Question on the Content of an Abbreviated 510(k)

O

Oscar Wang

#1
Hi, folks:
Our product is ultrasound Doppler diagnostic system and we are going to file a 510(K) to FDA. We looked several web training seminars and read a lot of guidance documents. Currently I am confused about the contents of this 510(k).
On one hand, the guidance document "Format for Traditional and Abbreviated 510k" illustrates the recommended documents structure as below:
1. Medical Device User Fee Cover Sheet (Form FDA 3601)
2. CDRH Premarket Review Submission Cover Sheet
3. 510(k) Cover Letter
4. Indications for Use Statement
5. 510(k) Summary or 510(k) Statement
6. Truthful and Accuracy Statement
7. Class III Summary and Certification
8. Financial Certification or Disclosure Statement
9. Declarations of Conformity and Summary Reports
10. Executive Summary
11. Device Description
12. Substantial Equivalence Discussion
13. Proposed Labeling
14. Sterilization and Shelf Life
15. Biocompatibility
16. Software
17. Electromagnetic Compatibility and Electrical Safety
18. Performance Testing – Bench
19. Performance Testing – Animal
20. Performance Testing – Clinical
21. Other
While on the other hand, the guidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" suggests that the abbreviated 510(k) content should follow the guidance's structure as below:

MDUFMA Cover Sheet
CDRH Premarket Review Cover Sheet
510(k) Cover Letter
Indications for Use Statement
510(k) Summary or Statement
Truthful and Accuracy Statement
Financial Certification or Disclosure
Declarations of Conformity and Summary Reports
Standards Form FDA-3654
Clinical Trials Form FDA-3674
Executive Summary
Reason for Submission
Submission Type (Track 1 or 3)
1.3 Indications for Use:
1.4 General Device Description:
1.5 Predicate Device Comparison:
1.6 Acoustic Output Reporting:
1.7 General Clinical Safety & Effectiveness:
1.8 Labeling:
2 Track 1 Specific Information
3 Track 3 Specific Information

My question is that which document structure should I follow? Can you guys give me a clue?
:thanx:
 
Elsmar Forum Sponsor

kreid

Involved In Discussions
#2
Hi Oscar,

If you device is one of the ones list on page 3 (section 1.1) of "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" then I would use this document.

My logic is that this is the most recently published of the source documents you could use to make your decision.

If there are any issues, you will be notified during the 'Acceptance Review' which will be within 15 days of receipt of your submission and so you should be able to respond quickly.
 
Thread starter Similar threads Forum Replies Date
C Question regarding Quality Manual Content and Specificity ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
S Internal Audit Format and Content question Internal Auditing 13
C 21 CFR Part 820 - Question About Calibration Procedure Content Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
A Medical Device Labeling Content Question EU Medical Device Regulations 2
C Accredited Calibration Certificate Content - ISO 17025 Section 5.10.4.2 Question ISO 17025 related Discussions 7
S Manufacturing Instructions and Forms for our Products - Question on Content Document Control Systems, Procedures, Forms and Templates 9
G Question - Supplier Quality Manual: Content, Purpose, Format? Supplier Quality Assurance and other Supplier Issues 17
Ed Panek Question from 13485 Auditor ISO 13485:2016 - Medical Device Quality Management Systems 2
C Question on KAFO (Knee Ankle Foot Orthosis device) classification CE Marking (Conformité Européene) / CB Scheme 0
T BMW GS 93010-2 Question Various Other Specifications, Standards, and related Requirements 1
S FDA 510(K) submission question US Food and Drug Administration (FDA) 4
Ron Rompen Question regarding CMM probe damage General Measurement Device and Calibration Topics 4
T FDA UDI Question - Class II Medical Device Other US Medical Device Regulations 1
C Complaint Return Sample Size Question 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
8 Drawing Feature Question Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
D Question: How to analyze numerical and attribute data Reliability Analysis - Predictions, Testing and Standards 11
D Question on electronic signatures and initials on batch records ISO 13485:2016 - Medical Device Quality Management Systems 4
A Special Characteristic question from Automotive CSR Customer and Company Specific Requirements 9
Ron Rompen GDT Question - is this even correct? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
A PPAP question for audit APQP and PPAP 16
C ISO Question - Do you say "I-S-O" or "I-Soh"? Misc. Quality Assurance and Business Systems Related Topics 14
D Question regarding where "validations" fit according to ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 1
D Question on Supplier Quality (SCAR) ISO 13485:2016 - Medical Device Quality Management Systems 6
A +0/-.001 Tolerance question - Feature size is 1.249 +0/-.001 - Actually measures 1.2493 (.0003 OHL Inspection, Prints (Drawings), Testing, Sampling and Related Topics 12
D Question and advice for a supplier self audit questionnaire ISO 13485:2016 - Medical Device Quality Management Systems 6
D Question on using audit checklist ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 20
D Question on Documented Calibration versus ISO 17025 Accredited Calibration ISO 13485:2016 - Medical Device Quality Management Systems 2
A Design Change/ECO Related Question 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Configuration Item definition question AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
C Quality Management System Question ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 32
Q ISO 9001/IATF 16949 Audit Finding Question - Document Retention IATF 16949 - Automotive Quality Systems Standard 11
J IATF 16949 Calibration/Verification records question ISO 26262 - Road vehicles – Functional safety 6
I IMDS Error Message Question RoHS, REACH, ELV, IMDS and Restricted Substances 1
lanley liao Question regarding the calibration of monitoring and measure equipment. Oil and Gas Industry Standards and Regulations 3
C Gauge R&R Question Using Minitab Software 1
J IATF 16949 Internal Audit question - Auditor's responsibility Internal Auditing 6
K Question on MDR classification EU Medical Device Regulations 4
D Question on equipment - when to use reference only or research only stickers ISO 13485:2016 - Medical Device Quality Management Systems 5
D Work Instruction Question ISO 13485:2016 - Medical Device Quality Management Systems 5
M Clinical Decision Support Software Question 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
John C. Abnet VDA 6.3 - Question 7.3 - "blocking of parts" VDA Standards - Germany's Automotive Standards 6
D Approved supplier list - Distributors question ISO 13485:2016 - Medical Device Quality Management Systems 6
D Equipment Register and PM question ISO 13485:2016 - Medical Device Quality Management Systems 2
D Question regarding "storage and distribution" ISO 13485:2016 - Medical Device Quality Management Systems 1
D Calibration tolerance question using Pipettes Medical Device and FDA Regulations and Standards News 3
D Question regarding customer feedback process ISO 13485:2016 - Medical Device Quality Management Systems 3
D Equipment Register related question ISO 13485:2016 - Medical Device Quality Management Systems 1
S Study sign off question / responsibilities ISO 13485:2016 - Medical Device Quality Management Systems 3
S Qualification question - ISO 13485 - Setting up a small lab Reliability Analysis - Predictions, Testing and Standards 2
M Question for Auditors - "Off the Record" Conversation? General Auditing Discussions 14

Similar threads

Top Bottom