The Cordis ATW Marker Wire Steerable Guidewires are intended for use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature. In addition, the Cordis ATW Marker Wire Steerable Guidewires are intended to facilitate the alignment of interventional devices and function as a measurement tool.

Device Description

The device description of the ATW Marker Wire Steerable Guidewire is as follows.
• Stainless Steel Corewire,
• Radiopaque platinum / nickel coilwire,
• Radiopaque Marker Bands with optional spacing (See package labeling), and
• PTFE coating on shaft.

AI/ML Overview

The provided document is a 510(k) summary for the "ATW Marker Wire Steerable Guidewire." This is a premarket notification for a medical device seeking clearance based on substantial equivalence to predicate devices, rather than a study demonstrating the device meets specific acceptance criteria based on performance testing against defined metrics.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not present in this type of submission.

Here's what can be extracted based on the provided text:

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

The document does not explicitly define quantitative acceptance criteria or report performance metrics in the way a clinical study would. Instead, it asserts substantial equivalence to predicate devices. The "Summary of Substantial Equivalence" states: "The ATW Marker Wire Steerable Guidewires are substantially equivalent to the previously cleared ST Steerable Guidewire, Wizdom Marker Wire, and Stabilizer Marker Wire Steerable Guidewires."

The shared characteristics that support this equivalence are:

Intended Use: "The Cordis ATW Marker Wire Steerable Guidewires are intended for use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature. In addition, the Cordis ATW Marker Wire Steerable Guidewires are intended to facilitate the alignment of interventional devices and function as a measurement tool." This is directly compared to the intended use of predicate devices (though not explicitly detailed in this excerpt).
Device Description:
- Stainless Steel Corewire
- Radiopaque platinum / nickel coilwire
- Radiopaque Marker Bands with optional spacing
- PTFE coating on shaft
Biocompatibility: "All materials used in the ATW Marker Wire Steerable Guidewires are biocompatible."

The implication is that because these characteristics are similar to predicate devices, the new device will perform acceptably without needing to meet new, specific performance acceptance criteria.

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

Not applicable. This is a 510(k) submission based on substantial equivalence, not a clinical trial or performance study with a test set of data.

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. No test set or ground truth in this context.

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

Not applicable. No test set adjudication.

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 device is a steerable guidewire, not an AI-powered diagnostic tool, and no MRMC study is mentioned.

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

Not applicable. This device is a physical medical instrument, not an algorithm.

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

Not applicable. Ground truth is not established in this type of submission; clearance is based on comparison to existing, cleared devices.

8. The sample size for the training set

Not applicable. This is not an AI/algorithm where a training set would be used.

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

Not applicable. No training set.

Summary

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Attachment 4

AN 13 2000

Attachment 4

Summary of Safety and Effectiveness

GeneralProvisions	Trade Name: ATW Marker Wire Steerable GuidewireCommon/Classification Name: Catheter Guide Wire
Name ofPredicateDevices	Wizdom Marker Wire Steerable GuidewireStabilizer Marker Wire Steerable GuidewireST Steerable Guidewire
Classification	Class II
PerformanceStandards	The FDA under section 514 of the Food, Drug and Cosmetic Act has not establishedperformance standards.
Intended Useand DeviceDescription	The Cordis ATW Marker Wire Steerable Guidewires are intended for use inangiographic procedures to introduce and position catheters and interventional deviceswithin the coronary and peripheral vasculature. In addition, the Cordis ATW MarkerWire Steerable Guidewires are intended to facilitate the alignment of interventionaldevices and function as a measurement tool.
	The device description of the ATW Marker Wire Steerable Guidewire is as follows.• Stainless Steel Corewire,• Radiopaque platinum / nickel coilwire,• Radiopaque Marker Bands with optional spacing (See package labeling), and• PTFE coating on shaft.
Biocompatibility	All materials used in the ATW Marker Wire Steerable Guidewires are biocompatible.
Summary ofSubstantialEquivalence	The ATW Marker Wire Steerable Guidewires are substantially equivalent to thepreviously cleared ST Steerable Guidewire, Wizdom Marker Wire, and StabilizerMarker Wire Steerable Guidewires.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 3 2000

Mr. Dennis Griffin Manager, Requlatory Affairs Cordis Corporation P.O. Box 025700 Miami, FL 33102-5700

Re: K994358 Trade Name: ATW Marker Wire Steerable Guidewire Regulatory Class: II Product Code: DQX December 20, 1999 Dated: Received: December 27, 1999

Dear Mr. Griffin:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation

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Page 2 - Mr. Dennis Griffin

you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-Also, please note the requlation entitled, "Misbranding by 4639. reference to premarket notification" (21CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.tda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Ouitopm. Al-for

Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment 2

Indications for Use Statement

510(k) Number(if known)	The 510(k) number has not yet been assigned.
Device Name	ATW Marker Wire Steerable Guidewire
Indications forUse	The Cordis guidewires are intended for use in angiographic procedures to introduceand position catheters and interventional devices within the coronary and peripheralvasculature. In addition, the Cordis ATW Marker Wire Steerable Guidewires areintended to facilitate the alignment of interventional devices and function as ameasurement tool.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
X
(Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

for Witten
Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number. K994358

Regulation Number and Section

§ 870.1330 Catheter guide wire.

(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.