The PowerPICC® Catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.

The Power PICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media. For blood sampling, infusion or therapy, use a 4 French or larger catheter. The maximum recommended infusion rate is 5ml/sec for power injection of contrast media. The maximum pressure of power injectors used with the Power PICC catheter may not exceed 300 psi.

Device Description

The PowerPICC " Catheters are open-ended radiopaque polyurethane catheters. .
. Catheter size is 5 Fr DI, with 55 cm usable length.
. The catheter has a reverse taper design.
. Catheter shaft tubing is marked with depth indicators, with '0' indicated to serve as a reference for the catheter insertion point.
. Catheters are provided sterile in radiology and nursing PICC configurations.
. Purple colorants were added to the catheter materials to provide the catheter with an appearance that allows the end user to differentiate the PowerPICC from other PICC catheters.
The catheter extension leg, junction and clamp ID tag were printed with markings to identify . the catheter as PowerPICC and to include information to facilitate proper use of the device.

AI/ML Overview

The provided text describes a 510(k) submission for the 5 Fr DL PowerPICC® Catheter, comparing it to a predicate device, the 6 Fr DL PowerPICC® Catheter. This is a medical device submission, primarily focused on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a clinical study or specific acceptance criteria with performance data in the typical sense of an AI/software as a medical device (SaMD) study.

Therefore, many of the requested points, especially those related to AI/SaMD specific studies (like MRMC studies, standalone algorithm performance, training set details), are not applicable to this 510(k) submission for a physical medical catheter.

However, I can extract information related to the performance data and the conclusion of substantial equivalence.

Here's a breakdown of the relevant information:

Acceptance Criteria and Device Performance

The document states that the new device (5 Fr DL PowerPICC® Catheter) underwent "Verification and validation testing...according to protocols based on the above referenced guidance document recommendations and standards, as well as in accordance with in-house protocols." It then concludes, "Performance data gathered in design verification testing demonstrated that the 5 Fr DL PowerPICC® catheter is substantially equivalent to the predicate 6 Fr DL PowerPICC catheter, and the risks associated with use of the new device were found acceptable when evaluated by FMEA."

And, "The 5 Fr DL PowerPICC® catheter meets all the predetermined performance acceptance criteria of the testing performed..."

Since this is a 510(k) for a physical medical device, the "acceptance criteria" are related to mechanical, material, and biocompatibility performance as outlined in the cited standards and guidance documents. The document does not list specific quantitative acceptance criteria values in a table, nor does it provide a table of reported device performance values. Instead, it provides a qualitative statement of meeting these criteria and substantial equivalence.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Predetermined Acceptance Criteria (Implicit from Standards/Guidance)	Reported Device Performance
Mechanical Performance	Meet requirements of ISO 10555-1:1997, ISO 10555-3:1997 and internal protocols for catheter integrity, flow rates, pressure limits, etc.	"Performance data gathered in design verification testing demonstrated that the 5 Fr DL PowerPICC® catheter is substantially equivalent to the predicate 6 Fr DL PowerPICC catheter." "meets all the predetermined performance acceptance criteria of the testing performed"
Material/Design equivalence	Be substantially equivalent to the predicate device (6 Fr DL PowerPICC® Catheter) in design, material, etc., or demonstrate safety/effectiveness of minor differences.	Minor differences identified, but "the basic fundamental scientific technology of the catheter has not changed." "The risks associated with use of the new device were found acceptable when evaluated by FMEA."
Biocompatibility	Meet requirements of ISO 10993 Biological Evaluation of Medical Devices Part-1 and FDA Modified ISO 10993 Test Profile for externally communicating, blood contacting, long-term devices.	"Biocompatibility requirements...were met. All materials used in the manufacture of the subject device were previously cleared for similar applications by Bard Access Systems."
Sterilization	Meet requirements of AAMI/ANSI ISO 11135:1994 Medical Devices -- Validation and Routine Control of Ethylene Oxide Sterilization.	Implied by the statement that the device "meets all the predetermined performance acceptance criteria of the testing performed." (Though not explicitly detailed for sterilization in performance section, it's listed as a standard used).

Study Details:

Sample size used for the test set and the data provenance:
- The document does not specify sample sizes for individual tests (e.g., how many catheters were tested for flow rate, burst pressure, etc.).
- Data provenance is not explicitly mentioned (e.g., country of origin). The testing was done at Bard Access Systems, Inc.
- The testing appears to be retrospective in the sense that it evaluates a manufactured device against established standards, rather than a prospective clinical trial.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in the context of this 510(k) for a physical medical device. "Ground truth" established by experts is typically for diagnostic devices or AI, where a human expert provides the definitive diagnosis or assessment. For a catheter, the "ground truth" is defined by the physical and material specifications and performance against industry standards.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials, especially for evaluating diagnostic accuracy where multiple reviewers assess a case and consensus or a tie-breaker is needed. For product verification, performance is measured objectively against defined physical parameters.
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:
- No. This is not applicable. An MRMC study is relevant for diagnostic devices, particularly those involving human interpretation of images or other data, often with AI assistance. This submission is for a physical intravascular catheter.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is not applicable. This refers to AI algorithm performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this medical device submission is the engineering specifications, material properties, and performance requirements outlined in international standards (ISO, AAMI/ANSI) and FDA guidance documents, along with the demonstrated performance of the predicate device. Compliance is tested against these objective benchmarks.
The sample size for the training set:
- This is not applicable. There is no "training set" in the context of a physical medical device 510(k) submission. This term relates to machine learning models.
How the ground truth for the training set was established:
- This is not applicable, as there is no training set for this type of device submission.

Summary

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

NOV 2 3 2005

Section 6 510(k) Summary

5 Fr DL PowerPICC® Catheter

510(k) Summary of Safety and Effectiveness Information 21CFR 807.92

6.1 Submitter Information

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. 7136
Fax Number:	(801) 595-5425
Contact Person:	Lynn M. Kirchoff
Date of Preparation:	November 18, 2005

6.2 Device Name

Device Name:	5 Fr DL PowerPICC® Catheter
Trade Name:	5 Fr DL PowerPICC® Catheter
Common/Usual Name:	Peripherally Inserted Central Catheter (PICC)
Classification Panel:	General Hospital
Classification Name:	80LJS- Long Term Intravascular Catheter21 CFR 880.5970, Class IIPeripherally Inserted Central Catheter (PICC)

6.3 Predicate Device Name(s)

Device Name:	6 Fr DL PowerPICC ® Catheter
Trade Name:	6 Fr DL PowerPICC® Catheter
Common/Usual Name:	Peripherally Inserted Central Catheter (PICC)
Classification Name:	Long Term Intravascular Catheter (80 LJS)
Premarket Notification:	K050931, concurrence date-June 15, 2005

6.4 Device Description

The PowerPICC " Catheters are open-ended radiopaque polyurethane catheters. .
. Catheter size is 5 Fr DI, with 55 cm usable length.
. The catheter has a reverse taper design.
. Catheter shaft tubing is marked with depth indicators, with '0' indicated to serve as a reference for the catheter insertion point.
. Catheters are provided sterile in radiology and nursing PICC configurations.
. Purple colorants were added to the catheter materials to provide the catheter with an appearance that allows the end user to differentiate the PowerPICC from other PICC catheters.

Image /page/0/Picture/19 description: The image shows the number '000007' with a small '4' superscripted to the left of the first zero. The numbers are printed in a bold, slightly distressed font, giving them a textured appearance. The digits are closely spaced, and the overall impression is that of a numerical code or identifier.

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

The catheter extension leg, junction and clamp ID tag were printed with markings to identify . the catheter as PowerPICC and to include information to facilitate proper use of the device.

Intended Use ર્ણને રાજ્યના સાથે સાથે છે. આ ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામનાં મુખ્યત્વે આવેલું એક ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલ

The PowerPICC® Catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.

The intended use has not changed.

6.6 Indications for Use

The indications for use have not changed from the predicate 6 Fr DL PowerPICC catheter (K050931).

Summary of Technological Characteristics in Relation to the Predicate Device 6.7

Does the new device have the same technological characteristics, e.g. design, material, etc.?

Not in all regards. The 5 Fr DL PowerPICC® catheter has some minor differences from the predicate 6 Fr DL PowerPICC® catheter. However, the basic fundamental scientific technology of the catheter has not changed.

Could the new characteristics affect safety or effectiveness?

Yes. The new characteristics could affect safety or effectiveness of the device.

Do the new characteristics raise new types of safety and effectiveness questions?

No. There are no new types of issues of safety and effectiveness.

Do accepted scientific methods exist for assessing effects of the new characteristics?

Yes. The following FDA guidance documents and international standards were used to evaluate the device's performance:

Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term . Intravascular Catheters, March 16, 1995
. ISO 10555-1:1997. Sterile, Single-Use Intravascular Catheters, General requirements
180 10555-1:1997, Sterile, Single-Use Intravascular Catheters, General requirements, . Amendment I
. ISO 10555-3:1997, Sterile, Single-Use Intravascular Catheters, Central venous catheters
AAMFANSI ISO 11135 1994 Medical Devices -- Falidation and Routine Control of Ethylene ◆ Oxide Steriliation

No new design validation was required. The design validation for the predicate device covered all issues pertaining to the subject device

Image /page/1/Picture/23 description: The image shows a sequence of numbers. The numbers are 000008. The numbers are black and the background is white. The numbers are slightly blurred.

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

Biocompatibility requirements of ISO 10993 Biological Evaluation of Medical Devices Part-1 : Evaluation and Testing and the FDA Modified ISO 10993 Test Profile for externally communicating, blood contacting, long-term devices were met. All materials used in the manufacture of the subject device were previously cleared for similar applications by Bard Access Systems.

Are performance data available to assess effects of new characteristics?

Yes. Verification and validation testing was performed according to protocols based on the above referenced guidance document recommendations and standards, as well as in accordance with inhouse protocols.

Do performance data demonstrate equivalence?

Yes. Performance data gathered in design verification testing demonstrated that the 5 Fr DL PowerPICC® catheter is substantially equivalent to the predicate 6 Fr DL PowerPICC catheter, and the risks associated with use of the new device were found acceptable when evaluated by FMEA.

Conclusion 6.8

The 5 Fr DL PowerPICC® catheter meets all the predetermined performance acceptance criteria of the testing performed and, based on FDA's decision tree, is substantially equivalent to the predicate device the 6 Fr DL PowerPICC catheter, K050931, concurrence date, June 15, 2005.

Image /page/2/Picture/8 description: The image shows the number 6 above the number 000009. The numbers are in a bold, sans-serif font. The number 6 is smaller than the number 000009. The number 000009 is centered below the number 6.

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

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 3 2005

Ms. Lynn M. Kirchoff Regulatory Affairs Specialist Bard Access Systems, Incorporated 5425 West Amelia Earhart Drive Salt Lake City, Utah 84116

Re: K051672

Trade/Device Name: 5 Fr DL PowerPICC® Catheter Regulation Number: 880.5970 Regulation Name: Percutaneous Implanted Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: November 18, 2005 Received: November 21, 2005

Dear Ms. Kirchoff:

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.

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

Page 2 – Ms. Kirchoff

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 modifine and regulations and regulations administered by other Federal agencies. of the Act of any I outsal the Act's requirements, including, but not limited to: registration 1 ou intext compry will and 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CFR in the quality systems (QS) regulation (21 CFR Part 820); and if requirences as betrenic 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) I rins reter notification. The FDA finding of substantial equivalence of your device to a promativer now! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), rr you don't 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 maj overnit 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,

Snute H. Michie 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

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

Section 1.2

Indications for Use Statement

510(k) Number (if known):

Device Name: 5 Fr DL PowerPICC® Catheter

Indications For Use:

The PowerPICC® catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media. For blood sampling, infusion or therapy, use a 4 French or larger catheter. The maximum recommended infusion rate is 5mVsec for power injection of contrast media. The maximum pressure of power injectors used with the PowerPICC catheter may not exceed 300 psi.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ching Veno

Sinn-Off) ാ വി-Off-Off)
എ Anesthesiology, General Hospital, lion Control, Dental Devices

Number: K451672

Image /page/5/Picture/15 description: The image shows the number 000006 in a bold, sans-serif font. The numbers are black against a white background. There is a small superscript to the left of the first zero, but it is difficult to read.

Regulation Number and Section

§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.

(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”