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

Device Description

The 4 Fr single lumen silicone Groshong® NXT PICC catheter is a 60 cm, trimmable catheter with depth markings. It has a closed, rounded, atraumatic, radiopaque distal tip with the 3-position, pressure-sensitive Groshong® valve.

It has a 2-piece connection with extension leg and lucr lock connector that is designed to be attached by the clinician after trimming the catheter tube to length. The connector has suture wings that are StatLockcompatible for stability.

AI/ML Overview

The provided document describes the 510(k) summary for the 4 Fr Single Lumen Groshong® NXT PICC Catheter, which is a medical device. This type of device is subject to performance testing against established criteria to demonstrate substantial equivalence to a predicate device, rather than a clinical study measuring diagnostic performance of an AI algorithm.

Therefore, many of the requested categories in your prompt (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance of an algorithm, and training set information) are not applicable to this type of device submission.

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "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" a list of 12 tests, with an additional 9 non-guidance tests. The report indicates 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."

While the document lists the types of tests performed, it does not explicitly state specific quantitative acceptance criteria or the numerical results for each test. Instead, it concludes that the device "demonstrate[s] equivalence" and is "substantially equivalent" to the predicate device.

Test Category	Acceptance Criteria (Implicit)	Reported Device Performance
Guidance-based Tests	Demonstrated substantial equivalence to predicate device based on FDA guidance.	Achieved Substantial Equivalence: Performance data demonstrated that the Groshong® NXT PICC is substantially equivalent to the predicate 5 Fr DL Groshong® PICC (K023374). Specific numerical results are not provided in this summary.
1. Dimensions
2. Priming Volume
3. Flow Rate
4. Tensile, Elongation and Stiffness (Modulus) of Catheter Shaft
5. Tensile Extension Leg to Proximal (2-piece) Connector
6. Tensile Proximal connector to Distal Connector (2-picce)
7. Tensile Catheter Shaft to Distal (2-piece) Connector
8. Catheter Tip Tensile
9. Assembly Leak (Leak at Hub)
10. Catheter Assembly Burst
11. Catheter Collapse
12. Catheter Flexural Fatigue Tolerance (Cyclic Flexure)
Additional Non-Guidance Tests	Demonstrated substantial equivalence to predicate device.	Achieved Substantial Equivalence: Performance data demonstrated that the Groshong® NXT PICC is substantially equivalent to the predicate 5 Fr DL Groshong® PICC (K023374). Specific numerical results are not provided in this summary.
13. Creep (Static)
14. Radiopacity
15. Valve Function
16. Kink Resistance
17. Stylet Drag
18. Flush-through Wire/fuer lock connector tensile
19. Flush-through Sytlet Luer Taper
20. Flush-through Stylet Air Leakage
21. Flush-through Stylet Ease of Assembly

Regarding the other points in your request:

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: This is a physical medical device. The "test set" refers to physical samples of the catheter that underwent various engineering and mechanical tests (e.g., tensile strength, flow rate). The sample sizes for these specific engineering tests are not provided in this 510(k) summary, nor is data provenance in terms of country of origin or retrospective/prospective.

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" in the context of diagnostic algorithms and expert consensus is not relevant here. The "ground truth" for a physical device is established by validated engineering standards and test methods. Scientific methods exist for assessing the effects of new characteristics.

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

Not Applicable: Adjudication methods are for human interpretation differences, typically in diagnostic studies. This is a physical device testing scenario applying established engineering principles.

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: An MRMC study is for evaluating diagnostic performance, often with AI. This document is for a physical medical device (catheter) and its inherent performance, not its use to assist human readers in diagnosis.

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

Not Applicable: This is not an AI algorithm; it is a physical medical device.

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

Not Applicable / Inherent: The "ground truth" for the device's performance is based on established engineering and material science principles, against which the physical properties of the catheter (e.g., burst pressure, flow rate, tensile strength) are measured and compared to predefined specifications or performance of a predicate device. The document explicitly states, "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."

8. The sample size for the training set

Not Applicable: There is no "training set" as this is not an AI/machine learning device. The device is manufactured according to specifications, and samples from production are tested for quality control and performance verification.

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

Not Applicable: No training set or associated ground truth in this context.

Summary

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

K034020

JAN 2 1 2004

4 Fr SL Groshong® NXT PICC 510(k)

Section 6 510(k) Summary of Safety and Effectiveness Information

4 Fr Single 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 Drive Salt Lake City, UT 84116 Telephone Number: (801) 595-0700, Ext. 5439 Fax Number: (801) 595-4903 Contact Person: Peggy Keiffer Date of Preparation: 12/22/03

6.2 Device Name

Device Name:	4 Fr Single Lumen Groshong®NXT PICC Catheter
Trade Name:	4 Fr Single 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® NXT PICC Catheter Groshong®NXT PICC Catheter Peripherally Inserted Central Catheter (PICC) Class II, 80 LJS - Long Term Intravascular Catheter General Hospital K023374

6.4 Device Description

000034

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

(4.5 Intended Use

The 4 Fr Single Lumcn 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, warnings, precautions, dosage and administration information.

This is the same intended use as previously cleared for the 5 Fr DL Groshong® NXT PICC Catheter, K023374.

6.5 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. I Iowever, the 4 Fr SL Groshong® NXT PICC has some minor differences from the predicate 5 Fr DL Groshong® NXT 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.

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.

Do performance data demonstrate equivalence?

00035

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

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.

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:

1. Dimensions
1. Priming Volume
Flow Rate 3)
Tensile, Elongation and Stiffness (Modulus) of Catheter Shaft 4)
Tensile Extension Leg to Proximal (2-piece) Connector 5)
Tensile Proximal connector to Distal Connector (2-picce) 6)
1. Tensile Catheter Shaft to Distal (2-piece) Connector
1. Catheter Tip Tensile
1. Assembly Leak (Leak at Hub)
1. Catheter Assembly Burst
1. Catheter Collapse
1. Catheter Flexural Fatigue Tolerance (Cyclic Flexure)

Additional non-guidance testing performed:

1. Creep (Static)
1. Radiopacity
1. Valve Function
1. Kink Resistance
1. Stylet Drag
1. Flush-through Wire/fuer lock connector tensile
1. Flush-through Sytlet Luer Taper
1. Flush-through Stylet Air Leakage
1. Flush-through Stylet Ease of Assembly

6.8 Conclusion

The 4 Fr SL Groshong® NXT PICC is substantially to the predicate device 5 Fr DL Groshong® NXT PICC, K023374, cleared December 18, 2002.

000036

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

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, composed of three curved lines that suggest the head, body, and tail feathers. The logo is rendered in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 1 2004

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

Re: K034020

Trade/Device Name: 4 Fr Single Lumen Groshong® NXT PICC Catheter Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted Long-tem Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: December 22, 2003 Received: December 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.

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

Page 2 - Ms. Keiffer

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has madc 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 (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 yours,

Cave

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

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

Section 1.2

4 Fr Single 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, 4 Fr Single Lumen Groshong® NXT PICC Catheter, is indicated for the following:

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

Buzzy Kriffo

Typed Name:

Peggy Keiffer Senior Regulatory Affairs Manager

Date:

12.27.03

*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

iRo3402D

Prescription Use

Over-The-Counter Use

Viola Hubbard, catering service Chief

eneral Hospital, nesthesic

510(k) Number: K034020

COOOOOO

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.”