In October 2019, FDA released a guidance suggesting new labeling and performance testing relative to 510(k) premarket notification submissions for coronary, peripheral, and neurovascular guidewires under the product codes DQX and MOF. According to FDA, these new recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of these medical device submissions in accordance with FDA regulatory compliance.
The Agency has stated that these new recommendations are necessary because of significant technological advancements since the initial regulations were developed for the medical devices. The new guidance recommends including documentation with 510(k) submissions that contains engineering drawings, technical and performance specifications, and materials (including coatings).
FDA further recommends that the function of all components and accessories, including packaging, be identified and explained. You should include a clear description of the basic operation of the device and identify any unique features (for example, a steerable tip) when applicable. You should also identify all sizes, configurations and models included within the scope of the submission.
The agency’s guidance also suggests comparisons with a similar legally marketed predicate device to support its substantial equivalence and that specific biocompatibility tests should be performed, including pyrogenicity, complement activation, thrombogenicity, and hemolysis, as well as specific simulated use and other bench testing.
Since guidewires contain patient-contacting materials which, even when used as intended, may induce a harmful biological response, FDA is recommending that the biocompatibility of all patient-contacting materials be determined. If your device is identical in composition and processing methods to guidewires with a history of successful use, you may reference previous testing experience or the literature, if appropriate. For some device materials, it may be applicable to provide a reference to either a recognized consensus standard, or to a LOA for a device MAF.
The FDA recommendations for labeling include adequate information for the intended user of the device, including indications, effects, routes, methods, frequency and duration of administration, and any relevant hazards, contraindications, side effects and precautions. The agency suggests several warnings/precautions that should be included in instructions for use, as applicable. For instance, these can include any of the following statements:
- A warning statement regarding the indications for which the device has been confirmed to perform as intended, such as the following: “The safety and effectiveness of the device has not been established or is unknown in vascular regions other than those specifically indicated.” For example, if a specific guidewire is only indicated for peripheral vascular use based on the information provided in the 510(k) submission, the device should include a warning that the safety and effectiveness of the device has not been established in the coronary vasculature or neurovasculature.
- A warning against reuse or re-sterilization of the device, which could affect medical device materials and components, such as “This device is intended for single use. Do not reuse or re-sterilize.”
- A warning statement about the unestablished safety and effectiveness of a reprocessed device intended for multiple uses. For example, “The device is intended for single-patient use and should not be reprocessed or used after reprocessing.”
- Guidewires should be used under fluoroscopic guidance. It is recommended that you consider the inclusion of important precautions and/or warnings to ensure the safety of device use associated with fluoroscopy for both patients and clinical operators.
FDA is also recommending that you include information on the potential adverse events that may result from use of your device. FDA acknowledges that the specific adverse events may depend on the specific design and intended use of the device. Such adverse events may include, but are not limited to:
- Access site complications
- Allergic reaction (to contrast, device or other)
- Angina or unstable angina
- Cardiac tamponade/pericardial effusion
- Embolization (plaque, thrombus, device, tissue, or other) · Infection
- Myocardial infarction or ischemia
- Stroke/cerebral vascular accident (CVA)/transient ischemic attack (TIA)
- Vessel trauma, perforation, dissection
- X-Ray radiation exposure complications (e.g., alopecia, burns ranging in severity from skin reddening to ulcers, cataracts, and delayed neoplasia)
To learn more about medical device compliance and the new FDA guidance for coronary, peripheral, and neurovascular guidewires, contact the medical device consulting experts here at MEDIcept.