(38 days)
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.
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 and has a body/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 a raised triangle 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 to the port and fed into a venous vessel and fed down into the vascular system. The catheter is radiopaque 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 contain 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.
The provided text describes a 510(k) premarket notification for the SportPort™ medical device, which is an implanted port and catheter system. The submission focuses on demonstrating substantial equivalence to a predicate device (NorPort CT-PC Port - K111101) rather than presenting a detailed study with acceptance criteria and performance data in the format typically seen for novel AI/diagnostic devices.
Based on the information provided, here's a breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not specify numerical "acceptance criteria" in the typical sense (e.g., sensitivity, specificity, accuracy targets) because it's for a physical medical device (implantable port) and focuses on mechanical and material equivalence to a predicate. Instead, the "performance" is demonstrated through various mechanical tests to show the device functions as intended and is comparable to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material Equivalence | Made from the same biocompatible materials as the predicate device (titanium, polysulfone, silicone rubber septum). |
| Manufacturing Process Equivalence | Utilizes the same manufacturing process as the NorPort product line. |
| Mechanical Integrity (Leaks) | Mechanically tested for leaks. |
| Mechanical Integrity (Septum Puncturing) | Mechanically tested for septum puncturing. |
| Mechanical Integrity (Catheter Tensile Strength) | Catheter tensile strength testing performed. |
| Mechanical Integrity (Catheter to Port Connection) | Catheter to port connection test performed. |
| Mechanical Integrity (Dynamic Failure) | Dynamic failure testing performed. |
| Mechanical Integrity (Patency Verification) | Patency verification testing performed. |
| Mechanical Integrity (Static Burst) | Static burst testing performed. |
| High-Pressure Injection Capability | Engineered to withstand high internal pressures in the chamber, catheter securing mechanism, and port outlet for "pressure injectable" clinical applications (power injection of contrast media). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of patient data or clinical studies. The "testing" appears to be entirely bench testing (mechanical testing) of the device prototypes. Therefore, there is no information on:
- Sample size used for a test set (as it relates to patients/data).
- Data provenance (country of origin, retrospective/prospective), as no patient data was used.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The ground truth for mechanical performance is established through engineering standards and testing protocols, not by expert medical review of a test set.
4. Adjudication Method for the Test Set
Not applicable, as no human adjudication for a test set (e.g., imaging review) is mentioned.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No. This type of study is specifically relevant for diagnostic devices where human readers interpret data (e.g., images), often with and without AI assistance, to assess the AI's impact on human performance. The SportPort™ is a physical medical device, not a diagnostic or AI-powered system, so an MRMC study is not relevant or mentioned.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. The SportPort™ is a physical medical device, not an algorithm or AI system.
7. The Type of Ground Truth Used
The ground truth for the device's performance is established by engineering specifications, material science, and mechanical testing standards. The success of the tests (e.g., no leaks, ability to withstand burst pressure, appropriate tensile strength) serves as the ground truth for validating the device's physical and functional integrity.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is not an AI or machine learning device. The development process for the SportPort™ relies on engineering design, material selection, and iterative mechanical testing rather than data-driven training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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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
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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.
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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.
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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
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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
§ 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.