(26 days)
Not Found
No
The device description and intended use are purely mechanical/material-based and do not mention any computational or analytical capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device facilitates the delivery of therapies and withdrawal of samples, but it does not directly treat a medical condition itself.
No
This device, the PowerPort™ implanted port, is used for repeated vascular access for infusion of medications, fluids, nutrition, blood products, and for blood withdrawal. It is a port system for delivering or acquiring substances, not for diagnosing conditions.
No
The device description clearly states it consists of a titanium port and silicone catheter, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "patient therapies requiring repeated access to the vascular system" for infusion of various substances and withdrawal of blood samples. This is a direct interaction with the patient's body for therapeutic and diagnostic purposes in vivo (within the living organism).
- Device Description: The description details an "implanted port" and "catheter," which are devices designed to be placed inside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the living organism) to provide information for diagnosis, monitoring, or compatibility testing. IVDs typically involve reagents, test kits, or instruments that analyze biological samples like blood, urine, or tissue in a laboratory setting.
The device described is a medical device used for vascular access and administration of substances directly into the patient's bloodstream. This falls under the category of implantable medical devices rather than in vitro diagnostics.
N/A
Intended Use / 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.
Product codes
LJT
Device Description
The subject PowerPort™ implanted port with Groshong™ catheter is a member of the PowerPort™ series of power injectable implanted ports. The subject device consists of a titanium port and silicone Groshong® tipped and valved catheter that is attached to the port with a cathlock compression fitting. The subject port 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Page 23 of 60
| 510(k) Summary | JUN - 4 2008 | ||
|---|---|---|---|
| General | |||
| Provisions | Submitter Name: | Bard Access Systems, Inc. (BAS) | |
| [Wholly owned subsidiary of C.R. Bard, Inc.] | |||
| Address: | 605 N 5600 W | ||
| Salt Lake City, UT 84116 | |||
| Telephone Number: | (801) 595-0700 ext. 7105 | ||
| Fax Number: | (801) 595-5425 | ||
| Contact Person: | Ji Hyun Kim | ||
| Date of Preparation: | May 30, 2008 | ||
| Registration Number: | 3006260740 BAS | ||
| 2212754 C. R. Bard | |||
| Subject | |||
| Device | Trade Name: | PowerPort™ Implanted Port | |
| with Groshong® Catheter | |||
| Common/Usual Name: | Implanted Infusion Port & Catheter | ||
| Classification Name: | 80 LJT – Subcutaneous, Implanted, Intravascular | ||
| Infusion Port & Catheter | |||
| Predicate | |||
| Devices | Trade Name: | PowerPort™ Implanted Titanium Port | |
| Common/Usual Name: | Implanted Infusion Port & Catheter | ||
| Classification Name: | 80 LJT – Subcutaneous, Implanted, Intravascular | ||
| Infusion Port & Catheter | |||
| Premarket Notification: | K060812, clearance date July 14, 2006 | ||
| Classification | Class II | ||
| 21 CFR §880.5965 | |||
| General Hospital | |||
| Performance | |||
| Standards | |||
| Performance standards have not been established by FDA under section 51- | |||
| of the Federal Food, Drug and Cosmetic Act. | |||
| Intended Use | |||
| PowerPort™ devices are totally implanted vascular access devices designed | |||
| to provide long-term, repeated access to the vascular system. | |||
| 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. |
510(k) Summary
pg 1 of 2
1
Page 24 of 60
| Device
Description | The subject PowerPort™ implanted port with Groshong™ catheter is a
member of the PowerPort™ series of power injectable implanted ports. The
subject device consists of a titanium port and silicone Groshong® tipped and
valved catheter that is attached to the port with a cathlock compression fitting.
The subject port 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. |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics | Technological characteristics of the subject PowerPort™ implanted port with
Groshong™ catheter are equivalent to those of the Bard Access Systems
predicate PowerPort™ Implanted Titanium Port [K060812]. |
| Safety &
Performance
Tests | 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. |
| Risk management, including a failure modes and effects analysis (FMEA), of
the subject device was conducted in accordance with an internal protocol
based on ISO 14971:2007, Medical Devices - Application of Risk
Management to Medical Devices (General). The analysis did not identify any
new types of safety or efficacy questions for the subject PowerPort™
implanted port with Groshong™ catheter. | |
| Summary of
Substantial
Equivalence | Based on the indications for use, technological characteristics, and safety and
performance testing, the subject PowerPort™ implanted port with Groshong™
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 ports cited as predicates. |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
JUN - 4 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Ji-Hyun Kim Regulatory Affairs Manager C.R. Bard, Incorporated Bard Access Systems, Incorporated 605 North 5600 West Salt Lake City, Utah 84116
Rc: K081311
Trade/Device Name: PowerPort™ Implanted Port with Groshong™ Catheter Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: May 8, 2008 Received: May 9, 2008
Dear Ms. Kim:
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.
3
Page 2 - Ms. Kim
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,
Clive
Chiu Lin, 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
4
Indications for Use Statement
510(k) Number (if known):
Ko81311
Device Name:
PowerPort™ Implanted Port with Groshong™ 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 (Part 21 CFR §801 Subpart D) (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)
Antony Lo huaton
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: 5981311