(38 days)
The Celerity™ HP Chemical Indicator is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units, when placed within packs to be sterilized, through a visible change from red to orange/yellow, when the device has been exposed to the:
· Lumen. Non Lumen, Flexible, Fast Non Lumen or Fast sterilization cycle of a V-PRO® Low Temperature Sterilization System, or
· Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP STERRAD® System, including those systems with ALLClear Technology.
The Celerity™ Vaporized VH2O2 Process Indicator Adhesive Label is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed units, when affixed to packs to be sterilized, through a visible change from magenta to orange/yellow or lighter, when the pack has been exposed to the:
· Lumen, Non Lumen, Flexible, Fast Non Lumen or Fast sterilization cycle of a V-PRO® Low Temperature Sterilization System, or
· Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP STERRAD® System, including STERRAD NX and 100NX with ALLClear Technology.
The VERIFY V24 Self-Contained Biological Indicator Vial Label is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed SCBIs, whilst affixed to SCBI vials to be sterilized, through a visible change from red to orange/yellow, when the SCBI has been exposed to the:
· Lumen. Non Lumen, Flexible, Fast Non Lumen or Fast sterilization cycle of a V-PRO® Low Temperature Sterilization System, or
• Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP STERRAD® System, including STERRAD NX and 100NX with ALLClear Technology.
The Celerity HP Chemical Indicator is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units through a visible change from magenta to orange/yellow or lighter, when the device has been exposed to the:
- . Lumen, Non-Lumen, Flexible, Fast Non Lumen or Fast sterilization cycle of a V-PRO® Low Temperature Sterilization System, or
- . Standard. Advanced, Express, Flex or Duo cycles of an ASP STERRAD® System, including those systems with ALLClear Technology.
The Celerity "10 HP Chemical indicator is provided in three formats:
- Version 1: Celerity™ Chemical Indicator (CI) .
- . Version 2: Celerity™ Vaporized |VH2O2 Process Indicator Adhesive Label (PI)
- Version 3: VERIFY V24 Self-Contained Biological Indicator Vial Label (PI)
The three formats differ in their intended location inside the load to be sterilized. Version 1 is to be placed inside a pack to be sterilized. Version 2 is to be affixed to the outside of a pack by means of the adhesive back. Version 3 is to be affixed to the outside of a Self-Contained Biological Indicator by means of the adhesive back.
The proposed devices are manufactured by application of the indicator ink by printing onto a substrate in a variety of shapes in three constructions:
- Construction C Polypropylene ●
- Construction B - Spun-bonded polyolefin with an adhesive and a glassine backing paper
- Construction D - polypropylene with an adhesive and a glassine backing paper.
The proposed devices will consist of one of the above substrates with an indicator ink printed thereon.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Testing Category | Methodology | Acceptance Criteria | Study Result |
|---|---|---|---|
| Type 1 Performance Testing | ANSI/AAMI/ISO 11140-1:2014 | - When exposed to VHP Resistometer cycles at the Fail parameters (Test Points 2 and 3): 100% Celerity™ HP Chemical Indicator stripes must show a FAIL result. |
- When exposed to VHP Resistometer cycles at the Pass condition (Test Point 1): Minimum 90% Celerity™ HP Chemical Indicator stripes must show a PASS result. | Pass |
| Simulated Use Testing | Internal Method Used | - When exposed to V-PRO maX Non Lumen 1/84 cycles with ≥50 lb load (Fail condition): 100% Celerity™ HP Chemical Indicator stripes must show a FAIL result. - When exposed to V-PRO and STERRAD cycles with the worst case loads: Minimum 90% Celerity™ HP Chemical Indicator stripes must show a PASS result. | Pass |
| Fluorescent Light Stability Testing | Internal Method & ANSI/AAMI/ISO 11140-1:2014 | - Indicator start color to remain unchanged after exposure to fluorescent lighting for ≥ 30 days before processing. - When exposed to VHP Resistometer cycles at the Fail parameters following exposure to fluorescent lighting for ≥ 30 days: 100% of Indicators tested must show a FAIL results (non-visible color change or color change to another color except orange/yellow).
- When exposed to VHP Resistometer cycles at the PASS parameters following exposure to fluorescent lighting for ≥ 30 days: Minimum 90% Indicators tested must show a PASS result (orange/yellow or lighter). | Pass |
| Temperature Extremes Exposure (Freeze/Thaw) Testing | Internal Method & ANSI/AAMI/ISO 11140-1:2014 | - Indicator start color to remain unchanged after exposure to extreme temperatures before processing. - When exposed to VHP Resistometer cycles at the Fail parameters following exposure to extreme temperatures: 100% of Indicators tested must show a FAIL results (non-visible color change or color change to another color except orange/yellow).
- When exposed to VHP Resistometer cycles at the PASS parameters following exposure to extreme temperatures: Minimum 90% Indicators tested must show a PASS result (orange/yellow or lighter). | Pass |
| Transference Testing | ANSI/AAMI/ISO 11140-1:2014 | - Indicators placed between a piece of the same substrate and held together with tape, then processed in a double V-PRO maX 2 Lumen cycle (no load) and evaluated for off-set, bleed and migration. | Pass |
| | | - Samples with reference and text ink processed in a double V-PRO maX 2 Lumen cycle (no load) and evaluated for smearing, discoloration and fading. | Pass |
| Adhesion Stability (Vials) Testing | Internal Method Used | - When exposed to two consecutive V-PRO maX 2 Lumen cycles:
• 0% samples show bleeding of the adhesive
• 100% must be firmly affixed
• 0% must show signs of peeling
• Minimum 90% must show a PASS result | Pass |
| Shelf Life Testing | ANSI/AAMI/ISO 11140-1:2014 | - After the process indicator has been aged: Minimum of 90% of indicators must PASS Type 1 PASS conditions. - After the process indicator has been aged: 100% of indicators must FAIL. | Pass |
| Post-Processing Stability Testing | Internal Method Used | - Indicator processed ink color remains unchanged for a minimum of 6 months following exposure to a PASS or FAIL cycle. | Pass |
2. Sample Size and Data Provenance for Test Set:
The document does not explicitly state the specific sample sizes (number of indicators) used for each individual test in the performance studies. However, for "Type 1 Performance Testing", "Simulated Use Testing", "Fluorescent Light Stability Testing", "Temperature Extremes Exposure Testing", "Shelf Life Testing", and "Adhesion Stability (Vials) Testing", the acceptance criteria mention percentages (e.g., "100% Celerity™ HP Chemical Indicator stripes", "Minimum 90% Celerity™ HP Chemical Indicator stripes"). This implies that multiple indicators were tested for each condition.
The data provenance is not explicitly stated in terms of country of origin. The manufacturing facility is in the United Kingdom, but the testing may have occurred elsewhere. The studies are described in the context of a 510(k) submission, which typically involves prospective testing designed to meet regulatory requirements.
3. Number of Experts and Qualifications for Ground Truth of Test Set:
This information is not provided. The performance testing for these chemical indicators relies on objective color changes and adherence to established standards (ANSI/AAMI/ISO 11140-1:2014), rather than expert interpretation of the results. The 'ground truth' is the objective physical change of the chemical indicator based on exposure to sterilization conditions.
4. Adjudication Method for the Test Set:
Not applicable. The performance testing for chemical indicators is based on objective observable color changes and compliance with quantitative standards, not subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where human readers interpret images or other data, and the comparison is how AI assistance affects their diagnostic accuracy. Chemical indicators, like the Celerity™ HP, are designed for direct visual interpretation of a color change, not complex interpretation by multiple human readers.
6. Standalone (Algorithm Only) Performance Study:
Yes, the studies described are standalone performance studies of the chemical indicator itself. The device is a "Type 1 vaporized hydrogen peroxide sterilization process indicator" that provides a direct visual cue (color change) to indicate exposure to sterilization conditions. Its performance is evaluated based on its intrinsic ability to change color accurately under specific conditions, without human interpretation beyond basic color recognition.
7. Type of Ground Truth Used:
The ground truth used is primarily based on physical exposure to defined sterilization conditions (VHP Resistometer cycles at specific "Fail parameters" and "Pass condition", and various V-PRO and STERRAD cycles with worst-case loads). The observable color change (or lack thereof) in the chemical indicator is then compared against these known exposure conditions to determine if the indicator provides an accurate visual signal according to the standard.
8. Sample Size for Training Set:
Not applicable. Chemical indicators are passive devices that rely on a chemical reaction for their function, not on machine learning algorithms that require a "training set" of data.
9. How Ground Truth for 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).