(76 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 or lighter, when the device has been exposed to the:
- · Lumen, Non Lumen, Flexible, Fast Non Lumen, Fast or Specialty 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™ HP Multivariable Chemical Indicator is a vaporized hydrogen peroxide multivariable chemical indicator. It is designed for routine monitoring of the following cycles:
- Lumen, Non Lumen, Flexible, Fast Non Lumen, Fast or Specialty 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 VERIFY® HPU 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 to indicate, through a visible change from magenta to yellow, when the device has been exposed to the Lumen, Non Lumen, Flexible, Fast Non Lumen, or Specialty sterilization cycle of a V-PRO® Low Temperature Sterilization System.
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) to peach, 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, maX 2, 60, and s2 Low Temperature Sterilization Systems.
- STERRAD® 100S Sterilizer (Default Cycle)
- . 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 without ALLClear.
The Celerity "M HP Chemical Indicator is an ISO 11140-1:2014 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/vellow or lighter. when the device has been exposed. No changes have been made to the device other than additional testing and updating the labeling for the Specialty Cycle.
The Celerity™ HP Multivariable Chemical Indicator is a chemical indicator strip consisting of indicator ink containing the reactive chemicals printed on one end of a polypropylene strip. If the critical variables are achieved, the color of the indicator ink changes from magenta to orange/yellow or lighter yellow when exposed to the V-PRO® Low Temperature Sterilization System cycles or ASP STERRAD® System cycles. The indicator is validated to function as a multiple variable indicator with increased resistance characteristics similar to ISO 11140-1:2014 end points for a Type 4 Vaporized Hydrogen Peroxide (VHP) Chemical Indicator (CI). No changes have been made to the device other than additional testing and updating the labeling for Specialty cycle.
The VERIFY HPU Chemical Indicator (Chemical Indicator) is a Type 1 process indicator in accordance with ANSI/AAMI/ISO 11140-1:2014. The indicators are used in the processing cycles to indicate exposure to the following sterilization cycles in the V-PRO Low Temperature Sterilization Systems. The indicator ink spot on the proposed Chemical Indicator undergoes a color change from magenta to vellow when exposed to the defined processing conditions.
The VERIFY VH2O2 Indicator Tape (Indicator Tape) is a 3/" 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 provided text describes premarket notification (510(k)) submissions for four chemical indicators (CIs) used in sterilization processes:
- Celerity™ HP Chemical Indicator (CI) (K231488) on pages 3-5.
- Celerity™ HP Multivariable Chemical Indicator (CI) (K231488) on pages 6-9.
- VERIFY HPU Chemical Indicator (CI) (K231488) on pages 10-12.
- VERIFY VH2O2 Indicator Tape (K231488) on pages 13-16.
For each of these devices, the core purpose of the 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, primarily by showing that the indicators function as intended even with an expanded "Indications for Use" to include the "Specialty" sterilization cycle of the V-PRO® Low Temperature Sterilization System.
The information provided does not pertain to a medical device that uses AI or machine learning, nor does it involve human readers/experts interpreting medical images. Instead, it describes performance testing of chemical indicators, which are physical objects designed to change color under specific sterilization conditions. Therefore, the requested information elements such as "Number of experts used to establish ground truth," "Adjudication method," "MRMC comparative effectiveness study," "Effect size of human readers improvement with AI," "Stand-alone algorithm performance," "Training set sample size," and "How ground truth for training set was established" are not applicable to this type of device and study.
The acceptance criteria and reported performance for each device are derived from "Simulated Use Testing" and are consistently focused on the physical color change and the indicator's integrity.
Here's a summary of the relevant information provided for each product:
1. Celerity™ HP Chemical Indicator (CI) (K231488)
Acceptance Criteria and Reported Device Performance:
| Testing | Acceptance Criteria | Study Result |
|---|---|---|
| Simulated Use Testing | Complete color change No reversion | Complete color change No reversion |
Study that proves the device meets the acceptance criteria:
- Sample Size: Not explicitly stated, but the context implies a sufficient number of indicators were tested to demonstrate consistent performance.
- Data Provenance: Not explicitly stated, but the manufacturing facility is in the United Kingdom, and the testing simulates "typical in-use applications in a V-PRO maX 2 Sterilizer Specialty cycle." This suggests laboratory-based, prospective testing designed to validate performance under specified conditions.
- Type of Ground Truth: The ground truth is the physical observation of the color change of the chemical indicator after exposure to the V-PRO maX 2 Sterilizer Specialty cycle, indicating that the sterilization conditions were met. This is a direct physical outcome.
2. Celerity™ HP Multivariable Chemical Indicator (CI) (K231488)
Acceptance Criteria and Reported Device Performance:
| Testing | Acceptance Criteria | Study Result |
|---|---|---|
| Simulated Use Testing | Complete color change No reversion | Complete color change No reversion |
Study that proves the device meets the acceptance criteria:
- Sample Size: Not explicitly stated.
- Data Provenance: Not explicitly stated, but similar to the previous Celerity CI, implies laboratory-based, prospective testing.
- Type of Ground Truth: The ground truth is the physical observation of the color change of the chemical indicator after exposure to the V-PRO maX 2 Sterilizer Specialty cycle, confirming proper function as a multivariable indicator.
3. VERIFY HPU Chemical Indicator (CI) (K231488)
Acceptance Criteria and Reported Device Performance:
| Testing | Acceptance Criteria | Study Result |
|---|---|---|
| Simulated Use Testing | Complete color change No reversion | Complete color change No reversion |
Study that proves the device meets the acceptance criteria:
- Sample Size: Not explicitly stated.
- Data Provenance: Not explicitly stated, but implies laboratory-based, prospective testing.
- Type of Ground Truth: The ground truth is the physical observation of the color change of the chemical indicator (magenta to yellow) after exposure to the V-PRO maX 2 Sterilizer Specialty cycle.
4. VERIFY VH2O2 Indicator Tape (K231488)
Acceptance Criteria and Reported Device Performance:
| Testing | Acceptance Criteria | Study Result |
|---|---|---|
| Simulated Use Testing | Complete color change Remained adhered after cycle | Complete color change Remained adhered after cycle |
Study that proves the device meets the acceptance criteria:
- Sample Size: Not explicitly stated.
- Data Provenance: Not explicitly stated, but implies laboratory-based, prospective testing. The manufacturing facility is in Buena Park, CA (USA).
- Type of Ground Truth: The ground truth is the physical observation of the color change of the indicator tape (pink to peach, yellow or lighter) and its physical integrity (remaining adhered) after exposure to the V-PRO maX 2 Sterilizer Specialty cycle.
Summary of non-applicable AI/ML specific criteria:
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth is based on physical/chemical reaction.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No human adjudication of complex data; rather, direct observation of state change.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical chemical indicator, not an algorithm.
- The sample size for the training set: Not applicable. These are physical devices, not AI models requiring training data.
- How the ground truth for the training set was established: Not applicable for the same reason.
In all cases, the primary purpose of the testing described is to confirm that the chemical indicators reliably undergo the expected color change (and adhere, for the tape) when exposed to the specific V-PRO maX 2 Sterilizer Specialty cycle, thereby demonstrating their continued safety and effectiveness for an expanded indication.
§ 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).