(171 days)
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No
The summary describes a standard steam sterilizer with pre-programmed cycles and electronic controls, with no mention of AI or ML capabilities.
No.
The device is an autoclave designed for sterilizing medical and surgical goods, which is a process to prepare instruments for use, not to directly treat or diagnose a medical condition.
No
The device is an autoclave, used for sterilizing medical and surgical goods. It does not perform any diagnostic functions.
No
The device description explicitly lists hardware components such as a sterilization chamber, electronic heating elements, a clean water reservoir, and housing. While it has an electronic control system, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is designed for sterilizing medical and surgical goods. This is a process applied to instruments and materials, not a test performed on biological samples to diagnose a condition.
- Device Description: The description details a steam sterilizer, which is a piece of equipment used for sterilization, not for in vitro diagnostic testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body (like blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is entirely different.
N/A
Intended Use / Indications for Use
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.
Product codes
FLE
Device Description
The EZ Plus 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., dental hand pieces; suction pipes) in ophthalmic, dental, and medical clinics; in first aid rooms; and in small laboratories. The device uses electrically generated heat to produce steam as the sterilizing agent. The device is equipped with multiple safety features. The door containing a safety locking mechanism that does not permit operation unless the door is closed, and does not permit the door to be opened until the internal chamber pressure is at atmospheric pressure. Additional EZ Plus safety features include an automatic safety shutoff to prevent chamber overheating; two (2) thermostats to detect overheating of the generator and the chamber; and a safety pressure valve for the pressure vessel. A digital display is used for monitoring and control purposes. There is an optional printer available to record cycle parameters.
The EZ Plus Series autoclaves are steam sterilizer 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Ophthalmic, dental, and medical clinics; in first aid rooms; and in small laboratories.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
Tuttnauer conducted validation studies in accordance with AAMI/ANSI ST55:2003. Testing shows that the EZ Plus Series autoclaves meet all aspects of the standard, including physical and microbiological performance requirements.
Since the EZ15 Plus autoclave is larger than provided under the table top standard of AAMI/ANSI ST55:2003, and since that standard therefore does not technically apply to the EZ15 Plus autoclave, Tuttnauer provides a summary of non-clinical testing performed for that model:
- . 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 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 was conducted based on the AAMI ST8 guidelines. The testing was conducted using cycles based on the 4 pre-programmed sterilization cycles; however, in some cases, less air removal pulses were necessary to achieve the required sterilization temperature. Recorded temperature data demonstrated that the EZ15 Plus autoclaye 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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
K090783, K063711, K021504, K993856
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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DEC - 8 2011