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Found 359 results
510(k) Data Aggregation
(273 days)
K251347**
Trade/Device Name: Sterilization Pouch/Roll
Regulation Number: 21 CFR 880.6850, 21 CFR 880.2800
Sterilization wrap; 2) Sterilization Process Indicator
Regulation Number: 1) 21 CFR 880.6850; 2)21 CFR 880.2800
| Classification | Class II | Class II | Class II | Same |
| Regulation | 21 CFR 880.685021 CFR 880.2800
| 21 CFR 880.685021 CFR 880.2800 | 21 CFR 880.6850 | Same |
| Product code | FRG; JOJ | FRG; JOJ
The Sterilization Pouch/Roll is intended to provide health care workers with an effective method to enclose devices intended for sterilization in the Steam or via Ethylene Oxide (EO). The recommended sterilization cycles are as follows:
- Steam Sterilization at 132°C (270°F) for 4 minutes; Drying time of 20 minutes.
- Ethylene Oxide (EO) with a concentration of 695 mg/L at 50°C (122°F) and 30% to 90% relative humidity for 4 hour. Aeration time of 7 days at room temperature.
The Sterilization Pouch/Roll is made with medical grade paper and medical compound film. The Sterilization Pouch/Roll maintains the sterility of the enclosed devices for up to 6 months post Steam or EO gas sterilization, and before sterilization has a maximum shelf life of 3 years from the date of manufacture.
The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EO sterilization process. Sterilization indicator will change color according to the sterilization method (ethylene oxide, steam). Ethylene oxide sterilization indicator color change from Pink before sterilization to Yellow after sterilization. The steam sterilization indicator color change from Blue before sterilization to Black after sterilization.
The Sterilization Pouch/Roll is composed of medical grade paper(60g/m2) and medical compound film(50μm), it is intended to be used to contain medical devices to be terminally sterilized by the EtO or Steam sterilization process.
The recommended sterilization cycle parameter is:
Steam: 4 minutes at 132°C(270°F); 20 minutes dry time.
Ethylene oxide: 4 hours at 50 °C(122°F); relative humidity between 30%- 90%; ethylene oxide concentration is 695 mg/L, 7 days aeration time at room temperature.
The medical devices are inserted into the Pouch/ Roll, sealed, and then sterilized for the EtO or Steam Sterilization Process. The pouch is self-sealed prior to sterilization processing. The roll is heat-sealed by a plastic sealing machine. After completion of the sterilization process, the Pouch/Roll maintain sterility of the enclosed medical devices until the seal is opened.
The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 6 months post sterilization.
The Pouch/Roll is printed with a chemical indicator bar that changes from Pink to yellow (EtO) or Blue to Black (Steam) when exposed to EtO gas or Steam vapor during process. The EtO and Steam Chemical Indicator offers an addition way to verity processing in the sterilization cycle. The Chemical Indicator should be used in addition to, not in place of, the biological indicator. The EtO and Steam Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to the EtO or Steam.
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(179 days)
Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213)
Regulation Number: 21 CFR 880.2800
Classification Name: Sterilization process indicator
Classification Regulation: 21 CFR 880.2800
| 21 CFR 880.2800 | Identical |
| Model# | 4012,4013,4014,4016 | 1322 | / |
| Indications for Use |
| 21 CFR 880.2800 | Identical |
The SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicators
| 21 CFR 880.2800 | Identical |
The SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicators
The SafeSecure Steam Sterilization Process Indicators are chemical process indicators intended for use by healthcare professionals to accompany individual units (e.g., wrapped packs) and to demonstrate that the unit has been exposed to a steam sterilization process.
The indicator changes color to signal exposure to sterilization conditions.
The indicators are validated for use in the following saturated steam sterilization cycles:
| Sterilization Type | Temperature | Time |
|---|---|---|
| Gravity | 250 °F/121°C | 30 minutes |
| Gravity | 270 °F/132°C | 3, 4, 10, 15, 25 minutes |
| Gravity | 275 °F/135°C | 3, 10 minutes |
| Dynamic air-removal | 250 °F/121°C | 15, 20, 30 minutes |
| Dynamic air-removal | 270 °F/132°C | 3, 3.5, 4, 5.5, 6, 9, 10, 15 minutes |
| Dynamic air-removal | 273 °F/134°C | 3, 3.5, 4 minutes |
| Dynamic air-removal | 275 °F/135°C | 4, 10 minutes |
The product includes both label and tape indicator. The labels can be printed or written on prior to application. The tapes are designed to adhere to common sterilization wraps, including untreated woven, non-woven, paper, and paper/plastic wraps.
The SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicators are chemical process indicators intended to accompany individual packages and visually confirm that the pack has been exposed to a validated Vaporized Hydrogen Peroxide sterilization cycle.
The indicator changes color to signal exposure to sterilization conditions.
The indicators are validated for use in the following Vaporized Hydrogen Peroxide sterilization systems:
- Standard Cycle of STERRAD® 100S
- Standard cycle and Advanced cycle of STERRAD® NX
- Standard cycle, Flex cycle and Express cycle of STERRAD® 100NX
- Non Lumen Cycle, Lumen Cycle and Flexible Cycle of V-PRO® maX
The product includes both label and card indicator. The labels can be printed or written on prior to application. The card is designed to be placed inside the sterilization package, next to the items being sterilized.
SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016)
The SafeSecure Steam Sterilization Process Indicators are Type 1 chemical process indicators compliant with ISO 11140-1:2014, designed for use in steam sterilization processes. These are external, single-use indicators intended to verify exposure to the sterilization cycle and distinguish between processed and unprocessed packs.
The product is available in two formats:
-
Label-type indicators (4013, 4014): consisting of coated paper or synthetic paper backing, pressure-sensitive adhesive, chemical indicator, and a glassine release liner for easy application. 4013 allows for handwritten labeling, while 4014 features a pre-printed label format.
-
Tape-type indicators (4012, 4016): composed of masking tape backing, pressure-sensitive adhesive, and a chemical indicator.
The adhesive is formulated for strong adhesion to untreated woven, non-woven, paper, and paper/plastic sterilization wraps, and allows clean removal after steam exposure.
Upon exposure to steam sterilization conditions, the indicator exhibits an irreversible color change:
- From off-white/yellow to dark brown/black (for 4012, 4013, and 4014)
- From green to gray/black (for 4016)
SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator(4211, 4212, 4213)
The SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicators are Type 1 chemical process indicators, compliant with ISO 11140-1:2014, designed for monitoring exposure to vaporized hydrogen peroxide sterilization cycles.
The product is available in two formats:
-
Card-type indicator (4211): intended to be placed inside the sterilization package, adjacent to the medical device. It consists of a printed indicator on a plastic substrate, membrane layer, and chemical indicator agent.
-
Label-type indicators (4212, 4213): intended to be affixed on the outside of the packaging. Each consists of a self-adhesive polypropylene (PP) base, glassine release liner, and an indicator agent.
The Vaporized Hydrogen Peroxide indicator undergoes a distinct, irreversible color change from red to light orange/yellow upon exposure to sterilization conditions, allowing visual confirmation of processing.
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(240 days)
.** | 21 CFR 880.685021 CFR 880.2800 | 21 CFR 880.685021 CFR 880.2800 | Same |
| Class |
The Self-Seal Sterilization Pouch and Roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the Steam or via Ethylene Oxide (EO). The recommended sterilization cycles are as follows:
• Steam Sterilization at 132°C (270°F) for 4 minutes; Drying time of 20 minutes.
• Ethylene Oxide (EO) with a concentration of 695 mg/L at 50°C (122°F) and 30% to 90% relative humidity for 4 hour. Aeration time of 7 days at room temperature.
The Self-Seal Sterilization Pouch and Roll are made with medical grade paper and medical compound film. The Self Sealing Sterilization Pouch and Roll maintains the sterility of the enclosed devices for up to 6 months post Steam or EO gas sterilization, and before sterilization has a maximum shelf life of 3 years from the date of manufacture.
The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EO sterilization process. Sterilization indicator will change color according to the sterilization method (ethylene oxide, steam). Ethylene oxide sterilization indicator color changes from red before sterilization to brown after sterilization. The steam sterilization indicator color changes from blue before sterilization to greenish black after sterilization.
The Self-Seal Sterilization Pouch and Roll is composed of medical grade paper (60g/m²) and PET/CPP medical compound film (52 μm), it is intended to be used to contain medical devices to be terminally sterilized by the EtO or Steam sterilization process.
The recommended sterilization cycle parameter is:
- Steam Sterilization at 132°C (270°F) for 4 minutes; Drying time of 20 minutes.
- Ethylene Oxide (EO) with a concentration of 695 mg/L at 50°C (122°F) and 30% to 90% relative humidity for 4 hour. Aeration time of 7 days at room temperature.
The medical devices are inserted into the Pouch/Roll, sealed, and then sterilized for the EtO or Steam Sterilization Process. The pouch is self-sealed prior to sterilization processing. The roll is not self-sealed; use a plastic sealing machine to seal it, and the temperature of the plastic sealing machine needs to reach 205°C, After completion of the sterilization process, the Pouch/Roll maintain sterility of the enclosed medical devices until the seal is opened.
The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 6 months post sterilization.
The Pouch/Roll is printed with a chemical indicator bar that changes from blue to greenish black (Steam) or red to brown (EtO) when exposed to EtO gas or Steam vapor during process. The EtO and Steam Chemical Indicator offers an addition way to verity processing in the sterilization cycle. The Chemical Indicator should be used in addition to, not in place of, the biological indicator. The EtO and Steam Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to the EtO or Steam.
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(270 days)
Sterilization pouch
Product Code: FRG, JOJ
Classification: Class II (21 C.F.R. 880.6850, 21 C.F.R. 880.2800
Chex-All® Sterilization Pouches and Tubes are intended to be used to enclose another medical device, in a single or double pouch configuration, that is to be sterilized by a health care provider using:
Hospital size sterilizer cycles
- Gravity steam at 121°C (250°F) for 30 minutes; 25 minutes dry time
- Pre-vacuum steam at 132°C (270°F) for 4 minutes; 20 minutes dry time
- Pre-vacuum steam at 135°C (275°F) for 3 minutes; 16 minutes dry time
Tabletop sterilizer cycles:
- Pre-vacuum steam at 132°C (270°F) for 4 minutes; 30 minutes dry time
Ethylene Oxide sterilization cycles:
- Ethylene Oxide (EO) with a concentration of 736 mg/L at 55°C (131°F) and 50% to 60% relative humidity for 60 minutes. Aeration time of 8 hours at 60°C (140°F).
Chex-All sterilization pouches and tubes can be used for steam sterilization of devices with lumens at maximum load as the following:
Metal lumen: 7 inch long, 3.2mm internal diameter
Plastic lumen: 5 inch long, 2.0 mm internal diameter.
Suitable Lumen cycles:
Hospital size sterilizers: pre-vacuum cycles with 132°C-4.0 min exposure (20 minutes dry time) and 135°C-3.0 min exposure (16 minutes dry time).
Table-top sterilizers: pre-vacuum cycle with 132°C-4.0 min exposure (30 minutes dry time).
Chex-All sterilization pouches and tubes can be used for steam sterilization in double pouch configuration, in gravity 250°F-30 min exposure cycles (25 minutes dry time) and in pre-vacuum 270°F-4 min exposure cycles (20 minutes dry time).
The Process chemical indicators on the Chex-All sterilization pouches and tubes are intended to demonstrate that the device has been exposed to the steam or EO sterilization process and to distinguish between processed and unprocessed pouches. The chemical indicators change from crème to gray/black after exposure to steam and from beige-pink to green after exposure to ethylene oxide.
If stored according to the recommended conditions, the products before sterilization have a maximum shelf life of 2 years from the date of manufacture. The pouches are intended to allow sterilization of the enclosed medical device(s) and to maintain sterility (SAL≥10-6). The subject device is intended and has been validated to maintain sterility of the enclosed devices for 30 months after steam sterilization and 12 months after EO sterilization.
The maximum pouch load is 2.65 lb. (1.2 kg) or less. The maximum pouch load for table-top sterilizers is 1.10 lb. (0.5 kg) or less. The maximum pouch size for use in table-top sterilizers is 13"x18".
The Chex-All® Sterilization pouches and tubes are made from a medical grade porous paper thermally sealed to a plastic film on the left, right, and bottom of the pouch. The top side is open to insert medical devices to be sterilized and to seal the pouch. They are available either pre-manufactured self-seal or heat-seal sizes or in a roll of heat-seal tubing for the customer to cut the pouches to their required size.
The pouches also contain chemical process indicators used to demonstrate that the pouches have been a subject of either a steam or ethylene oxide sterilization process.
All Chex-All sterilization pouches and tubes are flat and include the following products: Chex-All Heat-seal sterilization pouch, flat; Chex-All Heat-seal sterilization tube, flat, sold in rolls; Chex-All II Self-seal sterilization pouch, flat; Chex-All III Self-seal sterilization pouch, flat.
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(30 days)
K252680**
Trade/Device Name: Celerity™ 20 HP Biological Indicator
Regulation Number: 21 CFR 880.2800
Classification:** Class II
Classification Name: Indicator, Biological Sterilization Process [21 CFR 880.2800
effective, and performs as well as the legally marketed predicate device (K231490), Class II (21 CFR 880.2800
The Celerity™ 20 HP Biological Indicator (BI) is intended for routine monitoring of the following sterilizer cycles:
- Lumen, Non Lumen, Fast Non Lumen, Fast, Flexible and Specialty Cycles of the V-PRO 1, 1 Plus, maX, maX 2, 60 and s2 Low Temperature Sterilization Systems.
- STERRAD® 100S Sterilizer (Default Cycle)
- Standard and Advanced Cycles of the STERRAD® NX® Sterilizer with or without ALLClear
- Standard, FLEX, Express and DUO Cycles of the STERRAD® 100NX® Sterilizer with or without ALLClear® Technology
When used in conjunction with the Celerity™ HP Incubator or the Celerity™ Incubator, the Celerity™ 20 HP BI provides a fluorescent result within 20 minutes.
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, STERIS Celerity™ 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.
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(115 days)
Trade/Device Name:* Terragene® Bionova® BT20 Biological Indicator
Regulation Number: 21 CFR 880.2800
Classification Name:** Indicator, Biological Sterilization Process
Device Classification: Class II, 21 CFR 880.2800
Biological Indicator | Terragene® Bionova® SCBI BT220 |
| Product Code | FRC | Same |
| Regulation | 880.2800
marketed predicate device, the Terragene® Bionova® BT220 SCBI cleared per K163646, Class II (21 CFR 880.2800
Terragene® Bionova® BT20 Biological Indicator is a Self-Contained Biological Indicator (SCBI) intended for routine monitoring of the efficacy of the following steam sterilization processes:
• Gravity-displacement Steam Sterilization Cycles
- 121 °C, 30 minutes
- 132 °C, 25 minutes
- 132 °C, 15 minutes
- 132 °C, 10 minutes
- 134/135 °C, 10 minutes
• Vacuum-assisted Steam Sterilization Cycles
- 121 °C, 20 minutes
- 132 °C, 4 minutes
- 134/135 °C, 3 minutes
Terragene® Bionova® BT20 provides a final result after a 24 hour incubation at 60 ± 2 °C.
Terragene® Bionova® BT20 Biological Indicators are single-use Self-Contained Biological Indicators (SCBIs) that consist of a polypropylene tube, a filter paper spore carrier inoculated with a minimum of 10⁶ viable Geobacillus stearothermophilus ATCC® 7953 spores and a glass ampoule containing purple culture medium, enclosed with a plastic colored cap and a barrier permeable to steam. The culture medium contains a pH indicator that changes color upon acidification by the metabolism of living spores. On each BT20 Biological Indicator there is a propylene label printed with a chemical process indicator that changes from pink to brown when exposed to steam.
Final results: 24-hour readout after incubation at 60 °C. If the sterilization process was successful, culture medium will remain purple. If sterilization was not successful, culture medium will turn to yellow during incubation, thus indicating the presence of live G. stearothermophilus spores.
This document describes the acceptance criteria and the study proving the Terragene® Bionova® BT20 Biological Indicator meets these criteria.
It's important to note that this device is a Biological Indicator for sterilization, not an Artificial Intelligence (AI) or medical imaging device. Therefore, some of the requested information (like multi-reader multi-case studies, ground truth establishment for AI training, etc.) is not applicable. The information provided focuses on the rigorous testing required for biological indicators to demonstrate their efficacy in monitoring sterilization processes.
1. A table of acceptance criteria and the reported device performance
The following table summarizes the acceptance criteria and the "Results" कॉलम में "Passed" यह बताता है कि डिवाइस ने उन सभी मापदंडों को सफलतापूर्वक पूरा किया है।
| Test Performed | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Viable Spore Population Assay | Demonstrate that the product meets specifications for spore population. | - 50 to 300% of manufacturer's nominal population (ISO 11138-1:2017).- ≥ 10⁵ CFU/BI unit (FDA Guidance, ISO 11138-3:2017). | Passed |
| Resistance Characteristics Study | Evaluate the resistance characteristics (D-value, Z-value, Survival Time, Kill Time). | - D-value₁₂₁°C: ≥ 1.5 minutes- D-value₁₃₂°C: ≥ 10 seconds- D-value₁₃₅°C: ≥ 8 seconds- Z-value: ≥ 10°C- Minimum Expected Survival Time₁₂₁°C: ≥ 5 minutes- Minimum Expected Survival Time₁₃₂°C: ≥ 1 minute- Minimum Expected Survival Time₁₃₄/₁₃₅°C: ≥ 40 seconds- No negative results at Minimum Expected Survival Time.- No positive results at Maximum Expected Kill Time. | Passed |
| Recovery Protocols: Recovery Medium Test | Test suitability of the culture medium. | - All inoculated samples show positive result (color change to yellow) after 7-day incubation at 60°C.- Negative controls (uninoculated) show negative result (medium remains purple) after 7-day incubation at 60°C. | Passed |
| Carrier and Primary Packaging Materials Evaluation | Evaluate effect of materials on spore viability and suitability. | - No "no growth" in exposed carrier samples.- No "no growth" in unexposed carrier samples.<br;- No "no growth" in exposed primary packaging samples.- No "no growth" in unexposed primary packaging samples.- Valid growth medium controls. | Passed |
| Reduced Incubation Time (RIT) Test | Validate the 24-hour Reduced Incubation Time. | 24-hour RIT sensitivity ≥ 97% for each partial sterilization cycle for all three batches. | Passed |
| Holding Time Assessment | Validate maximum 7-day holding time between exposure and incubation. | - D-value within ± 20% following holding time.- All inoculated samples positive after 7 days incubation at 60°C.- Negative controls negative under same conditions. | Passed |
| Shelf Life Study (Biological Indicator) | Demonstrate stability of specifications throughout labeled shelf life. | - Spore population: 50% to 300% of initial nominal value.- D-Value: within ± 20% of initial value.- Product performance: Negative result for successful sterilization (purple), Positive result for unsuccessful/control (yellow) after 24-hour incubation at 60°C. | Passed |
| Performance Study for Bionova® BT20 Biological Indicator | Verify performance in claimed cycles. | The Biological Indicator should perform as intended in claimed cycles. | Passed |
| Pass/Fail Criteria for Chemical Indicator Label | Validate performance of chemical process indicator. | - Pass conditions: CI turns brown.- Fail conditions: CI does not reach endpoint.- Dry heat: No color change or significantly different from endpoint. | Passed |
| Endpoint Stability for Chemical Indicator Label | Demonstrate stability of endpoint reaction for CI. | Stability of endpoint reaction demonstrated at end of shelf life and for at least 6 months. | Passed |
| Shelf Life Study for Chemical Indicator Label | Provide real-time data for CI endpoint response. | Stability of endpoint reaction demonstrated throughout shelf life when stored under labeled conditions. | Passed |
| Biocompatibility for Chemical Indicator Label | Demonstrate CI label does not offset or transfer. | CI should not release any substance or bleed when in contact with substrate and subject to sterilization. | Passed |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the specific numerical sample sizes for each test in terms of "number of devices tested." However, it consistently refers to testing "three batches analyzed" for critical tests like Viable Spore Population Assay and Reduced Incubation Time (RIT) Test. This suggests a minimum sample size of three batches of the biological indicators for key performance evaluations.
- Data Provenance: The studies were non-clinical performance tests conducted by the manufacturer, Terragene S.A., based in Alvear, Santa Fe, Argentina. The studies are by nature prospective, as they involve manufacturing the device and then subjecting it to controlled tests to demonstrate performance against established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the device is a biological indicator for sterilization monitoring, not an AI or medical imaging device that relies on expert human interpretation for ground truth. The "ground truth" for a biological indicator is defined by the objective outcome of sterilization cycles (e.g., whether spores are killed or grow) and the established scientific standards for spore population, resistance, and growth media. These are measured objectively in a laboratory setting.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or AI evaluations where human experts are making subjective assessments that need to be reconciled. For a biological indicator, the results are objective (e.g., color change, spore growth/no growth, D-value calculation) based on laboratory protocols defined by ISO standards and FDA guidance.
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. This is a biological indicator designed to monitor sterilization, not an AI-assisted diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical biological indicator, not an algorithm. Its performance is evaluated in a standalone manner as a biological entity in controlled sterilization and incubation environments, without human intervention during the "reading" phase (i.e., the color change is observed visually or automatically after incubation, it's not a human performing a complex interpretation). The "algorithm" in this context is the biological response of the spores.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for a biological indicator is primarily established through:
- Microbiological Viability: The presence or absence of viable Geobacillus stearothermophilus spores after exposure to sterilization conditions, confirmed by observed growth or no growth in a suitable culture medium.
- Physical Parameters: Precisely controlled and measured physical parameters of the sterilization cycles (temperature, time, pressure) that are known to either kill or allow survival of the specific spore population.
- Referenced Standards: The "ground truth" is also defined by the detailed specifications and methodologies outlined in international standards such as ISO 11138-1:2017, ISO 11138-3:2017, and ISO 11138-8:2021, and FDA Guidance documents for biological indicators. These standards define the acceptable D-values, spore populations, survival times, and kill times under specified conditions.
Essentially, the ground truth is based on established scientific and microbiological principles and standardized test methodologies rather than subjective expert consensus or pathology.
8. The sample size for the training set
This information is not applicable as the device is a biological indicator and does not involve AI or machine learning that requires a "training set" of data.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as above.
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(269 days)
. | 21 CFR 880.6850, 21 CFR 880.2800 | 21 CFR 880.6850, 21 CFR 880.2800 | Same |
| Class | II | II |
The Sterilization Pouch and Roll are intended to provide health care workers with an effective method to enclose devices intended for steam sterilization. The recommended sterilization cycle is as follows:
• Pre-vacuum Steam: 4 minutes at 132°C (270°F); 30 minutes dry time.
The sterilization pouch and roll are made with medical grade paper and medical compound film. The sterilization pouch and roll maintain the sterility of the enclosed devices for up to 6 months post steam sterilization. The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone a steam sterilization process. The steam sterilization indicator color will change from blue before sterilization to dark grey after sterilization.
The subject Sterilization Pouch and Roll device has five types:
(1) Self-sealing sterilization pouches:
These pouches are made from a medical grade plastic film that is heat sealed on three sides. The fourth side has an adhesive strip that is used to seal the pouch. Release paper used in the pouch is a laminated sheet with composing structure of PE/paper/PE. It is a strip to cover the adhesive area and is released before seal the pouch. The medical grade paper conforms to recognized material standards and can be sterilized by steam. The Process Indicators Ink printed on the medical grade paper will exhibit a color change after the pouch is exposed to steam.
(2) Sterilization pouches, Flat:
These pouches have the same components with the Self-sealing sterilization pouches, except the fourth side is left opened instead of an adhesive strip and will be heat-sealed when using.
(3) Sterilization pouches, Gusseted:
These pouches are the same with the Sterilization pouches, flat, except that the plastic film is folded on both longest sides instead of flat. This design is convenient to enclose the medical devices with certain height.
(4) Sterilization rolls, Flat:
These rolls are made from a medical grade paper and plastic film that are heat sealed on opposite two sides. It will be cut into the suitable length and the opened sides will be heat-sealed. The indicators printed on the medical grade paper are the same with the self-sealing sterilization pouches.
(5) Sterilization rolls, Gusseted:
These rolls are the same with the flat sterilization roll, except that the plastic film is folded on both longest sides instead of flat. This design is convenient to enclose the medical devices with certain height.
The Sterilization pouch and roll is composed of medical grade paper (60g/m2) and medical compound film (52μm), it is intended to be used to contain medical devices to be terminally sterilized by the Steam sterilization process. The recommended sterilization cycle parameters are:
Pre-vacuum Steam: 4 minutes at 132°C (270°F); 30 minutes dry time.
The medical devices are inserted into the Pouch/Roll, sealed, and then sterilized for the Steam Sterilization Process. The heat-sealed pouch/roll are heat sealed prior to sterilization processing. After completion of the sterilization process, the Pouch/Roll maintain sterility of the enclosed medical devices until the seal is opened.
The device is intended to allow sterilization of enclosed devices and to maintain sterility of the enclosed devices until used up to 6 months post sterilization. The shelf life of the device is 3 months.
The Pouch/Roll is printed with a chemical indicator bar that changes from Blue to Dark grey when exposed to steam during the sterilization process. The steam chemical Indicator offers an addition way to verity processing in the sterilization cycle. The endpoint stability of the chemical indicator color change to dark grey is 3 months. The chemical Indicator should be used in addition to, not in place of, the biological indicator. The steam chemical indicator does not signify sterilization; it only indicates that the indicator has been exposed to steam.
The provided FDA 510(k) clearance letter and summary describe a Sterilization Pouch and Roll device, which is a Class II medical device. This is NOT an AI/ML device. Therefore, the questions related to AI/ML device performance metrics, such as effect size of human readers improving with AI, standalone algorithm performance, number of experts for ground truth, and training set information, are not applicable.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Acceptance Criteria (Endpoint) | Reported Device Performance (Results) |
|---|---|---|
| Sterilant Penetration/Drying Time | - Meets the requirement of SAL 10-6- The weight difference before sterilization and after drying shall not exceed 3% | Pass |
| Biocompatibility - Cytotoxicity | Non-cytotoxic | Under conditions of the study, did not show potential toxicity to L-929 cells. Pass |
| Biocompatibility - Irritation | Non-irritating | Under the conditions of the study, not an irritant. Pass |
| Biocompatibility - Sensitization | Non-sensitizing | Under conditions of the study, not a sensitizer. Pass |
| Package Appearance | The appearance of the sterilization pouch is clean, intact, and sealed on all four sides. | Pass |
| Thickness | 52 ± 12% μm | Pass |
| Tensile Strength of Paper | MD ≥ 4.4 KN/mCD ≥ 2.2 KN/m | Pass |
| Bursting Test | Burst value > 3 Kpa or No Burst | Pass |
| Dye Penetration Test | The dye solution is no any leakage across the seal width of sterile barrier system. (No Infiltration) | Pass |
| Seal Strength Test | ≥ 2.5 N/15mm | Pass |
| Vacuum Leakage Test | No water can penetrate the sterilization pouch. | Pass |
| Microbial Barrier | 0 CFU No growth | Pass |
| Chemical Indicator Functionality | Color of indicator changes from blue to dark grey after Steam sterilization | Pass |
| Chemical Indicator Shelf Life & Endpoint Stability | Shelf life: 3 monthsEndpoint stability: 3 months | Pass |
| Shelf Life (Product) | Shelf life: 3 months | Pass |
| Maintenance of Sterility | Maintains sterility of enclosed devices for up to 6 months post steam sterilization. (This is an indication from the "Indications for Use" and is generally supported by the package integrity and microbial barrier tests over time, often through accelerated aging studies). | The document states "The device is intended to allow sterilization of enclosed devices and to maintain sterility of the enclosed devices until used up to 6 months post sterilization." The "Maintenance of Sterility" is listed as a "Different" characteristic compared to the predicate (6 months vs. 3 years for EO and 6 months for Steam). The microbial barrier test is passed, supporting the general concept of sterility maintenance, but the specific validation for the 6-month claim is not detailed in the summary table. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document details various performance tests such as sterilant penetration, biocompatibility, package integrity, and chemical indicator testing. However, it does not explicitly state the sample sizes used for each of these test sets. The tests are "bench testing" (non-clinical) and do not involve human subjects.
The data provenance is from non-clinical bench testing. The tests were performed to evaluate the performance and functionality of the device against a requirement specification. There is no mention of country of origin for the data or whether it was retrospective or prospective, as these terms are typically relevant for clinical studies or data collection in human populations.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This device is a physical sterilization pouch and roll, and its performance is evaluated through standardized laboratory and bench testing against established physical, chemical, and biological criteria, not by human expert interpretation of data or images. Ground truth is established by objective measurements and standardized test methods.
4. Adjudication Method for the Test Set
Not applicable. As described above, the evaluation relies on objective measurements and established standards rather than expert interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI/ML devices where human performance with and without AI assistance is being compared. This document is for a physical sterilization product.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
Not applicable. This device is a physical product, not an algorithm or software. Therefore, there is no "standalone" algorithm performance to evaluate.
7. The Type of Ground Truth Used
The ground truth for this device's testing is based on:
- Standardized Test Methodologies and Acceptance Criteria: As outlined in the "Test Methodology" and "Acceptance Criteria or End Point" columns in Table 3 of the 510(k) summary. These include standards like ISO 17665-1, ISO 10993 series, ASTM F1886, ASTM F2251, ISO 1924-2, ASTM F1140, ASTM F1929, ASTM F88, ASTM D3078, DIN 58953-6, ISO 11140-1, and ASTM F1980.
- Physical and Chemical Measurement: For properties like thickness, tensile strength, burst strength, seal strength, and the color change of the chemical indicator.
- Microbiological Evaluation: For the microbial barrier test (e.g., 0 CFU No growth).
- Biocompatibility Testing: Evaluating potential toxicity, irritation, and sensitization in laboratory settings (e.g., L-929 cells).
- Sterilization Effectiveness: Meeting a specified Sterility Assurance Level (SAL 10-6).
8. The Sample Size for the Training Set
Not applicable. There is no AI/ML component described for this device, so there is no training set in the context of machine learning.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set.
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(28 days)
Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)
Regulation Number: 21 CFR 880.2800
Classification:** Class II
Classification Name: Indicator, Biological Sterilization Process [21 CFR 880.2800
Classification:** Class II
Classification Name: Indicator, Biological Sterilization Process [21 CFR 880.2800
effective, and performs as well as the legally marketed predicate device (K250044), Class II (21 CFR 880.2800
effective, and performs as well as the legally marketed predicate device (K250044), Class II (21 CFR 880.2800
Celerity 5 HP Biological Indicator:
The Celerity 5 HP Biological Indicator (BI) is intended for routine monitoring of the following sterilizer cycles:
- Lumen, Non Lumen, Fast Non Lumen, Fast, Flexible and Specialty Cycles of the V-PRO 1, 1 Plus, maX, maX 2, 60 and s2 Low Temperature Sterilization Systems
- Standard and Advanced Cycles of the STERRAD® NX® Sterilizer with or without ALLClear®
- Standard, FLEX, Express and DUO Cycles of the STERRAD® 100NX® Sterilizer with or without ALLClear®.
When used in conjunction with the Celerity® Incubator, the Incubator provides a fluorescent result within 5 minutes.
Celerity 5 HP Challenge Pack:
The Celerity 5 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 V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing of the Sterilizers.
Celerity 20 HP Biological Indicator
The Celerity 20 HP Biological Indicator (BI) is intended for routine monitoring of the following sterilizer cycles:
- Lumen, Non-Lumen, Fast Non Lumen, Fast, Flexible and Specialty Cycles of the V-PRO 1, 1 Plus, maX, maX 2, 60 and s2 Low Temperature Sterilization Systems.
- Standard and Advanced Cycles of the STERRAD® NX® Sterilizer with or without ALLClear
- Standard, FLEX, 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.
Celerity 20 HP Challenge Pack
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 V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing of the Sterilizers.
Celerity 5 HP BI
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, STERIS Celerity Incubator, within 5 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.
Celerity 5 HP Challenge Pack
The Celerity 5 HP Challenge Pack is used in the sterile processing department, usually by service technicians or biomedical technicians to qualify the unit following installation, relocation, malfunctions or major repairs and for routine requalification testing. It consists of a Celerity 5 HP Biological Indicator, a Celerity HP Chemical Indicator, and a layer of absorptive foam within a Tyvek pouch.
The intended change to the devices is to update the secondary container and product labeling. Specifically, the clear cellophane wrapper around the product carton will be replaced by a clear, laminated pouch. Labeling on the carton and the Instructions for Use (IFU) will be updated to specify that the product must remain stored in its original laminated pouch to maintain the claimed shelf-life. Additionally, a storage disclaimer label will be added to the exterior of the pouch to notify users of this change. Finally, this submission is intended to establish a 3-month in-use shelf-life following pouch opening, not to exceed the original expiration date.
Celerity 20 HP BI
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, STERIS Celerity 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.
Celerity 20 HP Challenge Pack
The Celerity 20 HP Challenge Pack is used in the sterile processing department, usually by service technicians or biomedical technicians to qualify the unit following installation, relocation, malfunctions or major repairs and for routine requalification testing. It consists of a Celerity 5 HP Biological Indicator, a Celerity HP Chemical Indicator, and a layer of absorptive foam within a Tyvek pouch.
The intended change to these devices is to update the secondary container and product labeling. Specifically, the clear cellophane wrapper around the product carton will be replaced by a clear, laminated pouch. Labeling on the carton and the Instructions for Use (IFU) will be updated to specify that the product must remain stored in its original laminated pouch to maintain the claimed shelf-life. Additionally, a storage disclaimer label will be added to the exterior of the pouch to notify users of this change. Finally, this submission is intended to establish a 3-month in-use shelf-life following pouch opening, not to exceed the original expiration date.
The provided text describes premarket notification for biological indicators and doesn't involve an AI/ML powered medical device. Therefore, many of the requested criteria, such as "multi-reader multi-case (MRMC) comparative effectiveness study" or "number of experts used to establish ground truth", which are specific to AI/ML powered devices, are not applicable here.
However, I can extract information related to the acceptance criteria and the study proving the device meets those criteria, as much as applicable for a non-AI medical device.
Device: Celerity 5 HP Biological Indicator (LCB052) & Challenge Pack (LCB059), and Celerity 20 HP Biological Indicator (LCB044) & Challenge Pack (LCB045)
Type of Device: Sterilization Process Indicator (Biological Indicator - BI). These devices contain a specific type of spore (Geobacillus stearothermophilus) and media to confirm the effectiveness of a sterilization process. A positive result (fluorescent signal) indicates sterilization failure, while a negative result indicates successful sterilization.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria and results are provided for two distinct product lines: Celerity 5 HP and Celerity 20 HP. Note that the "Result" for all tests is simply "PASS", indicating that the criteria were met.
For Celerity 5 HP Biological Indicator and Challenge Pack:
| Test | Acceptance Criteria | Result |
|---|---|---|
| Reduced Incubation Time Testing | All BI lots will demonstrate 97% or greater positive growth results at 7 days as compared to the fluorescent result at less than or equal to 5-minutes | PASS |
| Simulated Use Testing | All processed BIs shall be sterile following full cycle exposure sterilizer cycles. | PASS |
| Cap Media Testing | All BIs will demonstrate a positive fluorescent signal in the fluorescent incubators. | PASS |
| Stability Testing: Population | The mean initial population at the start of the stability study must be 1.0-4.0 x 10⁶ CFU/BI. At each subsequent time point, the mean population shall be 50-300% of the initial mean population. | PASS |
| Stability Testing: D-value | D-value between 6 and 20 seconds. | PASS |
| Stability Testing: Survival/Kill | Demonstration of one all survive time and one all kill time point. | PASS |
| Stability Testing: RIT | All BI lots will demonstrate 97% or greater positive growth results at 7 days as compared to the fluorescent result at less than or equal to 5 minutes. | PASS |
| Stability Testing: Media Testing | All BIs will demonstrate a positive fluorescent signal in the fluorescent incubators. | PASS |
For Celerity 20 HP Biological Indicator and Challenge Pack:
| Test | Acceptance Criteria | Result |
|---|---|---|
| Reduced Incubation Time Testing | All BI lots will demonstrate 97% or greater positive growth results at 7 days as compared to the fluorescent result at less than or equal to 20 minutes | PASS |
| Simulated Use Testing | All processed BIs shall be sterile following full cycle exposure sterilizer cycles. | PASS |
| Cap Media Testing | All BIs will demonstrate a positive fluorescent signal in the fluorescent incubators. | PASS |
| Stability Testing: Population | The mean initial population at the start of the stability study must be 1.0-4.0 x 10⁶ CFU/BI. At each subsequent time point, the mean population shall be 50-300% of the initial mean population. | PASS |
| Stability Testing: D-value | D-value between 6 and 20 seconds. | PASS |
| Stability Testing: Survival/Kill | Demonstration of one all survive time and one all kill time point. | PASS |
| Stability Testing: RIT | All BI lots will demonstrate 97% or greater positive growth results at 7 days as compared to the fluorescent result at less than or equal to 20 minutes. | PASS |
| Stability Testing: Media Testing | All BIs will demonstrate a positive fluorescent signal in the fluorescent incubators. | PASS |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample size (e.g., number of BIs or challenge packs) used for each specific test (Reduced Incubation Time, Simulated Use, Cap Media, Stability testing). It refers to "All BI lots" for Reduced Incubation Time and "All processed BIs" for Simulated Use, and implicitly "BIs" for Stability Testing. This suggests a statistically relevant number of units from manufactured lots were tested.
- Data Provenance: The document does not specify the country of origin of the data. Given the "U.S. Food & Drug Administration" letterhead and the manufacturer's address in Ohio, USA, it is highly likely that the testing was conducted in the US.
- Retrospective or Prospective: The testing appears to be prospective as it's a pre-market submission to demonstrate the device meets performance criteria for clearance. Stability testing also inherently involves prospective observation over time.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This concept is not applicable to this type of device. The "ground truth" for a biological indicator is determined by the biological and chemical reactions themselves (i.e., presence or absence of viable spores, or a color change in the chemical indicator), not by human expert interpretation of images or data. The determination of "sterile" or "non-sterile" from a biological indicator is a direct, objective measurement.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the results of biological indicators are typically objective and determined by the physical/chemical properties and reactions, not by subjective human interpretation requiring adjudication.
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 not an AI/ML device nor one that involves human "readers" interpreting medical images or data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical, biological and chemical indicator device, not a software algorithm. The "Celerity Incubator" is an accessory that reads the fluorescent signal, it is not an AI algorithm.
7. The Type of Ground Truth Used
The ground truth for these devices is based on biological viability (presence or absence of viable Geobacillus stearothermophilus spores) for the biological indicator and chemical reaction (color change) for the chemical indicator, validated against recognized sterilization parameters (e.g., D-value, Survival Time, Kill Time). This is a direct measure of the effectiveness of the sterilization process.
8. The Sample Size for the Training Set
Not applicable. These are not AI/ML devices that require training sets. The "training" of these devices (i.e., their manufacturing and design) is based on established microbiological and sterilization science.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" in the context of an AI/ML algorithm. The performance of these biological indicators relies on their inherent design and manufacturing quality, ensuring the spores exhibit the specified resistance characteristics and the media accurately detects their viability. This is established through rigorous quality control and adherence to relevant standards for biological indicators.
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(61 days)
Indiana 46514
Re: K251035
Trade/Device Name: DISINTEK™ PA Test Strips
Regulation Number: 21 CFR 880.2800
Product Code: JOJ
Class: II
Regulation Number: 21CFR 880.2800
Predicate Device: MEDIVATORS
RAPICIDE™ PA Minimum Required Concentration (MRC) Test Strips, REF ML02-0118, K152394, Class II (21CFR 880.2800
The Serim™ DISINTEK™ PA Test Strip is a chemical indicator for use in determining whether the concentration of peracetic acid, the active ingredient in the high-level disinfectant RAPICIDE™ PA HLD solution, is above the 850 ppm PAA minimum recommended concentration (MRC) established for RAPICIDE™ PA HLD at both 30°C and 20°C.
The device is a qualitative, single use, reagent chemical indicator made up of a 0.2-inch x 0.2-inch indicator pad that has been chemically treated to detect peracetic acid above or below the Minimum Recommended Concentration established for RAPICIDE™ PA High-Level Disinfectant. The indicator pad is affixed to one end of a 3.25-inch by 0.2-inch white plastic handle.
Here's an analysis of the acceptance criteria and study information based on the provided FDA 510(k) Clearance Letter for DISINTEK™ PA Test Strips:
Acceptance Criteria and Device Performance for DISINTEK™ PA Test Strips
1. Table of Acceptance Criteria and Reported Device Performance
| Study Parameter | Acceptance Criteria (Implicit from "Met Acceptance Criteria") | Reported Device Performance |
|---|---|---|
| Dynamic Range | Negative response at concentrations at or below MRC (850 ppm PAA), positive responses at higher concentrations. | 100% FAIL results at and below the 850 ppm PAA (MRC) and PASS results above the MRC at both 30°C and 20°C. |
| Instructions for Use Validation | Negative response at concentrations at or below MRC (850 ppm PAA), positive responses at higher concentrations, when used according to specified dip time (1-2 seconds) and sideblot time (25-30 seconds). | 100% FAIL results at and below the MRC and PASS results above the MRC with a 1-2 second dip time and a sideblot time at 25 seconds + 5 seconds for 30°C solutions and 30 seconds + 5 seconds for 20°C solutions. |
| Closed Bottle Shelf-Life Stability | Acceptable performance (100% FAIL at/below MRC, 100% PASS above MRC) for minimum claimed shelf-life (18 months) at specified storage conditions (≥ 10°C and up to 32°C). | Acceptable performance out to a minimum of 18 months shelf-life from ≥ 10°C storage up to 32°C, with 100% FAIL results at and below the MRC and PASS results above the MRC. (Data collection ongoing for extended shelf-life). |
| Open Bottle Use-Life Stability | Acceptable performance (100% FAIL at/below MRC, 100% PASS above MRC) for minimum claimed open bottle use-life (18 months) at specified storage conditions (constant high humidity, repeated openings). | Acceptable performance out to a minimum of 18 months open bottle use-life with 100% FAIL results at and below the MRC and PASS results above the MRC. (Data collection ongoing for extended open bottle use-life). |
| Comparative Sensitivity and Specificity | 100% comparative sensitivity and 100% comparative specificity against the predicate device. | Comparative sensitivity of 100% and comparative specificity of 100% was found for the DISINTEK PA test strips at both 30°C and 20°C. |
| Analytic Specificity – Bioburden | Acceptable performance (100% FAIL at/below MRC, 100% PASS above MRC) in the presence of bioburden (fetal bovine serum and hard water). | 100% FAIL results at and below the MRC and 100% PASS results above the MRC in the presence of fetal bovine serum and hard water. |
| Analytic Specificity – Other Disinfectants | Test strip yields PASS results when exposed to other peracetic acid disinfectants at their use concentrations. | Test strip yielded PASS results using these disinfectants. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific numerical sample sizes (e.g., number of test strips, unique disinfectant solutions tested, or replicates) used for each test set within the "Dynamic Range," "Instructions for Use Validation," "Closed Bottle Shelf-Life Stability," "Open Bottle Use-Life Stability," "Analytic Specificity – Bioburden," or "Analytic Specificity – Other Disinfectants" studies.
For Comparative Sensitivity and Specificity, the document also does not specify the numerical sample size.
Data Provenance: The studies were conducted by Serim Research Corporation themselves, implying the data is generated internally from their own testing facilities. The data appears to be prospective, as it describes the testing performed on the new DISINTEK™ PA Test Strips to demonstrate their performance against defined criteria. No information regarding country of origin of the data beyond "Serim Research Corporation" is provided, but as an FDA submission, the testing would likely adhere to US regulatory standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. For chemical indicators like this, "ground truth" typically refers to the analytically determined concentration of PAA in the test solutions. This would be established by validated chemical testing methods (e.g., titration or spectroscopy) rather than expert consensus on visual interpretation. The document implies that the "ground truth" for FAIL/PASS results is based on a known PAA concentration (below/at 850 ppm MRC as FAIL, above as PASS), which would be determined analytically.
4. Adjudication Method for the Test Set
The document describes chemical indicator functionality (color change) and the interpretation of those changes (PASS/FAIL based on visual comparison to color blocks or a "solid black color" for the predicate). There is no indication of an adjudication method involving multiple human readers for interpreting the results of the DISINTEK™ PA Test Strips. The expectation is that the visual interpretation by a single user, following the provided instructions and color chart, is sufficient.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is usually conducted for imaging diagnostics or devices where human interpretation directly impacts effectiveness and can be improved by AI assistance. This device is a chemical indicator with a direct visual interpretation, not a diagnostic imaging AI system.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
Yes, the studies described are essentially standalone in terms of the device's chemical performance. The studies evaluate the chemical indicator's ability to accurately reflect the PAA concentration, independent of human variability in reading.
However, the "Instructions for Use Validation" section does implicitly involve human interaction, as it validates the device when used as directed by a human with a specific dip and read time. The "performance" being measured (100% FAIL below MRC, 100% PASS above MRC) is the device's inherent chemical reaction, and the human's role is to correctly perform the test and interpret the color chart. So, while it's not an algorithm only in the AI sense, the core data is about the chemical functionality.
7. Type of Ground Truth Used
The ground truth used is based on analytically determined peracetic acid (PAA) concentrations in the RAPICIDE™ PA HLD solutions. Solutions were prepared with known concentrations below, at, and above the 850 ppm PAA Minimum Recommended Concentration (MRC). The "FAIL" result would be correlated with PAA concentrations ≤ 850 ppm, and the "PASS" result with PAA concentrations > 850 ppm.
8. Sample Size for the Training Set
This information is not applicable/not provided. The DISINTEK™ PA Test Strips are a chemical indicator, not an AI/machine learning device. Therefore, there is no "training set" in the context of an algorithm that learns from data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided for the reasons stated in point 8.
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(29 days)
Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118
Regulation Number: 21 CFR 880.2800
Chemical Indicator
Classification Name: Physical/Chemical sterilization process indicator 21 CFR 880.2800
safe, as effective and performs at least as well as the predicate device K152394, Class II (21 CFR 880.2800
The RAPICIDE™ PA Test Strips are chemical indicators used after the disinfection cycle to ensure that the RAPICIDE™ PA High-Level Disinfectant solution is met the minimum recommended concentration of 850ppm peracetic acid. The RAPICIDE PA Test Strips are designed for use by trained personnel who reprocess endoscopes and their accessories in facilities where endoscopies are performed.
Rapicide PA High-Level Disinfectant Test Strip has the ability to measure the disinfectant use solution concentration above 850 ppm Peracetic Acid (PAA). This is the minimum recommended concentration (MRC) of PAA for Rapicide PA high-level disinfectant. If the solution is at or below MRC, the test strip pad will indicate a failure by turning dark grey, blue grey, violet grey, light grey, or white (no change in color). A passing result will be indicated by the test strip pad turning solid black after contact with solution at concentrations of 1100 ppm ± 20 ppm PAA.
The provided FDA 510(k) clearance letter pertains to a chemical indicator device, "Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118," not an AI/ML-enabled medical device. Therefore, the information regarding the acceptance criteria and study proving its performance is focused on the chemical and physical properties of the test strips, rather than AI model performance metrics like sensitivity, specificity, MRMC studies, or ground truth establishment relevant to AI/ML devices.
Based on the document, I can extract the following information relevant to the device's acceptance criteria and studies:
Device Description and Intended Use:
The Rapicide PA High-Level Disinfection Test Strips are chemical indicators used after the disinfection cycle to verify that the RAPICIDE™ PA High-Level Disinfectant solution has met the Minimum Recommended Concentration (MRC) of 850ppm peracetic acid. A "pass" is indicated by the test strip pad turning solid black when exposed to solutions at concentrations of 1100 ppm ± 20 ppm PAA. A "failure" (solution at or below MRC) is indicated if the pad turns dark grey, blue grey, violet grey, light grey, or white (no color change).
Here's the breakdown of the acceptance criteria and the studies that prove the device meets these criteria, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Minimum Recommended Concentration (MRC) Recognition | The device must reliably indicate that the RAPICIDE™ PA HLD solution has met the MRC of 850ppm peracetic acid. |
| "Pass" Endpoint Specification | The test strip pad must turn solid black when the solution is at concentrations above 850ppm and specifically at 1100 ppm ± 20 ppm PAA. |
| "Fail" Endpoint Specification | The test strip pad must indicate failure (e.g., turn dark grey, blue grey, violet grey, light grey, or white) when the solution is at or below the MRC of 850ppm PAA. |
| Dynamic Range | The device must perform within its specified detection range for peracetic acid concentration. |
| Comparative Sensitivity and Specificity | The device must demonstrate appropriate sensitivity and specificity in detecting the target peracetic acid concentration against a known standard. |
| Analytic Specificity – Contaminants | The device's performance should not be adversely affected by common contaminants that might be present in the use environment. |
| Analytic Specificity – Other Germicides | The device should not cross-react or provide false readings due to the presence of other germicides. |
| Shelf Life | The device must maintain its specified performance characteristics for the stated shelf life (18 Months). |
| In-Use (Open Bottle) Stability | The device must maintain its specified performance characteristics for the stated open bottle shelf life (4 months). |
Study Details (Based on available information from the 510(k) Summary)
The provided document is a 510(k) clearance letter and an abbreviated 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It does not contain the detailed study protocols, raw data, or comprehensive statistical analyses that would be found in a full study report or clinical trial documentation. Therefore, many of the requested details for AI/ML device studies (sample size, data provenance, expert adjudication, MRMC studies, training set details) are not applicable or not provided for this type of chemical indicator device.
Here's a breakdown of the requested information based on the provided text:
-
Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the provided document. The 510(k) summary states that "Testing to assess and demonstrate performance of the subject device is summarized below," listing categories like "Dynamic Range," "Comparative Sensitivity and Specificity," etc., and concluding they "Met Acceptance Criteria." However, the exact number of test strips or solution samples used for each test is not disclosed.
- Data Provenance: Not specified. It can be inferred that the testing was conducted internally by STERIS Corporation, likely in a laboratory setting, to evaluate the chemical performance of the test strips. Retrospective or prospective nature is not mentioned for this type of chemical performance testing.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable / Not Provided: For a chemical indicator device, "ground truth" is typically established by precisely formulated chemical solutions (e.g., 850ppm PAA, 1100ppm PAA ± 20ppm PAA) with known concentrations, verified by analytical chemistry methods, rather than by human expert consensus or annotations as would be the case for medical imaging AI. The document does not mention the use of human experts for establishing ground truth.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable / None: Adjudication methods like 2+1 or 3+1 are used to resolve discrepancies in human expert annotations for complex data (e.g., medical images). For a chemical indicator, the output (color change) is objective and directly correlated with the chemical concentration. The "reading" of the strip is a visual interpretation of a chemical reaction against a defined color standard (solid black for pass, various greys for fail). Discrepancies would likely be addressed through re-testing or instrument calibration, not expert adjudication.
-
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: MRMC studies are specific to evaluating the impact of AI assistance on human reader performance in tasks like image interpretation. This device is a chemical indicator test strip, not an AI-assisted diagnostic tool.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable: This device is a physical chemical strip, not a software algorithm. Its performance is inherent in its chemical design.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Known Chemical Concentrations: The ground truth for this device is established by precisely prepared chemical solutions with known, verified concentrations of peracetic acid (e.g., 850ppm MRC, 1100ppm pass threshold). This is a direct physical or chemical measurement, not dependent on expert consensus, pathology, or outcomes data.
-
The sample size for the training set:
- Not Applicable: This device is a chemical indicator, not an AI/machine learning model that requires a training set. The "design" is based on chemistry and materials science, not data-driven learning.
-
How the ground truth for the training set was established:
- Not Applicable: As there is no "training set" for a chemical indicator, this question is irrelevant. The "design" and "calibration" involve chemical engineering and materials science, where the components are selected and optimized to react predictably to specific chemical concentrations.
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