CREGANNA TACTX LOTUS INTRODUCER SET (SMALL), CREGANNA TACTX LOTUS INTRODUCER SET (LARGE)

K140338 · Creganna-Tactx Medical · DYB · Aug 27, 2014 · Cardiovascular

Device Facts

• Record ID: K140338
• Device Name: CREGANNA TACTX LOTUS INTRODUCER SET (SMALL), CREGANNA TACTX LOTUS INTRODUCER SET (LARGE)
• Applicant: Creganna-Tactx Medical
• Product Code: DYB · Cardiovascular
• Decision Date: Aug 27, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Lotus™ Introducer Set is intended to provide femoral access to the vascular system.

Device Story

Sterile, single-use introducer catheter set; includes dilator and introducer sheath with flush port. Used for percutaneous femoral artery access; facilitates introduction of catheter-based devices into vascular system. Operated by clinicians using conventional minimally invasive catheterization techniques. Features PTFE liner on sheath ID; external hydrophilic coating on sheath and dilator increases lubricity when activated to aid delivery. Device provides access point for subsequent interventional procedures; benefits patient by enabling minimally invasive vascular access.

Clinical Evidence

No clinical data. Safety and effectiveness demonstrated via bench testing and literature review. Bench tests included shaft pressure integrity, corrosion resistance, tensile strength, valve leakage, insertion/removal forces, kink testing, and particulate testing. Biocompatibility testing included cytotoxicity, sensitization, irritation, systemic toxicity, hemolysis, complement activation, and thromboresistance.

Technological Characteristics

Sterile, single-use introducer set. Components: dilator and introducer sheath with flush port. Materials: medical-grade materials including PTFE liner on sheath ID; external hydrophilic coating on sheath and dilator. Mechanical design: conventional catheterization architecture. No software or electronic components.

Indications for Use

Indicated for patients requiring percutaneous femoral artery access for the introduction of catheter-based devices into the vascular system.

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

• RetroFlex3 Introducer Set (K093877)

Submission Summary (Full Text)

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Public Health Service

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

August 27, 2014

Creganna-Tactx Medical % Niall Fox Sr. Regulatory Affairs Specialist Parkmore West Galway, Ireland

Re: K140338

Trade/Device Name: Creganna-Tactx Lotus Introducer Set (small), Creganna-Tactx Lotus Introducer Set (large) Regulation Number: 21 CFR 870.1340 Regulation Name: Introducer Catheter Regulatory Class: Class II Product Code: DYB Dated: July 18, 2014 Received: July 23, 2014

Dear Niall Fox,

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 or any Federal statutes and regulations administered by other Federal agencies. You must comply

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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 devicerelated 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 Industry and Consumer Education at its toll-free 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" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours,

M.A. Hillebrand

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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K140338 Indications for Use Statement

# Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: Indications for Use: The Lotus Introducer Set is intended to provide femoral access to the vascular system. Prescription Use Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (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)

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## 510(k) Summary

### General Information

| Date : | January 31, 2013 |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | Class II, 21 CFR § 870.1340, Catheter introducer |
| Trade Name | Creganna-Tactx Lotus™ Introducer Set |
| Model Numbers | 139809-01, 139809-02 |
| Submitter | Creganna-Tactx Medical<br>Parkmore West<br>Galway, Ireland |
| Regulatory Contact | Niall Fox<br>Senior Regulatory Affairs Specialist<br>Creganna-Tactx Medical<br>Parkmore West<br>Galway, Ireland<br>Tel: + 91 474457<br>Email: [e-mail] |

## Intended Use

The Lotus™ Introducer Set is intended to provide femoral access to the vascular system.

## Predicate Device

RetroFlex3 Introducer Set cleared via 510(k) K093877. It is manufactured by Edwards Life Sciences.

#### Device Description

The Lotus™ Introducer Set is a sterile, single-use introducer catheter that provides percutaneous access to the femoral artery for introduction of catheter-based devices into the vascular system. The Lotus Introducer Set will be inserted into the femoral artery using conventional minimally invasive catheterization techniques. The Lotus Introducer Set is composed of a dilator and an introducer sheath with a flush port. The design features a PTFE liner on the ID of the introducer sheath and an external coating on both the introducer sheath and the dilator. When activated, the external hydrophilic coating increases the lubricity of the surface to aid in delivery.

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## Materials

The Creganna-Tactx Lotus™ Introducer Set assembly is comprised of materials that are commonly used in medical device applications.

# Testing

In vitro testing was performed on the Creganna-Tactx Lotus™ Introducer Set to assure reliable design and performance in accordance with applicable standards, intended use and user requirements. The non-clinical tests performed by the company include:

- Introducer shaft pressure integrity
- Corrosion resistance
- Introducer shaft tensile strength ●
- Tensile strength of Hub to Introducer Shaft joint
- Tensile strength of Luer to Dilator Shaft joint ●
- Tensile strength of Dilator Shaft
- Introducer valve leakage, unloaded
- . Introducer valve leakage, loaded with device/ loaded with guidewire
- Insertion / Removal force of Dilator
- . Dilator to guidewire interface – Insertion / Removal
- Kink testing
- Particulate Testing

## Biocompatibility

- Cytotoxicity
- Sensitization
- . Irritation / intracutaneous reactivity
- Systemic toxicity (acute)
- Hemolysis Study, Direct Contact
- Complement Activation Assay
- Thromboresistance Study

The test results demonstrate that the Creganna-Tactx Lotus™ Introducer Set meets the requirements in the applicable standards and specifications, and is substantially equivalent to legally marketed predicate device.

Clinical studies were not deemed necessary since in vivo testing and a literature review were sufficient to demonstrate safety and effectiveness by way of comparison to a legally marketed predicate device.

## Summary of Substantial Equivalence

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Creganna-Tactx Medical believes the Creganna-Tactx Lotus™ Introducer Set is substantially equivalent to the predicate product. The intended use, method of operation, methods of construction and materials used, are either identical or substantially equivalent to existing legally marketed predicate products.