(108 days)
Not Found
No
The document describes a physical implantable port system for vascular access and does not mention any computational or analytical capabilities that would suggest the use of AI or ML.
No.
The device facilitates the administration of therapies (such as medications, I.V. fluids, etc.) and withdrawal of blood samples, but it is not a therapeutic agent itself. It is a vascular access device.
No
The device description clearly states its purpose is for "long-term, repeated access to the vascular system" for infusion of substances or withdrawal of blood, and not for diagnosing a condition.
No
The device description clearly details physical components like a rigid housing, self-sealing septum, and catheters, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide long-term, repeated access to the vascular system for infusion of substances and withdrawal of blood samples. This is a therapeutic and procedural use, not a diagnostic one.
- Device Description: The device is an implantable port system with a rigid housing, septum, and catheter. It is designed for physical access to the bloodstream.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples, detect markers, or provide information for diagnosis. The blood withdrawal is for external analysis, not analysis performed by the device itself.
- Performance Studies: The performance studies focus on the safety and adverse event rates related to the physical use and maintenance of the port, not on the accuracy or performance of any diagnostic test.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used in vivo (inside the body) for therapeutic and procedural access.
N/A
Intended Use / Indications for Use
Power and Non Power-Injectable Implantable Ports are intended to be an implanted vascular access device designed to provide long-term, repeated access to the vascular system.
PowerPort®
The PowerPort® Implantable Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.
When used with a PowerLoc® Brand Safety Infusion Set, the PowerPort® device is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 mL/s.
Non Power-Injectable Ports
The BardPort®, SlimPort®, and X-Port® implantable ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.
Product codes (comma separated list FDA assigned to the subject device)
LJT
Device Description
PowerPort® Implantable Ports are designed to provide repeated access to the vascular system without the need for repeated venipuncture or daily care of an external catheter. Long-Term Implantable Ports consist of a rigid housing and a self-sealing septum. The catheters used with infusion ports are essentially the same design as externalized, stand-alone intravascular catheters. Groshong® catheters are attached to the port by the physician during implantation.
PowerPort® Implantable Ports can be used for routine vascular access using a noncoring access needle. However, for power injection procedures, PowerPort® ports must be accessed with a Bard PowerLoc® Safety Infusion Set (SIS) to create a powerinjectable system.
Non Power-Injectable Ports
Long-Term Implantable Ports are designed to provide repeated access to the vascular system without the need for repeated venipuncture or daily care of an external catheter. Long-Term Implantable Ports consist of a rigid housing and a self-sealing septum. The catheters used with infusion ports are essentially the same design as externalized, stand-alone intravascular catheters. Groshong® catheters are attached to the port by the physician during implantation.
Long-Term Implantable Ports can be used for routine vascular access using a non-coring access needle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Vascular system
Indicated Patient Age Range
adult males or females ≥ 21 years of age
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)
Safety & Performance Tests: Clinical
Bard currently recommends that Power and Non Power-Injectable Implantable Ports with Groshong® Catheter be filled with normal saline after each use, and if the port remains unused for long periods of time, the saline lock should be changed by flushing at least every four weeks. Under Institutional Review Board oversight, clinical data were independently collected from patients at five major oncology centers to provide clinical evidence in support of extending the maximum recommended maintenance flushing interval to at least every 90 days for Bard ports with distally-valved (Groshong®) catheters.
The study was conducted at five sites in the United States. Study subjects consisted of post-infusional adult males or females ≥ 21 years of age that had a Bard port implanted.
The primary endpoint was to compare the rate of adverse events at three time points in Group A versus extended accession intervals in Group B and Group C.
Considering solely the saline-only intervals, the study demonstrated that approximately 57% of the collected patient-day data represented flushing with saline only. Overall, there were 465 saline-only intervals recorded with 28,452 patient-days of follow-up. Only one adverse event was recorded in the saline-only group, yielding an incidence rate of 0.35 adverse events per 10,000 patient-days, with a 95% Poisson confidence interval (0.01, 1.96).
Maintenance flushing of Groshong® port systems has been shown to be safe for a wide variety of time intervals based on the very low adverse event rates noted in the clinical data. An extension of the maintenance flushing schedule from its current label of every four weeks to every 90 days with saline only is recommended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Incidence rate of 0.35 adverse events per 10,000 patient-days, with a 95% Poisson confidence interval (0.01, 1.96).
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.
K081311, K063377, K050310, K032044, K022983, K924250, K912702, K880571, K873213
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
(33335
Bard Access Systems, Inc. Ports
with Groshong® Catheter – Extended Maintenance Protocol
with Groshong® Catheter – Extended Maintenance Protocol
Traditional 510(k) Premarket Notification
ACCESS SYS
FEB 1 4 2014
Section 5 - 510(k) Summary
510(k) Summary 21 CFR 807.92(a)
| Submitter Name: | Bard Access Systems, Inc. | |
|---|---|---|
| General | ||
| Provisions | Address: | 605 North 5600 West |
| Salt Lake City, UT 84116 | ||
| Contact Person: | Amy Honey | |
| Regulatory Affairs Specialist | ||
| Telephone Number: | (801) 522-5671 | |
| Fax Number: | (801) 522-5425 | |
| Date of Preparation: | October 15, 2013 | |
| Subject | ||
| Device | Trade Name: | Power and Non Power-Injectable Implantable Ports with |
| Groshong® Catheter | ||
| Common Name: | Implanted Infusion Port & Catheter | |
| Classification Name: | LJT - Subcutaneous, Implanted, Intravascular Infusion Port | |
| & Catheter | ||
| Product Code: | LJT | |
| Regulation: | 21 CFR §880.5965 | |
| Predicate | ||
| Devices | Trade Name: | PowerPort® Implantable Port with Groshong® Catheter |
| Common Name: | Implanted Infusion Port & Catheter | |
| Classification Name: | LJT - Subcutaneous, Implanted, Intravascular Infusion Port | |
| & Catheter | ||
| Product Code: | LJT | |
| Regulation: | 21 CFR §880.5965 | |
| Premarket Notification: | K081311 | |
| Trade Name: | PowerPort® Polymeric Port with 8 F Single Lumen | |
| ChronoFlex® Catheter | ||
| Common Name: | Implanted Infusion Port & Catheter | |
| Classification Name: | LJT - Subcutaneous, Implanted, Intravascular Infusion Port | |
| & Catheter | ||
| Product Code: | LJT | |
| Regulation: | 21 CFR §880.5965 | |
| Premarket Notification: | K063377 | |
| Trade Name: | BardPort® Titanium Ports | |
| Common Name: | Implanted Infusion Port & Catheter | |
| Classification Name: | LJT - Subcutaneous, Implanted, Intravascular Infusion Port & Catheter | |
| Product Code: | LJT | |
| Regulation: | 21 CFR §880.5965 | |
| Premarket Notification: | K050310 | |
| Trade Name: | X-Port® Duo Port | |
| Common Name: | Implanted Infusion Port & Catheter | |
| Classification Name: | LJT - Subcutaneous, Implanted, Intravascular Infusion Port & Catheter | |
| Product Code: | LJT | |
| Regulation: | 21 CFR §880.5965 | |
| Premarket Notification: | K032044 | |
| Trade Name: | BardPort® X-Port® isp Port | |
| Common Name: | Implanted Infusion Port & Catheter | |
| Classification Name: | LJT - Subcutaneous, Implanted, Intravascular Infusion Port & Catheter | |
| Product Code: | LJT | |
| Regulation: | 21 CFR §880.5965 | |
| Premarket Notification: | K022983 | |
| Trade Name: | Plastic Low-Profile Subcutaneous Port | |
| Common Name: | Implanted Infusion Port & Catheter | |
| Classification Name: | LJT - Subcutaneous, Implanted, Intravascular Infusion Port & Catheter | |
| Product Code: | LJT | |
| Regulation: | 21 CFR §880.5965 | |
| Premarket Notification: | K924250 | |
| Trade Name: | Plastic Attachable Dual Port | |
| Common Name: | Implanted Infusion Port & Catheter | |
| Classification Name: | LJT - Subcutaneous, Implanted, Intravascular Infusion Port & Catheter | |
| Product Code: | LJT | |
| Regulation: | 21 CFR §880.5965 | |
| Premarket Notification: | K912702 | |
| Trade Name: | Cath-Tech Port Implantable Vascular Access System | |
| Common Name: | Implanted Infusion Port & Catheter | |
| Classification Name: | LJT - Subcutaneous, Implanted, Intravascular Infusion Port | |
| & Catheter | ||
| Product Code: | LJT | |
| Regulation: | 21 CFR §880.5965 | |
| Premarket Notification: | K880571 | |
| Trade Name: | Hickman Plastic Subcutaneous Port | |
| Common Name: | Implanted Infusion Port & Catheter | |
| Classification Name: | LJT - Subcutaneous, Implanted, Intravascular Infusion Port | |
| & Catheter | ||
| Product Code: | LJT | |
| Regulation: | 21 CFR §880.5965 | |
| Premarket Notification: | K873213 |
1
Section 5 - 510(k) Summary
2
PowerPort®
PowerPort® Implantable Ports are designed to provide repeated access to the vascular system without the need for repeated venipuncture or daily care of an external catheter. Long-Term Implantable Ports consist of a rigid housing and a self-sealing septum. The catheters used with infusion ports are essentially the same design as externalized, stand-alone intravascular catheters. Groshong® catheters are attached to the port by the physician during implantation.
PowerPort® Implantable Ports can be used for routine vascular access using a noncoring access needle. However, for power injection procedures, PowerPort® ports must be accessed with a Bard PowerLoc® Safety Infusion Set (SIS) to create a powerinjectable system.
Device Description
Non Power-Injectable Ports
Long-Term Implantable Ports are designed to provide repeated access to the vascular system without the need for repeated venipuncture or daily care of an external catheter. Long-Term Implantable Ports consist of a rigid housing and a self-sealing septum. The catheters used with infusion ports are essentially the same design as externalized, stand-alone intravascular catheters. Groshong® catheters are attached to the port by the physician during implantation.
Long-Term Implantable Ports can be used for routine vascular access using a non-coring access needle.
3
、
| Intended Use | Power and Non Power-Injectable Implantable Ports are intended to be an implanted
vascular access device designed to provide long-term, repeated access to the vascular
system. | |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Indications For
Use | PowerPort®
The PowerPort® Implantable Port is indicated for patient therapies requiring repeated
access to the vascular system. The port system can be used for infusion of medications,
I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of
blood samples. | |
| | When used with a PowerLoc® Brand Safety Infusion Set, the PowerPort® device is
indicated for power injection of contrast media. For power injection of contrast media,
the maximum recommended infusion rate is 5 mL/s. | |
| | Non Power-Injectable Ports
The BardPort®, SlimPort®, and X-Port® implantable ports are indicated for patient
therapies requiring repeated access to the vascular system. The port system can be
used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood
products, and for the withdrawal of blood samples. | |
| Technological
Characteristics | There have been no changes to the technological characteristics or design of the Power
and Non Power-Injectable Implantable Ports with Groshong® Catheter; therefore, they
are substantially equivalent with respect to basic design and function of the of the of the
predicate devices. Extending the maintenance protocol from a four-week flushing
period to a 90-day flushing period does not impact the intended use, and has been
shown through clinical data not to raise any new questions regarding safety or efficacy. | |
| Safety &
Performance
Tests: Non-
Clinical | Verification and validation testing were not required for this submission. Safety and
efficacy of the change was supported through clinical data; no physical testing was
required. | |
| | User requirements and use-related risks have been evaluated in and mitigated through
a clinical study, as well as in the Instructions for Use. | |
4
.
| Safety &
Performance
Tests: Clinical | Bard currently recommends that Power and Non Power-Injectable Implantable Ports
with Groshong® Catheter be filled with normal saline after each use, and if the port
remains unused for long periods of time, the saline lock should be changed by flushing
at least every four weeks. Under Institutional Review Board oversight, clinical data were
independently collected from patients at five major oncology centers to provide clinical
evidence in support of extending the maximum recommended maintenance flushing
interval to at least every 90 days for Bard ports with distally-valved (Groshong®)
catheters.
The study was conducted at five sites in the United States. Study subjects consisted of
post-infusional adult males or females ≥ 21 years of age that had a Bard port implanted.
The primary endpoint was to compare the rate of adverse events at three time points in
Group A versus extended accession intervals in Group B and Group C.
Considering solely the saline-only intervals, the study demonstrated that approximately
57% of the collected patient-day data represented flushing with saline only. Overall,
there were 465 saline-only intervals recorded with 28,452 patient-days of follow-up.
Only one adverse event was recorded in the saline-only group, yielding an incidence
rate of 0.35 adverse events per 10,000 patient-days, with a 95% Poisson confidence
interval (0.01, 1.96).
Maintenance flushing of Groshong® port systems has been shown to be safe for a wide
variety of time intervals based on the very low adverse event rates noted in the clinical
data. An extension of the maintenance flushing schedule from its current label of every
four weeks to every 90 days with saline only is recommended. |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of
Substantial
Equivalence | Based on the indications for use, technological characteristics, and safety and
performance testing, the subject Power and Non Power-Injectable Implantable Ports
with Groshong® Catheter met the minimum requirements for its intended use and is
substantially equivalent in design, materials, sterilization, principles of operation, and
indications for use to the predicate devices cited. |
5
Image /page/5/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 14, 2014
Bard Access Systems, Incorporated Ms. Amy Honey Regulatory Affairs Specialist 605 North 5600 West Salt Lake City, UT 84116
Re: K133335
Trade/Device Name: PowerPort®, Non Power-Injectable Ports Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port And Catheter Regulatory Class: II Product Code: LJT Dated: October 18, 2013 Received: October 29, 2014
Dear Ms. Honey:
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.
6
Page 2 - Ms. Honey
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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fdagov/MedicalDevices/ResourcesforYou/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 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,
Image /page/6/Picture/8 description: The image shows the name "Erin Freith-S" in a bold, sans-serif font. The name is written in black ink on a white background. The letters are evenly spaced and the name is easy to read. The text appears to be a logo or a brand name.
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Section 4 - Indications for Use Statement
Indications for Use
510(k) Number (if known): K133335
Device Name:
PowerPort®
Indications for Use:
The PowerPort® Implantable Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.
When used with a PowerLoc® safety infusion set, the PowerPort® device is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 mL/s.
Device Name:
Non Power-Injectable Ports
Indications for Use:
The BardPort®, SlimPort®, and X-Port® implantable ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.
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)
Richard C. 2014.02.27 10:55:21 -05'00'
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