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The Gas-Chex Indicator is an integrating indicator designed to respond to all critical parameters over a specified range of Ethylene Oxide sterilization cycles. The Gas-Chex Indicator is intended to be placed in each pack, pouch, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles:

1. 37°C, 736 mg/l EO, ≥35% RH, 3 hours exposure
2. 37°C, 759 mg/l EO, ≥35% RH, 3 hours exposure
3. 38°C, 736 mg/l EO, 40-80% RH, 4.5 hours exposure
4. 38°C, 759 mg/l EO, 40-80% RH, 4.5 hours exposure
5. 55°C, 736 mg/l EO, ≥35% RH, 1 hour exposure
6. 55°C, 759 mg/l EO, ≥35% RH, 1 hour exposure
7. 55°C. 600 mg/l EO. 60% RH. 4 hours exposure
   The Gas-Chex Indicator for EO sterilization has the following minimum Stated Values determined in a Resistometer:
   54℃, 42 min, EO 600 mg/l, RH 60±10%
   37℃,75 min. EO 600 mg/l. RH 60±10%
   55°C, 36 min, EO 736 mg/l, RH 50±10%
   37°C, 75 min, EO 736 mg/l, RH 50±10%
   55°C, 35 min, EO 759 mg/l, RH 50±10%
   37°C, 75 min, EO 759 mg/l, RH 50±10%

The Gas-Chex® Indicator is a single use chemical integrating indicator designed for Ethylene Oxide (EO) sterilization monitoring. Each indicator consists of reactive EO indicator ink printed on a 4" x 9/16" substrate paper strip. It can be also printed on other substrate sizes, for example 8" x 9/16" paper. Gas-Chex® Indicators are sold in boxes of 250 strips.
The indicator responds to all critical parameters of an EO sterilization cycle: exposure time, temperature, relative humidity and amount of Ethylene Oxide gas. During sterilization process the indicator ink chemicals react to EO gas forming a green compound. The degree of the reaction depends on the sterilization exposure. When the parameters achieve required level, the indicator ink chemistry changes color from brown-red to green. If the parameters do not achieve the required level, the indicator color will be brown-red, or brown-yellow.

The acceptance criteria and the study proving the device meets these criteria are detailed in the "Summary of Non-Clinical Testing" section of the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

• Pass Condition (Green):
  • 54°C, 42 min, EO 600 mg/l, RH 60%
  • 37°C, 75 min, EO 600 mg/l, RH 60%
  • 55°C, 36 min, EO 736 mg/l, RH 50%
  • 37°C, 73 min, EO 736 mg/l, RH 50%
  • 55°C, 35 min, EO 759 mg/l, RH 50%
  • 37°C, 73 min, EO 759 mg/l, RH 50%
• Fail Condition (Brown, Brown-red, Brown-yellow):
  • 49°C, 33.6min, EO 510 mg/l, RH 60%
  • 32°C, 60 min, EO 510 mg/l, RH 60%
  • 50°C, 28.8min, EO 625mg/l, RH 50%
  • 32°C, 58.4min, EO 625mg/l, RH 50%
  • 50°C, 28 min, EO 645 mg/l, RH 50%
  • 32°C, 58.4min, EO 645mg/l, RH 50% | Passed |
    | Testing in "No EO Gas" cycles | When tested in cycle with temperature 60°C±2°C, RH≥85%, time 90 min±1min, the indicator should not achieve end-point color. | Passed |
    | Testing against biological indicator | The integrator does not achieve end-point color before the biological indicator is inactivated and demonstrates parallel performance to the biological indicator. | Passed |
    | Single parameter variation testing | Variation of one parameter while other ones are maintained steady. Gas-Chex Indicator should not reach specified end-point green color. | Passed |
    | Testing in cycles with parameters typical for healthcare | Color change from brown-red to green. | Passed |
    | Biocompatibility study and ink transfer test | Evaluation of individual components for biocompatibility and review of biocompatibility of indicators with similar formulation with history on the market.

Testing according to ISO 11140-1:2014. Requirement: 6.2.2. No ink transfer should be observed on unprocessed and EO processed samples. | Passed |
| End-point stability and shelf-life study | Gas-Chex indicators processed in Pass and Fail cycles at various time points after production and at the end of shelf life should demonstrate stable color for at least 3 months.

Meet specifications after real-time 36 months shelf-life exposure. | Passed |

Detailed Information on the Study:

2. Sample size used for the test set and the data provenance:

   • The document does not specify the exact number of individual Gas-Chex Indicators or test runs used for each test. Instead, it states that various conditions (e.g., specific temperatures, EO concentrations, RH, and exposure times) were tested.
   • Data Provenance: The tests were performed to demonstrate conformance with FDA guidance for industry and FDA Staff: Pre-market notification [510(k)] submissions for chemical indicators, 2003. These are laboratory-based, non-clinical tests conducted in controlled environments (Ethylene Oxide BIER vessel). The specific country of origin is not explicitly stated for the testing location, but the applicant company is located in Long Island City, New York, USA. The study design is prospective in nature as it involves planned testing under specific conditions.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This type of device (chemical indicator for sterilization) does not typically involve human expert interpretation of complex data for ground truth establishment.
   • The "ground truth" is established by the known, objective physical and chemical parameters of the sterilization cycles (e.g., temperature, time, EO concentration, RH) and the expected color change response of the indicator based on its design and the established standards (e.g., ISO 11140-1:2014 and FDA guidance). The color change itself (brown-red to green, or remaining brown-red/brown-yellow) is a direct, observable, and objective outcome.
   • Therefore, no human experts are described as being used in an "adjudication" sense to establish fundamental ground truth for the device's performance in these non-clinical tests.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • No adjudication method from human experts is described since the assessment of the chemical indicator's color change is a direct observation against defined criteria (e.g., "green" for pass, "brown, brown-red, brown-yellow" for fail). This is a purely objective assessment against pre-defined color states.

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:

   • No MRMC comparative effectiveness study was done. This type of study is not applicable to a chemical sterilization indicator, which is a passive device with a direct visual output, rather than an AI-driven diagnostic or interpretative tool that assists human readers.

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:

   • Not applicable. The device is a chemical indicator that changes color; there is no algorithm involved. Its performance is inherent to its chemical formulation and physical design.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The ground truth is based on the known, controlled physical and chemical parameters of the Ethylene Oxide sterilization cycles (temperature, Ethylene Oxide concentration, relative humidity, and exposure time) generated in a Resistometer (BIER vessel). The expected outcome (color change to green for successful sterilization parameters, or no change/partial change for insufficient parameters) is derived from established sterilization science and regulatory standards for chemical indicators.

8. The sample size for the training set:

   • Not applicable. This device is a passive chemical indicator, not an AI/machine learning model, so there is no concept of a "training set."

9. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for this type of device.

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The STERIZONE® VP4 Test Pack is intended to be used for routine monitoring of the STERIZONE® VP4 Sterilizer cycle (Cycle 1) and for the performance validation of the STERIZONE® VP4 Sterilizer system.

The STERIZONE® VP4 Test Pack is a Process Challenge Device (PCD) designed to have greater resistance than the worst-case sterilization load of the STERIZONE® VP4 Sterilizer. The STERIZONE® VP4 Test Pack is intended to simulate products to be sterilized and to constitute a defined challenge to the sterilization process and used to assess the effective performance of the process.

The STERIZONE® VP4 Test Pack (subject device) is composed of a Self-contained Biological Indicator (the Terragene's Bionova® BT96), a 10 mL syringe and its plunger, and a diffusion restrictor. A STERIZONE® CI+ Chemical Indicator is also added, external to the syringe, to allow differentiating processed from unprocessed test packs. All components of the Test Pack are single-use, disposable items.

The provided text describes the performance testing of the STERIZONE® VP4 Test Pack (subject device) which uses the Terragene Bionova® BT96 biological indicator, compared to a predicate device that used a different biological indicator. The goal was to demonstrate substantial equivalence.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

The document does not explicitly state the numerical sample size for the test set (e.g., number of test packs, number of sterilization cycles). It mentions "all the limit parameter loads tested" for half-cycle survivability and "partial cycles" for increased resistance, implying multiple runs, but no specific number.

The data provenance is from bench testing ("Performance Testing - Bench") conducted by TSO3 Inc. (now part of Stryker) for this 510(k) submission. The location of the testing is not specified, but the submitter is TSO3 Inc. in Québec, Canada and Stryker in Portage, Michigan, USA. The nature of the study is prospective, as it's performance testing for a new device qualification.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. For biological indicators, the ground truth is typically established by the growth or non-growth of spores, which is a direct biological outcome, not subject to expert interpretation in the same way as, for example, a medical imaging diagnosis.

4. Adjudication method for the test set:

This information is not applicable and therefore not provided. The results of biological indicator testing (growth or no growth) are objective and do not require adjudication by multiple experts.

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:

This information is not applicable as the device is a sterilization process indicator, not an AI-powered diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not applicable. The device is not an algorithm, but a physical biological indicator used in a sterilization process. Its performance is inherent to its design and biological response, not an algorithm's output.

7. The type of ground truth used:

The ground truth used is biological growth/non-growth of Geobacillus stearothermophilus spores. This is a direct measure of the effectiveness of the sterilization process in inactivating microorganisms.

8. The sample size for the training set:

This information is not applicable. The STERIZONE® VP4 Test Pack is a physical device, not a machine learning model, so there is no training set in the context of AI/ML. The device's resistance characteristics are determined through experimental validation, not by "training" an algorithm.

9. How the ground truth for the training set was established:

This information is not applicable as there is no training set. The performance is assessed against established standards for biological indicators.

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The EOGas 4 Endo-SteriTest Rapid Readout Biological Indicator consists of a self-contained biological indicator inoculated with viable Bacillus atrophaeus bacterial spores that is placed in a dedicated biological indicator receptacle mounted on the purge probe in the sterilizer. It monitors the efficacy of the 6-hour gas exposure at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer.

The EOGas 4 Endo-SteriTest Rapid Readout Biological Indicator (RRBI) consists of a single-use self-contained biological indicator (SCBI) placed in a reusable biological indicator (BI) receptacle. It is designed for monitoring the efficacy of the 6-hour gas exposure at 50°C in an EOCas 4 Ethylene Oxide Gas Sterilizer.

The Bionova BT110 Rapid Readout Biological Indicator (K191021) consists of a plastic vial that serves as the culture tube and a cap including a filter material port to allow ethylene oxide to enter the vial. The plastic vial contains Bacillus atrophaeus spores inoculated onto a paper carrier, and a glass ampoule containing culture medium and a pH indicator. There is a chemical indicator printed on the unit label of the SCBI to indicate EO exposure by changing color from brown/red to green.

Following manufacturer's instructions, the operator inserts the Bionova BT110 Rapid Readout Biological Indicator into the reusable BI receptacle on the dedicated purge probe of the EOGas 4 Ethylene Oxide Gas Sterilizer, and initiates a 6-hour gas exposure at 50°C. After cycle completion, the SCBI is retrieved and activated by crushing the glass ampoule. The chemical indicator on the SCBI changes from brown/red to a green color after ethylene oxide exposure.

The activated SCBI and an unprocessed control are incubated in a Terragene Bionova IC10/20FR, IC10/20FRLCD or MiniBio Auto-Reader Incubator for 4 hours to detect fluorescent activity or 48 hours to detect color change. Evidence of microbial growth by presence of fluorescent activity or color change from blue to yellow must be interpreted as a failure to meet the conditions necessary for sterilization (cycle failed); no fluorescence or no color change indicates conditions for sterilization were achieved (cycle passed).

The provided document describes the EOGas 4 Endo-SteriTest RRBI, a rapid readout biological indicator for monitoring ethylene oxide sterilization cycles. The submission seeks to demonstrate substantial equivalence to a predicate device.

Here's a breakdown of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Notes on Acceptance Criteria:

• The document explicitly lists "Functionality" and "Shelf Life" tests with their acceptance criteria and "Pass" results.
• For the individual studies performed for the Bionova BT110 Rapid Readout Biological Indicators (which is a component of the EOGas 4 Endo-SteriTest RRBI), the document states that "The results of all studies met the established acceptance criteria," without enumerating the specific criteria for each.

2. Sample Sizes Used for the Test Set and Data Provenance

The document does not provide specific sample sizes (e.g., number of BIs or sterilization cycles) for the "test set" studies. It mentions that "The EOGas 4 Endo-SteriTest RRBI has been validated using applicable tests in FDA 2007 'Guidance for Industry and FDA Staff: Biological Indicator (BI) Premarket Notification [510(k)] Submissions', and ANSI/AAMI/ISO 11138-1:2017 'Sterilization of health care products -Biological indicators - Part 1: General requirements'." These standards typically define the requirements for testing, including sample sizes, but the specific numbers used in this submission are not stated.

Data provenance is not explicitly mentioned but is assumed to be prospective bench testing conducted by the manufacturer as part of the validation process for regulatory submission. There is no mention of country of origin for data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This device is a biological indicator designed to directly measure sterilization efficacy, not to be interpreted by human experts like medical images. The "ground truth" for a biological indicator is the direct observation of microbial growth (or lack thereof) after exposure to a sterilization process, relative to positive and negative controls.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the device's output (microbial growth/no growth, or fluorescent activity/no fluorescent activity) is a direct, objective measurement, not subject to subjective interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This is not an AI-assisted diagnostic or imaging interpretation device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an AI algorithm. The device itself (the biological indicator) is a standalone measurement tool.

7. The Type of Ground Truth Used

The ground truth used for biological indicators is the viability of the Bacillus atrophaeus bacterial spores.

• Failed Sterilization: Indicated by observable fluorescent activity or a color change from blue to yellow in the culture medium, signifying spore survival and growth.
• Successful Sterilization: Indicated by no fluorescence and no color change, signifying spore inactivation.
• Positive controls (unprocessed BIs) are expected to show growth, and negative controls (processed BIs from a successful cycle) are expected to show no growth, confirming the validity of the test.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

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The EOGas 4 Ethylene Oxide Gas Sterilize is designed to sterilize reusable medical devices that are sensitive to moisture, heat, chemical corrosion, or radiation. The critical process parameters for the two available cycles are summarized below:

Table 1. EOGas 4 Ethylene Oxide Sterilizer cycle parameters

The differences between the two options are the length of EO gas exposure and the length of mandatory ventilation after gas exposure; the gas exposure is chosen based on the devices to be sterilized. The appropriate purge probe and process challenge device (PCD) must be used: EOGas 4 SteriTest for a 3-hour gas exposure, EOGas 4 Endo-SteriTest for a 6-hour gas exposure.

The EOGas 4 Ethylene Oxide Gas Sterilizer 3-hour gas exposure is used for surface sterilization of medical devices, including instruments with diffusion-restricted spaces (hinges or mated surfaces), as well as for the sterilization of endoscopes with working length shorter than 1100 mm as specified in the labeling. The EOGas 4 SteriTest PCD is used with the 3-hour gas exposure.

The EOGas 4 Ethylene Oxide Gas Sterilizer 6-hour gas exposure is used for sterilization of duodenoscopes and colonoscopes with working length longer than 1100 mm as specified in the labeling. The EOGas 4 Endo-SteriTest PCD is used with the 6-hour gas exposure.

The EOGas 4 Ethylene Oxide Gas Sterilizer, model AN4000.60 (115V) or AN4000.61 (230V), is intended to sterilize moisture, temperature, chemical corrosion, or radiation-sensitive reusable medical devices in healthcare facilities. The sterilant is a unit dose of 100% ethylene oxide contained in a cartridge, and the sterilization chamber is a gas-impervious flexible sterilization bag.

Here's a summary of the acceptance criteria and study information for the EOGas 4 Ethylene Oxide Gas Sterilizer, based on the provided document:

Acceptance Criteria and Device Performance

Study Information:

1. Sample sizes used for the test set and data provenance:

   • Minimum Sterilization Parameters: Performed to define and validate the endoscope loads. The results indicate successful inactivation of 6-Log BIs for "two duodenoscopes, two colonoscopes, or one colonoscope and one duodenoscope in each load." The exact number of each type of load tested isn't specified, but implies multiple runs for different combinations.
   • Half Dose Validation: "Consecutive half dose cycles and full dose cycles were performed." No specific number of cycles or endoscopes is provided.
   • Simulated-Use Testing: "Inactivated biological indicators were obtained in all cycles for all duodenoscope and colonoscope loads tested." Again, the exact number of cycles or endoscopes is not specified.
   • In-Use Testing: "Duodenoscopes and colonoscopes, used on patients... processed using the 6-hour EO exposure." No specific number of patient-used scopes is provided.
   • EO Residuals: Tested on "Olympus TJF-Q180V, TJF-Q160VF, TJF-Q190V, PJF-160, CF-Q180AL, Pentax ED34-i10T2, ED-3490TK duodenoscopes and EC-3490Li colonoscopes" and "Fujifilm ED-530XT and EC-600HL." This indicates testing on a variety of endoscope models.
   • Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the context of a 510(k) submission for a medical device cleared in the U.S., the testing would typically be conducted to U.S. regulatory standards. "In-Use Testing" mentions "used in routine endoscopic procedures in a hospital or clinic setting," suggesting prospective collection of real-world use data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This document describes performance testing of a sterilizer, where the "ground truth" is defined by the inactivation of biological indicators and the adherence to specified chemical and physical parameters. These are objective measures and do not typically involve human "experts" establishing a subjective ground truth, as would be the case for image interpretation or diagnosis. Therefore, no information on experts for ground truth is applicable or provided.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable. As noted above, the ground truth is based on objective laboratory measurements (biological indicator cultures, chemical concentrations, temperature, humidity, and residual levels), not a subjective human assessment requiring adjudication.

4. 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 document pertains to the validation of an ethylene oxide gas sterilizer, not an AI-powered diagnostic or interpretive device. Therefore, no MRMC study or AI assistance evaluation was performed.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This device is a sterilizer, not an algorithm. Its performance is evaluated through its physical and biological sterilization capabilities.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The ground truth for the sterilization efficacy tests is primarily established by:
     • Biological Inactivation: The complete inactivation of 6-Log Bacillus atrophaeus biological indicators, confirmed by culture methods.
     • Physical Parameters: Measurement of critical process parameters (EO concentration, temperature, relative humidity, time) meeting defined specifications.
     • Chemical Residuals: Measurement of ethylene oxide residuals meeting ANSI/AAMI/ISO 10993-7 requirements.
     • Sterility Testing: For in-use testing, sterility was confirmed by a flush method per USP, indicating no microbial growth.

7. The sample size for the training set:

   • Not applicable. This device is a physical sterilizer and does not involve AI or machine learning models that require a training set.

8. How the ground truth for the training set was established:

   • Not applicable, as no training set is used for this type of device validation.

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