(66 days)
Nothing to extract
Not Found
No
The provided text describes a port access system for vascular access and power injection of contrast media. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses on the physical function and intended use of the port system.
No
The device is described as an access system for delivering medications, fluids, and blood products, and for blood sampling, and for power injection of contrast media. These are procedural functions, not therapeutic treatments.
No
The device is indicated for repeated access of the vasculature for delivery and sampling of substances, and for power injection of contrast media. These are therapeutic and procedural uses, not diagnostic.
No
The device description is not available, but the intended use clearly describes a "Port Access System" which is a physical device implanted in the vasculature. This is not a software-only device.
Based on the provided information, the Smart Port® CT Port Access System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Smart Port® Function: The Smart Port® is a device implanted in the body to provide repeated access to the vasculature system for delivering substances and sampling blood. It is a medical device used for treatment and access, not for performing diagnostic tests on samples outside the body.
The description clearly indicates its use for delivering medications, fluids, and for power injection of contrast media, all of which are in-vivo procedures. While it is used for blood sampling, the device itself is the access point, not the diagnostic test performed on the blood sample.
N/A
Intended Use / Indications for Use
The Smart Port® CT Port Access System is indicated for any patient requiring repeated access of the vasculature system, for the delivery of medications, nutritional supplementation, fluids, blood, blood products, and the sampling of blood. When used with non Y site LifeGuard Safety infusion sets in 20 Ga or 19 Ga sizes, the Smart Port® CT Access System is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/sec.
Product codes
LJT
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vasculature 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)
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines representing its wings and tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
JUN 1 7 2010
Food and Drug Administration 10903 New Hamoshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Teri Juckett Senior Regulatory Affairs Professional AngioDynamics, Incorporated 14 Plaza Drive Latham, New York 12110
Re: K101017
Trade/Device Name: AngioDynamics, Inc. Smart Port® CT, Mp and LP Lines Extensions Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous, Implanted Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: May 17, 2010 Received: May 19, 2010
Dear Ms. Juckett:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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Page 2 - Ms. Juckett
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Susan Russo
Anthony Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Confidential
INDICATIONS FOR USE
K 101017
510(k) Application: Special 510K Device Modification
AngioDynamics, Inc. Smart Port® CT, Mp and LP Lines Extensions Device Name:
Indications for Use: The Smart Port® CT Port Access System is indicated for any patient requiring repeated access of the vasculature system, for the delivery of medications, nutritional supplementation, fluids, blood, blood products, and the sampling of blood.
When used with non Y site LifeGuard Safety infusion sets in 20 Ga or 19 Ga sizes, the Smart Port® CT Access System is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/sec.
Prescription Use (Per 21 CFR 801.109) OR
Over-the-Counter Use
Please do not write below this line - continue on another page if needed
Concurrence of CDRH, Office of Device Evalus
Suze Rion
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K10617
AngioDynamics SmartPort CT, MP and LP Line Extensions 510(k) Design History File 100247
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