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510(k) Data Aggregation
(145 days)
Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120
The Tuttnauer Horizontal autoclave models 4472, 5596, 6690 and 66120 are intended for use by health care providers to sterilize medical products by means of pressurized steam. The devices that are intended to provide sterilization of heat stable medical devices: wrapped (IUSS) solids, hollow and porous products.
The Tuttnauer horizontal autoclave series models 4472, 5596 and 6690 are dynamic-air-removal autoclaves that are designed for sterilization of heat stable medical devices: wrapped and unwrapped (IUSS) solids, hollow and porous products. The sterilization medium is steam, which is directly introduced into the sterilization chamber. This eliminates the need to wait for water introduced into the chamber to boil and reach sterilization parameters. The autoclave operates in a temperature range of up to 137 C (279°F) and pressure up to 2.3 bar (34psi).
Each of the mentioned models differ from each other in chamber size and include different 1 or 2 door configurations. The models can come with onboard steam generation capability, but other configurations are used with external steam sources.
Here are the acceptance criteria and details of the study for the Tuttnauer Horizontal autoclave series, extracted and formatted from the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document presents acceptance criteria and reported performance (Pass/No Pass) directly within the "PERFORMANCE TESTING" section. No specific numerical results are provided beyond "Pass."
| Test Name | Purpose | Acceptance Criteria | Reported Performance |
|---|---|---|---|
| Electrical Safety | Verifying that device and its components meet electrical safety requirements | Meeting standard specification | Pass |
| EMC | Verifying that the device meets EMC requirements | Meeting standard specification | Pass |
| Pressure vessel testing | Verifying that the pressure vessel used for the 4472, 5596, 6690 and 66120 sterilizers meet the requirements for pressure vessel and is safe for use. | Meeting standard specification | Pass |
| Bowie & Dick test | Verify air removal performance (for dynamic air removal sterilizers) | The Bowie-Dick test indicator sheet shall show a uniform color change | Pass |
| Air-leak-rate (vacuum) test | Verify air removal performance (for dynamic air removal sterilizers) | average leak rate of 1 millimeter of mercury (mmHg) (0.13 kPa) (0.019 psia) per min or less over the measured time interval. | Pass |
| Empty chamber tests (121°C/132°C) – on wrapped and unwrapped (IUSS) load | to ensure that the sterilizer is capable of providing steady-state thermal conditions within the chamber consistent with the desired sterility assurance level (SAL) in the load | The temperature shall not exceed more than 3°C above the sterilization temperature. The temperature shall not be below the sterilization temperature. Actual exposure time (Implied to meet the specified sterilization times in the cycle tables). | Pass |
| Full chamber load test (121°C/132°C) – on wrapped and unwrapped (IUSS) load | to ensure that the sterilizer is capable of providing steady-state thermal conditions within the chamber consistent with the desired sterility assurance level (SAL) in the load | The temperature shall not exceed more than 3°C above the sterilization temperature. The temperature shall not be below the sterilization temperature. Actual exposure time (Implied to meet the specified sterilization times in the cycle tables). | Pass |
| Moisture retention tests - fabric PCD and wrapped instruments PCD | to ensure that the sterilizer is capable of meeting the moisture retention criteria | Moisture retained by the fabric PCD shall cause no more than a 3% increase in pre-sterilization test pack weight, and the pack shall exhibit no wet spots. When examined immediately after completion of the cycle, the wrapped instrument packs shall have no wet spots on the outer wrappers. Moisture retained by the 100% cotton towel shall cause no more than a 20% increase in the pre-sterilization weight of the towel. | Pass |
| Biological performance with a textile PCD | Verifying Biological performance on half sterilization time | Tested cycle has a 10^-6 SAL or an SAL providing a greater assurance of sterility when the textile PCD is used. | Pass |
| Biological performance with wrapped instrument PCD | Verifying biological performance on half sterilization time | Tested cycle has a 10^-6 SAL or an SAL providing a greater assurance of sterility when the wrapped instrument PCD is used. | Pass |
| Biological performance with unwrapped instrument PCD (IUSS) - minimum and maximum load tests | Verifying biological performance on half sterilization time | There shall be no growth observed in the vials containing turbines or in the extraction of any of the turbines, except for the positive controls. No growth shall be observed with the BIs except the positive control BI. Growth should be observed for the positive control turbine and BI. | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size (e.g., number of cycles performed) for each specific test or the "test set" in terms of physical units. However:
- The tests were conducted on the "Tuttnauer Horizontal autoclave series models: 4472, 5596, 6690, and 66120." It can be inferred that at least one of each model, or selected configurations, underwent these performance tests.
- The nature of sterilization validation studies typically involves multiple runs for each cycle type and load configuration to ensure reproducibility and meet sterility assurance levels.
- Data Provenance: Not explicitly stated regarding country of origin or whether the tests were retrospective or prospective. However, given it's a 510(k) submission, these are typically prospective performance validation studies conducted by the manufacturer according to recognized standards.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This section is not applicable as the device is a steam sterilizer, and the "ground truth" for its performance is established by objective physical and biological indicators, not human expert consensus on images or diagnostics. The performance tests rely on meeting physical parameters (temperature, pressure, leak rates, dry weight) and biological sterilisation criteria (no growth of biological indicators).
4. Adjudication Method for the Test Set
This is not applicable. The performance tests for a steam sterilizer involve objective measurements and biological indicator results, not subjective interpretation requiring an adjudication process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This is not applicable. An MRMC study is relevant for diagnostic devices that involve human interpretation of medical images or data. This device is a sterilizer.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)
This is not applicable. The device is a physical steam sterilizer, not an AI algorithm. Its performance is inherent to its physical operation and is tested directly. There is no "human-in-the-loop" component in its core sterilization function that would make this distinction relevant.
7. The Type of Ground Truth Used
The ground truth for the device's performance is established through:
- Physical Parameters: Measurements of temperature, pressure, time, and leak rates conforming to specific numerical thresholds (e.g., temperature not exceeding 3°C above sterilization temp, leak rate
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