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510(k) Data Aggregation
(155 days)
SGM BIOTECH, INC.
Smart-Read EZTest – Steam self-contained biological indicators (SCBI) are for monitoring the efficacy of saturated steam sterilization processes. Performance characteristics are established in accordance with USP 31 for the pre-vacuum 121°C steam process. Additional pre-vacuum saturated steam sterilization temperatures are also included in the Certificate of Analysis. Smart-Read EZTest – steam SCBIs are also appropriate for use in saturated steam processes of 132°C, 134°C and 135°C.
The biological indicator consists of a self-contained unit which includes: bacterial spores inoculated onto a paper carrier, a small glass ampoule containing sterile culture medium and color indicator, and a plastic vial that serves as the culture tube. This unit complies to the performance characteristics described in USP 31 and ANSI/AAMI/ISO 11138-1.
Acceptance Criteria and Device Performance Study for Smart-Read™ EZTest® - Steam Biological Indicator
This report describes the acceptance criteria and the study that proves the Smart-Read™ EZTest® - Steam biological indicator meets those criteria for reduced incubation time.
1. Table of Acceptance Criteria and Reported Device Performance
The core acceptance criterion for the reduced incubation time (RIT) study is that 97% of growth results observed at 7 days should be available at the RIT of 10 hours for the biological indicator (BI) that have been exposed to a partial sterilization cycle.
| Acceptance Criterion | Reported Device Performance (Growth at 10 hours vs. Growth at 7 days) |
|---|---|
| Reduced incubation time (10 hours) results must show a minimum of 97% concordance with the results obtained after a 7-day incubation period for BIs exposed to partial sterilization cycles. This is based on sets of 100 BIs exposed to a steam process that reduced the spore population to approximately 1 spore per BI, where 30-80 units demonstrated growth (indicating a partial kill). | Partial Cycle #1: 97.7% at 10 hours, 100% at 7 days (43/44 at 10h vs. 44/44 at 7d) |
| Partial Cycle #2: 97.8% at 10 hours, 100% at 7 days (44/45 at 10h vs. 45/45 at 7d) | |
| Partial Cycle #3: 97.3% at 10 hours, 100% at 7 days (71/73 at 10h vs. 73/73 at 7d) | |
| Partial Cycle #4: 97.5% at 10 hours, 100% at 7 days (78/80 at 10h vs. 80/80 at 7d) | |
| Partial Cycle #5: 100% at 10 hours, 100% at 7 days (52/52 at 10h vs. 52/52 at 7d) | |
| Partial Cycle #6: 100% at 10 hours, 100% at 7 days (23/23 at 10h vs. 53/53 at 7d when looking at the last full growth %) | |
| Partial Cycle #7: 100% at 10 hours, 100% at 7 days (73/73 at 10h vs. 73/73 at 7d) | |
| Partial Cycle #8: 100% at 10 hours, 100% at 7 days (48/48 at 10h vs. 48/48 at 7d) | |
| Partial Cycle #9: 97.8% at 10 hours, 100% at 7 days (45/46 at 10h vs. 46/46 at 7d) | |
| Partial Cycle #10: 98.3% at 10 hours, 100% at 7 days (59/60 at 10h vs. 60/60 at 7d) | |
| Partial Cycle #11: 98.4% at 10 hours, 100% at 7 days (60/61 at 10h vs. 61/61 at 7d) | |
| Partial Cycle #12: 97.5% at 10 hours, 100% at 7 days (78/80 at 10h vs. 80/80 at 7d) |
Overall, all partial cycles meet or exceed the 97% concordance requirement at 10 hours compared to 7 days, demonstrating the device's ability to achieve reduced incubation time. |
2. Sample Size Used for the Test Set and Data Provenance
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Sample Size for Test Set: The study involved multiple partial sterilization cycles, each using a varying number of biological indicators (BIs).
- Partial Cycle #1: 44 BIs
- Partial Cycle #2: 45 BIs
- Partial Cycle #3: 73 BIs
- Partial Cycle #4: 80 BIs
- Partial Cycle #5: 52 BIs
- Partial Cycle #6: 53 BIs
- Partial Cycle #7: 73 BIs
- Partial Cycle #8: 48 BIs
- Partial Cycle #9: 46 BIs
- Partial Cycle #10: 60 BIs
- Partial Cycle #11: 61 BIs
- Partial Cycle #12: 80 BIs
The total number of BIs tested across all partial cycles is 715.
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Data Provenance: The document does not explicitly state the country of origin but implies laboratory testing conducted by SGM Biotech, Inc., located in Bozeman, MT, USA. The study design is prospective as it involves controlled exposure of BIs to partial sterilization cycles. The report indicates that the test was performed with "four different spore crops and multiple lots of product from each crop", suggesting multiple batches of the device were evaluated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The ground truth for this device is established through microbiological growth assessment. This does not typically involve interpretation by human "experts" in the same way clinical imaging studies do. The assessment of growth (yellow color change) or no growth (clear and purple) is an objective, binary outcome. Therefore, there were no "experts" with specific qualifications like radiologists establishing the ground truth in this context. The results are based on direct observation of the color change in the culture medium, which is an intrinsic characteristic of the biological indicator's function.
4. Adjudication Method for the Test Set
Adjudication methods like 2+1 or 3+1 are typically used for subjective clinical interpretations. For the Smart-Read EZTest, the outcome (growth or no growth as indicated by color change) is a direct, objective result. There is no indication of an adjudication method being used because the results are determined by the biological reaction rather than human interpretation requiring consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, and the AI's role is to assist in that interpretation. The Smart-Read EZTest is a biological indicator designed for a direct chemical and biological reaction, not requiring human interpretation beyond observing a color change. Therefore, assessing how human readers improve with AI assistance is not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone study was performed. The data presented demonstrates the performance of the biological indicator itself in detecting sterilization failure (survival of spores). The "device performance" refers to the BI's ability to accurately show growth within the reduced incubation time, independent of any human intervention beyond activating and incubating the device and observing the final color change.
7. Type of Ground Truth Used
The ground truth used is a biological outcome (microbial growth of Geobacillus stearothermophilus spores) directly observed through a color change in the culture medium. For the purpose of establishing reduced incubation time, the 7-day incubation period serves as the gold standard ground truth, against which the 10-hour incubation results are compared. The 7-day result is considered the definitive indicator of spore survival or death.
8. Sample Size for the Training Set
The document does not explicitly state a separate "training set" for the reduced incubation time study. The study describes the methodology for establishing the reduced incubation time, which implies a development and testing process (i.e., the presented data acts as the validation that the 10-hour time is effective). The "test was performed with four different spore crops and multiple lots of product from each crop," suggesting robust testing across various manufacturing iterations and spore batches.
9. How the Ground Truth for the Training Set Was Established
As noted above, a distinct "training set" in the context of an AI/algorithm is not directly applicable here. However, the process for establishing the ground truth (7-day incubation) for the development and validation of the 10-hour reduced incubation time is as follows:
The ground truth for spore survival or death (growth or no growth) is established by incubation for 7 days at 60 ± 2°C. This extended incubation period ensures the maximum opportunity for any surviving spores to proliferate and cause a color change. This 7-day incubation serves as the reference standard against which the performance of the shorter (10-hour) incubation time is evaluated. The principle is that if spores survive, they will show growth within 7 days. The study then aimed to demonstrate that the same growth would be observable reliably at 10 hours.
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(198 days)
SGM BIOTECH, INC.
The Smart-Well incubator is intended for use with the Smart-Read EZTest selfcontained biological indicators (SCBI). The Smart-Read EZTest - steam SCBI is used for monitoring the efficacy of gravity or pre-vac saturated steam sterilization processes. This SCBI contains 105 spores of Geobacillus stearothermophilus derived from ATCC #7953. Performance characteristics were established in accordance with USP 32 and ISO 11138-1 for the 121°C steam process. Additional saturated steam sterilization conditions are also tested and appear on the Certificate of Analysis for Smart-Read EZTest - steam. These include 132°C, 134℃, and 135℃.
The Smart-Well microbiological incubator is specifically designed for the incubation of the SGM Smart-Read® EZTest steam self-contained biological indicator (SCBI). The Smart-Read EZTest biological indicator contains 10° spores of Geobacillus stearothermophilus derived from ATCC 7953 inoculated onto a paper carrier. The culture medium is a modified soybean casein digest broth containing bromcreso! purple and meets growth promotion requirements when inoculated with 100 spores or less (K930683 and K963841). This single temperature incubator uses a heated aluminum block to maintain the desired temperature of 60 + 2℃. The incubator has a specifically designed cavity in which to insert and activate the non-activated Smart-Read EZTest unit. The Smart-Read EZTest unit is inserted into this cavity and pulled forward to crush the glass media ampoule and activate the unit. This activated Smart-Read EZTest is removed from this cavity and placed into one of the eleven test cavities. Ten cavities are intended for use with exposed test units and one cavity is intended for use with a positive control. The unit is held in the test cavity for the desired duration of the incubation.
The incubator has telltale LED status lights in front of each test cavity. When a Smart-Read EZTest SCBI is placed into the test cavity, the LED is activated and illuminates amber. The LCD screen will display the particular cavity's test status. This message includes specific cavity number, test status and number of whole hours incubated.
The heated aluminum block provides the temperature desired to allow any surviving spores in the Smart-Read EZTest SCBI to germinate and grow. If viable spores are present in the Smart-Read EZTest SCBI, they will germinate and grow. When growth occurs the cells metabolize sugars and shift the pH of the culture medium to an acid pH. When the pH of the medium shifts to acid it will turn from its purple color to yellow. The monitoring of the color of the Smart-Read EZTest BI is accomplished by a very narrow band width LED. This light is absorbed by the purple color of the medium. However, when the media color shifts to yellow, light is transmitted through the sample and detected by a photo diode behind the sample. When a yellow color is present the photo diode is energized. These results are the same as those visually detected by the human eye under conventional incubation conditions. When the electronics in the cavity detect a yellow color (growth), the status LED will shift from amber to red. The LCD screen will indicate the cavity number, positive test status and the whole number of hours incubated when the test status changed.
If there are no viable spores in the Smart-Read EZTest BI, the incubation will be completed with no change in color status. The Smart-Read EZTest has been tested in accordance with the FDA CDRH protocol for reduced incubation time and meets a 10 hour incubation claim. Upon expiration of the setected incubation time and no cover change was detected (negative); the status LED in front of the cavity will shift from amber to green (no change in purple color). The LCD screen will indicate the cavity number, negative test status and the whole number of hours incubated which is the user selected incubation time duration.
When the test status LED changes from amber to either red or green, an audible prompt is communicated to the user to remove the Smart-Read EZTest SCBI from the cavity and visually observe its color either purple or yellow. The incubator is not making any decisions as to the acceptability of the test results; it is simply prompting the user to visually observe the samples and make appropriate decisions. The conditions detected by the incubator are 100% verifiable by the user. The results that the Smart-Well incubator vields can be achieved in any microbiological incubator that provides the same environment for the growth of viable spores required by the Smart-Read EZTest SCBI.
The Smart-Well incubator also has the provision to add a printer to document the testing events. The printer will document the change in status of the incubated Smart-Read EZTest unit. Information captured by the printer includes the incubator cell number, incubation start time and date, time of status change condition (positive or negative). The printer has the capability to print user pre-selected descriptions, as a convenience and if desired by the user, which include descriptions of the exposure conditions to which the Smart-Read EZTest SCBI was exposed. These options include the following: a) cycle temperature, b) cycle type (pre-vac/gravity), c) cycle exposure time, d) BI lot number, e) sterilizer number, f) user identification. If none of the above information is selected, the printer will leave blanks or print "?" mark to indicate that no information was selected.
The information that is sent to the printer can also be forwarded to a PC or data acquisition network.
The incubator functions exactly as described above if no printer is attached or no connection is made to a PC or data acquisition network.
The presented document is a 510(k) summary for the SGM Biotech Smart-Read EZTest SCBI (steam) and Smart-Well Incubator. This device is an accessory to Biological Sterilization Process Indicators. The document primarily focuses on the device's intended use, description, and substantial equivalence to a predicate device, rather than providing a detailed study report with specific acceptance criteria and performance metrics in the format requested.
Therefore, many of the requested sections (1-9) cannot be fully populated with specific data from the provided text. The information below extracts what can be inferred or directly stated from the document, and notes where specific details are missing.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) summary primarily focused on substantial equivalence and device description, explicit "acceptance criteria" for performance metrics like sensitivity and specificity are not provided in the document. The performance described is qualitative, referring to detection of color change.
| Acceptance Criteria (Inferred from intended use) | Reported Device Performance (Inferred from description) |
|---|---|
| Maintain temperature of 60 ± 2°C conducive to Geobacillus stearothermophilus spore growth. | "This single temperature incubator uses a heated aluminum block to maintain the desired temperature of 60 + 2°C." Also, "Smart-Well incubator maintains temperature of 60 + 2° C which is conducive to growth of Geobacillus stearothermophilus spores." |
| Prompt user visually and electronically when color change (purple to yellow) occurs, indicating spore growth. | "Each incubation cavity is provided with an electronic sensor that alerts the user and conveniently documents when this color change occurs. The user then verifies the visual color change." "When the electronics in the cavity detect a yellow color (growth), the status LED will shift from amber to red." |
| Prompt user when no color change occurs after incubation (negative result). | "Upon expiration of the setected incubation time and no cover change was detected (negative); the status LED in front of the cavity will shift from amber to green (no change in purple color)." |
| Provide accurate electronic detection of color change that is 100% verifiable by the user. | "The results that the Smart-Well incubator vields can be achieved in any microbiological incubator that provides the same environment for the growth of viable spores required by the Smart-Read EZTest SCBI." "The conditions detected by the incubator are 100% verifiable by the user." |
| Support a 10-hour reduced incubation time claim. | "The Smart-Read EZTest has been tested in accordance with the FDA CDRH protocol for reduced incubation time and meets a 10 hour incubation claim." |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample size used for a test set (e.g., number of SCBIs tested) or the data provenance (e.g., country of origin, retrospective/prospective) for the Smart-Well incubator's performance. It refers to the Smart-Read EZTest SCBI's testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The ground truth for biological indicators in this context is based on the visible color change of the media, which is a direct outcome of spore viability and metabolism. The incubator's function is to detect and report this change, not to interpret an image or complex medical data requiring expert consensus. The user is prompted to visually verify the change.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the "ground truth" is a direct chemical reaction (pH change indicated by color), not a subjective assessment requiring adjudication. The device's electronic detection is presented as 100% verifiable by the user's visual observation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
Not applicable. This device is an incubator for biological indicators, not an AI system assisting human readers in diagnostic tasks. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant or described.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device itself is essentially a "standalone" system that electronically detects the color change of the biological indicator and reports it. However, the document emphasizes the user's visual verification: "The incubator is not making any decisions as to the acceptability of the test results; it is simply prompting the user to visually observe the samples and make appropriate decisions. The conditions detected by the incubator are 100% verifiable by the user."
The statement "The Smart-Read EZTest has been tested in accordance with the FDA CDRH protocol for reduced incubation time and meets a 10 hour incubation claim" suggests a standalone performance evaluation of the SCBI (which the incubator is designed for), but not a specific "algorithm-only" study for the incubator's electronic detection performance separate from human verification.
7. The Type of Ground Truth Used
The ground truth used for determining positive or negative results of the biological indicator is based on visual color change of the culture medium (purple to yellow) due to a shift in pH caused by the metabolism of viable Geobacillus stearothermophilus spores. This is a direct biological and chemical outcome.
8. The Sample Size for the Training Set
The document does not provide a sample size for a "training set." This device is not described as utilizing a machine learning algorithm that requires a training set in the conventional sense. Its detection mechanism is based on optical sensors and pre-defined color spectrum changes.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as a training set for a machine learning algorithm is not indicated. The "ground truth" for the device's function (detecting color change) is based on the established scientific principle of the biological indicator's colorimetric response to spore growth.
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(153 days)
SGM BIOTECH, INC.
EZTest® - Steam self contained biological indicators are for monitoring the efficacy of saturated steam sterilization processors. Performance characteristics are established in accordance with USP XXIII for the 121 C steam process. Additional saturated steam sterilization conditions are also included in the Certificate of Performance. EZTest® - Steam Bls are also appropriate for use in the high temperature saturated steam processes of 132 C , 134 C and 135 C.
The biological indicator consists of a self-contained unit which includes: bacterial spores inoculated onto a paper carrier, a small glass ampule containing sterile culture medium and color indicator, and a plastic vial that serves as the culture tube. This unit complies to the performance characteristics described in the USP XXIII.
Here's a breakdown of the acceptance criteria and study information for the EZTest® - Steam biological indicator, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (USP XXIII) | Reported Device Performance (as listed in 510(k) summary) |
|---|---|---|
| Spore Population | 0.5 x 10^5 to 5.0 x 10^5 spores for a 10^5 BI | "between 0.5 x 10^5 and 5 x 10^5" (Matches USP guideline) |
| D-value at 121°C | Not explicitly stated in the summary, but implied by USP XXIII. | "D values at 121°C...", evaluated for at least three (3) spore lots using different spore crops and different media lots. (Specific values not provided) |
| Survival/Kill Time | Not explicitly stated in the summary, but implied by USP XXIII. | "Survival/Kill times at 121°C...", evaluated for at least three (3) spore lots using different spore crops and different media lots. (Specific values not provided) |
| D-value at 132°C | Not explicitly stated in the summary, but implied by USP XXIII. | "D values at 132°C...", evaluated for at least three (3) spore lots using different spore crops and different media lots. (Specific values not provided) |
| Survival/Kill Time | Not explicitly stated in the summary, but implied by USP XXIII. | "Survival/Kill times at 132°C...", evaluated for at least three (3) spore lots using different spore crops and different media lots. (Specific values not provided) |
| D-value at 134°C | Not explicitly stated in the summary, but implied by USP XXIII. | "D values at 134°C...", evaluated for at least three (3) spore lots using different spore crops and different media lots. (Specific values not provided) |
| Survival/Kill Time | Not explicitly stated in the summary, but implied by USP XXIII. | "Survival/Kill times at 134°C...", evaluated for at least three (3) spore lots using different spore crops and different media lots. (Specific values not provided) |
| D-value at 135°C | Not explicitly stated in the summary, but implied by USP XXIII. | "D values at 135°C...", evaluated for at least three (3) spore lots using different spore crops and different media lots. (Specific values not provided) |
| Survival/Kill Time | Not explicitly stated in the summary, but implied by USP XXIII. | "Survival/Kill times at 135°C...", evaluated for at least three (3) spore lots using different spore crops and different media lots. (Specific values not provided) |
| Z-value | Not explicitly stated in the summary, but implied by USP XXIII. | "Z values", evaluated for at least three (3) spore lots using different spore crops and different media lots. (Specific values not provided) |
| Spore Species | Bacillus stearothermophilus, ATCC 7953 or equivalent. | Bacillus stearothermophilus, ATCC 7953 or equivalent. (Meets criteria) |
| Sample Purity | Not explicitly stated as an acceptance criterion. | Evaluated as part of performance. (Details not provided) |
| Incubation Readout Time | Implied by CDRH guideline (48 hours). | Validation of 48 hours incubation read out time following the CDRH guideline. (Meets guideline) |
| Shelf Life Stability | Not explicitly stated as an acceptance criterion. | Stability of the product over the eighteen (18) month shelf life claim. (Reported as evaluated) |
| Post-Exposure Recovery | Not explicitly stated as an acceptance criterion. | Evaluation of the effect of holding time after exposure to sterilant until incubation, upon recovery of injured spores. (Reported as evaluated) |
| pH Indicator Effect | Not explicitly stated as an acceptance criterion. | Evaluation of the effect of the pH indicator upon the recovery of injured spores. (Reported as evaluated) |
| Media Support Growth | Not explicitly stated as an acceptance criterion. | Validation of the effect of the sterilization process on the ability of the media to support the growth of injured spores. (Reported as evaluated) |
Note: The summary states that "A significant portion of the quality assurance specification is testing to the performance characteristics of biological indicators as outlined in USP XXIII." and that "Such compliance is required on each lot prior to release." This implies that the specific numeric acceptance criteria for D-values, survival/kill times, and Z-values, although not explicitly listed in the 510(k) summary, are derived from USP XXIII and are met by the device. The summary provides a list of evaluated characteristics rather than specific quantitative performance values.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The summary states that "Claims were evaluated using at least three (3) spore lots using different spore crops and different media lots." This indicates a minimum of three distinct lots were used for testing resistance characteristics. The exact number of individual biological indicators tested within each lot is not specified.
- Data Provenance: The data is generated internally by SGM Biotech, Inc., as part of their "in-process quality control system" and "quality assurance specification." The summary does not provide information on the country of origin of the data or whether it was retrospective or prospective, but it implies a prospective testing approach as part of a release process for each lot.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this device. The ground truth for a biological indicator is inherent to its design and function: the presence or absence of viable spores after a sterilization cycle. The "ground truth" is established by direct microbiological methods (observing growth/color change), not by expert interpretation.
4. Adjudication Method for the Test Set
This is not applicable as the output of a biological indicator (color change, turbidity) is a direct, objective observation of microbial growth or lack thereof, rather than something requiring expert 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
This is not applicable. This device is a biological indicator, not an AI-based diagnostic tool. It does not involve human readers interpreting data or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
This is not applicable. This device is a biological indicator for monitoring sterilization, not an algorithm. Its "standalone" performance is its ability to accurately reflect sterilization efficacy based on spore survival.
7. The Type of Ground Truth Used
The ground truth used is based on microbiological growth/viability, specifically the survival and subsequent growth of Bacillus stearothermophilus spores. The change in the pH indicator (bromcresol purple changing from purple to yellow) is a direct, observable proxy for this microbiological activity. This is akin to a pathology/microbiology outcome.
8. The Sample Size for the Training Set
This is not applicable. As a biological indicator, the device does not employ a training set in the typical machine learning sense. Its performance is based on the inherent biological resistance of the spores and the chemical properties of the culture medium.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reasons as point 8. The "ground truth" for its operation is the established science of microbial heat resistance and culture medium efficacy, which is a foundational scientific principle rather than a dataset requiring ground truth establishment.
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