(518 days)
Tuttnauer electronic controlled pre-vacuum autoclaves are intended to be used for sterilization of solid metal instruments, solid metal hinged instruments and other materials that will withstand temperatures and pressure required for sterilization. The sterilizers have 5 cycles: unwrapped instruments (134°C at 3 minutes and 29 psi); wrapped instruments (134°C at 7 minutes and 29 psi); liquids (121°C at 30 minutes and 16 psi); Bowie Dick test program (134°C at 3.5 minutes and 29 psi); and a free program with adjustable sterilization times and temperatures. With the exception of the free program, all of these cycles are pre-programmed, requiring no user input. The free program allows the user to select their own sterilization parameters, however, the operations manual warns that sterilization has not been validated for user selected settings, and cautions the user that they must validate sterilization. These autoclaves are intended for use in ophthalmic, dental and medical clinics, first aid rooms, and small laboratories in conformity with 21 C.F.R. § 880.6880.
The Tuttnauer Model EPV series autoclave is a table-top steam sterilizer that includes as its main components a vacuum pump, water reservoir, heat source and sealed chamber. As with the predicate device, the EPV has three pre-programmed sterilization cycles, one user definable cycle and a Bowie-Dick test cycle. The three pre-programmed cycles are for unwrapped instruments (134°C at 3 minutes), wrapped instruments (134°C at 7 minutes) and liquids (121°C at 30 minutes). The Model EPV autoclave is produced in two sizes, the 2340EPV with a chamber size of 9" x 18.5" and the 2540EPV with a chamber size of 10" x 18.7". The pressure chamber, door and locking device are constructed from stainless steel. The pressure chamber, and components are designed, tested and stamped for conformance to ASME code. A microprocessor controls the cycle parameters. The software provides the microprocessor with the necessary information to control the device within its desired parameters. The software has been validated to ensure compliance with all applicable requirements.
The provided 510(k) summary for the Tuttnauer Model EPV Pre-vacuum Autoclave (K962282) states that "Evaluations have been completed to validate the safety and effectiveness of these devices." However, it does not provide specific numerical acceptance criteria for performance metrics, nor does it detail the results of a specific study in a quantifiable manner to demonstrate that these criteria were met.
Instead, the summary focuses on demonstrating substantial equivalence to a predicate device (Tuttnauer Model E series autoclave, K920478) and compliance with various safety standards. The performance aspects are described descriptively rather than with numerical targets and results.
Given the information provided, here's a breakdown of what can and cannot be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
As noted above, specific numerical acceptance criteria were not explicitly stated in the provided text. The performance is described qualitatively.
| Performance Metric | Acceptance Criteria (Implicit/Qualitative) | Reported Device Performance (Qualitative) |
|---|---|---|
| Sterilization Effectiveness | Render all recommended loads sterile; Effective sterilization of recommended loads within recommended cycles. | "The EPV rendered all recommended loads sterile on half-cycle and all other testing was completed successfully." "Based upon the test data submitted, the Model EPV provides effective sterilization of recommended loads within the recommended cycles." |
| Air Removal | Increased efficiency through removal of air pockets from packs and porous loads, allowing better steam penetration. | "The addition of a pre-vacuum cycle to the sterilization program increases the efficiency of the device through removal of air pockets from packs and porous loads, allowing better steam penetration into the packs." |
| Drying Performance | Better drying of sterilized material at the end of the cycle. | "The addition of a vacuum pump also provides better drying of sterilized material at the end of the cycle by creating a vacuum in the chamber to increase evaporation." |
| Temperature Control | Narrowed chamber temperature control specifications. | "The software has also been modified to narrow the chamber temperature control specifications in line with European requirements." |
| Safety Standards Compliance | Compliance with domestic and international safety standards. | "The Tuttnauer Model EPV complies with domestic and international safety standards including Underwriter's Laboratories UL 544, Canadian Standards Association (CSA) medical device standards, European TUV standards and Japanese safety standards. The pressure chamber complies with ASME standards for pressure vessels and Canadian CRN requirements." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document mentions "half-cycle and total kill endpoint analysis" and testing "under in-use, worst-case and simulated use conditions" but does not provide the number of sterilization cycles, loads, or biological indicators used in these tests.
- Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. Given that Tuttnauer USA Co. LTD. is based in New York, and the device adheres to "domestic and international safety standards," it's highly likely that testing involved a combination of internal validation and compliance with specified standards, potentially involving recognized testing laboratories. The nature of sterilizer validation implies prospective testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: The document does not describe the use of human experts to establish "ground truth" for the test set in the context often seen with AI/clinical decision support devices. Sterilizer validation typically relies on standardized biological and chemical indicators, calibrated equipment, and established protocols rather than expert human interpretation of results in the same way clinical imaging or diagnostic devices might.
4. Adjudication Method for the Test Set
- Not applicable in the conventional sense for this type of device. The "ground truth" for sterilization effectiveness is determined by objective measures like biological indicator kill, chemical indicator changes, and physical parameters rather than expert adjudication of interpretations.
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 clinical decision support devices where human readers (e.g., radiologists, pathologists) interpret data with and without AI assistance. The Tuttnauer Model EPV is a medical device for sterilization, not a diagnostic or AI-powered interpretative system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, a form of standalone performance evaluation was done. The device's "standalone" performance, in this context, refers to its ability to achieve sterilization outcomes independently without human intervention during the sterilization cycle itself. The testing described ("half-cycle and total kill endpoint analysis," "in-use, worst-case and simulated use conditions") evaluates the sterilizer's effectiveness on its own. The software controls the cycle parameters without human-in-the-loop decision-making during operation.
7. The Type of Ground Truth Used
The ground truth for sterilization efficacy is established through:
- Biological Indicators (BI): These contain highly resistant bacterial spores (e.g., Geobacillus stearothermophilus) that are killed only if proper sterilization conditions are met. A negative BI result (no growth) indicates sterilization. This is implicitly the "total kill endpoint analysis" mentioned.
- Chemical Indicators (CI): These change color or form when exposed to specific sterilant parameters (e.g., steam, temperature, time). They provide immediate confirmation of exposure to sterilant.
- Physical Monitoring: This involves monitoring and recording parameters directly from the sterilizer's sensors, such as temperature, pressure, and time.
- Pathology/Outcomes Data: Not typically used as primary ground truth for sterilizer validation; rather, the successful kill of microorganisms (as determined by BIs) is the direct measure of effectiveness.
8. The Sample Size for the Training Set
- Not applicable / Not specified. The Tuttnauer Model EPV is not an AI/machine learning device that requires a "training set" in the conventional sense. Its software controls predefined sterilization cycles based on fixed parameters, not adaptive learning from data. The software was "validated to ensure compliance with all applicable requirements," implying software testing and verification, but not machine learning training.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As the device does not employ machine learning with a distinct "training set," the concept of establishing ground truth for such a set is not relevant. The software logic and control parameters are based on established scientific principles of sterilization and engineering design, not on a data-driven training process.
§ 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).