The intended use of the Silicone Dual Lumen RadPICC Catheter is to provide venous access to infuse intravenous medication, nutritional therapy, or blood therapy.

The Indications for use is: The silicone RadPICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling. For blood therapy, utilize the larger lumen.

Device Description

The RadPICC® catheters are open-ended dual lumen catheters that are made of soft silicone elastomer containing barium sulfate throughout the tubing for enhanced radiopacity. The RadPICC® catheters are 5, 6 Fr dual lumen x 60 cm usable length. The catheter lumens are nonsymmetrical rounded D shape for maximized flow and mechanical properties. The proximal end of the RadPICC catheters consists of two luer lock connectors, glued compression sleeves, clear silicone extension legs for visibility during use and non-removable mini thumb clamps. The extension legs are pre-printed with the lumen gauge size. The extension legs are molded into the bifurcation. StatLock® compatible suture wings are molded into the bifurcation to facilitate easy, secure placement. The bifurcation is embossed with identification text. The proximal end of the catheter tubing has a stepped strain relief that minimizes the potential for kinking at the catheter tubing / strain relief interface. The tubing is pre-molded into the bifurcation with a "0" mark that serves as a reference for the catheter insertion point. The catheter can be inserted up to the "0" mark, which is sized to the exit site, thereby allowing the clinician to "plug" the insertion site. The catheter tubing has depth markings in centimeter increments originating from the proximal end and running the full length of the catheter. A stand-along hydrophilic stylet is provided as a kit components and is loaded by the clinician during the placement procedure. Catheters are provided sterile with kit components preferred by interventional radiologists.

AI/ML Overview

This document describes the 510(k) submission for the Silicone Dual Lumen RadPICC® Catheter, seeking clearance based on substantial equivalence to a predicate device. The information provided focuses on the device's characteristics and performance testing rather than the typical acceptance criteria and study design for software or AI models. Therefore, some of the requested information (like sample size for test sets, number of experts, adjudication methods, MRMC studies, training set details) is not applicable to this physical medical device submission.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes performance tests performed and states that the device "met all the predetermined performance criteria of design verification" and "met the requirements and were similar to the predicate device." Specific numerical acceptance criteria or performance metrics are not explicitly stated as a table with precise target values and achieved values. Instead, it refers to compliance with guidance and standards.

Here's an inferred table based on the listed tests and statements of compliance:

Acceptance Criteria Category	Reported Device Performance
Dimensions	Met requirements and similar to predicate device.
Flow Rate	Met requirements and similar to predicate device.
Tensile Strength	Met requirements (catheter body, extension leg to hub, extension leg to bifurcation, bifurcation to catheter body).
Catheter Stiffness (modulus)	Met requirements and similar to predicate device.
Catheter Elongation	Met requirements and similar to predicate device.
Leakag	Met requirements (at hub, at hub with burst, assembly leak).
Catheter Burst Pressure	Met requirements (assembly, extension leg, extension leg after clamping, catheter shaft tubing).
Catheter Collapse	Met requirements and similar to predicate device.
Catheter Flexural Fatigue	Met requirements and similar to predicate device.
Priming Volume	Met requirements and similar to predicate device.
Radiopacity	Met requirements and similar to predicate device.
Biocompatibility	Meets requirements of ISO-10993 and FDA Modified ISO 10993 Test Profile.
Creep	Performed, results led to substantial equivalence conclusion.
Stylet Withdrawal Force	Performed, results led to substantial equivalence conclusion.
Kink Resulting in Decreased Flow	Performed, results led to substantial equivalence conclusion.
Overall Equivalence	Substantially equivalent to predicate device (Per-Q-Cath PICC, K954104).

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes for each bench test performed. It generally refers to "bench testing" and compliance with "Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters", dated 3/16/95, and corresponding ISO Standards.

Data Provenance: The data are from bench testing (laboratory tests) performed on the device by the manufacturer, Bard Access Systems, Inc. The country of origin of the data is not specified beyond the location of the manufacturing company (Salt Lake City, UT). These are not clinical or "real-world" retrospective/prospective data in the context of human studies, but rather engineering and material property tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and their Qualifications

This information is not applicable as the "ground truth" for physical device performance tests typically refers to well-defined physical properties or engineering standards, not expert consensus on interpretations. The compliance is against established regulatory guidance and ISO standards.

4. Adjudication Method for the Test Set

This information is not applicable as the testing involves objective measurements against predefined engineering specifications and regulatory standards, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of images or other data, often with or without AI assistance, to assess the impact on human reader performance. This submission is for a physical medical device (catheter) and its inherent performance characteristics.

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

This information is not applicable as the device is a physical catheter, not an algorithm or software. Its "standalone performance" refers to its physical and material characteristics as tested in the lab.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is based on:

Established engineering specifications and physical properties (e.g., specific dimensions, flow rates, tensile strengths, burst pressures).
Compliance with guidance documents ("Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters", dated 3/16/95).
Adherence to relevant ISO Standards (e.g., ISO-10993 for biocompatibility).
Comparison to the predicate device characteristics, establishing substantial equivalence.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of an AI or statistical model. The development of the physical device involves design, prototyping, and iterative testing, but not machine learning training.

9. How the Ground Truth for the Training Set was Established

This information is not applicable as there is no "training set."

Summary

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Silicone RadPICC 510(k)

Section 6

FEB 0 7 2003

Silicone Dual Lumen RadPICC Catheter

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

Submitter Information 1 .

Submitter Name:	Bard Access Systems, Inc. (Subsidiary of C.R. Bard, Inc.)
Address:	5425 W. Amelia Earhart Drive Salt Lake City, UT 84116
Telephone Number:	(801) 595-0700, Ext. 4903
Fax Number:	(801) 595-5425
Contact Person:	Peggy Keiffer
Date of Preparation:	December 27, 2002

Device Name 2.

Device Name:	Silicone Dual Lumen RadPICC® Catheter
Trade Name:	RadPICC® Catheter
Common/Usual Name:	Peripherally Inserted Central Catheter (PICC)
Classification Name:	Class II, 80 LJS - Long Term Intravascular Catheter21 CFR 880.5970
Classification Panel:	General Hospital

3 Predicate Device Name:

Device Name:	Per-Q-Cath and Per-Q-Cath Dual Lumen PICC Catheter
Trade Name:	Per-Q-Cath and Per-Q-Cath Dual Lumen Catheter, Trays andaccessory devices
Common/Usual Name:	Peripherally Inserted Central Venous Catheter (PICC)
Classification Name:	Class II, 80 LJS - Long Term Intravascular Catheter
Classification Panel:	General Hospital

6. Device Description

The device description of the subject Silicone Dual Lumen RadPICC Catheter is as follows:

The RadPICC® catheters are open-ended dual lumen catheters that are made of soft silicone elastomer containing barium sulfate throughout the tubing for enhanced radiopacity.
. The RadPICC® catheters are 5, 6 Fr dual lumen x 60 cm usable length. The catheter lumens are nonsymmetrical rounded D shape for maximized flow and mechanical properties.
. The proximal end of the RadPICC catheters consists of two luer lock connectors, glued compression sleeves, clear silicone extension legs for visibility during use and non-removable mini thumb clamps. The extension legs are pre-printed with the lumen gauge size. The extension legs are molded into the bifurcation. StatLock® compatible suture wings are molded into the bifurcation to facilitate easy, secure placement. The bifurcation is embossed with identification text.

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. The proximal end of the catheter tubing has a stepped strain relief that minimizes the potential for kinking at the catheter tubing / strain relief interface. The tubing is pre-molded into the bifurcation with a "0" mark that serves as a reference for the catheter insertion point. The catheter can be inserted up to the "0" mark, which is sized to the exit site, thereby allowing the clinician to "plug" the insertion site.
. The catheter tubing has depth markings in centimeter increments originating from the proximal end and running the full length of the catheter.
. A stand-along hydrophilic stylet is provided as a kit components and is loaded by the clinician during the placement procedure.
Catheters are provided sterile with kit components preferred by interventional radiologists. .

5. Intended Use and Indication for Use

The intended use of the Silicone Dual Lumen RadPICC Catheter is to provide venous access to infuse intravenous medication, nutritional therapy, or blood therapy.

6. Technological Characteristics Summary:

6.1 Does the new device have the same indication statement?

Yes, with minor modification.

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

Not in all regards. The Silicone RadPICC catheters have some minor differences from the predicate Per-Q-Cath PICC catheters. However, the basic fundamental scientific technology of the catheter has not changed.

6.3 Could the new characteristics affect safety or effectiveness?

Yes. The integrity of the minor design changes and materials could affect the safety or effectiveness of the device.

6.4 Do accepted characteristics raise new types of safety and effectiveness questions?

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

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

Yes. The FDA's "Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters", dated 3/16/95, and corresponding ISO Standards were used to evaluate the device's performance.

Biocompatibility meets the 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.

6.6 Are performance data available to assess effects of new characteristics?

Yes. Bench testing was performed according to the above referenced guidance and standards. The results met the requirements and were similar to the predicate device.

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Are performance data available to assess effects of new characteristics? 6.7

Yes. Performance data demonstrate that the silicone dual lumen RadPICC Catheter is substantially equivalent to the predicate Per-Q-Cath PICC Catheter, K954104.

Performance Data (if applicable). 6.8

The following Catheter guidance tests were performed in accordance with "Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters", dated 3/16/95:

Dimensions .
Flow rate ●
Tensile: .
- Tensile strength of catheter body
- . Tensile strength of extension leg to hub attachment (luer connector) Tensile strength of extension leg to bifurcation
Tensile strength of bifurcation to catheter body
. Catheter stiffness (modulus) ●
. Catheter elongation
Leak: ●
- Leakage at hub Leak at hub with burst Catheter assembly leak
. Catheter burst pressure: Assembly Extension leg Extension leg after clamping Catheter shaft tubing
. Catheter collapse
Catheter flexural fatigue tolerance .
Priming volume .
Radiopacity .
Biocompatibility .

The following additional tests were performed:

. Creep
. Stylet withdrawal force
Kink resulting in decreased flow .

The following catheter guidance tests were NOT required for this product change:

Catheter tip (distal) attachment strength (there is no tip attachment) .

Conclusion 6.9

The Silicone RadPICC catheters met all the predetermined performance criteria of design verification. Based on FDA's decision tree, the silicone RadPICC catheters are substantially equivalent to the predicate device, the Per-Q-Cath PICC catheters, K954104, concurrence date November 21, 1995.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of a human figure with its head tilted back, with three lines representing the body. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 0 7 2003

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

Re: K030255

Trade/Device Name: Silicone Dual Lumen RadPICC® Catheter Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous Implanted, Long-term IntravascularCatheter Regulatory Class: II Product Code: LJS Dated: January 23, 2003 Received: January 24, 2003

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 - Ms. 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 (OS) 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 (301) 594-4618. 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/dsma/dsmamain.html

Sincerely vours.

Susan Gunser

Susan Runner, DDS, MA Interim 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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Section 1.2

Silicone Dual Lumen RadPICC® Catheter 510(k)

INDICATION(S) FOR USE STATEMENT*

I state in my capacity as Senior Regulatory Affairs Manager of Bard Access Systems, that this notification [510(k)] for the following devices, Silicone Dual Lumen RadPICC Catheters, are indicated for the following:

The RadPICCs are indicated for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling. For blood therapy, utilize the larger lumen.

Signature of 510(k) Submitter:

Quggy Arff

Printed Name of Submitter: Peggy Keiffer

Date:

1.03

*Suggested language and format to meet the requirements of sections 513(i) of the Federal Food, Drug, and Cosmetic Act, as amended, and sections 807.92(a)(5) and 801.4 of the Code of Federal Regulations, Title 21.

Concurrence of Office of Device Evaluation

510(k) Number

K030255

Division Sign-Off Office of Device Evaluation

Prescription Use

Over-The-Counter Use

Patricio Cucent

510(k) Number: KD30253

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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.”