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.

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.

AI/ML Overview

The provided document is a 510(k) summary for the CAS Medical Systems, Inc. 740 SELECT patient monitor. This document seeks to demonstrate substantial equivalence to previously cleared devices rather than providing a detailed study of the device's performance against specific acceptance criteria.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria cannot be fully extracted in the format requested, as the document states that "Clinical performance testing was not performed with the 740 SELECT for this submission. Clinical testing is not necessary to demonstrate safety and effectiveness." The submission relies on demonstrating substantial equivalence to predicate devices, and the performance criteria for those devices are not detailed here.

However, I can extract information about the types of performance testing that were conducted to support the substantial equivalence claim.

Summary of Information from the Document:

The 740 SELECT patient monitor, with the addition of ECG and Impedance Respiration, builds upon a previously cleared device (K140430) and is considered substantially equivalent to it and another predicate device (Zoe Medical Nightingale Monitoring System K130740).

The performance testing mentioned focuses largely on non-clinical aspects and compliance with recognized standards.

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided text, specific acceptance criteria with numerical targets and the device's reported performance against those targets are not explicitly stated for each physiological parameter in this 510(k) summary. Instead, the document refers to compliance with internal requirements and established safety/performance standards.

Category	Acceptance Criteria (Implied / Standard)	Reported Device Performance
Sterilization	Not applicable (device cannot be sterilized)	Not applicable
Biocompatibility	Accessories are biocompatible (claimed by manufacturers' premarket notification)	Accessories are claimed biocompatible
Software	Designed and developed in accordance with developer's software development processes; Verified and Validated	Software was designed, developed, verified, and validated
Electrical Safety	Compliance with IEC 60601-2-27:2011 (due to ECG addition) and other listed standards (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, ISO 80601-2-55:2011)	Proposed device has been tested to and meets these standards
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2:2007	Tested for EMC and complies with its predetermined specification
Performance Testing - Bench	Compliance with internal requirements and procedures	Device complies with predetermined requirements
Performance Testing - Animal	Not performed	Not performed
Performance Testing - Clinical	Not necessary to demonstrate safety and effectiveness (as per submission)	Not performed

2. Sample Size Used for the Test Set and the Data Provenance:

Sample Size for Test Set: Not applicable or not provided. The document explicitly states, "Clinical performance testing was not performed with the 740 SELECT for this submission." Bench testing is mentioned as complying with internal requirements, but specific sample sizes for this or other non-clinical tests are not detailed.
Data Provenance: Not applicable, as detailed clinical performance testing was not conducted and no specific data sets are described. The focus is on compliance with standards and substantial equivalence to predicate devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

Not applicable. No ground truth establishment by experts for a test set is described, as clinical performance testing was not performed.

4. Adjudication Method:

Not applicable. No adjudication method is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. No MRMC study was conducted or referenced. The submission explicitly states no clinical performance testing was done.

6. Standalone Performance:

Standalone performance (algorithm only) is not relevant for this type of device (a multi-parameter physiological monitor). The device itself is the "algorithm" and performs measurements directly. The document states that the device was tested for electrical safety, EMC, and bench performance according to internal requirements and relevant standards.

7. Type of Ground Truth Used:

Not applicable. Since clinical performance testing was not performed to evaluate the diagnostic or measurement accuracy against a gold standard in a patient population, no "ground truth" (e.g., pathology, outcomes data, or expert consensus) for such clinical performance is mentioned. The ground truth for electrical safety or EMC testing would be the specified limits within the relevant standards.

8. Sample Size for the Training Set:

Not applicable. This is a medical device, not an AI/ML algorithm that undergoes a training phase with a dataset.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As noted above, this is not an AI/ML algorithm that requires a training set.

Summary

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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

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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

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Indications for Use

510(k) Number: K150620

Device Name: 740 SELECT

Indications for Use statement:

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 AffairsPhone - (203) 488-6056Fax - (203) 488-9438Email – rjeffrey@casmed.comEstablishment 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:

CASMED 740 SELECT Monitor (K140430); ●
Zoe Medical Nightingale Monitoring System (K130740) .

DESCRIPTION

The non-invasive blood pressure (NIBP) parameter automatically inflates an occluding cuff and,

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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.

This clearance adds the parameter ECG and Impedance Respiration.

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The 740 SELECT Intended Use

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 TheyCompare
Intended UseStatement andDeviceParameters	The 740 SELECT series ofpatient monitors is indicatedfor use as a portable, multi-parameter, variable acuitydevice for use by health careprofessionals, clinicians andmedically qualifiedpersonnel, in a variety ofclinical environments andhospital departments, fornon-invasive spot checking,and/or continuousmonitoring, recording andalarming of multiplephysiological parameters foruse in adults, and pediatricpatients.The 740 SELECT series	The 740 SELECT series ofmonitors is indicated for useas a portable, multi-parameter, variable acuitydevice for use by health careprofessionals, clinicians andmedically qualifiedpersonnel, in a variety ofclinical environments andhospital departments, fornon-invasive spot checking,and/or continuousmonitoring and recording of:■ Blood pressure and pulserate of adult, pediatric andneonatal patients■ Functional oxygensaturation of arterial	The Zoe MedicalNightingale MonitoringSystem is indicated for usein adult & pediatric patientpopulations.The Zoe MedicalNightingale MonitoringSystem facilitates themonitoring of:■ ECG■ Impedance respiration■ Non-invasive bloodpressure■ Invasive blood pressure■ Body temperature■ Functional arterialoxygen saturation (SpO₂)	The proposed740SELECTutilizes thesame ZoeMedical ECGcomponent astheNightingaleMonitoringSystempredicatedevice. Theremainingparametersand featuresin theproposeddevice werecleared in the
Characteristic	740 SELECT(This submission)	740 SELECT(K140430)	Zoe Medical Nightingale(K130740)	How TheyCompare
	monitors come with multipleconfigurations and optionalfeatures. Standard andoptional parameters include:■ Blood pressure & pulserate■ Functional arterial oxygensaturation (SpO2) & pulserate■ Carbon Dioxideconcentration of theexpired and inspired breathand respiration rateincluding, with theCovidien MicrostreamMicroPod option, anIntegrated PulmonaryIndex (IPI)■ Electronic predictive andtemporal arterytemperature■ ECG and heart rate derivedfrom ECG■ Impedance respiration todetect the rate or absenceof respiratory effort withthe ECG option for adult,adolescent, child and infant■ Non-invasive monitoring,with Masimo RainbowSET technology, ofcarboxyhemoglobinsaturation (SPCO) and/orrespiration (RRa). Otherinformation displayedincludes: Signal IQWaveform, Low Signal IQ(Low SIQ), PerfusionIndex (PI), and/or PlethVariability Index (PVI) foruse during both no motionand motion conditions, andfor patients who are well orpoorly perfused.	hemoglobin (SpO2) &pulse rate of adult,pediatric and neonatalpatients■ Additionally the MasimoRainbow SET technologyprovides noninvasivemonitoring ofcarboxyhemoglobinsaturation (SpCO) and/orrespiration (RRa). Otherinformation displayed onthe 740 SELECT with theMasimo Rainbow SEToption includes: Signal IQWaveform, Low Signal IQ(Low SIQ), PerfusionIndex (PI), and/or PlethVariability Index (PVI)indicated for use duringboth no motion and motionconditions, and for patientswho are well or poorlyperfused■ Carbon Dioxideconcentration of theexpired and inspired breathand respiration rate ofadult, pediatric, infant orneonatal patient andincluded, with the Oridionoption, an IntegratedPulmonary Index (IPI)■ Intermittent predictivebody temperature (oral,axillary, rectal) of adult,pediatric and neonatalpatients■ Infrared (over the temporalartery) measurement ofbody temperature ofpeople of all ages.	■ End-tidal & inspired CO2The Zoe MedicalNightingale MonitoringSystem is a prescriptiondevice intended to be usedby healthcare professionalsin all areas of thehealthcare facility.	740 SELECTpredicateunderK140430.
Number ofWaveforms	3	NA	3 or 5	The proposed740SELECTuses a subsetof the Zoepredicatedevice
User Interface	Touch Screen	Touch Screen	Push Knob and dedicatedkeys	The740SELECTis the same
Display	7" Color LCD	7" Color LCD	8.4" Color LCD	The740SELECTis the same
OperatingModes	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 supplywith internal lithium-ionbattery	Medical grade power supplywith internal lithium-ionbattery	Medical grade powersupply with internallithium-ion battery	Same
Equipment Type	Portable, indoor use only	Portable, indoor use only	Portable, indoor use only	Same
IngressProtection	IPX1	IPX1	IPX1	Same
OperatingConditions	0 to 40°C (32 to 104°F)15 to 90% RH, non-condensing0 to 15,000 ft	0 to 40°C (32 to 104°F)15 to 90% RH, non-condensing0 to 15,000 ft	0 to 40°C (32 to 104°F)15 to 90% RH, non-condensing0 - 15,000 ft	Same
StorageConditions	-20 to 60°C (-4 to 140°F) 15to 95% RH, non-condensing0 to 40,000 ft	-20 to 60°C (-4 to 140°F) 15to 95% RH, non-condensing0 to 40,000 ft	-20 to 60°C (-4 to 140°F)15 to 95% RH, non-condensing0 to 40,000 ft	Same

Technological Equivalence

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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.
ElectromagneticCompatibility (EMC)	The 740 SELECT (and predicates) were tested for EMC in accordance with IEC60601-1-2:2007 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 thepredicate devices.
Performance Testing -Clinical	Clinical performance testing was not performed with the 740 SELECT for thissubmission. Clinical testing is not necessary to demonstrate safety and effectiveness.

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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).

Regulation Number and Section

§ 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).