EUM 100PRO

K131889 · Promedic, Inc. · OSP · Apr 23, 2014 · Obstetrics/Gynecology

Device Facts

• Record ID: K131889
• Device Name: EUM 100PRO
• Applicant: Promedic, Inc.
• Product Code: OSP · Obstetrics/Gynecology
• Decision Date: Apr 23, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2720
• Device Class: Class 2

Indications for Use

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 Story

EUM100Pro measures intrapartum uterine activity via transabdominal electromyography (EMG). System inputs: electrical signals from surface EMG electrodes placed on maternal abdomen. Components: multi-channel surface EMG sensor, 3D position sensor, and PC for data analysis/recording/GUI. Operation: system senses EMG activity, processes signals, and displays uterine contraction graphs similar to tocodynamometers. Used in clinical settings by trained medical personnel. Output: visual tracing of uterine activity on PC screen. Clinical utility: assists healthcare providers in monitoring labor progress; non-invasive alternative to tocodynamometry or intrauterine pressure catheters (IUPC).

Clinical Evidence

Clinical study enrolled 43 women at term in active labor. Simultaneous monitoring performed with EUM100Pro, tocodynamometry (TOCO), and intrauterine pressure catheter (IUPC). Three blinded physicians independently evaluated two sets of tracings per subject (first and second stage of labor). Physicians annotated contractions and assessed interpretability. Results demonstrated EUM100Pro performed substantially equivalently to predicate devices for detecting and displaying uterine activity.

Technological Characteristics

Transabdominal EMG sensing via surface electrodes. System includes multi-channel EMG sensor, 3D position sensor, and PC. Electrical safety per IEC 60601-1 and IEC 60601-2-40. Biocompatibility: electrodes are off-the-shelf (K990356). Power: mains power with laptop charger. Connectivity: PC-based system.

Indications for Use

Indicated for women at term (>36 weeks gestation) in labor with singleton pregnancies. Contraindicated for patients with implanted electronic devices, open wounds, or irritated skin.

Regulatory Classification

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.

Predicate Devices

• RRT SureCALL® (K090145)
• Monica AN24 (K112390)

Submission Summary (Full Text)

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| Date Prepared: | |
|----------------|--|
|----------------|--|

#### 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 - [phone] Fax - [phone]

| Official Contact: | Dr. Gal Ben-David<br>CEO | 510(k) number | Predicate<br>RRT SureCALL® | Predicate<br>Monica AN24 | Proposed device<br>EUM 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 monitor<br>OSP - CFR 884.2720<br>Class II | Name | External uterine contraction monitor | External uterine contraction monitor<br>External Fetal Heart Rate monitor | |
| Predicate Devices: | K090145 – RRT – SureCALL®<br>K112390 – Monica Healthcare – AN24 | CFR | 884.2740 | 884.2720 | 884.2720 |
| Indications for<br>Use | SureCALL® EMG labor Monitor is<br>a transabdominal electromyography<br>(EMG) monitor intended to measure<br>intrapartum uterine activity. | The Monica AN24 is an intrapartum<br>maternal-fetal monitor that non-invasively<br>measures and displays fetal heart rate<br>(FHR), uterine activity (UA), and maternal<br>heart rate (MHR). The AN24 acquires and<br>displays the FHR tracing from abdominal<br>surface electrodes that pick up the fetal<br>ECG (fECG) signal. Using the same<br>surface electrodes, the AN 24 also acquires<br>and displays the UA tracing from the<br>uterine electromyography (EMG) signal and<br>the MHR tracing from the maternal ECG<br>signal (mECG). | The EUM100Pro (Electro Uterine<br>Monitor) is a transabdominal<br>electromyography (EMG) monitor<br>intended to non-invasively measure<br>intrapartum uterine activity. The<br>EUM100Pro acquires the signal from<br>surface EMG electrodes placed on the<br>patient abdomen. | | |
| Patient population | It is intended for use on women who<br>are at term (>36 completed weeks),<br>in labor, with singleton pregnancies,<br>using surface electrodes on the<br>maternal abdomen | It is intended for use on women who are at<br>term (>36 completed weeks), in labor, with<br>singleton pregnancies, using surface<br>electrodes on the maternal abdomen | It is intended for use on women who are<br>at term (>36 completed weeks), in labor,<br>with singleton pregnancies, using surface<br>electrodes on the maternal abdomen | | |
| Prescriptive<br>Environments of<br>use | Trained medical personnel<br>Clinical settings | Trained medical personnel<br>Clinical settings | Trained medical personnel<br>Clinical settings | | |
| Power source | Mains power with laptop computer<br>charger | 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.

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.

#### Indications for Use:

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.

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K131889
Page 2 of 5

.

510(k) Summary

.

omparison to Predicate

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く131889
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## 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 electrode<br>xternal surface l | xternal surface EMG electrode | xternal surface EMG electrod |
| | | | |
| | | | |
| | Graphica | Graphica | Graphica |
| | | | |
| | કર<br>urface 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 [phone] or [phone] 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 (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.

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)