(29 days)
No
The device description and performance studies focus on the physical properties and mechanical performance of a guide wire, with no mention of AI or ML.
No
A guide wire is an accessory device used to facilitate the placement of other devices, not to directly treat a condition.
No
Explanation: The device is intended to facilitate the placement of other devices during diagnostic and interventional procedures, not to perform diagnosis itself.
No
The device description clearly states it is a "jacketed core wire with a hydrophilic coating," which are physical components, not software. The performance studies also focus on physical attributes like tensile strength and coating adherence.
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 test samples outside the body to diagnose conditions.
- Device Description: The description details a physical wire with a coating, designed for insertion into the body. This aligns with a medical device used in procedures, not an IVD which typically involves reagents, test strips, or analytical instruments for sample analysis.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes (proteins, DNA, antibodies, etc.)
- Providing diagnostic information based on sample analysis
Therefore, the Merit Hydrophilic Guide Wire is a medical device used for procedural support within the body, not an In Vitro Diagnostic device.
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 and angled 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. 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 based on Predicate device # 2 [K863138] Terumo Radiofocus® Glidewire®.
The following is a list of all significant testing that was successfully completed: Tensile Strength, Torque Strength, Torquability, Tip Flexibility, Coating Adherence/Integrity (including Evaluation using Anatomical Model), Catheter Compatibility (Durability), Surface, Fracture Test, Flex test, Size Designation/Dimensions and Radiopacity.
As all test results were comparable to the predicate devices and the subject Merit Hydrophilic guide wire met the predetermined acceptance criteria applicable to the safety and efficacy of the device, this has demonstrated the subject device is substantially equivalent to 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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Merit Medical Systems, Inc. Merit Hydrophilic Guide Wire Special Premarket Notification 510(k)
APR 0 5 2013
Section 6 510(k) Summary Submitter Name: Merit Medical Systems, Inc. Address: Parkmore Business Park Parkmore, Galway, Ireland Telephone Number: (+353) 91 703700 (3061) (+353) 91 680 104 Fax Number: Mark Mullaney Contact Person: 9616662 Registration Number: General Merit Medical Ireland Ltd. Correspondent Name: Provisions Address: Parkmore Business Park Parkmore, Galway, Ireland (+353) 91 703700 (3168) Telephone Number: (+353) 91 680 104 Fax Number: Martha Folan Contact Person: · 4th April 2013 Date of Preparation: Registration Number: 9616662 Merit Hydrophilic Guide Wire Trade Name: Subject Hydrophilic Guide Wire Common/Usual Name: Device Classification Name: Catheter Guide Wire Trade Name: Merit Hydrophilic Guide Wire Classification Name: Catheter Guide Wire Premarket Notification Predicate Device # 1 Predicate Merit Hydrophilic Guide Wire K120644 Device Manufacturer: Merit Medical Systems, Inc Premarket Notification Predicate Device # 2: Radiofocus® Glidewire® K863138 Manufacturer: Terumo Medical Corp. Class II 21 CFR § 870.1330, Classification Product code: DQX Division of Cardiovascular Devices The Merit Hydrophilic Guide Wire is intended to be used in the peripheral Intended Use vascular system to facilitate the placement of devices during diagnostic and interventional procedures.
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Merit Medical Systems, Inc.
Merit Hydrophilic Guide Wire
Special Premarket Notification 510(k)
| 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 and
angled 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
Wire [K120644]. The difference between the devices relates to the guide wire
diameter size. The guide wire design remains unchanged. Predicate device #2
[K863138] Terumo Radiofocus® Glidewire® is the predicate for performance
testing parameters. |
| 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. The difference in wire diameter between the modified device and the
cleared device [K120644] has raised no new issues. Performance testing was
based on Predicate device # 2 [K863138] Terumo Radiofocus® Glidewire®.
The following is a list of all significant testing that was successfully completed:
Tensile Strength, Torque Strength, Torquability, Tip Flexibility, Coating
Adherence/Integrity (including Evaluation using Anatomical Model), Catheter
Compatibility (Durability), Surface, Fracture Test, Flex test, Size Designation/
Dimensions and Radiopacity.
As all test results were comparable to the predicate devices and the subject
Merit Hydrophilic guide wire met the predetermined acceptance criteria
applicable to the safety and efficacy of the device, this has demonstrated the
subject device is substantially equivalent to 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 substantively equivalent to the
predicate device, the Merit Hydrophilic Guide Wire manufactured by Merit
Medical Systems Inc. |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Inside the circle is a stylized image of an eagle with its wings spread, which is a common symbol associated with the United States.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 5, 2013
Merit Medical Systems, Inc. Martha Folan Senior Regulatory Affairs Specialist Parkmore Business Park, Galway Ireland
Re: K130588
Trade Name: Merit Hydrophilic Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DOX Dated: March 4, 2013 Received: March 7, 2013
Dear Ms. Folan:
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. Ilsting 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
3
forth in 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.
ff you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree 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" (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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Kenneth: Cavañaug
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Merit Medical Systems, Inc. Merit Hydrophilic Guide Wire Special Premarket Notification 510(k)
Section 5
Indications for Use Statement
510 (k) Number:
Device Name: Merit Hydrophilic Guide Wire
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.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use | 7 (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)
Kenneth J. Cavanaugh 2013.04.05 14:05:59 -04'00'