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U.S. Department of Health and Human Services

Medical Devices

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510(k) Review Template Instructions

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Food and Drug Administration
Office of Device Evaluation & Office of In Vitro Diagnostics


Premarket Notification [510(k)] Review
Traditional/Abbreviated
K______________


 

Date:

To: The Record Office:
From: Division:

510(k) Holder:
Device Name:
Contact:
Phone:
Fax:
Email:

(Please see the italic text for instructions on how to complete the review memorandum.)

I. Purpose and Submission Summary:

The 510(k) holder would like to introduce (device name) into interstate commerce.
(Please give a brief discussion of the 510(k), a summary of the history of the file, your recommendation and rationale of why you made your recommendation.)

II. Administrative Requirements

 

 

Yes

No

N/A

Indications for Use page (Indicate if: Prescription or OTC)

 

 

 

Truthful and Accuracy Statement

 

 

 

510(k) Summary or 510(k) Statement

 

 

 

Standards Form

 

 

 


III. Device Description

 

 

Yes

No

N/A

Is the device life-supporting or life sustaining?

 

 

 

Is the device an implant (implanted longer than 30 days)?

 

 

 

Does the device design use software?

 

 

 

Is the device sterile?

 

 

 

Is the device reusable (not reprocessed single use)?

Are “cleaning” instructions included for the end user?

 

 

 


(Describe the purpose for the 510(k): modification to a currently marketed device, new feature, new product line, etc. Provide a summary about the device design, how it operates or performs its intended function, all important performance characteristics, etc.) 

IV. Indications for Use
(Please state the Indications for Use. Give a brief description of how the new indication differs from the predicate device’s indication.)

V. Predicate Device Comparison
(Provide a comparison between the subject device and the predicate device(s) with respect to intended use/indications for use, and technological characteristics.)

VI. Labeling
Labeling has been provided which includes instructions for use and an appropriate prescription statement as required by CFR 21.807.87 (e).
(Describe any specific labeling required for this device and discuss all claims made. Compare with the predicate device labeling.)

VII. Sterilization/Shelf Life/Reuse
(Please see “Review Template: Sterile Devices in Premarket Notification (510(k)) Submissions”to evaluate and document the sterilization information. For additional information, see the “Updated 510(k) Sterility Review Guidance K90-1”.)

VIII. Biocompatibility
(Please provide a list in tabular format of the materials (including adhesives) that contact the patient. For each material, list how the biocompatibility was determined. For additional information, please see “Biocompatibility Initial Evaluation Tests for Consideration”.)

IX. Software

Version:
Level of Concern:
 

Yes

No

Software description:

 

 

Device Hazard Analysis:

 

 

Software Requirements Specifications:

 

 

Architecture Design Chart:

 

 

Design Specifications:

Traceability Analysis/Matrix:

Development:

V&VT:

Revision level history:

Unresolved anomalies:

 

 

 

Traceability Analysis/Matrix:

 

 

 

Development:

 

 

 

Verification & Validation Testing:

 

 

 

Revision level history:

 

 

Unresolved anomalies:

 

 

 

(For each checkbox, please provide a brief description indicating if the information provided is adequate. Please ensure that complete software documentation has been provided, and describe how the traceability matrix links software requirements, specifications, hazards and validation, verification and testing activities. Please see “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices” for additional information on reviewing software.)

X. Electromagnetic Compatibility and Electrical, Mechanical and Thermal Safety
(Please indicate whether the sponsor completed adequate testing per ISO 60601-1, ISO 60601-1-2 and any other relevant standards.)

XI. Performance Testing – Bench
(Please provide a discussion of the performance testing provided/needed.)

XII. Performance Testing – Animal
(Please provide a discussion of the performance testing provided/needed.)

XIII. Performance Testing – Clinical
(Please provide a discussion of the performance testing provided/needed.)

XIV. Substantial Equivalence Discussion

 
Yes
No
 
1. Same Indication Statement?

 

 

If YES = Go To 3
2. Do Differences Alter The Effect Or Raise New Issues of Safety Or Effectiveness?

 

 

If YES = Stop NSE
3. Same Technological Characteristics?

 

 

If YES = Go To 5
4. Could The New Characteristics Affect Safety Or Effectiveness?

 

 

If YES = Go To 6
5. Descriptive Characteristics Precise Enough?

 

 

If NO = Go To 8

If YES = Stop SE

6. New Types Of Safety Or Effectiveness Questions?

 

 

If YES = Stop NSE
7. Accepted Scientific Methods Exist?

 

 

If NO = Stop NSE
8. Performance Data Available?

 

 

If NO = Request Data
9. Data Demonstrate Equivalence?

 

 

Final Decision:

Note: See the Flowchart to assist in decision-making process. Please complete the following table and answer the corresponding questions. "Yes" responses to questions 2, 4, 6, and 9, and every "no" response requires an explanation.

1. Explain how the new indication differs from the predicate device's indication:

2. Explain why there is or is not a new effect or safety or effectiveness issue:

3. Describe the new technological characteristics:

4. Explain how new characteristics could or could not affect safety or effectiveness:

5. Explain how descriptive characteristics are not precise enough:

6. Explain new types of safety or effectiveness question(s) raised or why the question(s) are not new:

7. Explain why existing scientific methods can not be used:

8. Explain what performance data is needed:

9. Explain how the performance data demonstrates that the device is or is not substantially equivalent:
 

XV. Deficiencies
When developing deficiencies please consider the following “Suggested Format for Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions of FDAMA” and “A Suggested Approach to Resolving Least Burdensome Issues.”

XVI. Contact History
(Please include all correspondence pertaining to the submission.)

XVII. Recommendation
Regulation Number: 21 CFR XXX.XXXX [Only one regulation can be used.]
Regulation Name:
Regulatory Class: Class I, II, III, or Unclassified [Should correspond to regulation.]
Product Code: XYZ [Note: The first code should correspond with the regulation and class thereafter, multiple product codes can be used even if they fall under a different regulation and class.]

 

 

Reviewer Date

 

Branch Chief Date