The Cordis AVIATOR Peripheral Dilatation catheter is intended to dilate stenoses in the 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 AVIATOR Peripheral Dilatation Catheter has an integrated shaft system and a balloon near the distal tip. The shaft has a combination of single lumen and dual lumen tubing. One lumen is used for inflation of the balloon with contrast medium. The second lumen, located only in the distal shaft, permits the use of a .014" diameter guidewire to facilitate the advancement of the catheter to and through the stenosis to be dilated. The catheter shaft has a distal port (hole) near the distal end that accesses the guidewire lumen. The guidewire lumen begins at the distal port and ends at the distal tip. This "rapid exchange" design allows insertion and removal of the catheter without extension of the guidewire.

The balloon has radiopaque marker(s) to aid in positioning the balloon. The balloon is further designed to provide an expandable segment of known diameter and length at a specific pressure.

The design of this catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.

A flushing needle accessory is also provided with the device to facilitate flushing/lubricating the catheter's inner guidewire lumen prior to use.

The AVIATOR Peripheral Dilatation Catheter is provided sterile and is intended for single use only.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Cordis AVIATOR Peripheral Dilatation Catheter. This document primarily focuses on demonstrating substantial equivalence to pre-existing predicate devices through non-clinical performance data. It does not contain information about clinical studies with "acceptance criteria" in the typical sense of measuring a device's effectiveness through patient outcomes or comparative clinical performance against a benchmark.

Here's a breakdown based on your request, highlighting the information that is present and absent:

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

Acceptance Criteria (What the device was tested for)	Reported Device Performance (Implied by substantial equivalence)
Biocompatibility	Demonstrated to be substantially equivalent to predicate devices.
Balloon minimum burst strength	Met specifications equivalent to predicate devices.
Balloon compliance (distensibility)	Met specifications equivalent to predicate devices.
Balloon inflation/deflation performance	Met specifications equivalent to predicate devices.
Balloon fatigue (repeated balloon inflation) endurance	Met specifications equivalent to predicate devices.
Bond strengths	Met specifications equivalent to predicate devices.
Catheter diameter and balloon profile	Matched specifications of predicate devices.
Catheter body minimum burst strength	Met specifications equivalent to predicate devices.
General	Safety and effectiveness demonstrated via non-clinical tests and analyses, as determined necessary per applicable risk analyses.

Important Note: The document explicitly states, "The safety and effectiveness of the Cordis AVIATOR Peripheral Dilatation Catheter have been demonstrated via data collected from non-clinical tests and analyses..." It does not provide specific numerical acceptance criteria or detailed numerical performance results for these tests, but rather asserts that the device met the necessary standards to be "substantially equivalent" to its predicate devices.

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

This information is not provided in the document. The text refers to "non-clinical tests and analyses" but does not detail sample sizes, data provenance (e.g., country of origin), or whether the data was retrospective or prospective.

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)

This information is not applicable and therefore not provided. The assessment was based on non-clinical engineering and material performance tests, not clinical evaluations requiring expert consensus on ground truth.

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

This information is not applicable and therefore not provided. As the testing was non-clinical, there wouldn't be an adjudication method for interpreting clinical test results.

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

An MRMC comparative effectiveness study was not done. This device is a physical medical device (catheter), not an AI diagnostic tool, so this type of study is irrelevant.

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

This information is not applicable. The device is a physical catheter, not an algorithm, so "standalone" performance in the context of an algorithm is not relevant. The device itself is designed to be used by a human operator (physician).

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

For the non-clinical tests, the "ground truth" would be established by engineering standards and specifications for medical devices (e.g., ASTM standards, internal company specifications for burst strength, compliance, etc.). There is no mention of expert consensus, pathology, or outcomes data, as these are typically associated with clinical studies.

8. The sample size for the training set

This information is not provided and not applicable in the context of this device. A "training set" typically refers to data used to train an AI algorithm, which is not what this device is. For non-clinical device testing, there might be "test sets" for various engineering experiments, but they are not referred to as training sets.

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

This information is not provided and not applicable, as there is no "training set" for this physical device.

Summary

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K013581

NOV 2 8 2001		510(k)
Summary of Safety and Effectiveness
Submitter:	Cordis Corporation, a Johnson & Johnson Company7 Powderhorn DriveWarren, New Jersey 07059
Contact Person:	Chuck RyanManager, Regulatory AffairsCordis Corporation, a Johnson & Johnson Company7 Powderhorn DriveWarren, New Jersey 07059Telephone: (908) 412-7446Fax: (908) 412-3915E-mail: cryan@crdus.jnj.com
Date Prepared:	October 26, 2001
Trade Name:	Cordis AVIATOR™ Peripheral Dilatation Catheter
Common Name:	Percutaneous Transluminal Angioplasty (PTA) BalloonCatheter
Classification Name:	(unclassified; FDA product code LIT)
Device Classification:	Class II

Summary of Substantial Equivalence:

0 0 0004

The design, materials, specifications, performance, packaging and intended use featured with the Cordis AVIATOR Peripheral Dilatation Catheter are substantially equivalent to those featured among the following predicate devices:

Cordis OPTA® LP PTA Catheter (ref. K971448 and K981407); .
Cordis SLALOM™ .018 PTA Balloon Catheter (ref. K003159); ●
Cordis M3 PTA Dilatation Catheter (ref. K003920); and, .
Guidant AVIATOR Peripheral Dilatation Catheter (ref. K010831). .

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In short, the subject AVIATOR Peripheral Dilatation Catheter represents a line extension to the predicate Cordis devices that introduces substitute catheter materials.

Device Description:

The balloon has radiopaque marker(s) to aid in positioning the balloon. The balloon is further designed to provide an expandable segment of known diameter and length at a specific pressure.

The design of this catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.

A flushing needle accessory is also provided with the device to facilitate flushing/lubricating the catheter's inner guidewire lumen prior to use.

The AVIATOR Peripheral Dilatation Catheter is provided sterile and is intended for single use only.

Intended Use:

The AVIATOR Peripheral Dilatation catheter is intended to dilate stenoses in the 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:

The subject AVIATOR Peripheral Dilatation Catheter incorporates substantially equivalent indications for use, design, and dimensional and performance specifications as those found with the aforementioned predicate devices. The AVIATOR Peripheral Dilatation Catheter is provided in a range of expanded diameters from 4 to 7 mm and in lengths of 15 to 40 mm. The device features a useable catheter length of 75 to 135 cm.

Performance Data:

The safety and effectiveness of the Cordis A VIATOR Peripheral Dilatation Catheter have been demonstrated via data collected from non-clinical tests and analyses, which addressed the following, among other considerations, as determined necessary per applicable risk analyses:

. Biocompatibility

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Balloon minimum burst strength .
Balloon compliance (distensibility) .
Balloon inflation/deflation performance .
Balloon fatigue (repeated balloon inflation) endurance .
Bond strengths ●
Catheter diameter and balloon profile .
Catheter body minimum burst strength .

A statement of substantial equivalence to another product is required by 21 CFR 807.87 and relates A statement of substantial can be marketed without prior reclassification or clinical only to whicher the present submission not related to the coverage of any patent and is not to apply of a present valsion or used as evidence in a patent infringement lawsuit. As the be interpreted as an administion of substantial equivalence under the Federal Food, commissioner of the stated, "I decembact that the product can be lawfully marketed without pre-Drug and Cosment received ton. This determination is not intended to have any bearing marker approval of reclassified in "This ingement suits." 42 Federal Register 42, 50 et seq. (1977).

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 8 2001

Mr. Chuck Ryan Manager, Regulatory Affairs Cordis Corporation, a Johnson & Johnson Company 7 Powder Horn Drive Warren, NY 07059

Re: K013581

Trade Name: Cordis AVIATOR™ Peripheral Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY and LIT Dated: October 26, 2001 Received: October 29, 2001

Dear Mr. Ryan:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becally be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enorosule) to regars) at tegally and the Medical Device Amendments, or to conninered print to thay 20, 1978, are cassified in accordance with the provisions of the Federal Food, DINAA de necs that have been recidential in quire approval of a premarket approval application (PMA). and Cosmetic Act (110c) that ao not requent of the general controls provisions of the Act. The 1 ou may, dicrorolo, market are act include requirements for annual registration, listing of general voltared provision 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 If your device is olassified (600 a00 voyals. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations of t may be subject to sach additions, 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 - Mr. Chuck Ryan

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 (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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4645. 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,

James E. Dillard III

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Cordis Franchise Form - CFF 20-014 Rev.01 Intended Use Statement

Page 1 of 1 Effective Date: 1 1/15/00

K013581

Image /page/5/Picture/2 description: The image shows the word "Cordis" in a bold, sans-serif font. A thick line underlines the word. Below the line, the name "Cordis-Johnson" is written in a smaller, cursive font. The text appears to be a logo or brand name.

Page 1 of 1

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Cordis AVIATOR Peripheral Dilatation Catheter

Indications for Use Statement

The Cordis AVIATOR Peripheral Dilatation catheter is intended to dilate senoses in the illio, femoral, ilio-I IIC Cordis A VIA I OK Feripies and for the treatment of obstructive lesions of naive or synthetic arteriovenous dialysis fistulae.

Division of Cardiovascular & Respiratory Devices
510(k) Number K01 3581

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Usc _________________

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Over-The-Counter Use

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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).