(211 days)
The Merit Hydrophilic Guide Wire is intended to be used in the peripheral vascular system to facilitate the placement of devices during diagnostic and interventional procedures.
The Merit Hydrophilic Guide Wire consists of a jacketed core wire with a hydrophilic coating applied to the jacket. The wire will be offered in straight, angled, standard and stiff configurations, in various lengths.
The provided text describes a 510(k) premarket notification for a medical device, the "Merit Hydrophilic Guide Wire." The document focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving novel effectiveness. Therefore, the study described is a comparative performance study against predicate devices, not an effectiveness study in the typical sense of a human-in-the-loop clinical trial or a standalone AI algorithm performance study.
Here's an analysis of the requested information based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The document does not provide a specific table of acceptance criteria with numerical targets and corresponding performance results for each criterion. It broadly states that a "battery of testing was conducted in accordance with protocols based on requirements outlined in guidance's and industry standards and these were shown to meet the acceptance criteria that were determined to demonstrate substantial equivalence."
The tests performed and their general outcomes are listed:
| Acceptance Criteria (Stated as tests performed) | Reported Device Performance (Implied by approval) |
|---|---|
| Coating Adherence/Integrity (Including Anatomical Model) | Successfully completed |
| Catheter Compatibility (Durability) | Successfully completed |
| Surface | Successfully completed |
| Fracture test | Successfully completed |
| Flex test | Successfully completed |
| Size Designation/ Dimensions | Successfully completed |
| Particulate Evaluation | Successfully completed |
| Biocompatibility testing | Successfully completed |
The general acceptance criterion is that the new Merit Hydrophilic Guide Wire performs substantially equivalently to the predicate devices in these physical and biological tests. The document declares that the device met these criteria, indicating successful performance in all listed tests.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document specifies that performance testing was performed on the 0.018" and 0.038" diameter wires only. These represent the "minimum and maximum wire diameters within the cleared device range." The manufacturer believes this is sufficient to demonstrate equivalence for intermediate diameters. The exact number of units or samples tested for each specific test (e.g., number of wires for flex test, number of samples for biocompatibility) is not provided.
- Data Provenance: The document does not explicitly state the country of origin of the data. However, the applicant is Merit Medical Systems, Inc. (South Jordan, UT, USA) with a correspondent in Ireland, suggesting that the testing could be internal to the company or contracted out to labs in various locations. Given the nature of a 510(k) submission, this testing is typically controlled in a laboratory setting for regulatory purposes. It is retrospective data in the sense that the tests were conducted prior to submission for regulatory clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This question is not applicable in the context of this device and study. The "ground truth" for a guidewire's performance is objective measurements against established engineering and biocompatibility standards, not expert evaluation of medical images or clinical outcomes. The tests evaluate physical properties, material compatibility, and biological safety, which are quantifiable against predefined acceptance limits or comparative performance with predicate devices.
4. Adjudication Method for the Test Set
This question is not applicable. The performance tests for a guidewire (e.g., fracture test, flex test, coating adherence) involve objective measurements and comparisons to engineering specifications or predicate device performance, not subjective human assessment requiring adjudication.
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. This is a 510(k) submission for a physical medical device (guidewire), not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related effectiveness analysis was performed or described.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This question is not applicable, as the device is a physical guidewire and not an algorithm or AI system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's evaluation is based on:
- Engineering specifications and performance standards: These are derived from industry standards (e.g., ISO 11070:1998, ASTM F1980-07) and FDA guidance documents (e.g., Coronary and Cerebrovascular Guide Wire Guidance January 1995).
- Biocompatibility standards: Primarily ISO 10993-1:2009 and FDA Modified ISO 10993 Test Profile FDA Memo G95-1.
- Comparative performance against predicate devices: The objective of the submission is to demonstrate "substantial equivalence" to existing, legally marketed guidewires. Therefore, the performance of the new device is compared to the established performance of the predicate devices in the listed tests.
8. The Sample Size for the Training Set
This question is not applicable. There is no "training set" in the context of this guidewire's regulatory submission, as it is a physical device and not an AI or machine learning model.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the reasons stated above (no training set for a physical device).
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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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 16, 2014
Merit Medical Systems, Inc. Mr. Michael O'Sullivan RA Specialist III Parkmore Business Park West Galway, Ireland
K141295 Trade/Device Name: Merit Hydrophilic Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: October 20, 2014 Received: October 23, 2014
Dear Mr. O' Sullivan,
Re:
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,
Kenneth J. Cavanaugh -S
for
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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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Merit Hydrophilic Guide Wire
Indications for Use (Describe)
The Merit Hydrophilic Guide Wire is intended to be used in the peripheral vascular system to facilitate the placement of devices during diagnostic and interventional procedures.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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| 510(k) Summary | |
|---|---|
| GeneralProvisions | Submitter Name: Merit Medical Systems, Inc.Address: 1600 West Merit ParkwaySouth Jordan, UT 84095Telephone Number: (+353) 91 703700 (Ext. 3061)Fax Number: (+353) 91 680104Contact Person: Mark MullaneyRegistration Number: 1721504Correspondent Name: Merit Medical Ireland Ltd.Address: Parkmore Business ParkParkmore, Galway, IrelandTelephone Number: (+353) 91 703700 (Ext. 3223)Fax Number: (+353) 91 680104Contact Person: Michael O'SullivanDate of Preparation: 15th May 2014Registration Number: 9616662 |
| SubjectDevice | Trade Name: Merit Hydrophilic Guide WireCommon/Usual Name: Hydrophilic Guide WireClassification Name: Catheter Guide Wire |
| PredicateDevice | Premarket Notification Predicate Device # 1:Merit Hydrophilic Guide Wire K131710Manufacturer: Merit Medical Systems, IncPremarket Notification Predicate Device # 2:Merit Hydrophilic Guide Wire K130588Manufacturer: Merit Medical Systems, IncPremarket Notification Predicate Device # 3:Merit Hydrophilic Guide Wire K123609Manufacturer: Merit Medical Systems, IncPremarket Notification Predicate Device # 4:Merit Hydrophilic Guide Wire K120644Manufacturer: Merit Medical Systems, Inc |
| Classification | Class II21 CFR § 870.1330Product code: DQXDivision of Cardiovascular Devices |
| Intended Use | The Merit Hydrophilic Guide Wire is intended to be used in the peripheralvascular system to facilitate the placement of devices during diagnostic andinterventional procedures. |
| DeviceDescription | The Merit Hydrophilic Guide Wire consists of a jacketed core wire with ahydrophilic coating applied to the jacket. The wire will be offered in straight,angled, standard and stiff configurations, in various lengths. |
| Comparison toPredicate | Technological characteristics of the subject Merit Hydrophilic Guide Wire aresubstantially equivalent to those of the predicates, the Merit Hydrophilic GuideWires [K131710], [K130588], [K123609] and [K120644]. The difference betweenthe devices relate to the process of application of the hydrophilic coating and themodification of the volume quantities of some materials. The guide wire designand indications remain unchanged. |
| Safety &PerformanceTests | No performance standards have been established under section 514 of theFood, Drug and Cosmetic Act for these devices. A battery of testing wasconducted in accordance with protocols based on requirements outlined inguidance's and industry standards and these were shown to meet theacceptance criteria that were determined to demonstrate substantialequivalence.Where appropriate, 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 11135-1: 2007 Sterilization of health care products-Ethylene oxide-Part 1: Requirements for the development, validation and routine controlof a sterilization process for medical devices. ASTM F1980-07 Standard Guide for Accelerated Aging of Sterile BarrierSystems 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. The Merit Hydrophilic Guide Wire was compared to the predicate device(s) forvarious performance attributes that support substantial equivalence of thedevice. Performance testing was performed on the 0.018" and 0.038" diameterwires only, as these represent the minimum and maximum wire diameters withinthe cleared device range and Merit believes that the testing on these (min/max)diameters is sufficient to demonstrate equivalence for the intermediate diameterwires of 0.025" and 0.035" also.The following is a list of all significant testing that was successfully completed:Coating Adherence/Integrity(Including Anatomical Model), Catheter Compatibility(Durability), Surface, Fracture test, Flex test, Size Designation/ Dimensions,Particulate Evaluation and Biocompatibility testing. |
| Summary ofSubstantialEquivalence | Based on the Indications for Use, design, safety and performance testing, thesubject Merit Medical Hydrophilic Guide Wire meets the requirements that areconsidered essential for its intended use and is substantively equivalent to thepredicate devices, the Merit Hydrophilic Guide Wires manufactured by MeritMedical Systems Inc., K131710(0.018"), K130588(0.025"), K123609(0.038")and K120644(0.035"). |
Section 5
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Merit Hydrophilic guide wire met the predeterminded acceptance criteria applicable to the safety and efficacy of the device,this has demonstrated the subject device is substantially equivalent to the predicate devices.
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§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.