(29 days)
Not Found
No
The summary describes a physical implanted port device and its intended uses, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is described as an "implanted vascular access device designed to provide long-term, repeated access to the vascular system" for infusion of medications, fluids, nutrition solutions, blood products, and for blood withdrawal, which are all therapeutic activities.
No
The device is an implanted port for vascular access, used for infusion of substances and withdrawal of blood samples. It does not diagnose medical conditions.
No
The device description clearly states it is an "implanted vascular access device," which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for accessing the vascular system for infusion of substances and withdrawal of blood samples from the patient. This is a direct interaction with the patient's body for therapeutic and diagnostic purposes (collecting samples), not for testing samples outside the body to diagnose a condition.
- Device Description: The description confirms it's an "implanted vascular access device."
- Lack of IVD Characteristics: There is no mention of analyzing samples, reagents, or any process that would be performed in vitro (in glass or outside the living organism) to diagnose a disease or condition.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device is used to access the body to deliver or collect substances, which is a different category of medical device.
N/A
Intended Use / Indications for Use
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 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.
Product codes (comma separated list FDA assigned to the subject device)
LJT
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
MAR 2 7 2009
510(k) Summary
21 CFR 807.92(a)
| PowerPort™ duo M.R.I.™ Implanted Port
with 9.5 Fr. Dual Lumen (D/L) ChronoFlex® Polyurethane Catheter
| February 20, 2009 | ||||
|---|---|---|---|---|
| General | ||||
| Provisions | 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. Dual | |||
| Lumen ChronoFlex® Polyurethane Catheter | ||||
| Predicate | ||||
| Devices | 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/L | ||||
| ChronoFlex® 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 | ||||
| Performance | ||||
| Standards | Performance standards have not been established by FDA under section 514 of the Federal | |||
| Food, Drug and Cosmetic Act. | ||||
| Intended Use | 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. | ||||
| Indications | ||||
| for Use | 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. | ||||
| Technological | ||||
| Characteristics | Technological similarities between the subject PowerPort™ duo M.R.I.™ Implanted Port | |||
| with 9.5 Fr. D/L ChronoFlex® Polyurethane Catheter and the cited predicate devices | ||||
| remain identical. There are no additional questions raised regarding safety or | ||||
| effectiveness of the subject PowerPort™ duo M.R.I.™ Implanted Port with 9.5 Fr. D/L | ||||
| ChronoFlex® Polyurethane Catheter. | ||||
| Summary of | ||||
| Substantial | ||||
| Equivalence | Based on the indications for use, technological characteristics, and safety and | |||
| performance testing, the subject PowerPort™ duo M.R.I.™ Implanted Port with 9.5 Fr. D/L | ||||
| ChronoFlex® Polyurethane Catheter meets the minimum requirements that are considered | ||||
| adequate for its intended use and is substantially equivalent in design, materials, | ||||
| sterilization, principles of operation, and indications for use to current commercially | ||||
| available implanted port cited predicates. |
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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