(85 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 used to facilitate the placement of other devices, not to treat a medical condition itself.
No
The device is a guide wire intended to facilitate the placement of other devices during procedures and is not used to diagnose. While it may be used during "diagnostic and interventional procedures," the guide wire itself does not perform diagnostics.
No
The device description clearly describes a physical guide wire with a jacketed core wire and hydrophilic coating, indicating it is a hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that 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 test samples outside the body to diagnose conditions.
- Device Description: The description of a "jacketed core wire with a hydrophilic coating" is consistent with a medical device used for navigation within blood vessels, not a diagnostic test kit or instrument.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This guide wire does not fit that description.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 11070:2014, Sterile Single-Use Intravascular Catheter Introducers.
• 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.
• 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.
• ISO 11607-1:2006, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
The Merit Hydrophilic Guide Wire was compared to the predicate device for various performance attributes that support substantial equivalence of the device. Most of the 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 exception to this is Biocompatibility, where the 0.035" OD variant of the wire was chosen for testing.
Testing successfully completed:
- Surface
- Flex
- Fracture
- Size Designation/Dimensions
- Coating Adherence/Integrity (Including Anatomical Model)
- Catheter Compatibility (Durability)
- Particulate Evaluation
- Lubricity
- Biocompatibility
Biocompatibility tests included:
- Cytotoxicity - ISO MEM Elution Assay: MEM Extraction
- Sensitization - ISO Guinea Pig Max. Sensitization Test: Sodium Chloride and Sesame Oil Extraction
- Irritation - ISO I.C. Reactivity Test: Sodium Chloride and Sesame Oil Extraction
- Acute Systemic Toxicity - ISO Acute Systemic Toxicity Test: Sodium Chloride and Sesame Oil Extractions
- Pyrogenicity - Material Mediated Pyrogen Test: Sodium Chloride Extraction
- Genotoxicity - Ames Bacterial Reverse Mutation Assay: Saline and Ethanol Extractions
- Hemocompatibility - ISO Complement Activation: Direct Contact, C3a and SC5b-9
- ASTM Hemolysis – Direct and Indirect Contact: Phosphate Buffered Saline Extraction
- ISO 4-Hour Thrombo. Study in Canine
Key results: As all test results were comparable to the predicate device and the subject Merit Hydrophilic guide wire met the predeterminded acceptance criteria. This has demonstrated the subject device is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
0
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.
June 22, 2017
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Merit Medical Systems, Inc. Mr. Michael O'Sullivan Senior Regulatory Affairs Specialist Parkmore Business Park West Galway, Ireland
Re: K170933
Trade/Device Name: Merit Hydrophilic Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: May 23, 2017 Received: May 24, 2017
Dear Mr. O'Sullivan:
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 device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 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,
Fernando
Aguel-S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K170933
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) |
|---|---|
| ------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------ |
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3
| K170993 | ||
|---|---|---|
| 510(k) Summary | ||
| General | ||
| Provisions | Submitter Name: | |
| Address: | ||
| Telephone Number: | ||
| Fax Number: | ||
| Contact Person: | ||
| Registration Number: | Merit Medical Systems, Inc. | |
| 1600 West Merit Parkway | ||
| South Jordan, UT 84095 | ||
| (+353) 91 703700 (Ext. 3061) | ||
| (+353) 91 680104 | ||
| Mark Mullaney | ||
| 1721504 | ||
| Correspondent Name: | ||
| Address: | Merit Medical Ireland Ltd. | |
| Parkmore Business Park | ||
| Parkmore, Galway, Ireland | ||
| Telephone Number: | ||
| Fax Number: | ||
| Contact Person: | ||
| Date of Preparation: | ||
| Registration Number: | (+353) 91 703700 (Ext. 3223) | |
| (+353) 91 680104 | ||
| Michael O'Sullivan | ||
| 23 May 2017 | ||
| 9616662 | ||
| Subject | ||
| Device | Trade Name: | |
| Common/Usual Name: | ||
| Classification Name: | Merit Hydrophilic Guide Wire | |
| Hydrophilic Guide Wire | ||
| Catheter Guide Wire | ||
| Predicate | ||
| Device | Predicate Device: | |
| Trade Name: | ||
| Classification Name: | ||
| Premarket Notification: | ||
| Manufacturer: | Merit Hydrophilic Guide Wire | |
| 21 CFR 870.1330 Catheter guide wire | ||
| K141295 | ||
| Merit Medical Systems, Inc | ||
| Classification | Class II | |
| 21 CFR 870.1330 Catheter guide wire | ||
| FDA Product Code: DQX | ||
| Review Panel: 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 predicate, the Merit Hydrophilic Guide | ||
| Wires [K141295]. The only difference between the devices relate to the Material | ||
| Formulation of the Gantrez™ AN-169 that is used in the Hydrophilic coating | ||
| process, which has changed to a "Benzene Free" Version of that same material, | ||
| Gantrez™ AN-169 BF. The guide wire design and indications for use remain | ||
| unchanged. | ||
| 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. | ||
| Safety & | ||
| Performance | ||
| Tests | Where appropriate, the tests were based on the requirements of the following | |
| documents: | ||
| • FDA guidance Coronary and Cerebrovascular Guide Wire Guidance | ||
| January 1995. | ||
| • ISO 11070:2014, Sterile Single-Use Intravascular Catheter Introducers. | ||
| • 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. | ||
| • 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. | ||
| • ISO 11607-1:2006, Packaging for terminally sterilized medical devices - | ||
| Part 1: Requirements for materials, sterile barrier systems and | ||
| packaging systems | ||
| The Merit Hydrophilic Guide Wire was compared to the predicate device for | ||
| various performance attributes that support substantial equivalence of the | ||
| device. Most of the 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 exception to this is |
K170993
4
The following is a list of all testing that was successfully completed:
| 1) | Surface | 2) | Flex | 3) | Fracture | 4) | Size
Designation/
Dimensions |
|----|--------------------------------------------------------------------------|----|-------------------------------------------|----|---------------------------|----|------------------------------------|
| 5) | Coating
Adherence/
Integrity
(Including
Anatomical
Model) | 6) | Catheter
Compatibility
(Durability) | 7) | Particulate
Evaluation | 8) | Lubricity |
| 9) | Biocompatibility | | | | | | |
Biocompatibility, where the 0.035" OD variant of the wire was chosen for testing.
5
| Cytotoxicity - ISO MEM Elution Assay: MEM Extraction Sensitization - ISO Guinea Pig Max. Sensitization Test: Sodium Chloride and Sesame Oil Extraction Irritation - ISO I.C. Reactivity Test: Sodium Chloride and Sesame Oil Extraction Acute Systemic Toxicity - ISO Acute Systemic Toxicity Test: Sodium Chloride and Sesame Oil Extractions Pyrogenicity - Material Mediated Pyrogen Test: Sodium Chloride Extraction Genotoxicity - Ames Bacterial Reverse Mutation Assay: Saline and Ethanol Extractions Hemocompatibility - ISO Complement Activation: Direct Contact, C3a and SC5b-9 ASTM Hemolysis – Direct and Indirect Contact: Phosphate Buffered Saline Extraction ISO 4-Hour Thrombo. Study in Canine |
|---|
| As all test results were comparable to the predicate device and the subject Merit Hydrophilic guide wire met the predeterminded acceptance criteria. This has demonstrated the subject device is substantially equivalent to the predicate devices. |
| 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 substantially equivalent to the predicate device, the Merit Hydrophilic Guide Wire manufactured by Merit Medical Systems Inc., K141295. |