(29 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 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.
PowerPort™ duo M.R.I.™ Implanted Port with 9.5 Fr. D/L ChronoFlex® Polyurethane Catheter devices are implanted vascular access devices designed to provide long-term, repeated access to the vascular system.
The provided text is a 510(k) Summary for a medical device (PowerPort™ duo M.R.I.™ Implanted Port with 9.5 Fr. Dual Lumen ChronoFlex® Polyurethane Catheter). It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on:
- Indications for Use: The current device has the same intended use as the predicate devices (PowerPort™ M.R.I.™ Implanted Port with 8.0 Fr. ChronoFlex® Polyurethane Catheter and X-Port™ duo Implanted Port with 9.5 Fr. D/L ChronoFlex® Polyurethane Catheter).
- Technological Characteristics: The summary states "Technological similarities between the subject PowerPort™ duo M.R.I.™ Implanted Port... and the cited predicate devices remain identical." It also claims "no additional questions raised regarding safety or effectiveness."
- Safety and Performance Testing: The summary broadly states that "safety and performance testing" was conducted, and the device "meets the minimum requirements that are considered adequate for its intended use." However, it does not provide any specific acceptance criteria, test results, or details about the studies performed.
Therefore, I cannot populate the table or answer the specific questions about the study design, sample size, ground truth, or expert involvement, as this information is not present in the provided document.
The document is a regulatory submission demonstrating substantial equivalence to predicate devices, which often relies on a comparison of design, materials, manufacturing processes, and sometimes bench testing, rather than extensive clinical studies with specific performance metrics and acceptance criteria for AI/diagnostic devices.
{0}------------------------------------------------
MAR 2 7 2009
510(k) Summary
21 CFR 807.92(a)
| PowerPort™ duo M.R.I.™ Implanted Portwith 9.5 Fr. Dual Lumen (D/L) ChronoFlex® Polyurethane CatheterFebruary 20, 2009 | ||||
|---|---|---|---|---|
| GeneralProvisions | Submitter of 510(k) | Bard Access Systems, Inc. (BAS)[Wholly owned subsidiary of C.R. Bard, Inc.] | ||
| PreMarket Notification: | Salt Lake City, UT 84116 | |||
| Contact Person: | Angela M. Brady, Regulatory Affairs Specialist | |||
| Device Trade Name: | PowerPort™ duo M.R.I.™ Implanted Port with 9.5 Fr. DualLumen ChronoFlex® Polyurethane Catheter | |||
| PredicateDevices | Predicate Device Name | |||
| PowerPort™ M.R.I.™ Implanted Port with 8.0 Fr.ChronoFlex® Polyurethane Catheter | K063377 | January 25, 2007 | ||
| Trade Name: | PowerPort™ M.R.I.™ Implanted Port with 8.0 Fr. ChronoFlex®Polyurethane Catheter | |||
| Common/Usual Name: | Implanted Infusion Port & Catheter | |||
| Classification Name: | LJT – Subcutaneous, Implanted, Intravascular Infusion Port &Catheter | |||
| CFR Reference: | 21 CFR §880.5965, Class II | |||
| Classification Panel: | General Hospital | |||
| Predicate Device Name | ||||
| X-Port™ duo Implanted Port with 9.5 Fr. D/LChronoFlex® Polyurethane Catheter | K034065 | January 15, 2004 | ||
| Trade Name: | X-Port™ duo Implanted Port with 9.5 Fr. Dual Lumen (D/L)ChronoFlex® Polyurethane Catheter | |||
| Common/Usual Name: | Implanted Infusion Port & Catheter | |||
| Classification Name: | LJT – Subcutaneous, Implanted, Intravascular Infusion Port &Catheter | |||
| CFR Reference: | 21 CFR §880.5965, Class II | |||
| Classification Panel: | General Hospital | |||
| Classification | 21 CFR §880.5965, Class II | |||
| LJT – Subcutaneous, Implanted, Intravascular Infusion Port | ||||
| PerformanceStandards | Performance standards have not been established by FDA under section 514 of the FederalFood, Drug and Cosmetic Act. | |||
| Intended Use | PowerPort™ duo M.R.I.™ Implanted Port with 9.5 Fr. D/L ChronoFlex® Polyurethane Catheterdevices are implanted vascular access devices designed to provide long-term, repeatedaccess to the vascular system. | |||
| Indicationsfor Use | PowerPort™ Implanted Port is indicated for patient therapies requiring repeated access tothe 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 forpower injection of contrast media. For power injection of contrast media, the maximumrecommended infusion rate is 5 ml/s. | |||
| TechnologicalCharacteristics | Technological similarities between the subject PowerPort™ duo M.R.I.™ Implanted Portwith 9.5 Fr. D/L ChronoFlex® Polyurethane Catheter and the cited predicate devicesremain identical. There are no additional questions raised regarding safety oreffectiveness of the subject PowerPort™ duo M.R.I.™ Implanted Port with 9.5 Fr. D/LChronoFlex® Polyurethane Catheter. | |||
| Summary ofSubstantialEquivalence | Based on the indications for use, technological characteristics, and safety andperformance testing, the subject PowerPort™ duo M.R.I.™ Implanted Port with 9.5 Fr. D/LChronoFlex® Polyurethane Catheter meets the minimum requirements that are consideredadequate for its intended use and is substantially equivalent in design, materials,sterilization, principles of operation, and indications for use to current commerciallyavailable implanted port cited predicates. |
:
·
:
. ... .. .
: :
{1}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
C.R. Bard, Incorporated C/o Ms. Angela M. Brady Regulatory Affairs Specialist Bard Access Systems 605 North 5600 West Salt Lake City, Utah 84116
MAR 2 7 2009
Re: K090512
Trade/Device Name: PowerPort™ duo M.R.I.TM Implanted Port with 9.5 Fr. Dual Lumen ChronoFlex® Polyurethane Catheter Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: February 24, 2009 Received: February 26, 2009
Dear Ms. Brady:
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.
{2}------------------------------------------------
Page 2 - Ms. Brady
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Anthony D. anston for
Ginette V. Michaud, M.D.
Ginette Y. Michaud. M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
510(k) Number (if known):
Device Name:
PowerPort™ duo M.R.I. ™ Implanted Port with 9.5 Fr. D/L 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 ffor 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 oontrast 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sd. All sen
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K090512
§ 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.