(149 days)
The True Form Reshapable Guide Wire is intended to facilitate the placement of catheters within the peripheral and coronary vasculature for various diagnostic and interventional procedures.
The True Form Reshapable Guide Wire should not be used in the neurovasculature
The Merit True Form Reshapable Guide Wire consists of a stainless steel core wire, flattened at the distal end, with a 5cm Gold Plated Tungsten coil attached to the distal tip and is fully jacketed with a radiopaque filled polymer jacket. The True Form Reshapable Guide Wire is fully coated with a hydrophilic coating. The 5cm radiopaque coil is attached to the internal stainless steel core wire with a multitude of solder joints.
The wires are placed within a spiralled hoop dispenser with a flush luer attached and clips to secure the wire within the hoop. Included within the pouch, with the spiralled hooped guidewire, is another pouch containing an Insertion Tool, a Tip Straightener, and a Torque device.
The wire will be offered in straight and angled versions, in various lengths.
The provided text outlines the acceptance criteria and a summary of the study performed for the Merit True Form Reshapable Guide Wire.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a specific table of discrete numerical acceptance criteria and corresponding reported device performance values. Instead, it states that 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."
For Biocompatibility, the document explicitly states: "All test results were comparable to the predicate devices and the subject Merit True Form Reshapable Guide Wire met the predetermined acceptance criteria. This has demonstrated that the subject device is substantially equivalent to the predicate devices."
For Performance Testing-Bench, the document lists various tests and implies that the device successfully met the acceptance criteria relevant to each:
- Size Designation
- Radiodetectability
- Tip Shape Testing
- Surface
- Tensile Strength
- Torque Strength
- Torqueability
- Tip Flexibility
- Fracture test
- Flex test
- Lubricity
- Corrosion Resistance
- Device Compatibility
- Tip Curve Shapeability
- Particulate
- Coating Durability
- Packaging
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for the test set for any of the performance or biocompatibility tests.
The data provenance (e.g., country of origin, retrospective/prospective) is also not mentioned. These studies appear to be bench tests and biocompatibility studies, so data provenance in terms of human subjects or clinical data is not applicable in the same way it would be for a clinical trial.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable as the tests conducted are primarily bench performance tests and biocompatibility evaluations, not evaluations requiring expert consensus on clinical images or diagnoses.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are typically used for clinical studies involving multiple readers to establish ground truth. As this document describes bench and biocompatibility testing, an adjudication method is not applicable.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not performed as the device is a medical guidewire, and the evaluation involved bench testing and biocompatibility rather than human interpretation tasks.
6. Standalone Performance Study
The reported studies are effectively "standalone" in the sense that they evaluate the device's inherent properties (performance and biocompatibility) against established standards and predicate devices, without human-in-the-loop assistance influencing the device's physical performance or biological interaction. Therefore, yes, standalone performance was assessed for the various physical and biological characteristics.
7. Type of Ground Truth Used
The "ground truth" for the tests appears to be defined by:
- Industry standards: e.g., ISO 11070:2014, ISO 11135:2014, ASTM F1980-07, ISO 10993-1:2009.
- FDA guidance documents: e.g., "FDA guidance Coronary and Cerebrovascular Guide Wire Guidance January 1995."
- Comparison to predicate devices: The results were deemed "comparable to the predicate devices" and met "predetermined acceptance criteria" for substantial equivalence.
8. Sample Size for the Training Set
The document describes bench testing and biocompatibility studies, not AI/machine learning development. Therefore, a "training set" in the context of machine learning is not applicable.
9. How the Ground Truth for the Training Set was Established
As there is no training set in the context of machine learning, this question is not applicable.
{0}------------------------------------------------
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are black and are arranged to create a sense of depth. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circle around the profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 21, 2017
Merit Medical Systems, Inc. Michael O'Sullivan Senior Regulatory Affairs Specialist Parkmore Business Park West Galway, Ireland
Re: K170532
Trade/Device Name: True Form Reshapable Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: June 15, 2017 Received: June 19, 2017
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. 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
{1}------------------------------------------------
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name True Form Reshapable Guide Wire
Indications for Use (Describe)
The True Form Reshapable Guide Wire is intended to facilitate the placement of catheters within the peripheral and coronary vasculature for various diagnostic and interventional procedures.
The True Form Reshapable Guide Wire should not be used in the neurovasculature
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}------------------------------------------------
| Submitter Name: | Merit Medical Systems, Inc. | |
|---|---|---|
| Address: | 1600 West Merit ParkwaySouth Jordan, UT 84095 | |
| Telephone Number: | (+353) 91 703700 (Ext. 3061) | |
| Fax Number: | (+353) 91 680104 | |
| Contact Person: | Mark Mullaney | |
| Registration Number: | 1721504 | |
| GeneralProvisions | Correspondent Name: | Merit Medical Ireland Ltd. |
| Address: | Parkmore Business ParkParkmore, Galway, Ireland | |
| Telephone Number: | (+353) 91 703700 (Ext. 3223) | |
| Fax Number: | (+353) 91 680104 | |
| Contact Person: | Michael O'Sullivan | |
| Date of Preparation: | 20th February 2017 | |
| Registration Number: | 9616662 | |
| SubjectDevice | Trade Name: | True Form Reshapable Guide Wire |
| Common/Usual Name: | Guide Wire | |
| Classification Name: | Wire, Guide, Catheter | |
| PredicateDevice | Premarket Notification Predicate #1: | |
| Trade Name: | Boston ChoICE PT | |
| Classification Name: | 21 CFR 870.1330 Catheter guide wire | |
| Premarket Notification: | K143587 | |
| Manufacturer: | Boston Scientific Corporation | |
| Premarket Notification Reference Predicate #2: | ||
| Trade Name: | Bard Porter | |
| Classification Name: | 21 CFR 870.1330 Catheter guide wire | |
| Premarket Notification: | K060551 | |
| Manufacturer: | Brivant Ltd. | |
| Classification | Class II | |
| 21 CFR § 870.1330 | ||
| Product code: | DQX | |
| Division of Cardiovascular Devices | ||
| Intended Use | The True Form Reshapable Guide Wire is intended to facilitate theplacement of catheters within the peripheral and coronaryvasculature for various diagnostic and interventional procedures.The True Form Reshapable Guide Wire should not be used in theneurovasculature | |
| DeviceDescription | The Merit True Form Reshapable Guide Wire consists of a stainlesssteel core wire, flattened at the distal end, with a 5cm Gold PlatedTungsten coil attached to the distal tip and is fully jacketed with aradiopaque filled polymer jacket. The True Form Reshapable GuideWire is fully coated with a hydrophilic coating. The 5cm radiopaquecoil is attached to the internal stainless steel core wire with amultitude of solder joints. | |
| The wires are placed within a spiralled hoop dispenser with a flushluer attached and clips to secure the wire within the hoop. Includedwithin the pouch, with the spiralled hooped guidewire, is anotherpouch containing an Insertion Tool, a Tip Straightener, and a Torquedevice. | ||
| The wire will be offered in straight and angled versions, in variouslengths. | ||
| Comparisonto Predicate | The Technological characteristics of the subject Merit True FormReshapable Guide Wire are substantially equivalent to those ofPredicate Device #1, the Boston Choice PT[K143587] andReference Predicate #2, the Bard Porter [K060551]. The subjectdevice has the same basic design as the predicates, in that they allconsist of a metallic core wire covered in a radiopaque polymerjacket with some or all the wire jacket having a hydrophilic coating.The fundamental technology and operating principles of the subjectand the predicates are the same and while the indications for usewordings are not identical, the intended use is the same, with allwires used for the placement of devices during intravascularprocedures. | |
| Safety &PerformanceTests | No performance standards have been established under section514 of the Food, Drug and Cosmetic Act for these devices. A batteryof testing was conducted, on the Merit True Form Reshapable GuideWire, in accordance with protocols based on requirements outlined |
{4}------------------------------------------------
Merit Medical Systems, Inc.
Merit True Form Reshapable Guide Wire
Traditional Premarket Notification 510(k)
{5}------------------------------------------------
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 11070:2014, 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 10993-1:2009, 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
- Tip Shape Testing ●
- Surface .
- Tensile Strenath ●
- Torque Strength ●
- Torqueability
- . Tip Flexibility
- Fracture test ●
- Flex test ●
- Lubricitv ●
- Corrosion Resistance
- Device Compatibility ●
- Tip Curve Shapeability ●
- Particulate ●
- Coating Durability ●
- Packaging
{6}------------------------------------------------
Merit Medical Systems, Inc.
Merit True Form Reshapable Guide Wire
Traditional Premarket Notification 510(k)
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 True Form Reshapable Guide Wire met the predetermined acceptance criteria. This has demonstrated that the subject device is substantially equivalent to the predicate devices. |
|---|
| Summary of Substantial EquivalenceBased on the Indications for Use, design, safety and performance testing, the subject Merit True Form Reshapable Guide Wire meets the requirements that are considered essential for its intended use and is substantively equivalent to Predicate Device #1, the Boston Choice PT [K143587], manufactured by Boston Scientific Corporation and Reference Predicate #2, the Bard Porter [K060551], manufactured by Brivant Ltd. |
§ 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.