(71 days)
Not Found
No
The device description focuses on the mechanical components and materials, and there is no mention of AI, ML, image processing, or data-driven performance metrics.
No.
The device is used to retrieve and manipulate foreign objects in the cardiovascular system, which is an intervention rather than a therapeutic treatment.
No
The device is described as a tool to retrieve and manipulate foreign objects, not to diagnose medical conditions or analyze patient data. Its components and functions are geared towards interventional procedures.
No
The device description explicitly lists physical components such as a snare, catheter, loader, and torquer, all of which are hardware.
Based on the provided information, the SeQure™ Snare System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "retrieve and manipulate foreign objects" within the cardiovascular system. This is a therapeutic or interventional procedure performed directly on the patient's body.
- Device Description: The device components (snare, catheter, loader, torquer) are designed for physical manipulation within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, etc.) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (in glass, or outside the body) to analyze biological samples. The SeQure™ Snare System is used in vivo (in the living body).
N/A
Intended Use / Indications for Use
The SeQure™ Snare System is intended for use in the cardiovascular system as a tool to retrieve and manipulate foreign objects.
Product codes
MMX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiovascular system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
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
- Delivery and Retrieving
- . Torque Strength
- Tensile Strength .
- . Biocompatibility
- Package
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.5150 Embolectomy catheter.
(a)
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.(b)
Classification. Class II (performance standards).
0
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: 86-755-86026416 Fax: 86-755-86026251 Email address: shixiaoli@lifetechmed.com; zhangdeyuan@lifetechmed.com
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
1
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.
2
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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.
3
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 (800) 638-2041 or (301) 796-7100 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
4
- 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