(259 days)
The monitors are intended to be used for monitoring, storing, and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates. The monitors are intended healthcare professionals in hospital environments.
The monitored physiological parameters include: ECG, respiration (RESP), temperature (TEMP), oxygen saturation of arterial blood (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), cardiac output (C.O.), anesthetic gas (AG), bispectral index (BIS), respiration mechanics (RM) and impedance cardiography (ICG).
BIS is intended for use on adult and pediatric patients.
ICG monitoring is intended for use on adults only.
The arrhythmia detection and ST Segment analysis are intended for adult patients.
The monitors are additionally intended for use during patient transport inside hospitals.
The monitors are not intended for MRI environments.
V series Patient Monitor including elite V5, elite V6 and elite V8 which can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time.
The V series Patient Monitor realize the monitoring of physiological parameters by configuration with different parameter modules which include SpO2 (pulse oxygen saturation, pulse rate and SpO2 plethysmogram) with EDAN SpO2 module or Nellcor SPO2 module, NIBP (systolic pressure, diastolic pressure, mean pressure and pulse rate), TEMP, ECG, RESP(respiration), CO2, IBP, C.O. and AG(anesthetic gas), RM(respiratory mechanics), BIS(bispectral index) and ICG(impedance cardiography).
The above is the maximum configuration for V series Patient Monitor, the user may select different monitoring parameters in according with their requirements.
elite V5 configures with 12.1-inch color TFT touch screen , elite V6 and elite V8 with same screen except different sizes 15-inch and 17-inch separately. Three models are all build-in Lithium-ion battery, support software upgrade online and networking.
The provided document is a 510(k) Premarket Notification for the Edan Instruments, Inc. Patient Monitor (models elite V5, elite V6, and elite V8). It does not contain primary study data with reported performance metrics against specific acceptance criteria for most of the listed physiological parameters. Instead, it focuses on demonstrating substantial equivalence to predicate devices by comparing specifications and stating compliance with relevant standards.
However, based on the information provided, specifically in the "Comparison to Primary Predicate elite V8" and "Comparison to the predicate device BeneView T8" tables, we can extract the acceptance criteria (from the "Proposed device" column, implying these were the target specifications) and the "reported device performance" as being equivalent to these criteria where a "Same" or "Similar" justification is provided and no specific performance numbers are listed for the proposed device, or where identical specifications are listed for both proposed and predicate devices.
Here's an attempt to structure the information, focusing on the comparison tables as they implicitly define the acceptance criteria by stating the proposed device meets or is similar to the predicate's established performance:
1. Table of Acceptance Criteria and Reported Device Performance
Since the document is a 510(k) submission focused on substantial equivalence, specific "acceptance criteria" for performance are broadly defined by the specifications of the predicate devices and compliance with recognized standards. The "reported device performance" is then claimed to meet or be similar to these specifications. Below is a selection of parameters from the comparison tables, structured to reflect this.
| Parameter (Module) | Acceptance Criteria (from Predicate/Proposed Spec) | Reported Device Performance (as per claim of similarity/equivalence) | Justification/Notes |
|---|---|---|---|
| ECG Monitor | |||
| HR Measurement Range (Adult) | 15 to 300 bpm | 15 to 300 bpm | Same as predicate. |
| HR Accuracy | ±1 bpm or ±1%, whichever is greater | ±1 bpm or ±1%, whichever is greater | Same as predicate. |
| ST Measurement Range | -2.0 mV ~ +2.0 mV | -2.0 mV ~ +2.0 mV | Same as predicate. |
| ST Accuracy | -0.8 mV to +0.8 mV: ±0.02 mV or 10%, whichever is greater. Beyond this range: not specified. | -0.8 mV to +0.8 mV: ±0.02 mV or 10%, whichever is greater. Beyond this range: not specified. | Same as predicate. |
| RESP Monitor | |||
| RR Measurement Range (Adult) | 0 to 120 rpm | 0 to 120 rpm | Same as predicate. |
| RR Accuracy (Adult) | 6 to 120 rpm: ±2 rpm, 0 to 5 rpm: not specified (for elite V8 predicate) | ||
| 7 to 150 rpm: ±2 rpm or ±2%, whichever is greater (for BeneView T8 predicate) | Adult: 6 to 120 rpm: ±2 rpm, 0 to 5 rpm: not specified | ||
| Similar to BeneView T8, implying within predicate's performance range. | Claimed as "Same" or "Similar" to predicates. For BeneView T8 comparison, specific accuracy differs slightly but deemed "Similar." Proposed device claims better accuracy than one predicate. | ||
| Apnea Alarm | 10s, 15s, 20s, 25s, 30s, 35s, 40s | 10s, 15s, 20s, 25s, 30s, 35s, 40s | Same as predicate. |
| NIBP Monitor | |||
| Overall Accuracy | Max mean error: ±5 mmHg, Max standard deviation: 8 mmHg | Max mean error: ±5 mmHg, Max standard deviation: 8 mmHg | Same as predicate. |
| Overpressure Protection (Pediatric) | 240±3mmHg (from BeneView T8 predicate) | 245±3mmHg (proposed Edan device) | Deemed "Similar". Slightly higher value for proposed device. |
| PR from NIBP Accuracy | ±3bpm or 3.5%, whichever is greater (from elite V8 predicate) | ||
| ±3bpm or ±3%, whichever is greater (from BeneView T8 predicate) | ±3bpm or 3.5%, whichever is greater (proposed Edan device) | Deemed "Same" or "Similar" to predicates. Ranges vary slightly between predicate types. | |
| SpO2 Monitor (EDAN) | |||
| Accuracy (Adult/Pediatric, no motion) | 70 to 100%: ±2% | 70 to 100%: ±2% | Same as predicate. |
| Accuracy (Neonates, no motion) | 70 to 100%: ±3% | 70 to 100%: ±3% | Same as predicate. |
| PR Accuracy | ±2bpm (Elite V8 predicate) | ||
| ±3 bpm (measured without motion), ±5 bpm (measured with motion) (BeneView T8 predicate) | ±2bpm (proposed Edan device) | Deemed "Similar" between predicates, implying satisfactory performance. | |
| Temperature Monitor | |||
| Accuracy | ±0.1°C (±0.2 °F) | ±0.1°C (±0.2 °F) | Same as predicate. |
| IBP Monitor | |||
| Accuracy | ±2% or ±1 mmHg, whichever is greater (without sensor) | ±2% or ±1 mmHg, whichever is greater (without sensor) | Same as predicate. |
| CO2 Monitor (Sidestream) | |||
| CO2 Measurement Range | 0 mmHg to 150 mmHg (proposed and elite V8 predicate) | ||
| 0 to 99 mmHg (BeneView T8 predicate) | 0 mmHg to 150 mmHg (proposed Edan device) | Deemed "Similar" to predicates. Proposed device range is better than BeneView T8. | |
| AwRR Accuracy | EDAN: Respiratory rate ≤60rpm: ± 2mmHg, 0mmHg to 40mmHg, ± 5% of reading, 41mmHg to 70mmHg, ± 8% of reading, 71mmHg to 100mmHg, ± 10% of reading, 101mmHg to 150mmHg, Respiratory rate >60rpm: ±12% or ± 4mmHg of reading, whichever is greater. Respironics: ± 2 mmHg, 0 to 40 mmHg, ± 5 % of reading, 41 to 70 mmHg, ± 8 % of reading, 71 to 100 mmHg, ± 10 % of reading, 101 to 150 mmHg, ± 12% of reading, RR is over 80 rpm (Proposed device in comparison to BeneView T8) | This detailed accuracy is listed as the proposed device's performance. BeneView T8 predicate had a simpler accuracy spec (0 to 38 mmHg: ±2 mmHg, 39 to 99 mmHg: ±5% of the reading+0.08% of (the reading-38)). | The proposed device offers specific accuracy tiers based on RR and CO2 levels, differing markedly from one predicate but is explicitly stated as the device's performance. |
| AG Monitor | |||
| Warm-up time |
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.