MDT UNISPORE AND SPOR-TEST BIOLOGICALINDICATOR
Device Facts
| Record ID | K960777 |
|---|---|
| Device Name | MDT UNISPORE AND SPOR-TEST BIOLOGICALINDICATOR |
| Applicant | Mdt Corp., Inc. |
| Product Code | FRC · General Hospital |
| Decision Date | May 23, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.2800 |
| Device Class | Class 2 |
Intended Use
The MDT Biologic Company Unispore® and Spor-Test® Biological Indicators are intended to be used for the monitoring of sterilization processes in health care facilities. A biological indicator is a calibrated population of bacterial spores (of high resistance to the sterilization process monitored) on or in a carrier, put up in a package which maintains the integrity of the inoculated carrier and which is of convenience to the ultimate user, that serves to demonstrate whether sterilization conditions are met.
Device Story
Biological indicators consist of bacterial spores on a carrier within protective packaging. Used in healthcare facilities to monitor sterilization efficacy (steam and chemical vapor). Users place indicators in sterilization cycles; post-cycle, indicators are cultured in proprietary medium to assess spore survival. Survival indicates sterilization failure; death indicates successful process. Device provides objective verification of sterilization conditions. This submission updates storage requirements to include controlled room temperature (15-30°C) in addition to refrigeration, and expands Unispore® labeling to include chemical vapor sterilization monitoring.
Clinical Evidence
Bench testing only. Shelf-life stability studies conducted (Dec 1992–Mar 1995) across multiple lots. Indicators tested in steam and chemical vapor BIER units. Endpoints included spore population counts, steam resistance, and chemical vapor resistance across freezer, refrigerator, and controlled room temperature storage conditions. Results confirmed stability and efficacy for updated storage and usage claims.
Technological Characteristics
Biological indicator consisting of bacterial spores on a carrier in protective packaging. Utilizes proprietary Culturing Set Medium for recovery. Tested in steam and chemical vapor BIER (Biological Indicator Evaluator Resistometer) units.
Indications for Use
Indicated for monitoring sterilization processes in health care facilities. Used to verify sterilization conditions via calibrated bacterial spore populations.
Regulatory Classification
Identification
Biological sterilization process indicator: A device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization. Physical/chemical sterilization process indicator: A device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.
Predicate Devices
- Unispore® (K792649)
- Unispore® (K801152)
- Spor-Test® (K800482)
- Spor-Test® (K801980)
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