(90 days)
The Merit Hydrophilic Guide Wire is intended to facilitate the placement of devices during diagnostic and interventional procedures.
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.
The provided text describes a 510(k) premarket notification for a medical device, the Merit Hydrophilic Guide Wire. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a de novo clinical trial with specific performance metrics against acceptance criteria. Therefore, most of the information requested in your prompt (especially regarding AI studies, expert ground truth, sample sizes for training/test sets, and human-in-the-loop performance) is not applicable or not provided in this document.
However, I can extract the relevant information about the acceptance criteria and how the device meets them based on the 510(k) summary provided.
Here's the breakdown:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No performance standards established under Section 514 of the Food, Drug and Cosmetic Act for these devices. | A battery of tests was performed according to protocols based on the requirements of industry standards and guidances. |
| Meet acceptance criteria that were determined to demonstrate the safety and efficacy of the device. | The tests were shown to meet the acceptance criteria. |
| Substantial equivalence to predicate devices in: Indication for Use, design, safety, and performance testing. | The Merit Hydrophilic Guide Wire meets the requirements that are considered essential for its intended use and is substantially equivalent to the predicate devices (Terumo Radiofocus® Glidewire® [K863138] and Lake Region Medical Hydrophilic Coated Guide Wire [K000011]). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This 510(k) submission primarily relies on non-clinical performance and substantial equivalence to predicate devices, not on human test sets or data in the way an AI/software device would. The tests performed are likely bench or in-vitro tests on the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. This document does not describe the use of human experts to establish ground truth for a test set. The "ground truth" for a medical device like a guide wire would be its physical properties and mechanical performance meeting specified engineering or industry standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. This document does not describe a clinical study requiring an adjudication method.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is a hardware medical device (guide wire), not an AI/software device. Therefore, no MRMC study involving human readers and AI assistance was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a hardware medical device. There is no algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth, in this context, would be the specified engineering and performance characteristics/measurements (e.g., lubricity, tensile strength, kink resistance, tip shape, coating integrity) derived from industry standards and guidances. The device's performance against these technical specifications forms the "ground truth" for demonstrating safety and efficacy.
8. The sample size for the training set
- Not Applicable. This is a hardware medical device; there is no training set in the context of machine learning or AI.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, this question is not relevant.
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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 | |
| GeneralProvisions | Submitter Name: | Merit Medical Systems, Inc. |
| Address: | 1600 West Merit ParkwaySouth 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 | |
| SubjectDevice | Trade Name: | Merit Hydrophilic Guide Wire |
| Common/Usual Name: | Guide Wire | |
| Classification Name: | Catheter Guide Wire | |
| PredicateDevices | 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 II21 CFR § 870.1330, 74 DQXDivision of Cardiovascular Devices | |
| Intended Use | The Merit Hydrophilic Guide Wire is intended to facilitate theplacement of devices during diagnostic and interventionalprocedures. | |
| DeviceDescription | The Merit Hydrophilic Guide Wire consists of a jacketed core wirewith a hydrophilic coating applied to the jacket.The wire will be offered with straight and angled tipconfigurations in various lengths. | |
| TechnologicalCharacteristics | Technological characteristics of the subject Merit Hydrophilic GuideWire are substantially equivalent to those of the predicate, thecurrently marketed Terumo Radiofocus® Glidewire® [K863138], andthe Lake Region Medical Hydrophilic Coated Guide Wire [K000011]. | |
| Safety &PerformanceTests | No performance standards have been established under Section 514of the Food, Drug and Cosmetic Act for these devices. However, abattery of tests was performed according to protocols based on therequirements of industry standards and guidances and were shownto meet the acceptance criteria that were determined to demonstratethe safety and efficacy of the device. | |
| Summary ofSubstantialEquivalence | Based on the indications for use, design, safety, and performancetesting, the subject Merit Hydrophilic Guide Wire meets therequirements that are considered essential for its intended use and issubstantially equivalent to the predicate devices, the currentlymarketed Radiofocus® Glidewire® manufactured by Terumo MedicalCorporation and the Hydrophilic Coated Guide Wire manufactured byLake 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
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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
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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
§ 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.