The MicroSlide™ Tearaway Introducer System is intended for use in percutaneous procedures to introduce catheters and other intravascular devices into the coronary and peripheral vasculature of adult and pediatric patients of all ages.

Device Description

The MicroSlide™ Tearaway Introducer is constructed using identical processes and materials as the predicate devices; Tearaway Introducer Sheath, Galt Medical, K000313 with the addition of smaller sizes 2 & 3French, and the Galt VTI™ Valved Tear-away Introducer, K112398 without the hemostasis valve.

The MicroSlide™ Tearaway Introducer device consists of two components; a dilator and an outer sheath. The outer sheath is a one piece, molded hub/sheath "tearaway" design that with minimal force will break and separate at the hub/wing to facilitate the removal of the sheath tube from the patient by peeling/splitting the tub longitudinally down its length. The dilator tube is an open plastic tube with an integral molded luer hub for guidewire insertion. The dilator is longer than the outer sheath with a tapered distal tip. The sheath hub and dilator hub lock together using a rotating motion to add in insertion of the device into the vasculature.

AI/ML Overview

The provided document describes the MicroSlide™ Tearaway Introducer, a medical device for introducing catheters and other intravascular devices. The document outlines substantial equivalence to predicate devices based on functional testing and other characteristics.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the performance specifications of the subject device and compared against predicate devices. The document explicitly lists performance specifications under the "Performance Specifications" row in the comparison table on page 2.

Performance Specification	Acceptance Criteria for MicroSlide™ Tearaway Introducer (2Fr & 3Fr)	Reported Device Performance (MicroSlide™ Tearaway Introducer)
Insertion Force (Avg.)	N/A (Compared to predicate 1)	2Fr = 82.4 grams, 3Fr = 95.5 grams
Hub Break Force	2.0 lbs - 5.5 lbs	Met the criteria for predicate devices (2.0 lbs - 5.5 lbs for Predicate 1 & 2, 2.0 lbs - 10.0 lbs for Predicate 3). Specific values for the MicroSlide are not provided but implied to be within these ranges as it's considered substantially equivalent.
Sheath Peel Strength	2Fr = 0.20 - 1.00 lbs, 3Fr = 0.20 - 1.70 lbs	Met the criteria for predicate devices. Specific values for the MicroSlide are not provided but implied to be within these ranges.
Sheath/Hub Strength	2Fr = 2.0 lbs min., 3Fr = 3.0 lbs min.	Met the criteria for predicate devices (2.0 lbs min. for 2Fr and 3.0 lbs min. for 3Fr). Specific values for the MicroSlide are not provided but implied to be within these ranges.

Study Proving Acceptance Criteria:

Functional testing was conducted to verify that the 2F & 3F MicroSlide™ Tearaway Introducer met product specifications. The document states: "Functional testing was conducted to verify that the 2F & 3F MicroSlide™ Tearaway Introducer met product specifications. Testing was conducted according to protocols based on international standards and Galt Medical requirements." (Page 3)

The functional tests included:

Penetration (Insertion) Force Test Ref. XE-022
Sheath Peel Force Test - Ref. XE-022
Sheath Perpendicular Pull Test- Ref. XE-022
Dilator Pull Test- Ref. XE-022

Additionally, sterilization validation, biocompatibility testing, and packaging/product shelf-life testing were performed to ensure the device's safety and effectiveness.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not specify the exact sample sizes used for each functional test (e.g., number of devices tested for insertion force). It broadly states that "Functional testing was conducted to verify that the 2F & 3F MicroSlide™ Tearaway Introducer met product specifications." (Page 3)

The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective. However, since the studies are described as "Functional testing" and "Biocompatibility testing" performed by Galt Medical and its contractors, it implies prospective, in-house testing rather than data from real-world usage or external retrospective studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to this type of device and study. The testing described is functional and performance-based, not diagnostic, and therefore does not rely on expert interpretation of results to establish "ground truth" in the way a diagnostic AI device would. The "ground truth" here is the physical measurement of the device's performance against predefined engineering specifications.

4. Adjudication Method for the Test Set

This information is not applicable for the type of device and study. The tests involve objective physical measurements rather than subjective assessments requiring 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

This information is not applicable. The device is a physical medical instrument (catheter introducer), not an AI-powered diagnostic tool, so an MRMC study is not relevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. The device is not an algorithm or AI system. Its performance is inherent to its physical design, materials, and manufacturing process.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance specifications is based on engineering specifications and established performance ranges of legally marketed predicate devices. For example, the hub break force acceptance criterion of "2.0 lbs - 5.5 lbs" is derived from the performance of the predicate devices. The functional tests directly measure physical properties, and the results are compared to these pre-defined numerical thresholds.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical instrument and does not involve a "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set Was Established

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

Summary

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K123430- Page 1 of 5

APR 1 2 2013

Manufacturer:	Galt Medical
	2220 Merritt Drive
	Garland, TX 75041
Official Contact:	David Derrick, Director of Quality and Regulatory Affairs
Date Prepared:	November 02, 2012

Device Information:

Device Name:	MicroSlide™ TearAway Introducer
Device Model Number:	TBD
Classification Name:	Catheter Introducer (DYB),21 CFR 870.1340
Device Classification:	Class II (Cardiovascular)

Predicate Devices:
Device 1	Tearaway Introducer Sheath, Galt Medical - K000313 (Xentek Medical)
	Device Class: II
Device 2	Galt VTI™ Valved Tear-away Introducer, Galt Medical - K112398
	Device Class: II
Device 3	Super Sheath Introducer Sheath, Togo Medikit Co. Ltd., K121504
	Device Class: II

Intended Use: The MicroSlide™ Tearaway Introducer System is intended for use in percutaneous procedures to introduce catheters and other intravascular devices into the coronary and peripheral vasculature of adult and pediatric patients of all ages.

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Device Description:

Materials of Construction:

Dilator hub: The hub of the dilator is made from a polyamide co-polymer resin base material with a white colorant .

Dilator Tube: The dilator tube is made from a polyamide co-polymer resin base material with a green colorant.

Sheath hub (wing): The sheath hub is made from a high density polypropylene base material with a blue or purple colorant depending on the French size.

Sheath tube: The sheath tube is made from PTFE, w/bismuth trioxide loading and a gray colorant.

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Image /page/2/Picture/0 description: The image shows a logo with a large, stylized letter 'G' at the top. Below the 'G', the word 'GALT' is written in a bold, sans-serif font. The logo is black and white, with the 'G' and the word 'GALT' appearing in black against a white background.

Comparison of Technological Characteristics and Substantial Equivalence:

The following table summarizes the technological comparison of the MicroSlide™ Tearaway Introducer and the predicate devices, Galt Tearaway Introducer, VTI™ Valved Tear-away Introducer, and Togo Medikit Super Sheath Introducer Sheath.

Mfr. / Product	Subject device	Predicate 1	Predicate 2	Predicate 3
	Galt MicroSlide™ TearawayIntroducer	Galt TearawayIntroducer	Galt VTI™ ValvedTearaway Introducer	Togo Medikit SuperSheath Introducer Sheath(3.3F)
510(k) Number	K123430	K000313	K112398	K121504
Device Classification	870.1340	870.1340	870.1340	870.1340
Product Code	DYB	DYB	DYB	DYB
Intended use	These introducers are usedfor the percutaneousintroduction of diagnostic ortherapeutic devices, such ascatheters and pacing leadsinto the coronary andperipheral vasculature ofadult and pediatric patientsof all ages.	These introducers areused for thepercutaneousintroduction ofdiagnostic ortherapeutic devices,such as catheters andpacing leads into thevasculature.	These introducers areused for thepercutaneousprocedures to introducecatheters and otherintravascular devicesinto the peripheralvasculature.	These introducers areused in the introduction ofdiagnostic andinterventional deviceinserted into humanvasculature of adult andpediatric patients of allages
PerformanceSpecifications	InsertionForce(Avg.)	$2Fr = 82.4$ grams$3Fr= 95.5$ grams	N/A	N/A	N/A
	Hub BreakForce	2.0 lbs - 5.5 lbs	2.0 lbs - 5.5 lbs	2.0 lbs - 10.0 lbs	N/A
	Sheath PeelStrength	$2Fr = 0.20 - 1.00$ lbs$3Fr = 0.20 - 1.70$ lbs	$4 - 15Fr = 0.20 - 1.70$lbs$16Fr = 0.20 - 2.25$ lbs	$4 - 15Fr = 0.20 - 1.70$lbs$16Fr = 0.20 - 2.25$ lbs	N/A
	Sheath/Hubstrength	$2Fr = 2.0$ lbs min.$3Fr = 3.0$ lbs min.	3.0 lbs min.	$6 - 15Fr = 2.6$ lbs min.$16Fr = 3.3$ lbs min	N/A
Design	Tear-away introducer with winged sheath hub andlocking dilator	Tear-away introducer with winged sheath hub andlocking dilator	Tear-away introducerwith winged sheath hub,integrated hemostasisvalve, optional sideport, w/stopcock andlocking dilator	Introducer with roundsheath hub, integratedhemostasis valve, sideport, w/stopcock andlocking dilator
Color		Gray sheath with color coded hub, Green dilator cannula		White Sheath with colorcoded hub, green dilatorcannula
Shape		Cylindrical cannula with winged hub		Cylindrical cannula withround hub
Sizes		3cm, and 7cm, lengthssizes 2F - 3F	14cm, 30cm, 44cmand 50cm lengthssizes 4F - 16F	13cm, and 23cm,lengthssizes 6F - 16F	5cm, and 7cm, lengths3.3 F size
Shelf life			4 years	3 Years
Sterilization			Ethylene Oxide (SAL 10⁶)	Ethylene Oxide
Packaging Configurations			Finished single sterile deviceFinished sterile kit	Finished singlesterile deviceFinished sterilekit

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Use Type: The MicroSlide ™ Tearaway Introducer is a single patient use, disposable device.

Summary of Non-Clinical Data Submitted: Functional testing was conducted to verify that the 2F & 3F MicroSlide™ Tearaway Introducer met product specifications. Testing was conducted according to protocols based on international standards and Galt Medical requirements. Functional Testing included the following:

Penetration (Insertion) Force Test Ref. XE-022 ■
트 Sheath Peel Force Test - Ref. XE-022
Sheath Perpendicular Pull Test- Ref. XE-022 . "
Dilator Pull Test- Ref. XE-022

Additionally the finished single device and kit versions of the 2F & 3F MicroSlide™ Tearaway Introducers were adopted into the existing ethylene oxide sterilization cycle for the Tearaway Introducer and Galt VTI products which was validated in accordance with ISO 11135-1 using a frictional cycle/overkill approach to a sterility assurance level (SAL) of 10 °. The ethylene oxide sterilization validation report is provided in Section 14, TAB 14.1

Biocompatibility testing was performed on the predicate devices provided in K000313 and K112398. The devices tested under K000313 and K112398 included raw materials and packaging materials utilized in the 2F & 3F MicroSlide™ Tearaway Introducers and is included in Section 15, TAB 15.1 of this 510(k) premarket notification. Additional testing was not conducted.

Packaging and product shelf life testing was conducted according domestic and international standards and in-house requirements, and includes the following:

. Package integrity (Visual)
.. Package integrity (Bubble Emission)
. Sheath Peel Force Test
. Sheath Perpendicular Pull Test
미 Dilator Pull Test

Final reports for packaging and product shelf life testing is provided in Section 18, TAB 18.2 , Test 0546 and TAB 18.3, Test 0541 of this 510(k) premarket notification.

Summary of Risk Management: Risk assessment is addressed in the Risk Management Report and FMEA "Tearaway Products Family", FMEA-022. Current controls have been identified and all potential Failure Modes identified in the FMEA currently fall into the "Broadly Acceptable" region as defined by Galt procedure # OP-072, Conducting Failure Mode and Effects Analysis. The risk analysis for the MicroSlide™ and Tearaway Introducer family is provided in Section 12, Tab 12.1.

Conclusion of Substantial Equivalence: The basis of substantial equivalence for the MicroSlide™ 2F & 3F Tearaway Introducer is based on the similarities in intended use, materials, function, performance, sterilization, design, technology and operational principle to the predicate devices. Risks associated with the smaller French sizes and new patient population were assessed and mitigated if applicable.

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Due to these similarities, Galt Medical believes that the MicroSlide™ 2F & 3F Tearaway Introducer does not raise any new safety or effectiveness issues and is determined to be substantially equivalent to the referenced predicate devices.

End of Section

GALT MEDICAL CORP. 2220 MERRITT DRIVE / GARLAND, TEXAS 75041-6146

Page 5 of 5

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 12, 2013

Galt Medical Corp. c/o Mr. David Derrick Director of Quality and Regulatory Affairs 2220 Merritt Dr. Garland, TX 75041

Re: K123430

Trade/Device Name: MicroSlide Tearaway Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: March 21, 2013 Received: March 22, 2013

Dear Mr. Derrick:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Mr. David Derrick

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Matthew G튀레illebrenner

for

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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INDICATIONS FOR USE

510(K) number (if known):_K/23430

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The Introducer System is intended for use in percutaneous procedures to introduce catheters and other intravascular devices into the coronary and peripheral vasculature of adult and pediatric patients of all ages

Prescription Use_ X (Per 21 CFR 801 Subpart D) OR

Over-The-Counter Use (Per 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)

Matthew G. Hillebrenner

Page_1 of 1

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).