(270 days)
The Enbio S is an air-removal (pre-vacuum) table-top steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. It is suitable for the sterilization of dental and medical instruments that are validated to be sterilized by steam. The Enbio S has not been designed to sterilize liquid loads, biomedical waste or materials not compatible with sterilization. The processing of such loads may result in incomplete sterilization and/or damage to the autoclave.
The Enbio S is an air-removal (pre-vacuum) table-top steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. It has a hermetically sealed, heated chamber made from aluminum, with two heaters sink inside chamber walls. Inside this chamber, the sterilized load is placed on a special perforated tray. After closing the chamber, the user selects the appropriate sterilization program through the TFT touch screen. The actual sterilization phase starts after the pre-vacuum phase. The aluminum steam generator produces superheated steam and applies it inside the chamber. That steam penetrates the sterilized instruments. The set temperature is maintained inside the chamber depending on the selected sterilization cycle (121C° or 134°C), during a specified time (30 minutes or 4 minutes). After that time all the steam accumulated inside the chamber is pumped out and the drying cycle begins. When sterilization is finished, device displays to the user that process is completed, and that the load is sterile.
This document is a 510(k) summary for the Enbio S steam sterilizer. It outlines the acceptance criteria and the non-clinical bench testing conducted to prove that the device meets these criteria. Since this is a sterilizer, the relevant acceptance criteria and studies revolve around its ability to achieve sterilization.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ANSI AAMI ST55:2016 Vacuum Test | Verify air removal performance | Average leak rate of 1 millimeter of mercury (mmHg) (0.13 kPa) (0.019 psia) per min or less | Pass |
| Bowie Dick Test | Verify air removal performance | The Bowie-Dick test indicator sheet shall show a uniform color change; i.e., the color in the center should be the same as that at the outer edges. | Pass |
| ANSI AAMI ST55:2016 Empty Chamber Study (134°C in 4 min & 121°C in 30 min) | Verify pressure and temperature – to ensure that the sterilizer is capable of providing steady-state thermal and pressure conditions within the chamber | +3°C/-0°C, ±0.3 bar | Pass |
| ANSI AAMI ST55:2016 Full Cycle Study (134°C in 4 min & 121°C in 30 min) | Verify pressure and temperature - to ensure that the sterilizer is capable of providing steady-state thermal and pressure conditions | +3°C/-0°C, ±0.3 bar | Pass |
| ANSI AAMI ST55:2016 Half Cycle Study (134°C in 4 min & 121°C in 30 min) | Verify pressure and temperature – to ensure that the sterilizer is capable of providing steady-state thermal and pressure conditions during the cycle | +3°C/-0°C, ±0.3 bar | Pass |
| ANSI AAMI ST55:2016 Full Cycle Biological Indicators (134°C in 4 min) | To verify biological sterilization performance | The tested cycle has a 10^-6 SAL (Sterility Assurance Level) | Pass |
| ANSI AAMI ST55:2016 Full Cycle Biological Indicators (121°C in 30 min) | To verify biological sterilization performance | The tested cycle has a 10^-6 SAL (Sterility Assurance Level) | Pass |
| ANSI AAMI ST55:2016 Half Cycle Biological Indicators (134°C in 2 min) | To ensure the efficacy of the equipment and the lethality of the recommended processing parameters by biological challenge | The tested cycle has a 10^-6 SAL (Sterility Assurance Level) | Pass |
| ANSI AAMI ST55:2016 Half Cycle Biological Indicators (121°C in 15 min) | To ensure the efficacy of the equipment and the lethality of the recommended processing parameters by biological challenge | The tested cycle has a 10^-6 SAL (Sterility Assurance Level) | Pass |
| ANSI AAMI ST55:2016 Half Cycle Study / Textile PCD (134°C in 2 min) | Verify half-cycle sterilization of BI inside textile PCD | The tested cycle has a 10^-6 SAL (Sterility Assurance Level) | Pass |
| ANSI AAMI ST55:2016 Half Cycle Study / Textile PCD (121°C in 15 min) | Verify half-cycle sterilization of BI inside textile PCD | The tested cycle has a 10^-6 SAL (Sterility Assurance Level) | Pass |
| IEC 61010-1, 61010-2 | Verify electrical safety | Meets specifications of standard | Pass |
| IEC 60601-1-2, IEC 61326-1, 47 CFR 15 Subpart B | Verify electromagnetic compatibility | Meets specifications of standards | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes non-clinical bench (performance) testing, not a test set in the sense of patient data or algorithm performance. Therefore, typical "sample size" and "data provenance" (country of origin, retrospective/prospective) don't directly apply here.
The tests conducted are physical performance tests on the sterilizer as a device. The "sample size" would refer to the number of sterilization cycles performed or units tested to demonstrate consistency and adherence to parameters. This specific detail is not provided in text, but it's implied that sufficient tests were run to determine a "Pass" for each criterion.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable for the given document. The "ground truth" for a steam sterilizer's performance is established by well-defined physical and biological standards (e.g., temperature/pressure tolerances, biological indicator kill rates). There isn't a need for human expert consensus in the same way there would be for a diagnostic imaging AI, for example.
4. Adjudication Method for the Test Set:
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for expert review of human-interpreted data (e.g., medical images). The tests performed on the sterilizer yield objective, measurable results (e.g., temperature readings, biological indicator color changes, leak rates) which do not require human adjudication in this context.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "The submission does not contain any data from clinical testing." MRMC studies are typically for evaluating the impact of an AI on human reader performance for diagnostic tasks. This device is a mechanical sterilizer, not a diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, in a sense, a "standalone" evaluation was done. The tests performed are directly on the performance of the sterilizer itself, without human interaction impacting the sterilization efficacy. For example, the biological indicator tests verify the sterilizer's ability to kill microorganisms on its own. While a human initiates the cycle, the effectiveness of the sterilization process is tested independently.
7. The Type of Ground Truth Used:
The ground truth used for these tests is based on established scientific and regulatory standards for sterilization, specifically:
- Physical Parameters: Defined temperature and pressure ranges, leak rates, and cycle times as specified in ANSI AAMI ST55:2016.
- Biological Efficacy: The 10^-6 Sterility Assurance Level (SAL), verified using biological indicators (BIs) which contain highly resistant bacterial spores (e.g., Geobacillus stearothermophilus). A successful sterilization run means the BIs show no growth, indicating a 1 in a million chance of a non-sterile item.
- Electrical Safety & EMC: Compliance with international safety and electromagnetic compatibility standards (IEC, CFR).
8. The Sample Size for the Training Set:
This information is not applicable. This device is a traditional medical device (steam sterilizer), not an AI/Machine Learning algorithm. Therefore, there is no "training set" in the context of data used to train an algorithm.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as point 8.
§ 880.6880 Steam sterilizer.
(a)
Identification. A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.(b)
Classification. Class II (performance standards).