(56 days)
Not Found
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
The device is described as a guide wire intended to facilitate the placement of other devices during procedures, not to provide therapy itself.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended to facilitate the placement of devices during diagnostic and interventional procedures." This indicates its role in diagnostic procedures.
No
The device description clearly states it is a "jacketed core wire with a hydrophilic coating," indicating a physical, hardware-based medical device. The performance studies also focus on physical attributes like tensile strength, torque strength, and coating adherence.
Based on the provided information, the Merit Hydrophilic Guide Wire is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "facilitate the placement of devices during diagnostic and interventional procedures." This describes a device used within the body to aid in medical procedures, not a device used to test samples outside the body (which is the definition of an IVD).
- Device Description: The description details a physical wire with a coating, designed for insertion into the body.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, reagents, or any other typical components or processes associated with in vitro diagnostics.
The device is clearly intended for use in vivo (within a living organism) to support medical procedures.
N/A
Intended Use / Indications for Use
The Merit Hydrophilic Guide Wire is intended to facilitate the placement of devices during diagnostic and interventional procedures.
Product codes (comma separated list FDA assigned to the subject device)
DQX, DOX
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
Not Found
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 following is a list of all the significant tests evaluated: 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, Particulate Testing. As all test results were comparable to the predicate devices and all predetermined acceptance criteria for tests were successful this has demonstrated the subject device is substantially equivalent to predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
K123609 Page 1 of 3
Merit Medical Systems, Inc.
Merit Hydrophilic Guide Wire
Special Premarket Notification 510(k)
JAN 1 6 2013
| Section 5 | |||
|---|---|---|---|
| 510(k) Summary | |||
| General | |||
| Provisions | Submitter Name: | Merit Medical Systems, Inc. | |
| Address: | 1600 West Merit Parkway | ||
| South Jordan, UT 84095 | |||
| Telephone Number: | (801) 208-4349 | ||
| Fax Number: | (801) 253-6967 | ||
| Contact Person: | |||
| Registration Number: | Stephanie Erskine | ||
| 1721504 | |||
| Correspondent Name: | Merit Medical Ireland Ltd. | ||
| Address: | Parkmore Business Park | ||
| Parkmore, Galway, Ireland | |||
| Telephone Number: | (353) 91 703700 (3168) | ||
| Fax Number: | (353) 91 771 888 | ||
| Contact Person: | Martha Folan | ||
| Date of Preparation: | 20-Dec-2012 | ||
| Registration Number: | 9616662 | ||
| Subject | |||
| Device | Trade Name: | Merit Hydrophilic Guide Wire | |
| Common/Usual Name: | Hydrophilic Guide Wire | ||
| Classification Name: | Catheter Guide Wire | ||
| Predicate | |||
| Devices | Trade Name: | Merit Hydrophilic Guide Wire | |
| Classification Name: | Catheter Guide Wire | ||
| Premarket Notification Predicate Device # 1 | |||
| Merit Hydrophilic Guide Wire K120644 | |||
| Manufacturer: Merit Medical Systems, Inc | |||
| Premarket Notification Predicate Device # 2: | |||
| Radiofocus® Glidewire® K863138 | |||
| Manufacturer: Terumo Medical Corp. | |||
| Classification | Class II | ||
| 21 CFR § 870.1330, | |||
| Product code: DQX | |||
| Division of Cardiovascular Devices | |||
| Intended Use | The Merit Hydrophilic Guide Wire is intended to facilitate the | ||
| placement of devices during diagnostic and interventional | |||
| procedures. |
1
K123609 Page 2 of 3
Merit Medical Systems, Inc. Merit Hydrophilic Guide Wire Special Premarket Notification 510(k)
The Merit Hydrophilic Guide Wire consists of a jacketed core wire with a Device Description hydrophilic coating applied to the jacket. The wire will be offered in straight and angled configurations in various lengths. Technological characteristics of the subject Merit Hydrophilic Guide Wire are substantially equivalent to those of the predicate, the Merit Comparison Hydrophilic Guide Wire [K120644]. The differences between the devices to Predicate 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. 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 . Safety & Barrier Systems for Medical Devices Performance ISO 10993-1: 2009, Biological Evaluation of Medical Devices Part . Tests 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 for various attributes that support substantial equivalence of the device. The differences 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 the significant tests evaluated: 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, Particulate Testing. As all test results were comparable to the predicate devices and all predetermined acceptance criteria for tests were successful this has demonstrated the subject device is substantially equivalent to predicate devices.
2
K123609 Page 3 of 3
Merit Medical Systems, Inc. Merit Hydrophilic Guide Wire Special Premarket Notification 510(k)
Based on the Indications for Use, design, safety and performance of Summary testing, the subject Merit Medical Hydrophilic Guide Wire meets the Substantial requirements that are considered essential for its intended use and is Equivalence substantively equivalent to the predicate device, the Merit Hydrophilic Guide Wire manufactured by Merit Medical Systems Inc.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/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" arranged around the perimeter. Inside the circle is a stylized symbol resembling a human figure in profile, with three overlapping heads or faces.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Merit Medical Systems, Inc. Martha Folan . Senior Regulatory Affairs Specialist Parkmore Business Park West Parkmore, Galway, Ireland
JAN 1 6 2013
Re: K123609
Trade/Device Name: Merit Hydrophilic Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DOX Dated: November 19, 2012 Received: November 21, 2012
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 Amendmouts, 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 to he 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
4
Page 2 -- Ms. Martha Folan
device-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 go to http://www.fda.gov/AboutFDA/CentersOffices/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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Matthew G. Hillebrenner
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Merit Medica! Systems, Inc. Merit Hydrophilic Guide Wire Special Premarket Notification 510(k)
Section 4
Indications for Use Statement
510 (k) Number: K 123609
Device Name: Merit Hydrophilic Guide Wire
Indications for Use:
The Merit Hydrophilic Guide Wire is intended 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 : (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)
M.S. Hillelum
(Division Sign-Off) (Division Sign-On)
Division of Cardiovascular Devices
510(k) Number
Page | 7