(27 days)
No
The device description focuses on the mechanical components and materials, and there is no mention of AI, ML, or any software-driven analysis or processing.
No.
The device is used to retrieve and manipulate foreign objects within the body, which is a procedural tool rather than directly addressing a disease or condition for therapeutic benefit.
No
The intended use of the device is for retrieving and manipulating foreign objects, repositioning catheters, and assisting with venipuncture procedures. These are all therapeutic or interventional actions, not diagnostic ones.
No
The device description explicitly lists multiple hardware components (snare, catheter, insertion tool, torque device) made of various materials.
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 coronary and peripheral vascular system or hollow viscous. This is an in vivo procedure, meaning it is performed within a living organism.
- Device Description: The description details a physical device (snare, catheter, etc.) designed for mechanical manipulation within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, not to directly interact with structures within the body in the way this snare system does.
N/A
Intended Use / Indications for Use
The EN Snare® Endovascular Snare System is intended for use in the coronary and peripheral vascular system or hollow viscous to retrieve and manipulate foreign objects. Retrieval and manipulation procedures include, indwelling venous catheter repositioning, indwelling venous catheter fibrin sheath stripping, and central venous access veupuncture procedure assistance.
Product codes
MMX
Device Description
The EN Snare Endovascular Snare System consists of four individual components: snare: catheter: insertion tool and torque device. Systems are available in various sizes and lengths. The snare is comprised of 3 interlaced stranded cables of platinum and super-elastic nitinol that form 3 loops and are mechanically secured with a crimp collar to a nitinol shaft wire. The superelastic nitinol construction enables the loops of the snare to be introduced through a catheter without the risk of deformation. The catheter is manufactured with a Pebax outer layer and a PTFE inner layer with an embedded iridium/platinum markerband at the distal end, a Pebax hub and a polycarbonate luer. A snare insertion tool is also included for optional back-end loading of the snare into a preplaced catheter. The snare insertion tool is manufactured from polypropylene. The snare is inserted into an intravascular catheter and manipulated by use of an external torque device. The snare is offered in sizes ranging from 2mm to 45mm, with catheter sizes of 3.2F, 6F, and 7F.
The technological characteristics of the subject Merit EN Snare Endovascular Snare System are substantially equivalent to the Primary Predicate Device#1 Merit EN Snare Endovascular Snare System (K092343), and the Reference Device#2, Merit ONE Snare System, 510(k), K122088, for the following performance data - Corrosion Testing, Luer Testing and Packaging Testing, The difference between the subject Merit EN Snare Endovascular Snare System and the Primary Predicate Device#1 Merit EN Snare Endovascular Snare System (K092343) relates to a modification to the catheter and insertion tool design and materials only. The snare device and the torque device remain unchanged. While the intended use remains unchanged the indications for use are being clarified.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and peripheral vascular 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)
Performance testing of the subject Merit EN Snare Endovascular Snare System was conducted based on risk analysis. A battery of testing was conducted in accordance with protocols based on requirements outlined in quidance's and industry standards and these were shown to meet the acceptance criteria that were determined to demonstrate substantial equivalence.
Where appropriate, the tests were based on the requirements of the following documents:
- FDA guidance Coronary and Cerebrovascular Guide Wire Guidance. January 1995.
- ISO 10555-1 2013 Intravascular catheters Sterile and single use catheters - Part 1: General Requirements.
- ISO 594-1:1986 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements
- ISO 594-2:1998 Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment - part 2: Lock fittings
- ISO 11135:2014 Sterilization of health care products-Ethylene oxide-Requirements for the development, validation and routine control of a sterilization process for medical devices.
- ASTM F1980-07 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- ISO 2233:2000 Packaging complete, filled transport packages and unit loads - conditioning for testing.
- ISO 10993-1:2009, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process, and the FDA Modified ISO 10993 Test Profile FDA Memo G95-1.
The following is a list of all significant testing that was successfully completed:
Catheter and Insertion Tool:
- Surface: external surface
- Radiodetectability of catheter/marker bands
- Dimensions: Catheter Markeband length
- Dimensions: Catheter Markerband placement
- Surface: Catheter PTFE Liner Inspection
- Dimensions: Catheter Tip Angle
- Dimensions: Catheter Tip Length
- Dimensions: Length, Diameter (ID/OD)
- Atraumatic Catheter Tip
- Markerband retention
- Torque Strength
- Kink resistance
- Buckling resistance
- Freedom from Liquid Leakage
- Freedom from Air Leakage
- Force at break(junction between catheter hub and tube)
- Force at break(junction between insertion tool hub and tube)
- Catheter hub with female luer
- Corrosion resistance
System:
- Snare Loop Resistance
- Guiding Catheter Resistance
- Snare insertion tool fitment
- Snare insertion
- Insertion Tool tear away force from the snare
- Snare inspection after insertion tool removal
- Snare loop protrusion
Biocompatibility testing included:
- Cytotoxicity
- Sensitization
- Irritation
- Acute Systemic Toxicity
- Pyrogenicity
- Genotoxicity
- Hemolysis
- Thrombogenicity
- Complement Activation
- Chemical Tests
The subject Merit EN Snare Endovascular Snare System met the acceptance criteria applicable to the safety and effectiveness of the device. This has demonstrated the subject device Merit EN Snare Endovascular Snare System is substantially equivalent to the Primary Predicate Device#1 EN Snare Endovascular Snare System, K092343.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 1, 2015
Merit Medical Systems, Inc. Siobhan King Senior Regulatory Affairs Specialist Parkmore Business Park West Galway, Ireland
Re: K151497
Trade/Device Name: EN Snare Endovascular Snare System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: MMX Dated: June 2, 2015 Received: June 4, 2015
Dear Siobhan King:
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 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
1
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 (800) 638-2041 or (301) 796-7100 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 Industry and Consumer Education 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.
M.A. Hillebrand
R
for Bram Zuckerman, MD
Director, Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K151497
Device Name EN Snare Endovascular Snare System
Indications for Use (Describe)
The EN Snare® Endovascular Snare System is intended for use in the coronary and peripheral vascular system or hollow viscous to retrieve and manipulate foreign objects. Retrieval and manipulation procedures include, indwelling venous catheter repositioning, indwelling venous catheter fibrin sheath stripping, and central venous access veupuncture procedure assistance.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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FORM FDA 3881 (8/14)
PSC Fublishing Services (301)-445-5740 EF
3
510(k) Summary Submitter Name: Merit Medical Systems, Inc. Address: 1600 West Merit Parkway South Jordan, UT 84095 Telephone Number: (+353) 91 703700 (3061) Fax Number: (+353) 91 703772 Contact Person: Mark Mullaney Registration Number: 1721504 General Correspondent Name: Merit Medical Ireland Ltd. Provisions Address: Parkmore Business Park West Galway, Ireland Telephone Number: (+353) 91 703700 (3052) Fax Number: (+353) 91 703772 Contact Person: Siobhan King Date of Preparation: 17 June 2015 Registration Number: 9616662 Trade Name: EN Snare Endovascular Snare System Subject Common/Usual Name: Device, Percutaneous Retrieval Device Classification Name: Device, Percutaneous Retrieval Primary Predicate Device #1: Trade Name: EN Snare Endovascular Snare System Classification Name: Device, Percutaneous Retrieval Premarket Notification: K092343 Manufacturer: Merit Medical Systems, Inc. Predicate Device Reference Device #2: ONE Snare System Trade Name: Classification Name: Percutaneous retrieval device Premarket Notification: K122088 Manufacturer: Merit Medical Systems, Inc. Class II 21 CFR 870.5150 Classification Device, Percutaneous Retrieval FDA Product Code: MMX Review Panel: Division of Cardiovascular Devices The EN Snare Endovascular Snare System is intended for use in the coronary and peripheral vascular system or hollow viscous to retrieve and manipulate Intended Use foreign objects. Retrieval and manipulation procedures include, indwelling venous catheter repositioning, indwelling venous catheter fibrin sheath stripping, and central venous access venipuncture procedure assistance.
Section 5
4
The EN Snare Endovascular Snare System consists of four individual components: snare: catheter: insertion tool and torque device. Systems are available in various sizes and lengths. The snare is comprised of 3 interlaced stranded cables of platinum and super-elastic nitinol that form 3 loops and are mechanically secured with a crimp collar to a nitinol shaft wire. The superelastic nitinol construction enables the loops of the snare to be introduced through a catheter without the risk of deformation. The catheter is manufactured with a Pebax outer layer and a PTFE inner layer with an embedded iridium/platinum markerband at the distal end, a Pebax hub and a polycarbonate luer. A snare insertion tool is also included for optional back-end loading of the snare into a preplaced catheter. The snare insertion tool is manufactured from polypropylene. The snare is inserted into an intravascular catheter and manipulated by use of an external torque device. The snare is offered in sizes ranging from 2mm to 45mm, with catheter sizes of 3.2F, 6F, and 7F.
The technological characteristics of the subject Merit EN Snare Endovascular Snare System are substantially equivalent to the Primary Predicate Device#1 Merit EN Snare Endovascular Snare System (K092343), and the Reference Device#2, Merit ONE Snare System, 510(k), K122088, for the following performance data - Corrosion Testing, Luer Testing and Packaging Testing, The Comparison to difference between the subject Merit EN Snare Endovascular Snare System and Predicate the Primary Predicate Device#1 Merit EN Snare Endovascular Snare System (K092343) relates to a modification to the catheter and insertion tool design and materials only. The snare device and the torque device remain unchanged. While the intended use remains unchanged the indications for use are being clarified.
No performance standards have been established under section 514 of the Food, Drug and Cosmetic Act for these devices. Performance testing of the subject Merit EN Snare Endovascular Snare System was conducted based on risk analysis. A battery of testing was conducted in accordance with protocols based on requirements outlined in quidance's and industry standards and these were shown to meet the acceptance criteria that were determined to demonstrate substantial equivalence.
Where appropriate, the tests were based on the requirements of the following documents:
- FDA guidance Coronary and Cerebrovascular Guide Wire Guidance . January 1995.
Safety & Performance Tests
Device
Description
- ISO 10555-1 2013 Intravascular catheters Sterile and single use ● catheters - Part 1: General Requirements.
- ISO 594-1:1986 Conical fittings with a 6% (Luer) taper for syringes, ● needles and certain other medical equipment - Part 1: General requirements
- ISO 594-2:1998 Conical fittings with 6% (Luer) taper for syringes, . needles and certain other medical equipment - part 2: Lock fittings
- . ISO 11135:2014 Sterilization of health care products-Ethylene oxide-Requirements for the development, validation and routine control of a sterilization process for medical devices.
- ASTM F1980-07 Standard Guide for Accelerated Aging of Sterile Barrier ● Systems for Medical Devices
5
-
ISO 2233:2000 Packaging complete, filled transport packages and unit ● loads - conditioning for testing . ISO 10993-1:2009, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process, and the FDA Modified ISO 10993 Test Profile FDA Memo G95-1. The following is a list of all significant testing that was successfully completed: Catheter and Insertion Tool Surface: external surface ● Radiodetectability of catheter/marker bands ● Dimensions: Catheter Markeband length ● Dimensions: Catheter Markerband placement ● Surface: Catheter PTFE Liner Inspection ● Dimensions: Catheter Tip Angle ● ● Dimensions: Catheter Tip Length Dimensions: Length, Diameter (ID/OD) ● Atraumatic Catheter Tip ● Markerband retention ● ● Torque Strength ● Kink resistance Buckling resistance ● Freedom from Liquid Leakage ● Freedom from Air Leakage ● Force at break(junction between catheter hub and tube) ● ●
System
- Snare Loop Resistance
- Guiding Catheter Resistance ●
- . Snare insertion tool fitment
- Snare insertion ●
- Insertion Tool tear away force from the snare ●
- . Snare inspection after insertion tool removal
- Snare loop protrusion
Biocompatibility testing included
- Cytotoxicity ●
- Sensitization ●
- Irritation ●
- Acute Systemic Toxicity ●
- Pyrogenicity ●
- Genotoxicity ●
- Hemolysis ●
- Thrombogenicity .
- Complement Activation
- Chemical Tests
The subject Merit EN Snare Endovascular Snare System met the acceptance criteria applicable to the safety and effectiveness of the device. This has demonstrated the subject device Merit EN Snare Endovascular Snare System is substantially equivalent to the Primary Predicate Device#1 EN Snare Endovascular Snare System, K092343.
Safety & Performance
Tests
continued
- Force at break(junction between insertion tool hub and tube)
- Catheter hub with female luer ●
- . Corrosion resistance
6
| Summary of | Based on the Indications for Use, design, safety and performance testing, the |
|---|---|
| Substantial | subject Merit EN Snare Endovascular Snare System is substantially equivalent |
| Equivalence | to the Primary Predicate Device#1 Merit EN Snare Endovascular Snare System, |
| K092343 and the Reference Device#2, Merit ONE Snare System, 510(k), | |
| K122088 for Performance data. |