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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 |
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