The Powerflex™ Pro Percutaneous Transluminal Angioplasty (PTA) catheter is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also indicated for post-dilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.

Device Description

The Powerflex™ Pro Percutaneous Transluminal Angioplasty (PTA) catheter with a distal inflatable balloon. The Powerflex™ Pro PTA Catheter is designed for use with a 0.035" guide wire and a catheter sheath introducer and is available in a variety of diameters and lengths. Two radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement. The catheter tip is tapered to ease entry into peripheral arteries and to facilitate the crossing of tight stenoses.

AI/ML Overview

The provided text describes the Cordis Powerflex™ Pro Percutaneous Transluminal Angioplasty Catheter. It outlines the device description, indications for use, and a summary of performance testing to establish substantial equivalence to predicate devices.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list "acceptance criteria" with specific quantitative thresholds. Instead, it states that the conducted in-vitro performance tests provide "reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use." The performance is demonstrated by the completion of these tests aligning with engineering standards and existing predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance
Device Design and Functionality:	The Powerflex™ Pro PTA Catheter is designed for use with a 0.035" guide wire and a catheter sheath introducer. It features two radiopaque marker bands for balloon placement and a tapered tip for ease of entry and crossing stenoses.
Material Biocompatibility:	All materials used in the proposed device are similar to the predicate devices and meet the requirements of ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and Testing within a risk management process.
Mechanical/Physical Performance (In-vitro tests):	All listed in-vitro performance tests (Marker Band Spacing, Balloon Diameter (Nominal, RBP), System Burst (Inflation Lumen & Guidewire Lumen), Hub to Shaft Pull Strength, CSI Insertion Kink Diameter, Catheter Shaft, Inflation/Deflation Time, Multiple Inflation (System Fatigue), Torque Testing, Particle Free, Hemolysis, Balloon Working Length, Balloon Burst, Marker Band Placement, Proximal Pull Strength, Tip to Balloon/Inner Body Pull Strength, CSI Withdrawal Force, Guide Wire Compatibility, Useable Catheter Length, Rated Burst Pressure, PreConditioning, Tensile Testing, Cytotoxicity, Physicochemical Aqueous Extraction) were completed. The submission states, "The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing." This implies acceptable performance across all these metrics relative to the predicate devices and industry standards.
Substantial Equivalence to Predicate Devices:	Comparison with Cordis Opta Pro/Powerflex™ P3 PTA Catheter and ClearStream Technologies, Savvy Long PTA Catheter (for dimensions) showed "technological characteristics such as materials, components, biocompatibility, performance properties, dimensions (size range), method of delivery, fundamental technology (operating principle), packaging configuration and packaging materials, labeling, manufacturing and sterilization processes featured with the Powerflex Pro PTA Catheter are substantially equivalent." The intended use is also identical, with the exception of the additional post-dilatation indication, for which the Cordis Corp., Aviator Plus PTA Catheter serves as a predicate.
Safety and Effectiveness:	Demonstrated via non-clinical design verification and validation tests, analyses, and post-market surveillance data analyses of the predicate devices. The document concludes that the device "has been shown to be appropriate for its intended use and is considered to be substantially equivalent."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the exact sample sizes used for each of the in-vitro performance tests. It merely lists the tests that were completed.
Data Provenance: The studies were "non-clinical design verification and validation tests and analyses," meaning they were laboratory/bench tests. The origin of the data is therefore laboratory-based, and not patient-specific (i.e., not a clinical study involving human subjects). It also mentions "post-market surveillance data analyses of the predicate devices," which would be retrospective data from existing devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. This device's safety and effectiveness were demonstrated through non-clinical, bench testing and comparison to predicate devices, not through a diagnostic accuracy study requiring expert consensus on a test set to establish "ground truth."

4. Adjudication Method for the Test Set

Not applicable, as there was no test set requiring human adjudication in the context of diagnostic accuracy. The testing was laboratory-based.

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. This is a medical device (catheter), not an AI diagnostic software.

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

Not applicable. This is a medical device (catheter), not an AI algorithm. The performance described is "standalone" in the sense that the device itself was tested in a lab setting, but not in the context of an AI algorithm's performance.

7. The Type of Ground Truth Used

For the in-vitro performance tests, the "ground truth" would be established by:

Engineering specifications and design requirements.
Industry standards (e.g., ISO for biocompatibility).
Performance characteristics of the legally marketed predicate devices.
Accepted scientific and engineering principles for material properties and mechanical function.

8. The Sample Size for the Training Set

Not applicable. This is a medical device (catheter), not an AI algorithm requiring a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. This is a medical device (catheter), not an AI algorithm requiring a training set.

Summary

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K112797 page 1 of 3

MAY -- 4 2012

Cordis®
a Johnson-Johnson company

510(k) Summary

Submitter:	Cordis Corporation, a Johnson & Johnson company430 Route 22 EastBridgewater, NJ 08807
------------	-----------------------------------------------------------------------------------------------

Contact Person: Donna Marshall Manager, Regulatory Affairs Ph: (908) 541-4781 Fax: (908) 541-4559 e-mail: dmarsha2@its.jnj.com

May 3, 2012 Date Prepared:

Device Trade Name: Powerflex™ Pro Percutaneous Transluminal Angioplasty Catheter

Device Common Name: Peripheral Transluminal Angioplasty Balloon Catheter

Class: ll
Classification Name: Percutaneous Catheter (21 CFR 870.1250)

LIT Product Code:

Predicate Devices:

Device	Company	ProductCode	510(k)Number	Predicate for:(if multiple predicates)
Powerflex™ ExtremePowerflex™ P3 & OPTA™ PROPTA Catheters	CordisCorporation	LIT	K032737	Design, Materials,Construction,Characteristics
Aviator Plus PTA BalloonDilatation Catheter	CordisCorporation	LIT	K071189	Intended Use
Savvy Long and Sleek PTACatheters	ClearstreamTechnologies, Ltd.	LIT	K072947	Dimensions - longer lengths(120 x 220 mm)

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Traditional 510(k) Cordis Powerflex™ Pro PTA Catheter

Device Description:

Indications for Use:

The Powerflex™ Pro Percutaneous Transluminal Angioplasty (PTA) catheter is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also indicated for post-dilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.

Summary of Performance Testing:

The safety and effectiveness of the Powerflex™ Pro PTA Catheter and the substantial equivalence to the predicate devices have been demonstrated via data collected in non-clinical design verification and validation tests and analyses as well as the post-market surveillance data analyses of the predicate devices. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing. All materials used in the proposed device are similar to the predicate devices and meet the requirements of ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and Testing within a risk management process.

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K112797 page 3 of 3

Traditional 510(k) Cordis Powerflex™ Pro PTA Catheter

The following in-vitro performance tests were completed for the Powerflex™ Pro PTA Catheter:

Marker Band Spacing Balloon Diameter (Nominal, RBP) System Burst (Inflation Lumen) System Burst (Guide wire Lumen) Hub to Shaft Pull Strength CSI Insertion Kink Diameter Catheter Shaft Inflation/Deflation Time Multiple Inflation (System Fatigue) Torque Testing Particle Free Hemolysis

Balloon Working Length Balloon Burst Marker Band Placement Proximal Pull Strength Tip to Balloon/Inner Body Pull Strength CSI Withdrawal Force Guide Wire Compatibility Useable Catheter Length Rated Burst Pressure PreConditioning Tensile Testing Cytotoxicity Physicochemical Aqueous Extraction

Summary of Substantial Equivalence.Comparison:

Comparison of the new and the following predicate devices: Cordis Corp. Opta Pro/Powerflex™ P3 PTA Catheter and ClearStream Technologies, Savyy Long (dimensions only) PTA Catheter show that technological characteristics such as materials, components, biocompatibility, performance properties, dimensions (size range), method of delivery, fundamental technology (operating principle), packaging configuration and packaging materials, labeling, manufacturing and sterilization processes featured with the Powerflex Pro PTA Catheter are substantially equivalent to those featured with the currently marketed Cordis Opta Pro/Powerflex P3 PTA Catheter and ClearStream Technologies, Savvy Long (dimensions) PTA Catheter. The intended use of the new and the above predicate devices are identical with the exception of the additional indication for post dilatation of balloon-expandable and self expanding stents in the peripheral vasculature of the subject device; Cordis Corp., Aviator Plus PTA Catheter is the predicate in regards to the post dilatation indication.

Conclusion:

Based on the intended use, technological characteristics, safety and performance testing, the Powerflex™ Pro Percutaneous Transluminal Angioplasty Catheter has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the Cordis Powerflex™ P3 and Opta™ Pro Percutaneous Transluminal Angioplasty Catheters (K032737), Aviator Plus PTA Balloon Dilatation Catheter (K071189) and ClearStream Savvy Long PTA Catheter (K072947).

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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 features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The logo is simple and monochromatic.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room ~WO66-G609 Silver Spring, MD 20993-0002

MAY - 4 2012

Cordis Corp. % Donna Marshall 430 Route 22 East Bridgewater, NJ 08807

Re: K112797

Trade/Device Name: Powerflex Pro PTA Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: April 9, 2012 Received: April 10, 2012

Dear Ms. Marshall:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Ms. Donna Marshall

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

M.L. Hieber

Cuckerman, M. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Traditional 510(k) Cordis Powerflex™ Pro PTA Catheter

Indications for Use Statement

510(k) Number (if known):

Device Name:

Powerflex™ Pro Percutaneous Transluminal Angioplasty Catheter

Indications for Use:

The Powerflex™ Pro PTA catheter is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also indicated for post-dilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.

Prescription Use × (Per 21 CFR 801 Subpart D) 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)

M. S. Helleben

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).