(271 days)
Not Found
No
The document describes a standard multi-parameter patient monitor and does not mention AI, ML, or related concepts in the device description, intended use, or performance studies.
No
The device is described as a multi-parameter physiological patient monitor indicated for continuous measurement of various physiological parameters and displays a range of physiological waveforms and indices. It does not provide any treatment or therapy.
Yes
The device is described as a "multi-parameter physiological patient monitor indicated for continuous measurement of physiological parameters" such as ECG, heart rate, blood pressure, CO2, O2, and CO-Oximetry. It displays waveforms and indices and provides alarms. These functions are inherently diagnostic as they provide information about a patient's physiological state to aid in the diagnosis and monitoring of conditions.
No
The device description explicitly states it is constructed with hardware features like a "rugged aluminum chassis" and an "8.4" TFT screen with touch screen operation," indicating it is a physical device with integrated software, not software only.
Based on the provided information, the LifeWindow™ LW8 Lite is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is a "multi-parameter physiological patient monitor indicated for continuous measurement of the following parameters." These parameters are measured directly from the patient's body (e.g., ECG, blood pressure, CO2 in breath, oxygen saturation in blood).
- Device Description: The description focuses on the physical characteristics and features of a patient monitor designed to measure physiological signals.
- Lack of In Vitro Testing: The description of performance studies mentions laboratory testing, usability studies, and compliance with standards for medical device safety and compatibility. There is no mention of testing involving biological samples outside of the body, which is characteristic of IVD devices.
- No Mention of Analyzing Samples: The device measures parameters directly from the patient. It does not analyze samples like blood, urine, or tissue in a laboratory setting.
IVD devices are specifically designed to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or compatibility purposes. The LifeWindow™ LW8 Lite measures physiological parameters in vivo (within the living body).
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
MWI, DRT, DSB, BZQ, DXN, DSK, FLL, DQA, DPZ, CCK, CCL
Device Description
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Patient sites vary by parameter measured
Indicated Patient Age Range
The defined patient population is adult through neonatal patients with appropriate accessories.
Intended User / Care Setting
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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 monitor met the acceptance criteria for compliance to the standards. 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 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.
Clinical Tests Submitted: (none)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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 (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
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)
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3
510(k) Summary in accordance with 21 CFR 807.92
| (a) | (1) | Submitted by: | Digicare Biomedical Technology, Inc.
107 Commerce Rd.
Boynton Beach
Florida 33426
Tel.: +1 (561) 689-0408
Fax: +1 (561) 689-0021
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
Monitor |
Common/Classification Name: Monitor, Physiological, Patient
Product Code(s):
| Regulation No. | Classification Name | Product
Code | Device
Class |
|----------------------------|--------------------------------------------------------------------------------|-----------------|-----------------|
| Main Product Code | | | |
| 21 CFR §870.2300 | Monitor, Physiological, Patient (Without Arrhythmia
Detection or Alarms) | MWI | Class II |
| Subsequent Product Code(s) | | | |
| 21 CFR § 870.2300 | Cardiac monitor (including cardiotachometer and
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 |
| Meditech Co., Ltd. | ||
| K122290 | EnviteC MySign® O Oxygen | |
| 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
Multi-Parameter Monitor | A3 Series Multi-
Parameter Monitor | MySign® O Oxygen
Measuring Device | Radical-7 Pulse CO-
Oximeter | Comparison Analysis | Indications for 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) | Patient monitors are
intended to be used for
monitoring, displaying,
reviewing, storing and
alarming of multiple
physiological parameters
including ECG (3-lead or
5-lead or 12-lead
selectable), arrhythmia
detection, ST segment
analysis, Heart Rate
(HR), Respiration Rate
(RESP), Temperature
(TEMP), Pulse Oxygen
Saturation (SpO2), Pulse
Rate (PR), Non-invasive
Blood Pressure (NIBP),
Invasive Blood Pressure
(IBP), Carbon dioxide
(C02), Anesthetic Gas
(AG), Impedance
Cardiograph (ICG),
Cerebral State Index
(CSI), Bispectral Index
(HIS), Total
Hemoglobin(SpHb),
Carboxyhemoglobin
(SpCO), and
Methemoglobin(SpMet).
The arrhythmia
detection, ST segment
analysis only applied to a
single adult patient.
The monitors are to be
used in healthcare
facilities by clinical
physicians or appropriate
medical staff under the
direction of physician.
It is not intended for
helicopter transport, | This oxygen measuring
device MySign® O is
designed for continuous
or spot monitoring of
inspired oxygen
concentrations in
breathing gas.
MySign® O can be
used for monitoring the
breathing gases
dispensed by the
following devices:
Anaesthesia breathing
systems
Respiratory equipment
Infant incubators
Oxygen therapy
systems
The system is suitable
for use inside hospitals
as well as during
transport (except by
air), emergencies, and
artificial respiration
provided at home. | The Masimo Radical 7
Pulse CO-Oximeter and
accessories are
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 Masimo
Radical 7 Pulse CO-
Oximeter and
accessories are
indicated for use with
adult, pediatric, and
neonatal patients during
both no motion and
motion conditions, and
for patients who are -
well or poorly perfused
in hospitals, hospital-
type facilities, mobile,
and home
environments. In
addition, the Masimo
Radical 7 Pulse CO-
Oximeter and
accessories are
indicated to provide the
continuous non-invasive
monitoring data
obtained from the
Masimo Radical 7 Pulse
CO-Oximeter end
accessories of
functional oxygen
saturation of arterial | See above- equivalent
monitoring function for
specified parameters
and sites |
|---------------------------|-------------------------------------------------|-------------------------------------------------|-------------------------------------------------|----------------------------------------------------------------------|-------------------------------------------------------------------------|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Manufacturer | Digicare Biomedical
Technology, Inc. | Guangdong Biolight
Meditech Co., Ltd. | EnviteC-Wismar GmbH
by Honeywell | Masimo Corporation | | | | | | | |
| Model Number(s) | LW8 | A3 Series | MySign® O | Radical-7 | | | | | | | |
| 510(k) Number | (pending - this
submission) | K131898 | K122290 | K110028 | | | | | | | |
| Application/Intended use: | Monitor multiple
physiological
parameters | Monitor multiple
physiological
parameters | Monitor fractional
inspired Oxygen
(FiO2) | Monitor pulse co-
oximetry and acoustic
respiration rate (RRa) | Equivalent monitoring
function for specified
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
Multi-Parameter Monitor | A3 Series Multi-
Parameter Monitor | MySign® O Oxygen
Measuring Device | Radical-7 Pulse CO-
Oximeter | Comparison Analysis |
|-----------------------------------|-------------------------------------------------|---------------------------------------------------------------------------------------|--------------------------------------|----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| | hospital ambulance, or
home use. | | | | |
| Alarms | YES | YES | YES | YES | Same |
| Application Site(s) | Patient sites vary by
parameter measured | Patient sites vary by
parameter measured | Inspired airway path | Pulse co-oximetry
site: digit, toe, ear,
foot, forehead;
acoustic respiration | Equivalent monitoring
function at specified
sites |
| Patient Population | Adult through neonatal
patients | Adult through neonatal
patients; (adults only for
arrhythmia and ST
segment) | Adult through neonatal
patients | Adult through neonatal
patients | Equivalent monitoring
function, LW8 does
not claim Arrhythmia
and ST segment. |
| Cardiac Monitor (ECG) | 3/5 Lead | 3/5/12 Lead | -- | -- | Equivalent function
Claims of the LW8 are
within the claims of the
predicate. |
| Detector and Alarm,
Arrhythmia | -- | Implemented/offered | -- | -- | Arrhythmia detection
not claimed by subject
device - claims of the
LW8 are within the
claims of the predicate |
| Monitor, ST Segment with
Alarm | -- | Implemented/offered | -- | -- | ST Segment
monitoring not claimed
by subject device -
claims of the LW8 are
within the claims of the
predicate |
| Impedance respiration | Implemented with ECG | Implemented w/ ECG | -- | -- | Equivalent function
with same technology |
10
| of
24
8
| Page |
|---|
| ----------------------- |
| Product/Feature | LifeWindow™ LW8 Lite
Multi-Parameter Monitor | A3 Series Multi-
Parameter Monitor | MySign® O Oxygen
Measuring Device | Radical-7 Pulse CO-
Oximeter | Comparison Analysis |
|--------------------------------|-------------------------------------------------|---------------------------------------|--------------------------------------|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Acoustic respiration | Masimo (RRa) | -- | -- | Masimo (RRa) | LW8 Acoustic respiration
rate utilizes the Masimo
RRa which is the same
technology utilized in
predicate Radical-7 |
| Invasive Blood pressure | YES | YES | -- | -- | Equivalent function
with same
measurement principle |
| Non-invasive blood
pressure | Oscillometric | Oscillometric | -- | -- | Equivalent function
with same technology |
| Patient Temperature | YSI 400 | YSI 400 | -- | -- | Equivalent function
with same
measurement principle |
| Pulse co-oximetry | Masimo technology | Masimo technology | -- | Masimo technology | Equivalent function
with same technology |
| Carbon Dioxide Gas
Analyzer | Mainstream and
sidestream | Mainstream and
sidestream | -- | -- | Equivalent function
with same technology |
| Inspired Oxygen (FiO2) | EnviteC technology | Paramagnetic | EnviteC technology | -- | Same as the MySign
O predicate device.
Primary predicate A3
offers a different type
of technology for
measuring FiO2. |
| Enflurane gas analyzer | -- | Implemented/offered | -- | -- | LW8 does not |
| Halothane gas analyzer | -- | Implemented/offered | -- | -- | measure nor claim
anesthetic agents. |
11
| Page 9 of 24 | |||
|---|---|---|---|
| -------------- | -- | -- | -- |
| Product/Feature | LifeWindow™ LW8 Lite
Multi-Parameter Monitor | A3 Series Multi-
Parameter Monitor | MySign® O Oxygen
Measuring Device | Radical-7 Pulse CO-
Oximeter | Comparison Analysis |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Nitrous Oxide gas
analyzer | -- | Implemented/offered | -- | -- | therefore there are no
claims related to these
gas measurements -
claims of the LW8 are
within the claims of the
predicate |
| Cerebral State Index
(EEG) | -- | Implemented/offered | -- | -- | LW8 does not measure
nor claim cerebral state
index (CSI) by EEG
method, are no claims
related to this parameter
measurements - claims
of the LW8 are within the
claims of the predicate |
| Environment of Use | May be used in hospitals,
hospital-type facilities,
surgery centers, and
emergency facilities. For
professional use only. Not
intended for helicopter
transport, hospital
ambulance, or home use. | (Professional healthcare
environments). not
intended for helicopter
transport, hospital
ambulance, or home use | For use inside hospitals
as well as during
transport (except by
air), emergencies, and
artificial respiration
provided at home | For use inside hospitals,
hospital-type facilities,
mobile, and home
environments | Both LW8 and primary
predicate A3 monitors
are specified for
professional healthcare
facilities, and not
transport or home.
MySign® O and Radical-
7 use includes home and
transport environments. |
| Scenario of Use | Patient connected monitor
for continuous monitoring
of vital signs with alarms | Patient connected
monitor for continuous
monitoring of vital signs
with alarms | Portable device for
continuous monitoring
of inspired Oxygen with
alarms | Portable device for
continuous monitoring
of inspired Pulse-CO
Oximetry and Breathing
Frequency (RRa) with
alarms | Same context of use as
continuous alarming
monitor |
| Moisture Protection Class | IP21 | IPX1 | IP54 | IPX1 | Equivalent to Primary
Predicate A3. The LW8
provides higher IP
classification than
primary predicate. |
| Classification according to
the IEC60601-1 | | | | | |
| Product/Feature | LifeWindow™ LW8 Lite
Multi-Parameter Monitor | A3 Series Multi-
Parameter Monitor | MySign® O Oxygen
Measuring Device | Radical-7 Pulse CO-
Oximeter | Comparison Analysis |
| Electrical Protection Class -
Mainframe | I | I | II | I | Same electrical
protection class as
primary predicate |
| Electrical Protection | CF Defibrillation proof | CF Defibrillation proof | BF | BF | Same protection class for
LW8 and primary
predicate 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 - 230
Neonatal: 40 - 130 | Adult: 40 - 260
Pediatric: 40 - 230
Neonatal: 40 - 130 | -- | -- | Same |
| Diastolic Measurement
range (mmHg) | Adult: 20 – 200
Pediatric: 20 - 160
Neonatal: 20 - 100 | Adult: 20 – 200
Pediatric: 20 - 160
Neonatal: 20 - 100 | -- | -- | Same |
12
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| of
24
1
Page
| 1 |
|---|
| ---------------------------- |
| Product/Feature | LifeWindow™ LW8 Lite
Multi-Parameter Monitor | A3 Series Multi-
Parameter Monitor | MySign® O Oxygen
Measuring Device | Radical-7 Pulse CO-
Oximeter | Comparison Analysis |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| MAP Measurement range
(mmHg) | Adult: 26 – 220
Pediatric: 26 - 183
Neonatal: 26 - 110 | Adult: 26 – 220
Pediatric: 26 - 183
Neonatal: 26 - 110 | -- | -- | Same |
| Pressure Measurement
Accuracy | Clinical Accuracy:
Meets accuracy
requirements of
ANSI/AAMI
SP10:2002(R)2008,
EN1060-4:2004 and ISO
81060-2:2009 | ± 3 mmHg (± 0.4 kPa) or
2 % of the reading above
200 mmHg for the
ambient temperature
range of 50°F to 104°F
(10℃ to 40℃), the
humidity range of 15 %
to 90 % | -- | -- | Same |
| Pressure transducer
accuracy | ±3mmHg between 0
mmHg and 300 mmHg for
operating conditions
between 0°C and 50°C. | ±3mmHg between 0
mmHg and 300 mmHg
for operating conditions
between 0°C and 50°C. | -- | -- | Same |
| PR range | 30 - 220 BPM | 30 - 220 BPM | -- | -- | Same |
| Pulse Rate Accuracy | 2% or 3 bpm, whichever
is greater | 2% or 3 bpm, whichever
is 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 Lite
Multi-Parameter Monitor | A3 Series Multi-
Parameter Monitor | MySign® O Oxygen
Measuring 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 BPM
Motion: ± 5 BPM
Low Perfusion: ± 3 BPM | No Motion: ± 3 BPM
Motion: ± 5 BPM
Low Perfusion: ± 3 BPM | -- | No Motion: ± 3 BPM
Motion: ± 5 BPM
Low 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 Lite
Multi-Parameter Monitor | A3 Series Multi-
Parameter Monitor | MySign® O Oxygen
Measuring 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 10: 1 | Information Not Available | -- | PI 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)
17 g/dl,
unspecified | -- | Adults, Pediatric:
$8 - 17 \pm 1$ g/dL | Same |
| Product/Feature | LifeWindow™ LW8 Lite
Multi-Parameter Monitor | A3 Series Multi-
Parameter Monitor | MySign® O Oxygen
Measuring 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 predicate
Radical-7, not
implemented on primary
predicate A3. |
| Resolution | 1 % | -- | -- | 1 % | Same as predicate
Radical-7, not
implemented on primary
predicate A3. |
| Respiration Rate (RRa) | | | | -- | |
| Measurement Range | 4 - 70 bpm | -- | -- | 4 - 69 bpm | Same as predicate
Radical-7, not
implemented on primary
predicate A3. |
| Accuracy | Adults/Pediatric:
4 - 70 ± 1 BPM | -- | -- | Adults/Pediatric:
4 - 70 ± 1 BPM | Same as predicate
Radical-7, not
implemented on primary
predicate A3. |
| Product/Feature | LifeWindow™ LW8 Lite
Multi-Parameter Monitor | A3 Series Multi-
Parameter Monitor | MySign® O Oxygen
Measuring Device | Radical-7 Pulse CO-
Oximeter | Comparison Analysis |
| Resolution | 1 BPM | -- | -- | 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 (±
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 complies
with current industry
standard. |
| Resolution | 0.1°C (0.2°F) | 0.1°C or 1°F | -- | -- | Same |
| IBP (Invasive Blood
Pressure) | | | | -- | |
| Pressure measurement
range | -40 to +300 mmHg | -50 mmHg to +350
mmHg | -- | -- | Equivalent Function
with slightly different
range - claims of the
LW8 are within the
claims of the predicate |
| Pressure Measurement
accuracy | ± 4 mmHg or ±4% of the
reading, whichever is
greater. | ±4 mmHg or ±4% of the
reading, whichever is the
greater (inclusion of
transducer) | -- | -- | Same |
14
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15
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17
Resolution
1 mmHg
Page 15 of 24
--
Same
--
(Transducer included)
1 mmHg
18
| Page | 16 of 24 | ||
|---|---|---|---|
| ------ | -- | -- | ---------- |
| Product/Feature | LifeWindow™ LW8 Lite
Multi-Parameter Monitor | A3 Series Multi-
Parameter Monitor | MySign® O Oxygen
Measuring Device | Radical-7 Pulse CO-
Oximeter | Comparison Analysis |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|---------------------------------|-----------------------------------------------------------------|
| Mainstream CO2 module
(CAPNOSTAT5)
Respironics | -- | -- | -- | -- | -- |
| Measurement range (EtCO2) | Percent (%): 0 – 19.7
mmHg: 0 – 150
kPa: 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 mmHg
41 - 70 mmHg ± 5% of
reading
71 - 100 mmHg ± 8% of
reading
101 - 150 mmHg ± 10% of
reading | 0 - 40 mmHg ± 2 mmHg
41 - 70 mmHg ± 5% of
reading
71 - 100 mmHg ± 8% of
reading
101 - 150 mmHg ± 10%
of reading | -- | -- | Same |
| awRR measurement range
(Resp Rate) | 0 - 150 BPM | 0 rpm to 150 rpm | -- | -- | Same |
| awRR measurement
accuracy (Resp Rate) | ± 1 BPM | ±1 rpm | -- | -- | Same |
| Measurement range
(InsCO2) | 3 to 50 mmHg | 3 to 50 mmHg | -- | -- | LifeWindow specification
is per cleared CO2
module. |
| Resolution (InsCO2) | 1 mmHg | 0.1 mmHg 0 to 50 mmHg | -- | -- | Equivalent Function not
offering decimal point
resolution |
| Product/Feature | LifeWindow™ LW8 Lite
Multi-Parameter Monitor | A3 Series Multi-
Parameter Monitor | MySign® O Oxygen
Measuring Device | Radical-7 Pulse CO-
Oximeter | Comparison Analysis |
| Accuracy (InsCO2) | 3 - 40 mmHg ± 2 mmHg
41 - 50 mmHg ± 5% of
reading | 3 - 40 mmHg ± 2 mmHg
41 - 50 mmHg ± 5% of
reading | -- | -- | Same |
| Respironics CO2 module
(LoFlo) Respironics | | | | | |
| Measurement range (EtCO2) | 0 - 19.7%
0 – 150 mmHg
0 – 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 mmHg
41 - 70 mmHg ± 5% of
reading
71 - 100 mmHg ± 8% of
reading
101 - 150 mmHg ± 10% of
reading
(when RR > 80 rpm, all
the range is ±12% of
reading) Gas temperature
at 25°C | 0 - 40 mmHg ± 2 mmHg
41 - 70 mmHg ± 5% of
reading
71 - 100 mmHg ± 8% of
reading
101 - 150 mmHg ± 10%
of reading
(when RR > 80 rpm, all
the range is ±12% of
reading) Gas
temperature at 25°C | -- | -- | Same |
| awRR measurement
range (Resp Rate) | 2 - 150 BPM | 2 rpm to 150 rpm | -- | -- | Same |
| awRR measurement
accuracy (Resp Rate) | ± 1 BPM | ±1 rpm | -- | -- | Same |
19
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20
| Product/Feature | LifeWindow™ LW8 Lite
Multi-Parameter Monitor | A3 Series Multi-
Parameter Monitor | MySign® O Oxygen
Measuring 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 mmHg
41 - 50 mmHg ± 5% of
reading | 3 - 40 mmHg ± 2 mmHg
41 - 50 mmHg ± 5% of
reading | -- | -- | Same |
| Resolution (InsCO2) | 1 mmHg | 0.1 mmHg 0 to 50 mmHg | -- | -- | Equivalent Function with
no decimal point
resolution |
| Resp Rate Resolution | 1 BPM | 1 BPM | -- | -- | Same |
| Inspired Fraction of
Oxygen (FiO2) | | | | | |
| Measurement Range | 0-100% Oxygen | -- | 0-100% Oxygen | -- | Same |
| Display Precision
(Resolution) | 1% | -- | 0.1% | -- | Equivalent Function with
no decimal point
resolution |
| Accuracy and Repeatability
(Precision) |