MICROSLIDER TEARAWAY INTRODUCER SET

K123430 · Galt Medical Corp. · DYB · Apr 12, 2013 · Cardiovascular

Device Facts

• Record ID: K123430
• Device Name: MICROSLIDER TEARAWAY INTRODUCER SET
• Applicant: Galt Medical Corp.
• Product Code: DYB · Cardiovascular
• Decision Date: Apr 12, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2
• Attributes: Pediatric

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 Story

MicroSlide™ Tearaway Introducer is a single-patient-use, disposable device consisting of a dilator and an outer sheath. Used in percutaneous procedures to facilitate catheter/device entry into coronary and peripheral vasculature. Physician operates device by inserting dilator and sheath into vasculature; sheath hub/wing design allows longitudinal splitting (peeling) for removal after device placement. Dilator features tapered tip and luer hub for guidewire insertion. Sheath hub and dilator hub lock via rotating motion. Device provides a pathway for interventional tools; benefits patient by enabling minimally invasive access to vasculature. Used in clinical settings.

Clinical Evidence

Bench testing only. Functional testing included penetration (insertion) force, sheath peel force, sheath perpendicular pull, and dilator pull tests. Sterilization validated per ISO 11135-1 (SAL 10^-6). Biocompatibility leveraged from predicate devices (K000313, K112398). Packaging and shelf-life integrity verified via visual and bubble emission testing.

Technological Characteristics

Components: Dilator (polyamide co-polymer), Sheath hub (high-density polypropylene), Sheath tube (PTFE with bismuth trioxide). Design: Tear-away winged hub, locking dilator. Sizes: 2F, 3F. Sterilization: Ethylene Oxide (SAL 10^-6). Connectivity: None (mechanical).

Indications for Use

Indicated for percutaneous introduction of catheters and intravascular devices into coronary and peripheral vasculature in adult and pediatric patients of all ages.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• Tearaway Introducer Sheath, Galt Medical (K000313)
• Galt VTI™ Valved Tear-away Introducer, Galt Medical (K112398)
• Super Sheath Introducer Sheath, Togo Medikit Co. Ltd. (K121504)

Submission Summary (Full Text)

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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),<br>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:

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.

#### 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™ Tearaway<br>Introducer | Galt Tearaway<br>Introducer | Galt VTI™ Valved<br>Tearaway Introducer | Togo Medikit Super<br>Sheath Introducer Sheath<br>(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<br>for the percutaneous<br>introduction of diagnostic or<br>therapeutic devices, such as<br>catheters and pacing leads<br>into the coronary and<br>peripheral vasculature of<br>adult and pediatric patients<br>of all ages. | These introducers are<br>used for the<br>percutaneous<br>introduction of<br>diagnostic or<br>therapeutic devices,<br>such as catheters and<br>pacing leads into the<br>vasculature. | These introducers are<br>used for the<br>percutaneous<br>procedures to introduce<br>catheters and other<br>intravascular devices<br>into the peripheral<br>vasculature. | These introducers are<br>used in the introduction of<br>diagnostic and<br>interventional device<br>inserted into human<br>vasculature of adult and<br>pediatric patients of all<br>ages | |
| Performance<br>Specifications | Insertion<br>Force(Avg.) | $2Fr = 82.4$ grams<br>$3Fr= 95.5$ grams | N/A | N/A | N/A |
| | Hub Break<br>Force | 2.0 lbs - 5.5 lbs | 2.0 lbs - 5.5 lbs | 2.0 lbs - 10.0 lbs | N/A |
| | Sheath Peel<br>Strength | $2Fr = 0.20 - 1.00$ lbs<br>$3Fr = 0.20 - 1.70$ lbs | $4 - 15Fr = 0.20 - 1.70$<br>lbs<br>$16Fr = 0.20 - 2.25$ lbs | $4 - 15Fr = 0.20 - 1.70$<br>lbs<br>$16Fr = 0.20 - 2.25$ lbs | N/A |
| | Sheath/Hub<br>strength | $2Fr = 2.0$ lbs min.<br>$3Fr = 3.0$ lbs min. | 3.0 lbs min. | $6 - 15Fr = 2.6$ lbs min.<br>$16Fr = 3.3$ lbs min | N/A |
| Design | Tear-away introducer with winged sheath hub and<br>locking dilator | Tear-away introducer with winged sheath hub and<br>locking dilator | Tear-away introducer<br>with winged sheath hub,<br>integrated hemostasis<br>valve, optional side<br>port, w/stopcock and<br>locking dilator | Introducer with round<br>sheath hub, integrated<br>hemostasis valve, side<br>port, w/stopcock and<br>locking dilator | |
| Color | | Gray sheath with color coded hub, Green dilator cannula | | White Sheath with color<br>coded hub, green dilator<br>cannula | |
| Shape | | Cylindrical cannula with winged hub | | Cylindrical cannula with<br>round hub | |
| Sizes | | 3cm, and 7cm, lengths<br>sizes 2F - 3F | 14cm, 30cm, 44cm<br>and 50cm lengths<br>sizes 4F - 16F | 13cm, and 23cm,<br>lengths<br>sizes 6F - 16F | 5cm, and 7cm, lengths<br>3.3 F size |
| Shelf life | | | 4 years | 3 Years | |
| Sterilization | | | Ethylene Oxide (SAL 10⁶) | Ethylene Oxide | |
| Packaging Configurations | | | Finished single sterile device<br>Finished sterile kit | Finished single<br>sterile device<br>Finished sterile<br>kit | |

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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

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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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

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## 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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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