(65 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 with 6 Fr ChronoFlex® polyurethane catheter is a member of the PowerPort™ series of power injectable implanted ports. The subject device consists of a titanium port and ChronoFlex® polyurethane 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 from K072549 predominantly describes the device, its intended use, and its substantial equivalence to predicate devices. It does not contain information about acceptance criteria for device performance, the study design, or specific performance metrics typically found in validation studies for AI/algorithm-based medical devices.
Therefore, I cannot populate the requested table with acceptance criteria and reported device performance, nor can I answer questions about sample size for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the provided document.
The document states:
- "No performance standards have been established by FDA under section 514 of the Federal Food, Drug and Cosmetic Act."
- "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."
This indicates that internal acceptance criteria were used for design verification testing, but the document does not specify these criteria or the results against them. The device is a physical implanted port and catheter, not an AI/algorithm.
Conclusion: The provided text does not contain the necessary information to answer your questions regarding acceptance criteria and performance studies for an AI/algorithm-based device. The document is a 510(k) summary for a physical medical device (an implanted port and catheter) and focuses on its substantial equivalence to existing predicate devices, rather than the validation of an AI algorithm.
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Page 22 of 55
Section 6 -- Summary of Safety & Effectiveness
510(k) Summary
| GeneralProvisions | Submitter Name: | Bard Access Systems, Inc. (BAS)[Wholly owned subsidiary of C.R. Bard, Inc.] |
|---|---|---|
| Address: | 605 N 5600 WSalt Lake City, UT 84116 | |
| Telephone Number: | (801) 595-0700 ext. 5484 | |
| Fax Number: | (801) 595-5425 | |
| Contact Person: | Susan Scott | |
| Date of Preparation: | August 28, 2007 | |
| Registration Number: | 1720496 BAS2212754 C. R. Bard | |
| SubjectDevice | Trade Name: | Titanium PowerPort™ isp Implanted Portwith 6 Fr. ChronoFlex® Polyurethane Catheter |
| Common/Usual Name: | Implanted Infusion Port & Catheter | |
| Classification Name: | 80 LJT - Subcutaneous, Implanted, IntravascularInfusion Port & Catheter | |
| PredicateDevices | Trade Name: | Titanium PowerPort™ Implanted Portwith 8 Fr. ChronoFlex® Polyurethane Catheter |
| Common/Usual Name: | Implanted Infusion Port & Catheter | |
| Classification Name:Premarket Notification: | 80 LJT - Subcutaneous, Implanted, IntravascularInfusion Port & CatheterK060812, clearance date July 14, 2006 | |
| Trade Name: | MRI PowerPort™ Polymeric Implanted Portwith 8 Fr. ChronoFlex® Polyurethane Catheter | |
| Common/Usual Name: | Implanted Infusion Port & Catheter | |
| Classification Name:Premarket Notification: | 80 LJT - Subcutaneous, Implanted, IntravascularInfusion Port & CatheterK063377, clearance date Jan 25, 2007 | |
| Classification | Class II | 21 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 with 6 Fr ChronoFlex®polyurethane catheter is a member of the PowerPort™ series of powerinjectable implanted ports. The subject device consists of a titanium port andChronoFlex® polyurethane catheter that is attached to the port with acathlock compression fitting. The subject device is distinguishable as amember 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 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 6 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,reduced size of the subject port body and catheter diameter. | |
| 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 Titanium PowerPort™ isp device with 6 FrChronoFlex® polyurethane catheter. | |
| Summary ofSubstantialEquivalence | Based on the indications for use, technological characteristics, and safety andperformance testing, the subject Titanium PowerPort™ isp device with 6 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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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, rendered in a simple, bold line drawing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 4 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: K072549
Trade/Device Name: Titanium PowerPort™ isp Implanted Port with 6 Fr ChronoFlex® Polyurethane Catheter Regulation Number: 880.5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: October 12, 2007 Received: October 15, 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,
Chis L. Lee, 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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Section 4 - Indications for Use Statement
Indications for Use Statement
510(k) Number (if known):
4072549
Device Name:
Titanium PowerPort™ isp Implanted Port with 6 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 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)
Am
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: _ k 472s4g
§ 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.