The EUM100Pro (Electro Uterine Monitor) is a transabdominal electromyography (EMG) monitor intended to non-invasively measure intrapartum uterine activity and fetal heart rate (FHR). The EUM100Pro acquires the signal from surface EMG electrodes placed on the patient abdomen.

The EUM100Pro is intended for use on women (>36 completed weeks of gestation) in labor, with singleton pregnancies.

The EUM100Pro is intended for use by healthcare professionals in a clinical setting.

Device Description

The EUM100Pro (electro uterine monitor) System is designed to present and transmit via RS232 protocol the electrical activity of the uterus and fetal heart rate. The data is shown and displayed as graphs (uterine activity and FHR) and similar to the commonly use toco-dynamometer / Doppler monitors.

The EUM100Pro is built around an EN 60950 certified computer.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study used to validate the EUM 100Pro device, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of specific performance thresholds (e.g., "sensitivity must be >X%"). Instead, it focuses on demonstrating non-inferiority of the EUM100Pro compared to a Doppler-based Fetal Monitor, using a fetal scalp electrode as the gold standard.

Performance Metric	Acceptance Criteria (Implied Non-inferiority)	EUM100Pro Performance	Doppler-based Fetal Monitor Performance (Reference)	Gold Standard (Fetal Scalp Electrode) Comparison
Percent of Interpretable FHR	Non-inferior to Doppler-based Fetal Monitor.	98.5% (95% CI [98.5%-99.6%])	96% (95% CI [95%-98.2%])	EUM showed "non-inferior results" compared to Doppler.
RMS error (vs. Gold Standard)	Lower RMS error compared to Doppler-based Fetal Monitor (indicating higher similarity to gold standard).	1.47 (from Bland Altman)	4.42 (from Bland Altman)	EUM is "more similar to gold standard fetal Scalp electrode measurement compared to Doppler."
Mean delta (vs. Gold Standard)	Lower mean delta compared to Doppler-based Fetal Monitor (indicating higher similarity to gold standard).	0.009 (95% CI [0.007-0.015])	0.232 (95% CI [0.227-0.256])	EUM is "more similar to gold standard fetal Scalp electrode measurement compared to Doppler."
Safety and Effectiveness Concerns	No new safety or effectiveness concerns compared to predicate/reference devices in terms of indications, patient population, environment, design, technology, and performance.	Document states "no differences" that raise concerns.	(Not explicitly a performance metric, but a safety/effectiveness claim)	(Based on a broader comparison beyond just FHR monitoring, as stated in the "Discussion of Differences" section.)

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

Sample Size: 33 women
Data Provenance: The document does not explicitly state the country of origin. It mentions "a clinical study was completed," implying a prospective study setting where subjects were enrolled for this specific study. Given the manufacturer's address (Israel), it's plausible the study was conducted there or in a comparable clinical research environment. It is a prospective study.

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

The document does not specify the number of experts used to establish the ground truth. The gold standard for FHR measurement was a fetal scalp electrode connected to a Philips HP 50 XM, which is an objective measurement tool rather than relying on expert interpretation for ground truth.

4. Adjudication Method for the Test Set

There is no mention of an adjudication method in the context of expert review or consensus for the test set. The ground truth was established by an objective medical device (fetal scalp electrode), so adjudication by human experts was not necessary for the FHR data itself.

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, a multi-reader, multi-case comparative effectiveness study was not explicitly described. The study focused on the standalone performance of the EUM100Pro as a device for FHR and uterine activity monitoring, comparing its readings directly against a gold standard and a reference device, rather than evaluating human reader performance with or without AI assistance. The EUM100Pro is a monitoring device, not an AI interpretation tool in the context of this summary.

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

Yes, a standalone performance study was conducted. The EUM100Pro device's FHR measurements were directly compared against the gold standard (fetal scalp electrode) and a reference device (GE/Corometrics 170 Doppler ultrasound cardiograph). The performance metrics (percent of interpretable FHR, RMS error, mean delta) directly reflect the device's output.

7. The Type of Ground Truth Used

The primary ground truth for the FHR measurement was data from a fetal scalp electrode connected to a Philips HP 50 XM (described as the "gold standard"). This is an objective physiological measurement.

8. The Sample Size for the Training Set

The document does not provide information on the sample size for a training set. This is a 510(k) summary for a substantial equivalence determination, and the clinical study described is a validation study (test set) for the FHR feature on the EUM100Pro. It's possible that the device's algorithms for FHR detection were developed using other datasets or prior knowledge, but this information is not included in this summary. The summary focuses on the comparative clinical performance for regulatory clearance.

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

Since information regarding a training set is not provided, how its ground truth was established is also not described in this document.

Summary

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Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three human profiles facing to the right. The profiles are connected by a flowing line.

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

August 6, 2015

OB Tools, LTD % Paul Dryden Regulatory Consultant ProMedic, Inc. 24301 Woodsage Drive Bonita Springs, FL 34134

Re: K150398

Trade/Device Name: EUM 100Pro Regulation Number: 21 CFR 884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: II Product Code: HGM: OSP Dated: July 6. 2015 Received: July 7, 2015

Dear Paul Dryden,

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,

Herbert P. Lerner -S

for

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K150398 Device Name EUM 100Pro Indications for Use (Describe)

The EUM100Pro is intended for use on women (>36 completed weeks of gestation) in labor, with singleton pregnancies.

The EUM100Pro is intended for use by healthcare professionals in a clinical setting.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Page 1 of 5

Date Prepared:OB-Tools Ltd.Mifaley HaEmek Industrial ZoneYozmot BuildingP.O Box 6672310502 Migdal HaEmek, IsraelTel – +972-4-6040162Fax - +972-4-6040114	4-Aug-15
Official Contact:	Dr. Gal Ben-DavidCEO
Proprietary or Trade Name:	EUM 100Pro (Electro Uterine Monitor)
Common/Usual Name:	External uterine contraction monitor with Fetal Heart Rate
Classification Name:	External uterine contraction monitorOSP - 21CFR 884.2720Class IIPerinatal monitoring system and accessoriesHGM - 21 CFR 884.2740Class II
Predicate Device:Reference Device:	K101801 - Monica Healthcare - AN24K131889 – OB Tools EUM 100Pro

Device Description:

The EUM100Pro is built around an EN 60950 certified computer.

Indications for Use:

The EUM100Pro is intended for use on women (>36 completed weeks of gestation) in labor, with singleton pregnancies.

The EUM100Pro is intended for use by healthcare professionals in a clinical setting.

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510(k) Summary Page 2 of 5 4-Aug-15

Comparison to Predicates

Tables 1 and 2 lists the similarities and differences of the predicates and the proposed device.

Table 1 - Table of the Similarities and Differences of Predicates vs. Proposed Device

	Predicate	Proposed device
	Monica AN24 – K101801	EUM 100Pro
Procode	HGM / OSP	HGM / OSP
Name	External uterine contraction monitorExternal Fetal Heart Rate monitor	External uterine contraction monitorExternal Fetal Heart Rate monitor
CFR	884.2740 / 884.2720	884.2740 / 884.2720
Indications for Use	The Monica AN24 is an intrapartummaternal-fetal monitor that non-invasivelymeasures and displays fetal heart rate(FHR), uterine activity (UA), and maternalheart rate (MHR). The AN24 acquires anddisplays the FHR tracing from abdominalsurface electrodes that pick up the fetalECG (fECG) signal. Using the samesurface electrodes, the AN 24 also acquiresand displays the UA tracing from theuterine electromyography (EMG) signaland the MHR tracing from the maternalECG signal (mECG).	The EUM100Pro (Electro Uterine Monitor)is a transabdominal electromyography(EMG) monitor intended to non-invasivelymeasure intrapartum uterine activity andfetal heart rate. The EUM100Pro acquiresthe signal from surface EMG electrodesplaced on the patient abdomen.
Patient population	It is intended for use on women who are atterm (>36 completed weeks), in labor, withsingleton pregnancies, using surfaceelectrodes on the maternal abdomen	The EUM100Pro is intended for use onwomen (>36 completed weeks of gestation)in labor, with singleton pregnancies.
Prescriptive	Trained medical personnel	Trained medical personnel
Environments of use	Clinical settings	Clinical settings
Power source	Battery	Mains power with isolation transformer
Method ofmeasuring FHR	External surface EMG electrodes	External surface EMG electrodes
Display ofinformation	Graphical	Graphical
Patient interface	Surface electrodes	Surface electrodes
Single patient use,disposable	Yes	Yes
Contraindicationsand Warnings	None	Patient with implanted electronic devicesOpen wounds or irritated skinAllergies to silver
Safety Testing	IEC 60601-1IEC 60601-1-2IEC 60601-1-2-47	IEC 60601-1IEC 60601-1-2IEC 60601-2-40
Clinical Testing forFetal Heart Rate	Comparison toFetal scalp electrode (FSE)	Comparison toCorometric Model 171 (reference deviceK991905)Fetal scalp electrode (FSE)

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510(k) Summary Page 3 of 5 4-Aug-15

Substantial Equivalence Discussion

The EUM 100Pro is viewed as substantially equivalent to the predicate devices because:

Indications –

The EUM 100Pro is indicated for as a transabdominal electromyography (EMG) monitor ● intended to measure fetal heart rate and intrapartum uterine activity.
Discussion This is identical to the predicate K101801 Monica AN24. ●

Patient Population -

It is intended for use on women who are (>36 completed weeks), in labor, with singleton ● pregnancies, using surface electrodes on the maternal abdomen
. Discussion - The patient population is identical to the predicate - K101801 - Monica AN24.

Environment of Use -

For use in clinical settings by trained medical personnel ●
Discussion The environments of use and personal are identical to the predicate -. K101801 - Monica AN24.

Technology -

The use of transabdominal electromyography (EMG) signals to sense fetal heart rate (FHR) and uterine activity via an array of surface electrodes placed on the maternal abdomen.
Discussion - This technology is identical to the predicate - K101801 - Monica AN24

Non-clinical Testing Summary -

For the fetal heart rate (FHR) feature there is no bench testing, we performed comparative clinical testing vs. the predicates.

Biocompatibility of Materials -

The materials in contact with the patient are the EMG electrodes which are off-the-shelf (K990356).
Discussion The EMG electrodes have been cleared for the intended use under ● K990356 and in the reference device - K131889 - OB Tools EUM 100Pro.

Electrical, EMC, EMI testing -

The proposed change to add the FHR feature was software only and there was no change ● in the electrical design of the reference device EUM 100Pro (K131889).
. Discussion - The proposed device is identical to the reference device - K131189 OB Tools EUM 100Pro.

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510(k) Summary Page 4 of 5 4-Aug-15

Clinical Testing Summary -

We performed a comparative clinical study that was to show non-inferiority of the EUM100Pro with Fetal Heart Rate (FHR) as compared to the GE Corometrics Series 170 (K991905) and a fetal scalp electrode.

A clinical study was completed in order to show the non-inferiority of the EUM100Pro in monitoring fetal heart rate compared to Doppler based Fetal Monitor.

Thirty three women at term, during active labor. were enrolled; each subject enrolled was instrumented with three technologies for measuring fetal heart rate (FHR) as follows:

EUM100Pro Test device ●
Scalp electrode connected to Philips HP 50 XM Gold standard .
GE/Corometrics 170 Doppler ultrasound cardiograph reference device ●

This study methodology allows comparison of the performance of EUM100Pro vs. Doppler as compared to the Scalp electrode gold standard.

Summary of Results

There are significant differences in the PPA; the mean positive percent of agreement for . EUM was 98.5% 95%CI [98.5%-99.6%] compared with 96% 95%CI [95%-98.2%] for Doppler, demonstrating non-inferior results of the EUM as compared to Doppler in terms of percent of interpretable FHR.
The mean RMS error from Bland Altman was 1.47 for EUM compared with 4.42 bpm ● for Doppler indicating that EUM is more similar to gold standard fetal Scalp electrode measurement compared to Doppler.
The mean delta from Scalp is 0.009 95%CI [0.007-0.015] for EUM compared with 0.232 . 95%CI [0.227-0.256] for Doppler indicating that EUM is more similar to gold standard fetal Scalp electrode measurement compared to Doppler.

Discussion of Differences

A review of the differences for the proposed EUM 100Pro with the FHR feature as compared to the predicates and reference devices shows that there are no differences in indications for use, patient population, environments of use, design, technology and performance that would raises any new safety or effectiveness concerns.

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510(k) Summary Page 5 of 5 4-Aug-15

Table 2 – Comparison to OB Tools EUM 100Pro (K131889) and the Proposed device

	Reference device	Proposed device
	OB Tools EUM 100Pro – K131889	EUM 100Pro
Procode	OSP	HGM / OSP
Name	External uterine contraction monitor	External uterine contraction monitorExternal Fetal Heart Rate monitor
CFR	884.2720	884.2740 / 884.2720
Indications for Use	The EUM100Pro (Electro UterineMonitor) is a transabdominalelectromyography (EMG) monitorintended to non-invasively measureintrapartum uterine activity. TheEUM100Pro acquires the signal fromsurface EMG electrodes placed on thepatient abdomen.	The EUM100Pro (Electro Uterine Monitor)is a transabdominal electromyography(EMG) monitor intended to non-invasivelymeasure intrapartum uterine activity and fetalheart rate. The EUM100Pro acquires thesignal from surface EMG electrodes placedon the patient abdomen.
Patient population	The EUM100Pro is intended for use onwomen (>36 completed weeks ofgestation) in labor, with singletonpregnancies.	The EUM100Pro is intended for use onwomen (>36 completed weeks of gestation)in labor, with singleton pregnancies.
Prescriptive	Trained medical personnel	Trained medical personnel
Environments of use	Clinical settings	Clinical settings
Power source	Mains power with isolation transformer	Mains power with isolation transformer
Method ofmeasuring FHR	External surface EMG electrodes	External surface EMG electrodes
Display ofinformation	Graphical	Graphical
Patient interface	Surface electrodes	Surface electrodes
Single patient use,disposable	Yes	Yes
Contraindicationsand Warnings	Patient with implanted electronic devicesOpen wounds or irritated skinAllergies to silver	Patient with implanted electronic devicesOpen wounds or irritated skinAllergies to silver
Safety Testing	IEC 60601-1IEC 60601-1-2IEC 60601-2-40	IEC 60601-1IEC 60601-1-2IEC 60601-2-40
Clinical Testing forFetal Heart Rate	N/A	Comparison toCorometrics Series 170 (reference device)Fetal scalp electrode (ESE)

Substantial Equivalence Conclusion -

The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predicate have been found to substantially equivalent.

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).