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510(k) Data Aggregation
(265 days)
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) | < 70 ml/min | Leakage of <70 ml/min |
| ISO 5367 (Resistance to Flow) | Adult < 0.06 cmH2O/l/m, Pediatrics < 0.12 cmH2O/l/m, Neonate < 0.74 cmH2O/l/m | Adult < 0.06 cmH2O/l/m, Pediatrics < 0.12 cmH2O/l/m, Neonate < 0.74 cmH2O/l/m |
| Performance after 30 days continuous use | Leakage and resistance to flow meet acceptance criteria per standard | Testing of leakage, resistance to flow met the acceptance criteria per each standard |
| Performance under various ventilator modes | Compatibility of the device with a ventilator | Testing over different ventilator modes was performed to confirm the compatibility of the device with a ventilator |
| ISO 10993-5 (Cytotoxicity) | Non-cytotoxic | Found non-cytotoxic |
| ISO 10993-10 (Sensitization/Irritation) | Non-sensitizer, Non-irritant | Non-sensitizer, Non-irritant |
| ISO 10993-11 (Pyrogenicity/Toxicity) | Non-pyrogenic, Non-toxic | Non-pyrogenic, Non-toxic |
| ISO 18562-2 (Particulate Material) | Met predefined acceptance criteria | Met the predefined acceptance criteria |
| ISO 18562-3 (Volatile Organic Chemicals) | Margin of Safety > 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 <0.5 ml/min) | 6 ml/min for Subject Device, 2 ml/min for Predicate Device |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes non-clinical performance data and comparative testing to a predicate device, rather than a clinical study with a "test set" of patient data. Therefore, information about patient sample size and data provenance (e.g., country of origin, retrospective/prospective) is not applicable in the context of this submission. The "test set" refers to the physical devices undergoing various laboratory tests. The devices were tested pre- and post-aging, after 30 days of use, and after storage conditions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable. The "ground truth" for the non-clinical performance tests is established by published ISO standards and engineering specifications, not by expert consensus on clinical cases.
4. Adjudication Method for the Test Set:
This information is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies for resolving discrepancies in expert interpretations of patient data. The non-clinical performance tests rely on objective measurements and established standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was mentioned. The submission focuses on non-clinical performance and substantial equivalence to a predicate device, not on human-in-the-loop performance or comparison of human readers with and without AI assistance.
6. Standalone (Algorithm Only) Performance:
This information is not applicable. The device is an exhalation valve, a physical medical device, not a software algorithm or AI. The tests performed are on the physical device's function.
7. Type of Ground Truth Used:
The "ground truth" for these performance tests is based on:
- International Standards (ISO): Specifically, ISO 5356-1, ISO 5367, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 18562-2, and ISO 18562-3.
- Engineering Specifications: Predefined acceptance criteria for various parameters like resistance to flow and material composition.
- Toxicological Risk Assessment: For volatile organic chemicals.
8. Sample Size for the Training Set:
This information is not applicable. There is no "training set" as this is a physical medical device, not an AI or machine learning model.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as above.
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