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U.S. Department of Health and Human Services

Medical Devices

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Sterile Devices in Premarket Notification [510(k)] Submissions



510(k) Sterile Temp

Review Template
Sterile Devices in Premarket Notification [510(k)] Submissions


1 Updated 510(k) Sterility Review Guidance K90-1; Final Guidance for Industry and FDA Document Issued on: August 30, 2002
2 Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single Use Devices

Read text description of Sterile Devices in Premarket [510(k)] Submissions Review Template

1. Sterilant:



a. Sterilization method description
(e.g., Steam, EtO, Radiation):



b. Dose, for radiation
(e.g., 25 – 40 kGy):



c. Sterilant residuals remaining on the device:
For EO, the maximum levels of residuals of EO and ethylene chlorhydrin that remain on the device (note: not to include ethylene glycol residual level because the recognized standard, "ANSI/AAMI/ISO 10993-7:1995 Biological Evaluation of Medical Devices – Part 7: Ethylene Oxide sterilization residuals," does not include measurement of ethylene glycol residuals);



2. A description of the Validation Method for the sterilization cycle (not data):
(Citation of an FDA recognized standard is acceptable
(e.g., ANSI/AAMI/ISO 11135))



3. Sterility assurance level (SAL):
(e.g., 10 -6 for all devices (except 10 -3 for devices that contact intact skin))



4. Is it labeled “Pyrogen Free”?



If so, a description of the method:
(e.g., LAL (Limulus Amebocyte Lysate test))



5. A description of the packaging
(not including package integrity test data):