At I3CGLOBAL, we offer turnkey solutions for 510k services to assist manufacturers and specification developers in navigating the FDA 510k clearance process for your medical devices. Our team of Regulatory experts are experienced in FDA pathways and ensure a smooth and successful outcome.
510K Clearance for Non-active Medical Device
Devices that do not use any external source of energy other than the human body and gravity to function are called non-active devices. Non-active devices that come under the 510(k) scope can range from examination gloves to orthopaedic implants.
The amount of documentation required for 510(k) submission of non-active devices depends on the risk it poses and the tests that need to be performed to prove the safety and efficacy of the device. A non-sterile device with minimal body contact will require much less documentation than a sterile implantable device.
510K Clearance for Active Medical Device
Active Medical Devices are devices that use electrical energy to achieve their intended purpose. For electrically powered medical devices and medical devices with electrical or electronic functions, evidence must be provided to prove that the medical device is safe and performs as intended in the environments of use. This evidence includes:
- EMC Information for Premarket Submissions
- EMC-Related Device Characteristics and Intended Use Environments
- Assessment of Medical Device Risks
- Consensus Standards (For both Non-implantable Medical Devices and Active Implantable Medical Devices (AIMDs))
- Essential Performance and Immunity Pass/Fail Criteria
- Medical Device Configuration and Functions Tested
- Results of EMC Testing
- Allowances
- Deviations
- Modifications
- Common Electromagnetic (EM) Emitters
- Labeling
510K Clearance for Software Medical Devices
Software medical devices are medical devices that contain one or more software components, parts, or accessories or are composed solely of software. The documentation recommended for software medical devices in a premarket submission generally depends on the device’s Level of Concern. As the level of concern goes high, more documentation will be needed to prove the safety and efficacy of the device. For a detailed understanding of the 510k software submission process of a software medical device refer to I3CGLOBAL.
Non-clinical Bench Performance Testing
The objective: Performed by the manufacturer or third-party testing facility with device specifics or device type specifics to prove substantial equivalence of the device with its predicate device in 510k submissions, whereas to demonstrate assurance of safety and effectiveness of the device in PMA.
It is majorly performed to test for design verification and validation testing.
Scope: Non-clinical bench Performance testing includes and is not limited to
- Mechanical and Biological Engineering performance
- Bench tests using Ex-Vivo (In-Vitro), In-Situ animal or human tissue, Animal carcass testing, and Human cadaveric testing.
Excludes
- Biocompatibility evaluation,
- Re-processing or sterilization validation,
- Human factors,
- Software Verification & Validation,
- Computational modeling
Guidelines for choosing a predicate device to accompany 510k submission.
- A predicate device can be any of the following, but most commonly, the first one specified below:
- A device that is found to be substantial equivalence (SE) through the 510(k) process.
- A device that was legally marketed before May 28, 1976 (preamendments device)
- A device which has been reclassified from Class III to Class II or I
- A device that was granted marketing authorization via the De Novo classification process (under section 513(f)(2) of the FD&C Act is not exempt from premarket notification requirements.
Criteria should be used for choosing a predicate device:
The predicate and new device should have a common Product Code. Database List of legally marketed devices Look for the same Intended Use.
Valid Predicate device(s) will either have the same technological characteristics or no significant change in the materials, design, energy source, or other features of the device.
Or Different technological characteristics (No new concerns for Safety and Effectiveness / As safe and effective as a predicate device) Predicate chosen after considering Best Practice Principles.
I. Predicate devices cleared using well-established methods.
FDA advises manufacturers to choose a valid predicate device that was cleared using well-established methods. Specifically, these methods include current FDA-recognized voluntary consensus standards, guidance documents, qualified medical device development tools, widely available or accepted methods published in the public domain or scientific literature to support the context of use, and methods deemed acceptable through the submitter’s previous premarket 510 submission.
If a manufacturer is deciding between two valid possible predicate devices – one that used current FDA consensus standards, and the other that didn’t – it is expected that the predicate device that used current guidance and/or standards be chosen.
II. Predicate devices that meet or exceed expected safety and performance.
The FDA guidance advises choosing a valid predicate device that continues to perform as intended and safely during use. This can be determined by using the Manufacturer and User Facility Device Experience (MAUDE) Database, Medical Device Reporting (MDR) Database, and Medical Product Safety Network (MedSun) Database to search for any reports of unexpected malfunctions, injuries, or deaths associated with any of the valid predicate devices.
III. Predicate devices without unmitigated use-related or design-related safety issues
The next best practice based on the FDA guidance is to choose a valid predicate device that does not have unmitigated design-related or use-related safety issues, including safety communications or emerging signals. The FDA defines emerging signals as new information that suggests a causal association between an adverse event and a device that has the potential to change the device’s benefit-risk profile.
Manufacturers can determine potential safety issues by using CDRH’s Medical Device Safety website and CBER’s Safety & Availability (Biologics) portal to find out if there are design-related or use-related safety issues with any of the valid predicate devices.
IV. Predicate devices without an associated design-related recall
The last best practice that the FDA recommends is to choose a valid predicate device that has not had a design-related recall. Although recalls can be for several reasons, including labelling or manufacturing defects, design-related recalls can indicate a fundamental issue with the design of the potential predicate device.
By following these steps and best practices as defined in the FDA guidance, manufacturers can improve their processes when selecting a predicate device and achieve the objective of a more transparent and consistent 510(k) premarket review process.
