(28 days)
The CELERITY 20 HP Challenge Pack is intended for qualification testing of the V-PRO Low Temperature Sterilization System following installation, relocation, malfunctions or major repairs and for routine requalification testing.
The Challenge Pack is placed in an otherwise empty sterilizer chamber; a hospital-defined chad is not included.
The challenge pack is not intended for routine monitoring of the V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing of the sterilizers.
The CELERITY 20 HP Challenge Pack (pack), is used by healthcare providers for qualification testing of the V-PRO Low Temperature Sterilization Systems. The pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included.
The user places the pack into the V-PRO Sterilizer and performs a sterilization cycle. After cycle completion, the VERIFY HPU Chemical Indicator (CI) and the CELERITY 20 HP Biological Indicator (BI) contained in the pack are retrieved. The CI is assessed for a passing color change immediately and the BI can either be immediately activated or it can be held at room temperature for a maximum of 72 hours (3 days) prior to activation.
The BI is activated by sealing the vial and thus puncturing the cap to release the contained media. The activated SCBI is incubated at 55-60 ℃ in the CELERITY HP Incubator for a final determination of viability within 20 minutes of incubation.
The provided text describes the CELERITY 20 HP Challenge Pack, a device used for qualification testing of the V-PRO Low Temperature Sterilization System. The description focuses on demonstrating substantial equivalence to a predicate device (K173488).
Here's an analysis of the provided information concerning acceptance criteria and study data:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria for Simulated Use Test:
"Demonstrate the pack shows passing results in worst-case load under worst-case sterilization conditions (Fast Non Lumen Cycle of V-PRO maX 2 Sterilizer)"
Reported Device Performance:
"PASS: All CI complete change. All BI inactivated."
Table format:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Simulated Use | Demonstrate the pack shows passing results in worst-case load under worst-case sterilization conditions (Fast Non Lumen Cycle of V-PRO maX 2 Sterilizer) | PASS: All CI complete change. All BI inactivated. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document (K220473 510(k) Summary) does not explicitly state the numerical sample size for the "Simulated Use" test. It only provides a qualitative conclusion ("All CI complete change, All BI inactivated").
Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. Given that it's a 510(k) submission for a medical device's performance, it would typically involve prospective testing to demonstrate the device's functionality.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The device in question is a sterilization process indicator (Biological Indicator Challenge Pack). Ground truth for a biological indicator is typically established by physical/biological testing (e.g., observing the chemical indicator color change and culturing the biological indicator to check for bacterial inactivation), not by human expert interpretation in the way one might assess medical images. Therefore, the concept of "experts" in the context of establishing ground truth for this specific device's test set may not directly apply as it would for, say, a diagnostic imaging AI.
4. Adjudication Method for the Test Set
This information is not applicable/not provided in the context of this device. The assessment of a chemical indicator's color change or a biological indicator's inactivation is typically a direct observation/measurement, not subject to human interpretation discrepancies that would require adjudication among multiple readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for AI or imaging devices where human readers interpret medical images, and the study evaluates how AI assistance impacts their performance. The CELERITY 20 HP Challenge Pack is a physical indicator for sterilization, not an imaging or diagnostic device involving human interpretation of complex data.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable in the conventional sense for this device. The CELERITY 20 HP Challenge Pack is a physical indicator. Its "performance" is its ability to accurately signal sterilization success or failure. The test described, "Simulated Use," is essentially a standalone performance test of the device under specific conditions. There's no "algorithm" in the typical software sense, nor a "human-in-the-loop" that would interact with an algorithm. The human interaction involves observing the chemical indicator change and incubating the biological indicator.
7. The Type of Ground Truth Used
The ground truth for this device's performance is based on direct physical and biological outcomes:
- Chemical Indicator (CI) complete change: This indicates that the chemical indicator underwent the expected color transformation due to exposure to the sterilization process.
- Biological Indicator (BI) inactivated: This means that the spores within the biological indicator were successfully killed by the sterilization process, confirmed by the absence of growth after incubation.
These are established physical and biological endpoints, not subjective expert consensus, pathology, or population outcomes data in the way one might see for a diagnostic medical device.
8. The Sample Size for the Training Set
This information is not applicable/not provided. The CELERITY 20 HP Challenge Pack is a physical device, a "Biological Indicator Challenge Pack," not a machine learning or AI-based device that would require training data or a training set. Its design and functionality are based on chemical and biological principles for indicating sterilization efficacy.
9. How the Ground Truth for the Training Set Was Established
As stated above, this question is not applicable since the device is not an AI/ML product and does not have a "training set."
§ 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).