(58 days)
The ELARA-11 is a table-top autoclave 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; and in first aid rooms.
The ELARA-11 is validated for use in sterilizing lumened device of no longer than 230 mm and no smaller than 3.4 mm for sterilization programs 2 and 4.
The ELARA-11 is validated for use in sterilizing fabric packs/textiles for sterilization programs 2 and 4.
The ELARA-11 is validated for use in sterilizing up to six dental handpieces for sterilization programs 2 and 4.
The Model 5075 HSG is a horizontal autoclave designed for the sterilization of wrapped and unwrapped instruments and related items found in dental, medical and veterinary clinics, first aid rooms, and hospitals.
The Model 5075 is validated for use in sterilizing lumened device of no longer than 370 mm and no smaller than 3.8 mm for sterilization programs 2 and 3.
The Model 5075 is validated for use in fabric packs/textiles for sterilization programs 2 and 4.
The ELARA-11 is a tabletop autoclave designed for sterilization of medical and surgical goods, including both wrapped and unwrapped, solid, hollow, porous products and tubes in ophthalmic, dental, and medical clinics; and in first aid rooms. The Model 5075 HSG is a horizontal autoclave designed for the sterilization of wrapped and unwrapped instruments and related items found in dental, medical and veterinary clinics, first aid rooms, and hospitals. These two devices are pre-vacuum and post-vacuum sterilizers that have an air removal stage (i.e., pre-vacuum) before the start of the sterilization stage, as well as a post-sterilization drying stage that is based upon the combined operation of heat plus vacuum with air inlet pulses. The sterilizing agent is steam that is electrically-generated from either mineral-free or distilled water that is added to the built-in reservoir.
The ELARA-11 is a steam sterilizer composed of a pressure vessel with steam jacket, heating elements, a clean water reservoir, a waste water reservoir, a vacuum pump, and a water pump. The device has several safety features, including a single manual safety door with a double-safety locking mechanism and an automatic safety shutoff. The front panel of the device consists of a display screen, a keypad, and a printer. The ELARA-11 electronic control system is automatic, fully-configurable, and has a total of six (6) programs: four (4) sterilization programs and two (2) test programs (Bowie & Dick test program with fixed (non-adjustable) parameters, and the Vacuum Test program). The components are made of yarying grades of stainless steel.
The 5075 HSG model is a steam sterilizer composed of a pressure vessel, heating elements, a clean water reservoir, a waste water reservoir, a vacuum pump, and a water pump. The device has several safety features, including a single manual safety door containing a double-safety locking mechanism, an automatic safety valve to protect personnel and equipment against build-up of high pressure, and a pressure gauge that indicates when there has been a failure in operation. The front panel of the device consists of a display screen, a keypad, and a printer. The 5075 HSG model electronic control system is automatic, fully-configurable, and has a total of six (6) programs: four (4) sterilization programs and two (2) test programs (Bowie & Dick test program with fixed (non-adjustable) parameters, and the Vacuum Test program). The components are made of varying grades of stainless steel and carbon steel.
This document describes the premarket notification for Tuttnauer Pre-Vacuum Tabletop Autoclave (Model ELARA-11) and Tuttnauer Pre-Vacuum Horizontal Autoclave (Model 5075 HSG). The information provided is for regulatory clearance and focuses on substantial equivalence to predicate devices, rather than a clinical study with acceptance criteria in the context of AI/ML.
Therefore, the requested information components related to acceptance criteria for AI/ML performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, and standalone performance are not applicable to this document. This document primarily details the device's technical specifications and intended use, comparing them to existing cleared devices to establish substantial equivalence.
1. Table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in terms of performance metrics like sensitivity or specificity. Instead, it states that the devices meet the requirements of AAMI/ANSI ST55:2003, which is a standard for table-top steam sterilizers.
| Acceptance Criteria (AAMI/ANSI ST55:2003) | Reported Device Performance (ELARA-11 & 5075 HSG) |
|---|---|
| Physical performance requirements | Meets all aspects of the standard |
| Microbiological performance requirements | Meets all aspects of the standard |
| Validation testing of all sterilization cycles using biological indicator overkill method | Meets all AAMI/ANSI testing requirements |
2. Sample sized used for the test set and the data provenance
Not applicable. This is not a study involving a test set in the context of AI/ML performance. The testing performed is related to the physical and microbiological efficacy of the sterilizers.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth in the context of expert consensus is not relevant here. The ground truth for sterilization efficacy is established through adherence to recognized standards (AAMI/ANSI ST55:2003) and biological indicator testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are not relevant to the type of testing described for steam sterilizers.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This document pertains to steam sterilizers, not AI/ML-driven diagnostic devices that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This document describes mechanical/electrical steam sterilizers, not algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the performance testing is based on the established safety and efficacy requirements outlined in the AAMI/ANSI ST55:2003 standard, specifically through physical and microbiological performance assessments, including the biological indicator overkill method.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device that requires a training set.
§ 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).