The CardioQ-EDM+ cardiac function and fluid status monitoring system is designed to provide clinicians with real-time information about a patient's left ventricular blood flow and key hemodynamic parameters. The CardioQ-EDM+ beat-to-beat data on cardiovascular status can be used by the managing clinician to evaluate and optimize hemodynamic performance in anesthetized, sedated or conscious patients in the operating room, intensive care unit, emergency room or ward.

Device Description

The CardioQ-EDM+, is a medical instrument designed to monitor cardiac function and fluid status, providing clinicians with real-time information about a patient's left ventricular blood flow and key hemodynamic parameters in anesthetized, sedated or conscious patients in the operating room, intensive care unit, emergency room or ward. In addition, the CardioQ-EDM+ includes a function to calculate arterial blood pressure based parameters from an output slaved from a vital signs monitor. The CardioQ-EDM+ combines Doppler measurement of blood flow with Pulse Pressure Waveform Analysis (PPWA). In "Flow Monitoring Mode" the system employs esophageal Doppler monitoring (EDM) techniques using 4 MHz continuous wave ultrasound to monitor and quantify the blood flow in the descending thoracic aorta. displaying this data as a maximum velocity curve, a velocity spectrum and derived measurements. Real-time information about cardiac function, in particular left ventricular flow, is displayed continuously. For the CardioQ-EDM+, the newly added "Pressure Monitoring Mode" the system slaves the arterial blood pressure signal supplied by the hospital patient monitoring system to provide systolic and diastolic pressures and derived parameters. The CardioQ-EDM+ uses these classical blood pressure measurements to calculate Stroke Volume (SV), Cardiac Output (CO), Stroke Volume Variation (SVV). Pulse Pressure Variation (PPV) and a small number of derived parameters. The pressure derived stroke volume is calibrated from the CardioQ-EDM+'s Doppler ultrasound measurement of stroke volume ensuring consistency and allowing frequent recalibration.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Deltex Medical CardioQ-EDM+ device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not contain a specific table detailing acceptance criteria for the CardioQ-EDM+ device's performance in terms of accuracy, precision, sensitivity, or specificity. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (CardioQ-EDM) by highlighting that the new device is a modification incorporating additional functionalities for blood pressure-based parameter calculation.

The performance comparison is implicitly made through the "Comparison technological features" table, which shows that the CardioQ-EDM+ offers the same ranges for directly measured Doppler parameters as the predicate device. The new "Pressure Monitoring Mode" adds new calculated parameters with specified ranges, but these are not compared against a defined acceptance criterion from a performance study within this document.

Implicit Performance Claim (based on substantial equivalence):
The CardioQ-EDM+ is designed to provide real-time information about a patient's left ventricular blood flow and key hemodynamic parameters, similar to the predicate device. The new pressure-based calculations are presented as additions to the existing capabilities, relying on the established performance of the Doppler measurement and the slaved arterial blood pressure signal.

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

Sample Size:
- Clinical Testing: The document explicitly states: "No clinical testing was conducted in support of this 510(k)." Therefore, there is no clinical test set sample size.
- Bench Testing: The document mentions "Comparative bench testing," but does not provide details on the number of samples, cases, or specific data points used in this testing.
Data Provenance: Not applicable for clinical data. For bench testing, the provenance is internal to Deltex Medical, as it was "Comparative bench testing... using a CardioQ-EDM Cardiac Output and Fluid Status Monitoring System (K111542)."

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

Since "No clinical testing was conducted in support of this 510(k)," there was no ground truth established by experts for a clinical test set.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was used to establish performance against a ground truth.

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

Was it done? No. The document explicitly states: "No clinical testing was conducted in support of this 510(k)."
Effect size of human readers improvement: Not applicable, as no such study was performed.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

While the device operates as a standalone monitoring system, the term "standalone study" typically refers to an evaluation of an AI algorithm's performance independent of human input or review. As this device is a medical instrument (hardware and integrated software) designed to measure physiological parameters rather than an AI-driven diagnostic or interpretative tool, this concept doesn't directly apply in the same way it would for, for instance, an AI-powered image analysis product.

The device's performance is demonstrated through its ability to measure and calculate parameters, and the validation of these calculations would be part of the bench testing. The 510(k) focuses on the "substantial equivalence" of the device, particularly the new features, to the predicate. The "Bench Testing" section confirms that the new device's performance is substantially equivalent to the predicate, implying that the algorithm's calculations were validated against expected outputs or the predicate's known outputs, but specific details of this validation are not provided.

7. Type of Ground Truth Used

Clinical: Not applicable, as no clinical testing was performed.
Bench Testing: The implicit ground truth for the bench testing would have been reference measurements or known values used to compare the CardioQ-EDM+ against the predicate CardioQ-EDM. The document states: "Comparative bench testing... supports the conclusion that the two systems have substantially equivalent performance." This implies that the CardioQ-EDM+'s outputs for new and existing parameters were compared against established and accepted values (e.g., from the predicate device or simulated physiological signals) during bench testing.

8. Sample Size for the Training Set

This device does not appear to use machine learning or AI in a way that requires a "training set" in the conventional sense (e.g., for image recognition or predictive modeling from a large dataset). Its algorithms are based on established physiological principles and signal processing for Doppler measurements and arterial pressure analysis. Therefore, there's no reported training set sample size.

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

Not applicable, as there is no apparent training set for machine learning. The algorithms are likely deterministic and based on validated mathematical models and physiological relationships.

Summary

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1.1.10 510(k) Summary

510(k) Summary (as required by 21 CFR 807.92 (c))

Owner's Name:

Deltex Medical Terminus Road Chichester West Sussex POI9 8TX United Kingdom Tel: 011 44 1243 523174 011 44 1243 532534 Fax:

OCT 1 0 2013

Classification:

Proprietary Name:	Deltex Medical CardioQ-EDM+
Common/Usual Name:	Esophageal Doppler Monitor
Classification Names:	Cardiovascular Blood Flowmeter
	Extravascular Blood Flow Probe
	Patient Transducer and electrode cable
Product Codes:	DPW, DPT, DSA
Regulation Numbers:	21 CFR 870.2100, 870.2120, 870.2900

Predicate Devices used to Demonstrate Substantial Equivalence:

The Deltex Medical CardioQ-EDM cleared on October 20, 2011 under 510(k) Number K 111542

Description, including Intended Use:

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Comparison technological features:

The CardioQ-EDM+ has been designed by Deltex Medical as a modification to the CardioQ-EDM which received FDA clearance on October 20, 2011 under K111542. It uses the same product architecture but with the addition of the components, software algorithms, and display modifications that allow the CardioQ-EDM+ to calculate and display the hemodynamic parameters from the slaved pressure inputs.

The CardioQ-EDM+ combines Doppler measurement of blood flow with Pulse Pressure Waveform Analysis (PPWA). In "Flow Monitoring Mode" the system employs esophageal Doppler monitoring (EDM) techniques using 4 MHz continuous wave ultrasound to monitor and quantify the blood flow in the descending thoracic aorta. displaying this data as a maximum velocity curve, a velocity spectrum and derived measurements. Real-time information about cardiac function, in particular left ventricular flow, is displayed continuously.

From the maximum value in the velocity spectrum the following Doppler parameters are calculated: Stroke Distance (SD), Stroke Volume (SV), Stroke Volume Variation (SVV), Patient's heart rate (HR), Cardiac Output (CO), Peak Velocity (PV), Mean Acceleration (MA), Corrected Flow Time (FTc), Cardiac Index (Cl), Minute Distance (MD), Systemic Vascular Resistance (SVR), Systemic Vascular Resistance Index (SVRI), Stroke Volume Index (SVI), Flow Time to Peak Velocity (FTp), Delivered Oxygen (DO2) and Delivered Oxygen index (DO2l).

For the CardioQ-EDM+, the newly added "Pressure Monitoring Mode" the system slaves the arterial blood pressure signal supplied by the hospital patient monitoring system to provide systolic and diastolic pressures and derived parameters.

The CardioQ-EDM+ uses these classical blood pressure measurements to calculate Stroke Volume (SV), Cardiac Output (CO), Stroke Volume Variation (SVV). Pulse Pressure Variation (PPV) and a small number of derived parameters (see below). The pressure derived stroke volume is calibrated from the CardioQ-EDM+'s Doppler ultrasound measurement of stroke volume ensuring consistency and allowing frequent recalibration.

From the Systolic and Diastolic pressures the following pressure-based parameters are calculated:

. Cardiac Output (CO).
. Cardiac Index (CI).
Stroke Volume (SV), .
Stroke Volume Index (SVI) .
Stroke Volume Variation (SVV) .
Pulse Pressure Variation (PPV) .
Systemic Vascular Resistance (SVR),

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K132139 page 3 of 8

Systemic Vascular Resistance Index (SVRI), .
Mean Arterial Pressure (MAP) .
Heart Rate (HR) ◆
Delivered Oxygen (DO2) ●
Delivered Oxygen Index (DO2I) ●

The CardioQ-EDM+ monitor will be supplied with a Patient Interface Cable for connecting onto a Deltex Medical probe, but not a probe or Arterial Blood Pressure Interface Lead, which must be purchased separately.

A comparison of the technological features of the proposed CardioQ-EDM+ and the predicate CardioQ-EDM is presented in the table below:

PREDICATE DEVICE COMPARISON-GENERAL SYSTEM DESCRIPTION
	Deltex CardioQ-EDM (K111542)	Deltex CardioQ-EDM+
	Predicate Device	Proposed Device
Device Classification	21 CFR 870.2100, 870.2120, 870.2900	21 CFR 870.2100, 870.2120, 870.2900
	Procode DPW, DPT, DSA	Procode DPW, DPT, DSA
Indications for use	The CardioQ-EDM cardiac functionand fluid status monitoring system isdesigned to provide clinicians withreal-time information about a patient'sleft ventricular blood flow and keyhemodynamic parameters. TheCardioQ-EDM's beat-to-beat data oncardiovascular status can be used by themanaging clinician to evaluate andoptimize hemodynamic performance inanesthetized, sedated or consciouspatients in the operating room,intensive care unit, emergency room orward	The CardioQ-EDM+ cardiac functionand fluid status monitoring system isdesigned to provide clinicians withreal-time information about a patient'sleft ventricular blood flow and keyhemodynamic parameters. TheCardioQ-EDM+ beat-to-beat data oncardiovascular status can be used by themanaging clinician to evaluate andoptimize hemodynamic performance inanesthetized, sedated or consciouspatients in the operating room.intensive care unit, emergency room orward.
Patient population	For use in patients59" (149 cm) or taller	same
Patient status	Anesthetized/sedated patients/awake	same
Insertion route	Oral or Nasal	same
Contraindications	Intra-aortic balloon pumping	same
	Severe coarctation of the aorta	same
	Pharyngo-esophago-gastric pathology	same
	Severe bleeding diatheses	same
System design	Esophageal probe transmits andreceives 4 MHz Continuous WaveDoppler (CWD) ultrasound to measureblood flow velocities in the descendingthoracic aorta	same
PREDICATE DEVICE COMPARISON-GENERAL SYSTEM DESCRIPTION
	Deltex CardioQ-EDM (K111542)	Deltex CardioQ-EDM+
	Predicate Device	Proposed Device
	Signals are returned via the PatientInterface Cable (PIC) to CardioQ-EDMMonitor	same
	CardioQ-EDM Monitor processes thesignal and displays it as real-timespectrum. to show the distribution ofred blood cell velocities over the entirecardiac cycle	same
	Maximum velocity envelope iscontinuously delineated and used tocalculate velocity-integral of thewaveform during systole	same
	Patient age, weight & height used withvelocity-integral to provide volumetricflow data, including cardiac output,from 'nomogram' calculation	same
System Components	CardioQ-EDM Monitor	CardioQ-EDM+ Monitor
	Power cord	same
	Patient Interface Cable	same
	no probes included	same
	Not required	arterial blood pressure interface lead(Not included)
Mode of operation	Continuous	same
Ultrasonic clutter rejection	450 Hz & 900 Hz high-pass filters	same
Spectral Display	512 point. Fast Fourier Transform	same
	Temporal resolution 6 ms	same
Velocity spectrum display timerange (x-axis)	Full screen: 4.3 seconds Split screen:1.4 seconds	same
Velocity display scales (y-axis)	50, 100, 200 cm/s250 cm/s	same
Doppler audio confirmation	Yes	same
Display	Color 10.4" TFT LCD screen (800 x600 pixels) SVGA	same
Ranges of directly measuredDoppler parameters	Peak Velocity (PV) 10 -- 250 cm/s	same
	Heart Rate (HR) 20 - 360 bpm	same
	Flow time (systolic) (FT)*42 - 1500 ms	same
*not displayed(see FTc below)	Flow time to peak (FTp)	same
	6 - 750 ms
PREDICATE DEVICE COMPARISON-GENERAL SYSTEM DESCRIPTION
	Deltex CardioQ-EDM (K111542)	Deltex CardioQ-EDM+
	Predicate Device	Proposed Device
	24 - 999 ms
	Stroke Distance (SD)0.2 - 165 cm	same
	Mean Acceleration (MA)0.1 - 366 m/s²	same
	Minute Distance (MD)4 - 59400 cm	same
	Stroke Volume (SV)0 - 999 ml	same
	Cardiac Output (CO)0 - 99.9 L/min	same
	Cardiac Index (CI)0 - 99.9 L/min/m²	same
	Stroke Volume Index (SVI)0 - 99.9 L/m²	same
	Systemic Vascular Resistance (SVR)0 - 9999 dyne.sec/cm⁵	same
	Systemic Vascular Resistance Index (SVRI)0 - 999 dyne.sec/cm⁵/m²	same
	Not Available	Stroke Volume Variation (SVV)0-100 %
	Not Available	Delivered Oxygen (DO₂)0-8040 ml/min
	Not Available	Delivered Oxygen Index (DO₂I)0-3965 ml/min/m²
Ranges of pressure-basedcalculated parameters	Not Available	Heart Rate (HR) 20 - 360 bpm
	Not Available	Stroke Volume (SV) 0 - 999 ml
	Not Available	Stroke Volume Variation (SVV)0-100 %
	Not Available	Cardiac Output (CO)0 - 99.9 L/min
	Not Available	Cardiac Index (CI)0 - 99.9 L/min/m²
	Not Available	Stroke Volume Index (SVI)0 - 99.9 L/m²
PREDICATE DEVICE COMPARISON-GENERAL SYSTEM DESCRIPTION
	Deltex CardioQ-EDM (K111542)Predicate Device	Deltex CardioQ-EDM+Proposed Device
	Not Available	Systemic Vascular Resistance(SVR)$0-9999 dyne.sec/cm^{-5}$
	Not Available	Systemic Vascular ResistanceIndex (SVRI)$0-999 dyne.sec/cm^{-5}/m^2$
	Not Available	Delivered Oxygen (DO₂)0-8040 ml/min
	Not Available	Delivered Oxygen Index (DO₂l)$0-3965 ml/min/m^2$
	Not Available	Systolic Pressure (Psys)15-500 mmHg
	Not Available	Diastolic Pressure (Pdia)0-485 mmHg
	Not Available	Mean Arterial Pressure (Pmap)7.5-492.5 mmHg
	Not Available	Pulse Pressure Variation (PPV)0-100 %
	Not Available	Blood Pressure (BP)15/0 - 500/485 mmHg
Operating modes	Patient Data entry	same
	Probe Focus	same
	Run Mode	same
Controls & user interface	Control knob (function dependent onscreen)	same
	Audio volume knob6 'soft' buttons (function dependent onscreen)	same
Parameters displayed	Eight of the following can be displayedabove the spectral display (access to allwith split screen):	same
	Doppler (Flow Monitoring Mode)Peak Velocity (PV)	same
	Heart Rate (HR)	same
	Stroke Distance (SD)	same
	Mean Acceleration (MA)	same
	Stroke Volume (SV)	same
	Cardiac Output (CO)	same
	Minute Distance (MD)	same
	Corrected Flow Time (FTc)	same
	Flow Time to peak (FTp)	same
PREDICATE DEVICE COMPARISON-GENERAL SYSTEM DESCRIPTION
	Deltex CardioQ-EDM (K111542)Predicate Device	Deltex CardioQ-EDM+Proposed Device
	Cardiac Index (CI)	same
	Stroke Volume Index (SVI)	same
	Systemic Vascular Resistance (SVR)	same
	Systemic Vascular Resistance Index(SVRI)	same
	Pressure (Pressure Monitoring Mode)	same
	Not Available	Heart Rate (HR)
	Not Available	Stroke Volume (SV)
	Not Available	Stroke Volume Variation (SVV)
	Not Available	Cardiac Output (CO)
	Not Available	Cardiac Index (CI)
	Not Available	Stroke Volume Index (SVI)
	Not Available	Systemic Vascular Resistance (SVR)
	Not Available	Systemic Vascular Resistance Index(SVRI)
	Not Available	Delivered Oxygen (DO₂)
	Not Available	Delivered Oxygen Index (DO₂1)
	Not Available	Systolic Pressure (Psys)
	Not Available	Diastolic Pressure (Pdia)
	Not Available	Mean Arterial Pressure (MAP)
	Not Available	Pulse Pressure Variation (PPV)
	Not Available	Blood Pressure (BP)
Parameters update rate	Every 1 to 20 heart beats	same
Trend history	Up to 240 hours/Unlimited	up to 48 hours
Trend temporal resolution	30 seconds	same
Accessories	Roll Stand	same
	Roll Stand Interface Kit	same
	Probes and Probe accessories:Deltex Medical 240 Hour EsophagealDoppler Probe (DP240)Deltex Medical 6 hour EsophagealDoppler Probe (I₂S)Deltex Medical 24 hour EsophagealDoppler Probe (I₂P)Deltex Medical 72 hour EsophagealDoppler Probe (I₂C)	same

Table TI - Technology Characteristics of New Device Compared to Predicate Device

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page 5 of 8 K132139

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page 8 of 8 K132139

Summary of Clinical and Non-Clinical Data:

Electrical Safety and Electromagnetic Compatibility:

Testing has been conducted following IEC 60601 series of standards, which are FDA recognized voluntary consensus standards.

Acoustic Output Testing:

Testing has been conducted following NEMA UD 2, which is a recognized voluntary consensus standard.

Bench Testing:

Comparative bench testing of the CardioQ-EDM+ Cardiac Function and Fluid Status Monitoring System, using a CardioQ-EDM Cardiac Output and Fluid Status Monitoring System (K111542), is included. The results of this testing supports the conclusion that the two systems have substantially equivalent performance.

Animal Testing:

No animal testing was conducted in support of this 510(k).

Clinical Testing:

No clinical testing was conducted in support of this 510(k).

Conclusions:

Based on the testing completed and the comparisons with predicate device, the CardioQ-EDM+ does not raise any new questions on safety and effectiveness and the results support a determination of substantial equivalence.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Image /page/8/Picture/3 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a bird or a person reaching out, which is the official symbol of HHS.

October 10, 2013

Deltex Medical, Ltd. Lawrence Brookfield Regulatory Affairs Manager Terminus Road Chichester West Sussex PO19 8TX United Kingdom

Re: K132139

Trade/Device Name: Deltex Medical Cardiog-EDM+ Regulation Number: 21 CFR 870.2100 Regulation Name: Esophageal Doppler Monitor Regulatory Class: Class II Product Code: DPW Dated: July 9, 2013 Received: July 12, 2013

Dear Lawrence Brookfield :

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems

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Page 2 - Lawrence Brookfield

(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 Small Manufacturers, International and Consumer Assistance 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

Feli Aguel Felipe Aguel

Bram D. Zuckerman, M.D. for Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K132139

Indications for Use Statement 1.1.9 INDICATIONS FOR USE STATEMENT

510(k) Number (if known): To Be Assigned

CardioQ-EDM+ Device Name:

Indications For Use:

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

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Felipe Aguel
2013.10.10 16
-04'00'

2013.10.10 16:42:46

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Regulation Number and Section

§ 870.2100 Cardiovascular blood flowmeter.

(a)
Identification. A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.(b)
Classification. Class II (performance standards).