(108 days)
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.
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.
The provided text describes a 510(k) premarket notification for Bard Access Systems' Power and Non Power-Injectable Implantable Ports with Groshong® Catheters, specifically regarding an extended maintenance protocol. The study aims to support extending the maximum recommended maintenance flushing interval from four weeks to 90 days with saline only.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state formal "acceptance criteria" in a quantitative, pre-defined manner for the device's performance in the context of this specific 510(k) submission. Instead, the focus is on demonstrating that extending the maintenance flushing protocol does not raise new questions regarding safety or efficacy and that the adverse event rate remains acceptably low.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| No new safety concerns with extended flushing interval. | "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." |
| Minimal adverse event rate for saline-only maintenance with 90-day interval. | "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)." This rate is presented as "very low," supporting the safety of the extended interval. |
| Device remains substantially equivalent to predicate devices. | "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." This statement implies that the extended maintenance protocol, supported by the clinical data, did not disrupt the substantial equivalence to previously cleared devices which had a shorter maintenance interval. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document mentions "465 saline-only intervals recorded with 28,452 patient-days of follow-up." While not a direct count of unique patients, this indicates a substantial amount of data collected over time. The study subjects consisted of "post-infusional adult males or females ≥ 21 years of age that had a Bard port implanted."
- Data Provenance: The study was conducted at "five major oncology centers" in the United States.
- Retrospective or Prospective: The study states that "clinical data were independently collected from patients... to provide clinical evidence in support of extending the maximum recommended maintenance flushing interval." This phrasing suggests a prospective data collection approach, specifically designed to gather evidence for the extended protocol.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The study focuses on clinical outcomes (adverse events) rather than expert interpretation of medical images or diagnoses, so a traditional "ground truth" establishment by a panel of experts, as might be seen for an AI diagnostic device, is not applicable or described. Adverse events would typically be recorded by medical staff involved in patient care.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe a formal adjudication method for adverse events in the sense of multiple reviewers and a tie-breaker. It mentions that the study was conducted "Under Institutional Review Board oversight" and that "clinical data were independently collected." This suggests standard clinical trial practices for adverse event reporting and monitoring by the sites and overall study coordination, but no specific adjudication scheme is detailed.
5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study was not done. This submission is not for an AI diagnostic device that assists human readers. It is for a medical device (implantable port) and a change to its maintenance protocol, with the study focusing on clinical safety and efficacy of that protocol change.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This submission is not for an algorithm or AI device. It's for a physical medical device and a revised post-implantation maintenance schedule.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is the outcomes data related to adverse events. Specifically, the occurrence or non-occurrence of adverse events during the extended maintenance flushing interval, as observed and recorded in clinical practice, served as the primary measure of safety.
8. The sample size for the training set
Not applicable. This submission does not involve a machine learning algorithm, therefore there is no training set. The study evaluates the performance and safety of an updated maintenance protocol for a medical device through direct clinical observation.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an algorithm. The clinical data for the study was collected and monitored under Institutional Review Board (IRB) oversight according to standard clinical research practices.
{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. | |
|---|---|---|
| GeneralProvisions | Address: | 605 North 5600 WestSalt Lake City, UT 84116 |
| Contact Person: | Amy HoneyRegulatory Affairs Specialist | |
| Telephone Number: | (801) 522-5671 | |
| Fax Number: | (801) 522-5425 | |
| Date of Preparation: | October 15, 2013 | |
| SubjectDevice | Trade Name: | Power and Non Power-Injectable Implantable Ports withGroshong® Catheter |
| Common Name: | Implanted Infusion Port & Catheter | |
| Classification Name: | LJT - Subcutaneous, Implanted, Intravascular Infusion Port& Catheter | |
| Product Code: | LJT | |
| Regulation: | 21 CFR §880.5965 | |
| PredicateDevices | 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 LumenChronoFlex® 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 implantedvascular access device designed to provide long-term, repeated access to the vascularsystem. | |
|---|---|---|
| Indications ForUse | PowerPort®The PowerPort® Implantable Port is indicated for patient therapies requiring repeatedaccess 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 ofblood samples. | |
| When used with a PowerLoc® Brand Safety Infusion Set, the PowerPort® device isindicated for power injection of contrast media. For power injection of contrast media,the maximum recommended infusion rate is 5 mL/s. | ||
| Non Power-Injectable PortsThe BardPort®, SlimPort®, and X-Port® implantable ports are indicated for patienttherapies requiring repeated access to the vascular system. The port system can beused for infusion of medications, I.V. fluids, parenteral nutrition solutions, bloodproducts, and for the withdrawal of blood samples. | ||
| TechnologicalCharacteristics | There have been no changes to the technological characteristics or design of the Powerand Non Power-Injectable Implantable Ports with Groshong® Catheter; therefore, theyare substantially equivalent with respect to basic design and function of the of the of thepredicate devices. Extending the maintenance protocol from a four-week flushingperiod to a 90-day flushing period does not impact the intended use, and has beenshown through clinical data not to raise any new questions regarding safety or efficacy. | |
| Safety &PerformanceTests: Non-Clinical | Verification and validation testing were not required for this submission. Safety andefficacy of the change was supported through clinical data; no physical testing wasrequired. | |
| User requirements and use-related risks have been evaluated in and mitigated througha clinical study, as well as in the Instructions for Use. |
{4}------------------------------------------------
.
| Safety &PerformanceTests: Clinical | Bard currently recommends that Power and Non Power-Injectable Implantable Portswith Groshong® Catheter be filled with normal saline after each use, and if the portremains unused for long periods of time, the saline lock should be changed by flushingat least every four weeks. Under Institutional Review Board oversight, clinical data wereindependently collected from patients at five major oncology centers to provide clinicalevidence in support of extending the maximum recommended maintenance flushinginterval 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 ofpost-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 inGroup A versus extended accession intervals in Group B and Group C.Considering solely the saline-only intervals, the study demonstrated that approximately57% 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 incidencerate of 0.35 adverse events per 10,000 patient-days, with a 95% Poisson confidenceinterval (0.01, 1.96).Maintenance flushing of Groshong® port systems has been shown to be safe for a widevariety of time intervals based on the very low adverse event rates noted in the clinicaldata. An extension of the maintenance flushing schedule from its current label of everyfour weeks to every 90 days with saline only is recommended. |
|---|---|
| Summary ofSubstantialEquivalence | Based on the indications for use, technological characteristics, and safety andperformance testing, the subject Power and Non Power-Injectable Implantable Portswith Groshong® Catheter met the minimum requirements for its intended use and issubstantially equivalent in design, materials, sterilization, principles of operation, andindications 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'
Page 1 of 1
§ 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.