Spsmedical Sporview 10 Steam Self Contained Biological Indicator
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K122024 FDA 510(k)
- FDA Product Code
- FRC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.2800 FDA 510(k)
- Regulation Number
- 880.2800 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The SporView 10 Steam Self-Contained Biological Indicator is a biological indicator designed to monitor the efficacy of saturated steam sterilization processes. It contains viable Geobacillus stearothermophilus bacterial spores, growth media, and a chemical indicator label for process validation. This device is classified as a Class II medical device under FDA regulations and is intended for use in sterilization cycles to ensure microbial inactivation.
The indicator is self-contained, requiring no external activation beyond exposure to steam sterilization. After processing, it is incubated at 55–60°C for 10 hours (or up to 24 hours as per some protocols) to detect microbial growth. Supplied as a single-use device, it is regulated under FDA 510(k) clearance (K122024) and complies with sterilization process validation standards. Storage and handling follow standard biological indicator protocols to maintain sterility and integrity prior to use.
Frequently asked questions
What is the SporView 10 Steam Self-Contained Biological Indicator used for?
This device is designed to monitor the effectiveness of saturated steam sterilization processes. It contains *Geobacillus stearothermophilus* spores, which are highly resistant to heat, ensuring accurate validation of microbial inactivation during sterilization cycles. By confirming the spores are destroyed, it guarantees the sterilization process meets required standards for medical instruments and devices.
How is the SporView 10 Biological Indicator supplied and prepared for use?
The SporView 10 is supplied as a single-use, self-contained device. No external activation is required beyond placing it in the steam sterilization cycle. After processing, it must be incubated at 55–60°C for 10 hours (or up to 24 hours per some protocols) to detect any surviving spores. This incubation period allows for microbial growth if the sterilization process was ineffective.
Is the SporView 10 Biological Indicator sterile before use?
The device is not sterile prior to use. It is designed to be exposed to the sterilization process itself, ensuring that any microbial contamination present would be validated by the indicator’s response. Sterility is only confirmed if the indicator shows no growth after incubation, indicating successful sterilization.
Can the SporView 10 Biological Indicator be reused?
No, the SporView 10 is intended for single-use only. After exposure to a sterilization cycle and subsequent incubation, the indicator is consumed in the validation process. Reusing it would compromise its accuracy and reliability, as the spores and growth media cannot be reset or reused.
What storage conditions are required for the SporView 10 Biological Indicator?
The device must be stored according to standard biological indicator protocols to maintain its integrity and viability. It should be kept in a clean, dry environment, protected from extreme temperatures, moisture, and direct sunlight. Proper storage ensures the spores remain viable until used in a sterilization cycle, allowing for accurate process validation.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Spsmedical Sporview 10 Steam Self Contained Biological Indicator, PDF SporView® 10 Steam Self-Contained BI - CROSSTEX, SporView® Steam Self-Contained Biological Indicator, Crosstex/SPS ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K122024 | Class II | Active |
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Manufacturer
- Manufacturer
- Spsmedical Supply Corp.
Sources (1)
- FDA 510(k) K122024 24 fields · synced Oct 1, 2026