FDA Grants Breakthrough Designation for Balloon Catheter
Concept Medical’s MagicTouch PTA sirolimus drug-coated balloon catheter (DBC) has received the FDA’s breakthrough device designation for use below-the-knee.
The device is designed for treating peripheral artery disease, a common circulatory issue involving reduced blood flow from narrowed arteries, usually in the legs.
In an ongoing clinical study, the device was effective and there were no incidents of device and procedure-related mortality, the devicemaker said.
FDA Clears Binx Health Diagnostic for STDs
The FDA granted Binx Health another 510(k) clearance for its Binx io platform, clearing the fully automated point-of-care test for chlamydia and gonorrhea.
The test uses polymerase chain reaction (PCR) amplification and electrochemical testing to detect the common STDs.
It delivers results in about a half hour, using vaginal swab samples that can be collected by a physician or by the patient.
Misonix Earns CE Mark for Ultrasonic Surgical Device
Misonix’s Nexus platform has gained the CE Mark, following the FDA’s approval of the system in June.
The ultrasonic surgical device combines all of the company’s solutions into a single platform, including its BoneScalpel, SonicOne and Sonastar, and it is designed to accommodate future devices.
Nexus features a new digital algorithm that provides more control and efficiency, and increased power to improve tissue resection rates.
Endologix Grabs IDE for Aneurysm Sealing Protocol
The FDA granted Endologix an investigational device exemption approval for its Nellix Chimney EndoVascular Aneurysm Sealing System (ChEVAS) for treating complex abdominal aortic aneurysms.
The system, an endovascular AAA treatment, is designed to join the company’s Nellix 3.5 endograft with parallel visceral stents.
Endovascular aneurysm sealing “will offer innovative new technology to a group of patients that are underserved by the current standard of care,” the devicemaker says.
Shimadzu’s Earns 510(k) Clearance for Radiographic Table
The FDA has granted Shimadzu Medical Systems 510(k) clearance for its Fluorospeed X1 platform, a radiographic/fluoroscopic (RF) system.
The Torrance, California devicemaker’s system offers high image quality and multiple features to improve workflow, including image recording and programmable function buttons.
The system supports a wide range of general RF applications, such as chest, abdomen, or extremities along with Upper GI’s.
NinePoint’s Imaging System Cleared by FDA
NinePoint Medical’s NvisionVLE Imaging System has received 510(k) clearance for use in the bile duct and pancreases.
The device’s new clearance allows it to be used to generate high-resolution, real-time volumetric images of tissues and subsurfaces in the pancreatic-biliary systems.
The imaging system is designed to be used with the company’s Low-Profile Optic Probe, which enables physicians to image small anatomies such as the pancreas and bile duct.
Infant Hemoglobin Monitor Receives CE Mark
Masimo gained the CE Mark for its SpHb hemoglobin monitor for newborns and infant patients that weigh less than 6.6 lbs.
The device is a noninvasive, continuous monitor that measures total hemoglobin, oxygen saturation and methemoglobin. It isn’t intended to replace laboratory blood testing, Masimo said.
With its receipt of the CE Mark, the device is now available to patients of all ages in the EU.
MT.DERM’s Microneedling Device Receives FDA Clearance
The FDA has granted German devicemaker MT.DERM 510(k) clearance for its microneedling device for treating acne scars and facial wrinkles.
The lightweight handpiece includes adjustable speed modes and it uses a separate power unit to prevent overheating.
Once a complaint has been deemed potentially reportable to the FDA as an MDR, a designated individual within the complaint handling unit must promptly begin an investigation.
The skill set for an MDR investigation is specialized and different from skills required for other investigations, says Dan O’Leary, president of Ombu Enterprises. Therefore, it is important that devicemakers carefully select and train employees to conduct MDR investigations.
The investigation must determine whether the device failed to meet a specification. If so, it also must ferret out the root cause of the inadequacy. It also must examine the relationship of the device to the reported incident or adverse event. The investigation should conclude with a determination of whether or not a CAPA is warranted. The complete results of the investigation must be included in the MDR event file.
The regulations require an individual MDR record for each event, the content of which can be quite extensive, including records from other sources. The information is collected in the MDR event file, which is linked to at least one individual complaint records. If a devicemaker has received multiple complaints about the same issue, the MDR event file for that issue or event could be linked to multiple individual complaint records.
These files need to include all information about the adverse event, such as documentation, deliberations, reportability decision-making, information submitted to the FDA and acknowledgements that the MDR was successfully uploaded to the FDA database. FDA employees must be allowed to access, copy and verify these records.
It is acceptable to for the MDR event file to be part of a complaint file. If a devicemaker does this, however, it must clearly identify the complaint file as having an associated or included MDR event file.
Complaints that don’t result in an MDR still need to be investigated if they allege:
Excerpted from the FDAnews management report: Complaint Management for Devicemakers — From Receiving and Investigating to Analyzing Trends.