SEQURE SNARE SYSTEM

K102484 · Lifetech Scientific (Shenzhen) Co., Ltd. · MMX · Nov 9, 2010 · Cardiovascular

Device Facts

• Record ID: K102484
• Device Name: SEQURE SNARE SYSTEM
• Applicant: Lifetech Scientific (Shenzhen) Co., Ltd.
• Product Code: MMX · Cardiovascular
• Decision Date: Nov 9, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The SeQure™ Snare System is intended for use in the cardiovascular system as a tool to retrieve and manipulate foreign objects.

Device Story

The SeQure™ Snare System is a percutaneous catheter-based tool used by clinicians in the cardiovascular system to retrieve and manipulate foreign objects. The device consists of a nitinol shaft with a pre-formed loop, a catheter, a loader, and a torquer. The nitinol loop is covered with a tungsten coil coated in laminated titanium and titanium nitride to enhance radiopacity. The super-elastic nitinol allows the loop to be introduced through the catheter without permanent deformation. The catheter includes a radiopaque markband at the distal tip for visualization. The device is pre-assembled and packaged with the catheter. Clinicians operate the device under imaging guidance to capture and maneuver objects within the vasculature, facilitating removal or repositioning to improve patient outcomes during interventional procedures.

Clinical Evidence

Bench testing only. Performance testing validated that the device met all design specifications and was substantially equivalent to the predicate device, including assessments of dimensions, delivery and retrieving capabilities, torque strength, tensile strength, and biocompatibility.

Technological Characteristics

Nitinol shaft and loop; tungsten coil coating; laminated titanium and titanium nitride coating for radiopacity; PE tubing catheter with radiopaque markband. Percutaneous catheter-based delivery. Mechanical retrieval mechanism. No software or energy source.

Indications for Use

Indicated for use in the cardiovascular system to retrieve and manipulate foreign objects in patients requiring percutaneous intervention.

Regulatory Classification

Identification

An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.

Predicate Devices

• ev3 Amplatz "Goose Neck" Snare Device (K972511)

Submission Summary (Full Text)

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K102484
NOV - 9 2010

Premarket Notification Section 510(k) Submission SeQure™ Snare System Section III 510(K) Summary Ref No .: LT/TS/18FDA-01

先继科技(深圳有限公司 Lifetech Scientific (Shen Zhen) Co., Ltd

Section III 510(k) Summary

This 510(k) Summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Submitted by: Xiaoli Shi / David Zhang Lifetech Scientific (Shenzhen) Co., Ltd Floor 1-3, Cybio Electronic Building, Langshan 2nd Street, North area of High-tech Park, Nanshan District, Shenzhen, Guangdong, 518057, P. R. China Telephone: [phone] Fax: [phone] Email address: [e-mail]; [e-mail]

Date of Submission: 2010-4-30

Proposed Device: SeQure™ Snare System

Classification: Class H, MMX, 21 CFR 870.5150 Catheter, Percutaneous

Predicate Device: ev3 Amplatz "Goose Neck" Snare Device as cleared in K972511.

Intended Use: The SeQure™ Snare System is intended for use in the cardiovascular system as a tool to retrieve and manipulate foreign objects

Device Description: The SeQure™ Snare System consists of a snare, a catheter, a loader and a torquer. The snare is constructed of a nitinol shaft and a loop with the plane of the loop perpendicular to the nitinol shaft. The nitinol loop is covered with a tungsten coil which is coated by laminated titanium and its nitride to enhance radiopaque. The pre-formed snare loop can be introduced through catheter without risk of permanent deformation because of super-elasticity of nitinol material. The catheter connector and PE tubing with a radiopaque markband at its distal tip to enhance the visibility during the operation. The snare is pre-assembled with the loader and the torque, and then packaged together with corresponding catheter.

## Comparation with Predicate device:

The design, dimension, components, structure and fundamental technology of SeQure™ Snare System are all identical with predicate device ev3 Amplatz "Goose Neck" Snare,

Performance Data: Performance testing was conducted to validate and verify that the proposed device met all design specifications and was substantially equivalent to the predicate device:

- . Dimension
11-1

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Premarket Notification Section 510{k) Submission SeQure™ Snare System
Section III 510(K) Summary Ref No.: LT/TS/18FDA-01

先锋科技(深圳有限公司 Lifetech Scientific (Shen Zhen) Co., Ltd

- Delivery and Retrieving ●
- . Torque Strength
- Tensile Strength .
- . Biocompatibility
- Package

SE Conclusion: The SeQure™ Snare System is safe and effective as Predicate Device ev3 Amplatz "Goose Neck" Snare Device based on performance testing.

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

Lifetech Scientific (Shenzhen) Co., Ltd. c/o Herbert Barkhuysen KEMA Quality B.V. Business Line Medical P.O. Box 5185, 6802 ED Arnhem The Netherlands

NOV - 9 2010

Re: K102484

Trade/Device Name: SeQure Snare System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II (Two) Product Code: MMX Dated: October 29, 2010 Received: November 2, 2010

Dear Mr. Barkhuysen:

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.

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Page 2 – Mr. Herbert Barkhuysen

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,

R. V. V.

Bram
Director

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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K102484

- 9 2010

Image /page/4/Picture/2 description: The image shows the logo for SesrCare Lifetech Scientific. The logo is in black and white and features the company name in a bold, sans-serif font. The word "SesrCare" is on the top line, and the words "Lifetech Scientific" are on the bottom line. The logo has a trademark symbol on the top right.

Premarket Notification Section 510(k) Submission SeQure™ Snare System Section II Indication for Use Statement Ref No.: LT/TS/18FDA-01

Section II Indication for Use Statement

510(k) Number: K 102481 Device Name: SeQure™ Snare System

Indications for Use:

The SeQure™ Snare System is intended for use in the cardiovascular system as a tool to retrieve and manipulate foreign objects.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

. R. v. v. v.

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K10Z484