(230 days)
The Early Vue VS30 is intended to measure, display, alarm and, record physiological information of adult, pediatric and neonatal patients in hospitals and in out-of-hospital patient care is administered by a healthcare professional (such as clinics, outpatient surgery facilities, long-term care facilities, and physician offices). It is not intended for use in mobile settings such as ambulances and aircraft. Clinical users may use the monitor during patient transport within a healthcare facility.
The intended use of measurement parameters for each patient type is shown in table below (Parameter (patient types)): Non-invasive BP--NBP (Adult, Pediatric, Neonatal); SpO2 --Masimo rainbow SET or Philips FAST (Adult, Pediatric, Neonatal); Pulse Rate -- PR -- derived from SpO2 or NBP (Adult, Pediatric, Neonatal); Temperature-Predictive, Temporal (Adult, Pediatric, Neonatal); end tidal CO2--etCO2 (Adult, Pediatric, Neonatal); Respiration Rate: airway respiration--awRR (Adult, Pediatric, Neonatal); Respiration Rate: acoustic respiration--RRa (Adult, Pediatric);
Non-invasive Total Hemoglobin--SpHb (Adult, Pediatric)
Contra-indications: Not for transport outside the healthcare facility. Not for use in home setting.
The subject device EarlyVue VS30 is a platform redesigned from the predicate device Suresign VS4 to provide the measurement of the same physiological parameters. It is a multi-parameter compact, portable monitor, offering several configurations and optional features that are intended to meet the customer's needs. The VS30 is designed with a simple, intuitive user interface for ease of operation. It is used to measure or monitor NBP, SpO2, SpHb, RRa, CO2 and optional temperature primarily in non-acute settings.
The subject VS30 also provides the wireless option. The wireless functions for VS30 are for the monitors to communicate with the hospital EMR system or to communicate with Philips IGS software over the hospital's wireless infrastructure.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:
Device: EarlyVue VS30 Vital Signs Monitor
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the EarlyVue VS30 are implied by its comparison to the predicate device, Philips SureSigns VS4. The document asserts that the VS30 has the "same fundamental technological characteristics" and that "performance data demonstrates the subject device Early Vue VS30 is as safe and effective as the predicate device for all the measurements." Therefore, the predicate device's specifications serve as the de facto acceptance criteria for each measurement parameter.
| Parameter | Acceptance Criteria (Predicate Device VS4 Performance) | Reported Device Performance (EarlyVue VS30) |
|---|---|---|
| Non-invasive BP (NBP) | Technique: Oscillometric, stepwise deflation. | |
| Measurement Range: Adult: Systolic 30-270mmHg, Diastolic 10-240mmHg, Mean 20-250mmHg; Pediatric: Systolic 30-180mmHg, Diastolic 10-150mmHg, Mean 20-160mmHg; Neonate: Systolic 30-130mmHg, Diastolic 10-100mmHg, Mean 20-120mmHg. | ||
| Accuracy: Max Std. Dev: 8 mmHg, Max Mean Error: +/- 5 mmHg. | ||
| Derived PR Accuracy: 40-100 bpm: +/- 5 bpm; 101-200 bpm: +/- 5% of reading; 201-300 bpm: +/- 10% of reading. | ||
| Initial Cuff Inflation: Adult: 160 mmHg; Pediatric: 140 mmHg; Neonatal: 100 mmHg. | Technique: Oscillometric, stepwise deflation. | |
| Measurement Range: Adult: Systolic 30-270mmHg, Diastolic 10-240mmHg, Mean 20-250mmHg; Pediatric: Systolic 30-180mmHg, Diastolic 10-150mmHg, Mean 20-160mmHg; Neonate: Systolic 30-130mmHg, Diastolic 10-100mmHg, Mean 20-120mmHg. | ||
| Accuracy: Max Std. Dev: 8 mmHg, Max Mean Error: +/- 5 mmHg. | ||
| Derived PR Accuracy: 40-100 bpm: +/- 5 bpm; 101-200 bpm: +/- 5% of reading; 201-300 bpm: +/- 10% of reading. | ||
| Initial Cuff Inflation: Adult: 160 mmHg; Pediatric: 140 mmHg; Neonatal: 100 mmHg. | ||
| Reported as "Identical" | ||
| SpO2 (Philips SpO2) | Measurement Range: SpO2: 0-100%, Pulse Rate: 30-300 bpm. | |
| PR Accuracy: Greater of +2% or +1 bpm. | ||
| Resolution: SpO2: 1%. | ||
| Accuracy (70-100%): Philips reusable sensors: +/- 2% (M1191B, BL, A, AL, M1192A), +/- 3% (M1191T, M1192T, M1193T adult, M1193A, M1194A, M1195A, M1196A, T, S), +/- 4% (M1193T neonatal). Philips disposable sensors: +/- 2% (M1132A, M1133A, M1134A), +/- 3% (M1131A). | Measurement Range: SpO2: 0-100%, Pulse Rate: 30-300 bpm. | |
| PR Accuracy: Greater of +2% or +1 bpm. | ||
| Resolution: SpO2: 1%. | ||
| Accuracy (70-100%): Philips reusable sensors: +/- 2% (M1191B, BL, A, AL, M1192A), +/- 3% (M1191T, M1192T, M1193T adult, M1193A, M1194A, M1195A, M1196A, T, S), +/- 4% (M1193T neonatal). Philips disposable sensors: +/- 2% (M1132A, M1133A, M1134A), +/- 3% (M1131A). | ||
| Reported as "Identical" | ||
| SpO2 (Masimo SpO2) | Measurement Range: 0-100%. | |
| Resolution: 1%. | ||
| Accuracy: No motion: 60-80 +/- 3% (adult/ped/inf), 70-100 +/- 2% (adult/ped/inf), 70-100 +/- 3% (neonates). Motion: 70-100 +/- 3% (all). Low perfusion: 70-100 +/- 2% (all). | Measurement Range: 0-100%. | |
| Resolution: 1%. | ||
| Accuracy: No motion: 60-80 +/- 3% (adult/ped/inf), 70-100 +/- 2% (adult/ped/inf), 70-100 +/- 3% (neonates). Motion: 70-100 +/- 3% (all). Low perfusion: 70-100 +/- 2% (all). | ||
| Reported as "Identical" | ||
| Pulse Rate (Masimo SpO2) | Range: 25-240 bpm. | |
| Resolution: 1 bpm. | ||
| Accuracy: +/- 5 bpm motion or low perfusion (worst case). | Range: 25-240 bpm. | |
| Resolution: 1 bpm. | ||
| Accuracy: +/- 5 bpm motion or low perfusion (worst case). | ||
| Reported as "Identical" | ||
| SpHb (Masimo) | Range: 0-25 g/dL. | |
| Accuracy: 8-17 g/dL (arterial/venous) adults/pediatrics: +/- 1 g/dL. | ||
| Resolution: 0.1 g/dL. | Range: 0-25 g/dL. | |
| Accuracy: 8-17 g/dL (arterial/venous) adults/pediatrics: +/- 1 g/dL. | ||
| Resolution: 0.1 g/dL. | ||
| Reported as "Identical" | ||
| Respiration Rate (RRa - Masimo) | Range: 0-70 bpm. Accuracy: 4-70 bpm: +/- 1 bpm (adults >30kg and adults/pediatrics >10kg). Resolution: 1 bpm. | Range: 0-70 bpm. Accuracy: 4-70 bpm: +/- 1 bpm (adults >30kg and adults/pediatrics >10kg). Resolution: 1 bpm. |
| Reported as "Identical" | ||
| Temperature (Predictive) | Measurement Range: 26.7–43.3°C (80–110°F). | |
| Accuracy (monitoring mode): +/- 0.1°C (+/- 0.2°F). | ||
| Measurement Time: Oral: 4-6s, Adult axillary: 12-15s, Pediatric axillary: 10-13s, Rectal: 10-13s. | ||
| Resolution: 0.1°C. | ||
| Measurement Sites: Oral, rectal, axillary. | Measurement Range: 26.7–43.3°C (80–110°F). | |
| Accuracy (monitoring mode): +/- 0.1°C (+/- 0.2°F). | ||
| Measurement Time: Oral: 4-6s, Adult axillary: 12-15s, Pediatric axillary: 10-13s, Rectal: 10-13s. | ||
| Resolution: 0.1°C (+/- 0.1°F). | ||
| Measurement Sites: Oral, rectal, axillary. | ||
| Reported as "Identical" | ||
| Temperature (Temporal) | Range: 16°C - 43°C. | |
| Clinical Accuracy: +/- 0.2°F or 0.1°C per ASTM E1112. | ||
| Arterial heat balance range: 34.5°C - 43°C (Normal: 35.9°C to 37.5°C). | ||
| Resolution: 0.1°C or 0.1°F. | ||
| Response Time: |
§ 870.1100 Blood pressure alarm.
(a)
Identification. A blood pressure alarm is a device that accepts the signal from a blood pressure transducer amplifier, processes the signal, and emits an alarm when the blood pressure falls outside a pre-set upper or lower limit.(b)
Classification. Class II (performance standards).