The PowerPort" Polymeric Port is a totally implantable vascular access device designed to provide long-term. repeated access to the vascular system 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 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 m}/s.

Device Description

The PowerPort™ device consists of a plastic port and an 8 Fr open-ended single lumen ChronoFlex® The rower of - device ocables of a pith a cathlock. The port is triangular in shape and has three palpation bumps to distinguish it as power injectable. Purple colorants have been added to the port and parpater materials to provide the device with an appearance that allows the placing physician to identify the PowerPort device as power injectable.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the PowerPort™ Implanted Polymeric Port with 8 Fr ChronoFlex® Catheter. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting a de novo study with strict acceptance criteria and performance metrics.

Therefore, the document does not contain the specific information requested in the prompt, such as:

A table of acceptance criteria and reported device performance (in terms of specific performance metrics like sensitivity, specificity, accuracy, etc.)
Details about a test set, including sample size, data provenance, ground truth establishment, or expert qualifications.
Information on MRMC studies or standalone algorithm performance.

Instead, the submission focuses on demonstrating that the new device has the same intended use and indications for use as the predicate device, and that technological differences do not raise new questions of safety or effectiveness. The "study" mentioned is primarily a series of verification tests based on established guidance documents and standards to show that the new polymeric port performs equivalently to the titanium predicate port.

Here's an breakdown of the information that is present, addressing the prompt's questions where applicable:

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

Acceptance Criteria for Equivalence: The primary "acceptance criteria" for this 510(k) submission is demonstrating substantial equivalence to the predicate device, the PowerPort™ Implanted Titanium Port with 8 Fr ChronoFlex® Catheter (K060812). This means showing that the new device shares the same intended use, indications for use, and that any technological differences do not raise new questions of safety or effectiveness, and that performance data demonstrates equivalence.
Reported Device Performance: The document states, "Performance data gathered in design verification testing demonstrated that the subject PowerPort™ Polymeric Port device is substantially equivalent to the predicate device..." However, it does not provide a table with specific quantitative performance metrics (e.g., durability, flow rates, biocompatibility results) from these tests, nor specific acceptance thresholds for those metrics. The verification testing was done to demonstrate that the new polymeric material performs comparably to the titanium in terms of relevant physical, chemical, and biological properties.

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

Not Applicable in the provided text: This type of information (sample size for a test set, data provenance, retrospective/prospective) is associated with clinical studies or performance evaluations that generate specific metrics for a novel device. For a 510(k) based on substantial equivalence, the "testing" refers to design verification tests against industry standards rather than a clinical efficacy or accuracy study. The document does not specify sample sizes for these verification tests, nor does it refer to "data provenance" in the context of clinical data.

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)

Not Applicable: "Ground truth" establishment by experts is relevant for diagnostic or AI-assisted devices where human interpretation or pathology is the reference standard. This device is an implanted infusion port, and its performance evaluation does not involve ground truth established by medical experts in this manner.

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

Not Applicable: Adjudication methods are used in clinical studies, particularly for subjective endpoints or when expert consensus is required for labeling. This document describes design verification testing, not a clinical study requiring adjudication of patient outcomes or image interpretation.

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 device is a physical medical implant (an infusion port), not an AI algorithm or a diagnostic tool that involves human readers interpreting cases. Therefore, MRMC studies and AI assistance are not relevant.

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

Not Applicable: This device is a physical medical implant, so "standalone algorithm performance" is not relevant.

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

Not Applicable: As stated in point 3, the concept of "ground truth" as typically applied to diagnostic or AI devices, is not relevant for the evaluation of this physical medical implant. The "ground truth" for its performance would be its conformance to specifications and established standards through design verification testing.

8. The sample size for the training set

Not Applicable: There is no "training set" as this is not an AI/machine learning device.

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

Not Applicable: As there is no training set, this question is not relevant.

Summary of "Study" and Equivalence Documentation from the provided text:

The "study" that proves the device meets the acceptance criteria (of substantial equivalence) consists of:

Verification Testing: "Verification testing was performed according to protocols based on the above-referenced guidance documents recommendations and additional standards." These guidance documents and standards include:
- Guidance on 510(k) Submissions for Implanted Infusion Ports (October 1990)
- Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters (March 1995)
- BS/EN/ISO 10555-1: 1997 (Sterile, single-use intravascular catheters, Part 1: General requirements)
- ISO 10555-1: 1995 Amendment 1: 1999
- BS/EN/ISO 10555-3: 1997 (Sterile, single-use intravascular catheters, Part 3: Central venous catheters)
- AAMI/ANSI/ISO 11135: 1994 (Medical Devices -- Validation and Routine Control of Ethylene Oxide Sterilization)
- AAMI/ANSI/ISO 10993-1: 2003 (Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, and the FDA Modified ISO 10993 Test Profile)
- NF S 94-370 (French Standard, Surgical Implants, implantable catheter chambers)
Basis for Equivalence: The submission argues that the technological characteristics of the new polymeric port are "similar to" those of the predicate titanium port in terms of intended use, indications for use, application, user population, basic design, performance, and labeling. While the material is different (polymeric vs. titanium), the claim is that this change "may affect safety or effectiveness" but does not raise "new types of safety and effectiveness questions" because accepted scientific methods (the listed standards and guidance) exist to assess these effects, and performance data demonstrated equivalence.

Summary

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K06-337

Carpe 1 of 3

PowerPort™ Polymeric Port Traditional 510(k)

Section 5 PowerPort™ Implanted Polymeric Port with 8 Fr ChronoFlex® Catheter 510(k) Summary of Safety and Effectiveness 21 CFR 807.92(a)

JAN 2 5 2007

5.1 General Information

Submitter Name:	Bard Access Systems, Inc. (BAS)[Wholly owned Subsidiary of C.R. Bard, Inc.]
Address:	5425 W. Amelia Earhart DriveSalt Lake City, UT 84116
Telephone Number:	(801) 595-0700 ext. 5541
Fax Number:	(801) 595-5425
Contact Person:	Michaela Rivkowich
Date of Preparation:	November 6, 2006
Registration Number:	1720496
Additional Registration Numbers:C.R. Bard	2212754

5.2 Subject Device Information

Device Name:	PowerPort TM Implanted Polymeric Port with 8 Fr ChronoFlex ® Catheter
Trade Name:	PowerPort TM , ChronoFlex ®
Common/Usual Name:	Implanted Infusion Port and Catheter
Classification Name:	Class II, 80 LJT
Classification Panel:	Subcutaneous, Implanted, Intravascular Infusion Port and CatheterGeneral Hospital

5.3 Predicate Device Information

Device Name:	PowerPort™ Implanted Titanium Port with 8 Fr ChronoFlex® Catheter
Trade Name:	PowerPort™, ChronoFlex®
Common/Usual Name:	Implanted Infusion Port and Catheter
Classification Name:	Class II, 80 LJT
Classification Panel:	Subcutaneous, Implanted, Intravascular Infusion Port and CatheterGeneral Hospital

5.4 Intended Use

The intended use is the same as for the predicate device.

The PowerPort" Polymeric Port is a totally implantable vascular access device designed to provide
long-term. repeated access to the vascular system long-term, repeated access to the vascular system.

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Indications for Use ર્ડ

The indications for use are the same as those for the predicate device.

Device Description ર્સ્ડર્

Technological Comparison to Predicate Device 5.7

The technological characteristics of the PowerPort™ Polymeric Port and 8 Fr ChronoFlex® Catheter are The teoliners of the se of the predicate PowerPort™ Titanium Port and 8 Fr ChronoFlex® Catheter in terms of intended use, indications for use, application, user population, basic design, performance and labeling.

510(k) Substantial Equivalence Decision Tree 5.8

New device is compared to Marketed Device?

Pres. PowerPort™ Polymeric Port device is compared to the predicate PowerPort™ Titanium A Port device.

Does the new device have the same indication statement and the same intended use as the predicate device?

Yes. The intended use and the indications for use are the same as those for the predicate A device.
Does the new device have the same technological characteristics, e.g. design, material, etc?
predicate PowerPort™ Titanium Port; however, the fundamental scientific technology of the device has not changed.

Could the new characteristics affect safety or effectiveness?

Yes. The design changes may affect safety or effectiveness of the device. A

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. Testing was based on FDA guidance documents and recognized standards to evaluate A the device's performance:
- Guidance on 510(k) Submissions for Implanted Infusion Ports, dated October 1990 "
- Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term I Intravascular Catheters, dated 3/16/95

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BS/EN/ISO 10555-1: 1997, Sterile, single-use intravascular catheters, Part 1. General . requirements.
ISO 10555-1: 1995, Sterile, single-use intravascular catheters, Part 1. General ' requirements, Amendment 1: 1999
BS/EN/ISO 10555-3: 1997, Sterile, single-use intravascular catheters, Part 3. Central 트 venous catheters
AAMI/ANSI/ISO 11135: 1994, Medical Devices -- Validation and Routine Control of 1 Ethylene Oxide Sterilization
AAMI/ANSI/ISO 10993-1: 2003, Biological Evaluation of medical Devices Part 1: l Evaluation and Testing, and the FDA Modified ISO 10993 Test Profile
NF S 94-370, French Standard, Surgical Implants, implantable catheter chambers, . intravenous, intraarterial, intraperitoneal, intrathecal and epidural use (April 1999)

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 documents recommendations and additional standards.

Do performance data demonstrate equivalence?

Yes. Performance data gathered in design verification testing demonstrated that the subject A PowerPort" Polymeric Port device is substantially equivalent to the predicate device, the PowerPort™ Titanium Port, K060812, concurrence date July 14, 2006.

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Image /page/3/Picture/1 description: The image shows a logo with a stylized eagle or bird symbol on the right side. To the left of the bird symbol, there is text arranged vertically, which reads 'DEPARTMENT OF HEALTH AND HUMAN SERVICES'. The logo appears to be a representation of a government agency or organization related to health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

C.R. Bard, Incorporated Mr. Michaela Rivkowich Associate Regulatory Affairs Manager Bard Access Systems, Incorporated 5425 West Amelia Earhart Drive Salt Lake City, Utah 84116

JAN 2 5 2007

Re: K063377

Trade/Device Name: PowerPort™ Implanted Polymeric Port Regulation Number: 880.5965 Regulation Name: Subcutaneous Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: November 6, 2006 Received: November 8, 2006

Dear Mr. Rivkowich:

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 offecting 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 - Mr. Rivkowich

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 proctice 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 vours.

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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2/11-1-77-4 PowerPort™ Polymeric Port Traditional 510(k)

Section 4

Indications for Use

510(k) Number (if known): ______________

Device Name: PowerPort™ Implanted Polymeric 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 infusion rate is 5 ml/s.

Prescription Use ਮ (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
NEED OF AND AFFERED AFF AFFEDED) NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anthony D. Avistar

长463377

000016

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.