(84 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 Titanium PowerPort™ isp device is a member of the PowerPort™ series of power injectable implanted ports. The subject device consists of a titanium port and 8 Fr ChronoFlex® polyurethane catheter that is attached to the port with a cathlock (compression fitting). The subject Titanium PowerPort™ isp device is distinguishable as a member of Bard Access Systems'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 describes a medical device submission (K072215) for the Titanium PowerPort™ isp Implanted Port with 8 Fr ChronoFlex® Polyurethane Catheter. It is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific clinical acceptance criteria in a comparative study.
Therefore, the requested information for a comprehensive study including acceptance criteria, sample sizes, expert involvement, and comparative effectiveness (MRMC) cannot be fully extracted from this document, as it is a premarket notification for a medical device seeking substantial equivalence, not a clinical trial report.
However, I can extract information regarding overall safety and performance testing and the ground truth used for that testing, as well as general statements about acceptance criteria.
Acceptance Criteria and Device Performance (as described for non-clinical testing for substantial equivalence)
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Predetermined acceptance criteria from design verification testing based on FDA guidance and recognized international standards. | Verification testing shown to meet predetermined acceptance criteria. |
| Risk management (FMEA) conducted in accordance with ISO 14971:2000. | Analysis did not identify any new types of safety or efficacy questions. |
| Substantial equivalence in design, materials, sterilization, principles of operation, and indications for use to predicate devices. | Device found substantially equivalent to predicate devices. |
Study Details from the Provided Text:
- Sample size used for the test set and the data provenance: Not applicable in the context of a clinical test set. The document describes "design verification testing" and a "failure modes and effects analysis (FMEA)". These are typically laboratory-based tests on device samples, not human subjects data. The provenance of these internal tests is Bard Access Systems, Inc.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in this context, refers to the established standards or internal protocols used for design verification and FMEA. These are defined by engineering and quality control teams within the manufacturer, and by regulatory standards like ISO 14971:2000. It doesn't involve clinical experts establishing ground truth for a diagnostic output.
- Adjudication method for the test set: Not applicable. Adjudication methods like 2+1 or 3+1 refer to consensus-building amongst human readers for image interpretation or clinical outcomes. This document describes device performance testing against engineering and safety standards.
- 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 study was not done. This device is an implanted port and catheter, not an AI software or diagnostic imaging device that would typically undergo such a study.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic device.
- The type of ground truth used:
- For design verification testing: Protocols based on FDA guidance and FDA recognized international standards.
- For risk management (FMEA): An internal protocol based on ISO 14971:2000, Medical Devices - Risk Management for Medical Devices.
- The sample size for the training set: Not applicable. This refers to a manufactured medical device, not a machine learning model.
- How the ground truth for the training set was established: Not applicable. This is not a machine learning model.
Summary of the Document's Focus:
This 510(k) summary is for a medical device seeking clearance based on substantial equivalence to previously cleared predicate devices. The "study" mentioned refers to design verification testing and risk management (FMEA) which are internal engineering and quality assurance processes, not clinical trials or studies involving human subjects or AI performance. The document explicitly states: "No performance standards have been established by FDA under section 514 of the Federal Food, Drug and Cosmetic Act. 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."
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NOV - 1 2007
K072215(A1xA2)
Section 7 - Summary of Safety & Effectiveness
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Page 24 of 53
510(k) Summary
| 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 ScottAugust 8, 20071720496 BAS2212754 C. R. Bard |
|---|---|---|
| SubjectDevice | Trade Name:Common/Usual Name:Classification Name: | Titanium PowerPort™ isp Implanted Portwith 8 Fr. ChronoFlex® Polyurethane 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: | Titanium PowerPort™ Implanted Portwith 8 Fr. ChronoFlex® Polyurethane CatheterImplanted Infusion Port & Catheter80 LJT - Subcutaneous, Implanted, IntravascularInfusion Port & CatheterK060812, clearance date July 14, 2006MRI PowerPort™ Polymeric Implanted Portwith 8 Fr. ChronoFlex® Polyurethane CatheterImplanted Infusion Port & Catheter80 LJT - Subcutaneous, Implanted, IntravascularInfusion Port & CatheterK063377, clearance date Jan 25, 2007 |
| 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 Titanium PowerPort™ isp device is a member of the PowerPort™series of power injectable implanted ports. The subject device consists of atitanium port and 8 Fr ChronoFlex® polyurethane catheter that is attached tothe port with a cathlock (compression fitting). The subject TitaniumPowerPort™ isp device is distinguishable as a member of Bard AccessSystems's power injectable port series by the triangular body shape, uniquepurple coloring, and three palpation bumps on the 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 Titanium PowerPort™ isp devicewith 8 Fr ChronoFlex® polyurethane catheter are equivalent to those of theBard Access Systems predicate Titanium PowerPort™ device [K060812].This equivalence extends to basic design, generic materials, construction,and surface anodization treatment. The distinguishing difference exists in thereduced size of the subject port body. The subject port catheter isunchanged from the predicate. | |
| 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 Ti PowerPort™ isp device with 8 Fr ChronoFlex®polyurethane catheter. | |
| Summary ofSubstantialEquivalence | Based on the indications for use, technological characteristics, and safety andperformance testing, the subject Ti PowerPort™ isp device with 8 FrChronoFlex® polyurethane catheter meets the minimum requirements thatare considered adequate for its intended use and is substantially equivalent indesign, materials, sterilization, principles of operation and indications for useto current commercially available power injectable implanted ports cited aspredicates. |
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Section 7 -- Summary of Safety & Effectiveness
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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-like symbol with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 1 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: K072215
Trade/Device Name: Titanium PowerPort™ isp Implanted Port with 8 Fr ChronoFlex® Polyurethane Catheter Regulation Number: 880.5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT, FPA Dated: October 1, 2007 Received: October 2, 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 (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.
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-Liang, Ph.D.
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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Indications for Use Statement
510(k) Number (if known):
Device Name:
Titanium PowerPort™ isp Implanted Port with
8 Fr ChronoFlex® Polyurethane 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 _ √ (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)
Anthony Ument
. ! Cran-Off) of Anesthesiology, General Hospital, Jann Control, Dental Devices
ber. Kmaals
§ 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.