The RapidCross™ PTA Rapid Exchange Balloon Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.

Device Description

The RapidCross PTA Rapid Exchange Balloon Dilatation Catheter (RapidCross catheter) is a rapid exchange (RX) coaxial catheter compatible with 0.014" guidewires, with a distally mounted semi-compliant inflatable balloon and an atraumatic, tapered tip. The distal portion of the catheter has a lubricious coating. The manifold includes an inflation lumen, which is used to inflate and deflate the dilatation balloon with a mixture of

AI/ML Overview

The provided text describes a 510(k) summary for the RapidCross™ PTA Rapid Exchange Balloon Dilatation Catheter, a medical device. This document focuses on demonstrating substantial equivalence to predicate devices through bench testing and biocompatibility testing, not on clinical acceptance criteria or a study proving performance against such criteria in the context of diagnostic or AI-driven systems.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not applicable to this type of device submission. This is a premarket notification for a physical medical device, not a diagnostic algorithm or image analysis software.

Here's a breakdown of the relevant (and non-relevant) information based on the provided text:

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

Acceptance Criteria: The document states that "The RapidCross catheter met all acceptance criteria for the bench testing with results similar to the predicates." However, specific numerical acceptance criteria for each test (e.g., "Balloon Burst Strength must be > X psi") are not detailed in this summary.
Reported Device Performance: The document lists the types of tests performed. It doesn't provide specific numerical results, but rather states that the device performed "similar to the predicates" and "met all acceptance criteria."

Test Performed	Reported Device Performance
Crossing Profile	Met acceptance criteria; similar to predicates
Balloon Burst Strength	Met acceptance criteria; similar to predicates
Balloon Compliance	Met acceptance criteria; similar to predicates
Balloon OD	Met acceptance criteria; similar to predicates
Inflation/Deflation Time	Met acceptance criteria; similar to predicates
Balloon Fatigue	Met acceptance criteria; similar to predicates
Bond Tensile Strength	Met acceptance criteria; similar to predicates
Kink	Met acceptance criteria; similar to predicates
Device Tracking	Met acceptance criteria; similar to predicates
Insertion Force	Met acceptance criteria; similar to predicates
Balloon Pull-back Force	Met acceptance criteria; similar to predicates
Repeat Inflations (In Stent)	Met acceptance criteria; similar to predicates
Torque Strength	Met acceptance criteria; similar to predicates
Radiopacity	Met acceptance criteria; similar to predicates
Presence of Coating	Met acceptance criteria; similar to predicates
Coating Durability	Met acceptance criteria; similar to predicates
Particle Generation	Met acceptance criteria; similar to predicates
Pushability	Met acceptance criteria; similar to predicates
Support Wire Securement	Met acceptance criteria; similar to predicates
Tip ID / RX Port ID	Met acceptance criteria; similar to predicates
Tip / Lesion Entry Profile	Met acceptance criteria; similar to predicates
Re-Insertion Force	Met acceptance criteria; similar to predicates
Catheter Working Length	Met acceptance criteria; similar to predicates
RX Port Length	Met acceptance criteria; similar to predicates
RX Port OD	Met acceptance criteria; similar to predicates
Biocompatibility (cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemolysis, pyrogen, complement activation, thromboresistance, partial thromboplastin time, platelet/leukocyte count)	Met acceptance criteria (per ISO 10993-1 for short duration contact); similar to predicates

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified for any of the bench tests.
Data Provenance: The testing was "Bench testing" and "biocompatibility testing." This is laboratory/engineering data, not clinical data from patients. Country of origin is not relevant for this type of testing.

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)

Not applicable. This relates to physical device performance and biocompatibility, not diagnostic interpretation requiring expert ground truth.

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

Not applicable. This applies to clinical data interpretation, not bench testing.

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 physical medical device, not an AI or diagnostic tool.

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

Not applicable. This is a physical medical device.

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

Ground Truth: For bench testing, the "ground truth" is typically defined by engineering specifications, validated test methods, and industry standards (e.g., ISO, ASTM). For biocompatibility, it's defined by ISO 10993-1.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an algorithm that requires a training set.

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

Not applicable. This is a physical medical device.

Summary

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K130911 p. 1 of 3

510(k) Summary

MAY 2 4 2013

RapidCross™ PTA Rapid Exchange Balloon Dilatation Catheter

510(k) Summary	This 510(k) summary information is submitted in accordancewith the requirements of 21 CFR §807.92.
Applicant	ev3 Inc.
Submitter	ev3 Inc.3033 Campus DrivePlymouth, MN 55441-2651Tel: 763-398-7000Fax: 763-591-3248
Contact Person	Laura J. Lind
Date Prepared	May 21, 2013
Device Trade Name	RapidCross™ PTA Rapid Exchange Balloon Dilatation Catheter
Device Common Name	PTA Dilatation Catheter
Classification Name	Catheter, Angioplasty, Peripheral, Transluminal(21 CFR 870.1250, Product Code LIT)
Classification Panel	Cardiovascular
Predicate Devices	RapidCross™ PTA Rapid Exchange Balloon Dilatation Catheter(K123544, cleared February 12, 2013), PowerCross™ .018OTW PTA Dilatation Catheter (K093286, cleared November 13,2009.)
Intended use	The RapidCross™ PTA Rapid Exchange Balloon DilatationCatheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for thetreatment of obstructive lesions of native or syntheticarteriovenous dialysis fistulae. This device is also indicated forstent post-dilatation in the peripheral vasculature.
Device Description	The RapidCross PTA Rapid Exchange Balloon DilatationCatheter (RapidCross catheter) is a rapid exchange (RX) coaxialcatheter compatible with 0.014" guidewires, with a distallymounted semi-compliant inflatable balloon and an atraumatic,tapered tip. The distal portion of the catheter has a lubriciouscoating. The manifold includes an inflation lumen, which is usedto inflate and deflate the dilatation balloon with a mixture of
Performance data	Bench testing and biocompatibility testing were performed tosupport a determination of substantial equivalence. Results fromthis testing provide assurance that the proposed device has beendesigned and tested to assure conformance to the requirementsfor its intended use.Using internal Risk Analysis procedures, the following testswere performed on the predicate RapidCross catheter and areleveraged for the modified RapidCross catheter (K123544):
	• Crossing Profile	• Radiopacity
	• Balloon Burst Strength	• Presence of Coating
	• Balloon Compliance	• Coating Durability
	• Balloon OD	• Particle Generation
	• Inflation/Deflation Time	• Pushability
	• Balloon Fatigue	• Support Wire Securement
	• Bond Tensile Strength	• Tip ID / RX Port ID
	• Kink	• Tip / Lesion Entry Profile
	• Device Tracking	• Re-Insertion Force
	• Insertion Force	• Catheter Working Length
	• Balloon Pull-back Force	• RX Port Length
	• Repeat Inflations (In Stent)	• RX Port OD
	• Torque Strength
	The following tests were performed on the modified RapidCrosscatheter:
	• Balloon Burst Strength (In Stent)
	hemolysis, pyrogen, complement activation, thromboresistance, partial thromboplastin time, and platelet/leukocyte count and is leveraged for the modified RapidCross catheter (K123544).
	The RapidCross catheter met all acceptance criteria for the bench testing with results similar to the predicates. Based on the bench test results, comparison to legally marketed predicates, and non-clinical test results, the RapidCross catheter is determined to perform as safely and effectively as the predicates for its intended use.
Summary ofSubstantialEquivalence	The RapidCross PTA Rapid Exchange Balloon Dilatation Catheter has the following similarities to the predicate devices:Same intended use Similar indications for use Same fundamental scientific technology Same operating principle Same technological characteristics Identical sterility assurance level and sterilization method
	The RapidCross catheter and the predicates have the same intended use - all devices are intended to treat peripheral arteries. All devices are intended to treat the same target population. The manner in accessing and treating lesions is similar for the devices.
	The modified RapidCross catheter indications for use are identical to the ev3 PowerCross PTA Dilation Catheter indications for use. The differences between modified and predicate RapidCross catheters do not raise new safety and effectiveness questions.
Conclusion	Based on the intended use, technological characteristics, and results from safety and performance testing, the RapidCross PTA Rapid Exchange Balloon Dilatation Catheter is considered substantially equivalent to the legally marketed predicate devices RapidCross PTA Rapid Exchange Balloon Dilatation Catheter (K123544) and the PowerCross PTA Dilatation Catheter (K093286).

ev3 Corporate World Headquarters / Peripheral Vascular - 3033 Campus Drive, Plymouth, MN 55441, USA - Ph +1 763 398 7000 ev3 Neurovascular • 9775 Toledo Way, Irvine, CA 92618 • Ph + 1 949 837 3700

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The predicate RapidCross catheter was tested for biocompatibility per ISO 10993-1 for short duration contact with blood (<24 hours). The testing included cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity,

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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, rendered in a thick, black line.

Public Health Service

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

May 24, 2013

ev3. Inc. c/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street NW Buffalo, MN 55313

Re: K130911

Trade/Device Name: RapidCross PTA Rapid Exchange Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: April 1, 2013 Received: April 2, 2013

Dear Mr. Job:

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. However, we remind you 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 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

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Page 2 - Mr. Mark Job

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

http://www.fda.gov/MedicalDevices/ResourcesforYourIndustry/default.htm.

Sincerely yours.

Bram D. Zoggerman -S

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

Enclosure

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Page 1 of 1

Indications for Use Statement

K130911 510(k) Number (if known):

Device Name: RapidCross™ PTA Rapid Exchange Balloon Dilatation Catheter Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

! AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bram I 2013 (

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).