Premarket Notification [510(k)] Review
Traditional/Abbreviated
K______________
Date:
To: The Record | Office: |
From: | Division: |
510(k) Holder:
Device Name:
Contact:
Phone:
Fax:
Email:
The 510(k) holder would like to introduce (device name) into interstate commerce.
II. Administrative Requirements
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Yes |
No |
N/A |
Indications for Use page (Indicate if: Prescription or OTC) |
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Truthful and Accuracy Statement |
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510(k) Summary or 510(k) Statement |
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Standards Form |
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III. Device Description
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Yes |
No |
N/A |
Is the device life-supporting or life sustaining? |
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Is the device an implant (implanted longer than 30 days)? |
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Does the device design use software? |
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Is the device sterile? |
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Is the device reusable (not reprocessed single use)? Are “cleaning” instructions included for the end user? |
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IV. Indications for Use
V. Predicate Device Comparison
VI. Labeling
VII. Sterilization/Shelf Life/Reuse
VIII. Biocompatibility
IX. Software
Version: |
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Level of Concern: |
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Yes |
No |
Software description: |
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Device Hazard Analysis: |
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Software Requirements Specifications: |
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Architecture Design Chart: |
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Design Specifications: Traceability Analysis/Matrix: Development: V&VT: Revision level history: Unresolved anomalies:
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Traceability Analysis/Matrix:
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Development:
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Verification & Validation Testing:
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Revision level history: |
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Unresolved anomalies:
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X. Electromagnetic Compatibility and Electrical, Mechanical and Thermal Safety
XI. Performance Testing – Bench
XII. Performance Testing – Animal
XIII. Performance Testing – Clinical
XIV. Substantial Equivalence Discussion
Yes |
No |
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1. Same Indication Statement? |
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If YES = Go To 3 |
2. Do Differences Alter The Effect Or Raise New Issues of Safety Or Effectiveness? |
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If YES = Stop NSE |
3. Same Technological Characteristics? |
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If YES = Go To 5 |
4. Could The New Characteristics Affect Safety Or Effectiveness? |
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If YES = Go To 6 |
5. Descriptive Characteristics Precise Enough? |
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If NO = Go To 8 If YES = Stop SE |
6. New Types Of Safety Or Effectiveness Questions? |
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If YES = Stop NSE |
7. Accepted Scientific Methods Exist? |
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If NO = Stop NSE |
8. Performance Data Available? |
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If NO = Request Data |
9. Data Demonstrate Equivalence? |
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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.
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
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 |
Updated August 1, 2007
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