(271 days)
The LifeWindow™ LW8 Lite is a multi-parameter physiological patient monitor indicated for continuous measurement of the following parameters:
- · ECG waveforms from 3 or 5 lead measurements
- · Heart Rate (from ECG)
· Non-invasive blood pressure (NIBP) automatically measures systolic and diastolic pressure and pulse rate, while calculating mean arterial pressure (MAP). The equation used to calculate MAP provides an approximate value
- · End-tidal CO2 concentration (EtCO2) Mainstream or Sidestream
- · Inspired CO2 concentration (insCO2) Mainstream or Sidestream
- · Fractional Inspired Oxygen (FiO2)
- · Acoustic Respiration Rate (RRa)
- · Respiration Rate (from bioimpedance or EtCO2 measurement, or RRa)
- Two Temperature channels
- · Two Invasive Pressure channels (IP1, IP2)
- · Pulse Rate in BPM (from Pulse CO-Oximetry and/or NIBP)
· Pulse CO-Oximetry and pulse rate - the LifeWindow LW8 Lite Pulse CO-Oximeter functions and accessories incorporating Masimo technology are indicated for the continuous nomitoring of the following parameters during both no motion and motion conditions, and for patients who are well or poorly perfused:
- o Functional oxygen saturation of arterial hemoglobin (SpO2)
- o Carboxyhemoglobin saturation (SpCO)
- o Methemoglobin saturation (SpMet)
- o Total hemoglobin concentration (SpHb)
The defined patient population is adult through neonatal patients with appropriate accessories. The monitor displays a range of physiological waveforms and indices and provides alarms.
The LifeWindow™ LW8 Lite multi-parameter patient monitor may be used in hospital-type facilities, surgery centers, and emergency facilities. For professional use only. It is not intended for helicopter transport. hospital ambulance, or home use.
The LifeWindow™ LW8 Lite Multi-Parameter Monitor is designed for the measurement and monitoring of multiple physiological parameters simultaneously in a single patient.
LifeWindow™ LW8 Lite Multi-Parameter Monitor is constructed with the following features:
- I Compact monitor design in a rugged aluminum chassis
- Integration of cleared vital signs modules
- 트 Patients from neonates through adults
- I High Definition 8.4" TFT screen with touch screen operation
- 트 Multi-channel vital signs trace display with variable sweep speeds
- I Hardcopy printing via an integrated strip chart or compatible printer
- 트 Waveforms sweep speeds from 6.25mm/s up to 50mm/s
- . Mainstream and sidestream Capnography options
- I Specification of cleared third-party patient-applied accessories
This document describes the 510(k) premarket notification for the LifeWindow™ LW8 Lite multi-parameter patient monitor. The submission primarily relies on demonstrating substantial equivalence to predicate devices through non-clinical testing against recognized standards and guidance documents. No clinical studies were submitted.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from recognized national and international standards and guidance documents regarding medical device safety, electromagnetic compatibility, usability, alarms, and specific physiological parameter monitoring. The reported device performance indicates compliance with these standards.
| Parameter/Characteristic | Acceptance Criteria (from Standards/Guidance) | Reported Device Performance (Compliance) |
|---|---|---|
| General Safety & Performance | ||
| Electrical Safety | IEC 60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007) + AM1 (2012) or IEC 60601-1: 2012 | Met acceptance criteria for compliance to the standards. |
| Electromagnetic Compatibility | IEC 60601-1-2:2007, 3rd Edition; AIM Standard 7351731:2016, Rev. 1 | Met acceptance criteria for compliance to the standards. |
| Usability/Human Factors | IEC 60601-1-6:2010; IEC 62366:2007; Applying Human Factors and Usability Engineering To Medical Devices - Guidance | Usability evaluation conducted, device found safe and effective for intended users, uses, and environments. |
| Medical Alarms | IEC 60601-1-8:2006+A1:2012 | Met acceptance criteria for compliance to the standards. |
| Risk Management | ISO 14971 | Met acceptance criteria for residual risks. |
| Software Lifecycle | IEC 62304:2006 (First Edition) + A1:2015; IEC 62304 with software safety class C; FDA Content of Premarket Submissions for Management of Cybersecurity | Software verified to requirements and validated to meet specified intended use(s). |
| Specific Physiological Parameters | ||
| ECG Monitors | IEC 60601-2-27:2011, 3rd Edition; Cardiac Monitor Guidance (including Cardiotachometer and Rate Alarm) | Met acceptance criteria for compliance to the standards and guidance. |
| NIBP (Automated) | IEC 80601-2-30:2013, Edition 1.1; FDA Non-invasive Blood Pressure (NIBP) Guidance Document | Met acceptance criteria for compliance to the standards and guidance. |
| Invasive Blood Pressure | IEC 60601-2-34:2011, 3rd Edition | Met acceptance criteria for compliance to the standards. |
| Multifunction Patient Monitors | IEC 60601-2-49:2011 | Met acceptance criteria for compliance to the standards. |
| Respiratory Gas Monitors | ISO 80601-2-55:2011, 1st Edition | Met acceptance criteria for compliance to the standards. |
| Clinical Thermometers | ISO 80601-2-56:2009; Guidance on the Content of Premarket Notification [510(k)] Submissions for Clinical Electronic Thermometers | Met acceptance criteria for compliance to the standards and guidance. |
| Pulse Oximeter | ISO 80601-2-61:2011, 1st Edition; Pulse Oximeters Premarket Notification Submissions [510(k)s] Guidance | Met acceptance criteria for compliance to the standards and guidance. |
| Specific Performance Values (Comparison to Predicate) | ||
| ECG Heart Rate Measurement Range | 10 - 300 BPM (Adult); 10 - 350 BPM (Pedi/Neo) | Same |
| ECG Heart Rate Resolution | 1 BPM | Same |
| ECG Heart Rate Accuracy | ± 1% or 1 BPM, whichever is greater | Same |
| Resp Rate (Impedance) Range | 0 to 150 BPM | Same |
| Resp Rate (Impedance) Resolution | 1 BPM | Same |
| Resp Rate (Impedance) Accuracy | ±2 BPM or ±2%, whichever greater | Same |
| NIBP Systolic Range | Adult: 40 - 260; Pediatric: 40 - 230; Neonatal: 40 - 130 | Same |
| NIBP Diastolic Range | Adult: 20 – 200; Pediatric: 20 - 160; Neonatal: 20 - 100 | Same |
| NIBP MAP Range | Adult: 26 – 220; Pediatric: 26 - 183; Neonatal: 26 - 110 | Same |
| NIBP Pressure Accuracy | Meets accuracy requirements of ANSI/AAMI SP10:2002(R)2008, EN1060-4:2004 and ISO 81060-2:2009 (Clinical Accuracy) | Same |
| NIBP Pressure Transducer Acc. | ±3mmHg between 0 mmHg and 300 mmHg | Same |
| NIBP PR Range | 30 - 220 BPM | Same |
| NIBP Pulse Rate Accuracy | 2% or 3 bpm, whichever is greater | Same |
| SpO2 Measurement Range | 0 - 100% | Same |
| SpO2 Resolution | 1% | Same |
| SpO2 Accuracy (No Motion) | Adults, Pediatric, Infants: 60–80 ± 3%, 70–100 ± 2%; Neonates: 70–100 ± 3% | Same |
| SpO2 Accuracy (Motion) | 70–100 ± 3% | Same |
| SpO2 Accuracy (Low Perfusion) | 70–100 ± 2% | Same |
| Pulse Rate (from SpO2) Range | 25–240 BPM | Same |
| Pulse Rate (from SpO2) acc. (No motion) | ± 3 BPM | Same |
| Pulse Rate (from SpO2) acc. (Motion) | ± 5 BPM | Same |
| Pulse Rate (from SpO2) acc. (Low Perf.) | ± 3 BPM | Same |
| Pulse Rate (from SpO2) Resolution | 1 BPM | Same |
| SpCO Measurement Range | 0–99% | Same |
| SpCO Accuracy (No Motion) | Adults, Pediatric, Infants: 1 - 40 ± 3% | Same |
| SpMet Measurement Range | 0 - 99.9% | Same |
| SpMet Accuracy | Adults, Pediatric, Infants, Neonates: 1 - 15 ± 1% | Same |
| Perfusion Index (PI) Range | 0.02 – 20% | Same |
| Perfusion Index (PI) Resolution | 0.01 (PI 10) | Same |
| SpHb Measurement Range | 0 - 25 g/dL | Same |
| SpHb Accuracy | Adults, Pediatric: 8 - 17 ± 1 g/dL | Same |
| SpHb Resolution | 0.1 g/dL | Same |
| SpHb Alarm Range | 1.0 - 24.5 g/dL | Same |
| SpOC Measurement Range | 0 - 35 ml/dL | Same |
| SpOC Resolution | 1 ml/dL | Same |
| PVI Measurement Range | 0 - 100% | Same as predicate Radical-7, not implemented on primary predicate A3. |
| PVI Resolution | 1 % | Same as predicate Radical-7, not implemented on primary predicate A3. |
| RRa (Acoustic) Range | 4 - 70 bpm | Same as predicate Radical-7, not implemented on primary predicate A3. |
| RRa (Acoustic) Accuracy | Adults/Pediatric: 4 - 70 ± 1 BPM | Same as predicate Radical-7, not implemented on primary predicate A3. |
| RRa (Acoustic) Resolution | 1 BPM | Same as predicate Radical-7, not implemented on primary predicate A3. |
| Temperature Accuracy | Rated Range: 35.0 - 42.0°C (95.0 - 107.6°F): ± 0.3 °C; Extended Range: -1.0 - 34.9°C (30.2 – 94.8°F) and 42.1 – 45.0°C: ± 0.4 °C | Equivalent Function, LifeWindow complies with current industry standard. |
| Temperature Resolution | 0.1°C (0.2°F) | Same |
| IBP Pressure Measurement Range | -40 to +300 mmHg | Equivalent Function with slightly different range - claims of the LW8 are within the claims of the predicate. |
| IBP Pressure Measurement Acc. | ± 4 mmHg or ±4% of the reading, whichever is greater | Same |
| IBP Resolution | 1 mmHg | Same |
| EtCO2 (Mainstream) Range | Percent: 0 – 19.7; mmHg: 0 – 150; kPa: 0 – 20 | Same |
| EtCO2 (Mainstream) Resolution | 1 mmHg | Same |
| EtCO2 (Mainstream) Accuracy | 0 - 40 mmHg ± 2 mmHg; 41 - 70 mmHg ± 5%; 71 - 100 mmHg ± 8%; 101 - 150 mmHg ± 10% | Same |
| awRR (Mainstream) Range | 0 - 150 BPM | Same |
| awRR (Mainstream) Accuracy | ± 1 BPM | Same |
| InsCO2 (Mainstream) Range | 3 to 50 mmHg | LifeWindow specification is per cleared CO2 module. |
| InsCO2 (Mainstream) Resolution | 1 mmHg | Equivalent Function not offering decimal point resolution (predicate offers 0.1 mmHg) |
| InsCO2 (Mainstream) Accuracy | 3 - 40 mmHg ± 2 mmHg; 41 - 50 mmHg ± 5% | Same |
| EtCO2 (Sidestream) Range | 0 - 19.7%; 0 – 150 mmHg; 0 – 20 kPa | Same |
| EtCO2 (Sidestream) Resolution | 1 mmHg | Same |
| EtCO2 (Sidestream) Accuracy | 0 - 40 mmHg ± 2 mmHg; 41 - 70 mmHg ± 5%; 71 - 100 mmHg ± 8%; 101 - 150 mmHg ± 10% (when RR > 80 rpm, all range is ±12%) | Same |
| awRR (Sidestream) Range | 2 - 150 BPM | Same |
| awRR (Sidestream) Accuracy | ± 1 BPM | Same |
| InsCO2 (Sidestream) Range | 3 to 50 mmHg | Same |
| InsCO2 (Sidestream) Accuracy | 3 - 40 mmHg ± 2 mmHg; 41 - 50 mmHg ± 5% | Same |
| InsCO2 (Sidestream) Resolution | 1 mmHg | Equivalent Function with no decimal point resolution (predicate offers 0.1 mmHg) |
| FiO2 Measurement Range | 0-100% Oxygen | Same |
| FiO2 Display Precision | 1% (Resolution) | Equivalent Function with no decimal point resolution (predicate offers 0.1%) |
| FiO2 Accuracy & Repeatability |
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).