LifeWindow LW8 Lite

K183687 · Digicare Biomedical Technology, Inc. · MWI · Sep 25, 2019 · Cardiovascular

Device Facts

• Record ID: K183687
• Device Name: LifeWindow LW8 Lite
• Applicant: Digicare Biomedical Technology, Inc.
• Product Code: MWI · Cardiovascular
• Decision Date: Sep 25, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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.

Device Story

LifeWindow LW8 Lite is a multi-parameter patient monitor; rugged aluminum chassis; 8.4" TFT touchscreen. Inputs: ECG (3/5 lead), NIBP, mainstream/sidestream capnography, FiO2 (electro-galvanic cell), acoustic respiration (Masimo RRa), temperature (YSI-400), invasive pressure, and pulse CO-oximetry (Masimo technology). Device processes physiological signals to display waveforms, indices, and trigger alarms. Used in hospitals/surgery centers by clinical staff. Output: real-time vital sign display, hardcopy printing, and audible/visual alarms. Affects clinical decision-making by providing continuous monitoring data for patient assessment. Benefits: enables simultaneous tracking of multiple physiological parameters to support patient care.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), usability evaluation (IEC 62366), and performance testing for specific modules (ECG, NIBP, IBP, CO2, pulse oximetry) per applicable ISO/IEC standards.

Technological Characteristics

Rugged aluminum chassis; 8.4" TFT touchscreen; Class I electrical protection; CF defibrillation-proof. Connectivity: USB, RJ45, VGA (with isolation). Power: 100-240 VAC or internal lead-acid battery. Measurement modules: ECG (bioimpedance), NIBP (oscillometric), Masimo pulse CO-oximetry, EnviteC electro-galvanic FiO2 cell, YSI-400 thermistors. Software: Major level of concern, IEC 62304 compliant.

Indications for Use

Indicated for continuous monitoring of vital signs in adult through neonatal patients. Parameters include ECG, heart rate, NIBP, EtCO2, insCO2, FiO2, acoustic respiration rate, respiration rate (bioimpedance/EtCO2), temperature, invasive pressure, pulse rate, SpO2, SpCO, SpMet, and SpHb. For professional use in hospitals, surgery centers, and emergency facilities. Not for home, ambulance, or helicopter transport.

Regulatory Classification

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.

Predicate Devices

• Biolight A Series and Q Series Patient Monitors (K131898)
• EnviteC MySign® O Oxygen Measuring Device (K122290)
• Radical-7 Pulse CO-Oximeter (K110028)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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

{1}------------------------------------------------

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 ([e-mail]) or phone [phone] 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

{2}------------------------------------------------

## 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)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

## 510(k) Summary in accordance with 21 CFR 807.92

| (a) | (1) | Submitted by: | Digicare Biomedical Technology, Inc.<br>107 Commerce Rd.<br>Boynton Beach<br>Florida 33426<br>Tel.: [phone]<br>Fax: [phone]<br>pedro(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-Parameter<br>Monitor |

## Common/Classification Name: Monitor, Physiological, Patient

## Product Code(s):

| Regulation No. | Classification Name | Product<br>Code | Device<br>Class |
|----------------------------|--------------------------------------------------------------------------------|-----------------|-----------------|
| Main Product Code | | | |
| 21 CFR §870.2300 | Monitor, Physiological, Patient (Without Arrhythmia<br>Detection or Alarms) | MWI | Class II |
| Subsequent Product Code(s) | | | |
| 21 CFR § 870.2300 | Cardiac monitor (including cardiotachometer and<br>rate 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 |

{4}------------------------------------------------

#### (3) Predicate Device(s): Substantial Equivalence to:

| K Number | Model | Manufacturer |
|----------|-------------------------------------------------|------------------------------------------|
| K131898 | Biolight A Series and Q Series Patient Monitors | Guangdong Biolight<br>Meditech Co., Ltd. |
| K122290 | EnviteC MySign® O Oxygen<br>Measuring 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:

{5}------------------------------------------------

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:

{6}------------------------------------------------

### Page 4 of 24

### Comparison of Technological Features to Predicate Devices:

| Product/Feature | LifeWindow™ LW8 Lite<br>Multi-Parameter Monitor | A3 Series Multi-<br>Parameter Monitor | MySign® O Oxygen<br>Measuring Device | Radical-7 Pulse CO-<br>Oximeter | Comparison Analysis | Indications for use: | The LifeWindow™ LW8<br>Lite is a multi-parameter<br>physiological patient<br>monitor indicated for<br>continuous measurement<br>of the following<br>parameters:<br>• ECG waveforms from 3<br>or 5 lead measurements<br>• Heart Rate (from ECG)<br>• Non-invasive blood<br>pressure (NIBP)<br>automatically measures<br>systolic and diastolic<br>pressure and pulse rate,<br>while calculating mean<br>arterial pressure (MAP).<br>The equation used to<br>calculate MAP provides<br>an approximate value.<br>• End-tidal CO2<br>concentration (EtCO2) –<br>Mainstream or<br>Sidestream<br>• Inspired CO2<br>concentration (insCO2) –<br>Mainstream or<br>Sidestream<br>• Fractional Inspired<br>Oxygen (FiO2)<br>• Acoustic Respiration<br>Rate (RRa)<br>• Respiration Rate (from<br>bioimpedance or EtCO2<br>measurement, or RRa)<br>• Two Temperature<br>channels<br>• Two Invasive Pressure<br>channels (IP1, IP2)<br>• Pulse Rate in BPM<br>(from Pulse CO-<br>Oximetry and/or NIBP) | Patient monitors are<br>intended to be used for<br>monitoring, displaying,<br>reviewing, storing and<br>alarming of multiple<br>physiological parameters<br>including ECG (3-lead or<br>5-lead or 12-lead<br>selectable), arrhythmia<br>detection, ST segment<br>analysis, Heart Rate<br>(HR), Respiration Rate<br>(RESP), Temperature<br>(TEMP), Pulse Oxygen<br>Saturation (SpO2), Pulse<br>Rate (PR), Non-invasive<br>Blood Pressure (NIBP),<br>Invasive Blood Pressure<br>(IBP), Carbon dioxide<br>(C02), Anesthetic Gas<br>(AG), Impedance<br>Cardiograph (ICG),<br>Cerebral State Index<br>(CSI), Bispectral Index<br>(HIS), Total<br>Hemoglobin(SpHb),<br>Carboxyhemoglobin<br>(SpCO), and<br>Methemoglobin(SpMet).<br>The arrhythmia<br>detection, ST segment<br>analysis only applied to a<br>single adult patient.<br>The monitors are to be<br>used in healthcare<br>facilities by clinical<br>physicians or appropriate<br>medical staff under the<br>direction of physician.<br>It is not intended for<br>helicopter transport, | This oxygen measuring<br>device MySign® O is<br>designed for continuous<br>or spot monitoring of<br>inspired oxygen<br>concentrations in<br>breathing gas.<br>MySign® O can be<br>used for monitoring the<br>breathing gases<br>dispensed by the<br>following devices:<br>Anaesthesia breathing<br>systems<br>Respiratory equipment<br>Infant incubators<br>Oxygen therapy<br>systems<br>The system is suitable<br>for use inside hospitals<br>as well as during<br>transport (except by<br>air), emergencies, and<br>artificial respiration<br>provided at home. | The Masimo Radical 7<br>Pulse CO-Oximeter and<br>accessories are<br>indicated for the<br>continuous non-invasive<br>monitoring of functional<br>oxygen saturation of<br>arterial hemoglobin<br>(SPO2), pulse rate,<br>carboxyhemoglobin<br>saturation (SpCO),<br>methemoglobin<br>saturation (SpMet), total<br>hemoglobin<br>concentration (SpHb),<br>and/or respiratory rate<br>(RRa). The Masimo<br>Radical 7 Pulse CO-<br>Oximeter and<br>accessories are<br>indicated for use with<br>adult, pediatric, and<br>neonatal patients during<br>both no motion and<br>motion conditions, and<br>for patients who are -<br>well or poorly perfused<br>in hospitals, hospital-<br>type facilities, mobile,<br>and home<br>environments. In<br>addition, the Masimo<br>Radical 7 Pulse CO-<br>Oximeter and<br>accessories are<br>indicated to provide the<br>continuous non-invasive<br>monitoring data<br>obtained from the<br>Masimo Radical 7 Pulse<br>CO-Oximeter end<br>accessories of<br>functional oxygen<br>saturation of arterial | See above- equivalent<br>monitoring function for<br>specified parameters<br>and sites |
|---------------------------|-------------------------------------------------|-------------------------------------------------|-------------------------------------------------|----------------------------------------------------------------------|-------------------------------------------------------------------------|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Manufacturer | Digicare Biomedical<br>Technology, Inc. | Guangdong Biolight<br>Meditech Co., Ltd. | EnviteC-Wismar GmbH<br>by Honeywell | Masimo Corporation | | | | | | | |
| Model Number(s) | LW8 | A3 Series | MySign® O | Radical-7 | | | | | | | |
| 510(k) Number | (pending - this<br>submission) | K131898 | K122290 | K110028 | | | | | | | |
| Application/Intended use: | Monitor multiple<br>physiological<br>parameters | Monitor multiple<br>physiological<br>parameters | Monitor fractional<br>inspired Oxygen<br>(FiO2) | Monitor pulse co-<br>oximetry and acoustic<br>respiration rate (RRa) | Equivalent monitoring<br>function for specified<br>parameters and sites | | | | | | |

{7}------------------------------------------------

# Page 5 of 24

{8}------------------------------------------------

Page 6 of 24

| • 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, | | |
| | | |

{9}------------------------------------------------

Page 7 of 24

| Product/Feature | LifeWindow™ LW8 Lite<br>Multi-Parameter Monitor | A3 Series Multi-<br>Parameter Monitor | MySign® O Oxygen<br>Measuring Device | Radical-7 Pulse CO-<br>Oximeter | Comparison Analysis |
|-----------------------------------|-------------------------------------------------|---------------------------------------------------------------------------------------|--------------------------------------|----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| | hospital ambulance, or<br>home use. | | | | |
| Alarms | YES | YES | YES | YES | Same |
| Application Site(s) | Patient sites vary by<br>parameter measured | Patient sites vary by<br>parameter measured | Inspired airway path | Pulse co-oximetry<br>site: digit, toe, ear,<br>foot, forehead;<br>acoustic respiration | Equivalent monitoring<br>function at specified<br>sites |
| Patient Population | Adult through neonatal<br>patients | Adult through neonatal<br>patients; (adults only for<br>arrhythmia and ST<br>segment) | Adult through neonatal<br>patients | Adult through neonatal<br>patients | Equivalent monitoring<br>function, LW8 does<br>not claim Arrhythmia<br>and ST segment. |
| Cardiac Monitor (ECG) | 3/5 Lead | 3/5/12 Lead | -- | -- | Equivalent function<br>Claims of the LW8 are<br>within the claims of the<br>predicate. |
| Detector and Alarm,<br>Arrhythmia | -- | Implemented/offered | -- | -- | Arrhythmia detection<br>not claimed by subject<br>device - claims of the<br>LW8 are within the<br>claims of the predicate |
| Monitor, ST Segment with<br>Alarm | -- | Implemented/offered | -- | -- | ST Segment<br>monitoring not claimed<br>by subject device -<br>claims of the LW8 are<br>within the claims of the<br>predicate |
| Impedance respiration | Implemented with ECG | Implemented w/ ECG | -- | -- | Equivalent function<br>with same technology |

{10}------------------------------------------------

| of<br>24<br>8<br>Page |
|-----------------------|
|-----------------------|

| Product/Feature | LifeWindow™ LW8 Lite<br>Multi-Parameter Monitor | A3 Series Multi-<br>Parameter Monitor | MySign® O Oxygen<br>Measuring Device | Radical-7 Pulse CO-<br>Oximeter | Comparison Analysis |
|--------------------------------|-------------------------------------------------|---------------------------------------|--------------------------------------|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Acoustic respiration | Masimo (RRa) | -- | -- | Masimo (RRa) | LW8 Acoustic respiration<br>rate utilizes the Masimo<br>RRa which is the same<br>technology utilized in<br>predicate Radical-7 |
| Invasive Blood pressure | YES | YES | -- | -- | Equivalent function<br>with same<br>measurement principle |
| Non-invasive blood<br>pressure | Oscillometric | Oscillometric | -- | -- | Equivalent function<br>with same technology |
| Patient Temperature | YSI 400 | YSI 400 | -- | -- | Equivalent function<br>with same<br>measurement principle |
| Pulse co-oximetry | Masimo technology | Masimo technology | -- | Masimo technology | Equivalent function<br>with same technology |
| Carbon Dioxide Gas<br>Analyzer | Mainstream and<br>sidestream | Mainstream and<br>sidestream | -- | -- | Equivalent function<br>with same technology |
| Inspired Oxygen (FiO2) | EnviteC technology | Paramagnetic | EnviteC technology | -- | Same as the MySign<br>O predicate device.<br>Primary predicate A3<br>offers a different type<br>of technology for<br>measuring FiO2. |
| Enflurane gas analyzer | -- | Implemented/offered | -- | -- | LW8 does not |
| Halothane gas analyzer | -- | Implemented/offered | -- | -- | measure nor claim<br>anesthetic agents. |

{11}------------------------------------------------

| Page 9 of 24 | | | |
|--------------|--|--|--|
|--------------|--|--|--|

| Product/Feature | LifeWindow™ LW8 Lite<br>Multi-Parameter Monitor | A3 Series Multi-<br>Parameter Monitor | MySign® O Oxygen<br>Measuring Device | Radical-7 Pulse CO-<br>Oximeter | Comparison Analysis |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Nitrous Oxide gas<br>analyzer | -- | Implemented/offered | -- | -- | therefore there are no<br>claims related to these<br>gas measurements -<br>claims of the LW8 are<br>within the claims of the<br>predicate |
| Cerebral State Index<br>(EEG) | -- | Implemented/offered | -- | -- | LW8 does not measure<br>nor claim cerebral state<br>index (CSI) by EEG<br>method, are no claims<br>related to this parameter<br>measurements - claims<br>of the LW8 are within the<br>claims of the predicate |
| Environment of Use | May be used in hospitals,<br>hospital-type facilities,<br>surgery centers, and<br>emergency facilities. For<br>professional use only. Not<br>intended for helicopter<br>transport, hospital<br>ambulance, or home use. | (Professional healthcare<br>environments). not<br>intended for helicopter<br>transport, hospital<br>ambulance, or home use | For use inside hospitals<br>as well as during<br>transport (except by<br>air), emergencies, and<br>artificial respiration<br>provided at home | For use inside hospitals,<br>hospital-type facilities,<br>mobile, and home<br>environments | Both LW8 and primary<br>predicate A3 monitors<br>are specified for<br>professional healthcare<br>facilities, and not<br>transport or home.<br>MySign® O and Radical-<br>7 use includes home and<br>transport environments. |
| Scenario of Use | Patient connected monitor<br>for continuous monitoring<br>of vital signs with alarms | Patient connected<br>monitor for continuous<br>monitoring of vital signs<br>with alarms | Portable device for<br>continuous monitoring<br>of inspired Oxygen with<br>alarms | Portable device for<br>continuous monitoring<br>of inspired Pulse-CO<br>Oximetry and Breathing<br>Frequency (RRa) with<br>alarms | Same context of use as<br>continuous alarming<br>monitor |
| Moisture Protection Class | IP21 | IPX1 | IP54 | IPX1 | Equivalent to Primary<br>Predicate A3. The LW8<br>provides higher IP<br>classification than<br>primary predicate. |
| Classification according to<br>the IEC60601-1 | | | | | |
| Product/Feature | LifeWindow™ LW8 Lite<br>Multi-Parameter Monitor | A3 Series Multi-<br>Parameter Monitor | MySign® O Oxygen<br>Measuring Device | Radical-7 Pulse CO-<br>Oximeter | Comparison Analysis |
| Electrical Protection Class -<br>Mainframe | I | I | II | I | Same electrical<br>protection class as<br>primary predicate |
| Electrical Protection | CF Defibrillation proof | CF Defibrillation proof | BF | BF | Same protection class for<br>LW8 and primary<br>predicate A3 monitor |
| Mode of Operation | Continuous | Continuous | Continuous | Continuous | Same |
| ECG Heart Rate | | | | | |
| Measurement range | 10 - 300 BPM (Adult)<br>10 - 350 BPM (Pedi/Neo) | 10 - 300 BPM (Adult)<br>10 - 350 BPM<br>(Pedi/Neo) | -- | -- | Same |
| Resolution | 1 BPM | 1 BPM | -- | -- | Same |
| Accuracy | ± 1% or 1 BPM,<br>whichever is greater | ± 1% or 1 BPM,<br>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%,<br>whichever greater | ±2 BPM or ±2%,<br>whichever is the greater | -- | -- | Same |
| NIBP (Suntech) | | | | | |
| Systolic Measurement range<br>(mmHg) | Adult: 40 - 260 Pediatric:<br>40 - 230<br>Neonatal: 40 - 130 | Adult: 40 - 260<br>Pediatric: 40 - 230<br>Neonatal: 40 - 130 | -- | -- | Same |
| Diastolic Measurement<br>range (mmHg) | Adult: 20 – 200<br>Pediatric: 20 - 160<br>Neonatal: 20 - 100 | Adult: 20 – 200<br>Pediatric: 20 - 160<br>Neonatal: 20 - 100 | -- | -- | Same |

{12}------------------------------------------------

# Page 10 of 24

{13}------------------------------------------------

| of<br>24<br>1<br>Page<br>1 |
|----------------------------|
|----------------------------|

| Product/Feature | LifeWindow™ LW8 Lite<br>Multi-Parameter Monitor | A3 Series Multi-<br>Parameter Monitor | MySign® O Oxygen<br>Measuring Device | Radical-7 Pulse CO-<br>Oximeter | Comparison Analysis |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| MAP Measurement range<br>(mmHg) | Adult: 26 – 220<br>Pediatric: 26 - 183<br>Neonatal: 26 - 110 | Adult: 26 – 220<br>Pediatric: 26 - 183<br>Neonatal: 26 - 110 | -- | -- | Same |
| Pressure Measurement<br>Accuracy | Clinical Accuracy:<br>Meets accuracy<br>requirements of<br>ANSI/AAMI<br>SP10:2002(R)2008,<br>EN1060-4:2004 and ISO<br>81060-2:2009 | ± 3 mmHg (± 0.4 kPa) or<br>2 % of the reading above<br>200 mmHg for the<br>ambient temperature<br>range of 50°F to 104°F<br>(10℃ to 40℃), the<br>humidity range of 15 %<br>to 90 % | -- | -- | Same |
| Pressure transducer<br>accuracy | ±3mmHg between 0<br>mmHg and 300 mmHg for<br>operating conditions<br>between 0°C and 50°C. | ±3mmHg between 0<br>mmHg and 300 mmHg<br>for operating conditions<br>between 0°C and 50°C. | -- | -- | Same |
| PR range | 30 - 220 BPM | 30 - 220 BPM | -- | -- | Same |
| Pulse Rate Accuracy | 2% or 3 bpm, whichever<br>is greater | 2% or 3 bpm, whichever<br>is greater | -- | -- | Same |
| SpO2 (Masimo)<br>Pulse CO-Oximetry | | | | | |
| SpO2 | | | | | |
| Measuremen…