(169 days)
No
The summary describes a device that acquires and displays physiological signals (EMG and FHR) as graphs, similar to existing non-AI/ML technologies (toco-dynamometer/Doppler). There is no mention of AI, ML, or related concepts like DNNs, image processing, or training/test sets for algorithmic development. The performance study focuses on signal interpretation and accuracy compared to existing methods, not on the performance of an AI/ML algorithm.
No
Explanation: The device is described as an EMG monitor intended to non-invasively measure intrapartum uterine activity and fetal heart rate. Its purpose is to monitor and display data, not to treat a condition or provide therapy.
Yes
The device is described as an "EMG monitor intended to non-invasively measure intrapartum uterine activity and fetal heart rate (FHR)". Measuring these physiological parameters to provide information about the patient's condition falls under the definition of a diagnostic device.
No
The device description explicitly states that the EUM100Pro acquires signals from surface EMG electrodes and is built around an EN 60950 certified computer, indicating the presence of hardware components beyond just software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The EUM100Pro is a transabdominal monitor that measures electrical signals from the body surface (abdomen) using electrodes. It does not analyze blood, urine, tissue, or other samples removed from the patient.
- The intended use is for non-invasive monitoring. The description explicitly states "non-invasively measure intrapartum uterine activity and fetal heart rate (FHR)". IVDs typically involve invasive procedures to obtain samples.
- The device description focuses on signal acquisition and display. It describes acquiring signals from surface electrodes and presenting them as graphs. This is characteristic of a physiological monitoring device, not an IVD.
Therefore, the EUM100Pro falls under the category of a medical device for physiological monitoring, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
HGM, OSP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdomen
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals in a clinical setting.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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
2
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 (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.
| 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 Zone
Yozmot Building
P.O Box 667
2310502 Migdal HaEmek, Israel
Tel – +972-4-6040162
| Fax - +972-4-6040114 | 4-Aug-15 |
|---|---|
| Official Contact: | Dr. Gal Ben-David |
| CEO | |
| 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 monitor |
| OSP - 21CFR 884.2720 | |
| Class II | |
| Perinatal monitoring system and accessories | |
| HGM - 21 CFR 884.2740 | |
| Class II | |
| Predicate Device: | |
| Reference Device: | K101801 - Monica Healthcare - AN24 |
| K131889 – OB Tools EUM 100Pro |
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.
Indications for Use:
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.
4
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 monitor | |
| External Fetal Heart Rate monitor | External uterine contraction monitor | |
| External Fetal Heart Rate monitor | ||
| CFR | 884.2740 / 884.2720 | 884.2740 / 884.2720 |
| Indications for Use | The Monica AN24 is an intrapartum | |
| maternal-fetal monitor that non-invasively | ||
| measures and displays fetal heart rate | ||
| (FHR), uterine activity (UA), and maternal | ||
| heart rate (MHR). The AN24 acquires and | ||
| displays the FHR tracing from abdominal | ||
| surface electrodes that pick up the fetal | ||
| ECG (fECG) signal. Using the same | ||
| surface electrodes, the AN 24 also acquires | ||
| and displays the UA tracing from the | ||
| uterine electromyography (EMG) signal | ||
| and the MHR tracing from the maternal | ||
| ECG signal (mECG). | The EUM100Pro (Electro Uterine Monitor) | |
| is a transabdominal electromyography | ||
| (EMG) monitor intended to non-invasively | ||
| measure intrapartum uterine activity and | ||
| fetal heart rate. The EUM100Pro acquires | ||
| the signal from surface EMG electrodes | ||
| placed on the patient abdomen. | ||
| 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 | The EUM100Pro is intended for use on | |
| women (>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 of | ||
| measuring FHR | External surface EMG electrodes | External surface EMG electrodes |
| Display of | ||
| information | Graphical | Graphical |
| Patient interface | Surface electrodes | Surface electrodes |
| Single patient use, | ||
| disposable | Yes | Yes |
| Contraindications | ||
| and Warnings | None | Patient with implanted electronic devices |
| Open wounds or irritated skin | ||
| Allergies to silver | ||
| Safety Testing | IEC 60601-1 | |
| IEC 60601-1-2 | ||
| IEC 60601-1-2-47 | IEC 60601-1 | |
| IEC 60601-1-2 | ||
| IEC 60601-2-40 | ||
| Clinical Testing for | ||
| Fetal Heart Rate | Comparison to | |
| Fetal scalp electrode (FSE) | Comparison to | |
| Corometric Model 171 (reference device | ||
| K991905) | ||
| Fetal scalp electrode (FSE) |
5
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.
6
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.
7
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 monitor |
| External Fetal Heart Rate monitor | ||
| CFR | 884.2720 | 884.2740 / 884.2720 |
| 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 (Electro Uterine Monitor) | |
| is a transabdominal electromyography | ||
| (EMG) monitor intended to non-invasively | ||
| measure intrapartum uterine activity and fetal | ||
| heart rate. The EUM100Pro acquires the | ||
| signal from surface EMG electrodes placed | ||
| on the patient abdomen. | ||
| Patient population | The EUM100Pro is intended for use on | |
| women (>36 completed weeks of | ||
| gestation) in labor, with singleton | ||
| pregnancies. | The EUM100Pro is intended for use on | |
| women (>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 of | ||
| measuring FHR | External surface EMG electrodes | External surface EMG electrodes |
| Display of | ||
| information | Graphical | Graphical |
| Patient interface | Surface electrodes | Surface electrodes |
| Single patient use, | ||
| disposable | Yes | Yes |
| Contraindications | ||
| and Warnings | Patient with implanted electronic devices | |
| Open wounds or irritated skin | ||
| Allergies to silver | Patient with implanted electronic devices | |
| Open wounds or irritated skin | ||
| Allergies to silver | ||
| Safety Testing | IEC 60601-1 | |
| IEC 60601-1-2 | ||
| IEC 60601-2-40 | IEC 60601-1 | |
| IEC 60601-1-2 | ||
| IEC 60601-2-40 | ||
| Clinical Testing for | ||
| Fetal Heart Rate | N/A | Comparison to |
| Corometrics 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.