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510(k) Data Aggregation
(265 days)
Meditera Tibbi Malzeme San Ve TIC AS
The exhalation valves are intended to be used in ventilator circuits consistent with the indicated use of the ventilator to which they are attached.
The single limb model directs flow and allows for pressure monitoring and may be used within hospitals and for home care use.
The dual limb model regulates flow and is for use in hospitals and for home care use.
The exhalation valve are used with adults, pediatrics, and neonates.
The exhalation valves are for single patient use and can be used for a maximum of 30 days.
The Altech® Exhalation Valves (Single Limb) are available in 2 configurations intended for use in Single and Dual Limb ventilator circuits. The difference between the configurations is location of exhaust of the expired gas to the room. In the Single limb, the valve is integrated to the limb and expired gas exhausts through the opening below the valve whereas in the valve is attached to the end of the exhalation limb and the expired gas exhausts through device end of the valve.
The Altech® Exhalation Valves (Single Limb and Dual Limb) underwent non-clinical performance testing to demonstrate substantial equivalence to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Methodology | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ISO 5356-1 (Conical fittings) | Meet performance criteria | Fittings were tested according to ISO 5356-1 and meet the performance criteria |
| ISO 5367 (Leakage) | 1 | Toxicological Risk Assessment resulted in Margin of Safety >1 |
| Leakage in main body | Not explicitly stated as acceptance criteria, but compared to predicate (predicate had |
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