitter's Name / Contact Person
| Manufacturer | Contact |
|---|---|
| RITA Medical Systems, Inc. | Mary Gossard, M.S. |
| One Horizon Way | Manager, Regulatory Affairs |
| Manchester, Georgia 31816 |
General Information
| Trade Name | Vortex® EZ Port Access System |
|---|---|
| Common Name | Vascular access port |
| Classification Name | Subcutaneous, implanted, intravascular infusion port and catheter |
| Classification Number: | |
| Classification Panel: | |
| Product Code: | |
| Modified Devices | LifePort® VTX® Access System (K010767) |
| LifePort® LPS 7013 (K905852) |
Device Description
The Vortex® EZ Port Access System is a device comprised of a vascular access port, a catheter, locking mechanism and introduction components. The Vortex® EZ Port is available in a Delrin port body configuration with a self sealing silicone septum designed to maintain integrity after repeated punctures with a non-coring needle. The port base is crafted of silicone so that the port can be sutured to the underlying tissue anywhere around this base. A pre-attached or a detached/attachable catheter is offered in either polyurethane or silicone models with or without a highly radiopaque tip molded on. The products are packaged in sterile trays with introduction components.
Intended Use / Indications
The Vortex® EZ Port Access System is indicated for any patient requiring repeated access of the vascular system or other selected body site, for the delivery of medications, nutritional supplementation, fluids, blood, blood products, and sampling of blood.
Substantial Equivalence Comparison
The Vortex® EZ Port Access System and the modified devices, LifePort® VTX® Access System and the LPS 7013 model of the LifePort® ports with silicone and polyurethane catheters share identical intended uses and fundamental scientific technology. The subject and modified devices are substantially similar in configuration, dimensions, and materials. The Vortex® EZ Port Access System design was evaluated through 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® EZ Port Access System.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes forming its body and wings, symbolizing health, services, and people. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
FEB 2 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Mary Gossard Manager, Regulatory Affairs RITA Medical Systems One Horizon Way Manchester. Georgia 31816
Re: K050176
Trade/Device Name: Vortex® EZ Port Access System Regulation Number: 880.5965 Regulation Name: Subcutaneous, Implanted Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: January 25, 2005 Received: January 26, 2005
Dear Ms. Gossard:
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 - Ms. Gossard
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-frec number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Clint Little, 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
3
Indications for Use
510(k) Number (if known): ¥050176
Vortex® EZ Port Access System Device Name:
Indications for Use:
The Vortex® EZ Port Access System is indicated for any patient requiring repeated access of the vascular system or other selected body site, for the delivery of medications, nutritional supplementation, fluids, blood, blood products, and sampling of blood.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cinta Umar
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മാന of Anesthesiology, General Hospital crion Control, Dental Devices