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510(k) Data Aggregation
(256 days)
The Hamilton Medical VENTILAIR II is intended for use in hospitals and other institutions as an alternative to central air or cylinder air to supply medical air at 30 psi nominal to the GALILEO and the RAPHAEL models of Hamilton Medical ventilators which are intended to be operated with 30 psi nominal medical air supply. It can also be used as a backup medical air supply for these ventilators in case of failure of their normal air supply.
The VENTILAIR II is an electromechanical and preumatic device only and has no software-based components. The device is rated at 115 V ± 10 %, 60 Hertz. It requires 466 Watts to power. The enclosure is designed to be mounted either on the GALILEO model or RAPHAEL model ventilator carts. Only one control is accessed during normal device operation, a power switch. The Power switch is switched ON both when the VENTILAIR II is configured and operated as a permanent air supply and when it is used as an emergency backup air supply. An indicator is provided to inform the user of the device performance status. This "Performance Gauge" is a pressure gauge calibrated for three zones of operation: Green (Normal Dry Operation), Yellow (Poor Drying Effect), and Red (Wet with Low Output Pressure). The VENTILAIR II has two air movements. The first is the cool, clean, dry compressed air movement that provides condensation-free compressed air to the ventilator. The second is the ambient air movement - an S-pattern that cools the entire drying system and compressor within the enclosure. The VENTILAIR II has been designed for easy maintenance. The compressor air intake filter element must be checked weekly. The 5 micron filter in the water trap must be replaced annually. Two internal pressure requlators and two other internal components must be checked annually and adjusted if necessary. Compressor overhaul is required periodically using the compressor manufacturer's overhaul kit. If the VENTILAIR II is used as an independent or continuous air source, an annual overhaul is recommended. If the compressor is used only as a backup in case of failure of the main air supply, overhaul is recommended every five years. All maintenance and overhaul procedures are described in the VENTILAIR II Operator's and Service Manuals. The VENTILAIR II is in full compliance with all required safety aspects of the current edition of IEC 60601-1. Several specific safety mechanisms have been incorporated into the VENTILAIR 11.
Here's an analysis of the provided text to extract the acceptance criteria and study information for the Hamilton Medical VENTILAIR II Medical Air Compressor:
The provided text is a 510(k) summary for the Hamilton Medical VENTILAIR II Medical Air Compressor. The purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to an already legally marketed device (predicate device). This typically involves comparing characteristics and performance data. The document does not describe acceptance criteria in the sense of predefined thresholds for a study to pass, but rather presents performance characteristics of the VENTILAIR II and compares them to predicate devices to establish substantial equivalence.
It's important to note that a 510(k) summary often summarizes testing, and a detailed study protocol with explicit acceptance criteria might be in the full submission, but not fully reproduced here.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a substantial equivalence submission, the "acceptance criteria" are implicitly the performance characteristics of the predicate devices, and the "reported device performance" is that of the VENTILAIR II. The goal is to show the VENTILAIR II performs as well as or better than the predicates for the relevant characteristics.
| Characteristic | Predicate Device Performance Examples (Range across predicates) | VENTILAIR II Performance | Implicit Acceptance Criteria (Substantial Equivalence) |
|---|---|---|---|
| Intended Use | Source of compressed air for various medical devices, including ventilators | Independent/backup 30 psi compressed air source for GALILEO and RAPHAEL ventilators | Comparable intended use (providing compressed air for medical ventilators). |
| Filtering | Unspecified to $\le$ 1 micron (Pre-compression HEPA, water trap filter) | $\le$ 5 microns at output; 0.5 micron filter in ventilator input | Effective filtration to ensure clean air supply, comparable to or better than predicates. The 5 micron output, coupled with the ventilator's 0.5 micron filter, likely deemed equivalent or superior. |
| Water Trap | Yes, with automatic vaporization | Yes, with automatic vaporization | Presence and function of water trap for removing moisture, comparable to predicates. |
| Pressure Relief Valve | Set to 59 PSIG - 85 PSIG | Set to 32 PSIG | Presence and functionality of a pressure relief valve for safety. The set point differs, but is appropriate for its intended output pressure. |
| Auto Backup Pressure (On) | Not available, 40.5 PSIG, or optional at 45 PSIG | On at 30 PSIG | Functionality for automatic backup. Set point appropriately aligned with intended operating pressure (30 psi nominal). |
| Auto Backup Pressure (Off) | 50 PSIG or 55 PSIG | Off at 38 PSIG | Functionality for automatic backup. Set point appropriately aligned with intended operating pressure (30 psi nominal). |
| Electrical Rating (Voltage) | 102 V - 132 V | 115 V $\pm$ 10 % | Compatibility with standard electrical outlets for medical equipment. |
| Electrical Rating (Hertz) | 60 Hertz | 60 Hertz | Compatibility with standard electrical frequencies. |
| Electrical Rating (Power) | Unspecified to 500 W | 466 W | Reasonable power consumption for the device's function. |
| Overcurrent Protection | Unspecified, Fuse, or Circuit breaker | Fuse | Presence of safety measures for electrical overcurrents. |
| Output | 30 l/min at 44 PSIG; 45 l/min at 50 PSIG; 55 l/min at 50 PSIG | 40 l/min at 30 PSIG | Sufficient air output capacity for its intended use (driving Hamilton ventilators). The pressure output (30 PSIG) is specific to the stated operating pressure of GALILEO and RAPHAEL ventilators. |
| Dew Point Depression | Unspecified, 5 °C below room temperature at 30 l/min, > 3 °F below room temperature at 55 l/min | 3.3 °C below room temperature at 40 l/min | Effective drying capability to prevent condensation and ensure quality medical air. |
| Input/Output Interface | Various DISS fittings | ¾" - 16 male DISS fitting with internal check valve (1 input, 1 output) | Standardized and safe connection for air supply. |
| Ambient Environment (Temp) | 20 to 104 °F | 50 to 104 °F | Operability within typical clinical environmental conditions. |
| Ambient Environment (RH) | 30 to 99 % non-condensing RH | < 85 % RH | Operability within typical clinical environmental conditions regarding humidity. |
| Ambient Environment (Altitude) | Unspecified to 13,000 ft max. altitude | 7,200 ft maximum altitude | Operability across a reasonable range of altitudes. |
| Noise Level | 46 to < 55 dB(A) | < 50 dB(A) | Noise levels acceptable for a clinical environment. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a "sample size" in the context of patients or individual devices tested in a clinical trial. The testing described is "laboratory performance verification and validation test data," which implies engineering and functional testing on units of the device.
- Test Set Sample Size: Not specified as a number of devices or subjects. It is implied that at least one Ventilair II unit was subjected to the listed performance tests.
- Data Provenance: The testing appears to be retrospective in the sense that it evaluates the performance of a manufactured device according to established engineering standards and comparisons. The location of the testing is not explicitly stated but is implicitly associated with Hamilton Medical AG (Switzerland) or its US subsidiary (Reno, NV). It is laboratory-based testing, not clinical data from patients in a specific country.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This section is not applicable as the described testing involves objective engineering and performance verification against known specifications and predicate device characteristics, not expert interpretation of medical images or patient data to establish "ground truth." There is no mention of human experts defining outcomes for test data in this context.
4. Adjudication Method for the Test Set
This section is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies where multiple human readers interpret data, and discrepancies need to be resolved. The testing described here is objective measurement of physical and electrical properties.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study involves multiple human readers evaluating cases, often with and without AI assistance, to measure diagnostic performance. The VENTILAIR II is a medical air compressor, not a diagnostic imaging device or an AI-powered analytical tool, so such a study would not be relevant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
No, a standalone algorithm performance study was not done. The VENTILAIR II is an electromechanical and pneumatic device with no software-based components, let alone an AI algorithm. Its performance is evaluated through direct measurement of its physical output and adherence to safety standards.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation of the VENTILAIR II is based on:
- Engineering specifications and standards: Compliance with IEC 60601-1 and other relevant safety and performance standards.
- Physical measurements: Direct measurements of output pressure, flow rate, dew point, noise level, electrical ratings, etc.
- Comparison to predicate device characteristics: The performance data of the legally marketed predicate devices (Draeger Medical Air Compressor, Infrasonics Air Star Portable Compressor, Bennett MC-2 Mobile Air Compresor) serve as the benchmark for demonstrating substantial equivalence.
8. The Sample Size for the Training Set
This section is not applicable. The VENTILAIR II is an electromechanical device with no AI or machine learning components requiring a "training set" of data.
9. How the Ground Truth for the Training Set was Established
This section is not applicable for the same reason as point 8.
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