(21 days)
The Indicator Tape is intended to secure items wrapped in synthetic wrap materials until used and to distinguish between processed and unprocessed units through a color change from the start color (pink/magenta) to orange, yellow or lighter. The Indicator Tape is also intended to be used as an external process indicator when applied to synthetic wrap materials and/or Tyvek pouches.
The tape may be used in the following sterilization cycles:
· Lumen, Non Lumen, Fast Non Lumen, Fast, Flexible, and Specialty Cycles of the V-PRO: 1, 1 Plus, maX 2, 60, and s2 Low Temperature Sterilization Systems.
· Standard and Advanced Cycles of the STERRAD® NX Sterilizer with or without ALLClear
· Standard, Flex Scope, Express and DUO Cycles of the STERRAD® 100NX Sterilizer with or without ALLClear.
The CELERITY HP Indicator Tape (Indicator Tape) is a ¾' wide crepe paper tape printed with diagonal stripes of a vaporized hydrogen peroxide (VHP) reactive ink. The ink is sealed with a varnish, the function of which is to inhibit removal of the ink via transference or by the adhesive (as the tape is dispensed). The reactive ink meets the performance specifications for a Type 1 process indicator for vaporized hydrogen peroxide as defined in ANSI/AAMI/ISO 11140-1:2014.
The STERIS CELERITY HP Indicator Tape is a chemical indicator designed to distinguish between processed and unprocessed units in various low-temperature sterilization systems using vaporized hydrogen peroxide (VHP).
1. Table of Acceptance Criteria and Reported Device Performance:
| Testing | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Simulated Use Testing | • Complete color change in full cycle | |
| • Incomplete color change in partial cycle | ||
| • Remain adhered after worst-case cycle | • Complete color change in full cycle | |
| • Incomplete color change in partial cycle | ||
| • Remains adhered after worst-case cycle | ||
| ISO 11140-1 Testing | Meets requirement of Type 1 VHP Indicator | Meets requirement of Type 1 VHP Indicator |
| Light Stability | Ink performs as intended when exposed to light for labeled period | Ink performs as intended when exposed to light for labeled period |
| Endpoint Stability | Endpoint color remains stable for labeled period | Endpoint color remains stable for labeled period |
| Shelf Life | Meets all performance requirements at labeled shelf-life | Meets all performance requirements at labeled shelf-life (Note: Real-time testing is ongoing; currently, a 5-month shelf-life is reported). |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for each specific test (e.g., number of indicator tapes per cycle, number of cycles tested). However, it mentions that "Performance testing was completed using well established methods such as those described in ISO 11140-1 and those used to verify the predicate design." This suggests that standard testing methodologies, which typically include specific sample size requirements, were followed.
The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given that this is a premarket notification (510(k)) for a medical device to be marketed in the US, the studies were likely conducted to meet US regulatory requirements.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:
This information is not provided in the document. For chemical indicators like the CELERITY HP Indicator Tape, the "ground truth" for successful processing is typically defined by the objective color change criteria specified by the manufacturer and validated against known sterilization conditions (full cycle vs. partial cycle). The interpretation of the color change might be assessed by trained personnel rather than "experts" in the traditional sense, but the document does not elaborate on this.
4. Adjudication Method for the Test Set:
This information is not provided in the document. For a chemical indicator, the color change itself is a direct visual output. Adjudication, if any, would likely involve confirmation that the observed color change aligns with the expected outcome (e.g., full color change for a successful cycle, incomplete for a partial cycle). However, the specific method (e.g., consensus among multiple observers) is not detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not performed. This type of study is typically associated with diagnostic imaging devices or algorithms where human readers interpret complex data, and the AI's impact on their performance is measured. The CELERITY HP Indicator Tape is a passive chemical indicator with a direct visual output, making an MRMC study irrelevant to its evaluation.
6. Standalone Performance Study:
Yes, a standalone study (algorithm only without human-in-the-loop performance) was done. The performance testing (Simulated Use Testing, ISO 11140-1 Testing, Light Stability, Endpoint Stability, Shelf Life) described in the document evaluates the intrinsic behavior and response of the CELERITY HP Indicator Tape itself, independent of human interpretation or assistance beyond observing the color change. The device's performance is determined by its physical and chemical properties and its reaction to sterilization conditions.
7. Type of Ground Truth Used:
The ground truth used for the performance testing is based on:
- Known Sterilization Conditions: The indicators are exposed to "full cycle" and "partial cycle" conditions within specified sterilization systems. A full cycle represents effective sterilization, while a partial cycle represents an insufficient process.
- Adherence to Standards: The "Meets requirement of Type 1 VHP Indicator" for ISO 11140-1 Testing implies that the ground truth for this aspect is defined by the objective performance criteria outlined in the ISO 11140-1 standard for Class 1 chemical indicators. These standards specify how the indicator should react to critical process variables.
- Stability over Time: For light stability and endpoint stability, the ground truth is the expectation that the ink's performance and the endpoint color remain consistent for the labeled period under specified environmental conditions.
8. Sample Size for the Training Set:
This information is not applicable and is not provided in the document. The CELERITY HP Indicator Tape is a chemical indicator, not an AI/ML algorithm that requires a training set. Its design and behavior are based on chemical formulations and physical characteristics, not on learned patterns from a dataset.
9. How the Ground Truth for the Training Set Was Established:
This information is 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).