The materials of construction are consistent with introducers presently in Device Description. The product is available in 4 French to 9 French. The sheath lengths are 5cm to 110cm.

AI/ML Overview

This document describes a 510(k) premarket notification for a Catheter Introducer. The information provided heavily focuses on substantial equivalence to predicate devices rather than a direct performance study with acceptance criteria.

The acceptance criteria described in the document are implicitly based on demonstrating that the Galt Medical Catheter Introducer is "substantially equivalent" to predicate devices. This means that its functionality and performance should be comparable to these existing, legally marketed devices.

Based on the provided text, there is no explicit statement of numerical acceptance criteria (e.g., minimum accuracy, sensitivity, or specificity thresholds) that would typically be seen for a device that relies on a direct performance evaluation against a defined ground truth. Instead, the "acceptance criteria" are met by demonstrating equivalence through non-clinical testing and shared technological characteristics and indications for use.

Here's an attempt to structure the information based on the request, acknowledging the limitations of the provided text for certain categories:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Acceptance Criteria (Implicit from Substantial Equivalence)	Reported Device Performance Against Criteria
Functionality	Comparable functionality to predicate catheter introducers.	"functionality and performance... are comparable to the currently marketed introducers."
Performance	Comparable performance to predicate catheter introducers.	"functionality and performance... are comparable to the currently marketed introducers."
Tensile Strength	Results comparable to currently marketed introducers.	"Test performed included: tensile strength, and valve leakage." (Results deemed comparable)
Valve Leakage	Results comparable to currently marketed introducers.	"Test performed included: tensile strength, and valve leakage." (Results deemed comparable)
Indications for Use	Same indications for use as predicate devices.	"Galt Medical's Catheter Introducer has the same indications for use and are otherwise technically the same as the predicate devices."
Technological Characteristics	Technically the same as predicate devices (materials, sizes, etc.).	"Galt Medical's Catheter Introducer has the same indications for use and are otherwise technically the same as the predicate devices."

Study Proving Acceptance Criteria:

The study that proves the device meets the (implicit) acceptance criteria is a non-clinical comparative testing program and a review of technological characteristics against predicate devices.

Detailed Breakdown of Study Information:

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The tests mentioned are "tensile strength, and valve leakage," which would involve a certain number of manufactured units of the Galt Medical Catheter Introducer. However, the specific quantity is not reported.
- Data Provenance: The tests were performed on the Galt Medical Catheter Introducer itself. There is no mention of external data or specific countries of origin beyond the company's location (Garland, TX). These were likely prospective tests performed on newly manufactured devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable / Not Mentioned. For a device demonstrating substantial equivalence through non-clinical testing (tensile strength, valve leakage), "experts" for ground truth in the traditional sense (e.g., clinical diagnosis) are not required. The "ground truth" would be objective measurements of physical properties compared against established benchmarks or predicate device performance.
Adjudication method for the test set:
- Not Applicable / Not Mentioned. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation (e.g., imaging, pathology). For non-clinical tests measuring physical properties, the results are quantitative and do not require expert adjudication to establish a "ground truth" among differing opinions.
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. This is not an AI/imaging device. No MRMC study was conducted.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI/algorithm device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the non-clinical tests (tensile strength, valve leakage) would be objective physical measurements and engineering specifications for the device, benchmarked against the predicate devices' known performance or industry standards. It's not a clinical "ground truth" in the sense of diagnosis or patient outcomes.
The sample size for the training set:
- Not Applicable. This is a physical medical device, not a machine learning model. There is no "training set."
How the ground truth for the training set was established:
- Not Applicable. As there is no training set, this question is not relevant.

Summary

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FEB - 9 2005

510(k) Summary of Safety and Effectiveness for Galt Medical Corp. Catheter Introducer

Ko43525

(Prepared in accordance with 21 CFRPart 807.92) Date 12/14/04

(1) Submitter: Galt Medical Corp. 2475 Merritt Drive Garland, TX 75041 (972) 271-5177 Contact Person: David Catlin

(2) Device Name: Catheter Introducer Trade Name: No proprietary name has been established. Classification Name: Catheter Introducer Classification Code: DYB
(3) Substantial Equivalency: Galt Medical Catheter Introducer is substantially equivalent to Catheter Introducers from:

K000313 Galt

(4) Device Description: The materials of construction are consistent with introducers presently in Device Description. The product is available in 4 French to 9 French. The sheath lengths are 5cm to 110cm.
(5) Technological Characteristics: Galt Medical's Catheter Introducer has the same indications for use and are otherwise technically the same as the predicate devices.
(6) Non-Clinical Tests: The results of these tests demonstrated that the functionality and performance Non-Chilter Tistis. The introducers are comparable to the currently marketed introducers. Test performed included: tensile strength, and valve leakage.
(7) Conclusions: Based on the information presented in this 510(k) premarket notification, Galt Medical's Coliciusious. Dasco on the internation provinally 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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract caduceus or a triple-stranded helix, rendered in black.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 9 2005

Mr. David G. Catlin Executive Vice President Galt Medical Corp. 2475 Merritt Drive Garland, TX 75041-6146

K043525 Re:

Trade/Device Name: Catheter Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Introducer Catheter Regulatory Class: II Product Code: DYB Dated: January 7, 2005 Received: January 10, 2005

Dear Mr. Catlin:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Securer 11 (2) the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass surver in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conninered prior conner as 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 1 ou may, therefore, mains of the Act include requirements for annual registration, listing of general controls 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 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 r reaso be action and 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 – Mr. David G. Catlin

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (2001). In the marketing your device as described in your Section 510(k) This letter will anow you to ough maniening of substantial equivalence of your device to a legally premarket notification: "The PDF intelligstification 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 If you desire specific advice for your at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain Misoraning of reference to presensibilities under the Act from the Division of Small other general 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/industry/support/index.html.

Sincerely yours,

Duma R. de Anes

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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K043525

Indications for Use

510(k) Number (if known): K043525

Device Name: Catheter Introducer

Indications For Use: The Sheath Introducer system is indicated for use in percutaneous manodione For See. Theatheters and other intravascular devices into the vasculature..

Prescription Use

(Part 21 CFR 801 Subpart D)

AND/OR Over-The-Counter Use

(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna R. Vochner

(Division Sign-Off)
Division of Cardiovascular Devices

510(K) Number_K O

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).