(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 < 1.00); 0.1 (PI < 10); 1 (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 | <1% vol. O2 if calibrated with 100% vol. O2 | Same |
2. Sample Size Used for the Test Set and the Data Provenance
The submission indicates reliance on non-clinical bench testing and simulations, not clinical studies with patient data. Therefore, there is no "test set" in the context of patient data, nor is there information on data provenance (country of origin, retrospective/prospective).
- For the Usability / Human Factors summative study, there were 15 representative professional users (USA) in a simulated critical care scenario with vital signs generation. This is a simulation study, not a clinical data study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. As described above, the studies conducted were non-clinical bench tests and a usability study. There were no "ground truth" experts in the traditional sense of medical image or diagnosis interpretation for patient data. For the usability study, "representative professional users" were involved, but their qualifications beyond being "professional users" are not further detailed.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring expert adjudication was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No MRMC comparative effectiveness study was done. The device is a multi-parameter patient monitor, not an AI-assisted diagnostic tool for interpretation of medical cases by human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is a standalone monitor. The non-clinical tests assess the performance of the device's various physiological measurement algorithms against established standards and predicate device specifications. These tests essentially evaluate the "standalone" performance of the embedded algorithms for each parameter.
7. The Type of Ground Truth Used
For the non-clinical tests, the "ground truth" was established by:
- Reference standards and test equipment: Compliance with international and national standards (e.g., IEC 60601 series, ISO 80601 series, ANSI/AAMI SP10) typically involves testing the device against calibrated reference instruments and simulated physiological signals that represent known "ground truth" values.
- Predicate device specifications: Performance characteristics were compared directly to the specifications of the identified predicate devices, which serve as a reference for equivalence.
8. The Sample Size for the Training Set
Not applicable. This device is a physiological patient monitor and does not describe the use of machine learning algorithms that require a "training set" in the context of large datasets for model development. The software development lifecycle adheres to IEC 62304 standards for medical device software.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set for machine learning.
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September 25, 2019
Digicare Biomedical Technology, Inc. Pedro Miranda VP of Software Engineering 107 Commerce Rd. Boynton Beach, Florida 33426
Re: K183687
Trade/Device Name: LifeWindow LW8 Lite Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MWI, DRT, DSB, BZQ, DXN, DSK, FLL, DQA, DPZ, CCK, CCL Dated: August 21, 2019 Received: August 23, 2019
Dear Pedro Miranda:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for LT Stephen Browning Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K183687
Device Name
Digicare Biomedical LifeWindow™ LW8 Lite multi-parameter patient monitor and accessories
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary in accordance with 21 CFR 807.92
| (a) | (1) | Submitted by: | Digicare Biomedical Technology, Inc.107 Commerce Rd.Boynton BeachFlorida 33426Tel.: +1 (561) 689-0408Fax: +1 (561) 689-0021pedro(at)digicarebiomedical.com |
|---|---|---|---|
| Contact Person: | Mr. Pedro Miranda | ||
| Position/Title: | Vice President of Software Engineering | ||
| Date of Preparation: | September 19, 2019 | ||
| (2) | Trade Name: | LifeWindow™ LW8 Lite Multi-ParameterMonitor |
Common/Classification Name: Monitor, Physiological, Patient
Product Code(s):
| Regulation No. | Classification Name | ProductCode | DeviceClass |
|---|---|---|---|
| Main Product Code | |||
| 21 CFR §870.2300 | Monitor, Physiological, Patient (Without ArrhythmiaDetection or Alarms) | MWI | Class II |
| Subsequent Product Code(s) | |||
| 21 CFR § 870.2300 | Cardiac monitor (including cardiotachometer andrate alarm) Cardiac monitor | DRT | Class II |
| 21 CFR § 870.2770 | Impedance plethysmograph | DSB | Class II |
| 21 CFR § 868.2375 | Breathing frequency monitor | BZQ | Class II |
| 21 CFR § 870.1130 | Non-invasive blood pressure measurement system | DXN | Class II |
| 21 CFR § 870.1110 | Blood pressure computer | DSK | Class II |
| 21 CFR § 880.2910 | Clinical Electronic Thermometer | FLL | Class II |
| 21 CFR § 870.2700 | Pulse Oximeter | DQA | Class II |
| 21 CFR § 870.2710 | Ear Oximeter | DPZ | Class II |
| 21 CFR § 868.1400 | Carbon Dioxide Gas Analyzer | CCK | Class II |
| 21 CFR § 868.1720 | Oxygen Gas Analyzer | CCL | Class II |
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(3) Predicate Device(s): Substantial Equivalence to:
| K Number | Model | Manufacturer |
|---|---|---|
| K131898 | Biolight A Series and Q Series Patient Monitors | Guangdong BiolightMeditech Co., Ltd. |
| K122290 | EnviteC MySign® O OxygenMeasuring Device | EnviteC-Wismar GmbH |
| K110028 | Radical-7 Pulse CO-Oximeter | Masimo Corporation |
(4) Description of Device:
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
(5) Intended use:
Multi-parameter monitoring of patient vital signs has been a standard of care for over 25 years and is established globally. Multi-parameter patient monitors provide clinicians with a range of continuous physiological measurements with alarms.
The intended use for the LifeWindow™ LW8 Lite Multi-Parameter Monitor is the same as the predicate device: measurement and monitoring of multiple physiological parameters, in an adult through neonatal patient population, with appropriate patient applied accessories. The LifeWindow™ LW8 Lite Monitor is specified for use in professional healthcare environments by clinical staff.
Indications for Use:
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The LifeWindow™ LW8 Lite is a multi-parameter physiological patient monitor indicated for continuous measurement of the following parameters:
- I ECG waveforms from 3 or 5 lead measurements
- Heart Rate (from ECG)
- l 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
- 트 Inspired CO2 concentration (insCO2) - Mainstream or Sidestream
- I Fractional Inspired Oxygen (FiO2)
- I Acoustic Respiration Rate (RRa)
- 트 Respiration Rate (from bioimpedance or EtCO2 measurement, or RRa)
- Two Temperature channels
- I Two Invasive Pressure channels (IP1, IP2)
- 트 Pulse Rate in BPM (from Pulse CO-Oximetry and/or NIBP)
- I Pulse CO-Oximetry and pulse rate - the LifeWindow LW8 Lite Pulse CO-Oximeter functions and accessories incorporating Masimo technology are indicated for the continuous noninvasive monitoring of the following parameters during both no motion and motion conditions, and for patients who are well or poorly perfused:
- Functional oxygen saturation of arterial hemoglobin (SpO2) o
- Carboxyhemoglobin saturation (SpCO) o
- Methemoglobin saturation (SpMet) o
- Total hemoglobin concentration (SpHb) O
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 hospitals, hospital-type facilities, surgery centers, and emergency facilities. For professional use only. It is not intended for helicopter transport, hospital ambulance, or home use.
Prescription device.
(6) Technological Characteristics:
LifeWindow™ LW8 Lite Multi-Parameter Monitor utilize the same technological principles as the predicate devices to measure patient vital signs: the incorporation of physiological measurement modules, with appropriate accessories. Refer to the following comparison table:
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Page 4 of 24
Comparison of Technological Features to Predicate Devices:
| Product/Feature | LifeWindow™ LW8 LiteMulti-Parameter Monitor | A3 Series Multi-Parameter Monitor | MySign® O OxygenMeasuring Device | Radical-7 Pulse CO-Oximeter | Comparison Analysis | Indications for use: | The LifeWindow™ LW8Lite is a multi-parameterphysiological patientmonitor indicated forcontinuous measurementof the followingparameters:• ECG waveforms from 3or 5 lead measurements• Heart Rate (from ECG)• Non-invasive bloodpressure (NIBP)automatically measuressystolic and diastolicpressure and pulse rate,while calculating meanarterial pressure (MAP).The equation used tocalculate MAP providesan approximate value.• End-tidal CO2concentration (EtCO2) –Mainstream orSidestream• Inspired CO2concentration (insCO2) –Mainstream orSidestream• Fractional InspiredOxygen (FiO2)• Acoustic RespirationRate (RRa)• Respiration Rate (frombioimpedance or EtCO2measurement, or RRa)• Two Temperaturechannels• Two Invasive Pressurechannels (IP1, IP2)• Pulse Rate in BPM(from Pulse CO-Oximetry and/or NIBP) | Patient monitors areintended to be used formonitoring, displaying,reviewing, storing andalarming of multiplephysiological parametersincluding ECG (3-lead or5-lead or 12-leadselectable), arrhythmiadetection, ST segmentanalysis, Heart Rate(HR), Respiration Rate(RESP), Temperature(TEMP), Pulse OxygenSaturation (SpO2), PulseRate (PR), Non-invasiveBlood Pressure (NIBP),Invasive Blood Pressure(IBP), Carbon dioxide(C02), Anesthetic Gas(AG), ImpedanceCardiograph (ICG),Cerebral State Index(CSI), Bispectral Index(HIS), TotalHemoglobin(SpHb),Carboxyhemoglobin(SpCO), andMethemoglobin(SpMet).The arrhythmiadetection, ST segmentanalysis only applied to asingle adult patient.The monitors are to beused in healthcarefacilities by clinicalphysicians or appropriatemedical staff under thedirection of physician.It is not intended forhelicopter transport, | This oxygen measuringdevice MySign® O isdesigned for continuousor spot monitoring ofinspired oxygenconcentrations inbreathing gas.MySign® O can beused for monitoring thebreathing gasesdispensed by thefollowing devices:Anaesthesia breathingsystemsRespiratory equipmentInfant incubatorsOxygen therapysystemsThe system is suitablefor use inside hospitalsas well as duringtransport (except byair), emergencies, andartificial respirationprovided at home. | The Masimo Radical 7Pulse CO-Oximeter andaccessories areindicated for thecontinuous non-invasivemonitoring of functionaloxygen saturation ofarterial hemoglobin(SPO2), pulse rate,carboxyhemoglobinsaturation (SpCO),methemoglobinsaturation (SpMet), totalhemoglobinconcentration (SpHb),and/or respiratory rate(RRa). The MasimoRadical 7 Pulse CO-Oximeter andaccessories areindicated for use withadult, pediatric, andneonatal patients duringboth no motion andmotion conditions, andfor patients who are -well or poorly perfusedin hospitals, hospital-type facilities, mobile,and homeenvironments. Inaddition, the MasimoRadical 7 Pulse CO-Oximeter andaccessories areindicated to provide thecontinuous non-invasivemonitoring dataobtained from theMasimo Radical 7 PulseCO-Oximeter endaccessories offunctional oxygensaturation of arterial | See above- equivalentmonitoring function forspecified parametersand sites |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Manufacturer | Digicare BiomedicalTechnology, Inc. | Guangdong BiolightMeditech Co., Ltd. | EnviteC-Wismar GmbHby Honeywell | Masimo Corporation | |||||||
| Model Number(s) | LW8 | A3 Series | MySign® O | Radical-7 | |||||||
| 510(k) Number | (pending - thissubmission) | K131898 | K122290 | K110028 | |||||||
| Application/Intended use: | Monitor multiplephysiologicalparameters | Monitor multiplephysiologicalparameters | Monitor fractionalinspired Oxygen(FiO2) | Monitor pulse co-oximetry and acousticrespiration rate (RRa) | Equivalent monitoringfunction for specifiedparameters and sites |
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| • Pulse CO-Oximetry and | hospital ambulance, or | hemoglobin (SpO2) and |
|---|---|---|
| pulse rate - the | home use. | pulse rate to multi- |
| LifeWindow LW8 Lite | parameter devices for | |
| Pulse CO-Oximeter | the display of those | |
| functions and | devices. | |
| accessories | ||
| incorporating Masimo | ||
| technology are indicated | ||
| for the continuous | ||
| noninvasive monitoring | ||
| 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 | ||
| hospitals, hospital-type | ||
| facilities, surgery centers, | ||
| and emergency facilities. | ||
| For professional use only. | ||
| lt is not intended for | ||
| helicopter transport, | ||
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| Product/Feature | LifeWindow™ LW8 LiteMulti-Parameter Monitor | A3 Series Multi-Parameter Monitor | MySign® O OxygenMeasuring Device | Radical-7 Pulse CO-Oximeter | Comparison Analysis |
|---|---|---|---|---|---|
| hospital ambulance, orhome use. | |||||
| Alarms | YES | YES | YES | YES | Same |
| Application Site(s) | Patient sites vary byparameter measured | Patient sites vary byparameter measured | Inspired airway path | Pulse co-oximetrysite: digit, toe, ear,foot, forehead;acoustic respiration | Equivalent monitoringfunction at specifiedsites |
| Patient Population | Adult through neonatalpatients | Adult through neonatalpatients; (adults only forarrhythmia and STsegment) | Adult through neonatalpatients | Adult through neonatalpatients | Equivalent monitoringfunction, LW8 doesnot claim Arrhythmiaand ST segment. |
| Cardiac Monitor (ECG) | 3/5 Lead | 3/5/12 Lead | -- | -- | Equivalent functionClaims of the LW8 arewithin the claims of thepredicate. |
| Detector and Alarm,Arrhythmia | -- | Implemented/offered | -- | -- | Arrhythmia detectionnot claimed by subjectdevice - claims of theLW8 are within theclaims of the predicate |
| Monitor, ST Segment withAlarm | -- | Implemented/offered | -- | -- | ST Segmentmonitoring not claimedby subject device -claims of the LW8 arewithin the claims of thepredicate |
| Impedance respiration | Implemented with ECG | Implemented w/ ECG | -- | -- | Equivalent functionwith same technology |
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| of248Page |
|---|
| ----------------------- |
| Product/Feature | LifeWindow™ LW8 LiteMulti-Parameter Monitor | A3 Series Multi-Parameter Monitor | MySign® O OxygenMeasuring Device | Radical-7 Pulse CO-Oximeter | Comparison Analysis |
|---|---|---|---|---|---|
| Acoustic respiration | Masimo (RRa) | -- | -- | Masimo (RRa) | LW8 Acoustic respirationrate utilizes the MasimoRRa which is the sametechnology utilized inpredicate Radical-7 |
| Invasive Blood pressure | YES | YES | -- | -- | Equivalent functionwith samemeasurement principle |
| Non-invasive bloodpressure | Oscillometric | Oscillometric | -- | -- | Equivalent functionwith same technology |
| Patient Temperature | YSI 400 | YSI 400 | -- | -- | Equivalent functionwith samemeasurement principle |
| Pulse co-oximetry | Masimo technology | Masimo technology | -- | Masimo technology | Equivalent functionwith same technology |
| Carbon Dioxide GasAnalyzer | Mainstream andsidestream | Mainstream andsidestream | -- | -- | Equivalent functionwith same technology |
| Inspired Oxygen (FiO2) | EnviteC technology | Paramagnetic | EnviteC technology | -- | Same as the MySignO predicate device.Primary predicate A3offers a different typeof technology formeasuring FiO2. |
| Enflurane gas analyzer | -- | Implemented/offered | -- | -- | LW8 does not |
| Halothane gas analyzer | -- | Implemented/offered | -- | -- | measure nor claimanesthetic agents. |
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| Page 9 of 24 | |||
|---|---|---|---|
| -------------- | -- | -- | -- |
| Product/Feature | LifeWindow™ LW8 LiteMulti-Parameter Monitor | A3 Series Multi-Parameter Monitor | MySign® O OxygenMeasuring Device | Radical-7 Pulse CO-Oximeter | Comparison Analysis |
|---|---|---|---|---|---|
| Nitrous Oxide gasanalyzer | -- | Implemented/offered | -- | -- | therefore there are noclaims related to thesegas measurements -claims of the LW8 arewithin the claims of thepredicate |
| Cerebral State Index(EEG) | -- | Implemented/offered | -- | -- | LW8 does not measurenor claim cerebral stateindex (CSI) by EEGmethod, are no claimsrelated to this parametermeasurements - claimsof the LW8 are within theclaims of the predicate |
| Environment of Use | May be used in hospitals,hospital-type facilities,surgery centers, andemergency facilities. Forprofessional use only. Notintended for helicoptertransport, hospitalambulance, or home use. | (Professional healthcareenvironments). notintended for helicoptertransport, hospitalambulance, or home use | For use inside hospitalsas well as duringtransport (except byair), emergencies, andartificial respirationprovided at home | For use inside hospitals,hospital-type facilities,mobile, and homeenvironments | Both LW8 and primarypredicate A3 monitorsare specified forprofessional healthcarefacilities, and nottransport or home.MySign® O and Radical-7 use includes home andtransport environments. |
| Scenario of Use | Patient connected monitorfor continuous monitoringof vital signs with alarms | Patient connectedmonitor for continuousmonitoring of vital signswith alarms | Portable device forcontinuous monitoringof inspired Oxygen withalarms | Portable device forcontinuous monitoringof inspired Pulse-COOximetry and BreathingFrequency (RRa) withalarms | Same context of use ascontinuous alarmingmonitor |
| Moisture Protection Class | IP21 | IPX1 | IP54 | IPX1 | Equivalent to PrimaryPredicate A3. The LW8provides higher IPclassification thanprimary predicate. |
| Classification according tothe IEC60601-1 | |||||
| Product/Feature | LifeWindow™ LW8 LiteMulti-Parameter Monitor | A3 Series Multi-Parameter Monitor | MySign® O OxygenMeasuring Device | Radical-7 Pulse CO-Oximeter | Comparison Analysis |
| Electrical Protection Class -Mainframe | I | I | II | I | Same electricalprotection class asprimary predicate |
| Electrical Protection | CF Defibrillation proof | CF Defibrillation proof | BF | BF | Same protection class forLW8 and primarypredicate A3 monitor |
| Mode of Operation | Continuous | Continuous | Continuous | Continuous | Same |
| ECG Heart Rate | |||||
| Measurement range | 10 - 300 BPM (Adult)10 - 350 BPM (Pedi/Neo) | 10 - 300 BPM (Adult)10 - 350 BPM(Pedi/Neo) | -- | -- | Same |
| Resolution | 1 BPM | 1 BPM | -- | -- | Same |
| Accuracy | ± 1% or 1 BPM,whichever is greater | ± 1% or 1 BPM,whichever is greater | -- | -- | Same |
| Resp Rate | |||||
| Measurement Range | 0 to 150 BPM | 0 to 150 BPM | -- | -- | Same |
| Resolution | 1 BPM | 1 BPM | -- | -- | Same |
| Accuracy | ±2 BPM or ±2%,whichever greater | ±2 BPM or ±2%,whichever is the greater | -- | -- | Same |
| NIBP (Suntech) | |||||
| Systolic Measurement range(mmHg) | Adult: 40 - 260 Pediatric:40 - 230Neonatal: 40 - 130 | Adult: 40 - 260Pediatric: 40 - 230Neonatal: 40 - 130 | -- | -- | Same |
| Diastolic Measurementrange (mmHg) | Adult: 20 – 200Pediatric: 20 - 160Neonatal: 20 - 100 | Adult: 20 – 200Pediatric: 20 - 160Neonatal: 20 - 100 | -- | -- | Same |
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|---|
| ---------------------------- |
| Product/Feature | LifeWindow™ LW8 LiteMulti-Parameter Monitor | A3 Series Multi-Parameter Monitor | MySign® O OxygenMeasuring Device | Radical-7 Pulse CO-Oximeter | Comparison Analysis |
|---|---|---|---|---|---|
| MAP Measurement range(mmHg) | Adult: 26 – 220Pediatric: 26 - 183Neonatal: 26 - 110 | Adult: 26 – 220Pediatric: 26 - 183Neonatal: 26 - 110 | -- | -- | Same |
| Pressure MeasurementAccuracy | Clinical Accuracy:Meets accuracyrequirements ofANSI/AAMISP10:2002(R)2008,EN1060-4:2004 and ISO81060-2:2009 | ± 3 mmHg (± 0.4 kPa) or2 % of the reading above200 mmHg for theambient temperaturerange of 50°F to 104°F(10℃ to 40℃), thehumidity range of 15 %to 90 % | -- | -- | Same |
| Pressure transduceraccuracy | ±3mmHg between 0mmHg and 300 mmHg foroperating conditionsbetween 0°C and 50°C. | ±3mmHg between 0mmHg and 300 mmHgfor operating conditionsbetween 0°C and 50°C. | -- | -- | Same |
| PR range | 30 - 220 BPM | 30 - 220 BPM | -- | -- | Same |
| Pulse Rate Accuracy | 2% or 3 bpm, whicheveris greater | 2% or 3 bpm, whicheveris greater | -- | -- | Same |
| SpO2 (Masimo)Pulse CO-Oximetry | |||||
| SpO2 | |||||
| Measurement range | 0 - 100% | 0 - 100% | -- | 0 – 100% | Same |
| Resolution | 1% | 1% | -- | 1% | Same |
| Product/Feature | LifeWindow™ LW8 LiteMulti-Parameter Monitor | A3 Series Multi-Parameter Monitor | MySign® O OxygenMeasuring Device | Radical-7 Pulse CO-Oximeter | Comparison Analysis |
| Accuracy | No Motion Adults,Pediatric, Infants:60–80 ± 3%70–100 ± 2%No Motion Neonates:70–100 ± 3%Motion:70–100 ± 3%Low Perfusion:70–100 ± 2%0% to 69%, unspecified | No Motion Adults,Pediatric, Infants:60–80 ± 3%70–100 ± 2%No Motion Neonates:70–100 ± 3%Motion:70–100 ± 3%Low Perfusion:70–100 ± 2%0% to 69%, unspecified | -- | No Motion Adults,Pediatric, Infants:60–80 ± 3%70–100 ± 2%No Motion Neonates:70–100 ± 3%Motion:70–100 ± 3%Low Perfusion:70–100 ± 2%0% to 69%,unspecified | Same |
| Measurement Range | 25–240 BPM | 25–240 BPM | -- | 25–240 BPM | Same |
| Accuracy | No Motion: ± 3 BPMMotion: ± 5 BPMLow Perfusion: ± 3 BPM | No Motion: ± 3 BPMMotion: ± 5 BPMLow Perfusion: ± 3 BPM | -- | No Motion: ± 3 BPMMotion: ± 5 BPMLow Perfusion: ± 3 BPM | Same |
| Resolution | 1 BPM | 1 BPM | -- | 1 BPM | Same |
| Measurement range | 0–99% | 0–100% | -- | 0–99% | Same |
| Product/Feature | LifeWindow™ LW8 LiteMulti-Parameter Monitor | A3 Series Multi-Parameter Monitor | MySign® O OxygenMeasuring Device | Radical-7 Pulse CO-Oximeter | Comparison Analysis |
| Accuracy | No Motion:Adults, Pediatric, Infants:$1 - 40 \pm 3 %$>40%, unspecified | No Motion:Adults, Pediatric, Infants:$1 - 40 \pm 3 %$>40%, unspecified | -- | No Motion:Adults, Pediatric,Infants:$1 - 40 \pm 3 %$>40%, unspecified | Same |
| SpMet | -- | ||||
| Measurement range | 0 - 99.9% | 0 – 100% | -- | 0 - 99.9% | Same |
| Accuracy | Adults, Pediatric, Infants,Neonates:$1 - 15 \pm 1 %$>15%, unspecified | 0% to 15%: ±1%(non-motion conditions)>15%,unspecified | -- | Adults, Pediatric,Infants, Neonates:$1 - 15 \pm 1 %$>15%, unspecified | Same |
| Perfusion Index (PI) | -- | ||||
| Measurement Range | 0.02 – 20% | 0.05 — 20% | -- | 0.02 – 20% | Same |
| Resolution | PI < 1.00: 0.01PI < 10: 0.1PI > 10: 1 | Information Not Available | -- | PI < 1.00: 0.01PI < 10: 0.1PI > 10: 1 | Same |
| SpHb | -- | ||||
| Measurement range | 0 - 25 g/dL | 0 - 25 g/dL | -- | 0 – 25 g/dL | Same |
| Accuracy | Adults, Pediatric:$8 - 17 \pm 1$ g/dL | 8 g/dl to 17 g/dl: ±1g/dl(non-motion conditions)<8 g/dl or >17 g/dl,unspecified | -- | Adults, Pediatric:$8 - 17 \pm 1$ g/dL | Same |
| Product/Feature | LifeWindow™ LW8 LiteMulti-Parameter Monitor | A3 Series Multi-Parameter Monitor | MySign® O OxygenMeasuring Device | Radical-7 Pulse CO-Oximeter | Comparison Analysis |
| Resolution | 0.1 g/dL | Information Not Available | -- | 0.1 g/dL | Same |
| Alarm Range | 1.0 - 24.5 g/dL | Information Not Available | -- | 1.0 - 24.5 g/dL | Same |
| SpOC | -- | ||||
| Measurement range | 0 - 35 ml/dL | 0 - 35 ml/dL | -- | 0 - 35 ml/dL | Same |
| Resolution | 1 ml/dL | Information Not Available | -- | 1 ml/dL | Same |
| Pleth Variability Index(PVI) | -- | ||||
| Measurement Range | 0 - 100% | -- | -- | 0 - 100% | Same as predicateRadical-7, notimplemented on primarypredicate A3. |
| Resolution | 1 % | -- | -- | 1 % | Same as predicateRadical-7, notimplemented on primarypredicate A3. |
| Respiration Rate (RRa) | -- | ||||
| Measurement Range | 4 - 70 bpm | -- | -- | 4 - 69 bpm | Same as predicateRadical-7, notimplemented on primarypredicate A3. |
| Accuracy | Adults/Pediatric:4 - 70 ± 1 BPM | -- | -- | Adults/Pediatric:4 - 70 ± 1 BPM | Same as predicateRadical-7, notimplemented on primarypredicate A3. |
| Product/Feature | LifeWindow™ LW8 LiteMulti-Parameter Monitor | A3 Series Multi-Parameter Monitor | MySign® O OxygenMeasuring Device | Radical-7 Pulse CO-Oximeter | Comparison Analysis |
| Resolution | 1 BPM | -- | -- | 1 BPM | Same as predicateRadical-7, notimplemented on primarypredicate A3. |
| Temperature | -- | ||||
| Accuracy | Rated Range:35.0 - 42.0°C (95.0 -107.6°F): ± 0.3 °C (±0.5°F)Extended Range:-1.0 - 34.9°C (30.2 –94.8°F) and 42.1 – 45.0°C(107.8 - 113°F): ± 0.4 °C(± 0.7°F) | Accuracy ±0.1°C or ±1°F(exclusive of probe) | -- | -- | Equivalent Function,LifeWindow complieswith current industrystandard. |
| Resolution | 0.1°C (0.2°F) | 0.1°C or 1°F | -- | -- | Same |
| IBP (Invasive BloodPressure) | -- | ||||
| Pressure measurementrange | -40 to +300 mmHg | -50 mmHg to +350mmHg | -- | -- | Equivalent Functionwith slightly differentrange - claims of theLW8 are within theclaims of the predicate |
| Pressure Measurementaccuracy | ± 4 mmHg or ±4% of thereading, whichever isgreater. | ±4 mmHg or ±4% of thereading, whichever is thegreater (inclusion oftransducer) | -- | -- | Same |
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Resolution
1 mmHg
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--
Same
--
(Transducer included)
1 mmHg
{18}------------------------------------------------
| Page | 16 of 24 | ||
|---|---|---|---|
| ------ | -- | -- | ---------- |
| Product/Feature | LifeWindow™ LW8 LiteMulti-Parameter Monitor | A3 Series Multi-Parameter Monitor | MySign® O OxygenMeasuring Device | Radical-7 Pulse CO-Oximeter | Comparison Analysis |
|---|---|---|---|---|---|
| Mainstream CO2 module(CAPNOSTAT5)Respironics | -- | -- | -- | -- | -- |
| Measurement range (EtCO2) | Percent (%): 0 – 19.7mmHg: 0 – 150kPa: 0 – 20 | 0% to 19.7 %0 mmHg to 150 mmHg | -- | -- | Same |
| Resolution (EtCO2) | 1 mmHg | 0.1% or 1mmHg | -- | -- | Same |
| Accuracy (EtCO2) | 0 - 40 mmHg ± 2 mmHg41 - 70 mmHg ± 5% ofreading71 - 100 mmHg ± 8% ofreading101 - 150 mmHg ± 10% ofreading | 0 - 40 mmHg ± 2 mmHg41 - 70 mmHg ± 5% ofreading71 - 100 mmHg ± 8% ofreading101 - 150 mmHg ± 10%of reading | -- | -- | Same |
| awRR measurement range(Resp Rate) | 0 - 150 BPM | 0 rpm to 150 rpm | -- | -- | Same |
| awRR measurementaccuracy (Resp Rate) | ± 1 BPM | ±1 rpm | -- | -- | Same |
| Measurement range(InsCO2) | 3 to 50 mmHg | 3 to 50 mmHg | -- | -- | LifeWindow specificationis per cleared CO2module. |
| Resolution (InsCO2) | 1 mmHg | 0.1 mmHg 0 to 50 mmHg | -- | -- | Equivalent Function notoffering decimal pointresolution |
| Product/Feature | LifeWindow™ LW8 LiteMulti-Parameter Monitor | A3 Series Multi-Parameter Monitor | MySign® O OxygenMeasuring Device | Radical-7 Pulse CO-Oximeter | Comparison Analysis |
| Accuracy (InsCO2) | 3 - 40 mmHg ± 2 mmHg41 - 50 mmHg ± 5% ofreading | 3 - 40 mmHg ± 2 mmHg41 - 50 mmHg ± 5% ofreading | -- | -- | Same |
| Respironics CO2 module(LoFlo) Respironics | |||||
| Measurement range (EtCO2) | 0 - 19.7%0 – 150 mmHg0 – 20 kPa | 0% to 19.7 %0 mmHg to 150 mmHg | -- | -- | Same |
| Resolution (EtCO2) | 1 mmHg | 0.1% or 1 mmHg | -- | -- | Same |
| Accuracy (EtCO2) | 0 - 40 mmHg ± 2 mmHg41 - 70 mmHg ± 5% ofreading71 - 100 mmHg ± 8% ofreading101 - 150 mmHg ± 10% ofreading(when RR > 80 rpm, allthe range is ±12% ofreading) Gas temperatureat 25°C | 0 - 40 mmHg ± 2 mmHg41 - 70 mmHg ± 5% ofreading71 - 100 mmHg ± 8% ofreading101 - 150 mmHg ± 10%of reading(when RR > 80 rpm, allthe range is ±12% ofreading) Gastemperature at 25°C | -- | -- | Same |
| awRR measurementrange (Resp Rate) | 2 - 150 BPM | 2 rpm to 150 rpm | -- | -- | Same |
| awRR measurementaccuracy (Resp Rate) | ± 1 BPM | ±1 rpm | -- | -- | Same |
{19}------------------------------------------------
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{20}------------------------------------------------
| Product/Feature | LifeWindow™ LW8 LiteMulti-Parameter Monitor | A3 Series Multi-Parameter Monitor | MySign® O OxygenMeasuring Device | Radical-7 Pulse CO-Oximeter | Comparison Analysis |
|---|---|---|---|---|---|
| Measurement Range(insCO2) | 3 to 50 mmHg | 3 to 50 mmHg | -- | -- | Same |
| Accuracy (InsCO2) | 3 - 40 mmHg ± 2 mmHg41 - 50 mmHg ± 5% ofreading | 3 - 40 mmHg ± 2 mmHg41 - 50 mmHg ± 5% ofreading | -- | -- | Same |
| Resolution (InsCO2) | 1 mmHg | 0.1 mmHg 0 to 50 mmHg | -- | -- | Equivalent Function withno decimal pointresolution |
| Resp Rate Resolution | 1 BPM | 1 BPM | -- | -- | Same |
| Inspired Fraction ofOxygen (FiO2) | |||||
| Measurement Range | 0-100% Oxygen | -- | 0-100% Oxygen | -- | Same |
| Display Precision(Resolution) | 1% | -- | 0.1% | -- | Equivalent Function withno decimal pointresolution |
| Accuracy and Repeatability(Precision) | <1% vol. O2 if calibratedwith 100% vol. O2 | -- | <1% vol. O2 if calibratedwith 100% vol. O2 | -- | Same |
{21}------------------------------------------------
Summary points from the device claims comparison:
- . The intended use for the LifeWindow™ LW8 Lite and the primary predicate device Biolight A Series Patient Monitor are the same: multi-parameter patient vital signs monitoring.
- The LifeWindow™ LW8 Lite Monitor does not claim arrhythmia detection & ● monitoring (product code DSI). ST seament monitoring (product code MLD). nor cerebral state by EEG (product code GWQ). LifeWindow™ LW8 Lite Monitor does not provide support for the measurement of anesthetic agents for halothane product code CBS), enflurane (product code CBQ), nor nitrous Oxide (CBR). The predicate Biolight A Series Patient Monitor does claim these monitoring parameters and classifications. The LifeWindow™ LW8 Lite Monitor utilizes parameter regulatory classifications that are within those utilized by the predicate Biolight A Series Patient Monitor.
- The LifeWindow™ LW8 Lite Monitor and predicate MySign O Oxygen ● Measuring Device are both indicated for continuous or spot monitoring of inspired oxygen concentrations in breathing gas.
- . The LifeWindow™ LW8 Lite Monitor and predicate Masimo Radical-7 Pulse CO-Oximeter are both indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SPO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa).
- . The LifeWindow™ LW8 Lite Multi-Parameter Monitor and the referenced predicate devices are specified for adult through neonatal patient types (based upon appropriate patient-applied accessories utilized for each parameter measurement). Application sites are equivalent and also based upon the selection of appropriate patient-applied accessories.
- The LifeWindow™ LW8 Lite Multi-Parameter Monitor and primary predicate ● device Biolight A Series Patient Monitor are specified for use in professional care environments. The EnviteC MySign O Oxygen Measuring Device is specified for hospital/professional, home, and (non-air) out transport environments. The Masimo Radical-7 Pulse CO-Oximeter is specified for professional and home environments. The claims of the LifeWindow™ LW8 Lite Multi-Parameter Monitor for professional use environments are within those of the referenced predicates.
- The LifeWindow™ LW8 Lite Multi-Parameter Monitor and predicate devices . are prescription devices specified for professional use. As described above, the Masimo Radical-7 Pulse CO-Oximeter is additionally specified for home use.
- Like the predicate monitors, the LifeWindow™ LW8 Lite Multi-Parameter . Monitor is a non-sterile device. Specific third-party patient-applied accessories such as invasive blood pressure transducers may be packaged/provided sterile by their respective manufacturers.
- Per the indications for use LifeWindow™ LW8 Lite Multi-Parameter Monitor . claims a monitoring feature set equivalent to the Biolight A Series Patient Monitor for the following parameters:
- o ECG waveforms and heart rate from 3 or 5 lead (Biolight A Series includes 12 lead)
- Non-invasive blood pressure (NIBP): systolic, diastolic, and mean o arterial pressure
- End-tidal CO2 concentration (EtCO2) Mainstream or Sidestream O
{22}------------------------------------------------
- Inspired CO2 concentration (insCO2) Mainstream or Sidestream O
- Fractional Inspired Oxygen (FiO2) O
- Respiration Rate (from bioimpedance or EtCO2 measurement) O
- Two Temperature channels O
- Two Invasive Pressure channels (IP1, IP2)
Pulse CO-Oximetry and pulse rate as previously described above с Summary points from specification comparisons:
- The LifeWindow™ LW8 Lite Multi-Parameter Monitor and the primary . predicate device Biolight A Series Patient Monitor measure the same vital parameters and specify similar ranges for performance characteristics.
- Both the LifeWindow™ LW8 Lite Multi-Parameter Monitor and the primary . predicate device Biolight A Series Patient Monitor offer the cleared Biolight electrocardiogram (ECG) measurement technology, which includes respiration rate by thoracic bioimpedance. ECG measurement principles and performance levels are equivalent, with some differences in waveform display.
- The LifeWindow™ LW8 Lite Monitor does not implement the EGC arrhythmia ● or ST seqment functionality, the predicate device Biolight A Series Patient Monitor does. The LifeWindow™ LW8 Lite Monitor offers 3 lead and 5 lead ECG, the Biolight A Series Patient Monitor offers 3 lead, 5 lead, and 12 lead monitoring.
- . Both the LifeWindow™ LW8 Lite Multi-Parameter Monitor and the primary predicate Biolight A Series Patient Monitor offer the cleared Masimo parameter measurement technology of multi-wavelength pulse co-oximetry, and offer similar third party Masimo sensor configurations (finger, disposable, etc.). Pulse co-oximetry measurement principles and performance levels are equivalent.
- The LifeWindow™ LW8 Lite Multi-Parameter Monitor and the predicate . Masimo Radical-7 Monitor both offer acoustic respiration rate measurement (RRa) using cleared Masimo technology and third party sensors, the Biolight A Series Patient Monitor does not claim this feature.
- Both the LifeWindow™ LW8 Lite Multi-Parameter Monitor and the primary . predicate Biolight A Series Patient Monitor offer the cleared Suntech noninvasive oscillometric (NIBP) parameter measurement technology. NIBP measurement principles and performance levels are equivalent.
- Both the LifeWindow™ LW8 Lite Multi-Parameter Monitor and the primary . predicate Biolight A Series Patient Monitor offer the cleared Respironics sidestream and mainstream end tidal CO2 (EtCO2) parameter measurement technology. EtCO2 measurement principles and performance levels are equivalent.
- . The LifeWindow™ LW8 Lite Multi-Parameter Monitor and the primary predicate Biolight A Series Patient Monitor both measure inspired Oxygen (FiO2). The measurement principles are different for the devices - the Biolight A Series Patient Monitor uses a paramagnetic Oxygen sensor and the LifeWindow™ LW8 Lite Monitor uses a cleared EnviteC electro-galvanic Oxygen cell. The measurement ranges are equivalent.
- The LifeWindow™ LW8 Lite Multi-Parameter Monitor and the primary . predicate Biolight A Series Patient Monitor both offer the measurement of invasive blood pressure (IBP) parameter using cleared third party blood pressure transducers. Pressure measurement principles and performance levels are equivalent.
{23}------------------------------------------------
- The LifeWindow™ LW8 Lite Multi-Parameter Monitor and the primary predicate Biolight A Series Patient Monitor both offer the measurement of patient temperature parameter via cleared third party thermistor sensors meeting the YSI-400 temperature specification. Temperature measurement principles and performance levels are equivalent. The LifeWindow™ LW8 Lite Monitor offers two temperature monitoring channels, the Biolight A Series Patient Monitor offers up to eight channels by adding measurement modules.
- The LifeWindow™ LW8 Lite Multi-Parameter Monitor and the predicate ● Biolight A Series Patient Monitor both provide physiological alarms and have similar low and high level alarm settings and functions. Both monitors provide visual and audible alarms. Audible alarms may be suspended.
- The environmental conditions of the LifeWindow™ LW8 Lite Multi-Parameter . Monitor and the primary predicate Biolight A Series Patient Monitors specify similar ranges. The EnviteC MySign® O Oxygen Measuring Device has been tested to meet non-air out of hospital transport requirements.
- The LifeWindow™ LW8 Lite Multi-Parameter Monitor and the predicate . Biolight A Series Patient Monitor both specify third party patient-applied accessories. Third party patient-applied accessories specified for use with the LifeWindow™ LW8 Lite Monitor have been 510(k) cleared by their respective manufacturers.
- The LifeWindow™ LW8 Lite Multi-Parameter Monitor and the predicate ● Biolight A Series Patient Monitor both utilize color TFT LCD displays and have similar sizes (8.4 inch, 8.0 inch, respectively).
- The LifeWindow™ LW8 Lite Multi-Parameter Monitor and the predicate Biolight A Series Patient Monitor both offer key input and touch screen input with similar menu functionality.
- . The LifeWindow™ LW8 Lite Multi-Parameter Monitor and the predicate Biolight A Series Patient Monitor both offer indicator LED's for the mains and battery charge status.
- . The LifeWindow™ LW8 Lite Multi-Parameter Monitor and the predicate Biolight A Series Patient Monitor both offer an integrated thermal dot array printer with thermal paper width of 50 mm.
- The LifeWindow™ LW8 Lite Multi-Parameter Monitor and the predicate ● Biolight A Series Patient Monitor both may be connected to an external VGA display - the LifeWindow™ LW8 Lite Monitor specifies isolation components (i.e. isolation transformer) to be used when connecting to external components.
- The LifeWindow™ LW8 Lite Multi-Parameter Monitor and the predicate ● Biolight A Series Patient Monitor both offer USB and RJ45 network connector to support external printers. For a USB or RJ45 connected printer the LifeWindow™ LW8 Lite Monitor specifies isolation components (i.e. port isolators, transformer) to be used when connecting to external components.
- The LifeWindow™ LW8 Lite Multi-Parameter Monitor and the predicate . Biolight A Series Patient Monitor both have similar mains power requirements including a universal power supply input range of 100-240 VAC, 50/60Hz.
- The LifeWindow™ LW8 Lite Multi-Parameter Monitor incorporates an internal ● rechargeable sealed lead-acid battery and the predicate Biolight A Series Patient Monitor utilizes an internal Li-Ion battery source - the functionality of the batteries is the same, operation when disconnected from mains.
- The physical size and weight of the LifeWindow™ LW8 Lite Multi-Parameter Monitor and the predicate Biolight A Series Patient Monitors are similar - the
{24}------------------------------------------------
LifeWindow™ LW8 Lite Multi-Parameter Monitor is slightly smaller in size at 235 x 175 x 165 mm, and at 4.5kg it weighs slightly more compared to 4.2 kg for the predicate Biolight Monitor.
In conclusion, the LifeWindow™ LW8 Lite Multi-Parameter Monitor is equivalent in its intended use to the predicate devices, the Biolight A Series and Q Series Patient Monitors, EnviteC MySign® O Oxygen Measuring Device, and Masimo Radical-7 Pulse CO-Oximeter.
In summary, the LifeWindow™ LW8 Lite Multi-Parameter Monitor utilizes equivalent technology and has similar technical specifications as the predicate devices and the reference devices, the Biolight A Series and Q Series Patient Monitors, EnviteC MySign® O Oxygen Measuring Device, and Masimo Radical-7 Pulse CO-Oximeter, respectively. The claims of the subject device are within those of the predicate and reference devices.
Therefore, in consideration of the above, the technological characteristics of the devices do not raise different questions of safety and effectiveness when used as labeled and do not impact the Intended Use of the device for use as a multiparameter monitor.
Non-Clinical Tests Submitted: (b) (1)
LifeWindow™ LW8 Lite Multi-Parameter Monitor was laboratory tested to current applicable standards for medical device electrical safety and electromagnetic compatibility as well as particular standards for multi-function patient monitors. The following standards were utilized in compliance testing:
- Electrical safety testing per IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 ● (2007) + AM1 (2012) or IEC 60601-1: 2012 (FDA recognition number 19-4)
- . Electromagnetic compatibility testing per IEC 60601-1-2:2007, 300 Edition (FDA recognition number 19-1)
- Usability evaluation per IEC 60601-1-6:2010 (FDA recognition number 5-89) ● and IEC 62366:2007 (FDA recognition number 5-114) for professional use
- . Medical alarm systems testing per IEC 60601-1-8:2006+A1:2012 (FDA recognition number 5-76)
- . Particular requirements for Electrocardiographic monitors per IEC 60601-2-27:2011, 3rd Edition (FDA recognition number 3-126)
- . Particular requirements for automated non-invasive sphygmomanometers per IEC 80601-2-30:2013, Edition 1.1 (FDA recognition number 3-152)
- Particular requirements for invasive blood pressure monitors per IEC 60601-2-● 34:2011, 31d Edition (FDA recognition number 3-115)
- Particular requirements for multifunction patient monitors per IEC 60601-2-49:2011 (FDA recognition number (none))
- Particular requirements for respiratory gas monitors per ISO 80601-2-55:2011. . 1st Edition (FDA recognition number 1-96)
- . Particular requirements for clinical thermometers per ISO 80601-2-56:2009 (FDA recognition number 6-403)
- Particular requirements for pulse oximeter equipment per ISO 80601-2-61:2011, 1st Edition (FDA recognition number 1-85)
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- Medical Electrical Equipment and System Electromagnetic Immunity Test for . Exposure To Radio Frequency Identification Readers, AIM Standard 7351731:2016, Rev. 1 (FDA recognition number 19-21)
The monitor met the acceptance criteria for compliance to the standards.
The monitor was evaluated to the requirements of the following quidance documents:
- . Cardiac Monitor Guidance (including Cardiotachometer and Rate Alarm), Issued November 5, 1998
- FDA Non-invasive Blood Pressure (NIBP) Guidance Document, March 10, 1997
- . Guidance on the Content of Premarket Notification [510(k)] Submissions for Clinical Electronic Thermometers, March 1993
- Pulse Oximeters Premarket Notification Submissions [510(k)s] Guidance for . Industry and Food and Drug Administration Staff March 4, 2013
- Applying Human Factors and Usability Engineering To Medical Devices -● Guidance For Industry And Food And Drug Administration Staff, Feb 3, 2016
The monitor met the requirements and/or recommendations of the quidance documents.
Risk management, risk and hazard analysis of the probes was performed to the following standard:
- . Application of risk management to medical devices per ISO 14971
The monitor met acceptance criteria for residual risks.
The LifeWindow™ LW8 Lite Multi-Parameter Monitor software was developed in accordance with FDA guidelines for MAJOR level of concern devices. The software lifecvcle process was evaluated to meet:
- Medical device software Software life-cvcle processes per IEC 62304:2006 ● (First Edition) + A1:2015 (FDA recognition number 13-79)
- Medical device software lifecycle process per IEC 62304 with software safety . class C (equivalent to MAJOR level of concern).
- FDA Content of Premarket Submissions for Management of Cybersecurity in . Medical Devices, October 2, 2014.
The device software was verified to requirements and validated to meet the specified intended use(s).
A usability / Human Factors/Usability summative study was conducted on the LifeWindow™ LW8 Lite Multi-Parameter Monitor with 15 representative professional users (USA) in a simulated critical care scenario with vital signs generation on the subject software. The study followed the FDA usability quidance. The subject device has been found to be safe and effective for the intended users. uses and use environments.
In summary, the LifeWindow™ LW8 Lite Multi-Parameter Monitor met test criteria for standards conformance to the applicable standards and guidance documents, and residual risks met criteria for acceptability for the intended use.
(2) Clinical Tests Submitted:
(none)
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(3) Conclusions from Tests:
As described in (b)(1) and (b)(2) above, the LifeWindow™ LW8 Lite Multi-Parameter Monitor is equivalent to the predicate devices as supported by compliance, laboratory, and biocompatibility testing.
The results of all tests demonstrate that the LifeWindow™ LW8 Lite Multi-Parameter Monitor meet specified requirements and criteria for substantial equivalence to the referenced predicate devices.
§ 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).