(30 days)
The SPSmedical SporView® Bacterial Spore Strip is designed for routine monitoring of Steam, Dry Heat, EO Gas, and Chemiclave® sterilization processes. For steam sterilizers operating at 121℃ and at 132℃ a 24 hour incubation time has been validated. The indicator should be placed in the most difficult to sterilize location of the sterilization load. After cycle completion, the spore strip is removed from the load and aseptically transferred into SPSmedical's SporView® Culture Media (Tryptic Soy Broth with Bromocresol Purple) and incubated at 60°C. The combination of SPSmedical's spore strip and media has been validated for a reduced incubation time of 24 hours for steam processes. For Dry Heat, EO Gas, or Chemiclave® sterilization processes, the incubation period is seven (7) days.
The SPSmedical SporView® Bacterial Spore Strip is designed to monitor steam sterilizer cycles at 121°C and 132°C. The combination of SPSmedical's spore strip and Sportiew® Culture Media (Tryptic Soy Broth, Modified with Bromocresol Purple) has Oper notice of 60°C for a reduced incubation time of 24 hours for steam sterilization processes.
The SPSmedical SporView® Bacterial Spore Strip is a .250" x 1 1/2" Whatman 3MM chromatography filter paper inoculated with either a single species (Geobacillus stearothermophilus ATCC# 7953) or a dual species (Geobacillus stearothermophilus ATCC# 7953 and Bacillus atrophaeus ATTC# 9372) bacterial spores. The strip is packaged in a blue glassine envelope.
This looks like a 510(k) premarket notification for a biological indicator for sterilization processes, not a medical device in the typical sense that would have "acceptance criteria" and "device performance" in terms of diagnostic accuracy or clinical outcomes.
The document describes the SPSmedical SporView® Bacterial Spore Strip as a device used to monitor the effectiveness of sterilization processes (Steam, Dry Heat, EO Gas, Chemiclave®). The primary "performance" being evaluated is its ability to provide a reduced incubation time for detecting sterilization failures, specifically 24 hours for steam sterilization when used with SPSmedical's SporView® Culture Media.
Therefore, the requested information categories need to be reframed to fit the nature of this particular device and its submission. Many of the requested categories (like number of experts, adjudication methods, MRMC studies, standalone performance with humans-in-the-loop, training set details) are not applicable to the biological indicator's validation.
Here's an interpretation of the requested information based on the provided text, adapting the categories to fit the context of biological indicator validation:
Description of Acceptance Criteria and Enabling Study for SPSmedical SporView® Bacterial Spore Strip
The acceptance criteria for the SPSmedical SporView® Bacterial Spore Strip's 24-hour reduced incubation time for steam sterilization are based on its ability to accurately indicate the success or failure of a sterilization cycle within that timeframe. The study demonstrates the equivalence to a predicate device and validates the reduced incubation time.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for 24-hour reduced incubation of steam sterilization) | Reported Device Performance |
|---|---|
| Equivalence to Predicate Device: The device must demonstrate similar performance characteristics and indicated use as the predicate device (SPSmedical SporView® Bacterial Spore Strip, K905425). | The device was found to be "substantially equivalent" to the predicate device, having the same indicated use, materials, shelf life, and packaging. |
| Validation of 24-hour Reduced Incubation Time for Steam: When used with SPSmedical's SporView® Culture Media, the strip must reliably indicate sterilization failure (or success) within 24 hours for steam processes at 121°C and 132°C. | "All lots tested resulted in a 24 hour reduced incubation time for the steam sterilization process when using the combination of the SPSmedical SporView® Bacterial Spore Strip and the SPSmedical's SporView® Culture Media." |
| Consistency Across Device Lots: The reduced incubation time performance must be consistent across different manufacturing lots, including newly manufactured, mid-range expiration, and near-expiration lots. | Testing was performed using three lots (newly manufactured, mid-range expiration, and nearing expiration), and "All lots tested resulted in a 24 hour reduced incubation time." |
| Incubation Conditions: The 24-hour reduced incubation time is specifically validated at 60°C. | The validation explicitly states incubation at 60°C for 24 hours for steam sterilization. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "three lots of biological indicators; this included a newly manufactured lot, mid-range expiration lot and a lot nearing its expiration date." The exact number of individual strips per lot tested is not specified in the document.
- Data Provenance: The study was conducted internally by SPSmedical Supply Corp. ("Testing was performed... using three lots of biological indicators; this included a newly manufactured lot, mid-range expiration lot and a lot nearing its expiration date. All lots were tested using SPSmedical's SporView® Culture Media"). The country of origin is implicitly the USA, where SPSmedical is located. The study is prospective as it involves controlled testing of the manufactured product.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This question is not applicable in the context of validating a biological indicator. Ground truth for a biological indicator's performance is typically established by physical/chemical sterilization parameters and microbiological growth/no-growth, not by expert interpretation of images or clinical data. The outcome (growth/no growth) is an objective measure.
4. Adjudication Method for the Test Set
- This question is not applicable. Adjudication typically refers to resolving disagreements among human readers or experts. The assessment of growth/no-growth for a biological indicator is an objective, deterministic outcome.
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 evaluating the performance of diagnostic devices interpreted by human readers, often with or without AI assistance. This document describes the validation of a biological indicator, which does not involve human interpretation in the same manner.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- This question is largely not applicable in the AI/algorithm sense. The device itself (the spore strip and culture media) acts in a "standalone" manner to indicate sterilization effectiveness through a biochemical reaction (spore growth). There is no "algorithm" in the computational sense, nor is there a "human-in-the-loop" for interpreting the primary outcome (color change indicating growth/no growth). The performance described is the inherent performance of the biological indicator system.
7. The Type of Ground Truth Used
- The ground truth used is microbiological growth/no-growth as evaluated in a controlled laboratory setting against known sterilization parameters. The strips are inoculated with specific bacterial spores (Geobacillus stearothermophilus ATCC# 7953 and/or Bacillus atrophaeus ATTC# 9372). Successful sterilization means no spore growth; failed sterilization means spore growth. This is the direct biological outcome of the sterilization process the indicator is designed to monitor.
8. Sample Size for the Training Set
- This question is not applicable. This device is not an AI/machine learning model that requires a "training set." The validation process involves testing the physical product itself.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable as there is no "training set" for this type of device.
§ 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).