(211 days)
Not Found
No
The device description and performance studies focus on the physical properties and performance of a guide wire, with no mention of AI or ML technologies.
No
The device is a guide wire intended to facilitate the placement of other devices during procedures, not to directly treat a medical condition.
No
The device is a guide wire, which is a tool used to facilitate the placement of other devices during medical procedures. While it can be used during "diagnostic and interventional procedures", the guide wire itself does not diagnose a condition; it is a mechanical aid.
No
The device description clearly states it is a "jacketed core wire with a hydrophilic coating," which is a physical hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used "in the peripheral vascular system to facilitate the placement of devices during diagnostic and interventional procedures." This describes a device used within the body for procedural assistance, not a device used to examine specimens outside the body to provide diagnostic information.
- Device Description: The description details a physical wire with a coating, designed for insertion into the vascular system. This aligns with an interventional or procedural device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVDs are specifically designed to be used in vitro (outside the living body) to examine specimens and provide information for diagnostic purposes. This device is used in vivo (within the living body) to aid in medical procedures.
N/A
Intended Use / Indications for Use
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.
Product codes
DQX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vascular system
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
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. 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 11135-1: 2007 Sterilization of health care products-Ethylene oxide- Part 1: 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 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 Hydrophilic Guide Wire was compared to the predicate device(s) for various performance attributes that support substantial equivalence of the device. Performance testing was performed on the 0.018" and 0.038" diameter wires only, as these represent the minimum and maximum wire diameters within the cleared device range and Merit believes that the testing on these (min/max) diameters is sufficient to demonstrate equivalence for the intermediate diameter wires 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.
Key Metrics
Not Found
Predicate Device(s)
K131710, K130588, K123609, K120644
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
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,
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)
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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| 510(k) Summary | |
|---|---|
| General | |
| Provisions | Submitter Name: Merit Medical Systems, Inc. |
| Address: 1600 West Merit Parkway | |
| South Jordan, UT 84095 | |
| Telephone Number: (+353) 91 703700 (Ext. 3061) | |
| Fax Number: (+353) 91 680104 | |
| Contact Person: Mark Mullaney | |
| Registration Number: 1721504 |
Correspondent Name: Merit Medical Ireland Ltd.
Address: Parkmore Business Park
Parkmore, Galway, Ireland
Telephone Number: (+353) 91 703700 (Ext. 3223)
Fax Number: (+353) 91 680104
Contact Person: Michael O'Sullivan
Date of Preparation: 15th May 2014
Registration Number: 9616662 |
| Subject
Device | Trade Name: Merit Hydrophilic Guide Wire
Common/Usual Name: Hydrophilic Guide Wire
Classification Name: Catheter Guide Wire |
| Predicate
Device | Premarket Notification Predicate Device # 1:
Merit Hydrophilic Guide Wire K131710
Manufacturer: Merit Medical Systems, Inc
Premarket Notification Predicate Device # 2:
Merit Hydrophilic Guide Wire K130588
Manufacturer: Merit Medical Systems, Inc
Premarket Notification Predicate Device # 3:
Merit Hydrophilic Guide Wire K123609
Manufacturer: Merit Medical Systems, Inc
Premarket Notification Predicate Device # 4:
Merit Hydrophilic Guide Wire K120644
Manufacturer: Merit Medical Systems, Inc |
| Classification | Class II
21 CFR § 870.1330
Product code: DQX
Division of Cardiovascular Devices |
| Intended Use | 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. |
| Device
Description | 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. |
| Comparison to
Predicate | Technological characteristics of the subject Merit Hydrophilic Guide Wire are
substantially equivalent to those of the predicates, the Merit Hydrophilic Guide
Wires [K131710], [K130588], [K123609] and [K120644]. The difference between
the devices relate to the process of application of the hydrophilic coating and the
modification of the volume quantities of some materials. The guide wire design
and indications remain unchanged. |
| Safety &
Performance
Tests | No performance standards have been established under section 514 of the
Food, Drug and Cosmetic Act for these devices. 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.
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 11135-1: 2007 Sterilization of health care products-Ethylene oxide-
Part 1: 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 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 Hydrophilic Guide Wire was compared to the predicate device(s) for
various performance attributes that support substantial equivalence of the
device. Performance testing was performed on the 0.018" and 0.038" diameter
wires only, as these represent the minimum and maximum wire diameters within
the cleared device range and Merit believes that the testing on these (min/max)
diameters is sufficient to demonstrate equivalence for the intermediate diameter
wires 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 of
Substantial
Equivalence | Based on the Indications for Use, design, safety and performance testing, the
subject Merit Medical Hydrophilic Guide Wire meets the requirements that are
considered essential for its intended use and is substantively equivalent to the
predicate devices, the Merit Hydrophilic Guide Wires manufactured by Merit
Medical Systems Inc., K131710(0.018"), K130588(0.025"), K123609(0.038")
and K120644(0.035"). |
Section 5
4
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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