(261 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of a guidewire, with no mention of AI or ML capabilities.
Yes
The device facilitates the placement of catheters within coronary and peripheral vasculature, implying it is used in a medical procedure to treat or manage a condition.
No
Explanation: The device, WORKER™ Guidewires, is used to facilitate the placement of catheters. This is an interventional or procedural use, not a diagnostic one. There is no mention of it being used to detect, diagnose, or monitor a disease or condition.
No
The device description clearly states it is a physical guidewire made of stainless steel and PTFE, and the performance studies focus on physical properties like tensile strength, torque, and biocompatibility. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The description clearly states that the WORKER™ Guidewires are used to facilitate the placement of catheters within the coronary and peripheral vasculature. This is an invasive procedure performed inside the body.
- Lack of IVD Characteristics: The provided information does not mention any testing of bodily specimens, analysis of biological markers, or any other activities typically associated with IVD devices.
Therefore, based on the provided information, the WORKER™ Guidewire is a medical device used for interventional procedures within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
WORKER™ Guidewires are for use in facilitating the placement of catheters within the coronary and peripheral vasculature.
Product codes
DQX
Device Description
WORKER™ Guidewires have a fixed stainless steel core with polytetrafluoroethylene (PTFE) coated stainless steel spring wire to reduce friction. The WORKER™ Guidewires have a diameter of either 0.035" or 0.038" and range in length from 80 to 260 cm. Guidewires are marketed in Standard, Amplatz and Bentson iterations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and peripheral vasculature
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
No performance standards have been established under section 514, performance standards, of the Food, Drug and Cosmetic Act for these devices. A series of testing was conducted in accordance with protocols based on requirements outlined in guidance's and industry standards and the below 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 Guidewire . Guidance January 1995.
- ISO 11135-1Sterilization of heath care products- Ethylene ● Oxide - Part 1: Requirements for the development. validation and routine control of a sterilization process for medical devices.
- ISO 10993-1, Biological Evaluation of Medical Devices Part ● 1: Evaluation and Testing within a risk management process.
The WORKER™ Guidewire is substantially equivalent to the specified predicate devices based on comparisons of the device functionality, technological characteristics, and Indications for Use. The device design has been qualified through the following tests:
- · Tensile Strength
- · Torque Strength
- · Torqueability
- · Tip Flexibility
- · Coating Adherence/Integrity
- · Catheter Compatibility
- · Particulate Testing
- · Radiopacity
Biocompatibility testing per ISO 10993-1 was performed, consisting of the following tests:
- · Cytotoxicity
- · Sensitization
- Acute systemic toxicity
- · Hemocompatibility
- Irritation/intracutaneous reactivity
The results of this testing demonstrates that the WORKERTM Guidewire, is substantially equivalent to the predicate devices and did not raise new safety or performance questions.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 8, 2016
Argon Medical Devices, Inc. Beckie Ellis Vice President, Regulatory Affairs/Quality Assurance 1445 Flat Creek Road Athens. Texas 75751
Re: K160785
Trade/Device Name: WORKER Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: November 3, 2016 Received: November 7, 2016
Dear Ms. Ellis:
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 (reporting of medical device-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.
1
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 yours,
Brian D. Pullin -S
for 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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Indications for Use
510(k) Number (if known) K160785
Device Name WORKER™ Guidewire
Indications for Use (Describe)
WORKER™ Guidewires are for use in facilitating the placement of catheters within the coronary and peripheral vasculature.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| Date Prepared: | October 10, 2016 |
|---|---|
| Company: | Argon Medical Devices, Inc. |
| 1445 Flat Creek Road Athens, | |
| Texas 75751 | |
| Facility Registration number: 1625425 | |
| Contact: | Suzanne Cheang |
| Regulatory Affairs Manager | |
| Phone: 972-378-6980 | |
| Fax: 972-403-0131 | |
| Email: suzanne.cheang@argonmedical.com | |
| Device trade name: | WORKER™ Guidewire |
| Device Common Name: | Guidewire |
| Device classification: | Catheter guide wire |
| Product code, DQX | |
| 21 CFR 870.1330 | |
| Class II | |
| Legally marketed device to which the device is substantially equivalent: | K082094 |
| Bard PTFE Coated Guidewires | |
| Description of the device: | WORKER™ Guidewires have a fixed stainless steel core with |
| polytetrafluoroethylene (PTFE) coated stainless steel spring wire to | |
| reduce friction. The WORKER™ Guidewires have a diameter of either | |
| 0.035" or 0.038" and range in length from 80 to 260 cm. Guidewires | |
| are marketed in Standard, Amplatz and Bentson iterations. | |
| Indications for Use: | WORKER™ Guidewires are for use in facilitating the placement of |
| catheters within the coronary and peripheral vasculature. | |
| Technological Characteristics: | Comparisons of the WORKER™ Guidewire and predicate devices |
| show that the technological characteristics such as product | |
| performance, design and intended use are substantially equivalent to | |
| the current marketed predicate devices. | |
| The WORKER™ Guidewire is similar in design - device dimensional | |
| specifications, intended use, shelf life, materials and sterilization | |
| process of that of the predicate devices. Below is the summarized | |
| technological characteristics comparison: |
4
| Feature | WORKER™
Guidewire | Bard PTFE (Teflon®) Coated
Guidewires |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for
Use | WORKER™Guidewires are
for use in facilitating the
placement of catheters
within the coronary and
peripheral vasculature. | Bard PTFE Coated Guide Wires
are indicated for percutaneous
entry of a guiding catheter into
a vessel using standard
percutaneous methods
(Seldinger's Technique) |
| Sizes | 0.035" & 0.038" | 0.035" & 0.038" |
| Tip Styles | J & Straight | J & Straight |
| Materials | Stainless steel, PTFE | Stainless steel, PTFE |
| Disposable | Yes | Yes |
Performance tests (Non-Clinical):
No performance standards have been established under section 514, performance standards, of the Food, Drug and Cosmetic Act for these devices. A series of testing was conducted in accordance with protocols based on requirements outlined in guidance's and industry standards and the below 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 Guidewire . Guidance January 1995.
- ISO 11135-1Sterilization of heath care products- Ethylene ● Oxide - Part 1: Requirements for the development. validation and routine control of a sterilization process for medical devices.
- ISO 10993-1, Biological Evaluation of Medical Devices Part ● 1: Evaluation and Testing within a risk management process.
The WORKER™ Guidewire is substantially equivalent to the specified predicate devices based on comparisons of the device functionality, technological characteristics, and Indications for Use. The device design has been qualified through the following tests:
- · Tensile Strength
- · Torque Strength
- · Torqueability
- · Tip Flexibility
- · Coating Adherence/Integrity
- · Catheter Compatibility
- · Particulate Testing
- · Radiopacity
5
Biocompatibility testing per ISO 10993-1 was performed, consisting of the following tests:
- · Cytotoxicity
- · Sensitization
- Acute systemic toxicity
- · Hemocompatibility
- Irritation/intracutaneous reactivity
The results of this testing demonstrates that the WORKERTM Guidewire, is substantially equivalent to the predicate devices and did not raise new safety or performance questions.
Based on the Indication for Use, design safety and performance testing, the subject WORKER™ Guidewire meets the requirements that are considered essential for its intended use and is substantially equivalent to the predicate devices.
Substantial Equivalence: