LaborView LV1000

K142583 · Obmedical Company · OSP · Jan 16, 2015 · Obstetrics/Gynecology

Device Facts

• Record ID: K142583
• Device Name: LaborView LV1000
• Applicant: Obmedical Company
• Product Code: OSP · Obstetrics/Gynecology
• Decision Date: Jan 16, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2720
• Device Class: Class 2

Intended Use

The LaborView LV1000™ Wireless Electrode System is a transabdominal electromyography and electrocardiography intrapartum maternal-fetal sensor. It works non-invasively via surface electrodes on the maternal abdomen with appropriate monitors to measure fetal heart rate (FHR), uterine activity (UA), and maternal heart rate (MHR). It is indicated for use on women who are at >36 completed weeks, in labor, with singleton pregnancies. It is intended for use by a healthcare professional in a clinical setting.

Device Story

LaborView LV1000 is a wireless, non-invasive intrapartum maternal-fetal sensor. It uses an abdominal surface electrode array to capture electromyography (EMG) and electrocardiography (ECG) signals. The system consists of a wireless front-end (digitizes signals), a back-end (processes signals), and a power supply. The back-end performs digital signal processing to derive fetal heart rate (FHR), maternal heart rate (MHR), and uterine activity (UA) curves. These outputs are transmitted via cable to existing perinatal monitors for clinical display and alarm functionality. Used in hospitals, clinics, and doctors' offices by healthcare professionals. The device replaces or supplements traditional ultrasound (for FHR), pulse oximetry (for MHR), and tocodynamometry (for UA). By providing continuous monitoring, it assists clinicians in assessing labor progress and fetal status, potentially reducing the need for invasive monitoring.

Clinical Evidence

Prospective, non-randomized multi-center study (n=107) of term intrapartum patients with IUPC. Evaluated LaborView performance against gold-standard IUPC and standard tocodynamometer (Toco). Primary endpoints: interpretability (PPA of 0.125s epochs), sensitivity (proportion of contractions detected within +/- 30s), and timing accuracy. Results indicated LaborView performed non-inferiorly to Toco for uterine activity measurement. Summative usability study confirmed users could successfully place sensors, interpret device feedback, and remove the array.

Technological Characteristics

Transabdominal EMG/ECG sensing via disposable surface electrode array. Wireless transmission between front-end and back-end. Interfaces with perinatal monitors via analog cables or USB. Power via isolated supply or rechargeable battery. Biocompatibility per ISO 10993-1 (cytotoxicity, sensitization, irritation). Electrical safety per ANSI/AAMI/ES 60601-1; EMC per IEC 60601-1-2.

Indications for Use

Indicated for women >36 weeks gestation, in labor, with singleton pregnancies. Contraindicated for preterm gestation (<36 weeks).

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

• Monica Healthcare - AN24 (K112390)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a human figure, with three faces in profile. The figure is stylized and appears to be in motion.

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

January 16, 2015

OBMedical Company % Paul Dryden Regulatory Consultant ProMedic, Inc. 107 SW 140th Terrace, Suite 1 Newberry, FL 32669

Re: K142583

> Trade/Device Name: LaborView LV1000 Regulation Number: 21 CFR 884.2720 Regulation Name: External uterine contraction monitor and accessories Regulatory Class: Class II Product Codes: OSP, HGM Dated: December 17, 2014 Received: December 18, 2014

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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

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

Sincerely yours,

# Benjamin R. Fisher -A

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)

K142583

Device Name

LaborView LV1000 Indications for Use (Describe)

> The LaborView LV1000™ Wireless Electrode System is a transabdominal electromyography and electrocardiography intrapartum maternal-fetal sensor. It works non-invasively via surface electrodes on the maternal abdomen with appropriate monitors to measure fetal heart rate (FHR), uterine activity (UA), and maternal heart rate (MHR). It is indicated for use on women who are at >36 completed weeks, in labor, with singleton pregnancies. It is intended for use by a healthcare professional in a clinical setting.

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

XX 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)

Page 1 of 2

PSC Publishing Services (301) 443-

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510(k) Summary Page 1 of 7 12-Jan-15

#### Date Prepared:

OBMedical Company 107 SW 140th Terrace, Suite 1 Newberry, FL 32669 Tel - 352.225.3682

| Official Contact: | Suha Jhaveri, COO |
|----------------------------|------------------------------------------------------------------------------------------------------------|
| Proprietary or Trade Name: | LaborView LV1000 |
| Common/Usual Name: | External uterine contraction monitor |
| Classification Name: | OSP - uterine electromyographic monitor (CFR 884.2720)<br>HGM - Perinatal monitoring system (CFR 884.2740) |
| Predicate Devices: | K112390 - Monica Healthcare - AN24 |

#### Device Description:

The LaborView LV1000 is a uterine activity and maternal and fetal heart rate sensor replacement intended to interface to existing perinatal monitors in use in hospital delivery environments.

LaborView is comprised of an electrode array, a wireless front-end ("Front-end"), computational back-end ("Back-end"), a power supply module, and optional adapters to connect to various perinatal monitors. The electrode array is sensitive to changes in electrical characteristics of the skin due to muscle contractions, maternal, and fetal ECG when placed on the expectant mother's abdomen. These signals are passed to LaborView, converted to a contraction curve and maternal heart rate (MHR), and fetal heart rate (FHR), and subsequently passed to the perinatal monitor. Note not all perinatal monitors support input of the MHR.

Labor View includes the hardware and firmware necessary to convert the electrical signals obtained via the electrode array into contraction, MHR, and FHR curves.

Labor View provides analog interfaces to the electrode array and the perinatal monitor but may also interface via USB to a data collection application running on a host PC.

The Front-end mates to the electrode array, digitizes the signals and transmits the signals wirelessly to the Back-end component. The Back-end receives the signals from the Front-end. implements the digital signal processing to create the MHR, FHR and contraction curves, then transmits them via the monitor cable/interface to the existing perinatal monitor.

A variety of connector adapters may exist between the Back-end and the perinatal monitor such that a single Back-end design can interface to a variety of perinatal monitor manufacturers and models.

The LaborView system power is supplied via an isolated power supply or a rechargeable battery pack.

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#### 510(k) Summary Page 2 of 7 12-Jan-15

All of the components of Labor View work together with the perinatal monitor to complete a system that can detect maternal contractions, MHR and FHR during labor. The perinatal monitor, in turn, may interface to a central monitoring system in order to conveniently present contraction information to clinicians.

#### Indications for Use:

Labor View LV1000 Wireless Electrode System is a transabdominal electromyography and electrocardiography intrapartum maternal-fetal sensor. It works non-invasively via surface electrodes on the maternal abdomen with appropriate monitors to measure fetal heart rate (FHR), uterine activity (UA), and maternal heart rate (MHR). It is indicated for use on women who are at >36 completed weeks, in labor, with singleton pregnancies. It is intended for use by a healthcare professional in a clinical setting.

#### Patient Population:

Women (>36 completed weeks of gestation) in labor, with singleton pregnancies.

#### Contraindications:

LaborView is contraindicated for use in preterm gestation (<36 completed weeks).

Labor View may display deflections from baseline that do not represent uterine contractions. These deflections from baseline may represent electrical activity in the myometrium that is not sufficiently organized to cause the uterine smooth muscle to contract. In the context of a preterm pregnancy, clinical misinterpretation of the uterine tracing may lead to unnecessary intervention, such as tocolysis, diagnostic procedures, and/or preterm delivery.

#### Environments of Use:

Hospitals, clinics, and doctors' offices

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#### 510(k) Summary

## Page 3 of 7

#### 12-Jan-15

#### Table 5.1 - Table of the Similarities and Differences of Predicate vs. Proposed Device

| | Predicate<br>Monica AN24 (K112390) | Proposed device<br>LaborView LV1000 |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Monica AN24 is an intrapartum maternal-fetal monitor<br>that non-invasively measures and displays fetal heart rate<br>(FHR), uterine activity (UA), and maternal heart rate (MHR).<br>The AN24 acquires and displays the FHR tracing from<br>abdominal surface electrodes that pick up the fetal ECG<br>(fECG) signal. Using the same surface electrodes, the AN 24<br>also acquires and displays the UA tracing from the uterine<br>electromyography (EMG) signal and the MHR tracing from<br>the maternal ECG signal (mECG). | The LaborView LV1000™ Wireless Electrode System is a<br>transabdominal electromyography and electrocardiography<br>intrapartum maternal-fetal sensor. It works non-invasively via<br>surface electrodes on the maternal abdomen with appropriate<br>monitors to measure fetal heart rate (FHR), uterine activity<br>(UA) and maternal heart rate (MHR). It is indicated for use on<br>women who are at >36 completed weeks, in labor, with<br>singleton pregnancies. It is intended for use by a healthcare<br>professional in a clinical setting. |
| Patient population | It is intended for use on women who are at term (>36<br>completed weeks), in labor, with singleton pregnancies, using<br>surface electrodes on the maternal abdomen | It is intended for use on women who are at term (>36<br>completed weeks), in labor, with singleton pregnancies, using<br>surface electrodes on the maternal abdomen |
| Prescriptive | Trained medical personnel | Trained medical personnel |
| Environments of use | Clinical settings | Clinical settings |
| Data collected from<br>sensor array | Uterine Activity (UA)<br>Fetal Heart rate (FHR)<br>Maternal Heart rate (MHR) | Uterine Activity (UA)<br>Fetal Heart rate (FHR)<br>Maternal Heart rate (MHR) |
| Components of the<br>"system" | Electrodes placed on abdomen<br>Cable<br>Monitor to process and display data | Electrodes placed on abdomen (an array)<br>Front-end wirelessly transmit data to receiver<br>Back-end receiver connects to cleared perinatal monitor<br>Monitor to process and display data*<br>* The LaborView does not include the perinatal monitor |
| Technology<br>employed | Transabdominal electromyography and electrocardiography<br>signals | Transabdominal electromyography and electrocardiography<br>signals |
| Information<br>displayed | On graphical monitor | On graphical monitor*<br>*Labor View is utilizing the existing monitor to display the<br>information |

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# 510(k) Summary

| | Predicate | Proposed device |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Monica AN24 (K112390) | LaborView LV1000 |
| Patient interface | Surface electrodes - Single patient use, disposable | Surface electrodes (array) - Single patient use, disposable |
| Contraindications | Contraindicated for use in preterm gestation (<36 completed<br>weeks). | Contraindicated for use in preterm gestation (<36 completed<br>weeks). |
| | May display deflections from baseline that do not represent<br>uterine contractions. These deflections from baseline may<br>represent electrical activity in the myometrium that is not<br>sufficiently organized to cause the uterine smooth muscle to<br>contract. | May display deflections from baseline that do not represent<br>uterine contractions. These deflections from baseline may<br>represent electrical activity in the myometrium that is not<br>sufficiently organized to cause the uterine smooth muscle to<br>contract. |
| | In the context of a preterm pregnancy, clinical<br>misinterpretation of the uterine tracing may lead to<br>unnecessary intervention, such as tocolysis, diagnostic<br>procedures, and/or preterm delivery. | In the context of a preterm pregnancy, clinical<br>misinterpretation of the uterine tracing may lead to<br>unnecessary intervention, such as tocolysis, diagnostic<br>procedures, and/or preterm delivery. |
| Clinical | Comparison to | Comparison to |
| performance | Tocodynamometer and IUPC for Uterine activity | Tocodynamometer and IUPC for Uterine activity |
| | Comparison to pulse oximeter for Maternal Heart Rate | Comparison to<br>Fetal Scalp Electrode (FSE) for Fetal Heart Rate |
| | | Maternal heart rate – ANSI / AAMI EC13 simulation |
| Biocompatibility | ISO 10993 | ISO 10993-1 for patient contacting materials |
| ISO 10993-1 | | Surface Contact, Skin, Limited duration of use (<24 hours) |
| | | Cytotoxicity, Sensitization, Irritation |
| Electrical / EMC / | IEC 60601-1 | ANSI/AAMI/ES 60601-1 |
| EMI | IEC 60601-1-2 | IEC 60601-1-2 |
| | IEC 60601-1-2-47 | |

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#### 510(k) Summary Page 5 of 7 12-Jan-15

#### Substantial Equivalence Discussion

The LaborView is viewed as substantially equivalent to the predicate devices because:

#### Indications -

- The LaborView is indicated for as a transabdominal electromyography (EMG) monitor ● intended to measure intrapartum uterine activity (UA), Fetal heart rate (FHR), and Maternal heart rate (MHR).
- Discussion - This is identical to the predicate K112390 - Monica AN2.

#### 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 predicate - K112390 - 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 K112390 - Monica AN24.

#### Technology -

- The use of transabdominal electromyography (EMG) signals to sense uterine activity, ● fetal heart rate, and maternal heart rate via an array of surface electrodes placed on the maternal abdomen.
- . The Labor View is only a sensor that sensing and transmits the signals to a standard perinatal monitor. It utilizes the existing GE Corometrics perinatal monitors for display and alarm functionality.
- Discussion - This technology is identical to the predicate K112390 - Monica AN24. The difference is that the LaborView is connected to a standard perinatal monitor that displays the data and has alarms. The Labor View is replacing or supplementing ultrasound for FHR; pulse oximeter for MHR; and Toco for uterine activity (UA). The Labor View plus an existing perinatal monitor create a total system equivalent to the predicate. This configuration has been demonstrated to be substantially equivalent and any difference does not raise any new safety risks that could not be confirmed through verification and validation testing.

#### Non-clinical Testing Summary -

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

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#### 510(k) Summary Page 6 of 7 12-Jan-15

#### Biocompatibility of Materials -

- . The only materials in contact with the patient are the electrodes. We have performed ISO 10993-1 testing as Surface Contact, Skin, Limited duration of use: cytotoxicity, sensitization, and irritation.
- Discussion The materials have been found to be non-reactive per ISO 10993-1 testing. ●

#### Electrical, EMC, EMI testing -

- We have evaluated the proposed device per ANSI/AAMI/ES 60601-1 and IEC 60601-1-. 2, and Wireless Coexistence and the device performed as intended meeting the requirements.
- . Discussion - The proposed device met the requirements of the standards and is considered safe.

#### Bench testing -

- Bench testing was performed to verify the performance to specifications of the proposed . device. In addition, Labor View was tested to ANSI/AAMI EC13 for verification for Maternal Heart Rate (MHR).
- . Discussion - The proposed device was tested to assure that it meets its performance specifications. Upon completion of the tests, it was found to meet its performance requirements.

#### Clinical Testing Summary -

#### Usability –

We performed a summative usability study with potential users. Participants used the instructions to complete a series of tasks to evaluate the sensor array placement, device feedback interpretation (i.e., what to do in the case of icons lighting up on the transmitter), and sensor array removal. All participants were able to complete all tasks successfully.

#### Comparative Clinical Testing -

#### Measurement of Uterine Activity

A prospective, non-randomized multi-center study enrolling intrapartum patients at term gestation in whom an intrauterine pressure catheter (IUPC) had been placed. Total enrollment was 107 subjects.

The purpose of the study was to evaluate the performance of the Labor View System in a series of term deliveries. The Labor View was compared to standard external sensors [tocodynamometer (Toco) for UA] relative to the gold standard internal sensors [IUPC].

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#### 510(k) Summary Page 7 of 7 12-Jan-15

#### Primary Endpoints:

- . For interpretability, a positive percent agreement (PPA) was calculated for each patient. LaborView (or Toco) uterine activity vs. IUPC gold standard was organized into a 2x2 table representing interpretable and uninterpretable data. PPA was defined as the percent of 0.125 second epochs with interpretable IUPC (gold standard data) that are also interpretable by the LaborView or Toco.
- . For sensitivity, the individual contractions identified by LaborView or toco and the IUPC gold standard vs. those detected only by the IUPC was tabulated. The proportion of contractions detected within +/- 30 seconds by Labor View or Toco was calculated.
- For timing accuracy, the difference in timing of corresponding contractions between the IUPC gold standard and the LaborView (or Toco) was calculated.

All three of the above endpoints were tested using non-inferiority hypotheses.

The results of the study indicated that the Labor View device performed as well as Toco for measuring uterine activity.

#### Substantial Equivalence Conclusion:

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