(90 days)
No
The device description and performance studies focus on the mechanical properties and biocompatibility of the snare system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is used for the retrieval and manipulation of foreign bodies, which is a diagnostic or interventional procedure, not a therapeutic one.
No.
The device is described as an endovascular microsnare system intended for the retrieval and manipulation of atraumatic foreign bodies, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly lists physical components like a snare, snare catheter, insertion tool, and torque device, all made of physical materials. The performance studies also focus on the physical properties and performance of these hardware components.
Based on the provided information, the ONE Snare Endovascular Microsnare System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device is for the "retrieval and manipulation of atraumatic foreign bodies located in the coronary and peripheral cardiovascular system and the extracranial anatomy." This describes a procedure performed within the body (in vivo), not on samples taken from the body (in vitro).
- Device Description: The description details a physical system with a snare, catheter, insertion tool, and torque device, designed for mechanical manipulation within the body. This is consistent with an interventional medical device, not a diagnostic test performed on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
Therefore, the ONE Snare Endovascular Microsnare System is an interventional medical device, not an IVD.
N/A
Intended Use / Indications for Use
The ONE Snare Endovascular Microspare System is intended for use in adult and pediations for the retrieval and manipulation of atraumatic foreign bodies located in the coronary and peripheral cardiovascular system and the extracranial anatomy.
Product codes (comma separated list FDA assigned to the subject device)
MMX
Device Description
ONE Snare Endovascular Microsnare System contains: (1) Snare, (1) Snare Catheter, (1) Insertion Tool and (1) Torque Device. The snare is constructed of nitinol cable and a gold plated tungsten loop. The pre-formed snare loop can be introduced through catheters without risk of snare deformation because of the snare's super-elastic construction. The snare catheter is constructed of polyether block amide (Pebax®) and contains a platinum/iridium radiopaque marker band.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and peripheral cardiovascular system and the extracranial anatomy
Indicated Patient Age Range
adult and pediatric populations
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 performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices. However, a battery of tests performed on the Merit ONE Snare Endovascular Microsnare System were designed to demonstrate that the device meets critical design specifications as well as clinical performance attributes for its intended use. Where appropriate, the tests were based on the requirements of the following documents: FDA guidance Coronary and Cerebrovascular Guide Wire Guidance January 1995. ISO 11070:1998, Sterile Single-Use Intravascular Catheter Introducers 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 ASTM F 2096-11 Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test) ASTM F 1929-12 Standard Test Method for Detecting Seal Leaks in porous Medical Packaging by Dye Penetration ASTM F88/F88M-09 Standard Test Method for Seal Strength of Flexible Barrier Materials ASTM D4169-09 Standard Practice for Performance Testing on Shipping Containers and Systems 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 11135:2014 – Sterilization of health care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices 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 Merit ONE Snare Endovascular Microsnare System was compared to the predicate devices for various performance attributes that demonstrate the substantial equivalence of the device. The following is a list of all significant testing that was successfully completed:
Catheter & Insertion Tool: Surface Finish, Radiopacity, Catheter tip atraumatic, Marker band placement, Effective Length, ID & OD, Catheter stiffness, Markerband retention, Tip integrity, Torque Strength, Kink resistance, Buckling force, Freedom from Liquid leakage, Freedom form Air leakage, Peak tensile force of catheter at hub, Force at break insertion tool at hub, Hub with Female luer testing, Corrosion Resistance.
ONE Snare Endovascular Microsnare System: Snare Loop Resistance, Guide Catheter resistance, Snare shape integrity, Insertion Tool Fitment, Snare insertion, Insertion Tool tear away force, Snare jacket after insertion tool removal inspection, Snare loop protruding.
Snare: Size designation, Snare Head Assembly, Radio detectability, Surface Finish, Tensile strength, Torqueability, Torque Strength, Flexing Test, Fracture Test, Tip Flexibility, Corrosion Resistance.
Biocompatibility testing included: Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity Pyrogenicity Genotoxicity Hemolysis Thrombogenicity Complement Activation Chemical Tests.
Packaging performance: before and after exposure to accelerated aging and simulated shipping and handling conditions (bubble emission dye penetration seal peel tensile strength burst strength visual inspection).
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.
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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a flowing ribbon-like element connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 13, 2014
Merit Medical Systems, Inc. Siobhan King RA Specialist II Parkmore Business Park West Galway, Ireland
Re: K142265
Trade/Device Name: One Snare Endovascular Microsnare System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: MMX Dated: August 12, 2014 Received: August 15, 2014
Dear Ms. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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 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" (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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Melissa A. Torres -S
For Bram D. Zuckerman, M.D. 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) K142265
Device Name
ONE Snare Endovascular Microsnare System
Indications for Use (Describe)
The ONE Snare Endovascular Microspare System is intended for use in adult and pediations for the retrieval and manipulation of atraumatic foreign bodies located in the coronary and peripheral cardiovascular system and the extracranial anatomy.
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)
3
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
+353 91-703761
+353 91-703772
Mark Mullaney
11-Nov-14
1721504 |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Correspondent Name:
Address:
Telephone Number:
Fax Number:
Contact Person:
Date of Preparation:
Registration Number: | Merit Medical Ireland Ltd.
Parkmore Business Park,
Galway, Ireland
+353 91-703752
+353 91-703772
Siobhan King
11-Nov-14
9616662 |
| Subject
Device | Trade Name:
Common/Usual Name:
Classification Name: | ONE Snare Endovascular Microsnare System
Percutaneous Retrieval Device
Device, Percutaneous Retrieval |
| Predicate
Device | Primary Predicate Device# 1:
Trade Name:
Classification Name:
Premarket Notification:
Manufacturer:
Reference Device# 2:
Trade Name:
Classification Name:
Premarket Notification:
Manufacturer: | Amplantz "GOOSE NECK" Microsnare
Catheter, Percutaneous
K970668
ev3 (Microvena Corp.)
Merit ONE Snare System
Percutaneous retrieval device
K122088
Merit Medical Systems, Inc. |
| Classification | Class II
21 CFR § 870.5150
FDA Product Code: MMX
Division of Cardiovascular Devices | |
| Intended Use | | The ONE Snare Endovascular Microsnare System is intended for use in
adult and pediatric populations for the retrieval and manipulation of
atraumatic foreign bodies located in the coronary and peripheral
cardiovascular system and the extra-cranial anatomy. |
| Device
Description | ONE Snare Endovascular Microsnare System contains: (1) Snare, (1)
Snare Catheter, (1) Insertion Tool and (1) Torque Device. The snare is
constructed of nitinol cable and a gold plated tungsten loop. The pre-formed
snare loop can be introduced through catheters without risk of snare
deformation because of the snare's super-elastic construction. The snare
catheter is constructed of polyether block amide (Pebax®) and contains a
platinum/iridium radiopaque marker band. | |
| Technological
Characteristics | Technological characteristics of the subject Merit ONE Snare Endovascular
Microsnare System are substantially equivalent to those of the Primary
Predicate#1, the currently marketed Amplantz "GOOSE NECK" Microsnare,
manufactured by ev3 Inc., 510(k) K970668 and Reference Device#2, Merit
Medical ONE Snare System, 510(k) K122088 for the following performance
data - Corrosion Testing, Luer Testing and Packaging Testing. | |
| Safety &
Performance
Tests | No performance standards have been established under Section 514 of the
Food, Drug and Cosmetic Act for these devices. However, a battery of tests
performed on the Merit ONE Snare Endovascular Microsnare System were
designed to demonstrate that the device meets critical design specifications
as well as clinical performance attributes for its intended use. Where
appropriate, the tests were based on the requirements of the following
documents:
FDA guidance Coronary and Cerebrovascular Guide Wire Guidance
January 1995. ISO 11070:1998, Sterile Single-Use Intravascular Catheter Introducers 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 ASTM F 2096-11 Standard Test Method for Detecting Gross Leaks in
Medical Packaging by Internal Pressurization (Bubble Test) ASTM F 1929-12 Standard Test Method for Detecting Seal Leaks in
porous Medical Packaging by Dye Penetration ASTM F88/F88M-09 Standard Test Method for Seal Strength of Flexible
Barrier Materials ASTM D4169-09 Standard Practice for Performance Testing on
Shipping Containers and Systems 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 11135:2014 – Sterilization of health care products -- Ethylene oxide
-- Requirements for the development, validation and routine control of a
sterilization process for medical devices 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. | |
4
5
The Merit ONE Snare Endovascular Microsnare System was compared to the predicate devices for various performance attributes that demonstrate the substantial equivalence of the device. The following is a list of all significant testing that was successfully completed:
Catheter & Insertion Tool
- Surface Finish ●
- Radiopacity
- Catheter tip atraumatic .
- Marker band placement ●
- Effective Length ●
- ID & OD
- Catheter stiffness .
- Markerband retention
- Tip integrity ●
- Torque Strength ●
- Kink resistance ●
- Buckling force ●
- Freedom from Liquid leakage ●
- Freedom form Air leakage
- Peak tensile force of catheter at hub ●
- Force at break insertion tool at hub ●
- Hub with Female luer testing
- Corrosion Resistance ●
ONE Snare Endovascular Microsnare System
- Snare Loop Resistance ●
- Guide Catheter resistance ●
- Snare shape integrity
- Insertion Tool Fitment .
- Snare insertion ●
- Insertion Tool tear away force ●
- Snare jacket after insertion tool removal inspection ●
- o Snare loop protruding
Snare
- Size designation .
- Snare Head Assembly .
- Radio detectability ●
- Surface Finish
- . Tensile strength
- o Torqueability
- Torque Strength ●
- Flexing Test ●
- Fracture Test o
- Tip Flexibility ●
- Corrosion Resistance ●
Biocompatibility testing included
- Cytotoxicity
- Sensitization ●
- . Irritation
Safety & Performance Tests (continued)
6
| Safety &
Performance
Tests
(continued) | Acute Systemic Toxicity Pyrogenicity Genotoxicity Hemolysis Thrombogenicity Complement Activation Chemical Tests Packaging performance before and after exposure to accelerated aging and
simulated shipping and handling conditions bubble emission dye penetration seal peel tensile strength burst strength visual inspection |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of
Substantial
Equivalence | Based on the indications for use, design, safety, and performance testing,
the subject Merit ONE Snare Endovascular Microsnare System is
substantially equivalent to the Primary Predicate#1 Amplantz “GOOSE
NECK” Microsnare, K970668, manufactured by ev3 Inc and the Reference
Device#2 Merit Medical ONE Snare System, K122088 for Performance
data. |