# K210836: InstruSafe Instrument Protection System

- Pathway: 510(k) (Traditional)
- Applicant: Summitt Medical, LLC
- Decided: Nov 30, 2021 after 253 days
- Product code: KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories)
- Device class: 2
- Regulation: 21 CFR 880.6850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K133015 (2014). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150540: Instru-Safe Instrument Protection System, Summit Medical, Inc. (2015) Summary page 5.

## Indications for use
InstruSafe® Instrument Protection System cassettes(trays) are used to organize and protect other medical devices that are sterilized by a healthcare provider. InstruSafe Instrument Protection System cassettes are intended to allow sterilization of the enclosed medical devices during STERIZONE VP4 sterilization Cycle 1. The InstruSafe Instrument Protection System cassettes are intended to be used in conjunction with a legally marketed wrap or Aesculap rigid container. The InstruSafe Instrument Protection System cassettes are not intended on their own to maintain sterility. Summit Medical has validated the use of the InstruSafe Instrument Protection System cassettes in Cycle 1 of the STERIZONE VP4 sterilizer through demonstrations of sterilization efficacy using representative samples of medical devices 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 InstruSafe 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 InstruSafe 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.

Source page: https://510kreport.com/device/K210836
Methodology: https://510kreport.com/methodology