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510(k) Data Aggregation
(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."
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(108 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 challenge load 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.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Simulated Use | Demonstrate the pack shows passing results in worst-case load under worst-case sterilization conditions | PASS |
| Cycle-Specific Testing | The pack provides an equivalent or greater challenge to the claimed cycle than the biological model under worst-case conditions. | PASS |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "Performance testing... has been completed" and implies that these tests were conducted by the manufacturer for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The tests seem to be laboratory-based performance evaluations against specific criteria rather than expert-based assessments.
4. Adjudication Method for the Test Set
This information is not provided as the tests appear to be objective performance evaluations (pass/fail) rather than requiring adjudication for subjective interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and its Effect Size
An MRMC comparative effectiveness study was not performed or reported in this document. The device is a sterilization process indicator, not an AI-assisted diagnostic tool that would typically involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
The device itself is a "Biological Indicator Challenge Pack" which is a physical product, not a software algorithm. The "performance" being tested is its ability to accurately indicate sterilization conditions. Therefore, a standalone algorithm-only performance study is not applicable in this context. The "incubation" part involves a device (CELERITY HP Incubator) that reads the biological indicator, which is a form of automated assessment, but not an "algorithm only" study in the typical sense of AI.
7. The Type of Ground Truth Used
The ground truth for the "Simulated Use" and "Cycle-Specific Testing" appears to be established through:
- Worst-case sterilization conditions: This refers to the scientific and engineering parameters that define a minimal challenge for sterilization.
- Biological model: This likely refers to the known and established resistance of the biological indicator organism (e.g., bacterial spores) to the sterilization process. The acceptance criteria imply a biochemical or microbiological ground truth (i.e., whether the biological indicator's spores are killed or not under defined conditions).
8. The Sample Size for the Training Set
This product is a physical device (sterilization indicator), not an AI model that requires a training set. Therefore, the concept of a "training set" and its sample size is not applicable.
9. How the Ground Truth for the Training Set was Established
As explained above, a training set is not applicable for this device.
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