(112 days)
Not Found
No
The document describes a vascular access port and infusion set, which are mechanical devices. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is used for patient therapies requiring repeated access to the vascular system, including infusion of medications, IV fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples, which are all therapeutic interventions.
No
The device is an implanted port system used for infusion of medications, fluids, parenteral nutrition, blood products, withdrawal of blood samples, and power injection of contrast media. Its purpose is therapeutic administration and access, not diagnosis.
No
The device description clearly details physical hardware components: an implanted titanium port with a catheter and a safety infusion set with a needle. There is no mention of software as the primary or sole component.
Based on the provided text, the PowerPort™ Implanted Port and PowerLoc™ Safety Infusion Set are not In Vitro Diagnostic (IVD) devices.
Here's why:
- Intended Use: The intended use clearly describes the devices as being used for accessing the vascular system for infusion of substances (medications, fluids, nutrition, blood products, contrast media) and withdrawal of blood samples. These are procedures performed on the patient's body, not on samples outside the body for diagnostic purposes.
- Device Description: The description details an implanted port and an infusion set, which are physical devices used for accessing and delivering substances into the vascular system.
- Lack of Diagnostic Function: There is no mention of the devices being used to analyze samples, detect markers, or provide diagnostic information about a patient's condition. The withdrawal of blood samples is for subsequent analysis, which would be performed by a separate IVD device or laboratory process.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or screening purposes. The PowerPort™ and PowerLoc™ facilitate access to the vascular system for therapeutic and sampling purposes, but they do not perform the diagnostic analysis themselves.
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 medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.
When used with the 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 PowerLoc™ Safety Infusion Set is an intravascular administration set with a non-coring right anqle needle and manually activated needle-stick safety mechanism. The device is used to access surgically implanted vascular ports. The PowerLoc™ Safety Infusion Set is indicated for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports. When used with the PowerPort™ device, the PowerLoc™ Safety Infusion Set is also indicated for power injection of contrast media into the central venous system only with an implanted port that is also indicated for power injection. The maximum recommended infusion rate is 5 ml/s for 19 Ga. And 20 Ga. Needles, and 2 ml/s for 22 Ga. Needles.
Product codes
LJT, FPA
Device Description
PowerPort™ Implanted Titanium Port Device
- The PowerPort™ Implanted Titanium Port is a titanium port with attachable open-ended, 45 . cm, 8 Fr ChronoFlex® polyurethane catheter.
- The PowerPort™ is designed for power injection of contrast media when used with the power . injectable PowerLoc™ SIS. Confirmation of PowerLoc™ and PowerPort™ as a requirement for power injection is directed in all associated literature.
- The purple color of the port body differentiates the PowerPort™ from other implantable . vascular access ports, highlighting the power injectable capability of the PowerPort™.
- The unique shape of the PowerPort™ (three sided port with three septum bumps) aids in . identification.
PowerLoc™ SIS Device
- The PowerLoc™ Safety Infusion Set is a standard non-coring Huber type needle and . administration set with an integral safety needle-stick prevention feature.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
central venous 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)
Verification testing was performed according to protocols based on the above referenced guidance document recommendations and additional standards.
Performance data gathered in design verification testing demonstrated the following: one, that the PowerPort™ Implanted Port is substantially equivalent to the predicate Implanted Titanium Port; and two, that the PowerLoc™ Safety Infusion Set is substantially equivalent to the predicate MiniLoc™ Safety Infusion Set.
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.
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i+4
PowerPort™ System
Traditional 510(k)
Section 11 510(K) Summary of Safety & Effectiveness Information
The following summary of safety and effectiveness takes account of both the primary device (PowerPort™ implanted titanium port) and accessory (PowerLoc™ of bon the planting dower injecting, are required to work together as a system.
11.1 Submitter Information
Primary Device & Accessory Device
| Submitter Name: | Bard Access Systems, Inc. (BAS)
[Subsidiary of C. R. Bard, Inc.] |
|----------------------|---------------------------------------------------------------------|
| Address: | 5425 W. Amelia Earhart Drive
Salt Lake City, UT 84116 |
| Telephone Number: | (801) 595-0700, Ext. 5484 |
| Fax Number: | (801) 595-5425 |
| Contact Person: | Susan Scott |
| Date of Preparation: | March 23. 2006 |
11.2 Device Name
PowerPort™ Port/Catheter Device
| Trade/Device Name: | PowerPort™ Implanted Titanium Port with 8 Fr. ChronoFlex® Catheter |
|---|---|
| Common/Usual Name: | Implanted Infusion Port |
| Classification Name: | Class II, 80 LJT - Subcutaneous, Implanted, Intravascular Infusion Port & Catheter (21 CFR §880.5965) |
| Classification Panel: | General Hospital |
PowerLoc™ SIS Device
| Proprietary Name: | PowerLoc™ Safety Infusion Set |
|---|---|
| Common/Usual Name: | Huber Needle Intravascular Administration Set |
| Classification Name: | Class II, FPA – Intravascular Administration Set |
| (21 CFR §880.5441) | |
| Classification Panel: | General Hospital and Personal Use |
11.3 Predicate Device(s):
PowerPort™ System Indications Predicate:
| Trade/Device Name: | 5 Fr Dual Lumen PowerPICC® Catheter |
|---|---|
| Common/Usual Name: | Peripherally Inserted Central Catheter (PICC) |
| Classification Name: | Class II, 80 LJS -- Long Term Intravascular Catheter |
| (21 CFR §880.5970) | |
| Classification Panel: | General Hospital |
| Premarket Notification: | K051672, Substantial Equivalence: November 23, 2005 |
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Image /page/1/Picture/0 description: The image shows handwritten text and printed text. The handwritten text at the top reads 'K060812' and '2of4'. The printed text below reads 'PowerPort System' and 'Traditional 510(k)'. The text appears to be part of a document or label.
PowerPort™ Port/Catheter Device Predicate:
| Trade/Device Name: | PowerPort™ Implanted Titanium Port with 8 Fr ChronoFlex Catheter |
|---|---|
| Common/Usual Name: | Implanted Infusion Port |
| Classification Name: | Class II, 80 LJT - Subcutaneous, Implanted, Intravascular Infusion Port & Catheter (21 CFR §880.5965) |
| Classification Panel: | General Hospital |
| Premarket Notification: | K050310, Substantial Equivalence: April 18, 2005 |
PowerLoc™ SIS Device Predicate:
| Trade/Device Name: | MiniLoc™ Safety Infusion Set |
|---|---|
| Common/Usual Name: | Huber Needle Intravascular Administration Set |
| Classification Name: | Class II, FPA – Intravascular Administration Set |
| (21 CFR §880.5440) | |
| Classification Panel: | General Hospital |
| Premarket Notification: | K050600, Substantial Equivalence: May 12, 2005 |
11.4 Device Description
PowerPort™ Implanted Titanium Port Device
- The PowerPort™ Implanted Titanium Port is a titanium port with attachable open-ended, 45 . cm, 8 Fr ChronoFlex® polyurethane catheter.
- The PowerPort™ is designed for power injection of contrast media when used with the power . injectable PowerLoc™ SIS. Confirmation of PowerLoc™ and PowerPort™ as a requirement for power injection is directed in all associated literature.
- The purple color of the port body differentiates the PowerPort™ from other implantable . vascular access ports, highlighting the power injectable capability of the PowerPort™.
- The unique shape of the PowerPort™ (three sided port with three septum bumps) aids in . identification.
PowerLoc™ SIS Device
- The PowerLoc™ Safety Infusion Set is a standard non-coring Huber type needle and . administration set with an integral safety needle-stick prevention feature.
11.5 Intended Use
The intended use of each of the components of the PowerPort™ System has not changed from that of the predicate.
PowerPort™ Port/Catheter Device
The PowerPort™ Implanted titanium Port is a totally implantable vascular access device designed to provide long term repeated access to the vascular access tervice intended use as compared to the predicate Implanted titanium Port.
PowerLoc™ SIS Device
The PowerLoc™ SIS is intended for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports. The intended use has not changed. This is the same intended use as the predicate MiniLoc™ Safety Infusion Set [K050600].
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11.6 Indications for Use
The Indications for Use were modified to reflect the addition of the power injection of contrast media procedure. The Indications for Use Statements can be found in Section 1.2.
PowerPort™ Port/Catheter Device
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 the PowerLoc™ Safety Infusion Set, the PowerPort™ device is indicated for power injection of contrast media. The maximum recommended infusion rate is 5 ml/s.
PowerLoc™ SIS Device
The PowerLoc™ Safety Infusion Set is an intravascular administration set with a non-coring right anqle needle and manually activated needle-stick safety mechanism. The device is used to access surgically implanted vascular ports.
The PowerLoc™ Safety Infusion Set is indicated for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports.
When used with the PowerPort™ device, the PowerLoc™ Safety Infusion Set is also indicated for power injection of contrast media into the central venous system only with an implanted port that is also indicated for power injection. The maximum recommended infusion rate is 5 ml/s for 19 Ga. And 20 Ga. Needles, and 2 ml/s for 22 Ga. Needles.
11.7 Technological Characteristics Summary
The following Summary Information refers to both the primary device (PowerPort™ port) and the accessory device (PowerLoc™ infusion set). Although these devices can be assessed individually for routine infusions, they are also addressed together as a system for power injection.
New device is compared to Marketed Device?
-
Yes. Both the port and infusion set devices are compared to legally marketed predicates.
Does the new device have the same indication statement?
- A No. The Indications For Use were expanded to include power injection of contrast media for both the port and infusion set devices.
Do the differences alter the intended therapeuticletc. effect (i.e. in deciding, impact on safety and effectiveness may be considered)?
- No, the differences do not alter the intended use of the port or infusion set device. A
Does the new device have the same technological characteristics, e.g. design, material, etc?
- a No, not in all regards.
- o The PowerPort™ Implanted Port has some minor differences from the predicate Implanted titanium Port, however, the fundamental scientific technology of the catheter has not changed.
- The PowerLoc™ Safety Infusion Set has some minor differences from the predicate o MiniLoc™ Safety Infusion Set. The basic fundamental scientific technology of the device has not changed.
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- PowerPort™ System Traditional 510(k)
Could the new characteristics affect safety or effectiveness?
-
Yes. The expanded indication to include power injection of contrast media through the PowerPort™/PowerLoc™ system could affect safety or effectiveness.
Do the new characteristics raise new types of safety and effectiveness questions?
-
No. There are no new types of safety and effectiveness questions.
Do accepted scientific methods exist for assessing effects of the new characteristics?
Yes.
The FDA's Guidance on 510(k) Submissions for Implanted Infusion Ports, dated October 1990 was used to evaluate the PowerPort™ device's performance.
The following two FDA documents were used to evaluate the PowerLoc™ device's performance: Guidance for Industry and FDA Staff: Intravascular Administration Sets Premarket Notification Submissions [510(k)], dated April 15, 2005; and ODE Supplementary Guidance on Premarket Notifications for Medical Devices with Sharps Injury Prevention Guards: Guidance for Industry and FDA, dated December 31, 2002.
Sterilization requirements of ISO 11135:1994, Medical Devices – Validation and Routine Control of Ethylene Oxide Sterilization, will be met.
Biocompatibility requirements of ISO-10993, Biological Evaluation of Medical Devices Part-1: Evaluation and Testing, were met for both the PowerPort™ implanted port and PowerLoc™ infusion set.
Are performance data available to assess effects of new characteristics?
- Yes. Verification testing was performed according to protocols based on the above-A referenced guidance document recommendations and additional standards.
Do performance data demonstrate equivalence?
- Yes. Performance data gathered in design verification testing demonstrated the following: A one, that the PowerPort™ Implanted Port is substantially equivalent to the predicate Implanted Titanium Port; and two, that the PowerLoc™ Safety Infusion Set is substantially equivalent to the predicate MiniLoc™ Safety Infusion Set.
11.8 Conclusion
The PowerPort™ System met all established acceptance criteria for performance testing and design verification testing. Based on FDA's decision tree, the components of the PowerPort™ System are substantially equivalent to their respective predicates: the PowerPort™ Implanted Titanium Port as compared to the Titanium Implanted Port [K050310, cleared on April 18, 2005]; and the PowerLoc™ Safety Infusion Set as compared to the MiniLoc™ Safety Infusion Set [K050600, cleared on May 12, 2005].
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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized caduceus, a symbol often associated with medicine and healthcare, alongside the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" arranged in a circular fashion around the symbol. The caduceus is depicted with three lines forming a stylized shape, and the text is in uppercase letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
C.R. Bard, Incorporated Ms. Susan Scott Regulatory Affairs Specialist Bard Access Systems, Incorporated 5425 West Amelia Earhart Drive Salt Lake City, Utah 84116
JUL 1 4 2006
Re: K060812
Trade/Device Name: PowerPort™ Implanted Titanium Port, PowerLoc™ Safety Infusion Set Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous, Implanted Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT, FPA Dated: June 23, 2006 Received: June 26, 2006
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 (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 vour 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Syngite Y. Michael Davis.
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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KO60812
127712 PowerPort™ System Traditional 510(k)
Section 1.2 A
Indications for Use
| 510(k) Number (if known): | |
|---|---|
| Device Name: | PowerPort™ Implanted Titanium Port |
| 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 medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. |
| When used with the 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
. ... n Control, Dental Devices
1660512 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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Image /page/7/Picture/0 description: The image shows the text "K060812 2 of 2 PowerPort System Traditional 510(k)". The text appears to be part of a document or label. The phrase "PowerPort System" is written in a slightly larger font size compared to the other text. The text is black and the background is white.
Section 1.2 B
Indications for Use
510(k) Number (if known): Device Name: PowerLoc™ Safety Infusion Set Indications for Use: The PowerLoc™ Safety Infusion Set is an intravascular administration set with a non-coring right angle needle and manually activated needle-stick safety mechanism. The device is used to access surgically implanted vascular ports. The PowerLoc™ Safety Infusion Set is indicated for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports. When used with the PowerPort™ device, the PowerLoc™ Safety Infusion Set is also indicated for power injection of contrast media into the central venous system. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s for 19 Ga. and 20 Ga. needles, and 2 ml/s for 22 Ga. needles. Prescription Use > 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
S.JI) Jign-Cit) n of Anesthesiology, General Hospital, uon Control, Dental Devices
... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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