K Number

Device Name

MICROSLIDER TEARAWAY INTRODUCER SET

Manufacturer

GALT MEDICAL CORP.

Date Cleared

2013-04-12

(156 days)

Product Code

DYB

Regulation Number

870.1340

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.

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K000313, K112398, K121504

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the mechanical properties and function of a physical introducer system, with no mention of software, algorithms, or data processing that would indicate AI/ML.

Therapeutic

No.
The device is intended to introduce catheters and other intravascular devices, not to treat a condition itself.

Diagnostic

The device is described as an introducer system intended to introduce catheters and other intravascular devices, which are interventional procedures, not diagnostic ones.

SaMD (Software as a Medical Device)

The device description clearly outlines physical components (dilator, outer sheath, hub, luer hub) and describes their construction and function, indicating it is a physical medical device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to introduce catheters and other intravascular devices into the coronary and peripheral vasculature. This is a procedure performed directly on the patient's body, not on a sample taken from the body.
Device Description: The device is a physical introducer system designed for insertion into blood vessels. It does not involve the analysis of biological samples.
Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory testing.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, treatment, or prevention of disease. This device is a tool for facilitating medical procedures, not for performing diagnostic tests on samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

DYB

Device Description

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.

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

coronary and peripheral vasculature

Indicated Patient Age Range

adult and pediatric patients of all ages

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 ■
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
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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K000313, K112398, K121504

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

Image /page/0/Picture/0 description: The image shows a logo for Galt. The logo consists of a stylized letter "G" in a bold, sans-serif font, with a portion of the upper right quadrant removed, giving it a slightly incomplete appearance. Below the "G", the word "GALT" is written in a similar bold, sans-serif font, with all letters capitalized. The entire logo is black against what appears to be a white background.

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.

Image /page/1/Picture/2 description: The image shows a logo with a stylized letter 'G' at the top and the word 'GALT' below it. The 'G' is formed by a thick, black shape with a white, crescent-shaped cutout inside, creating a bold and recognizable symbol. The word 'GALT' is written in a simple, sans-serif font, positioned directly beneath the 'G' to complete the logo.

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.

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™ Tearaway
Introducer	Galt Tearaway
Introducer	Galt VTI™ Valved
Tearaway Introducer	Togo Medikit Super
Sheath 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 used
for the percutaneous
introduction of diagnostic or
therapeutic devices, such as
catheters and pacing leads
into the coronary and
peripheral vasculature of
adult and pediatric patients
of all ages.	These introducers are
used for the
percutaneous
introduction of
diagnostic or
therapeutic devices,
such as catheters and
pacing leads into the
vasculature.	These introducers are
used for the
percutaneous
procedures to introduce
catheters and other
intravascular devices
into the peripheral
vasculature.	These introducers are
used in the introduction of
diagnostic and
interventional device
inserted into human
vasculature of adult and
pediatric patients of all
ages
Performance
Specifications	Insertion
Force(Avg.)	$2Fr = 82.4$ grams
$3Fr= 95.5$ grams	N/A	N/A	N/A
	Hub Break
Force	2.0 lbs - 5.5 lbs	2.0 lbs - 5.5 lbs	2.0 lbs - 10.0 lbs	N/A
	Sheath Peel
Strength	$2Fr = 0.20 - 1.00$ 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/Hub
strength	$2Fr = 2.0$ 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 and
locking dilator	Tear-away introducer with winged sheath hub and
locking dilator	Tear-away introducer
with winged sheath hub,
integrated hemostasis
valve, optional side
port, w/stopcock and
locking dilator	Introducer with round
sheath hub, integrated
hemostasis valve, side
port, w/stopcock and
locking dilator
Color		Gray sheath with color coded hub, Green dilator cannula		White Sheath with color
coded hub, green dilator
cannula
Shape		Cylindrical cannula with winged hub		Cylindrical cannula with
round hub
Sizes		3cm, and 7cm, lengths
sizes 2F - 3F	14cm, 30cm, 44cm
and 50cm lengths
sizes 4F - 16F	13cm, and 23cm,
lengths
sizes 6F - 16F	5cm, and 7cm, lengths
3.3 F size
Shelf life			4 years	3 Years
Sterilization			Ethylene Oxide (SAL 10⁶)	Ethylene Oxide
Packaging Configurations			Finished single sterile device
Finished sterile kit	Finished single
sterile device
Finished sterile
kit

Image /page/3/Picture/0 description: The image shows a logo with a stylized letter "G" inside a rounded shape. The letter "G" is bold and black, with a distinctive design where the upper part of the "G" is open. Below the symbol, the word "GALT" is written in bold, sans-serif letters. The logo appears to be for a company or organization named Galt.

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

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.

Image /page/4/Picture/0 description: The image shows a logo for Galt. The logo features a stylized letter "G" in a bold, sans-serif font. The letter "G" is partially filled in, creating a negative space within the letter. Below the letter "G", the word "GALT" is written in a similar bold, sans-serif font.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

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

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

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

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