(107 days)
Not Found
No
The device description and performance testing focus on the physical properties and mechanical performance of a guide wire, with no mention of AI or ML capabilities.
No.
The device is intended to facilitate the placement and exchange of devices during diagnostic and interventional procedures, acting as a tool rather than providing direct therapeutic action.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is intended to "facilitate the placement and exchange of devices during peripheral diagnostic and interventional procedures." The inclusion of "diagnostic" directly indicates its use in diagnostic procedures.
No
The device description clearly outlines physical components like a stainless-steel core wire, PTFE coating, coils, and an optional extension system connector, indicating it is a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "facilitate the placement and exchange of devices during peripheral diagnostic and interventional procedures." This describes a tool used within the body during a medical procedure, not a device used to test samples outside the body (in vitro).
- Device Description: The description details a guide wire with physical characteristics and components designed for navigating within blood vessels. This is consistent with an interventional medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, the Merit GO2WIRE™ is a medical device used for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Merit GO2WIRE™ is intended to facilitate the placement and exchange of devices during peripheral diagnostic and interventional procedures.
Product codes (comma separated list FDA assigned to the subject device)
DQX
Device Description
The Merit Go2Wire guide wire will consist of 0.035" guide wire configurations available in 145, 175, 210, 260, and 300cm. The distal tip flex configurations are Floppy, Standard and Intermediate (Modified J). The distal tip shapes are either straight or modified J.
The wire is composed of a stainless-steel core wire, a PTFE coated coil, a white PTFE sleeve, a platinum-tungsten marker coil, and an optional extension system connector. The wire's proximal end is covered by a white PTFE sleeve that terminates at 100cm from the distal tip. The distal 100 cm of the wire is covered with a green PTFE pre-coated coil. The PTFE coated coil and platinum-tungsten coil are welded to the core on the very distal tip. The distal tip is shapeable and radiopaque. A torque device is included to facilitate wire steering within the vascular anatomy.
An 0.035" extension wire consisting of PTFE coated stainless steel 155cm in length to extend the length of the wire to allow initial usage with a short wire and then extendable to allow catheter exchanges when required.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral
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. A battery of testing was conducted, on the Merit Go2Wire 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 is a list of all testing that was successfully completed:
Performance Testing-Bench
- Size Designation
- Radiodetectability
- Surface
- Tensile Strength
- Torque Strength
- Torqueability
- Tip Flexibility
- Fracture test
- Flex test
- Torturous Path Lubricity
- Corrosion Resistance
- Tip Shape Testing Validation
- Catheter and Needle Compatibility Validation
- Guidewire Clinical Use in Model Validation
- Extension System Clinical Use in Model Validation
- Particulate
Biocompatibility
- Cytotoxicity
- Sensitization
- Irritation
- Acute Systemic Toxicity
- Pyrogenicity
- Genotoxicity
- Hemolysis
- Thrombogenicity
- Complement Activation
All test results were comparable to the predicate devices and the subject Merit Go2Wire Guide Wire met the predeterminded acceptance criteria. This has demonstrated that the subject device is substantially equivalent to the 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
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 8, 2020
Merit Medical System, Inc. Michael O'Sullivan Senior Regulatory Affairs Specialist Parkmore Business Park West Galway, Ireland
Re: K193571
Trade/Device Name: Go2Wire Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: March 5, 2020 Received: March 9, 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-regulatoryassistance/contact-us-division-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,
Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Interventional Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name Go2Wire Guide Wire
Indications for Use (Describe)
The Merit GO2WIRE™ is intended to facilitate the placement and exchange of devices during peripheral diagnostic and interventional procedures.
Carefully read all instructions prior to use. Observe all warnings and cautions noted throughout these instructions. Failure to do so may result in complications.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Merit Medical Systems, Inc.
Merit Go2Wire Guide Wire
Traditional Premarket Notification 510(k)
| 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: | Michael O'Sullivan | |
| Date of Preparation: | 20 December 2019 | |
| Registration Number: | 9616662 | |
| Subject | ||
| Device | Trade Name: | |
| Common/Usual Name: | Guide Wire | |
| Classification Name: | Wire, Guide, Catheter | |
| Predicate | ||
| Device | Trade Name: | Wholey Guide Wire System |
| Classification Name: | 21 CFR 870.1330 Catheter Guide Wire | |
| Premarket Notification: | K120863 | |
| Manufacturer: | Covidien LLC. | |
| Classification | Class II | |
| 21 CFR § 870.1330 | ||
| Product code: DQX | ||
| Division of Cardiovascular Devices | ||
| Intended Use | The Merit GO2WIRE™ is intended to facilitate the placement and | |
| exchange of devices during peripheral diagnostic and | ||
| interventional procedures. | ||
| Carefully read all instructions prior to use. Observe all warnings | ||
| and cautions noted throughout these instructions. Failure to do so | ||
| may result in complications. | ||
| The Merit Go2Wire guide wire will consist of 0.035" guide wire | ||
| configurations available in 145, 175, 210, 260, and 300cm. The | ||
| distal tip flex configurations are Floppy, Standard and Intermediate | ||
| (Modified J). The distal tip shapes are either straight or modified J. | ||
| Device | ||
| Description | The wire is composed of a stainless-steel core wire, a PTFE coated | |
| coil, a white PTFE sleeve, a platinum-tungsten marker coil, and an | ||
| optional extension system connector. The wire's proximal end is | ||
| covered by a white PTFE sleeve that terminates at 100cm from the | ||
| distal tip. The distal 100 cm of the wire is covered with a green PTFE | ||
| pre-coated coil. The PTFE coated coil and platinum-tungsten coil | ||
| are welded to the core on the very distal tip. The distal tip is | ||
| shapeable and radiopaque. A torque device is included to facilitate | ||
| wire steering within the vascular anatomy. | ||
| An 0.035" extension wire consisting of PTFE coated stainless steel | ||
| 155cm in length to extend the length of the wire to allow initial | ||
| usage with a short wire and then extendable to allow catheter | ||
| exchanges when required. | ||
| Comparison | ||
| to Predicate | The Technological characteristics of the subject Merit Go2Wire | |
| Guide Wire are substantially equivalent to those of Predicate Device, | ||
| the Wholey Guide Wire System[K120863]. The Wholey Guide wire | ||
| was fully characterized by Merit and an equivalent wire was | ||
| developed by Merit based upon this characterization. The subject | ||
| device has the same basic design as the predicate, in that they are | ||
| composed of a stainless-steel core wire, a PTFE coated coil, a white | ||
| PTFE sleeve, a platinum-tungsten marker coil, and an optional | ||
| extension system connector. | ||
| The fundamental technology and operating principles of the subject | ||
| and the predicates are the same and while the indications for use | ||
| wordings are not identical, the intended use is the same, with all | ||
| wires used for the placement and exchange of devices during | ||
| peripheral diagnostic and interventional procedures. | ||
| 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 Merit Go2Wire 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. |
4
5
Where appropriate, the tests were based on the requirements of the following documents:
- 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
- FDA guidance Coronary and Cerebrovascular Guide Wire ● Guidance January 1995.
- 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 Modified ISO 10993 Test Profile FDA Memo G95-1.
The following is a list of all testing that was successfully completed:
Performance Testing-Bench
- Size Designation ●
- Radiodetectability
- Surface ●
- Tensile Strength ●
- Torque Strength .
- Torqueability .
- Tip Flexibility ●
- Fracture test ●
- Flex test ●
- Torturous Path Lubricity ●
- Corrosion Resistance
- Tip Shape Testing Validation .
- Catheter and Needle Compatibility Validation 0
- Guidewire Clinical Use in Model Validation .
6
- Extension System Clinical Use in Model Validation ●
- Particulate .
Biocompatibility
- Cytotoxicity .
- Sensitization .
- Irritation .
- Acute Systemic Toxicity .
- Pyrogenicity .
- Genotoxicity ●
- Hemolysis .
- Thrombogenicity .
- Complement Activation .
All test results were comparable to the predicate devices and the subject Merit Go2Wire Guide Wire met the predeterminded acceptance criteria. This has demonstrated that the subject device is substantially equivalent to the predicate devices.
Based on the comparisons noted, the subject Merit Go2Wire Guide Summary of Wire meets the requirements that are considered essential for its Substantial intended use and is substantively equivalent to the Predicate Equivalence Device, the Wholey Guide Wire System [K120863] manufactured by Covidien LLC