The PowerHohn" and PowerLine™ Catheters are intended for short or long term access to the central venous system for intravenous therapy and blood sampling.

PowerHohn and PowerLine Catheters are indicated for short or long term access to the central venous system. They are designed for administering I.V. fluids, blood products, drugs and parenteral nutrition solutions, as well as blood withdrawal and power injection of contrast media. The maximum recommended infusion rate is 5cc/sec. The maximum pressure of power injectors used with the PowerHohn and PowerLine catheters may not exceed 300 psi.

Device Description

The PowerHohn" and PowerLine™ Catheters are open-ended radiopaque polyurethane catheters.
Catheter size is 6 Fr DL with 50 cm (PowerLine) or 40 cm (PowerHohn) 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 basic radiology configurations.
Purple colorants were added to the catheter materials to provide the cath appearance that allows the end user to differentiate the PowerHohn" and PowerLine other CVC catheters.
The catheter extension leg. junction and clamp ID tag were printed with markings to identify the catheter as PowerHohn" and PowerLine" and to include information to facilitate proper use of the device.

AI/ML Overview

The provided text is a 510(k) summary for a medical device, the 6 Fr DL PowerHohn™ and PowerLine™ Catheter. It is a submission for marketing clearance, not a study report detailing specific performance metrics against acceptance criteria. Therefore, much of the requested information, particularly quantitative data regarding accuracy, sample sizes, and ground truth establishment, is not present.

However, based on the submission, I can infer and extract the following:

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

The document does not provide a specific table of numerical acceptance criteria or detailed performance results in the way one might expect from an AI/ML device study. Instead, it states that the device meets "predetermined performance acceptance criteria" and demonstrates "substantial equivalence" to predicate devices. This implies that the acceptance criteria were qualitative and based on standards and comparison to existing, cleared devices.

Acceptance Criteria Category	Reported Device Performance
Biocompatibility	Met 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. Materials were previously cleared for similar applications.
Equivalence to Predicate	Performance data gathered in design verification testing demonstrated that the 6 Fr DL PowerHohn™ and PowerLine™ catheter is substantially equivalent to the predicate 5 Fr SL PowerHohn™ and PowerLine™ catheter (K050185) and the Poly Per-Q-Cath PICC Catheters (K034019).
Risk Assessment	Risks associated with use of the new device were found acceptable when evaluated by FMEA (Failure Mode and Effects Analysis).
Material/Design Compliance	Conforms to relevant FDA guidance documents and international standards (ISO 10555-1, ISO 10555-3, AAMI/ANSI/ISO 11135).
Intended Use	Intended use has not changed from predicate, aligning with existing safety and effectiveness.
Indications for Use	Indications for use have not changed from predicate, aligning with existing safety and effectiveness.

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

This information is not provided in the document. The submission mentions "design verification testing" and "performance data," but does not detail the sample sizes for these tests, the type of data (e.g., in-vitro, in-vivo animal, human), or its provenance. This is typical for a 510(k) for a physical medical device where the focus is on engineering and biological testing, rather than clinical efficacy studies often seen with AI/ML devices.

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 information is not applicable and therefore not provided in the document. For a medical device like a catheter, "ground truth" as conceptualized for AI/ML performance assessment (e.g., expert consensus on image interpretation) is not relevant. The "ground truth" would be established by objective measurements and standardized testing procedures (e.g., mechanical strength, flow rates, biocompatibility assay results).

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

This information is not applicable and therefore not provided. Adjudication methods like "2+1" are used in AI/ML studies to resolve discrepancies in expert interpretation of data. For a physical device, performance is evaluated against predefined specifications through engineering and biological testing, not subjective 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

This information is not applicable and therefore not provided. MRMC studies are specific to AI/ML devices that assist human interpretation (e.g., radiologists reading images). This device is a physical catheter, not an AI/ML diagnostic tool, and therefore would not involve human readers in this context.

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

This information is not applicable and therefore not provided. This device is a physical catheter, not an algorithm. Standalone performance refers to the performance of an AI algorithm without human intervention.

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

The document implicitly refers to "ground truth" as the results derived from standardized engineering tests and biological evaluations against pre-defined specifications and regulatory requirements. For example:

Biocompatibility: Results from ISO 10993 tests.
Physical properties: Measurements of properties like flow rate, pressure limits, material strength, radiopacity.
Sterility: Results of sterilization validation as per AAMI/ANSI/ISO 11135.

These are objective, measurable outcomes, rather than subjective interpretations by experts.

8. The sample size for the training set

This information is not applicable and therefore not provided. This device is not an AI/ML algorithm that requires a training set.

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

This information is not applicable and therefore not provided. As above, this device does not involve a training set.

Summary

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JUN 3 0 2005

6 Fr DL PowerH Special 510(k)

page 1 of 3

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Section 6

510(k) Summary

6 Fr DL PowerHohn" and PowerLine" 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. 4903
Fax Number:	(801) 595-5425
Contact Person:	Peggy Keiffer
Date of Preparation:	May 26, 2005

6.2 Device Name

Device Name:	6 Fr DL PowerHohn™ and PowerLine™ Catheter
Trade Name:	6 Fr DL PowerHohn™ and PowerLine™ Catheter
Common/Usual Name:	Central Venous Catheter (CVC)
Classification Panel:	General Hospital
Classification Name:	80LJS - Long Term Intravascular Catheter
	21 CFR 880.5970, Class II
	Central Venous Catheter (CVC)

6.3 Predicate Device Name(s)

Device Name:	PowerHohnTM and PowerLineTM Catheter
Trade Name:	PowerHohnTM and PowerLineTM Catheter
Common/Usual Name:	Central Catheter (CVC)
Classification Name:	Long Term Intravascular Catheter (80 LJS)
Premarket Notification:	K050185, concurrence date -May 26, 2005.
Device Name:	Poly Per-Q-Cath PICC Catheter
Trade Name:	Poly Per-Q-Cath PICC Catheter
Common/Usual Name:	Peripherally Inserted Central Catheter (PICC)
Classification Name:	Long Term Intravascular Catheter (80 LJS)
Premarket Notification:	K034019, concurrence date - January 21, 2005

6.4 Device Description

The PowerHohn" and PowerLine™ Catheters are open-ended radiopaque polyurethane � catheters.
Catheter size is 6 Fr DL with 50 cm (PowerLine) or 40 cm (PowerHohn) 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 basic radiology configurations.

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6 Fr DL PowerHo

. Purple colorants were added to the catheter materials to provide the cath appearance that allows the end user to differentiate the PowerHohn" and PowerLine other CVC catheters.
. The catheter extension leg. junction and clamp ID tag were printed with markings to identify the catheter as PowerHohn" and PowerLine" and to include information to facilitate proper use of the device.

6.5 Intended Use

The PowerHohn" and PowerLine™ Catheters are intended for short or long term 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 PowerHohn" and PowerLine"" catheter (K050185).

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 6 Fr DL PowerHohn™ and PowerLine™ catheter has some minor differences from the predicate 5 Fr SL PowerHohn" and PowerLine" 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 effectivencss 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
. ISO 10555-1:1997, Sterile, Single-Use Intravascular Catheters, General requirements, Amendment I
ISO 10555-3:1997, Sterile, Single-Use Intravascular Catheters, Central venous catheters .
AAMI/ANSI/ISO 11135:1994, Medical Devices Validation and Routine Control of Ethylene . Oxide Sterilization

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

6 Fr DL PowerHohn

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 6 Fr DL PowerHohn" and PowerLine" catheter is substantially equivalent to the predicate 5 Fr SL PowerHohn"" and PowerLine"" catheter, and the risks associated with use of the new device were found acceptable when evaluated by FMEA.

6.8 Conclusion

The 6 Fr DL PowerHohn" and PowerLine " 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 5 Fr SL PowerHohn" and PowerLine" catheter, K050185, cleared May 26, 2005. and the Poly Per-Q-Cath PICC Catheters. cleared under K034019.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three wavy lines, which are meant to represent the human form.

Public Health Service

JUN 3 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Peggy Keiffer Senior Regulatory Affairs Manager C.R. Bard, Incorporated 5425 West Amelia Earhart Drive Salt Lake City, Utah 84116

Re: K051417

Trade/Device Name: 6 Fr DL PowerHohn™ and PowerLine™ Catheter Regulation Number: 21 CFR 880.5970 Regulation Name: Long Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: May 31, 2005 Received: June 1, 2005

Dear Ms. Keiffer:

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 - Mr. Keiffer

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,

Sulette y. Michael Oms.

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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6 Fr DL Po and PowerLine

Section 1.2

Special 510(k)

Page 1 of 1

Indications for Use Statement

510(k) Number (if known):

Device Name: 6 Fr DL PowerHohn" and PowerLine™ Catheter

Indications For Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)

Auu Suliom

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, D 510(k) Number

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.”