(3 days)
Not Found
No
The document describes a mechanical snare system for retrieving foreign objects and manipulating catheters. There is no mention of AI, ML, image processing, or any computational analysis of data that would suggest the use of AI/ML.
No
The device is described for retrieving and manipulating foreign objects and catheter-related procedures, not for treating or diagnosing a disease or condition.
No
The device description and intended use indicate that it is used for retrieving and manipulating foreign objects within the body, which are therapeutic or interventional procedures, not diagnostic ones.
No
The device description explicitly lists four physical components: snare, catheter, snare introducer, and torque device. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for retrieving and manipulating foreign objects within the cardiovascular system or hollow viscous. This is a direct intervention on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a physical snare and catheter system designed for mechanical manipulation within the body. This aligns with a surgical or interventional device, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory testing.
IVD devices are designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely mechanical and interventional.
N/A
Intended Use / Indications for Use
The EN Snare Endovascular Snare and Catheter is intended for use in the cardiovascular system or hollow viscous to retrieve and manipulate foreign objects. Manipulation procedures include indwelling venous catheter repositioning, indwelling venous catheter fibrin sheath stripping, and central venous access veni-puncture procedure assistance.
Product codes (comma separated list FDA assigned to the subject device)
MMX
Device Description
The EN Snare® Endovascular Snare System consists of four individual components: snare; catheter; snare introducer; and torque device.
The snare is comprised of 3 cable loops which are secured to a shaft wire. The construction of the snare enables it to be introduced through a catheter and manipulated by use of an external torque device. A snare introducer is also included for optional back-end loading of the snare into a pre-placed catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiovascular system or hollow viscous
Indicated Patient Age Range
Not Found
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)
No safety or performance testing is required to establish the safety and efficacy of the subject device.
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.
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
§ 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
AUG 0`7 2009
Merit Medical Systems, Inc.
EN Snare® Endovascular Snare System Traditional 510(k) Premarket Notification Section 5
510(k) Summary
.
Section 5
.
510(k) Summary
| General
Provisions | Submitter Name:
Address:
Telephone Number:
Fax Number:
Contact Person:
Date of Preparation:
Registration Number: | Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan, UT 84095
(801) 208-4795
(801) 253-6996
Glenn Norton
July 30, 2009
1721504 |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject
Device | Trade Name:
Common/Usual Name:
Regulation Name:
Manufacturer: | EN Snare® Endovascular Snare System
Intravascular snare and catheter
Device, Percutaneous Retrieval
Merit Medical Systems, Inc |
| Predicate
Device | Trade Name:
Common/Usual Name:
Regulation Name:
Manufacturer:
Premarket Notification:
Decision Date: | EN Snare® Endovascular Snare System
Intravascular snare and catheter
Device, Percutaneous Retrieval
Medical Device Technologies, Inc
K021606
05/31/2002 |
| Classification | Class II
Embolectomy Catheter
21 CFR § 870.5150, 74 MMX
Division of Cardiovascular Devices | |
| Intended Use | The EN Snare Endovascular Snare and Catheter is intended for use
in the cardiovascular system or hollow viscous to retrieve and
manipulate foreign objects. Manipulation procedures include
indwelling venous catheter repositioning, indwelling venous catheter
fibrin sheath stripping, and central venous access venipuncture
procedure assistance. | |
| Device
Description | The EN Snare ® Endovascular Snare System consists of four
individual components: snare; catheter; snare introducer; and torque
device. | |
| | The snare is comprised of 3 cable loops which are secured to a shaft
wire. The construction of the snare enables it to be introduced
through a catheter and manipulated by use of an external torque
device. A snare introducer is also included for optional back-end
loading of the snare into a pre-placed catheter. | |
| Technological
Characteristics | There are no technological differences between the subject and
predicate devices. The system is manufactured with identical
design, materials and processes as that of the currently marketed
EN Snare ® Endovascular Snare System. | |
| Safety &
Performance
Tests | No safety or performance testing is required to establish the safety
and efficacy of the subject device. | |
| Summary of
Substantial
Equivalence | The EN Snare device built by Merit is substantially equivalent to the
EN Snare device legally marketed by MD Tech via 510(k) K021606,
due to identical intended use, design specifications, material
specifications, manufacturing specifications and technological
characteristics. | |
:
..
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K0923413 page 1 of 1
Merit Medical Systems, Inc.
EN Snare® Endovascular Snare System Traditional 510(k) Premarket Notification
、
·
Section 5 510(k) Summary
:
:
·
.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing-like shapes, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-609 Silver Spring, MD 20993-0002
AUG 0 7 2009
Merit Medical Systems, Inc. c/o Glenn Norton 1600 West Merit Pkwy. South Jordan, UT 84095
Re: K092343
Trade/Device Name: EN Snare Endovascular Snare System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II (two) Product Code: MMX Dated: July 30, 2009 Received: August 3, 2009
Dear Mr. Norton:
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.
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
3
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
uma R. Kirchner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K0923343 page lot.1
Merit Medical Systems, Inc. EN Snare® Endovascular Snare System Traditional 510(k) Premarket Notification
Section 4 Indications for Use Statement
Section 4
Indications for Use Statement
KO92343
510(k) Number (if known):
Device Name: EN Snare® Endovascular Snare System
Indications for Use:
The EN Snare Endovascular Snare and Catheter is intended for use in the cardiovascular system or hollow viscous to retrieve and manipulate foreign objects. Manipulation procedures include indwelling venous catheter repositioning, indwelling venous catheter fibrin sheath stripping, and central venous access veni-puncture procedure assistance.
Prescription Use X (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duma R. V. Aimes
Sign-Off)
Division of Cardiovascular Devices
510(k) Number_
20