The PowerPICC® Catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.

The PowerPICC® catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, power injection of contrast media and allows for central venous pressure monitoring. For blood sampling, infusion or therapy, use a 4 French or larger catheter. The maximum recommended infusion rate is 5ml/sec. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used.

Device Description

The 4 Fr SL PowerPICC® Catheters are open-ended radiopaque polyurethane. Catheter usable length is 55 cm. The catheter has a reverse taper design Catheter shaft 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 and full PICC configurations with legally marketed kit components. Purple colorants were added to the catheter materials to provide the catheter with an appearance that allows the end user to differentiate Bard's power injectable catheters from other manufacturers' power injectable catheters. The catheter extension leg, junction and clamp ID tag were printed with markings to identify the catheter as PowerPICC® and to include information to facilitate proper use of the device.

AI/ML Overview

The provided text is for a 510(k) premarket notification for a medical device called the "4 Fr SL PowerPICC® Catheter." This is a regulatory submission for a medical device and not a study proving device performance against acceptance criteria in the way a clinical or AI performance study would.

Therefore, the requested information elements such as a table of acceptance criteria and reported device performance, sample sizes for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI models are not applicable to this document.

Instead, this document details the substantial equivalence of the 4 Fr SL PowerPICC® Catheter to predicate devices. Substantial equivalence means the device is as safe and effective as a legally marketed device (predicate device) and does not raise new questions of safety or effectiveness.

Here's a breakdown of what is contained in the document, which can be interpreted in relation to "acceptance criteria" for a regulatory submission of this type:

1. "Acceptance Criteria" (Regulatory Context) and "Reported Device Performance" (Substantial Equivalence Claims):

In the context of a 510(k), "acceptance criteria" are not reported as specific performance metrics against a threshold for a new study, but rather that the new device meets established standards and is substantially equivalent to predicates.

Criteria (Regulatory Focus)	Reported "Performance" (Substantial Equivalence)
Intended Use (Same as predicate)	The PowerPICC® Catheters are intended for short or long-term peripheral access to the central venous system for intravenous therapy and blood sampling. This is explicitly stated to be identical to predicate devices.
Indications for Use (Same as predicate)	The PowerPICC® catheter is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, power injection of contrast media and allows for central venous pressure monitoring. For blood sampling, infusion or therapy, use a 4 French or larger catheter. The maximum recommended infusion rate is 5ml/sec. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used. Stated to be substantially equivalent to predicates.
Technological Characteristics (Same as predicate)	Technological similarities between the subject 4 Fr SL PowerPICC® catheter and the predicate devices remain identical. "There are no new questions raised regarding safety or efficacy of the 4 Fr SL PowerPICC®."
Biocompatibility (Meets standards)	Met requirements of ISO 10993 Biological Evaluation of Medical Devices Part-1: Evaluation and Testing and the FDA Modified ISO 10993 Test Profile. All materials were previously cleared for similar applications.
Performance Testing (Meets standards)	Conducted in accordance with FDA guidance documents and international standards: - Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, March 16, 1995 - ISO 10555-1:1997, Sterile, Single-Use Intravascular Catheters, General requirements and Amendment 1 - ISO 10555-3:1997, Sterile, Single-Use Intravascular Catheters, Central venous catheters - AAMI/ANSI/ISO 11135:1994, Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization - AAMI/ANSI/ISO 10993-1:2003, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, and the FDA Modified ISO 10993 Test Profile - IEC 60601-2-34: 2000-10, Medical electrical equipment Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment - AAMI TIR9: 1992, Evaluation of Clinical Systems for Invasive Blood Pressure Monitoring - ANSI/AAMI BP22: 1994, Blood Pressure Transducers Subject product testing yielded acceptable safety & performance outcomes.
Sterilization (Meets standards)	EO sterilization adoption tests yielded acceptable results.
Overall Substantial Equivalence (Regulatory Outcome)	The device "meets the minimum requirements that are considered adequate for its intended use and is substantially equivalent in design, materials, sterilization, principles of operation and indications for use to current commercially available catheters/cited predicates."

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

N/A. This is not a study reporting on a "test set" in the context of an AI/algorithm. Performance testing was done against established standards for medical devices, but specific sample sizes for these tests (e.g., how many catheters were mechanically tested) are not provided in this summary. The data provenance would be from laboratory and engineering testing, not patient data.

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

N/A. This refers to expert consensus for ground truth, which is not relevant for this type of medical device submission. The "ground truth" here is compliance with recognized engineering, biocompatibility, and sterilization standards, which are evaluated by technical experts and regulatory bodies.

4. Adjudication method for the test set:

N/A. Not applicable, as there is no "test set" in the context of human expert review as in an AI study.

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:

N/A. This device is a catheter, not an AI or imaging diagnostic tool. An MRMC study is not relevant.

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

N/A. This device does not have an "algorithm-only" performance to assess.

7. The type of ground truth used:

For the performance claims made:
- Engineering/Laboratory Test Standards: Compliance with international and national standards (ISO, AAMI, IEC) for physical performance (e.g., flow rates, pressure resistance), biocompatibility, and sterilization.
- Predicate Device Compliance: The "ground truth" for substantial equivalence is that the new device shares fundamental characteristics and performance with previously cleared, legally marketed predicate devices.

8. The sample size for the training set:

N/A. This is not a machine learning or AI device, so there is no training set.

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

N/A. Not applicable, as there is no training set.

In summary, the provided document is a 510(k) summary demonstrating substantial equivalence for a physical medical device. It relies on compliance with established regulatory standards and comparison to predicate devices, rather than the types of clinical or AI performance studies described in the prompt's questions.

Summary

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K070996

4 Fr SL PowerPICC®

Special 510(k)

Section 6

510(k) Summary

4 Fr Single Lumen (SL) PowerPICC® Catheter

MAY - 8 2007

Summary of Safety & Effectiveness Prepared April 23, 2007

	Submitter of 510(k)Premarket Notification:	Bard Access Systems, Inc. (BAS)[Subsidiary of C.R. Bard, Inc.]Salt Lake City, Utah 84116Phone: (801) 595-0700, Ext. 7136Fax: (801) 595-5425
GeneralProvisions	Contact Person:	Lynn M. KirchoffRegulatory Affairs Specialist
	Device Trade Name:	4 Fr SL PowerPICC® Catheter
	Device Generic Name:	Peripherally Inserted Central Catheter (PICC)
	The predicate devices are listed below.
PredicateDevices	Device Name:Trade Name:Common/Usual Name:Classification Name:Premarket Notification:	6 Fr TL PowerPICC® CatheterPowerPICC® CatheterPeripherally Inserted Central Catheter (PICC)Long Term Intravascular Catheter (80 LJS)K053501, concurrence date-January 13, 2006
	Device Name:Trade Name:	5 Fr SL PowerPICC® CatheterPowerPICC® Catheter

PowerPICC® Catheter Common/Usual Name: Peripherally Inserted Central Catheter (PICC) Long Term Intravascular Catheter (80 LJS) Premarket Notification: K033389, concurrence date March 14, 2004 K051991, concurrence date October 20, 2005

Classification 21 CFR 880.5970, Class II, 80LJS - Long Term Intravascular Catheter Performance Performance standards have not been established by FDA under section 514 of the Standards Federal Food, Drug and Cosmetic Act. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Classification Name:

000003

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10000000 2005 4 Fr SL PowerPICC®
Special 510(k)

Intended Use	The PowerPICC® Catheters are intended for short or long term peripheral access to thecentral venous system for intravenous therapy and blood sampling.
Indications forUse	The PowerPICC® catheter is indicated for short or long term peripheral access to thecentral venous system for intravenous therapy, power injection of contrast media andallows for central venous pressure monitoring. For blood sampling, infusion or therapy,use a 4 French or larger catheter. The maximum recommended infusion rate is 5ml/sec.For central venous pressure monitoring, it is recommended that catheter lumen of 20gauge or larger be used.
DeviceDescription	The 4 Fr SL PowerPICC® Catheters are open-ended radiopaque polyurethane. Catheter usable length is 55 cm. The catheter has a reverse taper design Catheter shaft tubing is marked with depth indicators, with "0" indicated toserve as a reference for the catheter insertion point. Catheters are provided sterile in basic and full PICC configurations withlegally marketed kit components. Purple colorants were added to the catheter materials to provide the catheterwith an appearance that allows the end user to differentiate Bard's powerinjectable catheters from other manufacturers' power injectable catheters. The catheter extension leg, junction and clamp ID tag were printed withmarkings to identify the catheter as PowerPICC® and to include information tofacilitate proper use of the device.
TechnologicalCharacteristics	Technological similarities between the subject 4 Fr SL PowerPICC® catheter and thepredicate devices remain identical. There are no new questions raised regarding safetyor efficacy of the 4 Fr SL PowerPICC®.
Safety andPerformanceTests	Biocompatibility requirements of ISO 10993 Biological Evaluation of Medical DevicesPart-1: Evaluation and Testing and the FDA Modified ISO 10993 Test Profile forexternally communicating, blood contacting, long-term devices were met. Allmaterials used in the manufacture of the subject device were previously cleared forsimilar applications by Bard Access Systems.Performance testing of the 4 Fr SL PowerPICC® catheter was conducted in accordancewith the following FDA guidance documents and international standards: Guidance on Premarket Notification [510(k)] Submission for Short-Termand Long-Term Intravascular Catheters, March 16, 1995 ISO 10555-1:1997, Sterile, Single-Use Intravascular Catheters, Generalrequirements ISO 10555-1:1997, Sterile, Single-Use Intravascular Catheters, Generalrequirements, Amendment 1 ISO 10555-3:1997, Sterile, Single-Use Intravascular Catheters, Centralvenous catheters AAMI/ANSI/ISO 11135:1994, Medical Devices - Validation and RoutineControl of Ethylene Oxide Sterilization

Image /page/1/Picture/2 description: The image shows the number 4 in two different formats. The first format is "4]", which is likely a section or item number. The second format is "000004", which is a numerical representation of the number 4 with leading zeros. The number is written in a bold, sans-serif font.

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4 Fr SL PowerPIC Special 510(k)

AAMI/ANSI/ISO 10993-1:2003, Biological Evaluation of Medical . Devices Part 1: Evaluation and Testing, and the FDA Modified ISO 10993 Test Profile
IEC 60601-2-34: 2000-10, Medical electrical equipment Particular . requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment
. AAMI TIR9: 1992, Evaluation of Clinical Systems for Invasive Blood Pressure Monitoring
. ANSI/AAMI BP22: 1994, Blood Pressure Transducers

Subject product testing has yielded acceptable safety & performance outcomes.

In addition, EO sterilization adoption tests also yielded acceptable results. The results of these tests, in conjunction with the substantial equivalence claims as outlined in the premarket notification, effectively demonstrate the 4 Fr SL PowerPICC® catheters' substantial equivalence to the cited predicate devices.

Summary of Substantial Equivalence

Safety and

Performance

Tests Continued

Based on the indications for use, technological characteristics, and safety and performance testing, the subject 4 Fr SL PowerPICC® catheter meets the minimum requirements that are considered adequate for its intended use and is substantially equivalent in design, materials, sterilization, principles of operation and indications for use to current commercially available catheters/cited predicates.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a symbol. The symbol is a stylized representation of a caduceus, a staff with two snakes entwined around it, which is a symbol of medicine and healing. The seal is used to represent the HHS and its mission to protect the health of all Americans and provide essential human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 8 2007

Ms. Lynn M. Kirchoff Regulatory Affairs Specialist Bard Access Systems, Incorporated 5425 West Amelia Earhart Drive Salt Lake City, Utah 84116

Re: K070996

Trade/Device Name: 4 Fr Single Lumen (SL) PowerPICC® Catheter Regulation Number: 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: April 6, 2007 Received: April 9, 2007

Dear Ms. Kirchoff:

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. Kirchoff

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 (240) 276-0115. 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/industry/support/index.html.

Sincerely vours.

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

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K570YY6
4 Fr SL PowerPICC®
Special 510(k)

Section 1.2

Indications for Use Statement

5 10(k) Number (if known):

Device Name: 4 Fr Single Lumen (SL) PowerPICC® Catheter

Indications For Use:

The PowerPICC® catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, power injection of contrast media and allows for central venous pressure monitoring. For blood sampling, infusion or therapy, use a 4 French or larger catheter. The maximum recommended infusion rate is 5ml/sec for power injection of contrast media. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aitken V. Vartan

of Anesthesiology, General Hospital, Jon Control, Dental Dovices

Number: K970496

00002

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.”