The 750E Patient Monitor is intended to continuously monitor a patients ECG, heart rate, non-invasive blood pressure (NIBP), functional arterial oxygen saturation (Sp02), respiration rate, temperature and end tidal carbon dioxide (C02). The monitor is designed as a bedside/portable monitor and is intended for use on adult, pediatric and neonatal patients in the care of health care professionals.

Device Description

The CAS 750E Series Monitor, with ECG Synchronization and Mean Rate Deviation Measurement Trigger is a modification based on the existing 750E monitor. Only the 750E non-invasive blood pressure (NIBP) module portion of the multiparameter monitor is affected by the change. All other parameters of the 750E (Sp02, respiration rate, EtC02 and temperature) remain untouched. The individual module responsible for NIBP is called ND+. ECG Synchronization can use an ECG (R-wave) input signal to time correlate the occurrence of a cardiac contraction with the detection of the oscillometric blood pressure pulses occurring in a cuff wrapped around the patients upper arm. ECG Synchronization is available only when the ND+ module is operating in adult mode. ECG synchronization is taken from the edge of the ECG R-wave synchronization input signal. The delay between the subjects actual R-wave and the edge of the ECG synchronization pulse is user definable through software. This delay can be defined to be from 0 - 80ms in increments of I ms. Once set this delay must remain constant (± 5ms) throughout the blood pressure measurement. If during the NIBP measurement the ECG synchronization input stops providing pulses at a rate equal to 25 beats per minute (BPM), the ND+ module will stop using the ECG synchronization pulse to time correlate cardiac contractions with the detection of the oscillometric blood pressure pulses and complete the blood pressure measurement using only the oscillometric technique. On power-up and following a reset, ECG synchronization is disabled. The Mean Heart Rate Deviation Measurement Trigger functions while in the automatic interval measurement mode and with an ECG synchronization input present. In this mode, the Mean Heart Rate Deviation Measurement Trigger can be enabled to initiate an off-cycle blood pressure measurement when a user defined change in the subject's heart rate is detected by the ND module for a period of approximately 10 seconds. The last NIBP pulse rate measurement is compared to the current heart rate. If the current heart rate exceeds the user defined threshold, for a period of 10 seconds, an off-cycle blood pressure measurement shall be initiated. At all times there will be a minimum time between NIBP measurements of 30 seconds. The off-cycle blood pressure measurement shall restart the automatic interval timer.

AI/ML Overview

The provided text describes the CAS 750E Series Monitor with NIBP modification and a study conducted to demonstrate its substantial equivalence to a predicate device. Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Parameter / Feature	Acceptance Criteria	Reported Device Performance
ECG Synchronization (R-wave) Delay Adjustment	User definable from 0 - 80ms in increments of 1ms. Once set, delay must remain constant (± 5ms) throughout the blood pressure measurement.	Implicitly met, as the description details this functionality without indicating failure.
ECG Synchronization Disablement	If ECG synchronization input stops providing pulses at a rate of 25 BPM, the ND+ module will stop using ECG synchronization and complete measurement using oscillometric technique.	Implicitly met, as the description details this functionality without indicating failure.
Power-up/Reset ECG Synchronization	Disabled on power-up and following a reset.	Implicitly met, as the description details this functionality without indicating failure.
Mean Heart Rate Deviation Trigger	Initiate an off-cycle blood pressure measurement when a user-defined change in mean heart rate is detected for approximately 10 seconds. Thresholds: fixed value change (1-98 BPM) or percentage change (1-98%).	Implicitly met, as the description details this functionality without indicating failure.
Minimum Time Between NIBP Measurements	30 seconds (even with off-cycle measurements).	Implicitly met, as the description details this functionality without indicating failure.
DSP and ND+ Software Evaluation	"Evaluate the DSP and ND+ software in the model 750 monitor" (VP/VR 050041). "Evaluate the DSP software in the model 750 ND+ module for HR deviation functionality" (VR/VP 060059).	"All pass" for both software evaluations.
NIBP Accuracy	Compliance with ANSI/AAMI SP10:2002 standard for NIBP monitors.	"Complies with SP10" (as stated in the clinical testing section).

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

Sample Size for Clinical Test Set: Not explicitly stated in terms of number of subjects or measurements within the provided text for the ANSI/AAMI SP10 study. The study refers to "Adult/Pediatric Study."
Data Provenance: The clinical validation of the 750 monitor with the ND+ NIBP module w/ECG Gating was conducted at the University of Tennessee Medical Center. This indicates U.S. data. The text doesn't specify if it was retrospective or prospective, but clinical validation studies for medical device approvals are typically prospective.

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

The document does not explicitly state the number of experts used or their specific qualifications for establishing ground truth for the clinical NIBP accuracy study.
For NIBP monitors, "ground truth" typically involves comparison against an invasively measured arterial blood pressure, often by a trained medical professional (e.g., physician, nurse, or technician) following a standard protocol.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (like 2+1 or 3+1) for the clinical testing. For NIBP studies, ground truth is usually established directly through invasive measurements, rather than through expert consensus of subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No, an MRMC comparative effectiveness study was not done. This document describes a modification to a patient monitor (specifically the NIBP module) and its standalone performance against a consensus standard (ANSI/AAMI SP10). It does not involve human readers interpreting output or AI assistance.

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

Yes, a standalone study was done for the NIBP accuracy. The clinical study (ANSI/AAMI SP10) evaluates the device's ability to accurately measure blood pressure independently, without human interaction influencing the measurement results beyond proper cuff placement and operation. The software evaluations ("VP/VR 050041" and "VR/VP 060059") are also standalone performance tests of the device's software functionality.

7. The Type of Ground Truth Used

For the NIBP accuracy study (ANSI/AAMI SP10): The ground truth usually involves invasively measured arterial blood pressure (IBP) from a catheter placed in an artery. This is the gold standard for blood pressure measurement.
For the software evaluations (VP/VR 050041, VR/VP 060059): The ground truth would be the expected behavior and output of the software based on its design specifications and requirements.

8. The Sample Size for the Training Set

The document does not mention or specify a training set sample size. This is because the device described is a patient monitor with specific hardware and software functions (like ECG synchronization and heart rate deviation triggers) that are designed and verified against engineering specifications and clinical standards (like AAMI SP10). It is not an AI/Machine Learning algorithm that typically requires a large training dataset.

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

Since there is no explicit training set discussed for an AI/ML algorithm, this question is not applicable in the context of the provided information. The "ground truth" for the device's development would be its engineering specifications, design requirements, and the established medical standards it aims to meet.

Summary

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KOL3087 ャリア

Image /page/0/Picture/1 description: The image shows the word "CASMED" in large, bold, black letters. Below the word "CASMED" is the phrase "FOR WHAT'S VITAL" in a smaller font. The letters are all capitalized and the font is sans-serif. The trademark symbol is to the right of the word "CASMED".

DEC I 1 2006

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Submitter:	CAS Medical Systems, Inc.
------------	---------------------------

44 East Industrial Rd. Branford CT. 06405 USA Address:
Ron Jeffrey Director, Regulatory Affairs Contact: Phone - (203) 488-6056 Fax - (203) 488-9438 Email - rjeffrey@casmed.com
October 2, 2006 Prepared:
Trade Name: CAS 750E Series Monitor
Common Name: Multi-Function Patient Monitor
Classification Name: Oximeter (74DQA)

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EQUIVALENCE

The CAS 750E Series Monitor, with NIBP modification for ECG synchronization (gating) and Mean Heart Rate Deviation Measurement Trigger is equivalent to the following device:

CAS 750E Series Monitor (K051896)

DESCRIPTION

ECG Synchronization can use an ECG (R-wave) input signal to time correlate the occurrence of a cardiac contraction with the detection of the oscillometric blood pressure pulses occurring in a cuff wrapped around the patients upper arm. ECG Synchronization is available only when the ND+ module is operating in adult mode.

ECG synchronization is taken from the edge of the ECG R-wave synchronization input signal. The delay between the subjects actual R-wave and the edge of the ECG synchronization pulse is user definable through software. This delay can be defined to be from 0 - 80ms in increments of I ms. Once set this delay must remain constant (± 5ms) throughout the blood pressure measurement.

If during the NIBP measurement the ECG synchronization input stops providing pulses at a rate equal to 25 beats per minute (BPM), the ND+ module will stop using the ECG synchronization pulse to time correlate cardiac contractions with the detection of the oscillometric blood pressure pulses and complete the blood pressure measurement using only the oscillometric technique.

On power-up and following a reset, ECG synchronization is disabled.

The Mean Heart Rate Deviation Measurement Trigger functions while in the automatic interval measurement mode and with an ECG synchronization input present. In this mode, the Mean Heart Rate Deviation Measurement Trigger can be enabled to initiate an off-cycle blood pressure measurement when a user defined change in the subject's heart rate is detected by the ND module for a period of approximately 10 seconds. The last NIBP pulse rate measurement is compared to the current heart rate. If the current heart rate exceeds the user defined threshold, for a period of 10 seconds, an off-cycle blood pressure measurement shall be initiated. At all times there will be a minimum time between NIBP measurements of 30 seconds. The off-cycle blood pressure measurement shall restart the automatic interval timer

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To produce an off-cycle measurement, the "user defined" changes can be any of the following:

· a fixed value change in the mean heart rate of the patient between 1 and 98 BPM;
· a percentage change in the mean heart rate definable within 1 to 98%;

The monitor, its equivalent and parameters:

Model(s)	Parameters (Variations)
750E-1(750EM-1)	ECG, respiration and temperature, 100 – 240VAC 50/60Hz, AC power supply and battery; (same but with 12VDC power input and battery, Mounting clamp included).
750E-2(750EM-2)	ECG, respiration and temperature & NIBP, 100 – 240VAC 50/60Hz, AC power supply and battery; (same but with 12VDC power input and battery, Mounting clamp included).
750E-2MS,(750EM-2MS)	ECG, respiration and temperature & Masimo Sp02, 100 – 240VAC 50/60Hz, AC power supply and battery; (same but with 12VDC power input and battery, Mounting clamp included).
750E-2NL,(750EM-2NL)	ECG, respiration and temperature & Nellcor Sp02, 100 – 240VAC 50/60Hz, AC power supply and battery; (same but with 12VDC power input and battery, Mounting clamp included).
750E-3MSC(750EM-3MSC)	ECG, respiration and temperature, Masimo Sp02, and EtC02, 100 – 240VAC 50/60Hz, AC power supply and battery; (same but with 12VDC power input and battery, Mounting clamp included).
750E-3NLC(750EM-3NLC)	ECG, respiration and temperature, Nellcor Sp02, and EtC02, 100 – 240VAC 50/60Hz, AC power supply and battery; (same but with 12VDC power input and battery, Mounting clamp included).
750E-3MS(750EM-3MS)	ECG, respiration and temperature, Masimo Sp02, & NIBP, 100 – 240VAC 50/60Hz, AC power supply and battery; (same but with 12VDC power input and battery, Mounting clamp included).
750E-3NL(750EM-3NL)	ECG, respiration and temperature, Nellcor Sp02, & NIBP, 100 – 240VAC 50/60Hz, AC power supply and battery; (same but with 12VDC power input and battery, Mounting clamp included).
750E-4MS(750EM-4MS)	ECG, respiration and temperature, Masimo Sp02, EtC02 & NIBP, 100 – 240VAC 50/60Hz, AC power supply and battery; (same but with 12VDC power input and battery, Mounting clamp included).
750E-4NL(750EM-4NL)	ECG, respiration and temperature, Nellcor Sp02, EtC02 & NIBP, 100 – 240VAC 50/60Hz, AC power supply and battery; (same but with 12VDC power input and battery, Mounting clamp included).

750E Series Indications for Use

The 750E patient monitor is intended to continuously monitor a patients ECG, heart rate, non-invasive blood pressure (NIBP), functional arterial oxygen saturation (%Sp02), respiration rate, temperature and end tidal carbon dioxide (C02). The monitor is designated as a bedside/portable monitor and is intended for use on adult, pediatric and neonatal patients in the care of health care professionals.

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Comparison of Technological Characteristics

The 750E Series Monitor (with modifications) is derived from the CAS 750E (K051896) with regard to form factor and general overall look. A number of identical components are found in both products, most especially the ECG, Respiration, End Tidal C02 (EtC02), choice of pulse oximeters; Masimo SET® or Nellcor® OxiMax®, temperature and NIBP. It is only the non-invasive blood pressure MAXNIBP® parameter that is modified.

The modification does not affect indications for us and the fundamental scientific technology of the predicate 750E Series Monitor.

Nonclinical Performance Testing to Show Substantial Equivalence

The predicate model 750E has received a full suite of in-house and third party testing. All are determined to remain valid for this modification. The list below represents the additional V&V testing to assure functionality of the modification.

VP/VR 050041	750 w/ ND+ ECG Gating	Evaluate the DSP and ND+	All pass
HR Deviation	software in the model 750	monitor
Verification Plan
VR/VP 060059	750 V2.31 w/ ND+ECG	Evaluate the DSP software in the	All pass
Gating and HR Deviation	model 750 ND+ module for HR
Verification Plan	deviation functionality

Clinical Testing to Show Substantial Equivalence

The study referred to below represents clinical testing specifically related to the 750E modification.

ANSI/AAMISP10	Adult/Pediatric Study ofCAS Model 750 Non-Invasive Blood PressureMonitor using "ND+"NIBP Module w/ECGGating: AAMISP10:2002 FormatJuly 7, 2005	Long considered a consensusstandard by the US FDA forthis type of product. Theclinical validation of the 750monitor with the ND+ NIBPmodule w/ECG Gating wasconducted at the Univ.Tennessee Medical Center.	Complies withSP10
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Conclusions Drawn from Clinical and Nonclinical Testing

With the substantial testing of a non-clinical nature, it is the conclusion that the modified 750E is substantially equivalent to the predicate devices cited above.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 1 2006

CAS Medical Systems, Inc. c/o Ron Jeffrey Director, Regulatory Affairs 44 East Industrial Rd. Branford, CT 06405

Re: K063087

Trade/Device Name: 750E Series Monitor Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: II Product Code: MWI Dated: October 4, 2006 Received: October 10, 2006

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 hay or any 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

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Page 2 - Mr. Jeffrey

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 applicable, the electronic 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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Q.S.K.

For Bram 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 (if known): Ko63097

Device Name:

750E Series monitor

Indications for Use: The 750E Patient Monitor is intended to continuously monitor a patients ECG, heart rate, non-invasive blood pressure (NIBP), functional arterial oxygen saturation (Sp02), respiration rate, temperature and end tidal carbon dioxide (C02). The monitor is designed as a bedside/portable monitor and is intended for use on adult, pediatric and neonatal patients in the care of health care professionals.

Prescription Use x (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (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)

O.S.U.

(Division Sign-Off) Division of Cardiovascular Devices

Page 1 of

K063087 510(k) Number_

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).