T-026-001 Pre-submission meeting request
Table of contents
Purpose
Insert the overall purpose of the Pre-Submission, including goals for the outcome of the interaction with FDA.
Proposed intended use and indications for use
Provide sufficient information regarding the proposed intended use/indications for use, which may include:
- description of the disease or condition the device will prevent, mitigate, screen, monitor, treat, or diagnose;
- identification of the patient population for which the device is intended;
- part of the body or type of tissue to which the device will be applied or interacting;
- frequency of use;
- physiological use;
- statement of whether the device is intended for prescription and/or over-the-counter use.
Regulatory history
List any relevant previous communications with FDA about the subject device including but not limited to any marketing submissions, IDE, 513(g), and/or Q-Submissin application numbers relevant to the Pre-Submission.
Include submission numbers as appropriate.
Include a brief summary of these previous FDA interactions and submissions, including feedback received and resolution of that feedback (or justification of alternative paths) as applicable.
Planned follow-on submission
Indicate what type of future submission (i.e. IDE, 510(k), etc.) is the focus of the Pre-Submission questions to help direct FDA's feedback.
Background information
Include information on the disease and problem that is being addressed. Include sufficient background information to allow FDA to develop feedback for the Pre-Submission questions.
Device description
Provide sufficient information regarding the device description, which may include:
- explanation of how the device functions;
- pictures of the device (where applicable);
- engineering drawings (where applicable);
- physical, chemical and/or biological processes/principles used by the device to generate device output, if applicable;
- significant physical, performance, and biological characteristics of the device, if applicable;
- samples to demonstrate the use of the device (where feasible and appropriate);
- explanation of the user interface and/or how the device interacts with other devices or with the user (medical professional and/or patient);
- explanation of the materials used in the device;
- discussion of the mechanism of action and how the device and/or device output is used;
- how the device is used in the clinical setting;
- basic scientific concepts that form the basis for the device;
- the generic name of the device as well as any proprietary name or trade name.
Proposed predicate device(s)
Provide a summary of the predicate device(s) we plan to use for comparison of these characteristics, along with the indication(s) for use and technology of the device we would like to market (i.e., draft of your labeling). For each predicate device, provide:
- the predicate device trade name, including model, if available;
- the 510(k) number under which the predicate device was cleared;
- the classification of the predicate device;
- a comparison with the proposed device in terms of indications for use, technological characteristics, and performance testing;
- proposed indication for use;
- technology of the device.
For each identified predicate device, fill in the tables provided in this section. To fill in the tables, use the 510(k) summary sheet (or De Novo summary sheet) for the proposed predicate device(s).
| Predicate trade name | 510(k) or De Novo number | Classification | Intended use | Device technology |
|---|---|---|---|---|
| Device | Predicate name | New device name |
|---|---|---|
| Indications for use | ||
| Materials | ||
| Characteristics | ||
| Usage |
Discussion
Discuss the information in the comparison table above. Point out the similarities and differences between the new device and the predicate device and comment on whether new questions of safety and effectiveness are raised.
Risk analysis - Device evaluation strategy
Fill in the table provided in this section taking into account the following information to fill in each column:
- Device attribute: list each procedure-related function needed for the device to be used successfully; list each performance-related function or feature needed for acceptable device performance.; list each necessary basic safety-related feature.
- Potential failure modes: for each attribute, list the failure modes that could result if the attribute is not attained.
- Potential Device Effects of Failure: for each failure mode, list the potential effects of the failure mode on the device.
- Potential Clinical Effects of Failure: for each failure mode, list the potential effects of the failure mode on the patient.
- Device Design Information: list the design characteristics intended to provide the function or feature, identifying any anticipated benefits that may be associated with the characteristics; or address or mitigate the potential failure mode. Identify and reference the relevant information considered in the design of the device (i.e., design input) to support the assertions that: the function or feature will be attained; and/or the failure mode will not likely occur or will not be catastrophic if it does occur.
- Leveraged Nonclinical Information: identify and reference the nonclinical information leveraged from internal or external sources to support the assertions that the function or feature will be attained; and/or the failure mode will not likely occur or will not be catastrophic if it does occur. Explain and justify how the specific aspects of the testing or analysis are relevant to the evaluation of the attribute or failure mode under consideration.
- Supportive Clinical Information: identify and reference any relevant clinical experience obtained from internal or external sources for a similar device or indication to support the assertion that the function or feature will be attained; and/or based on an evaluation of the clinical effects of failure, the failure mode will not likely occur or will not be catastrophic if it does occur. Explain and justify how the specific aspects of the clinical experience are relevant to the evaluation of the attribute or failure mode under consideration.
- Proposed Nonclinical Device Testing: list and reference the testing and/or analyses on the study device (i.e., the final, manufactured device that will be the subject of the marketing application) to evaluate the attribute and the potential associated failure mode(s). For tests or analyses intended to address multiple attributes, identify the specific aspects of the testing or analysis relevant to the evaluation of the attribute or failure mode under consideration.
| Device attribute | Potential failure modes | Potential Device Effects of Failure | Potential Clinical Effects of Failure | Device Design Information | Leveraged Nonclinical Information | Supportive Clinical Information | Proposed Nonclinical Device Testing |
|---|---|---|---|---|---|---|---|
Overview of product development
Provide an overview of the product development, including an outline of nonclinical and clinical testing either planned or already completed.
Completed product testing
Testing may include early proof-of-concept testing on prototypes (early in development) or performance testing intended to support clearance/approval (later in development).
For performance testing, a summary may include the following:
- bench testing, such as biocompatibility, mechanical, electrical safety, electromagnetic compatibility (EMC), wireless compatibility, magnetic resonance (MR) compatibility, or software, and comparison to the predicate device;
- animal studies (in vivo and histopathology); and
- clinical studies.
Information with respect to performance may include a concise summary of the test report that includes:
- identification of the objective or purpose of the test;
- explanation of the sample size and statistical methods, as applicable;
- summary of the test methodology (if we are following a recognized standard, include the name of the standard and year of publication)
- explanation of study endpoints;
- explanation of study acceptance criteria;
- results summary;
- discussion of conclusions
Provide a discussion of any deviations from the test protocol or any anomalies in results that are produced during testing. Also, make sure you explain why these results are not concerning or how we have addressed them (e.g. design change).
Proposed nonclinical testing
Provide a summary of the planned nonclinical testing.
If we have questions related to the planned nonclinical testing, it is recommended to provide a concise summary of the test plan including:
- an identification of the objective or purpose of the test;
- the sample size and statistical methods;
- a summary of the test methodology (if we are following a recognized standard, include the name of the standard and year of publication);
- the acceptance criteria and a rationale for the selection of these criteria
Proposed clinical testing
Provide a summary of the planned clinical testing and any details needed for FDA to address our questions related to clinical studies (if any).
Specific questions
The Pre-Submission should include specific questions regarding the planned marketing application (e.g., questions regarding pre-clinical and clinical testing protocols or data requirements). It is recommended to submit no more than 3-4 substantial questions.
Examples of questions divided by topic are provided below.
Regulatory strategy questions:
- Are there concerns with the predicate device proposed?
- Can we obtain FDA's feedback and guidance on pursuing a De Novo request for classification pathway given that there is not a currently marketed device that we believe could serve as predicate under the 510(k) pathway?
- Based on the regulatory strategy provided, does FDA agree, based on the discussion provided, that additional clinical data is not needed to support a future 510(k)?
Indications for Use/Intended Use questions:
- Does FDA have any concerns with our proposal to label the described device as over the counter?
- Does FDA agree with the proposed definition of drug-resistant hypertension provided in the draft indications for use statement?
- Does the Agency agree with the proposed size range offered for the new device, based on the intended use?
Clinical study questions:
- Does FDA have any comments on the provided OUS study protocol regarding its ability to support a future HDE?
- Does FDA agree with the revised clinical study designs, statistical analysis and acceptance criteria included in this Pre-Sub supplement?
- Are the primary and secondary analyses appropriate for the Indications for Use for the monitoring indication proposed?
Labeling Questions:
- Does FDA agree with the proposed test plan in support of MR Conditional labeling for 1.5T scanners with an exclusion zone between the neck and groin?
- We intend to label our device for re-use if the attached cleaning instructions are followed. The test plan to support this label is provided in Attachment B. Does FDA agree with this plan?
Benchtop performance testing questions:
- Does FDA agree with the provided justification for the proposed worst case comparison testing?
- In the event that the prospective collection does not meet the protocol's intended number of specimens of a given type, we propose to use retrospective, characterized (banked) specimens to ensure these numbers are achieved. Is this approach acceptable to FDA?
- We have provided a justification of the worst-case testing volume that will be used, and provided an analysis of the sensitivity of the test, as requested. Does FDA find this justification and analysis adequate to support using the methodology described in our testing protocol? If not please provide further guidance.
- Does the Agency agree with our approach to use the average of valid measurements of the five replicate measurements?
- We have provided a response to FDA's question about sample sizes used in the in vitro test, along with a justification based on a power analysis. Is this plan acceptable? If not please provide further guidance.
Software/Firmware questions:
- Does FDA agree that our software/instrument is a moderate level of concern and that the level of documentation that will be included in an upcoming marketing submission is consistent with FDA's recommendations provided in FDA's guidance entitled
Guidance for the Content of Premarket Submission for Software Contained in Medical Devices?as part of the upcoming device submission? - Does FDA expect any further data validating functional operation of alerts and alarms in real or simulated circumstances beyond that recommended in FDA's guidance entitled
Guidance for the Content of Premarket Submission for Software Contained in Medical Devices?If so, can FDA give us additional guidance on what they might like to see? - Does FDA agree that the software documentation defined in Section 4.2 of this Pre-Sub does not need to be included in the PMA supplement for the device as it was previously reviewed and approved in other PMA supplements (i.e., the PMA supplement will reference previously submitted information)?
Human factors questions:
- Does the agency have comments on our proposed human factors engineering process?
- Is the attached use-related risk analysis plan adequate? Does the agency agree that we have identified all the critical tasks?
- Does the agency agree with our proposed test participant recruitment plan for the human factors validation testing?
Signature meaning
The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:
- Author: Team members involved
- Reviewer: JD-003, JD-004
- Approver: JD-001