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 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.

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.

AI/ML Overview

The provided document is a 510(k) summary for the PowerPort™ System, which includes the PowerPort™ Implanted Titanium Port and the PowerLoc™ Safety Infusion Set. This document is a premarket notification for a medical device and therefore describes a non-clinical (bench) study rather than a clinical study involving human subjects. It focuses on demonstrating substantial equivalence to predicate devices and meeting performance criteria based on established FDA guidance and international standards.

Acceptance Criteria and Device Performance for PowerPort™ System

The PowerPort™ System (comprising the PowerPort™ Implanted Port and PowerLoc™ Safety Infusion Set) met all established acceptance criteria for performance testing and design verification testing, demonstrating substantial equivalence to its respective predicates. The key acceptance criteria revolve around the expanded indication for power injection of contrast media.

The original document does not contain a specific table detailing "Acceptance Criteria" and "Reported Device Performance" in a direct comparative format as might be found in a clinical study report. However, based on the provided text, the acceptance criteria are implicitly derived from the FDA guidance documents and international standards referenced, and the reported device performance is that it met these criteria.

Here's an interpretation of the acceptance criteria and implied performance based on the document's content:

Acceptance Criterion	Performance Metric/Test	Reported Device Performance	Study Type/Reference Standard
PowerPort™ Implanted Port:
Substantial Equivalence to Predicate	Overall design, material, function for vascular access	Met accepted scientific methods and data demonstrating equivalence to predicate Implanted Titanium Port (K050310).	FDA Guidance on 510(k) Submissions for Implanted Infusion Ports (Oct 1990)
Power Injection Capability	Maximum recommended infusion rate of 5 ml/s when used with PowerLoc™ SIS for contrast media.	Met.	Design Verification Testing
Biocompatibility	Biological safety for an implanted device.	Met ISO-10993, Biological Evaluation of Medical Devices Part-1.	ISO-10993, Part-1
Sterilization	Ensure sterility of the device.	Met ISO 11135:1994, Medical Devices – Validation and Routine Control of Ethylene Oxide Sterilization.	ISO 11135:1994
PowerLoc™ Safety Infusion Set:
Substantial Equivalence to Predicate	Overall design, material, function for intravascular administration, and safety features.	Met accepted scientific methods and data demonstrating equivalence to predicate MiniLoc™ Safety Infusion Set (K050600).	FDA Guidance for Industry and FDA Staff: Intravascular Administration Sets Premarket Notification Submissions [510(k)] (Apr 2005); ODE Supplementary Guidance on Premarket Notifications for Medical Devices with Sharps Injury Prevention Guards (Dec 2002)
Power Injection Capability (19 Ga., 20 Ga. needles)	Maximum recommended infusion rate of 5 ml/s.	Met.	Design Verification Testing
Power Injection Capability (22 Ga. needles)	Maximum recommended infusion rate of 2 ml/s.	Met.	Design Verification Testing
Biocompatibility	Biological safety for a device in contact with the vascular system.	Met ISO-10993, Biological Evaluation of Medical Devices Part-1.	ISO-10993, Part-1
Sterilization	Ensure sterility of the device.	Met ISO 11135:1994, Medical Devices – Validation and Routine Control of Ethylene Oxide Sterilization.	ISO 11135:1994

1. A table of acceptance criteria and the reported device performance
See table above.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: The document describes "verification testing performed according to protocols," but it does not specify the exact sample sizes (e.g., number of ports or infusion sets) used for these engineering tests. This is typical for bench testing summaries in 510(k) applications, where the focus is on the methodology's rigor rather than statistical power from a large 'test set' of clinical cases.
Data Provenance: The data is generated from non-clinical (bench) performance testing and design verification testing conducted internally by Bard Access Systems, Inc. (BAS) located in Salt Lake City, UT, USA. The data is prospective in the sense that these tests were performed specifically for this 510(k) submission, but it's not "prospective" in the clinical trial sense. The country of origin of the data is the United States.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is a non-clinical (bench) testing summary for a medical device. There are no "experts" in the sense of medical professionals establishing a ground truth for a test set of medical images or patient data. The "ground truth" for these engineering tests is established by the specifications defined in the referenced FDA guidances and ISO standards (e.g., a specific pressure or flow rate should be sustained without failure). The expertise lies in the engineers and quality assurance personnel who designed and executed the tests and analyzed the results according to these predefined criteria. Their qualifications are not specified in this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This document describes non-clinical, engineering (bench) testing, not a study involving human interpretation or adjudication of results. The results are typically quantitative measurements against predefined engineering specifications.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This document relates to a physical medical device (implantable port and infusion set), not an AI-powered diagnostic system. Therefore, no MRMC study, AI assistance, or human reader improvement was evaluated.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This document is about a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the performance testing is based on established engineering specifications, performance standards, and regulatory guidance documents (e.g., required sterilization levels, biocompatibility, maximum flow rate capacity without failure). It's a quantitative "ground truth" derived from industry and regulatory standards, not clinical outcomes or expert consensus on medical findings.

8. The sample size for the training set

Not applicable. This document describes non-clinical performance and design verification testing of a physical medical device. There is no "training set" in the context of machine learning or AI models. The testing described is analogous to validation testing against predefined specifications.

9. How the ground truth for the training set was established

Not applicable. As there is no "training set," the establishment of its ground truth is also not relevant. The "ground truth" for the test data (i.e., the performance testing) was established by adherence to FDA guidance documents and international standards for medical device design verification and performance evaluation.

Summary

{0}------------------------------------------------

K060812

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 DriveSalt 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

{1}------------------------------------------------

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].

{2}------------------------------------------------

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

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.

{3}------------------------------------------------

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].

{4}------------------------------------------------

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.

{5}------------------------------------------------

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

{6}------------------------------------------------

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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

{7}------------------------------------------------

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

... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

page 47

Regulation Number and Section

§ 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.