(171 days)
The EZ Plus Series autoclaves are autoclaves designed for sterilizing medical and surgical goods, including both wrapped and unwrapped, solid, hollow, and porous products and goods defined as hollow A (e.g., dentil hand pieces; suction pipes) in ophthalmic, dental, and medical clinics; in first aid rooms; and in small laboratories.
The EZ Plus Series autoclaves are steam sterilizers composed of a sterilization chamber, electronic heating elements, a clean water reservoir, housing, and control system. The EZ Plus Series is electronically controlled, and includes four pre-programmed sterilization cycles. All components in the sterilization path are constructed of grades of stainless steel that are deemed acceptable for steam sterilizers.
The provided text describes the Tuttnauer EZ Plus Series Electronic Tabletop Autoclaves and the non-clinical testing performed to demonstrate their effectiveness.
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 acceptance criteria for the EZ Plus Series autoclaves are based on the AAMI/ANSI ST55:2003 standard for tabletop steam sterilizers, and for the larger EZ15 Plus, also AAMI ST8 guidelines. While specific quantitative pass/fail criteria for each test (e.g., specific log reduction for microbiological tests) are not explicitly stated in the summary, the overall acceptance criterion is to "meet all aspects of the standard," or demonstrate "sterilization efficacy" and "appropriate temperatures."
| Acceptance Criteria (Implied from Standards) | Reported Device Performance |
|---|---|
| Compliance with AAMI/ANSI ST55:2003 (Physical and Microbiological Performance Requirements) | "Testing shows that the EZ Plus Series autoclaves meet all aspects of the standard, including physical and microbiological performance requirements." (For EZ9 Plus and EZ11 Plus) |
| "The EZ9 Plus and EZ11 Plus autoclaves conform to all appropriate standards including the AAMI ST55 standard for table-top autoclaves." | |
| Sterilization Efficacy Validation (for EZ15 Plus, per AAMI ST8 and ST55 for handpieces) | "Sterilization efficacy validation testing according to AAMI ST8." |
| "Handpiece testing was conducted to AAMI ST55, even though the model size technically removes the device from this standard." | |
| "Sterility was validated to a sterility assurance level of 10^-6 using the biological indicator overkill method. The testing consisted of a one-half cycle tests based on each of the 4 pre-programmed sterilization cycles." | |
| "Testing with a fully loaded chamber. The test loads included instruments such as handpieces and lumen devices in the appropriate cycles." | |
| Thermal Profile Testing (for EZ15 Plus, per AAMI ST8 guidelines) | "Thermal profile testing was conducted based on the AAMI ST8 guidelines." |
| "Recorded temperature data demonstrated that the EZ15 Plus autoclave achieves the appropriate temperatures throughout the sterilization chamber, and that these temperatures can be maintained in a steady state during the exposure phase of the sterilization cycles." | |
| Dry Time Testing (for EZ15 Plus, per AAMI ST8 and AAMI ST55 for wrapped cycles) | "Dry time testing was conducted based on the dry time tests outlined in AAMI ST8 and AAMI ST55 for wrapped cycles only (cycles 2 and 4)." |
| "Testing included fabric wrapped instruments as well as paper/plastic pouch wrapped instruments. All results met or exceeded the minimum dry time criteria under the standards." |
2. Sample Size Used for the Test Set and Data Provenance
The exact sample sizes for each specific test (e.g., number of sterilization cycles, number of biological indicators) are not explicitly stated in the provided summary.
The data provenance is retrospective, generated from non-clinical validation studies conducted by Tuttnauer. The country of origin of the data is not specified, but the submission is for the U.S. market (FDA 510(k)).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the summary. For sterilization validation, ground truth is typically established by laboratory testing and adherence to established standards rather than expert consensus on individual cases.
4. Adjudication Method for the Test Set
This is not applicable for non-clinical sterilization validation studies. Adjudication methods are typically used in clinical studies involving human interpretation or subjective assessment. The "ground truth" for sterilization is determined by the absence of viable microorganisms after the sterilization process, as measured by biological indicators.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or screening devices where human readers interpret output, not for sterilization equipment.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
Yes, in essence, a standalone performance study was done. The studies described (sterilization efficacy, thermal profile, dry time) evaluate the performance of the autoclave device itself, independent of human intervention other than the initial setup and monitoring. The "algorithm" here would be the pre-programmed sterilization cycles and the device's operational parameters.
7. The Type of Ground Truth Used
The ground truth used for these non-clinical studies is:
- Sterility Assurance Level (SAL) of 10^-6: Demonstrated using the biological indicator overkill method. This is an objective, quantitative measure of sterility.
- Thermal Data: Recorded temperature data demonstrating appropriate temperatures and maintenance during the sterilization cycle. This is objective, quantitative data.
- Dryness: Meeting or exceeding minimum dry time criteria based on visual inspection or established moisture content limits (implied by "dry time testing"). This typically involves objective measurement of dryness.
- Compliance with Industry Standards: Adherence to AAMI/ANSI ST55:2003 and AAMI ST8 guidelines.
8. The Sample Size for the Training Set
This concept is not applicable here. These are not AI/machine learning devices that require training sets. The autoclaves are electromechanical devices with pre-programmed cycles.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for this type of device.
§ 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).