The 5 Fr Dual Lumen Groshong® NXT PICC Catheter is designed for use in short term or long term intravenous therapy and any other therapies requiring long term central venous access (e.g. blood sampling). It is used for administration of hyperalimentation, chemotherapy and other I.V. fluids. The dual lumen feature permits simultaneous infusion of incompatible solutions and/or aspiration of blood samples. Refer to the appropriate drug labeling for indications, contraindications, warnings, precautions, dosage and administration information.

The Groshong® NXT PICC provides short (less than 30 days) or long (greater than 30 days) term peripheral access to the central venous system for intravenous therapy or blood sampling.

Device Description

The 5 Fr Dual Lumen silicone Groshong® NXT PICC Catheters feature a reverse-taper catheter design. They are 45 or 55 cm in length. The catheters have two equal-sized lumens and a closed, rounded, atraumatic, radiopaque, distal tip with the 3-position, pressure-sensitive Groshong® valve in each lumen. Valves are staggered for simultaneous infusion of incompatible solutions and/or aspiration of blood samples.

The proximal end of the catheter has a bifurcation with integral Statlock compatible suture wings. There are red and white plastic luer lock connectors on the extension legs. Extension legs are insert molded into the proximal end of the bifurcation. Catheters are provided sterile with a preloaded hydrophilic stiffening stylet.

AI/ML Overview

The provided text describes the 510(k) submission for the 5 Fr Dual Lumen Groshong® NXT PICC Catheter, focusing on its substantial equivalence to a predicate device. It contains the general information requested by the FDA for such submissions, including nonclinical performance testing. However, it does NOT include a "study that proves the device meets the acceptance criteria" in the sense of a clinical trial or a detailed statistical analysis against specific acceptance criteria. The document states that "performance data gathered in design verification testing demonstrated that the Groshong® NXT PICC is substantially equivalent to the predicate 5 Fr DL Groshong® PICC (design)."

Therefore, I cannot provide a table of acceptance criteria and reported device performance from a clinical study, nor specific sample sizes, ground truth information, or details about expert involvement in a clinical evaluation. The information provided is primarily related to nonclinical engineering and material testing for regulatory submission.

Below is a summary of the information that can be extracted from the provided text, primarily focusing on the nonclinical performance testing and the regulatory process, as well as indicating what information is not available in the provided text for a clinical "study."

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria with corresponding performance results in a table format for a clinical study. Instead, it lists the types of nonclinical performance testing conducted to demonstrate substantial equivalence to the predicate device. The conclusion states that "Performance data demonstrate equivalence," implying that the results of these tests met the necessary standards for regulatory approval.

Acceptance Criteria Category (Nonclinical)	Reported Device Performance Summary (Nonclinical)
Dimensions	Demonstrated equivalence to predicate device.
Priming Volume	Demonstrated equivalence to predicate device.
Flow Rate	Demonstrated equivalence to predicate device.
Tensile, Elongation, Stiffness	Demonstrated equivalence to predicate device.
Leak (at Hub)	Demonstrated equivalence to predicate device.
Catheter Burst	Demonstrated equivalence to predicate device.
Catheter Collapse	Demonstrated equivalence to predicate device.
Catheter Flexural Fatigue Tolerance	Demonstrated equivalence to predicate device.
Creep (Static)	Demonstrated equivalence to predicate device.
Radiopacity	Demonstrated equivalence to predicate device.
Valve Function	Demonstrated equivalence to predicate device.
Stylet Drag	Demonstrated equivalence to predicate device.
Biocompatibility	In compliance with ISO-10993 and FDA-Modified ISO 10993 Test Profile (no new materials used).

2. Sample size used for the test set and the data provenance

Test Set Sample Size: Not specified for any clinical or nonclinical study. The nonclinical performance testing was conducted according to protocols based on FDA guidance and additional standards, but the number of units tested is not detailed.
Data Provenance: The data is from "design verification testing" conducted by Bard Access Systems, Inc. (BAS) for regulatory submission to the FDA. No information on country of origin of data or retrospective/prospective nature is given, as it pertains to engineering performance testing rather than patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable and not provided. The testing described is nonclinical performance testing of a medical device's physical and functional characteristics, not an evaluation against a clinical ground truth established by experts.

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

This information is not applicable and not provided. This relates to clinical evaluation and expert consensus, which is not described in the document.

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

No MRMC or comparative effectiveness study involving human readers or AI assistance was performed or described. This document pertains to the regulatory clearance of a physical medical device (PICC catheter), not an AI-powered diagnostic tool.

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

No standalone algorithm performance or human-in-the-loop performance studies were conducted or described. This document pertains to the regulatory clearance of a physical medical device (PICC catheter).

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

For the nonclinical performance testing, the "ground truth" was established by engineering specifications, accepted scientific methods, and compliance with FDA Guidance on Premarket Notification for Intravascular Catheters (dated 3/16/95), as well as ISO-10993 for biocompatibility. There is no clinical ground truth (expert consensus, pathology, outcomes data) mentioned in the provided text.

8. The sample size for the training set

Not applicable and not provided. This device is not an AI algorithm; therefore, there is no "training set."

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

Not applicable and not provided. This device is not an AI algorithm; therefore, there is no "training set" or corresponding ground truth establishment process.

Summary

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6.2

5 Fr DL Groshong® NXT 510(k)

Section 6

510(k) Summary of Safety and Effectiveness Information

5 Fr Dual Lumen Groshong®NXT PICC Catheter

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. 5439
Fax Number:	(801) 595-4903
Contact Person:	Peggy Keiffer
Date of Preparation:	September 26, 2002
Device Name

Device Name:	5 Fr Dual Lumen Groshong®NXT PICC Catheter
Trade Name:	5 Fr Dual Lumen Groshong®NXT PICC Catheter
Common/Usual Name:	Peripherally Inserted Central Catheter (PICC)
Classification Name:	Class II, 80 LJS - Long Term Intravascular Catheter
Classification Panel:	General Hospital

6.3 Predicate Device(s):

Device Name:

Trade Name:
Common/Usual Name:
Classification Name:
Classification Panel:
Premarket Notification:

5 Fr Dual Lumen Groshong® PICC Catheter 3.0 Fr Groshong® PICC Procedure Tray Groshong®PICC Catheter Peripherally Inserted Central Catheter (PICC) Class II, 80 LJS - Long Term Intravascular Catheter General Hospital K904558, concurrence date February 11, 1991 K926331, concurrence date March 11, 1994

6.4 Device Description

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10/3/02

6.5 Intended Use

This is the same basic intended use as previously cleared for the 5 Fr Groshong® PICC Catheter, K904558, and the 3.0 Fr Groshong® PICC Procedure Tray.

ર્ રીક Technological Characteristics Summary

New device is compared to Marketed Device

Yes.

Does the new device have the same indication statement?

Yes. However, there are minor modifications to the indication verbiage.

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

Not in all regards. The basic fundamental scientific technology of the catheter has not changed. However, the Groshong® NXT PICC has some mlnor differences from the predicate 5 Fr DL Groshong® PICC.

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 safety and effectiveness questions.

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

Yes. Design performance is in compliance with the FDA's Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, dated 3/16/ 95.

Biocompatibility of materials are in compliance with 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.

Are performance data available to assess effects of new characteristics?

Yes. Verification testing was performed according to protocols based on the above-referenced guidance document recommendations and additional standards.

ર૦

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Do performance data demonstrate equivalence?

Yes. Performance data gathered in design verification testing demonstrated that the Groshong® NXT PICC is substantially equivalent to the predicate 5 Fr DL Groshong® PICC (design).

6.6 Nonclinical Performance Testing

Testing was performed using the Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, dated 3/16/95 included assessments of:

Dimensions Priming Volume Flow Rate Tensile, Elongation and Stiffness (Modulus) of Catheter Shaft Tensile, Elongation and Stiffness (Modulus) of Extension Leg Tubing Tensile: Extension Leg to Connector Tensile Extension Leg to Bifurcation Tensile Catheter Shaft to Bifurcation Tensile Catheter Tip Tensile Assembly Leak (Leak at Hub) Catheter Burst: Assembly Extension Leg tubing Catheter Collapse Catheter Flexural Fatigue Tolerance (Cyclic Flexure)

Additional non-guidance testing performed: Creep (Static) Radiopacity Valve Function Stylet Drag

Guidance testing not performed: Biocompatibility. No new materials were used

6.8 Conclusion

The 5 Fr DL Groshong® NXT PICC is substantially equivalent in design and intended use to the predicate device 5 Fr DL Groshong® PICC, K904558, cleared February 11, 1991 and has the same indication for use as the 3.0 Fr Groshong® PICC Procedure Tray, K926331, cleared March 11, 1994.

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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 an abstract symbol that resembles a stylized human figure with three heads or profiles facing to the right, with flowing lines beneath them.

Public Health Service

Food and Drug Administrat 9200 Corporate Boulevard Rockville MD 20850

EC 1 8 200

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

Re: K023374

Trade/Device Name: 5 Fr Dual Lumen Groshong® NXT PICC Catheter Regulation Number: 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: October 3, 2002 Received: October 8, 2002

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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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 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 (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours,

Susan Romoe

Fimothy A. Ulatowski 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-B

5 Fr Dual Lumen Groshong® NXT PICC 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, 5 Fr Dual Lumen Groshiong® NXT PICC Catheter, are indicated for the following:

The Groshong® NXT PICC provides short (less than 30 days) or long (greater than 30 days) term peripheral access to the central venous system for intravenous therapy or blood sampling.

Buzzy Krife

Peggy Keiffer

Typed Name:

Senior Regulatory Affairs Manager

Date:

10.4.02

*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

40.233.4

510(k) Number: Jr

Division Sign-Off Office of Device Evaluation

Paltico Cuente

ivision Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

0000006

10/3/02

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.”