(29 days)
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 and unprocessed 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, Fast or Specialty 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™ Vaporized | H2O2 Process Indicator Adhesive Label (PI) is to be affixed to the outside of a pack by means of the adhesive back. It is designed to distinguish between processed and unprocessed 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 Fast or Specialty 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 provided text describes a 510(k) premarket notification for a Class II medical device, the Celerity™ Vaporized VH2O2 Process Indicator Adhesive Label (PCC078). This document primarily focuses on demonstrating substantial equivalence to a predicate device and extending the indications for use.
Based on the provided text, the device is a chemical indicator, not an AI/ML powered device. Therefore, a study proving the device meets AI/ML specific acceptance criteria as you've requested is not applicable here. The information you've asked for regarding acceptance criteria, sample size for test/training sets, expert involvement, and ground truth establishment typically applies to the evaluation of AI/ML models in diagnostic or predictive applications.
However, I can extract information related to the performance evaluation of this chemical indicator, which serves a similar purpose of demonstrating its effectiveness as intended.
Here's an analysis based on the provided document:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for this chemical indicator are based on its ability to demonstrate a visible color change from magenta to orange/yellow or lighter when exposed to specific sterilization cycles. The performance is gauged by its visual change and adherence under these conditions.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Visible color change from magenta to orange/yellow or lighter | The device is designed to distinguish between processed and unprocessed units, when affixed to packs to be sterilized, through a visible change from magenta to orange/yellow or lighter. This is the core claim for its function. The submission asserts that the device conforms to ANSI/AAMI/ISO 11140-1:2014 requirements for a VH2O2 Type 1 Process Indicator, which implies it meets the performance standards for color change under defined sterilization conditions. |
| Adheres to packs during sterilization | Testing from K231490 (reference device) demonstrated that the VERIFY V24 Self-Contained Biological Indicator (SCBI) label remained adhered to the vial. The document states that this testing is applicable to the subject device because it has the same adhesive and is adhered to plastic of a pouch similar to the reference device adhering to a plastic SCBI vial. This implies the subject device also meets the adherence requirement. |
| Performance in specific V-PRO cycles (Lumen, Non Lumen, Flexible, Fast Non Lumen, Fast, Specialty) | The device's intended use specifies these cycles, indicating expected performance within them. The submission extends the indication to the "Specialty" cycle based on testing from the reference device (K231490), noting that the subject device is cleared for use in the V-PRO maX 2 Fast Non Lumen Cycle which has identical preconditioning and exposure phases to the Specialty Cycle. This implies successful performance in the Specialty cycle. |
| Performance in specific ASP STERRAD cycles (Standard, Advanced, Express, Flex, Duo) including ALLClear Technology | The device's intended use specifies these cycles, indicating expected performance within them. No specific new test data is provided for these cycles in this submission, as the modification focuses on the V-PRO "Specialty" cycle. The continued inclusion implies prior documentation or equivalence for these cycles. |
| Endpoint stability (15 months) | The comparison table states the "Endpoint stability" for both the predicate and modified device is "15 months," indicating this is a maintained performance characteristic. No new study details are provided on how this was re-verified for the modified device in this specific submission, but it's listed as a "Same" characteristic. |
| Conformance to ANSI/AAMI/ISO 11140-1:2014 for VH2O2 Type 1 Process Indicator | The document explicitly states that the device Conforms to ANSI/AAMI/ISO 11140-1:2014 requirements for a VH2O2 Type 1 Process Indicator. This is a crucial, overarching acceptance criterion, signifying compliance with established standards for chemical indicators. This standard dictates specific performance attributes like color change kinetics, resistance to over-processing, and storage stability. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the sample size (number of indicators) used for the testing. It refers to testing previously submitted as part of K231490 for a reference device (VERIFY V24 Self-Contained Biological Indicator). The current submission leverages the equivalence of materials (indicator ink, substrate, adhesive) and the similarity of the V-PRO cycles to claim applicability of the previous testing.
- Data Provenance: Not explicitly stated regarding country of origin. The testing supporting the extended indication (Specialty Cycle) is retrospective, as it refers to data from a previously cleared device (K231490) rather than a new, dedicated prospective study for the Celerity™ label.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- This question is not applicable for this type of device. Chemical indicators do not involve human interpretation like medical images that require experts to establish ground truth. Their "ground truth" is their physical chemical reaction (color change) in response to a specific sterilization process. The compliance with standards like ANSI/AAMI/ISO 11140-1:2014 verifies their performance.
4. Adjudication Method for the Test Set
- Not applicable. This device doesn't involve subjective human interpretation of outputs that would require an adjudication method. The outcome is a clear physical change (color).
5. 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 a chemical indicator, not an AI-assisted diagnostic tool. No human "readers" or AI are involved in interpreting its output beyond confirming a color change.
6. 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.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for a chemical indicator is the defined sterilization process parameters (e.g., specific concentrations of VH2O2, exposure times, temperature), and the physical-chemical reaction of the indicator itself when exposed to those parameters. Compliance with international standards (ANSI/AAMI/ISO 11140-1:2014) serves as the primary validation for this ground truth, indicating the device performs as a "Type 1 Process Indicator" (meaning it reacts to the presence of the agent). For the new indication, the ground truth is established by the V-PRO Specialty Cycle parameters and the observed, expected color change of the indicator within these parameters, leveraging prior testing equivalence.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML 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).