(559 days)
The Model 2100 and 3100 are table-top natural convective (static air type) dry heat sterilizers designed for use in healthcare facilities for the sterilization of wrapped and unwrapped metal instruments. The single sterilization cycle runs at 160°C (320°F) for 1 hour (60 minutes).
The Model 2100 and 3100 are table-top natural convective (static air type) dry heat sterilizers designed for use in healthcare facilities for the sterilization of wrapped and unwrapped metal instruments and glassware. The single sterilization cycle runs at 160°C (320°F) for 1 hour (60 minutes). Items to be sterilized are placed horizontally on the removable trays inside the chamber.
Both models are plug-in units designed to run on standard 115 VAC household current. A thermocouple is used to measure the chamber temperature. All functions of the sterilizer are controlled by an embedded PCB. Access to the heating chamber is through a hinged door on the front of unit. A LED digital display located on the front of the unit indicates chamber temperature and remaining cycle time.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text.
Note: This document describes a medical device (sterilizer), not an AI/ML algorithm. Therefore, many of the requested fields related to AI/ML studies (like training sets, expert ground truth, MRMC studies, and standalone algorithm performance) are not applicable and will be marked as such. The "performance" here refers to the device's ability to sterilize, not an AI's diagnostic performance.
Device Name: Steri-Dent Model 2100 and 3100 (Table Top Dry Heat Sterilizer)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Goal) | Reported Device Performance |
|---|---|
| Effectiveness (Sterilization): Achieve a 10⁻⁶ SAL (Sterility Assurance Level) | Effectiveness Met: The sterilizers consistently provide a 12-log reduction of the Bacillus atrophaeus spores and produce a 10⁻⁶ SAL. Testing demonstrated that the F₀ values exceed the minimum of 30 minutes as required in AAMI ST50 for all test cycles. All 84 test samples (inoculated instruments including lumen devices and Biological Indicator (BI) strips challenged in the cold spot) were negative for growth (indicating successful sterilization). The positive controls were positive for growth, validating the test. |
| Thermal Profile: Consistently achieve and maintain the proper temperature (160°C / 320°F) inside the chamber. | Thermal Profile Met: Thermal profile tests for each sterilizer were run three times using a small load and three times using a full load. These tests demonstrated that each sterilizer was able to consistently achieve and maintain the proper temperature inside the chamber. The thermal profiles also identified the top tray as the cold spot, which was then used for efficacy testing. |
| Safety: Comply with relevant electrical and safety standards. | Safety Met: Models 2100 and 3100 complied with: |
- ANSI/UL 61010-1: Electrical Equipment for Measurement, Control, and Laboratory Use; Part 1 - General Requirements
- CAN/CSA C22.2 No. 61010-1: Electrical Equipment for Measurement, Control, and Laboratory Use; Part 1 - General Requirements
- IEC 61010-2-040: Particular Requirements for Sterilizers and Washer-Disinfectors Used to Treat Medical Materials.
These are stated to be the same standards the predicate device complied with. |
Study Details (Non-Clinical Performance Data)
This section describes the studies conducted to prove the device meets its acceptance criteria.
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Sample Size Used for the Test Set and Data Provenance:
- Effectiveness (Sterile Efficacy Studies): Three full-load half-cycle (30 minute) tests were run on each model (Model 2100 and Model 3100). The total number of test samples (inoculated instruments and BI strips) challenged across these tests was 84.
- Thermal Profile Studies: Three runs with a small load and three runs with a full load were performed for each sterilizer model.
- Data Provenance: The studies were performed by SPS Medical. The location/country of origin of the data is not explicitly stated, but given the US-based manufacturer and FDA submission, it's presumed to be within the US or compliant with US standards. The studies were non-clinical performance evaluations, not involving human subjects, so retrospective/prospective distinctions regarding patient data do not apply.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. This is a physical device sterilizer, not an AI/ML algorithm requiring expert review for ground truth establishment. The ground truth (sterility) was established experimentally using biological indicators and growth media.
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Adjudication Method for the Test Set:
- Not applicable. This is a physical device sterilizer. Results were based on biological and thermal measurements, not expert consensus on interpretations.
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If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- Not applicable. This is a physical device sterilizer, not an AI-assisted diagnostic tool.
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If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical device sterilizer.
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The Type of Ground Truth Used:
- Effectiveness: Biological indicators (spores of Bacillus atrophaeus) are the ground truth for sterility. A "negative for growth" result (no bacterial growth) confirmed successful sterilization. Positive controls were used to validate the test.
- Thermal Profile: Direct temperature measurements using thermocouples confirmed the thermal performance.
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The Sample Size for the Training Set:
- Not applicable. This is a physical device sterilizer, not an AI/ML algorithm requiring a training set.
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How the Ground Truth for the Training Set Was Established:
- Not applicable.
§ 880.6870 Dry-heat sterilizer.
(a)
Identification. A dry-heat sterilizer is a device that is intended for use by a health care provider to sterilize medical products by means of dry heat.(b)
Classification. Class II (performance standards).