(59 days)
No
The document describes a standard multi-parameter patient monitor using established physiological measurement techniques (oscillometric, pulse oximetry, infrared temperature, capnography, ECG, impedance respiration). There is no mention of AI, ML, or any algorithms that would suggest learning or adaptive capabilities beyond standard signal processing and parameter calculation.
No
The device is a patient monitor, which measures and displays physiological parameters. It does not provide any therapeutic intervention.
Yes
Explanation: The device is a patient monitor that measures multiple physiological parameters (blood pressure, heart rate, SpO2, CO2, temperature, ECG, respiration). This collection of data is used by healthcare professionals to assess a patient's health status, which is a diagnostic purpose.
No
The device description clearly outlines multiple hardware components and physical measurements (blood pressure cuff, SpO2 sensor, temperature probes, CO2 analyzers, ECG electrodes) that are integral to the device's function. While software is mentioned as being verified and validated, the device is fundamentally a hardware-based patient monitor with integrated software.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use describes the device as a "portable, multi-parameter, variable acuity device for use by health care professionals... for non-invasive spot checking, and/or continuous monitoring, recording and alarming of multiple physiological parameters". This focuses on monitoring physiological signals directly from the patient's body.
- Device Description: The description details how the device measures parameters like blood pressure, SpO2, temperature, etCO2, ECG, and impedance respiration using non-invasive methods applied to the patient.
- Lack of In Vitro Testing: There is no mention of the device being used to test samples (like blood, urine, or tissue) outside of the body. IVDs are specifically designed for testing these types of samples in a laboratory or point-of-care setting.
The device is a patient monitor that measures physiological parameters in vivo (within the living body).
N/A
Intended Use / Indications for Use
The 740 SELECT series of patient monitors is indicated for use as a portable, multi-parameter, variable acuity device for use by health care professionals, clinicians and medically qualified personnel, in a variety of clinical environments and hospital departments, for non-invasive spot checking, and/or continuous monitoring, recording and alarming of multiple physiological parameters for use in adults, and pediatric patients.
The 740 SELECT series monitors come with multiple configurations and optional features. Standard and optional parameters include:
- Blood pressure and pulse rate:
- Functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate; .
- Carbon Dioxide concentration of the expired and inspired breath and respiration rate including, with the Covidien Microstream MicroPod option, an Integrated Pulmonary Index (IPI);
- Electronic predictive and temporal artery temperature;
- ECG and heart rate derived from ECG:
- Impedance respiration to detect the rate or absence of respiratory effort with the ECG option for adult, adolescent, child and infant;
- Non-invasive monitoring, with Masimo Rainbow SET technology, of carboxyhemoglobin saturation (SpCO) and/or respiration (RRa). Other information displayed includes: Signal IO Wayeform. Low Signal IO (Low SIO), Perfusion Index (PI), and/or Pleth Variability Index (PVI) for use during both no motion and motion conditions, and for patients who are well or poorly perfused.
Product codes
MWI
Device Description
The 740 SELECT is a rugged portable non-invasive multi-parameter device used for spot checking or continuous monitoring of blood pressure, pulse rate, functional oxygen saturation (%Sp02), body temperature, etCO2, FiC02 Respiratory rate derived from etC02, ECG and Impedance Respiration in selected modes of operation.
The non-invasive blood pressure (NIBP) parameter automatically inflates an occluding cuff and, using the oscillometric step-deflation measurement technique, determines systolic, diastolic and mean arterial pressure as well as pulse rate. Measurement results along with user prompts and error messages are displayed on the front panel. The frequency of NIBP determination can be elected by the user in times between one and ninety minutes. The auto (timed), STAT and manual NIBP operating modes provide additional clinical utility.
The pulse oximeter parameter (%SpO2) determines arterial oxyhemoglobin saturation by measuring the absorption of red and infrared light passing through the tissue. Changes in absorption caused by pulsations of blood in the vascular bed are used to determine arterial saturation and pulse rate. The oximeter requires no routine calibration or maintenance. Oxygen saturation and heart rate are displayed on a light emitting diode (LED) digital display. On each detected pulse, the perfusion LED indicates patient perfusion signals. This bar graph gives the user a pulse-by-pulse visual indication of waveform signal quality. An audio "beep" can be enabled that is generated each time the SpO2 module detects a pulse. In addition to % SpO2 the 740 SELECT (equipped with the Masimo Rainbow® Pulse CO-Oximetry™ and Masimo SET ® oximetry) can monitor Pulse Rate (PR), Carboxyhemoglobin (SpC0®), Acoustic Respiration Rate (RRa™) and Pleth Variability Index (PVI®). Alternately, the customer can choose a Nellcor Pulse Oximeter at the of ordering. The Nellcor Oximeter provides Response Mode and Sat Seconds.
The 740 SELECT has (2) options for measuring temperature. The Covidien™ FILAC 3000 predictive temperature parameter has the capability of taking temperature in either normal (predictive) or monitor mode. In the normal mode, the thermometer's microprocessor "predicts" body temperature in about four (4) seconds for oral temperatures, about ten (10) seconds for axillary temperatures and about fifteen (15) seconds for rectal temperatures. The default setting used by the monitor for temperature determinations is the Predictive (normal) mode. Alternately, the customer can choose an Exergen TemporalScanner™ (infrared) Thermometer at the time of ordering. The Exergen TemporalScanner Thermometer, which captures core body temperature, has the capability of taking the Temporal Artery (TA) Temperature in about 3 seconds. The Exergen Temporal scanner has the ability to display the measurement of the patient's core temperature in either °F or °C.
The 740 SELECT offers the optional choice of Sidestream and/or Mainstream etC02 parameter monitoring. The customer choices for Sidestream C02 monitoring are the Masimo - Phasein™ Infrared Sidestream Gas Analyzer (ISA™) or the Covidien Microstream® MicroPod™ which is integrated with the microMediCO2™ board. Customers may also choose Mainstream etCO2 parameter monitoring by using the Masimo Phasein™ infrared Mainstream Gas analyzer (IRMA™). Each of these CO2 options is externally attached to the SELECT.
This clearance adds the parameter ECG and Impedance Respiration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults, and pediatric patients.
Intended User / Care Setting
health care professionals, clinicians and medically qualified personnel, in a variety of clinical environments and hospital departments
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
Not Found
Summary of Performance Studies
Non-Clinical and Clinical Performance Testing to Demonstrate Substantial Equivalence
- Sterilization Validation: Not applicable. The 740 SELECT (and predicates) are not and cannot be sterilized.
- Biocompatibility: The 740 SELECT and the provided accessories are claimed biocompatible by their manufacturers' premarket notification.
- Software: Software for the 740 SELECT (and predicates) was designed and developed in accordance with developer's software development processes and has been verified and validated.
- Electrical Safety: The 740 SELECT proposed device has been tested to IEC 60601-2-27:2011 due to the addition of the ECG parameter. The 740 SELECT predicate device, and by extension, the proposed device, also meet: AAMI/AAMI ES 60601-1:2005, IEC 60601-1:2005, ANSI/AAMI/ISO 81060-2, IEC 60601-1-6:2006, IEC 60601-1-8:2006, IEC 80601-2-30:2009, IEC 60601-2-49:2011, ISO 80601-2-56:2009, ISO 80601-2-61:2011, and ISO 80601-2-55:2011.
- Electromagnetic Compatibility (EMC): The 740 SELECT (and predicates) were tested for EMC in accordance with IEC 60601-1-2:2007 and comply with its predetermined specification.
- Performance Testing - Bench: The 740 SELECT was tested in accordance with internal requirements and procedures, with test results indicating that the device complies with predetermined requirements.
- Performance Testing - Animal: Animal performance testing was not performed for the proposed device or the predicate devices.
- Performance Testing - Clinical: Clinical performance testing was not performed with the 740 SELECT for this submission. Clinical testing is not necessary to demonstrate safety and effectiveness.
Key Metrics
Not Found
Predicate Device(s)
CASMED 740 SELECT Monitor (K140430); Zoe Medical Nightingale Monitoring System (K130740)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is written in a simple, sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 8, 2015
CAS Medical Systems, Inc. c/o Mr. Ron Jeffrey Director, Regulatory Affairs 44 East Industrial Rd. Branford, Connecticut 06405
Re: K150620 Trade/Device Name: 740 SELECT Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: Class II Product Code: MWI Dated: March 6, 2015 Received: March 10, 2015
Dear Mr. Ron Jeffrey,
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerelv vours.
Mitchell Stein
forBram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number: K150620
Device Name: 740 SELECT
Indications for Use statement:
The 740 SELECT series of patient monitors is indicated for use as a portable, multi-parameter, variable acuity device for use by health care professionals, clinicians and medically qualified personnel, in a variety of clinical environments and hospital departments, for non-invasive spot checking, and/or continuous monitoring, recording and alarming of multiple physiological parameters for use in adults, and pediatric patients.
The 740 SELECT series monitors come with multiple configurations and optional features. Standard and optional parameters include:
- . Blood pressure and pulse rate:
- Functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate; .
- Carbon Dioxide concentration of the expired and inspired breath and respiration rate including, with the Covidien Microstream MicroPod option, an Integrated Pulmonary Index (IPI);
- . Electronic predictive and temporal artery temperature;
- . ECG and heart rate derived from ECG:
- . Impedance respiration to detect the rate or absence of respiratory effort with the ECG option for adult, adolescent, child and infant;
- . Non-invasive monitoring, with Masimo Rainbow SET technology, of carboxyhemoglobin saturation (SpCO) and/or respiration (RRa). Other information displayed includes: Signal IO Wayeform. Low Signal IO (Low SIO), Perfusion Index (PI), and/or Pleth Variability Index (PVI) for use during both no motion and motion conditions, and for patients who are well or poorly perfused.
| Prescription Use ✓ | AND/OR | Over-the-Counter Use ________ |
|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of
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Image /page/3/Picture/1 description: The image shows the word "CASMED" in large, bold, red letters. The letters are slightly stylized, with a rounded, sans-serif font. A small, circled "R" trademark symbol is located in the upper right corner of the word, next to the letter "D". The background is plain white.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| Submitter: | CAS Medical Systems, Inc. |
|---|---|
| Address: | 44 East Industrial Rd. Branford CT. 06405 USA |
| Contact: | Ron Jeffrey - Director, Regulatory Affairs |
| Phone - (203) 488-6056 | |
| Fax - (203) 488-9438 | |
| Email – rjeffrey@casmed.com | |
| Establishment Registration # 2244861 | |
| Prepared: | March 6, 2015 |
| Trade Name: | 740 SELECT |
| Common Name: | Monitor, Physiological, Patient |
| Classification Name: | Cardiovascular Monitoring Device 870.2300 (MWI), Panel 7- |
| Classification: | Class II |
Substantially Equivalent Device(s):
The 740 SELECT is equivalent to the following devices:
DESCRIPTION
The 740 SELECT is a rugged portable non-invasive multi-parameter device used for spot checking or continuous monitoring of blood pressure, pulse rate, functional oxygen saturation (%Sp02), body temperature, etCO2, FiC02 Respiratory rate derived from etC02, ECG and Impedance Respiration in selected modes of operation.
The non-invasive blood pressure (NIBP) parameter automatically inflates an occluding cuff and,
4
using the oscillometric step-deflation measurement technique, determines systolic, diastolic and mean arterial pressure as well as pulse rate. Measurement results along with user prompts and error messages are displayed on the front panel. The frequency of NIBP determination can be elected by the user in times between one and ninety minutes. The auto (timed), STAT and manual NIBP operating modes provide additional clinical utility.
The pulse oximeter parameter (%SpO2) determines arterial oxyhemoglobin saturation by measuring the absorption of red and infrared light passing through the tissue. Changes in absorption caused by pulsations of blood in the vascular bed are used to determine arterial saturation and pulse rate. The oximeter requires no routine calibration or maintenance. Oxygen saturation and heart rate are displayed on a light emitting diode (LED) digital display. On each detected pulse, the perfusion LED indicates patient perfusion signals. This bar graph gives the user a pulse-by-pulse visual indication of waveform signal quality. An audio "beep" can be enabled that is generated each time the SpO2 module detects a pulse. In addition to % SpO2 the 740 SELECT (equipped with the Masimo Rainbow® Pulse CO-Oximetry™ and Masimo SET ® oximetry) can monitor Pulse Rate (PR), Carboxyhemoglobin (SpC0®), Acoustic Respiration Rate (RRa™) and Pleth Variability Index (PVI®). Alternately, the customer can choose a Nellcor Pulse Oximeter at the of ordering. The Nellcor Oximeter provides Response Mode and Sat Seconds.
The 740 SELECT has (2) options for measuring temperature. The Covidien™ FILAC 3000 predictive temperature parameter has the capability of taking temperature in either normal (predictive) or monitor mode. In the normal mode, the thermometer's microprocessor "predicts" body temperature in about four (4) seconds for oral temperatures, about ten (10) seconds for axillary temperatures and about fifteen (15) seconds for rectal temperatures. The default setting used by the monitor for temperature determinations is the Predictive (normal) mode. Alternately, the customer can choose an Exergen TemporalScanner™ (infrared) Thermometer at the time of ordering. The Exergen TemporalScanner Thermometer, which captures core body temperature, has the capability of taking the Temporal Artery (TA) Temperature in about 3 seconds. The Exergen Temporal scanner has the ability to display the measurement of the patient's core temperature in either °F or °C.
The 740 SELECT offers the optional choice of Sidestream and/or Mainstream etC02 parameter monitoring. The customer choices for Sidestream C02 monitoring are the Masimo - Phasein™ Infrared Sidestream Gas Analyzer (ISA™) or the Covidien Microstream® MicroPod™ which is integrated with the microMediCO2™ board. Customers may also choose Mainstream etCO2 parameter monitoring by using the Masimo Phasein™ infrared Mainstream Gas analyzer (IRMA™). Each of these CO2 options is externally attached to the SELECT.
This clearance adds the parameter ECG and Impedance Respiration.
5
The 740 SELECT Intended Use
The 740 SELECT series of patient monitors is indicated for use as a portable, multi-parameter, variable acuity device for use by health care professionals, clinicians and medically qualified personnel, in a variety of clinical environments and hospital departments, for non-invasive spot checking, and/or continuous monitoring, recording and alarming of multiple physiological parameters for use in adults, and pediatric patients.
The 740 SELECT series monitors come with multiple configurations and optional features. Standard and optional parameters include:
- . Blood pressure and pulse rate:
- Functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate;
- . Carbon Dioxide concentration of the expired and inspired breath and respiration rate including, with the Covidien Microstream MicroPod option, an Integrated Pulmonary Index (IPI);
- Electronic predictive and temporal artery temperature;
- ECG and heart rate derived from ECG;
- . Impedance respiration to detect the rate or absence of respiratory effort with the ECG option for adult, adolescent, child and infant;
- . Non-invasive monitoring, with Masimo Rainbow SET technology, of carboxyhemoglobin saturation (SpCO) and/or respiration (RRa). Other information displayed includes: Signal IQ Waveform, Low Signal IQ (Low SIQ), Perfusion Index (PI), and/or Pleth Variability Index (PVI) for use during both no motion and motion conditions, and for patients who are well or poorly perfused.
| Characteristic | 740 SELECT
(This submission) | 740 SELECT
(K140430) | Zoe Medical Nightingale
(K130740) | How They
Compare |
|-------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use
Statement and
Device
Parameters | The 740 SELECT series of
patient monitors is indicated
for use as a portable, multi-
parameter, variable acuity
device for use by health care
professionals, clinicians and
medically qualified
personnel, in a variety of
clinical environments and
hospital departments, for
non-invasive spot checking,
and/or continuous
monitoring, recording and
alarming of multiple
physiological parameters for
use in adults, and pediatric
patients.
The 740 SELECT series | The 740 SELECT series of
monitors is indicated for use
as a portable, multi-
parameter, variable acuity
device for use by health care
professionals, clinicians and
medically qualified
personnel, in a variety of
clinical environments and
hospital departments, for
non-invasive spot checking,
and/or continuous
monitoring and recording of:
■ Blood pressure and pulse
rate of adult, pediatric and
neonatal patients
■ Functional oxygen
saturation of arterial | The Zoe Medical
Nightingale Monitoring
System is indicated for use
in adult & pediatric patient
populations.
The Zoe Medical
Nightingale Monitoring
System facilitates the
monitoring of:
■ ECG
■ Impedance respiration
■ Non-invasive blood
pressure
■ Invasive blood pressure
■ Body temperature
■ Functional arterial
oxygen saturation (SpO₂) | The proposed
740SELECT
utilizes the
same Zoe
Medical ECG
component as
the
Nightingale
Monitoring
System
predicate
device. The
remaining
parameters
and features
in the
proposed
device were
cleared in the |
| Characteristic | 740 SELECT
(This submission) | 740 SELECT
(K140430) | Zoe Medical Nightingale
(K130740) | How They
Compare |
| | monitors come with multiple
configurations and optional
features. Standard and
optional parameters include:
■ Blood pressure & pulse
rate
■ Functional arterial oxygen
saturation (SpO2) & pulse
rate
■ Carbon Dioxide
concentration of the
expired and inspired breath
and respiration rate
including, with the
Covidien Microstream
MicroPod option, an
Integrated Pulmonary
Index (IPI)
■ Electronic predictive and
temporal artery
temperature
■ ECG and heart rate derived
from ECG
■ Impedance respiration to
detect the rate or absence
of respiratory effort with
the ECG option for adult,
adolescent, child and infant
■ Non-invasive monitoring,
with Masimo Rainbow
SET technology, of
carboxyhemoglobin
saturation (SPCO) and/or
respiration (RRa). Other
information displayed
includes: Signal IQ
Waveform, Low Signal IQ
(Low SIQ), Perfusion
Index (PI), and/or Pleth
Variability Index (PVI) for
use during both no motion
and motion conditions, and
for patients who are well or
poorly perfused. | hemoglobin (SpO2) &
pulse rate of adult,
pediatric and neonatal
patients
■ Additionally the Masimo
Rainbow SET technology
provides noninvasive
monitoring of
carboxyhemoglobin
saturation (SpCO) and/or
respiration (RRa). Other
information displayed on
the 740 SELECT with the
Masimo Rainbow SET
option includes: Signal IQ
Waveform, Low Signal IQ
(Low SIQ), Perfusion
Index (PI), and/or Pleth
Variability Index (PVI)
indicated for use during
both no motion and motion
conditions, and for patients
who are well or poorly
perfused
■ Carbon Dioxide
concentration of the
expired and inspired breath
and respiration rate of
adult, pediatric, infant or
neonatal patient and
included, with the Oridion
option, an Integrated
Pulmonary Index (IPI)
■ Intermittent predictive
body temperature (oral,
axillary, rectal) of adult,
pediatric and neonatal
patients
■ Infrared (over the temporal
artery) measurement of
body temperature of
people of all ages. | ■ End-tidal & inspired CO2
The Zoe Medical
Nightingale Monitoring
System is a prescription
device intended to be used
by healthcare professionals
in all areas of the
healthcare facility. | 740 SELECT
predicate
under
K140430. |
| Number of
Waveforms | 3 | NA | 3 or 5 | The proposed
740SELECT
uses a subset
of the Zoe
predicate
device |
| User Interface | Touch Screen | Touch Screen | Push Knob and dedicated
keys | The
740SELECT
is the same |
| Display | 7" Color LCD | 7" Color LCD | 8.4" Color LCD | The
740SELECT
is the same |
| Operating
Modes | Continuous | Continuous | Continuous | Same |
| Characteristic | 740 SELECT
(This submission) | 740 SELECT
(K140430) | Zoe Medical Nightingale
(K130740) | How They Compare |
| Trends | 1 minute to 4 hours | 1 minute to 4 hours | 72 hours | The 740SELECT is the same |
| Size | 11" W x 7.63" H x 5.75" D | 11" W x 7.63" H x 5.75" D | 11.3" W x 7.2" H x 3.3" D | The 740SELECT is the same |
| Electrical | Medical grade power supply
with internal lithium-ion
battery | Medical grade power supply
with internal lithium-ion
battery | Medical grade power
supply with internal
lithium-ion battery | Same |
| Equipment Type | Portable, indoor use only | Portable, indoor use only | Portable, indoor use only | Same |
| Ingress
Protection | IPX1 | IPX1 | IPX1 | Same |
| Operating
Conditions | 0 to 40°C (32 to 104°F)
15 to 90% RH, non-
condensing
0 to 15,000 ft | 0 to 40°C (32 to 104°F)
15 to 90% RH, non-
condensing
0 to 15,000 ft | 0 to 40°C (32 to 104°F)
15 to 90% RH, non-
condensing
0 - 15,000 ft | Same |
| Storage
Conditions | -20 to 60°C (-4 to 140°F) 15
to 95% RH, non-condensing
0 to 40,000 ft | -20 to 60°C (-4 to 140°F) 15
to 95% RH, non-condensing
0 to 40,000 ft | -20 to 60°C (-4 to 140°F)
15 to 95% RH, non-
condensing
0 to 40,000 ft | Same |
Technological Equivalence
6
7
Non-Clinical and Clinical Performance Testing to Demonstrate Substantial Equivalence
| Category | Testing Summary |
|---|---|
| Sterilization Validation | Not applicable. The 740 SELECT (and predicates) are not and cannot be sterilized. |
| Shelf Life | |
| Biocompatibility | The 740 SELECT and the provided accessories are claimed biocompatible by their |
| manufacturers' premarket notification. | |
| Software | Software for the 740 SELECT (and predicates) was designed and developed in |
| accordance with developer's software development processes and has been verified | |
| and validated. | |
| Electrical Safety | The 740 SELECT proposed device has been tested to IEC 60601-2-27:2011 due to the |
| addition of the ECG parameter. The 740 SELECT predicate device, and by extension, | |
| the proposed device, also meet: AAMI/AAMI ES 60601-1:2005, IEC 60601-1:2005, | |
| ANSI/AAMI/ISO 81060-2, IEC 60601-1-6:2006, IEC 60601-1-8:2006, IEC 80601-2- | |
| 30:2009, IEC 60601-2-49:2011, ISO 80601-2-56:2009, ISO 80601-2-61:2011, and ISO | |
| 80601-2-55:2011. | |
| Electromagnetic | |
| Compatibility (EMC) | The 740 SELECT (and predicates) were tested for EMC in accordance with IEC |
| 60601-1-2:2007 and comply with its predetermined specification. | |
| Performance Testing - | |
| Bench | The 740 SELECT was tested in accordance with internal requirements and procedures, |
| with test results indicating that the device complies with predetermined requirements. | |
| Performance Testing - | |
| Animal | Animal performance testing was not performed for the proposed device or the |
| predicate devices. | |
| Performance Testing - | |
| Clinical | Clinical performance testing was not performed with the 740 SELECT for this |
| submission. Clinical testing is not necessary to demonstrate safety and effectiveness. |
8
Conclusions Drawn from Clinical and Non-Clinical Testing
With the addition of ECG and Impedance Respiration as the only change from the previous 740 SELECT clearances, it has been determined that the 740 SELECT is substantially equivalent to the predicate device(s).