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510(k) Data Aggregation
(139 days)
The Getinge GSS610N21 Series Steam Sterilizer is intended for use by health care facilities to sterilize wrapped and unwrapped porous and nonporous heat and moisture stable items such as surgical instruments and linens by means of pressurized steam.
The steam sterilizer is used by health care facilities to sterilize wrapped and unwrapped porous and nonporous heat and moisture stable items such as surgical instruments and linens by means of pressurized steam. The Getinge GSS610N21 Series Steam Sterilizer employs both gravity/downward displacement with positive pulse conditioning and pressure/vacuum pulsing for dynamic air removal. All cycle phases are sequenced and monitored by the control system, providing both audible and visual notification of deviation from certain operating parameters.
Here's a breakdown of the acceptance criteria and study information for the Getinge GSS610N21 Series Steam Sterilizer, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Performed | Acceptance Criteria | Reported Performance |
|---|---|---|
| Biological Performance Tests: Sterilization Efficacy Validation with a fabric PCD | Sterility Assurance Level (SAL) 10⁻⁶ | Pass |
| Biological Performance Tests: Biological Performance with liquid loads | Sterility Assurance Level (SAL) 10⁻⁶ | Pass |
| Biological Performance Tests: Biological Performance with a wrapped instrument PCD | Sterility Assurance Level (SAL) 10⁻⁶ | Pass |
| Biological Performance Tests: Biological performance of immediate-use steam sterilization for single-wrapped or unwrapped nonporous items | Sterility Assurance Level (SAL) 10⁻⁶ | Pass |
| Physical Performance Test: Chamber Temperature Profile | +3°C (or +6°F) and -0°C (or -0°F) of the selected sterilization exposure temperature | Pass |
| Physical Performance Test: Mechanical Air Removal Test (Exposure Temperature) | Load reaching exposure temperature within 10 secs | Pass |
| Physical Performance Test: Mechanical Air Removal Test (Color Change) | Color change on BD chemical indicator sheet | Pass |
| Physical Performance Test: Air Leak Rate Test | Average leak rate of 1 mmHg (0.13 kPa) (0.019 psia) per minute or less over the measured time interval | Pass |
| Physical Performance Test: Moisture Retention Test | < 3% increase in presterilization test pack weight for fabric pack & <20% increase for wrapped instrument pack | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific numerical sample size (e.g., number of cycles run for each test) for the test set. It mentions the "Load Configuration" for each cycle type, indicating the maximum number of items per load (e.g., 36 full instrument packs, 80 full fabric packs, 1 B&D Test Pack, 3 vented bottles). These load configurations were used during the testing validations.
The data provenance is not explicitly stated in terms of country of origin. The device is manufactured by Maquet GmbH, located in Rastatt, Germany, which suggests the testing might have been conducted in Germany or a location compliant with AAMI standards. The testing is prospective as it was performed to validate the device's performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
This information is not provided in the document. The acceptance criteria relate to objective measurements (Sterility Assurance Level, temperature, leak rate, moisture retention) and observable physical changes (color change on chemical indicator), not subjective expert assessment of images or data. Therefore, the concept of "experts establishing ground truth" in the diagnostic sense is not applicable here. The ground truth would be established by the validated testing methodologies and their results against the predefined criteria.
4. Adjudication Method for the Test Set:
An adjudication method is not applicable in this context. The tests performed are objective performance validations against predefined technical standards (AAMI ST8). The results are either "Pass" or "Fail" based on whether the measured parameters meet the acceptance criteria. There's no subjective interpretation requiring adjudication.
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 devices where human readers interpret data (e.g., radiology images) and the AI's effect on their performance is evaluated. The Getinge GSS610N21 is a sterilizer, an automated device that performs a physical sterilization process, not a diagnostic tool requiring human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, the studies performed are standalone performance validations of the device. The tests evaluate the sterilizer's ability to achieve sterility and maintain physical parameters independently. There is no "human-in-the-loop" aspect to the core sterilization function being evaluated in these performance tests.
7. The Type of Ground Truth Used:
The ground truth used for these performance tests is objective, measurable criteria based on established industry standards (AAMI ST8:2013 (R2018)). This includes:
- Sterility Assurance Level (SAL) 10⁻⁶: This is a statistically derived measure of the probability of a single viable microorganism occurring on an item after sterilization.
- Temperature ranges: Specific temperature tolerances (+3°C / -0°C) for the exposure phase.
- Time measurements: Such as the load reaching exposure temperature within 10 seconds.
- Physical changes: Like the color change on a chemical indicator sheet.
- Quantitative measurements: For air leak rate (1 mmHg per minute or less) and moisture retention (< 3% or <20% increase in weight).
8. The Sample Size for the Training Set:
This information is not applicable/not provided because the Getinge GSS610N21 is a steam sterilizer, a physical medical device that performs a mechanical and thermal process, not an AI or algorithm-based diagnostic tool that requires a "training set" in the machine learning sense. Its performance is validated through physical and biological challenge tests, not by learning from labeled data.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable/not provided for the same reason as point 8. There is no "training set" for a steam sterilizer. The "ground truth" for its validation is based on established scientific principles of sterilization and recognized industry standards (AAMI ST8).
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