The MindChild Medical Meridian Fetal Heart Rate Monitor is an intrapartum fetal monitor that externally or internally measures and displays fetal heart rate (FHR). The MindChild Meridian acquires and displays the FHR tracing from abdominal surface electrodes that detect the fetal ECG signal (fECG). The MindChild Meridian may also be used to measure and display fetal heart rate using direct ECG (DECG) with a fetal scalp electrode. The MindChild Meridian is indicated for use on women who are at term (> 36 completed weeks), in labor, with singleton pregnancies, using surface electrodes on the maternal abdomen. The MindChild Meridian is intended for use by healthcare professionals in a clinical setting.

Device Description

The MindChild Medical Meridian Fetal Heart Rate Monitor is an AC powered fetal heart rate (FHR) monitor. The product consists of a signal processor containing hardware circuitry and software which acquires and processes analog signals using external, abdominal electrode sensors. Software algorithms extract ECG morphology and monitor fetal heart rate. Data is stored locally for retrieval in an off-line mode. The patient data is displayed real time on a touch screen LCD display monitor. Data may be printed out offline for permanent hard copy records. The system also possesses the ability to acquire and analyze signals from a fetal scalp electrode using the device's direct ECG (DECG) capability. The entire system is housed within a medical grade roll-up cart. The device is intended to be used in a hospital environment by trained medical staff.

AI/ML Overview

Here's an analysis of the provided text regarding the MindChild Medical Meridian Monitor, structured to answer your questions about acceptance criteria and the supporting study:

The document (K120018) describes the MindChild Medical Meridian Fetal Heart Rate (FHR) Monitor, an intrapartum fetal monitor. The primary study mentioned is a clinical validation of the Meridian algorithm for calculating FHR from fECG signals.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" with numerical targets in a formal table. However, based on the clinical validation section, we can infer the primary performance metric and its outcome. The comparator device, the HP M1350A Fetal Monitor/FSE, serves as the "Gold Standard" or reference for evaluating performance.

Acceptance Criteria (Inferred from study goals)	Reported Device Performance
FHR accuracy within a clinically acceptable number of beats per minute (BPM) compared to Gold Standard.	Mean RMS error of 5 BPM for the Meridian algorithm (similar to other FDA cleared FHR monitors).
Percent successful recordings (i.e., # comparator signals / # of Meridian signals x 100)	At least 94% successful signal reading for all signals recorded with the comparator FSE device.

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

Sample Size: The document does not explicitly state the total number of patients or recordings used in the clinical validation study. It mentions a "single Bland Altman (BA) difference plot was generated... for each patient," which implies multiple patients were included, but the exact count is not given.
Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective). However, the study involved acquiring and recording fetal ECG signals simultaneously using the Meridian Monitor and the HP M1350A Fetal Monitor/FSE, suggesting it was a prospective data collection in a clinical setting.

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

The document does not mention the use of experts to establish ground truth for the test set. Instead, the HP M1350A Fetal Monitor/FSE itself was considered the "comparator" or "Gold Standard" for FHR measurements.

4. Adjudication Method for the Test Set

No adjudication method is described. The comparison was directly between the Meridian algorithm's FHR calculations and those from the HP M1350A Fetal Monitor/FSE.

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

No MRMC comparative effectiveness study was done or mentioned. This study focuses on the standalone algorithm's performance against a reference device, not human reader performance or improvement with AI assistance.

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

Yes, a standalone (algorithm-only) performance study was conducted. The clinical validation directly compared the fetal heart rates calculated by the Meridian algorithm to the fetal heart rates calculated by the HP M1350A Fetal Monitor/FSE. There is no mention of human interpretation being part of this primary performance evaluation.

7. The Type of Ground Truth Used

The ground truth for the clinical validation was derived from the HP M1350A Fetal Monitor/FSE, which served as the "Gold Standard device" or comparator for calculating fetal heart rate. This is a form of reference device comparison or device-derived ground truth.

8. The Sample Size for the Training Set

The document does not provide any information regarding a training set or its sample size. The clinical validation solely describes the testing of the Meridian algorithm.

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

Since no training set is mentioned, there is no information on how its ground truth was established.

Summary

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K120018

510(k) Summary MindChild Medical Meridian Monitor

SEP 1 9 2012

Submitter:

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ﺗ

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MindChild Medical 1600 Osgood Street, #2-17 North Andover, MA 01845 Phone: 978.975.1160 · Fax: 978.688.8875

Contact Person:

Leo Basta NorthStar Biomedical Associates 755 Westminster St., Unit 120 Providence, RI, 02903 Phone: 617.834.9866 lbasta@northstarbiomedical.com

Date Prepared:	August 18, 2012
Trade Name:	MindChild Medical Meridian Monitor
Regulation Name:	Perinatal monitoring system andaccessories
Classification Number:	21 CFR 884.2740
Product Code:	HGM
Predicate Devices:	Monica Healthcare AN24 (K101801)HP M1350A Fetal Monitor (K900480)
Device Description:	The MindChild Medical Meridian Fetal Heart Rate Monitoris an AC powered fetal heart rate (FHR) monitor. Theproduct consists of a signal processor containing hardwarecircuitry and software which acquires and processes analogsignals using external, abdominal electrode sensors.Software algorithms extract ECG morphology and monitorfetal heart rate. Data is stored locally for retrieval in an off-line mode. The patient data is displayed real time on atouch screen LCD display monitor. Data may be printedout offline for permanent hard copy records. The systemalso possesses the ability to acquire and analyze signals

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from a fetal scalp electrode using the device's direct ECG (DECG) capability. The entire system is housed within a medical grade roll-up cart. The device is intended to be used in a hospital environment by trained medical staff.

Descriptive information, laboratory bench testing, electrical safety/EMC screening, software validation, and a biocompatibility assessment were provided to demonstrate the device meets its design specifications, performs as intended, and is safe for its intended use.

In addition, a clinical validation of the Meridian algorithm responsible for calculating FHR from fECG signals was performed. For this validation of the algorithm, fetal ECG signals were acquired and recorded using the Meridian Monitor technology and HP M1350A Fetal Monitor/FSE simultaneously. The HP M1250A Fetal Monitor/FSE was the comparator for the clinical validation study. The Meridian Monitor signals were subjected to analysis by the Meridian algorithm to calculate fetal heart rate. The resulting heart rates were compared to heart rates calculated using HP M1350A Fetal Monitor/FSE. The analyses performed included FHR accuracy and percent successful recordings (i.e., # comparator signals/ # of Meridian signals x 100). This algorithm validation demonstrated that in either mode (abdominal electrode or DECG), the fetal heart rates calculated using the Meridian Monitor algorithm were close to the comparator's fetal heart rate calculations within a clinically acceptable number of beats per minute (BPM). There were no

Intended Use:

Functional Testing:

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statistically significant differences across different BMI groups analyzed. In addition, for all signals recorded with the comparator FSE device, the Meridian technology provided a successful signal reading on at least 94% of the signals.

Lastly, a single Bland Altman (BA) difference plot was generated for the Meridian Monitor FHR calculations versus those calculated using the Gold Standard device for each patient and a root mean square (RMS) error was determined. A BA difference plot is a scatter plot of the difference between the device and Gold Standard measurements versus the Gold Standard measurement. RMS error is the square root of the mean of the squared differences. The mean RMS error of 5 BPM (Beats Per Minute) for the Meridian algorithm is similar to results observed in other FDA cleared fetal heart rate monitors.

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Non-Resident


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Characteristic	Proposed MindChild Meridian Device - K120018	Monica AN24, Monica Healthcare - K101801
Indications forUse	The MindChild Medical Meridian Fetal Heart Rate Monitor is an intrapartumfetal monitor that externally or internally measures and displays fetal heart rate(FHR). The MindChild Meridian acquires and displays the FHR tracing fromabdominal surface electrodes that detect the fetal ECG signal (fECG). TheMindChild Meridian may also be used to measure and display fetal heart rateusing direct ECG (DECG) with a fetal scalp electrode. The MindChildMeridian is indicated for use on women who are at term (> 36 completedweeks), in labor, with singleton pregnancies, using surface electrodes on thematernal abdomen. The MindChild Meridian is intended for use by healthcareprofessionals in a clinical setting.	The Monica AN24 is an intrapartum maternal-fetal monitor that non-invasivelymeasures and displays fetal heart rate (FHR) and uterine activity (UA). TheAN24 acquires and displays the FHR tracing from abdominal surface electrodesthat pick up the fetal EGG (fECG) signal. Using the same surface electrodes, theAN24 also acquires and displays the UA tracing from the uterineelectromyography (EMG) signal. The AN24 is indicated for use on women whoare at term (>36 completed weeks), in labor, with singleton pregnancies, usingsurface electrodes on the maternal abdomen. The AN24 maternal-fetal monitor isintended for use by healthcare professionals in a clinical setting.
Method	Acquisition of fetal ECG signals via external abdominal sensor electrodes.From these signals the fetal heart rate is extracted. Also may use direct ECG(DECG) acquisition using a fetal scalp electrode.	The electrical signals are passivelymonitored on three channels using external sensor electrodes placed on thepregnant abdomen. in specific locations. From these electrical signals the FetalHeart Rate (FHR) are continuously extracted and displayed. No DECG option.
Software	Proprietary algorithm to calculate heart rate.	Proprietary algorithm to calculate heart rate.
SignalProcessing	Analog to digital	Analog to digital
Display	24" diagonal real time LCD display (1900 x 1200 pixels) that graphicallydisplays clinical parameters received from signal processors. Touch screenprovides user with interface to control operation of unit.	Ability to download data to PC or view via optional 15" cart mounted monitor or10" mobile touch screen.
Controls	Power "On" button on control unit activates main operating screen on LCDdisplay. On-screen display buttons to adjust various parameters.	On/Off switch, "Event" button, battery status, signal quality, memory status.
Connections	Five connectors for electrode leads and optional fetal scalp electrode, standardUSB connector,standard AC plug and power connection	Electrode leads connector attaches to the top of the unit.
Input VoltageRange	85 - 264 VAC	AN24 and optional mobile 10" viewing monitor (VS10) - Battery operated
Frequency	50/60 Hz	Battery operated
MeasurementRange	80 - 240 BPM; abdominal sensor mode, 30 - 50 BPM; DECG Mode	UNK
Safety	Complies with FDA recognized standards pertaining to electrical safety.Complies with FDA recognized standards pertaining to electrical safety andEMC.	Complies with FDA recognized standards pertaining to electrical safety.Complies with FDA recognized standards pertaining to electrical safety andEMC.

MindChild 510(k)
Rev. B

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Summary of Substantial Equivalence:

The design, intended use, principles of operation, and technological characteristics of the MindChild Meridian device are substantially equivalent to those of the predicate devices cited above. Substantial equivalence is based upon descriptive characteristics of the various cited predicate devices and upon the testing conducted to demonstrate that the subject device performs as intended and is substantially equivalent to the predicate devices in terms of its ability to monitor fetal heart rate using its abdominally placed external electrode sensors. In addition, fetal heart rate monitoring through the device's DECG mode was demonstrated to be substantially equivalent to that of marketed devices.

MindChild 510(k) Rev. B

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing segments, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circle's perimeter. The logo is black and white.

Public Health Service

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

MindChild Medical % Mr. Leo Basta Owner NorthStar Biomedical Associates 755 WestMinster Street, Unit 120 PROVIDENCE RI 02903

SEP 1. 9 2012

Re: K120018

Trade/Device Name: MindChild Meridian Fetal Heart Rate Monitor Regulation Number: 21 CFR§ 884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: II Product Code: HGM Dated: September 14, 2012 Received: September 17, 2012

Dear Mr. Basta:

We have reviewed your Section 510(k) premarket notification of intent to market the device indication We nave reviewed your Scellon >10(t) premierity is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosule) to regarly manated producal Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Medical Frederal Frederal Fred commerce prior to May 20, 1976, the excordance with the provisions of the Federal Food, Drug, devices that have been recalismed in accession in a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a presisions of the Act . The and Costhere Act (Act) that do not require apple the general controls provisions of the Act. The Act. The Act. The Act. The You may, dielefone, market the device, basjever to the may begistration, listing of general condois provisions of the rice labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability adulteration. Flease note. ODIC access 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), If your device is classified (see above) and or regulations affecting your device can be
it may be subject to additional controls. Existing major regulations affecting your it may be subject to adultional controls. Entraling migrid to 898. In addition, FDA may
round in the Code of I cacial resgueening your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a buce complies with other requirements of the Act
that FDA has made a determination that your device complies with other requiremen that FDA has made a decemination and regulations administered by other Federal and listing of any Federal Statutes and regulations annline, but not limited to: registration and listing of media comply with an the Act sTequilements, merading, outsist and the more of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set device-leheu adverse events) (21 CFR 003); good many (21 CFR Part 820); and if applicable, the electronic forth in the quality Systems (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 IT you desire specific advice for your as nte coffices/CDRH/CDRHOffices/ucm115809.htm for go to mip.//www.ida.gov/rtoodid Drives/Health's (CDRH's) Office of Compliance. Also, please the Concer for Dorroos and reading by reference to premarket notification" (21CFR Part note the regulation emilied, "Misoranding of releases to presents 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 You may oodain outer general mormational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address (000) 030-2011 01 (00:00)Devices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin R. Tucker

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATION FOR USE

K120018
Not Assigned

510(k) Number (if known):

Device Name:

MindChild Meridian Fetal Heart Rate Monitor

Indications for Use:

The MindChild Medical Meridian Fetal Heart Rate Monitor is an intrapartum fetal monitor than The MindChild Wedical Meridian Peter Fetal heart rate (FHR). The MindChild Meridian externally of medially measures and displays from abdominal surface electrodes that detal acquires and displays the Prix training nominal may also be used to measure and display fetal heart rate using direct ECG (DECG) with a fetal scalp electrode. The MindChild Meridian is indicated for use on women who are at term (> 36 completed weeks), in labor, with singleton in indicated for use on women who are at term ( - 30 - 8 - 6 - 6 - 6 - 6 - 1 - MindChild Meridian is intended for use by healthcare professionals in a clinical setting.

AND/OR X Prescription Use: _ (Per 21 CFR 801 Subpart D)....................................................................................................................................................

Over-The Counter Use: (Per 21 CFR 801 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 1

Aogui M. Whim

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K120018

MindChild 510(k) Rev. A

Confidential

Regulation Number and Section

§ 884.2740 Perinatal monitoring system and accessories.

(a)
Identification. A perinatal monitoring system is a device used to show graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of the well-being of the fetus during pregnancy, labor, and delivery. This generic type of device may include any of the devices subject to §§ 884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 884.2720. This generic type of device may include the following accessories: Central monitoring system and remote repeaters, signal analysis and display equipment, patient and equipment supports, and component parts.(b)
Classification. Class II (performance standards).