The Powerflex™ Pro PTA catheter is intended to dilate stenoses in illiac, 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-difatation of balloon-expandable and self-expanding stents in the peripheral vasculature.

Device Description

The Powerflex™ Pro Percutaneous Transluminal Angioplasty (PTA) catheter is a 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

Here's a breakdown of the acceptance criteria and study information based on the provided text, though it's important to note that this document is a 510(k) summary for a medical device (a catheter) and not for a software or AI/ML device. Therefore, many of the requested fields related to software performance evaluation (like multi-reader studies, standalone algorithm performance, number of experts for ground truth, etc.) are not applicable in this context.

The document describes the process for obtaining 510(k) clearance for additional sizes of an existing Percutaneous Transluminal Angioplasty (PTA) catheter, demonstrating substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and the Reported Device Performance:

The document lists performance tests conducted, implying these tests have associated acceptance criteria that the device met. However, the specific numerical acceptance criteria for each test are not provided in this summary. It only states that the tests were "completed" and "no new safety or performance issues were raised."

Acceptance Criteria (Implied)	Reported Device Performance
Marker Band Spacing	Met requirements
Balloon Diameter (Nominal, RBP)	Met requirements
System Burst (Inflation Lumen)	Met requirements
System Burst (Guidewire Lumen)	Met requirements
Hub to Shaft Pull Strength	Met requirements
CSI Insertion	Met requirements
Kink Diameter	Met requirements
Catheter Shaft	Met requirements
Inflation/Deflation Time	Met requirements
Multiple Inflation (System Fatigue)	Met requirements
Torque Testing	Met requirements
Particle Free	Met requirements
Hemolysis	Met requirements
Balloon Working Length	Met requirements
Balloon Burst	Met requirements
Marker Band Placement	Met requirements
Proximal Pull Strength	Met requirements
Tip to Balloon/Inner Body Pull Strength	Met requirements
CSI Withdrawal Force	Met requirements
Guidewire Compatibility	Met requirements
Usable Catheter Length	Met requirements
Rated Burst Pressure	Met requirements
Preconditioning	Met requirements
Tensile Testing	Met requirements
Cytotoxicity	Met requirements (met ISO 10993-1:2009)
Physicochemical Aqueous Extraction	Met requirements

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

Sample Size: The document does not specify the sample size for each performance test. It generically states that "non-clinical design verification" and "in-vitro performance tests" were completed.
Data Provenance: The data is from "non-clinical design verification" and "in-vitro performance tests" conducted by the manufacturer (Cordis Corporation). This is retrospective, in-house testing. Country of origin is not explicitly stated for the testing, but the company is based in Bridgewater, NJ, USA.

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

Not Applicable. This is a medical device (catheter) 510(k) summary, not a software or AI/ML device. Ground truth, in this context, would be established by engineering specifications and objective measurements, not by expert interpretation for diagnostic accuracy.

4. Adjudication Method for the Test Set:

Not Applicable. As above, this pertains to physical device performance and conformity to engineering specifications, not subjective interpretation 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:

Not Applicable. This is not a software or AI/ML device that assists human readers.

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

Not Applicable. This is not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for the device's performance tests would be based on:

Engineering Specifications: Predetermined design parameters and performance thresholds (e.g., specific balloon diameters, burst pressures, tensile strengths).
Standardized Test Methods: Adherence to established test protocols (likely internal company protocols and potentially relevant ISO standards, as Bio-compatibility refers to ISO 10993-1:2009).
Objective Measurements: Direct physical measurements and observations of the device components and entire system during in-vitro testing.

8. The Sample Size for the Training Set:

Not Applicable. This is a physical medical device, not a software or AI/ML model that requires a training set.

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

Not Applicable. (See point 8).

Summary

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

K121442

JUN 1 4 2012 . . .

Special 510(k) Cordis Powerflex™ Pro PTA Catheter

Cordis®
a Johnson-Johnson company

510(k) Summary

Submitter:	Cordis Corporation, a Johnson & Johnson company430 Route 22 EastBridgewater, NJ 08807
Contact Person:	Donna MarshallManager, Regulatory AffairsPh: (908) 541-4781Fax: (908) 541-4559e-mail: dmarsha2@its.jnj.com
Date Prepared:	May 14, 2012
Device Trade Name:	Powerflex™ Pro Percutaneous Transluminal Angioplasty Catheter
Device Common Name:	Peripheral Transluminal Angioplasty Balloon Catheter
Class:	II
Classification Name:	Percutaneous Catheter (21 CFR 870.1250)
Product Code:	LIT

Predicate Devices: ·

. :

. . .

Device	Company	ProductCode	510(k)Number	Predicate for:(if multiple predicates)
Powerflex™ PRO PTA Catheters	CordisCorporation	LIT	K112797	Design, Materials,Construction,Characteristics

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

Special 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 illiac, 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-difatation 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. 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 the same to the predicate device and meet the requirements of ISO 10993-1:2009 Biological evaluation of medical dévices - Part 1: Evaluation and Testing within a risk management process.

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

Special 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:

The subject Powerflex Pro PTA Catheter is identical to the predicate Powerflex Pro PTA Catheter described in 510(k) #K112797, with the exception of additional length/diameter combinations within the existing ranges of length and diameter. The subject device has the same fundamental scientific technology and intended use as the current, legally marketed Powerflex™ Pro PTA Catheter. The subject and predicate devices share the same materials, design, fundamental technology (operating principle), labeling, packaging materials and configuration, shelf life and sterilization process. The additional sizes meet the same requirements as the current FDA cleared [510(k) K112797] devices.

Conclusion:

Based on the intended use, technological characteristics, safety and performance testing, the additional sizes of 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™ Pro Percutaneous Transluminal Angioplasty Catheter (K112797).

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

Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is written in a bold, sans-serif font. The words are arranged on a single line and are centered horizontally.

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

JUN 1 4 2012

Cordis Corporation c/o Donna Marshall 430 Route 22 East Bridgewater, NJ 08807

Re: K121442

Trade/Device Name: Powerflex™ Pro Percutaneous Transluminal Angioplasty (PTA) Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT, DQY Dated: May 14, 2012 Received: May 15, 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.

Image /page/3/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

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

Page 2 - Ms. Donna Marshall

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); 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.J. Killele

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

Enclosure

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

Special 510(k) Cordis Powerflex™ Pro PTA Catheter

Indications for Use Statement

510(k) Number (if known): K12 1442

Device Name:

Powerflex™ Pro Percutaneous Transluminal Angioplasty Catheter

Indications for Use:

The Powerflex™ Pro PTA catheter is intended to dilote stenoses in iliac, femoral, ilio-femoral, popliteal, infra poplited 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 א OR (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 A Wilhelm

diovascular Devices

510(k) Number K121442

Page 16 of 496

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).