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510(k) Data Aggregation
(234 days)
The Getinge GSS610N 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 GSS610N Series Steam Sterilizer is available in 3 models differentiated by chamber length: GSS610N Model 610N10 (40.9 inch chamber), GSS610N Model 610N14 (51.1 inch chamber), and GSS610N Model 610N15 (60.6 inch chamber).
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 GSS610N Series Steam Sterilizer employs both with 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
This document is about the FDA 510(k) clearance for the Getinge GSS610N Series Steam Sterilizer (K201927). It describes the device, its intended use, and the non-clinical testing performed to demonstrate its substantial equivalence to a predicate device.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biological Performance Tests | ||
| Sterilization Efficacy Validation Biological Performance with a fabric PCD | Sterility Assurance Level (SAL) 10⁻⁶ | Pass |
| Biological Performance with liquid loads | Sterility Assurance Level (SAL) 10⁻⁶ | Pass |
| Biological Performance with a wrapped instrument PCD | Sterility Assurance Level (SAL) 10⁻⁶ | Pass |
| 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 |
| Mechanical Air Removal Test | Load reaching exposure temperature within 10 secs; Color change on B&D chemical indicator sheet | Pass |
| 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 |
| 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 the data provenance:
- Sample Size for Test Set: The document does not explicitly state the numerical sample size for each test (e.g., number of sterilization runs, number of items per test). It mentions "Full instrument packs" and "Full fabric packs" for various cycles, and "1 B&D Test Pack." The results are simply reported as "Pass," indicating that the tests were conducted according to the specified standards and the outcomes met the criteria.
- Data Provenance: The tests were "non-clinical testing" performed by Maquet GmbH, located in Rastatt, Germany. The document indicates these were validation tests for the device, implying they were prospective studies conducted specifically for this 510(k) submission. No information about country of origin of the data in terms of patient data (as this is a sterilizer, not a diagnostic device using human data).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to this type of device and study. The "ground truth" for a steam sterilizer is defined by objective physical and biological parameters related to sterilization efficacy (e.g., Sterility Assurance Level, temperature profiles, air removal) as established by consensus standards (like AAMI ST8). Human expert interpretation of images or clinical outcomes is not part of establishing the ground truth for a sterilizer's performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
No adjudication method is described because this involves objective physical and biological measurements, not subjective human assessments that require 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 medical imaging AI devices where human readers interpret medical images with and without AI assistance. This document is for a medical device (steam sterilizer) where the efficacy is determined by objective physical and biological tests, not by human interpretation of clinical cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The concept of "standalone performance" for an algorithm is not directly applicable here. The device itself (the sterilizer) performs its function (sterilization) based on its design and programmed cycles. The tests conducted (biological and physical performance tests) are in essence evaluating the "standalone" performance of the machine in achieving sterilization. There is no human "in the loop" assisting the sterilizer during the sterilization process itself.
7. The type of ground truth used:
The ground truth for this device's performance is established by:
- Sterility Assurance Level (SAL) 10⁻⁶: This is a widely accepted measure that indicates a probability of one in a million chance of a single viable microorganism remaining after sterilization. Biological indicators (spore tests) are used to confirm this.
- Physical Parameters: Objective measurements of temperature (e.g., within +/-3°C or 6°F of target), air removal (e.g., load reaching exposure temperature within 10 seconds), and moisture retention (e.g., <3% weight increase for fabric packs, <20% for wrapped instrument packs).
- Chemical Indicators: Color change on B&D (Bowie-Dick) chemical indicator sheets.
These ground truths are based on established consensus standards, specifically AAMI ST8:2013 (R2018).
8. The sample size for the training set:
This information is not applicable. This document describes the clearance of a physical medical device (steam sterilizer) and its performance through validation testing. It is not an AI/ML device that requires training data and a training set.
9. How the ground truth for the training set was established:
This information is not applicable as there is no "training set" for this device.
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