EASY PASS HYDROPHILIC COATED VASCULAR GUIDEWIRE by GALT MEDICAL CORP.

These guidewires are intended for use in percuttaneous procedures to introduce and position catheters, pacing leads, and other interventional devices within the coronary and peripheral vasculature.

Device Description

The materials of construction stainless steel, nitinol, platinum are consistent with guidewires presently in commercial distribution. The wires are available straight, angled or with "J" end. The wires range from .014" diameter through .. 065" diameter and lengths from 20cm. to 360 cm. The wires are coated with a plastic hydrophilic or hydrophilic coating.

AI/ML Overview

This 510(k) summary does not contain information about acceptance criteria or a study proving the device meets them. This document is a 510(k) Premarket Notification, which focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive performance data from dedicated studies.

Here's why and what's typically missing:

Substantial Equivalence: The primary goal of a 510(k) is to show that a new device is as safe and effective as a legally marketed predicate device. This is often done by comparing technological characteristics and intended use, not necessarily by conducting independent clinical trials or detailed performance studies with acceptance criteria.
"Same as Predicate" Justification: The document explicitly states: "Galt Medical's guidewires have the same indications for use and are otherwise technically the same as the predicate devices." This implies that the performance is presumed to be similar to the predicate, and new performance data against specific acceptance criteria is not provided in this summary.

Therefore, I cannot populate the requested table or answer most of the questions based solely on the provided text.

However, I can extract what is present:

Device: Hydrophilic Coated Vascular Guidewires
Intended Use: "These guidewires are intended for use in percutaneous procedures to introduce and position catheters, pacing leads, and other interventional devices within the coronary and peripheral vasculature."
Predicate Devices: K982559, K021990, and K031916

Regarding the specific questions:

A table of acceptance criteria and the reported device performance: Not provided. The document focuses on substantial equivalence based on technical characteristics and intended use being similar to predicate devices.
Sample size used for the test set and the data provenance: Not applicable/Not provided. This type of information would be part of a dedicated performance study, which is not detailed here. The submission relies on equivalence to existing devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. This relates to clinical or performance studies, which are not outlined.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/Not provided.
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 guidewire, not an AI-powered diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a guidewire, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/Not provided.
The sample size for the training set: Not applicable/Not provided. (Again, this is not an AI/algorithm-based device).
How the ground truth for the training set was established: Not applicable/Not provided.

Summary

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DEC = 5 2003

LD33542

510(k) Summary of Safety and Effectiveness for Galt Medical's Hydrophilic Coated Vascular Guidewires (Prepared in accordance with 21 CFRPart 807.92) Date 11/18/03

(1) Submitter: Galt Medical Corp. 2475 Merritt Drive Garland, TX 75041 (972) 271-5177 Contact Person: David Catlin
(2) Device Name: Guidewire Trade Name: Easy Pass Hydrophilic Coated Vascular Guidewire Classification Name: Wire, Guide, Catheter Classification Code: DQX
(3) Substantial Equivalency: Galt Medical Corp. guidewires are substantially equivalent to guidewires from K982559, K021990, and K031916
(4) Device Description: The materials of construction stainless steel, nitinol, platinum are consistent with guidewires presently in commercial distribution. The wires are available straight, angled or with "J" end. The wires range from .014" diameter through .. 065" diameter and lengths from 20cm. to 360 cm. The wires are coated with a plastic hydrophilic or hydrophilic coating.

These guidewires are intended for use in percutaneous procedures to introduce and position catheters, pacing leads and other interventional devices within the coronary and peripheral vasculature.

(5) Technological Characteristics: Galt Medical's guidewires have the same indications for use and are otherwise technically the same as the predicate devices.
(6) Conclusions: Based on the information presented in this 510(k) premarket notification, Galt Medical's hydrophilic coated vascular guidewires are considered substantially equivalent to the currently marketed predicate devices.

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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, which is a symbol often associated with healthcare. The caduceus consists of a staff with two snakes coiled around it and a pair of wings at the top.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 5 2003

Galt Medical Corporation c/o Mr. David G. Catlin Executive Vice President 2475 Merrit Drive Garland, TX 75041-6146

Re: K033542

Hydrophilic Coated Vascular Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: November 6, 2003 Received: November 10, 2003

Dear Mr. Catlin:

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 - Mr. David G. Catlin

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), please contact the Office of Compliance at (301) 594-4648. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address

http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Alva D. Herz for

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

Enclosure

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510 (k) Number (if known): ___ Lt 335542_

Device Name: Hydrophilic Coated Vascular guidewire

Indications For Use: These guidewires are intended for use in percutancous procedures to introduce and position catheters, pacing leads, and other interventional devices within the coronary and peripheral vasculature.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use,
(Per 21 CFR 801.109)

12/5/3

Prescription Use OR Over-the Counter Use
(Per 21 CFR 801.109)

Division of Cardiovascular & Respiratory Devices
510(k) Number

(Optional Format 1-2-96)

12/5/3

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.