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

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

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

Device Description

The EUM100Pro System is designed to present and record the electrical activity of the uterus. The activity is shown as graphs similar to the commonly use toco-dynamometer.

The EUM100Pro is built around an EN- 60950 certified computer. Analog signals are obtained from CE certified amplifier box from Delsys Inc., Boston, MA. Delsys also supply the input modules, power supply, electrodes and disposable stickers.

The system is comprised of a multi-channel surface electromyogram operative to sense electromyographic (EMG) activity, a three-dimensional position sensor and a personal computer providing data analysis, recording media and a graphical user interface.

AI/ML Overview

Here's a summary of the acceptance criteria and study details for the EUM100Pro device, based on the provided text:

Acceptance Criteria and Device Performance

The provided text does not explicitly list quantitative acceptance criteria in a table format. Instead, it describes the clinical study's purpose as providing "evidence that the EUM 100Pro performed substantially equivalently to the legally marketed predicate devices for detecting and displaying uterine activity."

Therefore, the implicit acceptance criteria are based on demonstrating substantial equivalence to predicate devices (Tocodynamometry - TOCO and Intrauterine Pressure Catheter - IUPC) in detecting and displaying uterine activity, as assessed by physicians.

Acceptance Criterion (Implicit)	Reported Device Performance
Substantial equivalence in detecting and displaying uterine activity compared to TOCO and IUPC	"The study provided evidence that the EUM 100Pro performed substantially equivalently to the legally marketed predicate devices for detecting and displaying uterine activity in women at term gestation in active labor." Physicians independently evaluated tracings from EUM, TOCO, and IUPC, annotating contractions and commenting on interpretability. The outcomes of this physician evaluation led to the conclusion of substantial equivalence.
Interpretability of tracings	Physicians were asked to "comment on the interpretability of the tracing." While no specific metric is provided, the overall conclusion of substantial equivalence suggests satisfactory interpretability.
Total number of uterine contractions detected	Physicians were asked to "indicate the total number of uterine contractions on the tracing." The conclusion of substantial equivalence implies that the EUM 100Pro's detection of total contractions was comparable to the predicate devices.
Electrical, EMC, EMI compliance to IEC 60601-1 and IEC 60601-2-40	The device "passed the requirements."
Biocompatibility of materials (electrodes)	The electrodes "have been cleared for the intended use under K990356."

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: 43 women.
- Data Provenance: The text does not specify the country of origin. It indicates the study was "conducted a clinical study enrolling 43 women at term gestation in active labor." The context suggests this was a prospective clinical study as women were enrolled specifically for this evaluation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Three (3) physicians.
- Qualifications: The text only states "three physicians." No specific qualifications (e.g., years of experience, specialty) are provided.
Adjudication method for the test set:
- The physicians "evaluated independently" and were "masked to the technology used to acquire the tracings." They were asked to annotate contractions and indicate the total number. The text does not explicitly state an adjudication method like 2+1 or 3+1 for discrepancies. It implies that the individual assessments of these three physicians, when compared across the different tracing types (EUM, TOCO, IUPC), formed the basis for concluding substantial equivalence.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was not reported. This study assessed the standalone performance of the EUM100Pro device (which incorporates an algorithm) in comparison to established methods (TOCO and IUPC) as interpreted by physicians. The focus was on the device's ability to generate signals comparable to existing methods, rather than on improving human reader performance with aid.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, a standalone evaluation of the EUM100Pro's output was done. The EUM100Pro is described as generating "graphs similar to the commonly use toco-dynamometer," and these tracings were presented to physicians for interpretation. The study was designed to show the device's performance in detecting and displaying uterine activity itself, which is a standalone function of the algorithm and hardware. The physicians then interpreted these device-generated tracings.
The type of ground truth used:
- The ground truth was established by expert consensus/interpretation of established predicate technologies (Tocodynamometry - TOCO and Intrauterine Pressure Catheter - IUPC) and the EUM100Pro's own output, all compared simultaneously. The study design implicitly uses the TOCO and IUPC as the "established" or "reference" methods against which the EUM100Pro's output is compared, with expert physician interpretation serving as the ultimate arbiter of what constitutes a contraction on any of the tracings.
The sample size for the training set:
- The document does not provide any information about a separate training set or its sample size. The clinical study described appears to be a validation or test set. Without information on an AI/ML component that requires explicit training, details about a training set are not included.
How the ground truth for the training set was established:
- As no information on a training set is provided, the method for establishing its ground truth is also not stated.

Summary

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Date Prepared:
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21-Apr-14

APR 2 3 2014

OB-Tools Ltd. Mifaley HaEmek Industrial Zone Yozmot Building P.O Box 667 2310502 Migdal HaEmek, Israel Tel - +972-4-6040162 Fax - +972-4-6040114

Official Contact:	Dr. Gal Ben-DavidCEO	510(k) number	PredicateRRT SureCALL®	PredicateMonica AN24	Proposed deviceEUM 100Pro
Proprietary or Trade Name:	EUM 100Pro (Electro Uterine Monitor)	K090145	OSP	K112390	OSP
Common/Usual Name:	External uterine contraction monitor	Procode	OSP	OSP	External uterine contraction monitor
Classification Name:	External uterine contraction monitorOSP - CFR 884.2720Class II	Name	External uterine contraction monitor	External uterine contraction monitorExternal Fetal Heart Rate monitor
Predicate Devices:	K090145 – RRT – SureCALL®K112390 – Monica Healthcare – AN24	CFR	884.2740	884.2720	884.2720
Indications forUse	SureCALL® EMG labor Monitor isa transabdominal electromyography(EMG) monitor intended to measureintrapartum uterine activity.	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) signal andthe MHR tracing from the maternal ECGsignal (mECG).	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.
Patient population	It is intended for use on women whoare at term (>36 completed weeks),in labor, with singleton pregnancies,using surface electrodes on thematernal abdomen	It is intended for use on women who are atterm (>36 completed weeks), in labor, withsingleton pregnancies, using surfaceelectrodes on the maternal abdomen	It is intended for use on women who areat term (>36 completed weeks), in labor,with singleton pregnancies, using surfaceelectrodes on the maternal abdomen
PrescriptiveEnvironments ofuse	Trained medical personnelClinical settings	Trained medical personnelClinical settings	Trained medical personnelClinical settings
Power source	Mains power with laptop computercharger	Battery	Mains power with isolation transformer

Device Description:

The EUM100Pro System is designed to present and record the electrical activity of the uterus. The activity is shown as graphs similar to the commonly use toco-dynamometer.

Indications for Use:

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

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

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K131889
Page 2 of 5

510(k) Summary

omparison to Predicate

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く131889
Page 3 of 5

510(k) Summary

		1-Apr-14
			roposed devic EUM 100Pro
	Predicate RRT SureCALL®	Predicate Monica AN24
	6090145	K112390
الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموق	EMG electrodexternal surface l	xternal surface EMG electrode	xternal surface EMG electrod


	Graphica	Graphica	Graphica

	કરurface electrod	urface electrode	urface electrod
iingle patient use Lisposable Contraindication Contraindication Ind Warnings	Yes	Yes	Yes

	None	None	atient with implanted electronic device pen wounds or irritated skin


afety Testing	ectrical safety

		EC 60601-1 EC 60601-1-2 EC 60601-1-2-4	Nergies to silve! EC 60601-1 EC 60601-11-2 EC 60601-11-2 EC 60601-11-2 EC 60601-2-40
linical Testin	Comparison to Tocodynamometer Tocodynamometer UPC	omparison to	omparison to

		Tocodynamomen IUPC_	Tocodynamome IUPC

Substantial Equivalence Discussi

he EUM 100Pro is viewed as substantially equivalent to the predicate devices becaus

Indications =

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510(k) Summary Page 4 of 5 21-Apr-14

Discussion - This is identical to the predicates, except that the EUM 100Pro does not monitor additional features, i.e., FHR, MHR as does K112390 -- Monica AN24, nor does it connect to other traditional sensors which can be displayed on its screen as does K090145 -- RRT SureCALL® for HR, FHR, IUPC, or TOCO sensors.

Patient Population -

It is intended for use on women who are at term (>36 completed weeks), in labor, with . singleton pregnancies, using surface electrodes on the maternal abdomen Discussion - The patient population is identical to the predicates - K 1 12390 - Monica AN24 and K090145 - RRT SureCALL®

Environment of Use -

For use in clinical settings by trained medical personnel . Discussion -- The environments of use and personal are identical to the predicates -K 112390 - Monica AN24 and K090145 - RRT SureCALL®

Technology -

The use of transabdominal electromyography (EMG) signals to sense uterine activity via . an array of surface electrodes placed on the maternal abdomen.
- Discussion This technology is identical to the predicates K112390 Monica AN24 and K090145 - RRT SureCALL®

Non-clinical Testing Summary -

We have performed a number of tests appropriate for the proposed device. These tests include:

Biocompatibility of Materials -

The only 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.

Electrical, EMC. EMI testing -

We have evaluated the proposed device per IEC 60601-1 and IEC 60601-2-40 and the . device passed the requirements.
Discussion - The proposed device met the requirements of the standards.

Clinical Testing Summary -

The sponsor conducted a clinical study enrolling 43 women at term gestation in active labor who agreed to simultaneous uterine activity monitoring with the EUM 100Pro, tocodynamometry (TOCO), and intrauterine pressure catheter (IUPC). For each study subject, two sets of tracings (one during the first stage and the other during the second stage of labor) consisting of EUM, TOCO, and IUPC were evaluated independently by three physicians who were masked to the technology used to acquire the tracings. Physicians were asked to annotate the tracings above

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510(k) Summary Page 5 of 5 21-Apr-14

each deflection above baseline they considered to be a contraction. They were also asked to indicate the total number of uterine contractions on the tracing as well as to comment on the interpretability of the tracing. The study provided evidence that the EUM 100Pro performed substantially equivalently to the legally marketed predicate devices for detecting and displaying uterine activity in women at term gestation in active labor.

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.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing a globe or sphere, representing the department's mission to protect and promote the health of all Americans.

Public Health Service

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

April 23, 2014

OB Tools Ltd. % Paul E. Dryden President ProMedic, Inc. 24301 Woodsage Drive Bonita Springs, FL 34134

Re: K131889

Trade/Device Name: EUM100Pro (Electro Uterine Monitor) Regulation Number: 21 CFR§ 884.2720 Regulation Name: External uterine contraction monitor and accessories Regulatory Class: II Product Code: OSP Dated: March 20, 2014 Received: March 27, 2014

Dear Paul E. 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 may or subject to additions, 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.

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Page 2 - Paul E. Dryden

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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,

Image /page/6/Picture/6 description: The image shows the name "Herbert P. Lerner -S" in a bold, sans-serif font. The name is written in black ink on a white background. The letters are evenly spaced and the name is easy to read. There is some noise around the "P. Lerner" portion of the name.

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

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K131889

Device Name EUM100Pro (Electro Uterine Monitor)

Indications for Use (Describe)

The EUM100Pro is intended for use on women in term (>36 completed weeks of gestation) 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)

ﺗ

Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

... Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Herbert P. Lerner 2014.04.23 10:

FORM FDA 3881 (9/13)

Regulation Number and Section

§ 884.2720 External uterine contraction monitor and accessories.

(a)
Identification. An external uterine contraction monitor (i.e., the tokodynamometer) is a device used to monitor the progress of labor. It measures the duration, frequency, and relative pressure of uterine contractions with a transducer strapped to the maternal abdomen. This generic type of device may include an external pressure transducer, support straps, and other patient and equipment supports.(b)
Classification. Class II (performance standards).