(28 days)
The SPSmedical SporView® PA Culture Set is intended for use with the STERIS System 1® sterilizer using STERIS® 20 sterilant only. The SporView® PA Culture Set provides independent confirmation that sterilization conditions were achieved during the STERIS System 10 processing cycle. A reduced incubation time of 16 hours has been wallated for the SporView® PA Culture Set using SPSmedical's SporView® culture media.
SporView® PA Culture Set is intended to monitor the STERIS System 1 sterilization process, with STERIS® 20 sterilant. The product contains paper strips that are process, with G. stearothermophilus spores. Sterile tubes of SporView® Culture Media (modified soybean casein broth) and a transfer clip are included.
Here's a breakdown of the acceptance criteria and study information for the SPSmedical SporView® PA Culture Set based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Stated Goal) | Reported Device Performance |
|---|---|
| Reduced incubation time for peracetic acid sterilization process. | 16-hour reduced incubation time for the peracetic acid sterilization process using the SPSmedical SporView® PA Culture Set. |
Study Information
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Sample Size Used for the Test Set and Data Provenance:
- Sample Size: "three lots of biological indicators" were tested.
- Data Provenance: Not explicitly stated, but implies the testing was conducted by or on behalf of SPSmedical Supply Corp. The context of a 510(k) submission suggests in-house or outsourced lab testing, likely within the U.S. (given the FDA submission). It is a prospective study for the purpose of validating the device.
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Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Not applicable/Not mentioned. The "ground truth" for a biological indicator is typically objective (growth/no growth) based on established microbiological methods.
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Adjudication Method for the Test Set:
- Not applicable/Not mentioned. The study involves objective microbiological testing.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a MRMC comparative effectiveness study was not done. This type of study is more relevant for imaging devices or diagnostics that involve human interpretation. This device is a biological indicator with objective results.
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Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Yes, this was a standalone performance study of the biological indicator itself. There is no "algorithm" or human-in-the-loop component in the evaluation of a biological indicator; its performance is determined by its biological response. The study assessed the device's ability to show growth or no growth within a reduced incubation time.
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Type of Ground Truth Used:
- The ground truth is based on microbiological growth/no growth of G. stearothermophilus spores after exposure to the sterilant and subsequent incubation, which is an objective biological outcome. This is aligned with standards for biological indicator testing.
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Sample Size for the Training Set:
- Not applicable/Not mentioned. This device is not an AI/machine learning model, so there is no concept of a "training set" in the traditional sense. The "training" for the biological indicator's performance is inherent in its design and manufacturing.
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How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set. The performance validation relies on the inherent biological properties of the spores and media under defined test conditions.
§ 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).