(90 days)
Not Found
No
The summary describes a physical guide wire with a hydrophilic coating and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is a guide wire intended to facilitate the placement of other devices during diagnostic and interventional procedures, 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 a condition.
No
The device description clearly states it is a "jacketed core wire with a hydrophilic coating," which are physical components, not software.
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 tool used within the body during a medical procedure, not a device used to examine specimens outside the body.
- Device Description: The description details a physical wire with a coating, designed for insertion into the body.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in specimens
- Providing information for diagnosis, monitoring, or screening based on specimen analysis.
The Merit Hydrophilic Guide Wire is a medical device used in vivo (within the body) to aid in procedures, not an in vitro diagnostic device.
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
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 with straight and angled tip 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)
No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices. However, a battery of tests was performed according to protocols based on the requirements of industry standards and guidances and were shown to meet the acceptance criteria that were determined to demonstrate the safety and efficacy of the device.
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
Merit Medical Systems, Inc.
Merit Hydrophilic Guide Wire Traditional Premarket Notification 510(k) Section 5
510(k) Summary
.
| Section 5 | ||
|---|---|---|
| 510(k) Summary | OCT 2 7 2009 | |
| General | ||
| Provisions | Submitter Name: | Merit Medical Systems, Inc. |
| Address: | 1600 West Merit Parkway | |
| South Jordan, UT 84095 | ||
| Telephone Number: | (801) 208-4789 | |
| Fax Number: | (801) 253-6919 | |
| Contact Person: | Susan Christensen | |
| Date of Preparation: | July 28, 2009 | |
| Registration Number: | 1721504 | |
| Subject | ||
| Device | Trade Name: | Merit Hydrophilic Guide Wire |
| Common/Usual Name: | Guide Wire | |
| Classification Name: | Catheter Guide Wire | |
| Predicate | ||
| Devices | Trade Name: | Radiofocus® Glidewire® |
| Classification Name: | Catheter Guide Wire | |
| Premarket Notification: | K863138 | |
| Manufacturer: | Terumo Medical Corporation | |
| Trade Name: | Hydrophilic Coated Guide Wire | |
| Classification Name: | Catheter Guide Wire | |
| Premarket Notification: | K000011 | |
| Manufacturer: | Lake Region Medical | |
| Classification | Class II | |
| 21 CFR § 870.1330, 74 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. | ||
| 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 with straight and angled tip | ||
| configurations in various lengths. | ||
| Technological | ||
| Characteristics | Technological characteristics of the subject Merit Hydrophilic Guide | |
| Wire are substantially equivalent to those of the predicate, the | ||
| currently marketed Terumo Radiofocus® Glidewire® [K863138], and | ||
| the Lake Region Medical Hydrophilic Coated Guide Wire [K000011]. | ||
| Safety & | ||
| Performance | ||
| Tests | No performance standards have been established under Section 514 | |
| of the Food, Drug and Cosmetic Act for these devices. However, a | ||
| battery of tests was performed according to protocols based on the | ||
| requirements of industry standards and guidances and were shown | ||
| to meet the acceptance criteria that were determined to demonstrate | ||
| the safety and efficacy of the device. | ||
| Summary of | ||
| Substantial | ||
| Equivalence | Based on the indications for use, design, safety, and performance | |
| testing, the subject Merit Hydrophilic Guide Wire meets the | ||
| requirements that are considered essential for its intended use and is | ||
| substantially equivalent to the predicate devices, the currently | ||
| marketed Radiofocus® Glidewire® manufactured by Terumo Medical | ||
| Corporation and the Hydrophilic Coated Guide Wire manufactured by | ||
| Lake Region Medical. |
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Merit Medical Systems, Inc. Merit Hydrophilic Guide Wire Traditional Premarket Notification 510(k)
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
OCT 2 7 2009
Merit Medical Systems, Inc. c/o Ms. Susan Christensen 1600 West Merit Parkway South Jordan, UT 84095
Re: K092303
Trade/Device Name: Merit Hydrophilic Guide Wire Common Name: Catheter Guidewire Regulation Number: 21 CFR 870.1330 Regulatory Class: II Product Code: DQX Dated: July 28, 2009 Received: July 29, 2009
Dear Ms. Christensen:
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.
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
Page 2 - Ms. Susan Christensen
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/CDRH/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 yours.
Wmat.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 4
Indications for Use Statement
510(k) Number (if known):
长092303
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 × (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)
W.M.F.
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_k092303