(84 days)
Not Found
No
The summary describes a physical implanted port device and its intended use for vascular access and power injection. There is no mention of software, algorithms, or data processing that would suggest the use of AI or ML.
Yes
The device is used for patient therapies requiring repeated access to the vascular system for infusion of medication, IV fluids, parenteral nutrition solutions, blood products, and withdrawal of blood samples. These are all therapeutic applications.
No
This device is an implanted port used for repeated vascular access for infusion of medication, fluids, nutrition solutions, blood products, and for the withdrawal of blood samples. It is a delivery and access device, not one that performs diagnostic functions.
No
The device description explicitly details physical components: a titanium port, a polyurethane catheter, and a cathlock. It is an implanted port system, which is a hardware device.
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 and withdrawal of substances from the body. This is a therapeutic and access device, not a device used to examine specimens outside the body to provide information about a physiological state, health, or disease.
- Device Description: The description details an implanted port and catheter system designed for direct access to the vascular system. This aligns with its intended use as an access device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any process that would be performed in vitro (outside the living organism).
Therefore, the PowerPort™ implanted port is a medical device used for vascular access and infusion, not an in vitro diagnostic device.
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 (comma separated list FDA assigned to the subject device)
LJT, FPA
Device Description
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.
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)
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 14971:2000, Medical Devices - Risk Management for Medical Devices. The analysis did not identify any new types of safety or efficacy questions for the subject Ti PowerPort™ isp device with 8 Fr ChronoFlex® polyurethane catheter.
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
NOV - 1 2007
K072215(A1xA2)
Section 7 - Summary of Safety & Effectiveness
・
Page 24 of 53
510(k) Summary
| General
Provisions | 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 W
Salt Lake City, UT 84116
(801) 595-0700 ext. 5484
(801) 595-5425
Susan Scott
August 8, 2007
1720496 BAS
2212754 C. R. Bard |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject
Device | Trade Name:
Common/Usual Name:
Classification Name: | Titanium PowerPort™ isp Implanted Port
with 8 Fr. ChronoFlex® Polyurethane Catheter
Implanted Infusion Port & Catheter
80 LJT - Subcutaneous, Implanted, Intravascular
Infusion Port & Catheter |
| Predicate
Devices | Trade Name:
Common/Usual Name:
Classification Name:
Premarket Notification:
Trade Name:
Common/Usual Name:
Classification Name:
Premarket Notification: | Titanium PowerPort™ Implanted Port
with 8 Fr. ChronoFlex® Polyurethane Catheter
Implanted Infusion Port & Catheter
80 LJT - Subcutaneous, Implanted, Intravascular
Infusion Port & Catheter
K060812, clearance date July 14, 2006
MRI PowerPort™ Polymeric Implanted Port
with 8 Fr. ChronoFlex® Polyurethane Catheter
Implanted Infusion Port & Catheter
80 LJT - Subcutaneous, Implanted, Intravascular
Infusion Port & Catheter
K063377, clearance date Jan 25, 2007 |
| Classification | Class II
21 CFR §880.5965
General Hospital | |
| Performance
Standards | Performance standards have not been established by FDA under section 514
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. | |
| Device
Description | 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. | |
| Technological
Characteristics | Technological characteristics of the subject Titanium PowerPort™ isp device
with 8 Fr ChronoFlex® polyurethane catheter are equivalent to those of the
Bard 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 the
reduced size of the subject port body. The subject port catheter is
unchanged from the predicate. | |
| 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 14971:2000, Medical Devices - Risk Management for Medical
Devices. The analysis did not identify any new types of safety or efficacy
questions for the subject Ti PowerPort™ isp device with 8 Fr ChronoFlex®
polyurethane catheter. | |
| Summary of
Substantial
Equivalence | Based on the indications for use, technological characteristics, and safety and
performance testing, the subject Ti PowerPort™ isp device with 8 Fr
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 power injectable implanted ports cited as
predicates. | |
1
0.2.02 / 72311
Section 7 -- Summary of Safety & Effectiveness
Page 25 of 53
.
2
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.
3
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
4
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