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SporView Plus Steam Biological Indicator Test Pack

FDA 510(k)

Class II (US FDA 510(k))

510(k) K051173

by Spsmedical Supply Corp.

Identifiers

510(k) Number
K051173 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 Plus Steam Biological Indicator Test Pack is a biological indicator designed for monitoring biological effectiveness in steam sterilization processes. It detects the presence of viable microorganisms after exposure to steam sterilization cycles, ensuring the sterilization process has been effective in killing bacterial spores. This device is classified as an indicator for biological sterilization processes and is used to validate the sterilization of non-implant loads in medical settings.

This test pack is intended for use in both gravity displacement and prevacuum steam sterilizers, providing routine and challenge monitoring of sterilization cycles. Supplied as single-use items, the test packs are regulated under FDA 510K clearance (K051173) and fall under device class II. Each pack is designed for one-time use and must be stored under conditions that maintain its integrity until use. The device is not MRI-safe and requires adherence to standard sterilization protocols for proper application.

Frequently asked questions

What is the SporView Plus Steam BI Test Pack used for?

The SporView Plus Steam BI Test Pack is designed to monitor the biological effectiveness of steam sterilization processes. It detects viable microorganisms after exposure to steam sterilization cycles, confirming whether the sterilization process successfully killed bacterial spores. This validation is critical for ensuring the safety and sterility of non-implant medical loads in healthcare settings.

How is the SporView Plus Steam BI Test Pack supplied and used?

Each SporView Plus Steam BI Test Pack is supplied as a single-use item, meaning it is intended for one-time use only. After use, the pack must be discarded to maintain sterility and accuracy of results. The test pack is placed in the sterilizer alongside medical instruments or loads to validate the sterilization cycle’s effectiveness.

Is the SporView Plus Steam BI Test Pack sterile before use?

The SporView Plus Steam BI Test Pack is not pre-sterile. It is designed to be exposed to the steam sterilization process itself, where it detects the presence of viable spores. The pack’s purpose is to confirm the sterilizer’s ability to kill microorganisms, not to be sterile before use.

Can the SporView Plus Steam BI Test Pack be reused?

No, the SporView Plus Steam BI Test Pack is explicitly designed for single-use only. Reusing the pack could compromise its accuracy and reliability, as it may no longer provide valid results after exposure to steam sterilization. Always use a new pack for each sterilization cycle.

What storage conditions are required for the SporView Plus Steam BI Test Pack?

The SporView Plus Steam BI Test Pack must be stored under conditions that preserve its integrity until use. This includes protecting it from physical damage, contamination, and extreme temperatures or humidity. Follow manufacturer guidelines to ensure the pack remains effective for its intended purpose.

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: PDF SBT-SCbi_SporViewPl_PP-1s - CROSSTEX, SporView™ Plus Biological Indicator Test Pack CROSSTEX, Spsmedical Sporview Plus Steam Bi Test Pack, SporView™ Plus Biological Indicator Test Pack Case of 25

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Spsmedical Supply Corp.

Sources (1)

  • FDA 510(k) K051173 24 fields · synced Oct 1, 2026