(119 days)
ZAN Lung-Function Lab is used to measure or monitor pulmonary function in adult and pediatric subjects during exercise (including diagnosis, training, and stress testing) or while at rest (including Spirometry, airway strength and output, diffusion capacity, body plethysmography, nutritional assessment, and indirect cardiac output) for diagnosis, training, assessment, and other related activities.
The ZAN Lung-Function Lab (LFL) is a full-featured, PC-based system for professional evaluation of pulmonary function, cardiopulmonary exercise capacity, and metabolism. A personal computer (PC) is the central component of the system, collecting data from pulmonary instruments, calculating lung-function test, stress, and training parameters, entering demographic and other subject information, and displaying/reporting the results. The system comprises Four pulmonary instruments (flow sensor with airway pressure capability, diffusion-gas analyzer, ventilation-gas analyzer, and body plethysmograph), a PC running a proprietary ZAN test program, test gases of known compositions, leads, tubes, and valves connecting the instruments and computer, and an optional cart for normalizing expansion. In addition, optional physiologic sensing equipment (including exercise electrocardiographs, pulse oximeters, etc.) may supply data to the LFL to provide expanded testing capability.
Here's a breakdown of the acceptance criteria and study information for the ZAN Lung-Function Lab, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary for the ZAN Lung-Function Lab primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant standards, rather than defining explicit acceptance criteria for specific performance metrics with target values to achieve. However, based on the text, we can infer some performance expectations and the reported compliance.
| Acceptance Criteria (Inferred from text) | Reported Device Performance |
|---|---|
| Conformance to international consensus standards (e.g., EN 60601-1, EN 60601-1-2) for safety and electromagnetic compatibility. | Proprietary components "demonstrate conformance" to these standards. |
| Measurement performance meets or exceeds "published American Thoracic operating conditions" requirements under stated and anticipated operating conditions. | "In-house and third-party testing demonstrate that the LFL measurement performance meets or exceeds published American Thoracic operating conditions requirements under stated and anticipated operating conditions." |
| Effective and safe use in actual-use conditions by patients and clinicians. | "CE marking and years of successful operation in Europe demonstrate that patients and clinicians can safely and effectively use the LFL under actual-use conditions." |
| Accuracy for CO analyzer (0.2% CO test gas) |
§ 868.1880 Pulmonary-function data calculator.
(a)
Identification. A pulmonary-function data calculator is a device used to calculate pulmonary-function values based on actual physical data obtained during pulmonary-function testing.(b)
Classification. Class II (performance standards).