The Poly Per-Q-Cath PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling. For blood therapy, it is recommended that a 4 French or larger catheter be used. The Poly RadPICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling. For blood therapy, it is recommended that a 4 French or larger catheter be used.

Device Description

The Poly Per-Q-Cath PICC Catheters are open-ended radiopaque polyurethane catheters. Catheter sizes are 3, 4, 5 Fr SL and 4, 5, 6 Fr DL. All are 60 cm usable length. The catheter has a reverse taper design. The catheter extension legs provide for improved durability and resistance to alcohol and have a thumb clamp. Catheter 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, intermediate and RadPICC configurations.

AI/ML Overview

The provided text is a 510(k) summary for the Poly Per-Q-Cath PICC catheters, detailing modifications to a predicate device. This document focuses on demonstrating substantial equivalence to a previously cleared device (K012902) rather than presenting a de novo clinical study with specific acceptance criteria and detailed device performance metrics in the way a new device might.

Therefore, many of the requested elements for a study proving device performance against acceptance criteria are not explicitly present in the provided text. The document refers to "predetermined acceptance criteria" and "performance data demonstrating equivalence" but does not detail these criteria or the test results themselves.

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

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

The provided 510(k) summary does not contain a table of acceptance criteria and reported device performance. It states generally:

"The modified devices met the acceptance criteria for the tests performed."
"The modified Poly Per-Q-Cath PICCs met predetermined performance acceptance criteria of testing performed and are substantially equivalent to the predicate Poly Per-Q-Cath PICC catheters."

The specific performance data and the exact acceptance criteria are not presented in this summary document. The focus is on the equivalence of the modified device to the predicate for "design, material, etc." where "the durometer of the extension leg material was changed for improved durability and resistance to alcohol." The performance data would pertain to these changes, but details are not included.

2. Sample sized 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 510(k) summary. The document mentions "Verification and validation testing was performed according to protocols," but does not specify the sample sizes, data provenance (e.g., country of origin), or whether it was retrospective or prospective. Given the nature of a 510(k) for modifications to an existing device, the testing would likely be bench testing rather than clinical studies on human subjects.

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 not provided. The device is an intravascular catheter, and the evidence presented in this 510(k) summary is based on engineering and biocompatibility testing (bench testing), not on expert-adjudicated clinical data requiring ground truth establishment by medical professionals.

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

This information is not applicable and not provided. Adjudication methods are typically used in clinical studies where expert consensus is needed to establish ground truth for diagnostic or prognostic endpoints. The testing performed for this device was verification and validation testing against engineering standards.

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 not provided. An MRMC study is relevant for AI-powered diagnostic devices involving human readers. This device is a medical catheter and does not involve AI or human readers for diagnostic interpretation.

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

This information is not applicable and not provided. As mentioned above, this device is a medical catheter, not an algorithm, so standalone algorithm performance is irrelevant.

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

The "ground truth" in this context refers to the established standards and guidance documents for medical device testing. The document states:

"Design validation was performed to meet the recommendations of the FDA guidance document, Design Control Guidance for Medical Device Manufacturers, dated March 11, 1997."
"The FDA's Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, dated 3/16/95, and relevant ISO 10555 Standards were used to determine the appropriate methods for evaluating the modified device's performance."
"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."

So, the "ground truth" for demonstrating performance was compliance with these established regulatory and international standards for medical device testing and biocompatibility.

8. The sample size for the training set

This information is not applicable and not provided. The device is a physical medical catheter, not a software algorithm that requires a training set. The testing performed would be lab-based verification and validation.

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

This information is not applicable and not provided. As explained above, there is no "training set" for this type of medical device's assessment.

Summary

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

K03//29

Poly Per-Q-Cath PICC 510(k)

Modifications

Section 6

510(k) Summary Poly Per-Q-Cath PICC Catheters

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

1.	Submitter Information:
	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:	April 4, 2003
2.	Device Name:
	Device Name:	Poly Per-Q-Cath PICC (Peripherally Inserted Central VenousCatheter)
	Trade Name:	Poly Per-Q-Cath PICC Catheter
		Poly RadPICC
	Common/Usual Name:	Poly Per-Q-Cath PICC
	Classification Name:	Long Term Intravascular Catheter (80LJS)
3.	Predicate Device:
	Device Name:	Poly Per-Q-Cath PICC (Peripherally Inserted Central Venous
		Catheter)
	Trade Name:	Poly Per-Q-Cath PICC Catheter
	Common/Usual Name:	Poly Per-Q-Cath PICC
	Classification Name:	Long Term Intravascular Catheter (80LJS)
	Premarket Notification:	K012902, cleared for marketing on September 10, 2001
4.	Device Description

The Poly Per-Q-Cath PICC Catheters are open-ended radiopaque polyurethane catheters .
. Catheter sizes are 3, 4, 5 Fr SL and 4, 5, 6 Fr DL. All are 60 cm usable length
The catheter has a reverse taper design.
. The catheter extension legs provide for improved durability and resistance to alcohol and have a thumb clamp.
. Catheter 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, intermediate and RadPICC configurations ..
ડ. Intended Use

The modified Poly Per-Q-Cath PICC catheters are intended for short- or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.

Summary of Technological Characteristics in relation to Predicate Device: 6.

Does the new device have the same indication statement?

Yes.

Image /page/0/Picture/17 description: The image shows the number 000042. The number is written in a bold, sans-serif font. The number 42 is written in a smaller font size than the other numbers. The image is black and white.

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

KC3il29

Poly Per-O-Cath PICC 510(k) Modifications

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

Yes, except the durometer of the extension leg material was changed for improved durability and resistance to alcohol

Could the new characteristics affect safety or effectiveness?

Yes. The durometer of the extension leg material could affect safety and effectiveness of the device.

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

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

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

Yes. Design validation was performed to meet the recommendations of the FDA guidance document, Design Control Guidance for Medical Device Manufacturers, dated March 11, 1997.

The FDA's Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, dated 3/16/95, and relevant ISO 10555 Standards were used to determine the appropriate methods for evaluating the modified device's performance.

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.

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 in-house protocols. The modified devices met the acceptance criteria for the tests performed.

Do performance data demonstrate equivalence?

Yes. Performance data demonstrated that the modified Poly Per-Q-Cath PICCs are substantially equivalent to the predicate devices and/ or met pre-determined acceptance criteria, and the risks associated with use of the new device were found acceptable when evaluated by FMEA.

7. Conclusion

The modified Poly Per-Q-Cath PICCs met predetermined performance acceptance criteria of testing performed and are substantially equivalent to the predicate Poly Per-Q-Cath PICC catheters, cleared under K012902.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circle.

MAY - 5 2903

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: K031129

Trade/Device Name: Poly Per-Q-Cath PICC Regulation Number: 21 CFR 880.5970 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJS Dated: April 4, 2003 Received: April 9, 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.

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

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 (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,

Susan Rhodes

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

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

Section 1.2

INDICATION(S) FOR USE STATEMENT*

The Poly RadPICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling. For blood therapy, it is recommended that a 4 French or larger catheter be used.

Signature of 510(k) Submitter:

Printed Name of Submitter:

Buzzy Kriff

Peggy Keiffer Sr. Regulatory Affairs Manager

Date:

*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

K031129

Division Sign-Off Office of Device Evaluation

Prescription Use

OR Over-The-Counter Use

Patricio Cussiante

siology. General Hospital,

00000

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.”