(38 days)
Not Found
No
The device description focuses on the physical components and mechanical function of a vascular access port and catheter system. There is no mention of software, algorithms, or any capabilities that would suggest the use of AI or ML. The performance studies described are mechanical tests, not evaluations of algorithmic performance.
Yes
The device is used for the administration of drugs, blood products, and contrast media, and for the withdrawal of blood as part of a therapy regimen; these are direct therapeutic interventions or support therapeutic processes.
No
The device description and intended use clearly state that the SportPort™ is designed for repeated access to the vascular system for infusions and withdrawals, and for long-term delivery of medications and fluids. There is no mention of it being used to collect or analyze data for diagnostic purposes.
No
The device description clearly details physical components made of titanium and polysulfone, a silicone rubber septum, a catheter, and various surgical kit items. This indicates a hardware-based medical device, not a software-only one.
Based on the provided text, this device 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. They are used to provide information for diagnosis, monitoring, or screening.
- SportPort™ Function: The SportPort™ is a vascular access device. Its purpose is to provide repeated access to the patient's vascular system for the administration of substances (drugs, blood, contrast media) and the withdrawal of blood. It is a device implanted in the body, not a test performed on a sample taken from the body.
The description clearly outlines its use for direct access to the vascular system for therapeutic and diagnostic procedures (like blood withdrawal), but it does not involve testing a sample outside the body to diagnose or monitor a condition.
N/A
Intended Use / Indications for Use
The SportPort™ is indicated for use when the patient requires the following: repeated access to the vascular system for injections, infusion of drugs, administration of blood or blood products, and/or withdrawal of blood as part of the therapy regimen.
When used with a power injectable needle infusion set, the SportPort™ is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s with a 19 or 20 gauge non-coring power injectable needle and 2 ml/s with a 22-gauge non-coring power injectable needle.
Product codes (comma separated list FDA assigned to the subject device)
LIT
Device Description
The devices are to be used by or on the order of a physician. The SportPort™ line of ports has a body/septum retainer made of either commercially pure grade 2 titanium or medical grade polysulfone. The port body has a septum chamber with a silicone rubber septum designed for repeated needle puncturing. The SportPort™ comes in a standard design to enable regular use as an infusion/withdrawal port and has high-pressure injection capability to aid to the delivery of large volumes or special fluids such as contrast media. The shape of the base plate of the port body is triangular and is compatible with most imaging systems. The top of the port (septum retainer) has expansive fins to secure the septum in place during high-pressure use and to enable palpable or image system identification. The port has six (6) elongated holes for suture fixation to the deep fascia tissue during implantation. The fixation is required to prevent migration or flipping of the port. A catheter comes with the port and is inserted into the vascular system. The catheter is assembled into a venous vessel and fed down into the vascular system to enable visualization for proper placement. The kit provided to aid in insertion of the catheter and placement of the port may include items like needles, sheaths, vein picks, guidewires, straighteners, and dilators. Likewise, the cut down kit for port placement may encompass most infusion sets with Lucent Non-Coring needles, straight pointed Huber needles, blunt needles, and syringes along with the port and catheter.
The Norfolk Medical SportPort™ family of ports provides a simple method for the delivery of volumes of medications, fluids and special fluids like chemotherapy agents via a chamber leading to a catheter and opening into a large vessel in the body. The catheter is inserted into a large vessel that ideally terminates in the superior vena cava/high right atrial junction. The port is surgically implanted subcutaneously in the soft tissue near the clavicle on the patient's right upper chest wall. Medications, fluids, nutritional liquids or chemotherapy agents can then be administered as necessary. The ports are intended for long-term placement.
The Norfolk Medical SportPort™ family of Vascular Access Devices is a group of ports and catheter sets with infusion and withdrawal capabilities via a port and an access catheter to the large vessels in the vascular system. These ports must be properly attached to a catheter during a procedure.
When used with a legally marketed power capable needle infusion set, the SportPort™ 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 19 or 20 gauge needle and 2ml/sec with a 22 gauge needle set.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue near the clavicle on the patient's right upper chest wall (for port implantation), large vessels in the vascular system, ideally terminating in the superior vena cava/high right atrial junction (for catheter placement).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
by or on the order of a physician
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)
Mechanical testing was performed for: leaks, septum puncturing, catheter tensile strength testing, catheter to port connection test, dynamic failure testing, patency verification testing, and static burst testing. The results demonstrated that the SportPort™ is as safe, as effective, and performs as well as the predicate device.
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.
NorPort CT-PC Port - 510(k) # K111101
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
2112713
page 1 of 3
7350 N. Ridgeway, Skokie, IL 60076 • 847-674-7075
Norfolk (
510(k) Summary Table 1
OCT 2 7 201
Date:
Submitter:
September 16, 2011 Norfolk Medical Products Inc. 7350 N. Ridgeway Skokie, IL 60076
Contact Person:
Michael J. Dalton President Norfolk Medical Inc 847-674-7075 847-674-7066 (fax) mjdalton@norfolkmedical.com
Device:
Trade Name: SportPort™ Common/Usual Name: Port and catheter, implanted, subcutaneous, intravascular Classification Names: CFR Reference: 21CFR 880.5965 Classification Name: Port and catheter, implanted, subcutaneous, intravascular Product Code: LIT Predicate Devices: NorPort CT-PC Port - 510(k) # K111101
1
page 2 of
7350 N. Ridgeway, Skokie, IL 60076 • 847-674-7075
Norfolk C Medical
Device Description 2.1
The devices are to be used by or on the order of a physician. The SportPort™ line of ports has a body/septum retainer made of either commercially pure grade 2 titanium or medical grade nas a bodyboptan rohamber with a silicone rubber septum designed for repeated needle puncturing. The SportPort™ comes in a standard design to enable regular use as an infusion/withdrawal port and has high-pressure injection capability to aid to the delivery of large mrasions fluids such as contrast media. The shape of the base plate of the port body is volumes or openany natible with most imaging systems. The top of the port (septum retainer) has thangular and is compansive the septum to secure the septum in place during high-pressure use and to enable palpable or image system identification. The port has six (6) elongated holes for suture fixation to the deep fascia tissue during implantation. The fixation is required to prevent suite inkation or flipping of the port. A catheter comes with the port and is inserted into the vascular migration of mpping of the per." Freed into a venous vessel and fed down into the vascular system. System: The catheter is assuble visualization for proper placement. The kit provided to aid in insertion of the catheter and placement of the port may include items like needles, sheaths, vein picks, guidewires, straighteners, and dilators. Likewise, the cut down kit for port placement may press, garas most infusion sets with Lucent Non-Coring needles, straight pointed Huber needles, blunt needles, and syringes along with the port and catheter.
The Norfolk Medical SportPort™ family of ports provides a simple method for the delivery of volumes of medications, fluids and special fluids like chemotherapy agents via a chamber leading to a catheter and opening into a large vessel in the body. The catheter is inserted into a large vessel that ideally terminates in the superior vena cava/high right atrial junction. The port is surgically implanted subcutaneously in the soft tissue near the clavicle on the patient's right upper chest wall. Medications, fluids, nutritional liquids or chemotherapy agents can then be administered as necessary. The ports are intended for long-term placement.
The Norfolk Medical SportPort™ family of Vascular Access Devices is a group of ports and catheter sets with infusion and withdrawal capabilities via a port and an access catheter to the large vessels in the vascular system. These ports must be properly attached to a catheter during a procedure
When used with a legally marketed power capable needle infusion set, the SportPort™ 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 19 or 20 gauge needle and 2ml/sec with a 22 gauge needle set.
2.2 Intended Use
The intended use and precautions and complications to be considered prior to the use of the Port are contained in the Instructions For Use / User's Manual attached as Exhibit A. The SportPort™ is indicated for use when the patient requires the following - repeated access to the vascular system for injections, infusion drugs, administration of blood or blood products, and/or withdrawal of blood as part of the therapy regimen.
2
7350 N. Ridgeway, Skokie, IL 60076 • 847-674-7075
Norfolk (C Medical
When used with a legally marketed power injectable needle infusion set, the SportPort™ is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s with a 19 and 20 gauge non-coring power injectable needle and 2 ml/s with a 22-gauge non-coring power injectable needle.
2.3 Technology
The SportPort™ does not alter the fundamental scientific technology of the predicate device.
2.4 Conclusion
The results of these measurements demonstrated that the SportPort™ is as safe, as effective, and performs as well as the predicate device.
The indications for use statements for the SportPort™ and all substantially equivalent devices are similar. All the products have similar target populations as described in their intended use statements. All of them target a population of patients who must have repeated access to their vascular system for the delivery of medications, I.V. fluids, special fluids such as contrast media, or nutritional substances and blood products or withdrawal of blood.
The SportPort™ and the predicate product are similar in design. All the materials are similar in the titanium and polysulfone products. The SportPort™ and the predicate devices have "power injectable" capabilities and they have been engineered to withstand high internal pressures in the chamber and through the catheter securing mechanism, and port outlet for certain "pressure injectable" clinical applications.
All the products are intended for use as sterile, single use products. The SportPort™and the NorPort product line of ports have the same biocompatible materials in their construction. They are made from the same materials, utilizing the same manufacturing process.
The SportPort™ has been mechanically tested for leaks, septum puncturing, catheter tensile strength testing, catheter to port connection test, dynamic failure testing, patency verification testing, and static burst testing.
There are no chemical safety issues, no energy use/energy generation issues, nor any environmental compatibility issues with the SportPort™. There are no electrical, thermal, or radiation safety issues with this port.
3
Image /page/3/Picture/0 description: The image shows a 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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the left side of the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 2 7 2011
Mr. Michael J. Dalton President Norfolk Medical Products, Incorporated 7350 North Ridgeway Skokie, Illinois 60076
Re: K112713
Trade/Device Name: SportPort™ Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: September 16, 2011 Received: September 28, 2011
Dear Mr. Dalton:
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.
4
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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Rh for
Anthony D. 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
5
Norfolk & Medic
7350 N. Ridgeway, Skokie, IL 60076 • 847-674-7075
Indications for Use
510(k) Number (if known): Unknown at the present time
Device Name: SportPort™
Indications For Use:
The SportPort™ is indicated for use when the patient requires the following: repeated access to the vascular system for injections, infusion of drugs, administration of blood or blood products, and/or withdrawal of blood as part of the therapy regimen.
When used with a power injectable needle infusion set, the SportPort™ is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s with a 19 or 20 gauge non-coring power injectable needle and 2 ml/s with a 22-gauge non-coring power injectable needle.
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 IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -------------------------------------------------------- | -- |
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of 1
510(k) Number: K112713
Special 510(k) SportPort™
In Ar
September 16, 2011