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Phase 1 – Initial Details

Requirements

Scope of I3CGlobal

Scope of 510(k) Applicant

1. Intended use
  • Send requisition for Intended use

 

  • Identification of product code
  • Provide an appropriate intended use of the Software device.

 

  • Confirmation of product code
2. Indications of Use Statement

(Form 3881)

  • Send requisition for indications for use.

 

  • Filling of form based on details provided by the 510(k) applicant.

 

  • Assist the applicant to frame the appropriate Indications for use statement based on the intended use and product code if required.
  • Provide appropriate indications for use of the Software device in compliance with the intended use.

 

  • Provide Device Name.

 

  • Confirm the type of Device i.e., Prescription Use or Over Counter Use.
3. Device Description
  • Send requisition regarding device description to the applicant through mail communication.

 

  • Review of device description details shared by applicant.

 

  • Preparation and documentation of Device Description template as per FDA premarket submission Guidance.
  • Provide the basic details of the software device which include

 

  • features of the software.

 

  • Summary of the functions of the device.

 

  • software description

 

  • Software architecture diagram.
4. Predicate Device
  • Identify and share the potential predicate device concerning indications for use and technological characteristics.
  • Approval of a suitable predicate device.
5. 510(K) Summary
  • Develop a template.

 

  • Fill in the manufacturer and device details.

 

  • Fills the predicate device details, supporting information like technological characteristics, discussion on similarities and differences, and conclusion on SE.
  • Provide details regarding the manufacturer- name, address, contact person at the company, contact number, etc.
6. Software Level Of Concern
  • Share the queries related to the level of concern for documentation level evaluation.

 

  • Determine the level of concern i.e., Minor, Moderate, and Major, and documentation evaluation level – Basic or Enhanced Level.
  • Provide answers to the queries related to the level of concern shared by I3CGlobal.

 

  • Confirmation of Level of Concern Documentation.

Phase 2 – Software Supporting Documentation based on Level of Concern

Identification of document requirements for the 510(k) based on LOC of software.

Document Requirements

Scope of I3CGlobal

Scope of 510(k) Applicant

2.1 Proposed Labelling
  • Send a requisition for User Manual and Promotional material.

 

  • Review the User Manual and promotional material shared by the applicant.

 

  • Document the User manual and Promotional material for 510(k) Submission.
  • Provide User Manual and promotional Material.
2.2 Software Description
  • Send a requisition for software description and share a list of the sections like Device features other f software, Assessment data and Inputs, and Outputs and points to be mentioned in the software description.

 

  • Review the software description data shared by the applicant and suggest the necessary corrections to the document for 510(k) submission.

 

  • Review and document for 510(k) submission.
  • Provide the software description details of Device Feature controlled by software, Analysis of Data, and Inputs and Outputs.

 

  • Make the changes in the document as requested by I3CGlobal
2.3 System and Software Architecture
  • Send a requisition for System and Software Architecture for moderate to a major level of concern documentation level and instruct the elements to be specified.

 

  • Review the System and Software Architecture data shared by the applicant and suggest the necessary corrections to the document for 510(k) submission.

 

  • Review and document for 510(k) submission.
  • Provide the software architecture diagram with details requested by I3CGlobal.

 

  • Make the changes in the document as requested by I3CGlobal
2.4 Software Requirement Specifications
  • Send a requisition for Software Requirement Specifications and specify the details necessary for the software device based on the Level of concern.

 

  • Review the Software Requirement Specifications data shared by the applicant and suggest the necessary corrections to the document for 510(k) submission.

 

  • Review and document for 510(k) submission.
  • Provide the SRS document as per the LOC of software with all the requirements suggested by I3CGLOBAL.

 

  • Make the changes in the document as requested by I3CGlobal

 

 

 

2.5 Software Design Specifications
  • Send a requisition for Software Design Specifications and specify the details necessary for the software device based on the Level of concern:

 

  • Review the Software Design Specifications data shared by the applicant and suggest the necessary corrections to the document for 510(k) submission.

 

  • Review and document for 510(k) submission.
  • Provide the SDS document as per the LOC of software with all the requirements suggested by I3CGLOBAL.

 

  • Make the changes in the document as requested by I3CGlobal
2.6 Software Development and Maintenance Practices  

 

  • Send a requisition for Software Development and Maintenance Practices and specify the details necessary for software device based on Level of Concern

 

  • Guide the applicant by referring to the appropriate standard required to document the software lifecycle development plan.

 

  • Review the Software Development and Maintenance Practices data shared by the applicant and suggest the necessary corrections to the document for 510(k) submission.

 

  • Review and document for 510(k) submission.
  • Provide a summary of the life cycle development plan and a summary of configuration management and maintenance activities.

 

  • Make the changes in the document as requested by I3CGlobal
2.7 Software testing as part of verification and validation
  • Send a requisition for Software testing as part of verification and validation and specify the details necessary for the software device based on the Level of concern

 

  • Review the Software testing as part of verification and validation data shared by the applicant and suggest the necessary corrections to the document for 510(k) submission.

 

  • Review and document for 510(k) submission.
  • Provide System level test plan, software verification document and software validation documents, test reports, and Summary.

 

  • Make the changes in the document as requested by I3CGlobal

 

2.8 Risk Management File
  • Send a requisition for Risk Management File and Instruct to document Risk management Plan and Report identifying risk hazards, risk assessment and demonstrating that risks have been appropriately mitigated and risk management report and covering cyber security elements

 

 

  • Provide a template of the Risk management plan and risk management report covering all the device-related risks on request from the applicant.

 

  • Review the Risk Management File data containing Plan and Report shared by the applicant and suggest the necessary corrections to the document for 510(k) submission.

 

  • Review and document for 510(k) submission.
  • Provide a Risk management plan, risk assessment demonstrating that risks have been appropriately mitigated and a risk management report covering cyber security elements like threat modeling, hazard analysis, trace matrix, mitigation measures, etc.

 

  • Make the changes in the document as requested by I3CGlobal
2.9 Revision History
  • Send a requisition for Revision History and instruct to document in tabulate form regarding the major changes to the software
  • Review the Revision of History data shared by the applicant and suggest the necessary corrections to the document for 510(k) submission.

 

  • Review and document for 510(k) submission.
  • Provide the Revision history tabulating the major changes to the software

 

  • Make the changes in the document as requested by I3CGlobal
2.10 Unresolved Anomalies
  • Send a requisition for software anomalies, impact on safety or effectiveness, and Usability
  • Review the Unresolved Anomalies data shared by the applicant and suggest the necessary corrections to document for 510(k) submission.
  • Review and document for 510(k) submission.
  • Provide the List of remaining software anomalies (e.g., bugs, defects).

 

  • Make the changes in the document as requested by I3CGlobal
2.11 Hardware Requirements
  • Send a requisition for Hardware Requirements involved in the functioning of the software device.
  • Review the Hardware Requirements data shared by the applicant and suggest the necessary corrections to document for 510(k) submission.
  • Review and document for 510(k) submission.
  • Provide all the hardware involved in the functioning of the software device.

 

  • Make the changes in the document as requested by I3CGlobal
2.12 Software Compliance Documents and Certificates
  • Send a requisition for Software Compliance Documents and Certificates necessary for the software device.

 

  • Provide guidance about required elements to be documented in concern to software compliance documents based on the device details provided by the applicant.

 

  • Provide the information relates to certification concerns to software devices based on device details shared by the applicant.

 

  • Review the Software Compliance Documents and Certificates data shared by the applicant and suggest the necessary corrections to the document for 510(k) submission.

 

  • Review and document for 510(k) submission.
  • Provide all the compliance documents applicable to the software device.

 

  • Make the changes in the document as requested by I3CGlobal

Phase 3 – Administrative and Substantial Equivalence Demonstration

Document Requirements

Scope of I3CGlobal

Scope of 510(k) Applicant

3.1 CDRH Premarket Review Submission Cover Sheet (FDA Form 3514)
  • Fill the FDA Form 3514 based on the details provided by the applicant.
3.2 Class III Summary and Certification
  • We will prepare the document based on the classification of the medical device.
3.3 Financial Certification or Disclosure statement
  • We will prepare the document based on Clinical study requirements.
3.4 Executive Summary
  • Create a template and prepare the document.

 

  • Justify any differences between the proposed device and predicate device.

 

  • Comparative study between the proposed device and predicate device chosen.
3.5 Substantial Equivalence Discussion
  • Create a template and prepare the document.

 

  • Comparative study between the proposed device and predicate device chosen.

Phase 4 – Administrative Documents

Document Requirements

Scope of I3CGlobal

Scope of 510(k) Applicant

4.1 510(k) Cover Letter
  • Prepare and provide the document to the applicant covering all details required for cover letter and share to the applicant instructing to use the letterhead and provide the authorized person signature.
  • The document printed on company letterhead must be signed and a hard copy couriered to the US office.

 

  • Provide a Soft copy of the signed 510(k) cover letter for 510(k) documentation.
4.2 Truthful and Accuracy Statement
  • Provide the document for Truthful and Accuracy Statement.
  • The document signed by the contact person at the firm should be provided.
4.3 Declarations of conformity and Summary report
  • Prepare the DOC based on the use of the voluntary consensus standards.
  • The document signed by the contact person at the firm should be provided.
4.4 MDFUSC

(FDA Form 3601)

  • Create a medical device user fee cover sheet and PIN.
  • Make payment to FDA. (Before submission of 510(k) file.)

Phase 5 – RTA Checklist and E-Copy

Document Requirements

Scope of I3CGlobal

Scope of 510(k) Applicant

5.1 RTA Checklist
  • Create an RTA Checklist Template based on the type of submission.

 

  • Fill out the checklist and ensure that mentioned documents are submitted to the FDA and shared with the applicant.
  • Approval of Verification of RTA Checklist.
5.2 E-Copy
  • Arrangement of submission folder sections as per FDA Guidance and share with the applicant.

 

  • Convert to e-copy.

 

  • E-copy submission to US Agent
  • Approval of Final submission Folder documentation.