(90 days)
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.
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.
The provided text describes the 510(k) premarket notification for the ONE Snare Endovascular Microsnare System. However, it does not explicitly define acceptance criteria or specific study results in the format requested. The document primarily lists performance attributes that were tested to demonstrate substantial equivalence to predicate devices, rather than providing quantitative acceptance criteria and corresponding detailed device performance data.
Based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table with specific numerical or quantitative acceptance criteria and corresponding performance metrics for the ONE Snare Endovascular Microsnare System. Instead, it lists a comprehensive set of tests performed and states that these tests were "successfully completed" or "designed to demonstrate that the device meets critical design specifications as well as clinical performance attributes for its intended use."
The identified performance attributes tested include (but are not limited to):
| Category | Tested Performance Attributes |
|---|---|
| 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 | 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) |
The document implies that the device "meets critical design specifications as well as clinical performance attributes for its intended use" by successfully completing these tests, but the specific numerical "acceptance criteria" and "reported device performance" are not detailed.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for any of the tests conducted. It also does not provide information on data provenance (e.g., country of origin, retrospective or prospective) as the studies appear to be bench and laboratory-based performance tests rather than clinical studies with patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not applicable as the studies described are in vitro or bench tests, not clinical studies requiring expert interpretation of medical images or patient outcomes for ground truth establishment.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as #3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No MRMC comparative effectiveness study is mentioned in the provided text. The studies focus on the device's physical and functional performance and biocompatibility.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable as the device is a physical medical instrument (an endovascular microsnare system), not an algorithm or AI software. There is no "algorithm only" performance to evaluate.
7. The Type of Ground Truth Used
For the performance tests described (e.g., tensile strength, corrosion resistance, biocompatibility), the "ground truth" would be objective measurements and established standards (e.g., ISO, ASTM, FDA guidance documents). The tests were designed to demonstrate adherence to critical engineering specifications and regulatory requirements.
8. The Sample Size for the Training Set
This is not applicable as the device is a physical medical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reasons as #8.
Summary of Study Type:
The studies described are a series of bench testing, laboratory testing, and biocompatibility assessments to demonstrate the physical, chemical, and functional performance of the ONE Snare Endovascular Microsnare System. The purpose of these tests was to establish substantial equivalence to predicate devices under the 510(k) pathway, not to evaluate clinical efficacy or diagnostic accuracy using patient data or expert adjudicated ground truth. The acceptance of the device is based on its ability to perform robustly under various conditions and meet recognized standards (e.g., ISO, ASTM) and design specifications.
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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
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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
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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)
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FORM FDA 3881 (8/14)
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510(k) Summary
| GeneralProvisions | Submitter Name:Address:Telephone Number:Fax Number:Contact Person:Date of Preparation:Registration Number: | Merit Medical Systems, Inc.1600 West Merit ParkwaySouth Jordan, UT 84095+353 91-703761+353 91-703772Mark Mullaney11-Nov-141721504 |
|---|---|---|
| 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 91-703772Siobhan King11-Nov-149616662 | |
| SubjectDevice | Trade Name:Common/Usual Name:Classification Name: | ONE Snare Endovascular Microsnare SystemPercutaneous Retrieval DeviceDevice, Percutaneous Retrieval |
| PredicateDevice | Primary Predicate Device# 1:Trade Name:Classification Name:Premarket Notification:Manufacturer:Reference Device# 2:Trade Name:Classification Name:Premarket Notification:Manufacturer: | Amplantz "GOOSE NECK" MicrosnareCatheter, PercutaneousK970668ev3 (Microvena Corp.)Merit ONE Snare SystemPercutaneous retrieval deviceK122088Merit Medical Systems, Inc. |
| Classification | Class II21 CFR § 870.5150FDA Product Code: MMXDivision of Cardiovascular Devices | |
| Intended Use | The ONE Snare Endovascular Microsnare System is intended for use inadult and pediatric populations for the retrieval and manipulation ofatraumatic foreign bodies located in the coronary and peripheralcardiovascular system and the extra-cranial anatomy. | |
| DeviceDescription | ONE Snare Endovascular Microsnare System contains: (1) Snare, (1)Snare Catheter, (1) Insertion Tool and (1) Torque Device. The snare isconstructed of nitinol cable and a gold plated tungsten loop. The pre-formedsnare loop can be introduced through catheters without risk of snaredeformation because of the snare's super-elastic construction. The snarecatheter is constructed of polyether block amide (Pebax®) and contains aplatinum/iridium radiopaque marker band. | |
| TechnologicalCharacteristics | Technological characteristics of the subject Merit ONE Snare EndovascularMicrosnare System are substantially equivalent to those of the PrimaryPredicate#1, the currently marketed Amplantz "GOOSE NECK" Microsnare,manufactured by ev3 Inc., 510(k) K970668 and Reference Device#2, MeritMedical ONE Snare System, 510(k) K122088 for the following performancedata - Corrosion Testing, Luer Testing and Packaging Testing. | |
| Safety &PerformanceTests | No performance standards have been established under Section 514 of theFood, Drug and Cosmetic Act for these devices. However, a battery of testsperformed on the Merit ONE Snare Endovascular Microsnare System weredesigned to demonstrate that the device meets critical design specificationsas well as clinical performance attributes for its intended use. Whereappropriate, the tests were based on the requirements of the followingdocuments:FDA guidance Coronary and Cerebrovascular Guide Wire GuidanceJanuary 1995. ISO 11070:1998, Sterile Single-Use Intravascular Catheter Introducers ISO 10555-1 2013 Intravascular catheters - Sterile and single usecatheters - 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: Generalrequirements 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 inMedical Packaging by Internal Pressurization (Bubble Test) ASTM F 1929-12 Standard Test Method for Detecting Seal Leaks inporous Medical Packaging by Dye Penetration ASTM F88/F88M-09 Standard Test Method for Seal Strength of FlexibleBarrier Materials ASTM D4169-09 Standard Practice for Performance Testing onShipping Containers and Systems ASTM F1980-07 Standard Guide for Accelerated Aging of SterileBarrier Systems for Medical Devices ISO 2233:2000 Packaging - Complete, filled transport packages andunit loads - conditioning for testing ISO 11135:2014 – Sterilization of health care products -- Ethylene oxide-- Requirements for the development, validation and routine control of asterilization 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 FDAModified ISO 10993 Test Profile FDA Memo G95-1. |
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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)
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| Safety &PerformanceTests(continued) | Acute Systemic Toxicity Pyrogenicity Genotoxicity Hemolysis Thrombogenicity Complement Activation Chemical Tests Packaging performance before and after exposure to accelerated aging andsimulated shipping and handling conditions bubble emission dye penetration seal peel tensile strength burst strength visual inspection |
|---|---|
| Summary ofSubstantialEquivalence | Based on the indications for use, design, safety, and performance testing,the subject Merit ONE Snare Endovascular Microsnare System issubstantially equivalent to the Primary Predicate#1 Amplantz “GOOSENECK” Microsnare, K970668, manufactured by ev3 Inc and the ReferenceDevice#2 Merit Medical ONE Snare System, K122088 for Performancedata. |
§ 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).