The FoxCross PTA Catheter is intended for dilatation of lesions in the femoral, renal, iliac, popliteal, peroneal, and profunda arteries and native or synthetic arteriovenous dialysis fistulae. This catheter is not intended for the expansion or delivery of stents.

Device Description

The FoxCross PTA Catheter is a standard over-the-wire PTA catheter. The double lumen catheter has a balloon located near the distal tip. One lumen is used for inflation of the balloon, while the second lumen allows access to the distal tip of the catheter for guide wire insertion (max 0.035''). The balloon has two radiopaque markers for positioning the balloon relative to the stenosis. The balloon material expands to a known diameter at specific pressures.

AI/ML Overview

The provided text is a 510(k) summary for the FoxCross PTA Catheter and describes its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria through a clinical trial or algorithm evaluation.

Instead, the document states: "The results of the in vitro bench tests and analyses demonstrate the safety and effectiveness of the FoxCross PTA Catheter Line Extension." This indicates that the device's safety and effectiveness were demonstrated through bench testing and analyses, not through a clinical study with human subjects, an MRMC study, or a standalone algorithm performance study.

Therefore, I cannot provide the requested information in the table format because the details are not present in the provided text.

Here's an explanation of why the requested information cannot be extracted:

Acceptance Criteria and Reported Device Performance: This information is typically found in a clinical study report or a detailed summary of verification and validation testing, which is not included here. The document only mentions "in vitro bench tests and analyses" in general terms.
Sample size for test set and data provenance: No test set is described, as the evaluation was based on bench tests.
Number of experts and qualifications: Not applicable, as there was no study involving human readers or expert ground truth establishment for a test set in the context of an algorithm.
Adjudication method: Not applicable.
Multi Reader Multi Case (MRMC) comparative effectiveness study: No such study is mentioned or implied.
Standalone (algorithm only) performance: This device is a physical medical device (a catheter), not an algorithm or AI. Therefore, standalone algorithm performance is not relevant.
Type of ground truth used: Not applicable for this type of device and evaluation.
Sample size for training set: Not applicable for this type of device.
How ground truth for training set was established: Not applicable.

Summary

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K090509 page 1 of 1

FoxCross PTA Catheter Special 510(k)

510(k) SUMMARY

The 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92

Submitter's Name:	Abbott Vascular
Submitter's Address:	3200 Lakeside DriveSanta Clara, CA 95054	MAR 20 2009
Telephone:	951-914-3311
Fax:	951-914-0339
Contact Person:	Nadine Smith
Date Prepared:	February 12, 2009
Device Trade Name:	FoxCross PTA Catheter (with 14mm balloon diameter)
Device Common Name:	Percutaneous Catheter
Device Classification Name:	Catheter
Device Classification No.:	21 CFR 870.1250
Device Classification:	Class II
Device Product Code:	DOY

Summary of Substantial Equivalence

The FoxCross PTA Catheter Line Extension (14mm balloon diameter) is substantially equivalent to the prodicate devices, the FoxCross PTA Catheter and the Agiltrac .035 PT A Catheter. The results of the in vitro bench tests and analyses demonstrate the safety and effectiveness of the FoxCross PTA Catheter Line Extension.

Device Description

Intended Use

The intended use for the device has not changed as a result of the modification.

Summary of Technological Characteristics Compared to Predicate Device

The FoxCross PTA Catheter Line Extension (with 14mm balloon diameter) is identical in technological characteristics, to the FoxCross PTA Catheter, with respect to product code, classification section, classification name, intended use, catheter lengths, introducer sheath size, and guide wire compatibility.

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od and Drug Administration 200 Corporate Boulevard Rockville MD 20850

Abbott Vascular c/o Ms. Nadine Smith Regulatory Affairs 26531 Ynez Road Temecula, CA 92591

MAR 2 0 2009

Re: K090509

FoxCross PTA Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY Dated: February 25, 2009 Received: February 26, 2009

Dear Ms. Smith:

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. Nadine Smith

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 (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

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

Enclosure

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Abbott Vascular

Indications For Use Statement

510(k) Number (if known)

KO90509

Device Name

FoxCross PTA Catheter

Indications for Use

The FoxCross PTA Catheter is intended for dilatation of lesions in the femoral, renal, iliac, popliteal, peroneal, and profunda arteries and native or synthetic arteriovenous dialysis fistula.

This catheter is not intended for the expansion or delivery of stents.

Prescription Use (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

1-Off
Division of Cardiovascular Devices
for K090509

Page

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).