FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

· 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 with or without ALLClear

When used in conjunction with the Celerity HP Incubator, the Celerity 20 HP BI provides a fluorescent result within 20 minutes

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.

Device Description

Biological Indicator: The product is intended to monitor the vapor phased hydrogen peroxide sterilization cycles described in the indications for use. It produces an optical change (signal) that is detected by the STERIS proprietary reader, CELERITY 20 HP Incubator, within 20 minutes to confirm the viability of the biological indicator at the end of a sterilization process. The product consists of Geobacillus stearothermophilus spores and a defined nutrient media in a plastic vial. A reporter enzyme, which is produced by the organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety.

Challenge Pack: 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Celerity 20 HP Biological Indicator and Celerity 20 HP Challenge Pack, based on the provided document.

CELERITY 20 HP Biological Indicator

Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria	Reported Device Performance
BI Simulated Use in the V-PRO maX 2 Sterilizer Fast Non Lumen Cycle	All BIs processed in full cycles will be negative for growth	PASS
Recoverable Population after exposure to STERRAD ALLClear	Recoverable Population of 50 – 300% of the label claim	PASS

Sample Size 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 states that "Performance testing demonstrated that the subject device met its acceptance criteria."
Number of Experts and Qualifications: Not applicable for this type of device (biological indicator testing for sterilization).
Adjudication Method: Not applicable for this type of device. The determination of "negative for growth" or "recoverable population" is based on objective microbiological assays.
Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not applicable. This device is an objective indicator, not subject to human reader interpretation in the context of diagnostic imaging.
Standalone (Algorithm Only) Performance: The document describes the Celerity 20 HP BI as a standalone device whose performance is assessed through its growth characteristics after exposure to sterilization cycles. The "fluorescent result within 20 minutes" when used with the Celerity HP Incubator is the objective output of the system.
Type of Ground Truth Used: The ground truth is based on the biological viability of Geobacillus stearothermophilus spores after exposure to sterilization, and the quantitative recovery of these spores. This is a direct measure of microbial survival/kill.
Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set in that sense. The device is a biological indicator with inherent characteristics that are tested.
How Ground Truth for Training Set was Established: Not applicable.

CELERITY 20 HP Challenge Pack

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

Sample Size and Data Provenance: Similar to the Biological Indicator, the document does not explicitly state the sample size used for the test set or the data provenance. It states "Performance testing demonstrated that the subject device met its acceptance criteria."
Number of Experts and Qualifications: Not applicable.
Adjudication Method: Not applicable. The results are based on the objective outcome of the biological indicator and chemical indicator within the pack after a sterilization cycle.
Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not applicable.
Standalone (Algorithm Only) Performance: The CELERITY 20 HP Challenge Pack's performance is intrinsically standalone, as it's a physical pack designed to present a challenge to the sterilization process. Its outcome is determined by the biological and chemical indicators it contains.
Type of Ground Truth Used: The ground truth is established by assessing the biological (spore kill/survival) and chemical (color change) indicators within the pack after exposure to standardized sterilization conditions, particularly under "worst-case sterilization conditions" and against a "biological model."
Sample Size for Training Set: Not applicable.
How Ground Truth for Training Set was Established: Not applicable.

Overall Note: This document describes the 510(k) submission for a traditional biological indicator and challenge pack, not an AI/ML powered device. Therefore, many of the requested points related to AI/ML study methodologies (experts, adjudication, MRMC, training sets) are not applicable to this submission. The focus is on the physical and biological performance characteristics of the indicator and pack.

Summary

Regulation Number and Section

§ 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).