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510(k) Data Aggregation
K Number
K210836Device Name
InstruSafe Instrument Protection System
Manufacturer
Date Cleared
2021-11-30
(253 days)
Product Code
Regulation Number
880.6850Why did this record match?
Applicant Name (Manufacturer) :
Summitt Medical LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
InstruSafe® Instrument Protection System cassettes(trays) are used to organize and protect other medical devices that are sterlized by a healthcare provider. Instrument Protection System cassettes are intended to allow sterilization of the enclosed medical devices during STERIZONE VP4 sterlization Cycle 1. The Instrusate Instrument Protection System cassettes are intended to be used in conjunction with a legally marketed wrap or Aesculap rigid container. The Instrument Protection System casettes are not intended on their own to maintain sterility.
Summit Medical has validated the use of the Instrument Protection System cassettes in Cycle 1 of the STERIZONE VP4 sterilizer through demonstrations of sterilization efficacy using representative samples including general instruments, rigid and semi-rigid instruments with lumens, and flexible endoscopes. The validation provided information that has been used to establish design limits that are applied across the range of Instrument Protection System cassettes to ensure that all models fall within the validated limits for cassette ventilation, internal shelving, and weight:
- Minimum ventilation-to-volume ratio, general instruments: 0.073
- Minimum ventilation-to-volume ratio, flexible endoscopes: 0.263
- Maximum number of internal shelves: Two (2)
- Maximum cassette weight (including contents): 25 lbs/cassette
Refer to Table for the validated loads using Instrument Protection System cassettes. Refer to the sterilizer manufacturer's instructions for use to ensure that loads do not exceed the claimed limits for the sterilizer.
Device Description
Summit Medical LLC InstruSafe Instrument Protection Systems are cassettes/trays used to enclose and hold surgical instruments and instrument accessories in an organized manner during the sterilization process and subsequent storage and transportation. The cassettes/trays do not have direct patient contact. The cassettes/trays by themselves do not maintain sterility. The cassettes/trays are different sizes of the same basic configuration: a rectangular base with latchable cover. The cassettes/trays have perforations to allow sterilant penetration. The cassettes/trays contain silicone inserts in the base and/or cover to hold, organize, and protect the surgical instruments within the cassette/tray during the sterilization process and subsequent storage and transportation.
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