(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 |
§ 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).