(14 days)
The PowerPort™ implanted port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medication, 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.
The subject MRI PowerPort™ device with 9.6 Fr silicone catheter is a member of the PowerPort™ series of power injectable implanted ports. The subject device consists of a plastic port and silicone catheter that is attached to the port with a cathlock compression fitting. The subject device is distinguishable as a member of BAS's power injectable port series by the triangular body shape, unique purple coloring, and three palpation bumps on the septum. PowerPort™ implanted ports can be used for routine vascular access using a non-coring access needle. However, for power injection procedures, PowerPort™ ports must be accessed with a Bard PowerLoc™ safety infusion set to create a power injectable system.
The provided text is a 510(k) Summary for the MRI PowerPort™ Implanted Port with 9.6 Fr Silicone Catheter. It indicates that the device's safety and performance were established through design verification testing and risk management, which showed the device met predetermined acceptance criteria for its intended use and was substantially equivalent to predicate devices. However, the document does not contain explicit details about specific acceptance criteria values, reported device performance metrics tied to those criteria, the sample sizes for test or training sets, data provenance, the number and qualifications of experts for ground truth, adjudication methods, multi-reader multi-case (MRMC) studies, or standalone algorithm performance.
The document states:
"No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for this device. However, design verification testing was performed according to protocols based on the recommendations/requirements of applicable FDA guidance and FDA recognized international standards. Verification testing, determined to be applicable to the safety and efficacy of the device, was shown to meet predetermined acceptance criteria listed therein."
Given the information provided, it's not possible to populate the requested table and details comprehensively as the document explicitly states that specific performance standards have not been established by the FDA, and while internal testing was done, the specifics of "predetermined acceptance criteria listed therein" are not included in this summary.
Therefore, the table and answers below will reflect the lack of specific information in the provided text regarding these points.
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | Not specified in document |
Study Details
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify the sample size used for the test set or the data provenance. It only states that "design verification testing was performed." -
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 device is an implanted port, not an imaging or diagnostic device that typically requires expert interpretation for ground truth. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the document. -
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 MRMC comparative effectiveness study was mentioned. The device is a medical implant, not an AI-assisted diagnostic tool. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
No standalone algorithm performance study was mentioned. The device is a medical implant, not an algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The concept of "ground truth" as typically understood in AI/diagnostic studies does not directly apply here. The document refers to "design verification testing" and meeting "predetermined acceptance criteria" related to the safety and efficacy of the physical device and its intended use (e.g., flow rates, material compatibility). -
The sample size for the training set:
Not applicable, as this is a physical medical device, not a machine learning algorithm that requires a training set. -
How the ground truth for the training set was established:
Not applicable, as this is a physical medical device, not a machine learning algorithm that requires a training set.
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Section 6 – Summary of Safety & Effectiveness
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Page 22 of 55
| GeneralProvisions | Submitter Name:Address:Telephone Number:Fax Number:Contact Person:Date of Preparation:Registration Number: | Bard Access Systems, Inc. (BAS)[Wholly owned subsidiary of C.R. Bard, Inc.]605 N 5600 WSalt Lake City, UT 84116(801) 595-0700 ext. 5484(801) 595-5425Susan ScottDecember 3, 20071720496 BAS2212754 C. R. BardDEC 1 9 2007 |
|---|---|---|
| SubjectDevice | Trade Name:Common/Usual Name:Classification Name: | MRI PowerPort™ Implanted Portwith 9.6 Fr Silicone CatheterImplanted Infusion Port & Catheter80 LJT - Subcutaneous, Implanted, IntravascularInfusion Port & Catheter |
| PredicateDevices | Trade Name:Common/Usual Name:Classification Name:Premarket Notification:Trade Name:Common/Usual Name:Classification Name:Premarket Notification: | MRI PowerPort™ Polymeric Implanted Portwith 8 Fr. ChronoFlex® Polyurethane CatheterImplanted Infusion Port & Catheter80 LJT - Subcutaneous, Implanted, IntravascularInfusion Port & CatheterK063377, clearance date Jan 25, 2007Hickman™ Plastic Subcutaneous PortImplanted Infusion Port & Catheter80 LJT - Subcutaneous, Implanted, IntravascularInfusion Port & CatheterK873213, clearance date Oct. 27, 1987 |
| Classification | Class II21 CFR §880.5965General Hospital | |
| PerformanceStandards | Performance standards have not been established by FDA under section 514of the Federal Food, Drug and Cosmetic Act. | |
| Intended Use | PowerPort™ devices are totally implanted vascular access devices designedto provide long-term, repeated access to the vascular system. | |
| Indicationsfor Use | The PowerPort™ implanted port is indicated for patient therapies requiringrepeated access to the vascular system. The port system can be used forinfusion of medication, I.V. fluids, parenteral nutrition solutions, bloodproducts, and for the withdrawal of blood samples.When used with a PowerLoc™ safety infusion set, the PowerPort™ device isindicated for power injection of contrast media. For power injection ofcontrast media, the maximum recommended infusion rate is 5 ml/s. | |
| DeviceDescription | The subject MRI PowerPort™ device with 9.6 Fr silicone catheter is amember of the PowerPort™ series of power injectable implanted ports. Thesubject device consists of a plastic port and silicone catheter that is attachedto the port with a cathlock compression fitting. The subject device isdistinguishable as a member of BAS's power injectable port series by thetriangular body shape, unique purple coloring, and three palpation bumps onthe septum.PowerPort™ implanted ports can be used for routine vascular access using anon-coring access needle. However, for power injection procedures,PowerPort™ ports must be accessed with a Bard PowerLoc™ safety infusionset to create a power injectable system. | |
| TechnologicalCharacteristics | Technological characteristics of the subject MRI PowerPort™ device with 9.6Fr silicone catheter are equivalent to those of the Bard Access Systemspredicate MRI PowerPort™ device [K063377]. This equivalence extends toport's basic design, generic materials, and construction. The distinguishingdifference exists in the size and material of the subject catheter. | |
| Safety &PerformanceTests | No performance standards have been established under Section 514 of theFood, Drug and Cosmetic Act for this device. However, design verificationtesting was performed according to protocols based on therecommendations/requirements of applicable FDA guidance and FDArecognized international standards. Verification testing, determined to beapplicable to the safety and efficacy of the device, was shown to meetpredetermined acceptance criteria listed therein.Risk management, including a failure modes and effects analysis (FMEA), ofthe subject device was conducted in accordance with an internal protocolbased on ISO 14971:2000, Medical Devices - Risk Management for MedicalDevices. The analysis did not identify any new types of safety or efficacyquestions for the subject MRI PowerPort™ device with 9.6 Fr siliconecatheter. | |
| Summary ofSubstantialEquivalence | Based on the indications for use, technological characteristics, and safety andperformance testing, the subject MRI PowerPort™ device with 9.6 Fr siliconecatheter meets the minimum requirements that are considered adequate forits intended use and is substantially equivalent in design, materials,sterilization, principles of operation and indications for use to currentcommercially available implanted ports cited as predicates. |
510(k) Summary
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Section 6 – Summary of Safety & Effectiveness
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Page 23 of 55
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 9 2007
Ms. Susan D. Scott Regulatory Affairs Specialist C.R. Bard, Incorporated Bard Access Systems 605 North 5600 West Salt Lake City, Utah 84116
Re: K073423
Trade/Device Name: MRI PowerPort™ Implanted Port with 9.6 Fr Silicone Catheter Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: December 3, 2007 Received: December 5, 2007
Dear Ms. Scott:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2 - Ms. Scott
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
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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Section 4 - Indications for Use Statement
Indications for Use Statement
510(k) Number (if known):
Device Name:
MRI PowerPort™ Implanted Port with 9.6 Fr Silicone Catheter
Indications for Use:
The PowerPort™ implanted port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medication, 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.
Prescription Use _ V Over-The-Counter Use AND/OR (21 CFR §801 Subpart C) (Part 21 CFR §801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Arten D. m
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
§ 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.