(142 days)
The ONE 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 venipuncture procedure assistance.
The ONE Snare™ System contains: (1) Snare, (1) Snare Catheter, (1) Introducer 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 a traditional Premarket Notification 510(k) for the Merit ONE Snare™ system. This type of submission focuses on demonstrating substantial equivalence to a predicate device through performance testing rather than clinical study data. Therefore, many of the requested data points related to clinical trials, ground truth, expert adjudication, and separate training/test sets are not applicable or explicitly stated in this type of submission.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states, "a battery of tests performed on the Merit ONE Snare™ system were designed to demonstrate that the device meets critical design specifications as well as clinical performance attributes for its intended use." It then lists numerous safety and performance tests. However, specific numerical acceptance criteria and their corresponding reported device performance values are NOT provided in this summary. The summary only states that these tests were "successfully completed."
Below is a table summarizing the types of tests performed. Note that specific quantitative acceptance criteria and performance metrics are not detailed in the provided text.
| Test Category | Specific Tests Mentioned (Examples) | Acceptance Criteria (Not Explicitly Stated - Assumed Success) | Reported Device Performance (Not Explicitly Stated - Assumed Success) |
|---|---|---|---|
| Device (General) | Surface Finish, Torque Strength, Torqueability, Compatibility of snare with snare catheter, Snare Catheter to Guiding Catheter compatibility, Snare introducer fit, Introducer Removal Force from Snare, Dimensional Inspection | Met critical design specifications | Successfully completed all tests |
| Snare Specific | Radiodetectability (Snare wire), Size Designation, Tensile Test, Tip Flexibility, Fracture Test, Flexing Test, Corrosion resistance | Met critical design specifications | Successfully completed all tests |
| Catheter & Introducer Specific | Radiodetectability (Snare catheter / marker bands), Catheter Atraumatic Tip Finish, Marker Band Retention, Force at break (at Catheter Tip and Junction), Catheter Pushability (kink or accordion resistance), Catheter flexibility (buckling resistance), Hub with Female Luer testing, Dimensions, Freedom from leakage, Surface Finish, Force at break (Junction), Corrosion resistance, Snare Torque Strength | Met critical design specifications | Successfully completed all tests |
| Biocompatibility | L929 MEM Elution, Kligman Maximization, Irritation Intracutaneous Injection Test, Systemic Injection, Material Medicated Rabbit Pyrogen Test, Genotoxicity (Salmonella typhimurium and Escherichia Coli), Hemocompatibility (Rabbit Blood - indirect & direct, Complement Activation Assay, In Vivo Thrombogenicity study in Dogs), USP Physicochemical Tests | Met biological safety standards and regulations | Successfully completed all tests |
| Packaging | Bubble emission, dye penetration, seal peel tensile strength, burst strength, visual inspection (before and after accelerated aging and simulated shipping) | Maintained sterile barrier integrity and physical properties | Successfully completed all tests |
2. Sample Size Used for the Test Set and Data Provenance
The text describes a "battery of tests" performed to demonstrate the device meets critical design specifications and clinical performance attributes. These are bench and laboratory tests, not typically clinical trials involving human subjects or extensive clinical data sets. Therefore:
- Sample Size for Test Set: Not explicitly stated as a number of "cases" or "patients." The sample size would refer to the number of individual devices or components tested for each specific bench test. This information is not detailed in the summary.
- Data Provenance: The tests are laboratory-based, implying the data is generated in a controlled testing environment, consistent with product development and regulatory submission requirements for a device of this nature. It is not clinical data in the sense of patient records or imaging. Likely, the tests were conducted at Merit Medical's facilities or accredited testing labs. It is not retrospective or prospective clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable in the context of this 510(k) summary. The "ground truth" for bench and lab testing of a medical device like a snare system involves meeting engineering specifications, material properties, and functional performance metrics established by industry standards (e.g., ISO, ASTM) and internal design requirements. There typically isn't a need for "experts" to establish a clinical ground truth in the way it's done for diagnostic AI.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or expert reviews of complex diagnoses, particularly for AI performance evaluation. For bench testing of a device, performance is evaluated against predefined pass/fail criteria for each test, not by expert consensus or adjudication on clinical cases.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This question is not applicable. The Merit ONE Snare™ system is a physical medical device (a retrieval snare), not an AI algorithm or a diagnostic tool that assists human "readers" in interpreting data. Therefore, an MRMC study or AI assistance effect size is irrelevant to this device.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
This question is not applicable as the Merit ONE Snare™ system is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this device, the "ground truth" refers to the established engineering specifications, material properties, and functional performance requirements (e.g., tensile strength, flexibility, biocompatibility, dimensions, seal integrity). These are defined by relevant international (ISO) and national (ASTM, FDA guidance) standards, as well as the manufacturer's internal design controls. It is not expert consensus, pathology, or outcomes data in the clinical sense.
8. The sample size for the training set
This question is not applicable. Bench testing for a medical device like this does not involve a "training set" in the context of machine learning or AI. Performance is evaluated against predefined criteria, not by training a model.
9. How the ground truth for the training set was established
This question is not applicable for the same reasons as #8.
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Merit Medical Systems, Inc.
Merit ONE Snare™ system
Traditional Premarket Notification 510(k)
.
4 Section 10 Executive Summary
| Section $5$ | DEC | 5 2012 | |||
|---|---|---|---|---|---|
| 510(k) Summary | |||||
| GeneralProvisions | Submitter Name:Address:Telephone Number:Fax Number:Contact Person:Registration Number: | Merit Medical Systems, Inc.1600 West Merit ParkwaySouth Jordan, UT 84095(801) 208-4349(801) 253-6967Stephanie Erskine1721504 | |||
| Correspondent Name:Address:Telephone Number:Fax Number:Contact Person:Date of Preparation:Registration Number: | Merit Medical Ireland Ltd.Parkmore Business Park,Galway, Ireland(353) 91 703 761(353) 91 771 888Mark Mullaney23-Nov-20129616662 | ||||
| SubjectDevice | Trade Name:Common/Usual Name:Classification Name: | Merit ONE Snare™ SystemPercutaneous retrieval devicedevice, Percutaneous retrieval | |||
| PredicateDevice | Trade Name:Classification Name:Premarket Notification:Manufacturer: | AMPLATZ GOOSE NECK SNARE KIT/CATHETERcatheter, embolectomyK972511ev3 Inc. | |||
| Classification | Class II21 CFR § 870.5150Division of Cardiovascular Devices | ||||
| Intended Use | The ONE Snare™ endovascular snare system is intended for use in thecoronary and peripheral vascular system or hollow viscous to retrieve andmanipulate foreign objects. | ||||
| Retrieval and manipulation procedures include indwelling venous catheterrepositioning, indwelling venous catheter fibrin sheath stripping, and centralvenous access venipuncture procedure assistance. |
.T.
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K122088
page 2 of 4
Section 10
Executive Summary
ONE Snare™ System contains: (1) Snare, (1) Snare Catheter, (1) Introducer and (1) Torque Device. The snare is constructed of nitinol cable and a gold plated tungsten loop. Device The pre-formed snare loop can be introduced through catheters without risk Description 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 of the subject Merit ONE Snare™ system are Technological substantially equivalent to those of the predicate, the currently marketed AMPLATZ GOOSE NECK SNARE KIT/ CATHETER, manufactured by ev3 Characteristics Inc., 510(k) K972511. 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™ 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 1995 Sterile, single-use intravascular catheters, . Part 1 - General Requirements. . ISO 594-1:1996, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment -- Part Safety & 1: General requirements Performance ISO 594-2:1998, Conical fittings with 6% (Luer) taper for ● Tests 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 1929-98 (Reapproved 2004); Standard Test Method for Detecting Seal Leaks in porous Medical Packaging by Dye Penetration ASTM F 88-09; Standard Test Method for Seal Strength of . Flexible Barrier Materials. ASTM D4169 - 09 Standard Practice for Performance Testing ● of Shipping Containers and Systems ASTM F1980-07 Standard Guide for Accelerated Aging of . Sterile Barrier Systems for Medical Devices
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Merit Medical Systems, Inc. Merit ONE Snare™ system Traditional Premarket Notification 510(k)
- ISO 11135:2007 Sterilization of health care products --. Ethylene oxide -- Part 1: Requirements for 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™ system was compared to the predicate device for various performance attributes that demonstrate substantial equivalence. The following is a list of all significant testing that was successfully completed:
ONE Snare System (Snare device, Catheter, Introducer and Torque Device)
- Surface Finish, Torque Strength, Torqueability, Compatibility of . snare with snare catheter, Snare Catheter to Guiding Catheter compatibility, Snare introducer fit, Introducer Removal Force from Snare and Dimensional Inspection
Snare
- Radiodetectability (Snare wire), Size Designation, Tensile Test, � Tip Flexibility, Fracture Test & Flexing Test and Corrosion resistance
Catheter & Introducer
-
Radiodetectability (Snare catheter / marker bands), Catheter Atraumatic Tip Finish. Marker Band Retention. Force at break (at Catheter Tip and Junction between Catheter Hub and Tube), Catheter Pushability (kink or accordion resistance) & Catheter flexibility (buckling resistance), Hub with Female Luer testing, Dimensions, Freedom from leakage, Surface Finish, Force at break (Junction between Introducer Hub and Tube), Corrosion resistance and Snare Torque Strength.
Biocompatibility testing included -
L929 MEM Elution: MEM extraction .
-
Kligman Maximization: Saline and cottonseed oil extractions .
-
Irritation Intracutaneous Injection Test Intracutaneous Injection: . Saline and cottonseed oil extractions
-
. Systemic Injection: Saline and cottonseed oil extractions
-
Material Medicated Rabbit Pyrogen Test: Saline extraction .
-
Genotoxicity Salonella typhimurium and Escherichia Coli Reverse t Mutation Assay - ISO
-
. Hemocompatibility - Rabbit Blood - Indirect
-
Hemocompatibility Rabbit Blood direct .
-
Hemocompatibility Complement Activation Assay ISO direct . Contact
-
. Hemocompatibility - In Vivo Thrombogenicity study in Dogs
-
USP Physicochemical Tests for Plastics USP <661> Non-Volatile . Residue
Safety & Performance Tests (continued)
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Merit Medical Systems, Inc.
Merit ONE Snare™ system
Traditional Premarket Notification 510(k)
4 Section 10 Executive Summary
| Packaging performance before and after exposure to accelerated aging andsimulated shipping and handling conditions | ||
|---|---|---|
| Safety &PerformanceTests(continued) | 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™ system meets the requirements that areconsidered essential for its intended use and is substantially equivalent tothe predicate device, the currently marketed AMPLATZ GOOSE NECKSNARE KIT/CATHETER, manufactured by ev3 Inc. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three overlapping human profiles, representing the department's focus on people and health.
· Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
DEC 5 2012
Merit Medical Systems, Inc. Mr. Mark Mullaney Regulatory Affairs Manager 1600 West Merit Parkway South Jordan, UT 4095
Re: K122088
Trade/Device Name: Merit ONE Snare System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: MMX Dated: November 22, 2012 Received: November 26, 2012
Dear Mr. Mullaney:
We have reviewed vour Section 510(k) premarket notification of intent to market the device i 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
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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,
Kenneth J.
Cavanaugh®
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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Section 4
Indications for Use Statement
510(k) Number (if known):
Device Name: Merit ONE Snare™ System
Indications for Use:
The ONE 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 venipuncture procedure assistance
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
K
vision Sign-Off) vision of Cardiovascular Devices
510(k) Number $\underline{K*{1} \geq 2*{0} \gamma 8}$
§ 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).