(178 days)
The NAMSA Biological Indicator Spore Strip (single species Geobacillus stearothermophilus ATCC® 7953, or dual species Geobacillus stearothermophilus ATCC® 7953 and Bacillus atrophaeus ATCC® 9372) · is intended for use in testing the efficacy of steam sterilization for single species and steam and ethylene oxide sterilization for dual species.
Performance characteristics are established in accordance with ANSI/AAMI/ISO 11138 and USP for 121°C steam gravity displacement for 30 minutes and ethylene oxide at 600 mg/L, 60% RH and 55°C for 2 hours, 10 minutes.
A reduced incubation time of 24 hours for steam sterilization has been validated when the Biological Indicator Spore Strips are used in conjunction with Tryptic Soy Broth (TSB) modified with Bromocresol Purple.
The NAMSA Biological Indicator Spore Strip consists of a 1.25" x 0.25" filter paper strip inoculated with either a single species (Geobacillus stearothermophilus ATCC® 7953, 105) or dual species (Geobacillus stearothermophilus ATCC® 7953, 106 and Bacillus atrophaeus ATCC® 9372, 106) bacterial spores. The strip is packaged in a 30# glassine pouch.
Operational Principles: The NAMSA Biological Indicator Spore Strip (single species Geobacillus stearothermophilus ATCC® 7953, or dual species Geobacillus stearothermophilus ATCC® 7953 and Bacillus atrophaeus ATCC® 9372) is intended for use in testing the efficacy of steam sterilization for single species and steam and ethylene oxide sterilization for dual species.
Performance characteristics are established in accordance with ANSI/AAMI/ISO 11138 and USP for 121°C steam gravity displacement for 30 minutes and ethylene oxide at 600 mg/L, 60% RH and 55°C for 2 hours, 10 minutes.
The media containing the spore strip should be incubated at the organism's growth temperature. Media should be monitored daily for visible signs of growth and results recorded.
When standard media is utilized, incubate strips for a minimum of 7 days. Growth will be indicated by the presence of turbidity. A reduced incubation time of 24 hours for steam sterilization has been validated when the Biological Indicator Spore Strips are used in conjunction with Tryptic Soy Broth (TSB) modified with Bromocresol Purple.
The provided document describes the NAMSA Biological Indicator Spore Strips and their performance, focusing on their substantial equivalence to predicate devices for assessing sterilization efficacy.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state a table of acceptance criteria with numerical targets. Instead, it refers to compliance with recognized standards. The performance characteristics are established according to:
- ANSI/AAMI/ISO 11138: This is a series of international standards for biological indicators.
- USP (United States Pharmacopeia): This outlines pharmaceutical and medical device standards.
The performance is reported in the context of these standards for specific sterilization parameters:
| Acceptance Criteria (Based on ANSI/AAMI/ISO 11138 and USP) | Reported Device Performance |
|---|---|
| For Steam Sterilization (Single Species: Geobacillus stearothermophilus ATCC® 7953): |
- Efficacy for 121°C steam gravity displacement for 30 minutes.
- Required resistance characteristics (e.g., D-value, Z-value, Survival/Kill Windows) must meet standard specifications.
- Required Total Viable Spore Count.
- Medium suitability for organism growth.
- Holding time assessment must confirm stability.
- Recovery protocols must be effective.
- Reduced incubation time (24 hours with specific media) validation (if applicable). | Demonstrates efficacy in testing steam sterilization for Geobacillus stearothermophilus ATCC® 7953.
- Testing performed for Total Viable Spore Count.
- Testing performed for Resistance Characteristics Studies including D-value, Z-value and Survival/Kill Windows.
- Compliance with ANSI/AAMI/ISO 11138 and USP for 121°C steam gravity displacement for 30 minutes.
- Holding Time Assessment performed.
- Recovery Protocols evaluated.
- Medium Suitability evaluated.
- Reduced incubation time of 24 hours for steam sterilization has been validated when used with Tryptic Soy Broth (TSB) modified with Bromocresol Purple. |
| For Steam and Ethylene Oxide (EO) Sterilization (Dual Species: Geobacillus stearothermophilus ATCC® 7953 and Bacillus atrophaeus ATCC® 9372): - Efficacy for 121°C steam gravity displacement for 30 minutes.
- Efficacy for ethylene oxide at 600 mg/L, 60% RH and 55°C for 2 hours, 10 minutes.
- Required resistance characteristics (e.g., D-value, Z-value, Survival/Kill Windows) must meet standard specifications.
- Required Total Viable Spore Count.
- Medium suitability for organism growth.
- Holding time assessment must confirm stability.
- Recovery protocols must be effective.
- Reduced incubation time (24 hours with specific media) validation (if applicable). | Demonstrates efficacy in testing steam and ethylene oxide sterilization for Geobacillus stearothermophilus ATCC® 7953 and Bacillus atrophaeus ATCC® 9372.
- Testing performed for Total Viable Spore Count.
- Testing performed for Resistance Characteristics Studies including D-value, Z-value and Survival/Kill Windows.
- Compliance with ANSI/AAMI/ISO 11138 and USP for 121°C steam gravity displacement for 30 minutes and ethylene oxide at 600 mg/L, 60% RH and 55°C for 2 hours, 10 minutes.
- Holding Time Assessment performed.
- Recovery Protocols evaluated.
- Medium Suitability evaluated.
- Reduced incubation time of 24 hours for steam sterilization has been validated when used with Tryptic Soy Broth (TSB) modified with Bromocresol Purple. |
| General Acceptance Criteria: - Total viable spore count within specified limits.
- Carrier and Primary Packaging Materials Evaluation to ensure integrity and compatibility. | - Total Viable Spore Count testing was performed.
- Carrier and Primary Packaging Materials Evaluation was performed. |
The study described indicates that "testing was performed for steam for single specie spore strips and steam and Ethylene Oxide (EO) sterilization processes for dual species," validating the performance characteristics against these standards. The conclusion is that the device is "substantially equivalent to the predicate device."
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document states that "Multiple lots of NAMSA Biological Indicator Spore Strips were utilized" for testing. However, it does not provide a specific numerical sample size for the test set (e.g., how many strips per lot, how many lots).
- Data Provenance: The document does not specify the country of origin of the data. It is a submission to the FDA in the US for a US-based company (NAMSA). The data is undoubtedly retrospective as it describes testing already performed to demonstrate device performance for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not provided in the document. Biological indicator testing focuses on measurable biological and physical parameters (spore count, D-value, survival/kill) rather than human interpretation. Therefore, "experts" in the context of ground truth establishment as it applies to image interpretation or diagnostic test reading would not typically be relevant here. The ground truth is intrinsically tied to the viability of the spores after exposure to sterilization processes, assessed by laboratory culture methods.
4. Adjudication Method for the Test Set:
- This information is not applicable/provided. Adjudication methods are typically employed in studies where human readers or multiple assessments are involved (e.g., radiology studies). For biological indicators, the outcome (growth/no growth, quantitative spore count) is a direct, objective measurement.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., medical imaging AI). Biological indicators are laboratory-based tools with objective outcomes.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable in the context of an "algorithm." This device is a biological indicator, not a software algorithm. The "standalone performance" is the inherent performance of the spore strip itself as it responds to sterilization processes, which is what the testing describes.
7. The Type of Ground Truth Used:
- The ground truth in this context is based on direct biological measurement and adherence to established physical/chemical parameters of sterilization. Specifically:
- Culture-based viability: Growth or no growth of spores after exposure to sterilization, assessed by incubating the strips in suitable media. This determines survival.
- Quantitative Spore Count: Measurable number of viable spores.
- Resistance Characteristics (D-value, Z-value, Survival/Kill Windows): These are quantitative measures directly derived from the resistance of the spores to specific sterilization conditions, which are established scientific benchmarks for biological indicators.
- Adherence to ANSI/AAMI/ISO 11138 and USP standards: These standards define the accepted performance criteria for effective sterilization monitors.
8. The Sample Size for the Training Set:
- This information is not provided and is not applicable in the context of this device. Biological indicators do not involve machine learning algorithms that require training sets. Their performance is inherent to their biological and physical composition and is validated through experimental testing.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As stated above, there is no "training set" for a biological indicator. The ground truth for validating their performance is established through rigorous laboratory testing against defined sterilization cycles and using culture methods to confirm spore viability, all under the guidelines of recognized standards like ANSI/AAMI/ISO 11138 and USP.
§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).