The CAS 740 Series Vital Signs Monitor is indicated for use for non-invasive monitoring of blood pressure, oxygen saturation, pulse and temperature of adult, pediatric and neonatal patients, in the care of health professionals.

Device Description

The CAS 740 Monitor is a replacement monitor based on the existing 9303 Vital Signs Monitor, and the CAS 9001 or 9002 EMS monitors. The 740 are primarily a repackaging of these monitors. The primary parameter is non-invasive blood pressure, which is included in all models. Blood pressure measurement is based on oscillometric technology. The additional two parameters are pulse oximetry and temperature. A purchaser has pulse oximetry choices that include modules manufactured by Masimo, Nellcor or Nonin. The temperature parameter utilizes predictive technology from SureTemp (Welch Allyn Inc.). The monitor is a rugged, portable and lightweight unit widely adaptable for many applications and mounting schemes. Used for spot-checking or continuous monitoring, features include an easily replaceable Nickel Metal Hydride rechargeable battery pack, wireless infrared printer communication, and many more.

AI/ML Overview

The provided document describes the CAS 740 Series Monitor, a vital signs monitor, and details its equivalence to predicate devices, not an AI/ML powered device. Therefore, the questions related to AI/ML specific studies, such as multi-reader multi-case studies, standalone algorithm performance, or ground truth establishment for training sets, are not applicable.

However, the document does provide information regarding acceptance criteria and a study for the Non-Invasive Blood Pressure (NIBP) component.

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Standard Reference)	Reported Device Performance (CAS 740 Series NIBP)
Non-Invasive Blood Pressure	AAMI SP10:2002 requirements	Performance equivalent to the NB module (predicate) in bench test simulations. Clinical studies in accordance with AAMI SP10:2002, with results meeting the standard.

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

The document states that the clinical studies for NIBP were conducted in accordance with AAMI SP10:2002. The AAMI SP10 standard (now ISO 81060-2) typically requires a minimum of 85 subjects for clinical validation to ensure a statistically robust evaluation of NIBP device accuracy. The document does not specify the exact number of subjects or the country of origin, nor whether the data was retrospective or prospective, beyond stating "clinical studies."

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

For Non-Invasive Blood Pressure measurements validated against a standard like AAMI SP10, the "ground truth" is typically established by simultaneously taken reference blood pressure measurements (e.g., intra-arterial measurements or trained auscultatory measurements using a mercury sphygmomanometer) by qualified healthcare professionals. The document does not specify the exact number or qualifications of these professionals beyond implying adherence to the AAMI SP10 standard, which mandates specific protocols for reference measurements.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method in the context of expert consensus, as this is not typically applicable for NIBP accuracy studies where direct physiological measurements serve as the reference. Adherence to AAMI SP10 implies a standardized method for obtaining reference measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is not applicable as the CAS 740 Series Monitor is a vital signs monitor and not an AI/ML powered device requiring interpretation of medical images or data by multiple readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, for the Non-Invasive Blood Pressure component, standalone performance was assessed. The document states: "CAS has tested and demonstrated ND Plus performance equivalent to the NB module in bench test simulations." This refers to the algorithm's performance in simulation without human interaction to interpret the NIBP readings. Additionally, the clinical studies, while involving patients, assess the device's ability to accurately measure blood pressure on its own.

7. The Type of Ground Truth Used

For the Non-Invasive Blood Pressure (NIBP) component, the ground truth was based on reference blood pressure measurements obtained according to the AAMI SP10:2002 standard during clinical studies. These are direct physiological measurements.

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of an AI/ML algorithm. The NIBP measurement relies on oscillometric technology and algorithms that were likely developed and refined using physiological data, but the term "training set" with specific size is not mentioned for this type of device.

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

As there is no mention of a "training set" in the AI/ML context, this question is not directly applicable. The underlying algorithms for oscillometric NIBP would have been developed and validated against a combination of empirical data and theoretical models of blood pressure oscillations, with accuracy verified through extensive testing against established reference methods.

Summary

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MEDICAL SYSTEMS, INC. TECHNOLOGY APPLIED TO MEDICINE

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Ref.:	K033048
Submitter:	CAS Medical Systems, Inc.
Address:	44 East Industrial Rd. Branford CT. 06405 USA
Contact:	Ron Jeffrey - Director, Regulatory AffairsPhone - (203) 488-6056 Fax - (203) 488-9438Email - rjeffrey@casmed.com
Prepared:	September 25, 2003 Revised January 30, 2004 / June 1, 2004
Trade Name:	CAS 740 Series Monitor
Common Name:	Vital Signs Monitor
Classification Name: Noninvasive Blood Pressure Measurement System

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EQUIVALENCE

The CAS 740 Monitor is equivalent to the following devices:

- CAS 9303 Neonatal / Adult Vital Signs Monitor (K982776);
- CAS 9001 EMS NIBP Monitor (K982135);
- CAS 9002 EMS NIBP / Sp02 Monitor (K980879);
- Nellcor Puritan Bennett N-550 Pulse Oximeter (K021090);
- Nellcor Puritan Bennett N-595 Pulse Oximeter (K012891);
- Masimo Set 2000 Pulse Oximeter / accessories (K990966)

DESCRIPTION

A purchaser has pulse oximetry choices that include modules manufactured by Masimo, Nellcor or Nonin.

The temperature parameter utilizes predictive technology from SureTemp™ (Welch Allyn Inc.)

The monitor is a rugged, portable and lightweight unit widely adaptable for many applications and mounting schemes. Used for spot-checking or continuous monitoring, features include an easily replaccable Nickel Metal Hydride rechargeable battery pack, wireless infrared printer communication,

and many more. The table below defines the different models within the 740 series and the relationship to the CAS predicate devices

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The monitor, its equivalent and parameters:

Model(s)	CAS Equiv.	Parameters (Variations)
740-3MS,740M-3MS	9303, 9001	ND NIBP, Masimo Sp02 & W/A Temp - domestic and international versions100 – 240 VAC, and RS 232; (12VDC version; mounting versions available)
740-3NL,740M-3NL	9303, 9001	ND NIBP, Nellcor Sp02 & W/A Temp - domestic and international versions100 – 240 VAC, and RS 232; (12VDC version; mounting versions available)
740-3NN,740M-3NN	9303, 9001, 9002	ND NIBP, Nonin Sp02 & W/A Temp - domestic and international versions100 – 240 VAC, and RS232; (12VDC version; mounting versions available)

740 Series Intended Use

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SUBSTANTIAL EQUIVALANCE COMPARISON – PREDICATE(S) VS. 740

CATEGORY	CAS 9303, 9001 AND 9002(predicate)	CAS 740 SERIES
Indications foruse	The CAS predicate devices areindicated for use for non-invasivemonitoring of blood pressure,oxygen saturation, pulse andtemperature of adult, pediatric andneonatal patients in the care ofhealth professionals. The 9001 and9002 monitors are further indicatedfor use with the EMS / transportuser, relying on a rechargeablebattery and charger. These modelshave no direct mains AC input.	The CAS 740 Series devices areindicated for use for non-invasivemonitoring of blood pressure, oxygensaturation, pulse and temperature ofadult, pediatric and neonatal patientsin the care of health professionals.In summary, the 740 series monitorhas all of the same indications for useas its predicate device. This includes:condition or disease monitored,prescription vs. over the counter, partof the body applied to, frequency ofuse, physiological purpose and patient
Targetpopulation	9303 family - adults, pediatric andneonatal patients. 9001 and 9002 -adults and pediatric patients only.	population.740 series - adults, pediatric, infantand neonatal patients.
Design	9303 family is comprised of threemodels: 9301 – non-invasive bloodpressure only; 9302 - non-invasiveblood pressure and pulse oximeteronly; 9303 - non-invasive bloodpressure, pulse oximeter andtemperature. The 9001 is similarto the 9301 and the 9002 is similarto the 9302. All predicate CASmonitors are small lightweight andportable.The entire line of predicatemonitors utilizes modularcomponents for non-invasive bloodpressure, pulse oximetry andtemperature, if included.In all cases the non-invasive bloodpressure module is a CAS designand the same item; (NB non-invasive blood pressure module).	The 740 series is designed to be amulti-parameter monitor. The 740series will replace the 9301, 9302,9303, 9001 and 9002 monitors. The740 series is small lightweight andportable.Like its predicate, the 740 utilizemodular parameters for non-invasiveblood pressure, pulse oximetry andtemperature.CAS designs the blood pressurecomponent, called the ND Plus. Theprimary difference with the ND Plus,as compared to the predicates NBboard, is its smaller size and its lowerpower use. Also, there is theadditional of a secondary safetyprocessor. The boards are similar inthat ND Plus has the same front-endcontrol and the same basic algorithmas the NB board.
CATEGORY	CAS 9303, 9001 AND 9002	CAS 740 SERIES
	(predicate)
	Where a pulse oximeter is includedit is a purchased OEM modulefrom Nonin Medical Systems.	Where a pulse oximeter is included,CAS provides three possible OEMoptions. The predicate deviceprovided only one. The customer hasthe option of selecting the pulseoximeter of their choice. Availableare the Masimo, Nellcor and Nonin(same as predicate) pulse oximeters.The FDA in the manufacturers ownfinished medical devices has clearedall three of these pulse oximeters.
	The temperature function is onlyavailable in the 9303 monitors andis an OEM purchased predictivetemperature module manufacturedby Welch Allyn.	The temperature function is availableif desired. Like the predicate, it is anOEM purchased predictivetemperature module manufactured byWelch Allyn. The FDA has clearedthis module, in the manufacturersmonitor, for marketing.In summary, with the exceptionsnoted above, and the new look of itscase design, the 740 is essentially thesame as the predicate devices.
Materials	Monitor case – ABS U.L.approved material;	Monitor case – ABS U.L. approvedinjection molded material. Thismonitor is a custom industrial design
	Monitor interior – Series of PCboards (Control / Display, interfaceand non-invasive blood pressure) Ifordered with pulse oximeter ortemperature, these would beadditional PC board modules.	Monitor interior – Series of PC boards(Control / Display, interface and non-invasive blood pressure) If orderedwith pulse oximeter or temperature,these would be additional PC boardmodules.
	Power center – 9303 family hasAC mains input and a rechargeablelead acid type battery. 9001/9002monitors have no AC mains andget power from a rechargeablepower supply (or direct DC fromtransport vehicle) and lead acidbattery.	Power center – 740 series has ACmains and a rechargeable NickelMetal Hydride customer replaceablebattery. A DC version is part of theseries where the power is obtainedfrom the transport vehicle.
	Non-invasive blood pressure	Non-invasive blood pressure module(NIBP) – Of the three possible
CATEGORY	CAS 9303, 9001 AND 9002(predicate)	CAS 740 SERIES
	module (NIBP) -- Of the threepossible parameters offered, thismodule is the only one designedand manufactured by CAS. Allmonitors in this group contain theNB NIBP module version whichconsists of microprocessor,circuitry, software, valves, pumptransducer, and hardware.	parameters offered, this module is theonly one designed and manufacturedby CAS. All monitors in this groupcontain the ND Plus NIBP moduleversion, which consists ofmicroprocessor, circuitry, software,valves, pump transducer, andhardware.The "design" section containsreference to the subtle differences.
	Pulse oximeter module - Thisparameter is an option in the 9302and 9002 only. It is the samemodule in both cases and ismanufactured by Nonin MedicalSystems.	Pulse oximeter module - As with thepredicate monitors, the same Noninmodule is one of the three typesoffered. The other two types of pulseoximeters are Masimo and Nellcor(Tyco Healthcare). These are activelymarketed OEM devices designed foruse by other manufacturers as well asthe company's own branded devices.All three types of pulse oximeteroccupy the same footprint andconsume the same power.
	Temperature module (9303 only) -See design section.	Temperature module - The 740 hasthis parameter. See "Design" section.
	Components / Accessories -Included are blood pressure cuffs,inflation tube, power cord, usersmanual, at a minimum. Formonitors with the options of pulseoximeter and temperature, themanufacturers recommendedaccessories are included.	Components / Accessories - Includedare blood pressure cuffs, inflationtube, power cord, users manual, at aminimum. These are the same as thepredicate devices. For pulse oximetryand temperature, the manufacturersrecommended accessories areincluded.
CATEGORY	CAS 9303, 9001 AND 9002(predicate)	CAS 740 SERIES
Performance(Clinical and non-clinical)	With regard to non-invasive blood pressure, CAS has tested and passed performance qualification to the SP10 requirements.There is historical acceptance of these monitors from an accuracy viewpoint. CAS has very few complaints related to accuracy issues.	With regard to non-invasive blood pressure, CAS has tested and demonstrated ND Plus performance equivalent to the NB module in bench test simulations. No new issues of safety and effectiveness were raised.Note: Predicate devices use NB NIBP module. 740 Series uses the ND Plus NIBP module.In addition, the 740 monitor has undergone a series of clinical studies in accordance with AAMI SP10:2002, with results meeting the requirements of the standardIn summary, performance equivalence has been demonstrated.
Sterility	None of the equipment or its accessories is sterilized.	None of the equipment or its accessories is sterilized.
Biocompatibility	All patient contact equipment and accessories have been tested, at some level, for biocompatibility.	All patient contact equipment and accessories have been tested for biocompatibility. Where the accessories are provided "ready for sale" by the manufacturer of the pulse oximeter and temperature components, there is documentation showing that the manufacturer has obtained adequate biocompatibility results.
Mechanical Safety	These predicate devices have undergone mechanical safety testing as part of the successful, and ongoing evaluation by Underwriters Laboratories as well as testing to the medical equipment safety standard, IEC60601-1 and its applicable collateral and particular standards.	The 740 series monitors have been evaluated to the following standards: UL2601-1, IEC 60601-1, IEC 60601-2-30, IEC 60601-2-49, AAMI SP10 and other collateral and particular safety standards. A follow-up services program is planned for quarterly inspection for these standards.In summary, the 740 has received greater testing for mechanical safety than the predicate devices.
Chemical Safety	Not applicable to these products	Not applicable to these products
CATEGORY	CAS 9303, 9001 AND 9002(predicate)	CAS 740 SERIES
Anatomical Sites	Blood pressure - arms and thigh(Neonates – arm and leg)Sp02 – fingers and toesTemperature – Orally or rectally(neonates – axillary)	Blood pressure – arms and thigh(Neonates – arm and leg)Sp02 – fingers and toesTemperature – Orally or rectally(neonates – axillary)In summary, there is no difference inanatomical sites.
Human Factors	With these monitors human factorsissues were not monumental fromthe beginning. Human factorswere considered during thedevelopment of the monitors.Some of the issues that did persistwere designed out during theproduct lifetime	With the 740 series monitor additionalhuman factors were employed.Examples of these are:✓ Easier battery access forreplacement;✓ Visible battery state ofcondition;✓ Auto off to save battery life;✓ Attached label explainingsymbols used;✓ All cables and cords betterlocated to avoid tangling;✓ Designed for ease ofassembly;✓ Numerous mountingopportunities - tables, pole,wall or rail;✓ Wireless communication toprinter;✓ More rugged than predicates;✓ Additional languages offered.

CATEGORY	CAS 9303, 9001 AND 9002(predicate)	CAS 740 SERIES
Energy used	The 9303 monitor contains aswitching power supply whichhandles input of 100 to 250VAC50/60 Hz at 0.3A. This power runsthe monitor and charges a 6VDClead acid battery.	The 740 series contains the samepower supply, essentially the same asthe 9303 with the exception of thebattery, which in this case is a 7.2 voltNickel Metal Hydride (NiMH) batterypack.
	The 9001 & 9002 monitors do nothave internal power supplies.These monitors, designed withportability EMS conditions inmind, contain a 6VDC Lead Acidbattery, which is charged by a120VAC power supply.	A version of the monitor is availablefor transport use where its power isderived from a vehicles 12VDCpower. In this case there is no internalpower supply or a mains connection.This version also uses the samebattery pack.
		In summary, the move to NiMHgreatly improves capacity and chargetime.
Compatibilitywithenvironment andother devices	In general these devices do notrepresent environmentalcompatibility challenges.Compatibility with other devices isclearly specified by themanufacturer in the user manuals.Product safety and EMC rulesrequire that limits be establishedby testing and documented.	In general these devices do notrepresent environmental compatibilitychallenges. Compatibility with otherdevices is clearly specified by themanufacturer in the user manuals.Product safety and EMC rules requirethat limits be established by testingand documented.
		In general there is equivalence here,however the safety and EMC testingauthority has required that tightercontrols be placed on connection toother devices.
	Where used	Hospitals, intra-hospital and inter-hospital transport, clinics, doctor'soffice, dental offices, emergencyvehicles, and first responders. Notindicated for home use
		In summary, there is no differencehere.
CATEGORY	CAS 9303, 9001 AND 9002 (predicate)	CAS 740 SERIES
Standards met	UL2601 or 544, EN 60601-1, EN60601-1-2, EN 60601-2-30, EN1061 and SP10 (accuracy)	UL2601-1, IEC60601-1, IEC60601-1-1, IEC60601-1-2, IEC60601-1-4,IEC60601-2-30, IEC60601-2-49, EN865, and AAMI SP10:2002.In summary, There were morestandards met and in some cases they
Electrical Safety	These predicate devices haveundergone mechanical safetytesting as part of the successful,and ongoing evaluation byUnderwriters Laboratories as wellas testing to the medical equipmentsafety standard, IEC60601-1 andits applicable collateral andparticular standards.	The 740 monitor has undergoneelectrical safety testing as part of thesuccessful, and ongoing evaluation byUnderwriters Laboratories as well astesting to the medical equipmentsafety standard, IEC60601-1 and itsapplicable collateral and particularstandards.In summary, the 740 has receivedgreater testing for electrical safetythan the predicate devices.
Thermal Safety	These devices do not presentthermal safety risks. Some aspectsof over-temperature are evaluatedduring safety testing.	These 740 series does not presentthermal safety risks. Some aspects ofover-temperature are evaluated duringsafety testing.In summary, there are no differences.
Radiation safety	Not a risk	Not a risk

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Image /page/10/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 1 2004

Mr. Ron Jeffrey Director, Regulatory Affairs CAS Medical Systems, Incorporated 44 East Industrial Road Branford, Connecticut 06405

Re: K033048

Trade/Device Name: CAS 740 Series Monitor Models 740-3MS, 740M-3MS, 740-3NL, 740M-3NL, 740-3NN, 740M-3NN Regulation Number: 870.1025 Regulation Name: Patient Physiologic Monitor Regulatory Class: II Product Code: MHX Dated: May 13, 2004 Received: May 14, 2004

Dear Mr. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Mr. Jeffrey

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirely as as tronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Chiu Lin, Ph.D

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number: K033048

Device Name: 740 Series monitor

The CAS 740 Series Vital Signs Monitor is indicated for use for non-Indications for use: invasive monitoring of blood pressure, oxygen saturation, pulse and temperature of adult, pediatric and neonatal patients, in the care of health professionals.

Prescription Use Over-The-Counter Use AND/OR (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)

K033048

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

510(k) Number: Jum

Page 1 of 1

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.