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.

Device Description

The Poly Per-Q-Cath PICC Single and Dual Lumen Catheters are open-ended catheters extruded from polyurethane loaded with barium sulfate for radiopacity. All are 63 cm in length. The proximal ends of the catheter tubing are expanded to serve as strain reliefs for their connection to junctions with integral suture wings. Integral extension legs are attached to the proximal ends of all SL and DL junctions of PQC catheters. The extension legs serve as a conduit for fluids into and out of the catheters, and can be occluded with provided thumb clamps. Catheter tubing is marked with depth indicators, with "0" indicated to serve as a reference for catheter insertion point. Catheters are provided sterile with inserted hydrophilic stylets. They are packaged individually, or sold in procedural kits containing accessories that are provided to aid in their placement.

AI/ML Overview

This document describes a 510(k) summary for the Poly Per-Q-Cath PICC Catheter. The submission focuses on modifications to an existing device, specifically changes to the strain relief design and increased barium sulfate content for enhanced radiopacity. As such, the emphasis is on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with acceptance criteria for a novel AI/ML device.

Therefore, many of the requested sections regarding acceptance criteria, study details for AI/ML performance, and ground truth establishment are not applicable based on the provided document. The document describes traditional medical device validation through engineering and biocompatibility testing.

Here's an analysis of the relevant information from the provided text:

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

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

However, the specific acceptance criteria and detailed reported device performance values for each test are not provided in this 510(k) summary. It only indicates that they were met. The new characteristics were evaluated through:

Design Validation: Performed to meet recommendations of the FDA guidance document, "Design Control Guidance for Medical Device Manufacturers," dated March 11, 1997.
Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters (3/16/95): Used to determine appropriate methods for evaluating the modified device's performance.
Relevant ISO 10555 Standards: Used for evaluating the modified device's performance.
Biocompatibility requirements of ISO-10993, Biological Evaluation of Medical Devices Part-1: Evaluation and Testing: Met for externally communicating, blood-contacting, long-term devices.
FDA-Modified ISO 10993 Test Profile: Met.

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 510(k) summary. The document describes "Design validation," "Verification and validation testing," and "performance data," but no details on sample sizes or data provenance are included.

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 is not applicable as the document describes validation of a physical medical device (catheter) through engineering and biocompatibility testing, not an AI/ML diagnostic device requiring expert interpretation for ground truth.

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

This is not applicable as the document describes validation of a physical medical device, not an AI/ML diagnostic device requiring expert adjudication.

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 is not applicable. The document describes validation of a physical medical device, not an AI/ML-assisted diagnostic tool.

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

This is not applicable as the document describes validation of a physical medical device, not an AI/ML algorithm.

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

The "ground truth" for this medical device would be defined by engineering specifications, material properties, and established biological safety standards (e.g., ISO standards for catheters and biocompatibility). The testing aimed to confirm the device met these objective performance and safety criteria.

8. The sample size for the training set

This is not applicable as this is not an AI/ML device submission.

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

This is not applicable as this is not an AI/ML device submission.

Summary

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(0)2902

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. 4923
Fax Number:	(801) 595 5425
Contact Person:	Stephanie Erskine
Date of Preparation:	August 24, 2001
2. Device Name:

Device Name:

28 Aug., 2001

Trade Name: Common/Usual Name: Classification Name:

Catheter) Poly Per-Q-Cath PICC Catheter Poly Per-Q-Cath PICC Long Term Intravascular Catheter (80LJS)

Poly Per-Q-Cath PICC (Peripherally Inserted Central Venous

Poly Per-O-Cath PICC (Peripherally Inserted Central Venous

Predicate Device: 3. Device Name:

Trade Name:

Catheter) Poly Per-Q-Cath PICC Catheter Poly Per-Q-Cath PICC Common/Usual Name: Long Term Intravascular Catheter (80LJS) Classification Name: Premarket Notification: K001901, cleared for marketing on September 19, 2000

4. Device Description

The Poly Per-Q-Cath PICC Single and Dual Lumen Catheters are open-ended catheters ● extruded from polyurethane loaded with barium sulfate for radiopacity. All are 63 cm in length
The proximal ends of the catheter tubing are expanded to serve as strain reliefs for their . connection to junctions with integral suture wings
Integral extension legs are attached to the proximal ends of all SL and DL junctions of PQC . catheters. The extension legs serve as a conduit for fluids into and out of the catheters, and can be occluded with provided thumb clamps
Catheter tubing is marked with depth indicators, with "0" indicated to serve as a reference for . catheter insertion point
Catheters are provided sterile with inserted hydrophilic stylets. They are packaged . individually, or sold in procedural kits containing accessories that are provided to aid in their placement

5. 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.

This is the identical intended use for the predicate Poly Per-Q-Cath PICCs. Please note that references to Midlines are not included in this Premarket Notification. Therefore, the Intended Use does not reference Midlines.

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

6.1 Does the new device have the same indication statement?

Yes. The reference to Midlines was removed as Midlines are not included in this Special 510(k) Premarket Notification.

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

The basic fundamental scientific technology of the catheters has not changed. The strain relief The basic inindinental occinance resistance to kinking; barium sulfate content has been increased to enhance visualization by radiographic imaging techniques.

Could the new characteristics affect safety or effectiveness? 6.3

Yes. The modified strain relief design and the increased barium sulfate content of the catheter could affect safety and effectiveness of the device.

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

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. 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. No materials are used in the manufacture of the modified device that have not already been cleared for similar applications by Bard Access Systems.

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

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? 6.7

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.

7.0 Conclusion

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

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

Public Health Service

92
Ro

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Stephanie A. Erskine Director of Regulatory Affairs C.R. Bard, Incorporated 5425 West Amelia Earhart Drive Salt Lake City, Utah 84116

Re: K012902

Trade/Device Name: Poly Per-Q-Cath Single Lumen PICC Catheter Regulation Number: 880.5970 Regulation Name: Peripherally Inserted Central Catheter Regulatory Class: II Product Code: LJS Dated: August 28, 2001 Received: August 29, 2001

SEP 1 0 2001

Dear Ms. Erskine:

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.

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

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Page 2 - Ms. Erskine

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 (section 531-542 of the Act; 21); CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), 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 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.

Sincere

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATION(S) FOR USE STATEMENT*

Signature of 510(k) Submitter:

Stephanie A. Erskine

101

Printed Name of Submitter:

Stephanie A. Erskine Director, Regulatory Affairs

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

K012902

Number _

Division Sign-Off Office of Device Evaluation

Prescription Use
OR Over-The-Counter Use
(Division Sign-Off)
Division of Dental, Infection Control,
General Hospital Devices K012902
000002
2

... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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.”