(65 days)
The SPSmedical Gas Plasma Chemical Indicators are indicated for use as process indicators to verify exposure to vapor hydrogen peroxide in the STERRAD® 100, STERRAD® 100S and STERRAD® 50 sterilization processes. They are intended to be used by health care providers with articles such as sterilization wraps, containers, cassettes, or pouches to distinguish between processed and unprocessed items. Indicators change to a signal color of BLUE after exposure to vapor hydrogen peroxide in these sterilization processes.
The SPSmedical Gas Plastua Chemical Indicators are process indicators used to verify exposure to vapor hydrogen peroxide in the STERRAD® 100, STERRAD® 100S and STERRAD® 50 sterilization processes. They provide a visual indication to belp distinguish between processed and unprocessed items. There are two indicators types. The first indicator changes from a YELLOW beginning color to a BLUE signal color and the second changes from a RED begiming color to a BLUE signal color.
This premarket notification describes the SPSmedical Gas Plasma Chemical Indicator. The study conducted aimed to demonstrate substantial equivalence to the predicate device, the Advanced Sterilization Products (ASP) Gas Plasma Indicator Strip (K921910).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Adequate Color Change for Incomplete Cycle (Clearly distinguish unprocessed or incompletely processed items) | All SPSmedical gas plasma indicator samples processed for incomplete reaction cycles showed "No change or a change that is markedly different from the change occurring after exposure" to the relevant full plasma sterilization process cycle (a color other than BLUE). This indicates successful differentiation of incomplete cycles. The H2O2 concentration was adjusted to 120 uL, resulting in 0.5 mg/L of H2O2, which is significantly less than normal (1440 uL for 6.0 mg/L). |
| Adequate Color Change for Complete Cycle (Clearly indicate successful processing) | All SPSmedical gas plasma indicator samples processed in complete reaction cycles showed "A full signal color change to BLUE." This confirms successful indication of complete sterilization. The H2O2 concentration was adjusted to one half (720 uL) of the nominal (1440 uL), resulting in 3.0 mg/L of H2O2. |
| Consistency with Predicate Device | Throughout the various testing, the SPSmedical indicators and the ASP chemical indicator strips reacted similarly in all test configurations. This supports the claim of substantial equivalence. |
| Stability (Light) | Results verified the stability of the product to retain their initial indicator color and their post-processing signal color over a 2 ½ month period when subjected to natural and artificial light sources. Indicators were not affected by, nor did they experience any substantial fading. |
| Stability (Shelf Life - Intermediate) | Five and one-half month interim results verified that all indicators turned to their appropriate signal color when subjected to a STERRAD® cycle with an injection volume of 720 µL of the 58% H2O2 solution (3.0 mg/L H2O2). A two-year stability study is ongoing, but initial results support the 2-year shelf life claim. |
| Resistance to Interfering Substances | Testing verified that the indicators in their unprocessed form are not sensitive to an acidic or basic environment. Testing verified that the indicators in their processed form are sensitive to an acidic or basic environment, leading to a precaution in the instructions for use. This indicates awareness and mitigation of potential interference. |
| Inertness to Other Sterilization Methods (Steam/EO Gas) | Indicators were unaffected by the EO Gas process. Indicators printed on polypropylene shrunk slightly but were otherwise unaffected in the steam process. Indicators printed on Tyvek were grossly deformed in the steam process (this does not hinder the intended H2O2 use). |
| Biocompatibility | Indicators are printed using nontoxic inks and coatings that will not alter the chemical composition of the products being sterilized and are safe for human contact. The synthetic paper used complies with 21 CFR 177.1520. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "between 3,000-4,000 indicators were tested from 13 separate lots of indicators containing multiple lots of substrates and indicator inks." Multiple lots of the predicate ASP indicator strips and tape were also included.
- Data Provenance: The testing was conducted in-house by SPSmedical Supply Corp. The data is retrospective, as it was generated to support the 510(k) submission. No specific country of origin for the data is mentioned other than the submitter's location (Rush, NY, U.S.A.). It is expected that the testing was performed in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- The ground truth in this context is the actual state of sterilization (incomplete or complete). This was established by controlling the H2O2 concentration within defined parameters (e.g., 0.5 mg/L for incomplete, 3.0 mg/L for complete, 6.0 mg/L for nominal). The "ground truth" was therefore determined by the controlled experimental conditions rather than human expert opinion. There were no human experts used to establish a subjective "ground truth" for the test set; the ground truth was inherently objective based on the physical process parameters.
4. Adjudication Method for the Test Set
- Not applicable. As the ground truth was established by controlled experimental conditions (H2O2 concentration), subjective adjudication by experts was not required. The results were objectively recorded as "No change or a change that is markedly different from the change occurring after exposure" or "A full signal color change to BLUE."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging devices where human readers interpret medical images. This device is a chemical indicator with an objective color change.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- This is a chemical indicator, not an algorithm. Therefore, the concept of "standalone (algorithm only)" performance is not applicable. The device's performance is its inherent color change in response to H2O2 exposure. The testing described demonstrates the direct performance of the chemical indicator itself.
7. The Type of Ground Truth Used
- The ground truth used was controlled physical parameters (specifically, varying concentrations of vapor hydrogen peroxide within a STERRAD® 100 GMP test vessel). The "correct" outcome (color change or no color change) was determined by whether the H2O2 concentration represented an incomplete or complete sterilization cycle.
8. The Sample Size for the Training Set
- There is no explicit "training set" as this is a physical chemical indicator, not an AI/ML algorithm that requires training data. The device's performance is based on its chemical properties.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this type of device.
§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is 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.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is 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.(2)
Classification. Class II (performance standards).