To dilate stenoses in the peripheral arteries (iliac, femoral, ilio-femoral, popliteal, infra popliteal, renal arteries); and
. For the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Device Description

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" guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The distal 20 cm of the catheter shaft and the entire length of the balloon are coated with Microglide®, a silicone based material used to reduce friction by providing a surface film over the catheter shaft.

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

The provided text describes a 510(k) submission for the AGILTRAC™ .035 Peripheral Dilatation Catheter. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria based on clinical performance.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies, tailored to your request:

Acceptance Criteria and Device Performance

The submission does not define specific quantitative performance acceptance criteria (e.g., accuracy, sensitivity, specificity, or specific physical measurements with thresholds) and then report how the device met those for a clinical outcome. Instead, the "Performance Data" section states:

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

This indicates that the safety and effectiveness were assessed through bench testing, likely comparing physical and mechanical characteristics to the predicate device, rather than patient outcomes. The primary "acceptance criterion" appears to be substantial equivalence to the predicate device, the AGILTRAC™ .018 Peripheral Dilatation Catheter, in terms of design, materials, method of delivery, intended use, technological characteristics, biocompatibility, mode of operation, performance properties (presumably physical/mechanical), sterilization, and packaging.

Since no specific performance metrics are given for the new device and accepted as meeting criteria, the table below will reflect this.

Acceptance Criteria (e.g., performance metric and threshold)	Reported Device Performance
Substantial equivalence to predicate device	Demonstrated through in vitro bench tests and analyses in terms of design, materials, method of delivery, intended use, technological characteristics, biocompatibility, mode of operation, performance properties, sterilization, and packaging.

Study Details:

Given that this is a 510(k) for substantial equivalence based on bench testing, many of the requested details about clinical studies, expert-based ground truth, and reader studies are not applicable or not provided.

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in terms of patient numbers or specific clinical cases. The "test set" consisted of in vitro bench tests and analyses.
- Data Provenance: Not applicable in the context of clinical data provenance as the data is from bench tests.
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. Ground truth for bench tests typically refers to engineering specifications, validated test methods, and reference standards, not expert clinical consensus.
Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable as no clinical test set requiring adjudication is described.
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 MRMC study was done, as this is a medical device (catheter) and not an AI or imaging diagnostic device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable as this is a medical device (catheter), not an algorithm or AI system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For in vitro bench tests, the "ground truth" would be established by engineering specifications, validated physical measurements (e.g., balloon diameter at specified pressure, shaft flexibility, burst pressure), and adherence to material standards, rather than clinical ground truth types like pathology or expert consensus.
The sample size for the training set
- Not applicable. This device is not an AI/ML algorithm that requires a "training set." The development process would involve iteration and testing, but not in the sense of an ML training set.
How the ground truth for the training set was established
- Not applicable. No training set in the context of AI/ML.

Summary of the Document's Scope:

The provided 510(k) documentation focuses on establishing substantial equivalence for a peripheral dilatation catheter to an already marketed predicate device. This process primarily relies on demonstrating that the new device has "technological characteristics such as materials, biocompatibility, mode of operation, performance properties, sterilization and packaging" that are substantially equivalent, supported by in vitro bench tests and analyses. It does not describe clinical studies with human subjects that measure specific clinical outcomes against predefined acceptance criteria, nor does it involve AI or imaging algorithms.

Summary

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K022738

SEP 1 3 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:	(650) 617-5218
Fax:	(650) 617-5024
Contact Person:	Nadine Sakakini
Date Prepared:	August 16, 2002
Device Trade Name:	AGILTRACTM .035 Peripheral Dilatation Catheter
Device Common Name:	Percutaneous Transluminal Angioplasty Catheter
Device Classification Name:	DQY
Device Classification:	Class II

Summary of Substantial Equivalence:

The AGILTRACTM .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 AGILTRACTM .035 Peripheral Dilatation Catheter is substantially equivalent to Guidant's AGILTRACTM . 018 Peripheral Dilatation Catheter consisting of balloon diameters of 4.0-12.0mm, balloon lengths of 20, 30, 40 and 60 mm with system lengths of 80cm and 135 cm. The AGILTRACTM .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.

Indications for Use:

The AGILTRACTM . 035 Peripheral Dilatation Catheter is intended:

To dilate stenoses in the peripheral arteries (iliac, femoral, ilio-femoral, popliteal, infra popliteal, renal arteries); and
. For the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Technological Characteristics:

Comparisons of the subject 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, the AGILTRACTM . 018 Peripheral Dilatation Catheter.

Performance Data:

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

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Image /page/2/Picture/1 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 image of three human profiles facing right, stacked on top of each other, with flowing lines connecting them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 3 2002

Guidant Corporation c/o Ms. Nadine Sakakini Regulatory Affairs Associate 1525 O'Brian Drive Menlo Park, CA 94025

K022738 Re:

Trade Name: AGILTRACTM .035 Peripheral Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (two) Product Code: DQY Dated: August 16, 2002 Received: August 19, 2002

Dear Ms. Sakakini:

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 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

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Page 2 -- Ms. Nadine Sakakini

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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

K. Deen Telle

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

Enclosure

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Indications for Use Statement

510(k) Number (if known):	1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1

Device Name: AGILTRACTM .035 Peripheral Dilatation Catheter

Indications for Use:

The AGILTRACTM .035 Peripheral Dilatation Catheter is indicated for the dilatation of stenoses in the peripheral arteries (iliac, femoral, ilio-femoral, popliteal, renal arteries) and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

Division of Cardiovascular & Respiratory Devices

510(k) Number

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).