The MindChild Medical Meridian M100 Fetal Heart Rate Monitor is an intrapartum fetal monitor that externally measures and displays fetal heart rate (FHR). The MindChild Meridian M100 acquires and displays the FHR tracing from abdominal surface electrodes that detect the fetal ECG signal (fECG). FHR tracings are displayed onto a primary fetal monitor. In addition, the M100 synchronizes the TOCO transducer signal which is also displayed to the primary fetal monitor.

The MindChild Meridian M100 is indicated for use on women who are at >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 Meridian M100 Fetal Heart Rate Monitor is a modification of the cleared M1000 Fetal Heart Rate Monitor (K120018). The modifications are ones that do not affect the intended use or the fundamental scientific technology. The M100 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.

The M100 connects to existing cleared fetal heart rate monitors with DECG (i.e., primary monitor) using the primary monitor's screen for display of fetal heart rate. The patient data is displayed real time on the primary monitor's display. The Meridian M100 is used as an accessory to a main/primary fetal monitor replacing the Doppler sensor on those monitors. The M100 is for use with the GE Corometrics 120 and the GE Corometrics 250 Fetal Monitors.

AI/ML Overview

This document is a 510(k) summary for the MindChild Meridian M100 Fetal Heart Rate Monitor, which is a modification of a previously cleared device, the M1000. Therefore, the acceptance criteria and study information provided pertain to demonstrating substantial equivalence to the predicate device, rather than a full de novo validation.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" in the format of specific thresholds for clinical performance metrics (e.g., sensitivity, specificity, accuracy for FHR detection). Instead, it focuses on demonstrating that the device meets its design specifications and performs as intended, largely by confirming that the modifications from the predicate M1000 do not adversely affect safety and effectiveness.

The "Performance Testing" section (page 11) lists various tests performed and their results:

Test	Purpose	Reported Device Performance
Dimensional Verification	To verify products meets specified dimensions and weight	Met design specification
Fetal Heart Rate Output	Verify FHR output waveform for both minimum and maximum amplitude fetal heart output.	Met design specification
TOCO Output	Verify Toco output voltage for pressure application	Met design specification
Packaging Testing	Verification of packaging and labeling.	Met design specification
Cable Pull Strength	Verify the cable connections are maintained when a 5 ft/lb. load is applied.	Met design specification
Drop Test	Verification that unit could sustain drop	Met specification
Push Test	Verify mechanical strength of enclosure by applying a 250N force to all sides and bottom of enclosure	Met specification
Cleaning	Verify that cleaning, disinfecting, and sterilizing the monitor do not create hazards and are compatible with the M100.	Met specification
Software Validation	Verify that all software modifications made performed as intended. Complete re-validation of the software was performed.	Software validation demonstrated that the software performed according to design specifications, met requirement specifications and that there were no unintended effects due to any software modifications made.

Additional performance indicators from the "Device Characteristic Comparison" section (pages 6-10) include:

Intended Use: Identical to predicate.
Indications for Use: Very similar to predicate, differences don't affect safety or effectiveness.
Regulation Number: Identical to predicate (884.2740).
Display: Identical information displayed as predicate; M100 uses primary monitor.
Controls: Each unit has power on/off; M100 utilizes primary monitor for other controls.
Printer: Both allow for downloading/transfer of patient data.
Front/Top Connections: Similar functionality for external electrodes; M100 adds TOCO connection, M1000 had optional fetal scalp electrode connection. These differences do not affect substantial equivalence.
Rear Connections: M100 has connections to primary monitor; M1000 only power. Functionally identical.
Side Connections: No impact.
Input Voltage Range: Identical (120 VAC ±10%).
Frequency: Identical (60 Hz).
Method: Algorithm for fECG acquisition and processing is the same as the M1000. M100 adds TOCO signal synchronization.
Measurement Range: Identical (50 - 240 BPM; abdominal sensor mode).
Signal Processing: Identical (Analog to digital).
Safety: Identical patient protection isolation barrier and compliance to FDA recognized standards.
Software: Microsoft Windows 7 embedded operating system; proprietary MindChild ECG algorithm is the same. M100 has software modification for syncing uterine contraction signal.

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

The document states: "The algorithm used in the M100 to acquire and process fetal ECG signals through externally placed abdominal electrodes is the same as that used and clinically validated in the cleared M1000 device." (page 5) and "The clinical validation of the software responsible for calculating FHR from fECG signals was performed in support of the cleared 510(k) for the M1000. This clinical validation is directly applicable to the modified design as the signal acquisition components (external electrodes) and the signal processing software and algorithm remains the same in the modified M100 device. Therefore further clinical validation was not necessary for the modified device." (page 13).

This implies that no new clinical test set was used for the M100 device itself to validate the FHR algorithm. The previous validation for the M1000 is leveraged. The document does not provide details of the M1000's clinical validation, including sample size or data provenance (e.g., country of origin, retrospective/prospective). New hardware and software modifications were assessed through bench testing and software validation (pages 11-12), but these are not clinical studies with a "test set" in the sense of patient data.

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

As stated above, no new clinical test set was required for the FHR algorithm for the M100 due to its substantial equivalence to the M1000's algorithm. Details about experts used for the M1000's original clinical validation are not provided in this document.

4. Adjudication Method for the Test Set

Not applicable, as no new clinical test set was explicitly detailed for the M100 device's FHR algorithm validation.

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

Not applicable. This device is a Fetal Heart Rate Monitor, not an AI diagnostic imaging tool or a system designed to assist human readers in interpreting complex data like medical images where MRMC studies are common. It calculates and displays FHR, and its core algorithm was previously validated as part of the M1000.

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

The document heavily implies that the FHR algorithm's performance was evaluated independently during the M1000's initial clearance, as it's a "fetal heart rate monitor" that "acquires and processes analog signals using external, abdominal electrode sensors" and "Software algorithms extract ECG morphology and monitor fetal heart rate." (page 4). The consistency of this algorithm between M1000 and M100 suggests a standalone performance evaluation of the algorithm for FHR calculation. However, specific details of this standalone performance, such as metrics (accuracy, precision, recall) or dataset used, are not in this document, as it focuses on demonstrating equivalence.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the M100's FHR calculation algorithm, the ground truth methodology would have been established during the M1000's original clinical validation. This document does not specify the type of ground truth used for that validation (e.g., comparison against an internal uterine pressure catheter for FHR).

8. The Sample Size for the Training Set

The document does not provide information about a training set for the FHR algorithm. This is typical for traditional signal processing algorithms rather than modern deep learning AI models, which explicitly require separate training and testing sets. The algorithm was "clinically validated" for the M1000, suggesting a validation dataset, but not necessarily a "training set" in the current AI sense.

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

Not applicable, as no specific training set or its ground truth establishment is mentioned in this document.

Summary

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

April 17, 2015

Mindchild Medical % Leo Basta Owner NorthStar Biomedical Associates 93 Benefit Street Providence. RI 02904

Re: K142883

Trade/Device Name: MindChild Meridian M100 Fetal Heart Rate Monitor Regulation Number: 21 CFR 884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: Class II Product Code: HGM Dated: September 30, 2014 Received: October 2, 2014

Dear Leo Basta,

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

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related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K142883

Device Name MindChild Meridian M100 Fetal Heart Rate Monitor

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary MindChild Meridian M100 Fetal Heart Rate Monitor

Submitter:	MindChild Medical1600 Osgood Street, #2017North Andover, MA 01845Phone: 978.975.1160Fax: 978.688.8875
Contact Person:	Leo BastaNorthstar Biomedical Associates93 Benefit St.Providence, RI, 02904Phone: 617.834.9866lbasta@northstarbiomedical.com
Date Prepared:	March 14, 2015
Trade Name:	MindChild Meridian M100 Fetal Heart Rate Monitor
Regulation Name:	Perinatal monitoring system andaccessories
Classification Number:	21 CFR 884.2740
Product Code:	HGM
Predicate Devices:	Meridian M1000 Monitor (K120018)

Device Description:

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The M100 differs from the cleared M1000 in the following ways:

1. The M100 has connection ports for connection of the M100 to existing cleared fetal heart rate monitors. Through these connections, the M100 uses the existing primary monitor's display for fetal heart rate whereas the M1000 incorporates a 24" LCD display,
1. The M100 incorporates a standard input connection for a uterine contraction device. The M100 acts as a pass-through of this signal allowing for the uterine contraction data to be displayed on the primary monitor screen along with the fetal heart rate. The M1000 did not include this feature. Instead, viewing uterine contraction data required a separate monitor placed beside the M1000 device and viewing data on two screens. The M100 does not process uterine contraction signals but only synchronizes them to the fetal heart rate data.
1. The primary monitor, to which the M100 is connected, is used for DECG measurements using a fetal scalp electrode should that be necessary. The M1000 had a dedicated DECG connection and adapter for a fetal scalp electrode.
1. The M100 is set on a table top whereas the M1000 is housed within a rollup cart.

The algorithm used in the M100 to acquire and process fetal ECG signals through externally placed abdominal electrodes is the same as that used and clinically validated in the cleared M1000 device.

Indications for Use:

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monitor. In addition, the M100 synchronizes the TOCO transducer signal which is also displayed to the primary fetal monitor.

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Device Characteristic Comparison

Characteristic	M100 Fetal Heart Rate Monitor[current 510(k)]	M1000 Fetal Heart Rate Monitor- K120018	SubstantialEquivalence
DevicePhotograph	Image: M100 Fetal Heart Rate Monitor	Image: M1000 Fetal Heart Rate Monitor	Different footprint of the M100 allows forplacement on the table top. Firmware forthe M1000 is contained within a roller cartwith drawer and display monitor. M100device uses the display of the primary fetalheart rate monitor to which it is connected.The software and firmware of the M100and M1000 is identical varying only inregard to the system administrativesoftware. The fetal heart rate algorithmremains the same.
Intended Use	A fetal cardiac monitor used to monitor fetal heartactivity during pregnancy and labor.	A fetal cardiac monitor used to monitor fetal heartactivity during pregnancy and labor.	Identical
Indications forUse	The MindChild Medical Meridian M100 Fetal HeartRate Monitor is an intrapartum fetal monitor thatexternally measures and displays fetal heart rate(FHR). The MindChild Meridian M100 acquiresand displays the FHR tracing from abdominalsurface electrodes that detect the fetal ECG signal(fECG). FHR tracings are displayed onto a primaryfetal monitor. In addition, the M100 synchronizesthe TOCO transducer signal which is also displayedto the primary fetal monitor. The MindChildMeridian M100 is indicated for use	The MindChild Medical Meridian Fetal Heart RateMonitor is an intrapartum fetal monitor thatexternally or internally measures and displays fetalheart rate (FHR). The MindChild Meridianacquires and displays the FHR tracing fromabdominal surface electrodes that detect the fetalECG signal (fECG). The MindChild Meridian mayalso be used to measure and display fetal heart rateusing direct ECG (DECG) with a fetal scalpelectrode. The MindChild Meridian is indicated foruse on women who are at term (> 36 completedweeks), in labor, with singleton pregnancies, usingsurface electrodes on the maternal abdomen. The	Very similar. The differences don't affect theor effectiveness as all of the same functionscan be operated either through the M100 orthe primary monitor (should the invasiveDECG using a fetal scalp electrode beclinically indicated.
Characteristic	M100 Fetal Heart Rate Monitor[current 510(k)]on women who are at >36 completed weeks, inlabor, with singleton pregnancies, using surfaceelectrodes on the maternal abdomen. TheMindChild Meridian is intended for use byhealthcare professionals in a clinical setting.	M1000 Fetal Heart Rate Monitor– K120018MindChild Meridian is intended for use byhealthcare professionals in a clinical setting.	SubstantialEquivalence
RegulationNumber	884.2740	884.2740	Identical
Display	2 inch LCD screen on front of unit for systemonly information. The M100 uses the display ofthe primary fetal heart monitor to display the fetalheart rate.	24" diagonal real time LCD display (1900 x 1200pixels) that graphically displays clinical parametersreceived from signal processors. Touch screenprovides user with interface to control operation ofunit.	Identical information displayed. M100utilizes the primary monitor to display fetalheart rate calculated from ECG signalscollected via abdominal electrodes andcalculated using the Meridian algorithm.The algorithm remains the same as theM1000.
Controls	Power "On" button on rear side of the M100 toactivate.	Power "On" button on front side of M1000 toactivate. The LCD display incorporates "Action"buttons that are touch sensitive to control operationof the unit.	Each unit has a power "On/Off" switch toactivate the monitor. The M100 switch islocated on the rear of the unit, whereas theM1000 is on the front of the unit. TheM1000 also has control buttons on thedisplay screen that operates certainfunctions of the M1000. The M100 utilizesthe primary monitor to control the samefunctions when the M100 is attached.
Printer	The M100 does not include an integrated printer;however, patient data including graphical displaymay be downloaded via the primary monitor towhich the M100 is attached.	The Meridian Monitor does not include anintegrated printer; however, patient data includinggraphical display may be downloaded via integralUSB port to a standard USB jump drive forprinting or transfer of data.	Both systems allow for the same function.The M100 and the M1000 allow fordownloading patient data and transfer ofinformation. The proposed M100accomplishes this through use of theprimary monitor to which it is attached,whereas the cleared M1000 possesses thiscapability through a USB jump drive.
Front or topConnections	There are six connectors on the front of the unit.Five of the connectors are for cable connections tothe external electrode sensors including referenceand ground. The sixth connector is for theconnection of cleared TOCO uterine contractiondevices.	There are five connectors on the front of the unit.All five of the connectors are for cable connectionsto the external electrode sensors includingreference and ground. The fifth connector is alsoused for the connection to the optional fetal scalpelectrode.	Similar. Each unit has connections for theexternally placed maternal abdominalelectrodes used to acquire bioelectricsignals of the fetal heart. The M100provides a connection to TOCO uterinecontraction accessories whereas the M1000incorporates a connection for an optional
Characteristic	M100 Fetal Heart Rate Monitor	M1000 Fetal Heart Rate Monitor	Substantial
	[current 510(k)]	- K120018	Equivalencefetal scalp electrode. These differences donot affect substantial equivalence as theM100 does not process uterine contractiondata but instead passes the information onto the primary monitor whereas the M1000was used in conjunction with a TOCOmonitor and the user was required toreview the FHR data on the M1000 inparallel with the uterine contraction data.Functionally Identical.Although the M100 does not incorporatethe fetal scalp electrode connection, it doesallow for the use of a fetal scalp electrode ifindicated using the connection on theprimary monitor. Functionally Identical.Because the M100 utilizes the display of theprimary monitor for displaying fetal heartrate and uterine contraction information,the device incorporates connection ports tocouple the two monitors. Functionally, theM100 and M1000 are very similar andallow for the provision of the identicalinformation to the user.
Rear Connections	Power connection and connections to the primarymonitor.	Power connection.	Because the M100 utilizes the display of theprimary monitor for displaying fetal heartrate and uterine contraction information,the device incorporates connection ports tocouple the two monitors. Functionally, theM100 and M1000 are very similar andallow for the provision of the identicalinformation to the user.
Side Connections	No connections	No connections	No impact on substantial equivalence.
Input VoltageRange	120 VAC ±10%	120 VAC ±10%	No impact on substantial equivalence.
Characteristic	M100 Fetal Heart Rate Monitor	M1000 Fetal Heart Rate Monitor	Substantial
	[current 510(k)]	- K120018	Equivalence
Frequency	60 Hz	60 Hz	No impact on substantial equivalence.
Method	Acquisition of fetal ECG signals via multipleexternal abdominal sensor electrodes, which arethen processed on the signal processor which iscomprised of the signal processing card andsystem controller.Direct ECG (DECG) acquisition using FDAcleared fetal scalp probes composed of a reusableDECG leg plate cable, leg plate attachmentelectrode and Philips Spiral Electrode.Connection on the primary monitor is used for thefetal scalp electrode.TOCO connection is incorporated in the M100.The M100 does not process the uterine contractioninformation. It syncs the information with thefetal heart rate and passes the information on tothe primary monitor.	Acquisition of fetal ECG signals via multipleexternal abdominal sensor electrodes, which arethen processed on the signal processor which iscomprised of the signal processing card and systemcontroller.Direct ECG (DECG) acquisition using FDAcleared fetal scalp probes composed of a reusableDECG leg plate cable, leg plate attachmentelectrode and Philips Spiral Electrode.M1000 monitor used in parallel while the physicianlooks at a TOCO monitor while reviewing the fetalheart rate on the M1000.	The changes made resulting in the M100device have no adverse impact onsubstantial equivalence.
MeasurementRange	50 - 240 BPM; abdominal sensor modeDECG Mode dependent on primary monitor.	50 - 240 BPM; abdominal sensor mode50 - 240 BPM; DECG Mode	No impact on substantial equivalence.
Signal Processing	Analog to digital	Analog to digital	No impact on substantial equivalence.

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Characteristic	M100 Fetal Heart Rate Monitor[current 510(k)]	M1000 Fetal Heart Rate Monitor- K120018	SubstantialEquivalence
Safety	Patient protection isolation barrier provides4KVDC of galvanic isolation for all patient inputconnections. The cables that connect directly tothe patient pass through this isolation barrier.Will be certified to comply with FDA recognizedstandards pertaining to electrical safety and EMC.	Patient protection isolation barrier provides4KVDC of galvanic isolation for all patient inputconnections. The cables that connect directly to thepatient pass through this isolation barrier.Will be certified to comply with FDA recognizedstandards pertaining to electrical safety and EMC.	No impact on substantial equivalence.
Software	Microsoft Windows 7 embedded operating systemcustomized to support specific Meridianhardware. Proprietary MindChild ECG algorithmprovides processing and filtering to extract fetalECG and calculate fetal heart rate. Softwaremodification allowing for syncing uterinecontraction signal with fetal heart rate (does notalter or manipulate uterine contraction data).	Microsoft Windows 7 embedded operating systemcustomized to support specific Meridian hardware.Proprietary MindChild ECG algorithm providesprocessing and filtering to extract fetal ECG andcalculate fetal heart rate.	No impact on substantial equivalence.
	Graphical and numeric data displayed on primarymonitor display. Patient data may be stored onprimary monitor and downloaded or printed usingprimary monitor's functions.	Graphical and numeric data display on touch screenmonitor. Individual patient data may be stored onthe unit and downloaded via user supplied USBJump drive for inclusion into hospital electronicrecords. Hard copies of graphical display may beprinted in standard format.	No impact on substantial equivalence.

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Performance Testing:

Descriptive information, laboratory bench testing, electrical safety/EMC testing, and software validation were provided to demonstrate the device meets its design specifications, performs as intended, is safe for its intended use and that the modifications made from the M1000 device do not adversely affect safety and effectiveness.

The following testing was performed:

Test	Purpose	Results
Dimensional Verification	To verify products meetsspecified dimensions and weight	Met design specification
Fetal Heart Rate Output	Verify FHR output waveform forboth minimum and maximumamplitude fetal heart output.	Met design specification
TOCO Output	Verify Toco output voltage forpressure application	Met design specification
Packaging Testing	Verification of packaging andlabeling.	Met design specification
Cable Pull Strength	Verify the cable connections aremaintained when a 5 ft/lb. load isapplied. Results are force applied toeach of the patient cable connectorextraction.	Met design specification
Drop Test	Verification that unit couldsustain drop	Met specification
Push Test	Verify mechanical strength ofenclosure by applying a 250N forceto all sides and bottom of enclosure	Met specification
Cleaning	Verify that cleaning, disinfecting, andsterilizing the monitor in accordancewith the instructions for doing so inthe Operator's Manual and ServiceManual do not create any hazards orhazardous situations. Ensure thatcleaning substances are compatiblewith the M100.	Met specification
Software Validation	Verify that all software modificationsmade performed as intended.Complete re-validation of thesoftware was performed.	Software validation demonstratedthat the software performedaccording to designspecifications, met requirementspecifications and that there wereno unintended effects due to anysoftware modifications made.

Hardware

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Biocompatibility Testing

Biocompatibility testing was not required as the M100 using the same patient contacting materials as that used in the cleared M1000 device.

Primary Monitor Compatibility

The M100 Monitor is intended to be used with the currently marketed GE Corometrics 120 and 250 Fetal Monitors. Compatibility testing was performed using the M100 monitor with each of the marketed primary monitors. Testing demonstrated the M100 is compatible with each of these monitors.

Electrical Safety and EMC

In addition, electrical safety, electromagnetic compatibility, and usability testing was performed in accordance with the following standards. The M100 monitor met all test criteria.

1. IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance; IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007)
1. IEC 60601-1-2: ed3.0 (2007-03), Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (FDA recognized number: 19-1)
1. IEC 60601-1-6:2010 (Third Edition), Medical Electrical Equipment Part 1-6: General Requirements For Basic Safety And Essential Performance -Collateral Standard: Usability (FDA recognized number: 5-85)
1. IEC 60601-2-49 (Second Edition): 2011, Medical electrical equipment Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
1. IEC 62366:2007(ed.1), Medical devices Application of usability engineering to medical devices (FDA recognized number: 5-67)

Clinical Validation

The algorithm responsible for calculating fetal heart rate in the M100 Monitor is the same as that used in the cleared M1000 monitor. Further, the signal acquisition components (external electrodes) and signal processing software remain the same. The clinical validation of the software responsible for calculating FHR from fECG signals was performed in support of the cleared 510(k) for the M1000. This clinical validation is directly applicable to the modified design as the signal acquisition components (external electrodes) and the signal processing software and algorithm remains the same in the

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modified M100 device. Therefore further clinical validation was not necessary for the modified device.

Summary of Substantial Equivalence:

The design, intended use, principles of operation, and technological characteristics of the MindChild Meridian M100 device are substantially equivalent to those of the already cleared M1000 device. Substantial equivalence is based upon descriptive characteristics of the modifications and upon the testing conducted and summarized in this 510(k). The changes made resulting in the M100 device do not change the device's intended use or the fundamental scientific technology used and the testing performed in support of this notification demonstrate that the M100 device is substantially equivalent to the M1000 device.

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).