(124 days)
Not Found
No
The description focuses on the physical properties and performance of a guide wire, with no mention of AI or ML capabilities.
No
The device is a guide wire used to facilitate the placement of other devices, not to directly treat a condition.
Yes
The "Intended Use / Indications for Use" states that the device is "Intended to be used in the peripheral vascular system to facilitate the placement of devices during diagnostic and interventional procedures." This indicates that it supports diagnostic procedures.
No
The device description clearly states it is a "jacketed core wire with a hydrophilic coating," which is a physical, hardware component. The performance studies also focus on physical attributes like torqueability, fracture, flex, and biocompatibility.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to be 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 guide wire with a coating, designed for insertion into blood vessels. This aligns with an interventional medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
Therefore, this device is a medical device used for interventional procedures, not an IVD.
N/A
Intended Use / Indications for Use
"Intended to be used in the peripheral vascular system 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 in straight and angled tip shapes, standard and stiff wire configurations, and in various wire lengths and wire diameters."
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, on the subject Merit Hydrophilic Guide Wire, 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 testing was successfully completed:
Performance Testing
-
- Size Designation
-
- Surface
-
- Torqueability
-
- Fracture Test
-
- Flex Test
-
- Lubricity/Coating Integrity
-
- Clinical Acceptability
-
- Particulate Testing
-
- Needle Compatibility Design Validation
-
- Lubricity/Coating Integrity Design Validation
-
- Clinical Assessment Design Validation
-
- Catheter Compatibility Design Validation
Biocompatibility
- Cytotoxicity
- Sensitization
- Irritation
- Acute Systemic Toxicity
- Pyrogenicity
- Hemocompatibility Hemolysis
- Hemocompatibility Thrombogenicity
- Hemocompatibility Complement Activation
All test results were comparable to the predicate devices and the subject Merit Hydrophilic Guide Wire met the predeterminded acceptance criteria.This has demonstrated that the subject device is substantially equivalent to the predicate 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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.
Merit Medical Systems, Inc. Michael O'sullivan Senior Regulatory Affairs Specialist Parkmore Business Park West Galway, Galway H91 W274, Ireland
Re: K201595
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: June 9, 2020 Received: June 12, 2020
Dear Michael 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/ training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory-assistance/contact-usdivision-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201595
Device Name Merit Hydrophilic Guidewire
Indications for Use (Describe)
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
K201595 510(k) Summary
| General
| Provisions | Submitter Name: | Merit Medical Systems, Inc. |
|---|---|---|
| Address: | 1600 West Merit Parkway | |
| South Jordan, UT 84095 | ||
| Telephone Number: | (+353) 91 703700 (Ext. 3061) | |
| Fax Number: | (+353) 91 680104 | |
| Contact Person: | Mark Mullaney | |
| Registration Number: | 1721504 | |
| General | ||
| Provisions | Correspondent Name: | Merit Medical Ireland Ltd. |
| Address: | Parkmore Business Park | |
| Parkmore, Galway, Ireland | ||
| Telephone Number: | (+353) 91 703700 (Ext. 3223) | |
| Fax Number: | (+353) 91 680104 | |
| Contact Person: | ||
| Date of Preparation: | ||
| Registration Number: | Michael O'Sullivan | |
| 09 June 2020 | ||
| 9616662 | ||
| Subject | ||
| Device | Trade Name: | |
| Common/Usual Name: | ||
| Classification Name: | Merit Hydrophilic Guide Wire | |
| Guide Wire | ||
| Wire, Guide, Catheter | ||
| Predicate | ||
| Device | Trade Name: | Merit Hydrophilic Guide Wire |
| Classification Name: | 21 CFR 870.1330 Catheter Guide | |
| Wire | ||
| Premarket Notification: | K170933 | |
| Manufacturer: | Merit Medical Systems, Inc. | |
| Classification | Class II | |
| 21 CFR § 870.1330 | ||
| Product code: DQX | ||
| Division of Cardiovascular Devices |
4
| 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 and angled tip shapes, standard and stiff wire
configurations, and in various wire lengths and wire diameters. |
| | Technological characteristics of the subject Merit Hydrophilic Guide
Wire are substantially equivalent to those of the predicate Merit
Hydrophilic Guide Wire [K170933]. |
| | The Nitinol core and polyurethane plastic jacket of the subject Merit
Hydrophilic Guide Wire remain unchanged from the predicate Merit
Hydrophilic Guide Wire [K170933]. |
| Comparison
to Predicate | The pre-coating step on the predicate has been replaced by a new
base-coating of polyurethane on the subject device, which is applied
to the polyurethane plastic jacket. While the predicate has two
coating applications of the hydrophilic polymer, the subject device
has a single application of the same polymer. The coating material
formulation has been modified, and there are also some changes in
material quantities for the post-coating step. |
| | Process parameters such as oven timings and temperatures have
been modified also. |
| 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, on the subject Merit Hydrophilic Guide
Wire, 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: |
5
-
- FDA Guidance "Coronary, Peripheral, and Neurovascular Guidewires -Performance Tests and Recommended Labelling- Guidance for Industry and Food and Drug Administration Staff" - October 2019
-
- FDA Guidance "Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings - Labeling Considerations" - October 2019
-
- 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 10993-1:2018. Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process, and the FDA Guidance for Industry, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
The subject Merit Hydrophilic Guide Wire was compared to the predicate device for various performance attributes that support substantial equivalence of the device.
The following testing was successfully completed:
Performance Testing
-
- Size Designation
-
- Surface
-
- Torqueability
-
- Fracture Test
-
- Flex Test
-
- Lubricity/Coating Integrity
-
- Clinical Acceptability
-
- Particulate Testing
-
- Needle Compatibility Design Validation
-
- Lubricity/Coating Integrity Design Validation
-
- Clinical Assessment Design Validation
-
- Catheter Compatibility Design Validation
Biocompatibility
6
Merit Medical Systems, Inc. Merit Hydrophilic Guide Wire - Hydrophilic Coating Formulation and Process Change Traditional Premarket Notification 510(k)
- Cytotoxicity ●
- . Sensitization
- Irritation ●
- . Acute Systemic Toxicity
- Pyrogenicity ●
- Hemocompatibility Hemolysis ●
- Hemocompatibility Thrombogenicity .
- Hemocompatibility Complement Activation ●
All test results were comparable to the predicate devices and the subject Merit Hydrophilic Guide Wire met the predeterminded acceptance criteria.This has demonstrated that the subject device is substantially equivalent to the predicate device.
Based on the Indications for Use, design, safety and performance Summary of testing, the subject Merit Medical Hydrophilic Guide Wire meets the Substantial requirements that are considered essential for its intended use and Equivalence is substantially equivalent to the Merit Hydrophilic Guide Wire [K170933] predicate device.