The AGILTRAC™ .035 Peripheral Dilatation Catheter is an over the wire catheter with an XCELON™ (nylon blend) balloon bonded at the distal end. The shaft is a dual lumen design. The smaller lumen provides for inflation of the balloon with contrast medium and the larger lumen permits use of a 0.035" quide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The distal 20 cm of the dual lumen tubing and the entire length of the balloon are coated with Microglide®, a silicone based material used to reduce friction by providing a suface film over the dual lumen tubing.
The balloon, which has two (2) radiopaque markers to aid in positioning the balloon in the stenosis, is designed to provide an expandable segment of known diameter and length at specific pressures.
The proximal end of the catheter has a sidearm adaptor that provides access to the inflation lumen and guidewire lumen. It is designed with a luer-lock fitting for connection with an inflation device.

AI/ML Overview

This document describes the AGILTRAC™ .035 Peripheral Dilatation Catheter (K023320), a balloon catheter for dilating stenoses in peripheral arteries, treating obstructive lesions in A-V fistulae, securing attachment systems in iliac arteries, and expanding vascular prosthesis limbs.

Acceptance Criteria and Device Performance:

The submission explicitly states that "The safety and effectiveness of the AGILTRAC™ .035 Peripheral Dilatation Catheter has been demonstrated through data collected from in vitro bench tests and analyses." However, no specific quantitative acceptance criteria or detailed performance data are provided in the excerpt. The device's clearance is based on its substantial equivalence to a predicate device, the Guidant's Ancure® Iliac Balloon Catheter, in terms of design, materials, method of delivery, and intended use. This implies that the performance of the AGILTRAC™ device is expected to meet the established safety and effectiveness profile of the predicate device, although specific metrics are not detailed.

Given the information provided, a table of acceptance criteria and reported device performance cannot be fully constructed with quantitative data.

Acceptance Criterion	Reported Device Performance
Safety and Effectiveness	Demonstrated through in vitro bench tests and analyses. Deemed substantially equivalent to the predicate device (Guidant Ancure® Iliac Balloon Catheter) in terms of materials, biocompatibility, mode of operation, performance properties, sterilization, and packaging.
Mechanical Performance (e.g., burst pressure, inflation/deflation times, guidewire compatibility, marker visibility)	(Not explicitly detailed, but implied to be equivalent to predicate in in vitro tests)
Material Biocompatibility	Deemed substantially equivalent to the predicate device.
Sterilization	Deemed substantially equivalent to the predicate device.
Packaging	Deemed substantially equivalent to the predicate device.

Detailed Study Information:

Sample size used for the test set and the data provenance:
- The study relied on "in vitro bench tests and analyses." The specific sample sizes for these tests are not provided in the given text.
- The data provenance is in vitro (laboratory-based), implying controlled experimental conditions rather than human or animal studies. The country of origin for the data is not explicitly stated but is implicitly associated with Guidant Corporation, a U.S. company.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as the clearance is based on in vitro bench tests and a comparison of technological characteristics to a predicate device, not on clinical data requiring expert review for ground truth establishment.
Adjudication method for the test set:
- This information is not applicable as the clearance is based on in vitro bench tests and a comparison of technological characteristics, not on clinical data requiring adjudication.
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:
- No, an MRMC comparative effectiveness study was not conducted. This device is a medical instrument (catheter), not an AI-powered diagnostic or assistive technology.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm-only performance study was not done. This device is a physical medical device, not an algorithm or software.
The type of ground truth used:
- For the in vitro bench tests, the "ground truth" would be objective measurements and established engineering specifications for performance parameters (e.g., material properties, dimensional accuracy, burst pressure, force resistance, biocompatibility standards). These are typically defined by industry standards, internal company specifications, and regulatory guidelines for similar devices. There is no clinical ground truth (like pathology or outcomes data) mentioned for this submission.
The sample size for the training set:
- This information is not applicable. This is a physical device, not an AI model, so there is no "training set."
How the ground truth for the training set was established:
- This information is not applicable as there is no training set for an AI model.

Summary

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KO23320

DEC 1 0 2002

510(k) SUMMARY

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

Submitter's Name:	Guidant CorporationEndovascular Solutions
Submitter's Address:	1525 O'Brien DriveMenlo Park, CA 94025
Telephone:Fax:	(650) 470-6372(650) 617-5024
Contact Person:	Michelle Grossman
Date Prepared:	October 2, 2002
Device Trade Name:	AGILTRAC™.035 Peripheral Dilatation Catheter
Device Common Name:	Balloon Catheter
Device Classification Name:	LIT
Device Classification:	Class II

Summary of Substantial Equivalence:

The AGILTRAC™ .035 Peripheral Dilatation Catheter is available with balloon diameters of 4.0-10.0 mm, with lengths of 20. 40 and 60 mm, 12.0 and 14.0 mm balloon diameters with lengths of 20 and 40 mm, 4.0-8.0 mm balloon diameters with a length of 80mm and 4.0-7.0 mm balloon diameters with a length of 100mm. The catheter lengths are 55 cm, 80 cm and 135 cm. The AGILTRAC™ .035 Peripheral Dilatation Catheter is substantially equivalent to Guidant's Ancure® Iliac Balloon Catheter consisting of balloon diameters of 9.5 - 14.5 in 1 mm increments, balloon lengths of 30 mm with system. The AGILTRAC™ .035 Peripheral Dilatation Catheter is substantially equivalent to the legally marketed comparison device with respect to design, materials, method of delivery and intended use.

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Device Description:

The balloon, which has two (2) radiopaque markers to aid in positioning the balloon in the stenosis, is designed to provide an expandable segment of known diameter and length at specific pressures.

The proximal end of the catheter has a sidearm adaptor that provides access to the inflation lumen and guidewire lumen. It is designed with a luer-lock fitting for connection with an inflation device.

Indications for Use:

The AGILTRAC™ .035 Peripheral Dilatation Catheter is intended:

. To secure attachment systems in the iliac arteries and/or
To expand vascular prosthesis limbs. .

Technological Characteristics:

Comparisons of the subiect and predicate device show that technological characteristics such as materials, biocompatibility, mode of operation, performance properties, sterilization and packaging are substantially equivalent to the currently marketed predicate device, Ancure® Iliac Balloon Catheter.

Performance Data:

The safety and effectiveness of the AGILTRAC™ .035 Peripheral Dilatation Catheter has been demonstrated through data collected from in vitro bench tests and analyses.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized design featuring an eagle's head and three horizontal bars.

ood and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850

DEC 10 2002

Guidant Corporation c/o Ms. Michelle Grossman 1525 O'Brien Drive Menlo Park, CA 94025

Re: K023320

Guidant Aqiltrac .035 Peripheral Dilatation Catheter Regulation Number: 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY and LIT Dated: October 2, 2002 Received: October 4, 2002

Dear Ms. Grossman:

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.

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

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Page 2 - Ms. Michelle Grossman

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 (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

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

. 510(k) Number (if known): K023320

Device Name: Guidant Agiltrac .035 Peripheral Dilatation Catheter

Indications For Use: The AGILTRAC™ .035 Periheral Dilatation Catheter is intended to:

dilate stenoses in peripheral arteries
treat obstructive lesions of native or synthetic A-V fistulae
secure the attachment systems in the iliac arteries, and
to expand vascular prosthesis limbs

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

A. Cardiovascular & Recipient Form
(k) Number K023320

(Optional Format 3-10-98)

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).