# K091950: Smart-Well Eztest Incubator

- Pathway: 510(k) (Traditional)
- Applicant: Sgm Biotech, Inc.
- Decided: Jan 15, 2010 after 198 days
- Product code: FRC (Indicator, Biological Sterilization Process)
- Device class: 2
- Regulation: 21 CFR 880.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K855101 (1986). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K855101: Assert TM Biological/Chemical Indicator, Surgicot, Inc. (1986) Summary page 1.

## Indications for use
The Smart-Well incubator is intended for use with the Smart-Read EZTest self-contained biological indicators (SCBI1). The Smart-Read EZTest - steam SCBI3 is used for monitoring the efficacy of gravity or pre-vac saturated steam sterilizati on processes. This SGBI1 contains I05 spores of Geobacillus stearothennophilus derived from ATCC #7953. Performance characteristics were established in accordance with USP 32 and ISO 11138-1 for the 1210 C steam process. Additional saturated steam sterilization conditions are also tested and appear on the Certificate of Analysis for Smart-Read EZest - steam. These include 132 0 C, l34'C, and 135'CC The operational principles of the device are as follows. The Smart-Read EZest - steam SCHI3 is placed into a difficult to sterilize position in the load and a sterilization cycle appropriate for the particular type~of load is run. As sterilization conditions are met, the bacterial spores are destroyed by logarithmic thermal death principles. Following the sterilization cycle, the operator removes the SCBI from the load and waits approximately 10 minutes until the device has cooled so it can be comfortably handled. The'operator then places the'SCBI3 in the activation cavity of the Smart-Well incubator. The SCBI is then gently tilted forward towards the operator to fracture the glass media ampoule inside the plastic sleeve. This allows the culture media to mix with any surviving spores in the SCB3I. The activated BI is then placed into one of the ten incubator cavities. The Smart-Well incubator provides a constant pie-set temperature of 60-f- 2 0 C which is conducive to growth of any bacterial spores which may have survived the sterilization process. The unit is also supplied with an NIST traceable thermomneter to independently indicate the incubator block temperature. Growth of the indicator organisms will produce acid in the microbiological culture mediumecontaining bromcresol purple, thus lowejing the pH-of the solution and invoking a yellow color change of the media components. If all spores have been killed, the media will remain clear and purple. The-mediamneets the requirements for growth promotion. When the activated SCBI is placed into one of the incubation cavities the LED in front of the cavity will illuminate amber, which indicates that the incubator electronically recognizes the Smart-Read EZTest SCBI unit for incubation. Each incubation cavity also has an electronic monitoring system that detects if the BKis either purple or yellow. The Smart-Well incubator can also be supplied with a printer whichidocuments each individual EZTest steam SCBI tested. The printer can also display information that is normally manually entered into a log book. The recommended incubation hold time of IO hours has been established using the FDA CDRH Reduced Incubation Time protocol. The printer can also be configured to display HI exposure information that includes 1) exposure time and temperature; 2) cycle type; 3) sterilizer number; 4) HI lot number; and 5) user identification. These are optional entries. If no selection is made, the printed report will default to the previously entered information of place a "?" mark or blank indicating no selection was made The printed record will always indicate real time and date, incubation cavity being reported, the incubation start time when the SCBI was placed into the incubation cavity, and the time the test status changed. The result options art 1) NEGATIVE (purple) - incubation time completed with no detectable color change in the Smart-Read EZTest unit, 2) POSITIVE (yellow) - time that a yellow color was detected in the Smart-Read EZTest unit, or 3) TESTING - when a printout is requested and event 1) or 2) have not happened. These results are easily verified by the user as performed in all conventional incubators without printers. The incubated SCOBI should be properly disposed of after the results have been properly recorded. The recommended disposal is to "sterilize by steam 12100C for not less then 30 minutes" of follow your institution's practice for disposal or biological waste.

Source page: https://510kreport.com/device/K091950
Methodology: https://510kreport.com/methodology