(62 days)
Not Found
No
The summary describes a physical medical device (vascular access port) and its performance characteristics under various tests. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as "intended for use for patient therapy requiring repeated vascular access for infusion therapy, power injected diagnostic techniques using contrast media, and blood infusion/withdrawal." The term "patient therapy" indicates a therapeutic purpose.
No
Explanation: The device is a vascular access port used for infusions, including power-injected diagnostic techniques using contrast media, and blood infusion/withdrawal. While it facilitates diagnostic techniques, it does not perform the diagnosis itself. Its function is to provide access for the delivery of substances used in diagnosis.
No
The device description clearly details physical components made of titanium, silicone, and polysulfone, and the performance studies focus on the mechanical integrity and flow characteristics of these physical components. There is no mention of software as a component or its function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for patient therapy requiring repeated vascular access for infusion therapy, power injected diagnostic techniques using contrast media, and blood infusion/withdrawal. This describes a device used in vivo (within the body) for treatment and diagnostic procedures, not for testing samples in vitro (outside the body).
- Device Description: The description details a vascular access port and catheter, which are implanted devices used to access the bloodstream. This is consistent with an in vivo device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) to provide diagnostic information about a patient's condition. The diagnostic aspect mentioned is related to using contrast media for imaging, which is a procedure performed in vivo.
Therefore, the Vital-Port® Vascular Access System Power Injectable Port is a medical device used for vascular access and power injection in vivo, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Vital-Port® Vascular Access System Power Injectable Port is intended for use for patient therapy requiring repeated vascular access for infusion therapy, power injected diagnostic techniques using contrast media, and blood infusion/withdrawal. For the power injection of contrast media, the maximum recommended infusion rate is 5 ml/s using media with a maximum viscosity of 11.8 cP.
Product codes
LJT
Device Description
The Vital-Port Vascular Access System Power Injectable Port is a titanium body vascular access port with a silicone septum and silicone filled suture holes. The subject device's catheter is a 7.5 Fr silicone catheter that may be supplied pre-attached or detached. The catheter lock is polysulfone with a silicone strain relief. The supplied catheter is 50 cm in length.
When used with a power injectable infusion set, the Vital-Port Vascular Access System Power Injectable Port device is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s using contrast with a maximum viscosity of 11.8 cP. The maximum pressure limit setting for power injectors used with the Vital-Port may not exceed 325 psi and the flow rate may not exceed 5 ml/s.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular access
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
- Dynamic Failure Flow Test: The purpose of this testing was to subject the port system to increasing flow rates to determine the maximum sustainable flow rate. The acceptance criterion was a minimum of 5 ml/s without a failure. The acceptance criterion for the testing was met.
- Instantaneous Burst Test: The purpose of this testing was to determine the ultimate pressure limit of the Vital-Port system. The acceptance criterion was a mean burst pressure greater than the mean reservoir pressures characterized in previous testing. The acceptance criterion for the testing was met.
- Static Burst Test: The purpose of this testing was to determine the effects, if any, of elevated pressures over a defined period of time. All devices were required to withstand 120 psi (827.3 KPa) for three minutes without failure. All test articles met or exceeded the acceptance criterion.
- Cyclic/Puncture Life Test: The acceptance criterion was no leakage at a flow rate of 5 ml/s. All test articles met this criterion.
- Life Cycle Power Injection Test: The purpose of this test was to verify the Vital-Port would maintain system integrity after multiple power injections. Each Vital-Port configuration maintained system integrity during all consecutive power injections. The acceptance criterion for the testing was met.
Key Metrics
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 21, 2015
Cook Incorporated Mr. Steven Lawrie Regulatory Affairs Team Lead 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402
Re: K150733
Trade/Device Name: Vital-Port® Vascular Access System Power Injectable Port Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: April 23, 2015 Received: April 24, 2015
Dear Mr. Lawrie:
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.
1
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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 vours.
Tina
Kiang-S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K150733
Device Name
Vital-Port® Vascular Access System Power Injectable Port
Indications for Use (Describe)
The Vital-Port® Vascular Access System Power Injectable Port is intended for use for patient therapy requiring repeated vascular access for infusion therapy, power injected diagnostic techniques using contrast media, and blood infusion/ withdrawal. For the power injection of contrast media, the maximum recommended infusion rate is 5 ml/s using media with a maximum viscosity of 11.8 cP.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | ☑ |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
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510(k) SUMMARY
Submitted By:
COOK INCORPORATED
750 DANIELS WAY, P.O. BOX 489
BLOOMINGTON, IN 47402-0489 U.S.A.
PHONE: 812.339.2235 TOLL FREE: 800.457.4500
WWW.COOKMEDICAL.COM
Steven Lawrie Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47402 Phone: (812) 335-3575 x104518 Fax: (812) 332-0281 Date Prepared: 11 May 2015
Device:
Trade Name: Common Name: Classification Name:
Vital-Port® Vascular Access System Power Injectable Port Port & Catheter, Implanted, Subcutaneous, Intravascular Subcutaneous, implanted, intravascular infusion port and catheter LJT (21 CFR $880.5965) Class II, General Hospital
Class/Panel:
Indications for Use:
The Vital-Port Vascular Access System Power Injectable Port is intended for use for patient therapy requiring repeated vascular access for infusion therapy, power injected diagnostic techniques using contrast media, and blood infusion/withdrawal. For the power injection of contrast media, the maximum recommended infusion rate is 5 ml/s using media with a maximum viscosity of 11.8 cP.
Predicate Device:
The subject device in this submission is substantially equivalent to the predicate device, the Vital-Port Vascular Access System Power Injectable Port, cleared on September 30, 2008 under 510(k) number K081425.
Technological Characteristics and Comparison to Predicate Device:
It has been demonstrated that the proposed Vital-Port Vascular Access System Power Injectable Port is substantially equivalent to the predicate device, the Vital-Port Vascular Access System Power Injectable Port (K081425), in that these devices are identical in terms of intended use, principals of operation, materials of construction, and basic technological characteristics. The performance and reliability of the subject device are supported by testing. A full comparison of the predicate and subject devices is presented in Table 1.
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| Table 1: Comparison Table for the Vital-Port Vascular Access System Power Injectable | |||
|---|---|---|---|
| Port |
| PREDICATE DEVICE | SUBJECT DEVICE | |
|---|---|---|
| Vital-Port Vascular Access System | ||
| Power Injectable Port (K081425) | Vital-Port Vascular Access System | |
| Power Injectable Port | ||
| (Subject of this Submission) | ||
| Regulation Number | 880.5965 | Identical |
| Product Code | LJT | Identical |
| Classification | Class II | Identical |
| Intended Use | For use in patient therapy requiring | |
| repeated vascular access for infusion | ||
| therapy, power injected diagnostic | ||
| techniques using contrast media and blood | ||
| infusion/withdrawal. | ||
| For power injection of contrast media, the | ||
| maximum recommended infusion rate is | ||
| 5 ml/s with a maximum viscosity of | ||
| 11.8 cP. | Identical | |
| Port Body Material | Titanium | Identical |
| Catheter | 9.5 Fr Silicone | |
| 9.5 Fr Polyurethane | 7.5 Fr Silicone | |
| Catheter Lock | Polysulfone | Identical |
| Catheter Lock | ||
| Reinforcing Sleeve | Silicone | Identical |
| Septum | Silicone | Identical |
| Suture Hole Plug | Silicone | Identical |
| Sterilization | EtO | Identical |
| Sterility Assurance | ||
| Level (SAL) | 10-6 | Identical |
| Packaging | Inner and Outer Tray with Tyvek® Lidstock | Identical |
Device Description:
The Vital-Port Vascular Access System Power Injectable Port is a titanium body vascular access port with a silicone septum and silicone filled suture holes. The subject device's catheter is a 7.5 Fr silicone catheter that may be supplied pre-attached or detached. The catheter lock is polysulfone with a silicone strain relief. The supplied catheter is 50 cm in length.
When used with a power injectable infusion set, the Vital-Port Vascular Access System Power Injectable Port device is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s using contrast with a maximum viscosity of 11.8 cP. The maximum pressure limit setting for power injectors used with the Vital-Port may not exceed 325 psi and the flow rate may not exceed 5 ml/s.
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Table 2: Device Specifications
| Subject Device | Catheter size and
material | Maximum Flow Rate* | Injection Pressure
Limit Setting |
|----------------------------------------------------------------------|-------------------------------|--------------------|-------------------------------------|
| The Vital-Port
Vascular Access
System Power
Injectable Port | 7.5 Fr silicone | 5 ml/s | 325 psi |
*Flow rates were achieved using a room temperature infusate equivalent to Omnipaque 300º and a Medrad Injector. Omnipaque 300 has a viscosity of 11.8 centipoise at room temperature (20 °C). A change in the temperature or viscosity of the media will result in a change in achievable flow rate. Omnipaque 300 is a registered trademark of GE Healthcare.
Test Data:
A risk assessment was performed to assess the risks presented by the subject device. Design control activities were then performed in order to address the modifications noted in Table 1. Specifically, the following tests have been conducted on the subject device to ensure reliable design and performance under the specified design requirements, and no new risks were identified for the subject device with respect to the predicate device. These tests include:
- Dynamic Failure Flow Test The purpose of this testing was to subject the port system to . increasing flow rates to determine the maximum sustainable flow rate. The acceptance criterion was a minimum of 5 ml/s without a failure. The acceptance criterion for the testing was met.
- . Instantaneous Burst Test - The purpose of this testing was to determine the ultimate pressure limit of the Vital-Port system. The acceptance criterion was a mean burst pressure greater than the mean reservoir pressures characterized in previous testing. The acceptance criterion for the testing was met.
- . Static Burst Test - The purpose of this testing was to determine the effects, if any, of elevated pressures over a defined period of time. All devices were required to withstand 120 psi (827.3 KPa) for three minutes without failure. All test articles met or exceeded the acceptance criterion.
- . Cyclic/Puncture Life Test - The acceptance criterion was no leakage at a flow rate of 5 ml/s. All test articles met this criterion.
- Life Cycle Power Injection Test The purpose of this test was to verify the Vital-Port . would maintain system integrity after multiple power injections. Each Vital-Port configuration maintained system integrity during all consecutive power injections. The acceptance criterion for the testing was met.
In conclusion, the results of these tests support a determination of substantial equivalence to the predicate device.