(261 days)
WORKER™ Guidewires are for use in facilitating the placement of catheters within the coronary and peripheral vasculature.
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.
The provided document is a 510(k) summary for the WORKER™ Guidewire, a medical device. It details the device's technical characteristics, indications for use, and a comparison to a predicate device, along with the non-clinical performance tests conducted to demonstrate substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that 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." However, the document does not explicitly list the quantitative acceptance criteria for each test. It only lists the types of tests performed and states that the device "meet[s] the acceptance criteria."
Therefore, here's a table based on the information provided, with the specific acceptance criteria and reported performance being implied as "Met Acceptance Criteria" because the document states they were met without specifying the numerical thresholds.
| Feature | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Performance Tests | (Implied: Conforming to requirements outlined in FDA guidance Coronary and Cerebrovascular Guidewire (January 1995) and relevant industry standards. Specific quantitative criteria not provided in this document.) | Met Acceptance Criteria |
| Tensile Strength | (Implied: Demonstrated sufficient tensile strength to meet product specifications and ensure safe use, likely based on force applied before breakage or deformation.) | Met Acceptance Criteria |
| Torque Strength | (Implied: Demonstrated sufficient resistance to torsional forces, ensuring the guidewire does not twist or break during manipulation.) | Met Acceptance Criteria |
| Torqueability | (Implied: Demonstrated ability to transmit torque from the operator's hand to the distal tip effectively, allowing for precise steering.) | Met Acceptance Criteria |
| Tip Flexibility | (Implied: Demonstrated appropriate flexibility of the guidewire tip to navigate tortuous anatomy without causing damage or kinking.) | Met Acceptance Criteria |
| Coating Adherence/Integrity | (Implied: Demonstrated the PTFE coating remained intact and adhered to the guidewire, preventing flaking or separation during use, which is critical for reducing friction and preventing particulate shedding.) | Met Acceptance Criteria |
| Catheter Compatibility | (Implied: Demonstrated that the guidewire could be smoothly advanced and retracted through various catheters without excessive friction, kinking, or damage to either device.) | Met Acceptance Criteria |
| Particulate Testing | (Implied: Demonstrated that the guidewire did not shed an unacceptable amount of particulates during use, complying with established safety limits for foreign material in the bloodstream.) | Met Acceptance Criteria |
| Radiopacity | (Implied: Demonstrated sufficient visibility under fluoroscopy to allow for accurate positioning and manipulation within the vasculature.) | Met Acceptance Criteria |
| Biocompatibility Testing (per ISO 10993-1) | (Implied: No evidence of adverse biological reactions when in contact with biological systems, as outlined by ISO 10993-1.) | Met Acceptance Criteria |
| Cytotoxicity | (Implied: No toxic effects on cells.) | Met Acceptance Criteria |
| Sensitization | (Implied: No evidence of inducing allergic or hypersensitivity reactions.) | Met Acceptance Criteria |
| Acute systemic toxicity | (Implied: No evidence of adverse systemic effects following a single or repeated exposure over a short period.) | Met Acceptance Criteria |
| Hemocompatibility | (Implied: No adverse effects on blood components, such as hemolysis, thrombosis, or complement activation.) | Met Acceptance Criteria |
| Irritation/intracutaneous reactivity | (Implied: No evidence of local irritation or inflammatory reactions when in contact with tissues.) | Met Acceptance Criteria |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes non-clinical performance and biocompatibility testing of a physical medical device (guidewire), not a clinical study involving patients or a software algorithm evaluating data. Therefore, the concepts of "test set" in the context of patient data, data provenance, or retrospective/prospective studies are not applicable to this submission.
The tests performed are laboratory-based, evaluating the physical and biological characteristics of the device itself. The document does not specify the number of guidewire samples used for each test.
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)
This question pertains to studies where human experts provide a "ground truth" for evaluating an algorithm or a diagnostic device, typically in image analysis or similar fields. Since this document describes the non-clinical testing of a physical guidewire, this information is not applicable. The "ground truth" here is the physical and chemical properties of the device as measured in a lab, against established engineering and biological safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Similar to point 3, the concept of "adjudication" (typically involving multiple human readers/experts to resolve discrepancies) is not applicable to this non-clinical device testing. The results of the mechanical, chemical, and biological tests are based on objective measurements and established laboratory procedures, not subjective human interpretation requiring adjudication.
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
This type of study (MRMC) and the concept of "improving human readers with AI assistance" are specifically related to the evaluation of AI/CADe/CADx software devices, particularly in diagnostic imaging. Since the WORKER™ Guidewire is a physical medical device used for catheter placement, this information is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is also relevant to the evaluation of AI/software algorithms. The WORKER™ Guidewire is a physical device; therefore, this information is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance and biocompatibility tests conducted for the WORKER™ Guidewire, the "ground truth" implicitly refers to:
- Established engineering specifications and performance thresholds for guidewires.
- Industry standards (e.g., ISO 11135-1 for sterilization, ISO 10993-1 for biocompatibility).
- FDA guidance documents (e.g., Coronary and Cerebrovascular Guidewire, January 1995).
These standards and guidelines define what constitutes acceptable performance and safety for such devices.
8. The sample size for the training set
This question is pertinent to machine learning or AI algorithm development. Since this document describes the non-clinical testing of a physical medical device, there is no concept of a "training set."
9. How the ground truth for the training set was established
As there is no "training set" for a physical medical device undergoing non-clinical testing, this question is not applicable.
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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.
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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 75751Facility Registration number: 1625425 |
| Contact: | Suzanne CheangRegulatory Affairs ManagerPhone: 972-378-6980Fax: 972-403-0131Email: suzanne.cheang@argonmedical.com |
| Device trade name: | WORKER™ Guidewire |
| Device Common Name: | Guidewire |
| Device classification: | Catheter guide wireProduct code, DQX21 CFR 870.1330Class II |
| Legally marketed device to which the device is substantially equivalent: | K082094Bard PTFE Coated Guidewires |
| Description of the device: | WORKER™ Guidewires have a fixed stainless steel core withpolytetrafluoroethylene (PTFE) coated stainless steel spring wire toreduce friction. The WORKER™ Guidewires have a diameter of either0.035" or 0.038" and range in length from 80 to 260 cm. Guidewiresare marketed in Standard, Amplatz and Bentson iterations. |
| Indications for Use: | WORKER™ Guidewires are for use in facilitating the placement ofcatheters within the coronary and peripheral vasculature. |
| Technological Characteristics: | Comparisons of the WORKER™ Guidewire and predicate devicesshow that the technological characteristics such as productperformance, design and intended use are substantially equivalent tothe current marketed predicate devices.The WORKER™ Guidewire is similar in design - device dimensionalspecifications, intended use, shelf life, materials and sterilizationprocess of that of the predicate devices. Below is the summarizedtechnological characteristics comparison: |
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| Feature | WORKER™Guidewire | Bard PTFE (Teflon®) CoatedGuidewires |
|---|---|---|
| Indication forUse | WORKER™Guidewires arefor use in facilitating theplacement of catheterswithin the coronary andperipheral vasculature. | Bard PTFE Coated Guide Wiresare indicated for percutaneousentry of a guiding catheter intoa vessel using standardpercutaneous 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
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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:
§ 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.