(266 days)
The Family of steam Sterilizers B 28 series B CLASSIC-28 and B FUTURA-28 models are table top steam sterilizers to be used in medical and dental practices, hospitals, clinics, nursing homes, and other facilities to sterilize reusable surgical instruments (including dental handpieces) and medical materials, heat and moisture resistant and compatible with steam sterilization process.
The Family of Steam Sterilizers B 28 series is validation of fabric packs/textiles for sterilization programs C1 and C2.
The Family of Steam Sterilizers B 28 series is validated for sterilization up to 9 dental handpieces for sterilization programs C1 and C2.
The Family of Steam Sterilizers B 28 series is validated for sterilization up to 6 lumen devices (specifications in the table below)
The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products.
The Family of steam sterilizers B 28 series includes table-top steam sterilizers that use saturated steam at high pressures and temperatures to kill infectious bio-organisms. The B Classic-28 and B Futura-28 models differ only for some minor characteristics such as color touchscreen, optional Wi-FI connection, illumination of the working area and Ethernet connection
The steam is generated by a steam generator connected to the sterilization chamber without disconnecting devices. An electric heating element surrounds the chamber for preheating of the chamber and maintaining the temperature. The subject family is characterized by a fractionated vacuum system for the complete air removal also from hollow and porous materials as well as by a final vacuum drying phase able to eliminate any trace of condensation from the load.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
This document is a 510(k) summary for a medical device (CEFLA S.C.'s Family of Steam Sterilizers B28 series), which focuses on demonstrating substantial equivalence to predicate devices rather than proving novel clinical effectiveness with detailed studies involving human readers or extensive ground truth adjudication. Therefore, many of the requested points from the prompt (like "multi-reader multi-case (MRMC) comparative effectiveness study," "effect size of how much human readers improve with AI vs without AI assistance," "number of experts used to establish the ground truth," etc.) are not applicable to this type of regulatory submission and information.
The acceptance criteria here are based on the performance standards for steam sterilizers, particularly AAMI ST55:2010. The "study" refers to the validation tests performed to ensure compliance with these standards.
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Based on AAMI ST55:2010) | Reported Device Performance |
|---|---|
| Biological Performance (SAL) | |
| - Textile PCD: SAL of 10⁻⁶ reduction (no growth at half cycle with validation loads) | All biological indicators of each cycle tested resulted sterile, ensuring a SAL of 10⁻⁶. |
| - Wrapped instruments and lumen devices (double package): SAL of 10⁻⁶ reduction | All biological indicators of each cycle tested resulted sterile, ensuring a SAL of 10⁻⁶. |
| - Dental handpieces (double package): SAL of 10⁻⁶ reduction | All biological indicators of each cycle tested resulted sterile, ensuring a SAL of 10⁻⁶. |
| Chamber Temperature Stability | |
| - During sterilization holding time: between -0°C and +3°C of the sterilization temperature set point (AAMI ST55:2010, points 4.4.3 / 5.4.3) | Chamber temperatures are always between -0°C and +3°C of the sterilization temperature set point during sterilization holding time. Results are in compliance with acceptance criteria. |
| Bowie-Dick Test | |
| - Uniform color change (AAMI ST55:2010, point 5.6.1.1) | After the test run, the Bowie-Dick test indicator showed a uniform color change. |
| Air Leak Test | |
| - Average leak rate: |
§ 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).